Dikloberl 75 mg / 3 ml 5's solution for injection in ampoules
- $11.50
The instruction for medical use
of Dikloberl medicine N 75
the Trade name
of Dikloberl N 75
the International unlicensed
name Diclofenac Dosage Form Solution for injections of 75 mg / 3мл
Structure
contains In one ampoule:
active agent – diclofenac of sodium, 75 mg
excipients: propylene glycol, benzyl alcohol, Acetylcysteinum, Mannitolum, 1 M hydroxide sodium solution, water for injections
the Description
Transparent colourless or almost colourless solution without visible particles
Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs.
Non-steroidal anti-inflammatory drugs. Acetic acid derivatives. Diclofenac.
The ATX M01AB05 code
the Pharmacological
Pharmacokinetics Later properties of intramuscular administration of drug the maximum concentration about 2.5 mkg/ml (8 µmol/l), in plasma is reached in 10 – 20 minutes, after rectal administration - approximately in 30 minutes.
Right after its achievement the fast decrease in concentration of drug in plasma is observed. The amount of the soaking-up active agent is in linear dependence on drug dose size. Area size under a curve concentration time (AUC) after intramuscular introduction of Dikloberl is approximately twice more, than after its oral or rectal administration as in the last cases about a half of amount of diclofenac is metabolized at the first passing through a liver.
After repeated use of drug the pharmacokinetic indicators do not change. On condition of observance of the recommended intervals between administrations of drug of cumulation it is not noted.
Linking with serum proteins makes 99.7%, it happens, mainly to albumine (99.4%). The approximate volume of distribution is 0.12-0.17 l/kg.
Diclofenac gets into synovial fluid where its maximum concentration is reached at 2-4 o'clock later, than in blood plasma. Approximate elimination half-life makes 3-6 hours of synovial fluid. In 2 hours after achievement of the maximum concentration in plasma the concentration of diclofenac in synovial fluid is higher, than in plasma, and its values remain higher till 12 o'clock.
Metabolism of diclofenac is carried out partially by a glyukuronization of not changed molecule, but, mainly, by means of a single and repeated metoksilirovaniye that leads to formation of several phenolic metabolites (3 '-hydroxy, 4' - hydroxy, 5 '-hydroxy, 4', 5-digidroksi- and 3 '-hydroxies-4 '-metoksidiklofenaka), the majority of which turns into glyukuronidny conjugates. Two of these phenolic a metabolite are biologically active, but in much smaller degree, than diclofenac.
The general system plasma clearance of diclofenac is 263±56 ml/min. Final elimination half-life makes 1-2 hours. Elimination half-life of 4 metabolites, including two pharmacological active, is also short and makes 1-3 hours. One of metabolites, 3 '-hydroxies-4 '-metoksi-diclofenac, has longer elimination half-life, however this metabolite is completely inactive.
About 30% of active ingredient are allocated in the form of metabolites with a stake.
After metabolic transformations in a liver (hydroxylation and conjugation) of about 70% of active ingredient it is removed through kidneys in the form of pharmacological inactive metabolites.
The pharmacokinetics at separate groups of patients
At some patients of advanced age 15-minute intravenous infusion resulted in concentration, higher for 50%, in plasma, than it was observed at young healthy faces.
At patients with a renal failure when assigning DikloberlN 75 in usual single doses of accumulation of diclofenac it was not noted. However eventually metabolites are removed with bile.
At patients with chronic hepatitis or the compensated cirrhosis the indicators of pharmacokinetics of diclofenac are similar to that at patients without liver diseases.
The pharmacodynamics
DikloberlN 75 contains sodium diclofenac, the substance of nonsteroid structure rendering the significant anti-inflammatory, analgetic and febrifugal action. Slowing down of biosynthesis of prostaglandins is considered the main mechanism of effect of diclofenac. Prostaglandins play an important role in genesis of inflammation, pain and fever.
In rheumatic diseases the protivospalitelny and analgetic DikloberlN 75 properties provide the clinical effect which is characterized by considerable reduction of expressiveness of such symptoms and complaints as pain at rest and at the movement, morning constraint and a swelling of joints and also function improvement.
Diclofenac of sodium does not suppress biosynthesis of proteoglycans of cartilaginous tissue.
The considerable analgetic effect of drug at a moderate and severe pain syndrome of not rheumatic genesis is revealed. DikloberlN 75 it is capable to eliminate pain at primary dysmenorrhea.
Diclofenac is non-steroidal anti-inflammatory drug which efficiency was proved in not clinical trials, the mechanism of effect of drug consists in prostaglandin synthesis suppression. Diclofenac reduces the pains, hypostases and the increased temperature caused by inflammatory process. Besides, diclofenac suppresses the aggregation of thrombocytes caused by ADF and collagen.
Indications
Symptomatic treatment in the profound acute pain accompanying:
- acute arthritis (including a gout attack)
- chronic arthritis, in particular a pseudorheumatism (chronic polyarthritis)
- an ankylosing spondylitis (Bekhterev's disease) and other inflammatory diseases of a backbone of the rheumatic nature
- the irritation phenomenon in degenerative diseases of joints and a backbone (arthrosis and a spondylarthrosis)
- inflammatory diseases of soft tissues of the rheumatic nature
- hypostases or posttraumatic inflammation with a pain syndrome
the Note:
Solution for injections is shown only in case especially fast effect is required and also if intake or introduction are not presented in the form of a candle by possible. In such cases, as a rule, treatment is recommended to be carried out only in the form of a single injection - within initial therapy.
Route of administration and doses
Adult:
The injection of Dikloberla® N 75 is carried out once. For continuation of treatment use dosage forms for oral or rectal administration. At the same time, even in day of an injection, the total dose should not exceed 150 mg.
The way and duration of use
of Dikloberl® N 75 enter in oil deeply into the area of a buttock.
Due to the potential risk of development of anaphylactic reactions (up to shock) the patient after introduction of Dikloberla® N 75 should be under observation not less than an hour, at the same time the necessary for rendering emergency aid and serviceable (functioning) medical tools have to be on call. The patient needs to explain the meaning of these measures.
Usually injections of drug are appointed for a period of 1 up to 5 days. Duration of use of drug is defined by the attending physician.
Special groups of patients
Patients of advanced age:
Special dose adjustment is not required. In case of elderly patients more careful control of their state because of possible side effects is necessary.
Depression of function of kidneys and liver:
At depression of function of kidneys and a liver of easy and average extent of reduction of a dose it is not required (recommendations for patients with a heavy renal failure).
Side effects
Very often (≥ 1/10)
- gastrointestinal complaints, such as nausea, vomiting and diarrhea and also insignificant gastrointestinal bleedings, in rare instances with development of anemia
it is frequent (³ 1/100 - & lt, 1/10)
- pseudo anaphylactic reactions
- reactions of hypersensitivity, such as skin rash and itching
- disturbances from the central nervous system, such as headache, dizziness, oglushennost, excitement, irritability or fatigue
- the dispeptitchesky phenomena, a meteorism, gripes in a stomach, lack of appetite and also gastrointestinal ulcers (with risk of bleeding and perforation)
- increase in activity of transaminases in blood serum
- reactions in the place of an injection, pain in the place of an injection, an induration in the place of an injection
- a liquid delay
Sometimes (³ 1/1,000 - & lt, 1/100)
- urticaria
- a hematemesis, a melena or a bloody diarrhea.
- an abnormal liver function, especially at long therapy, an acute hepatitis with jaundice or without it (lightning hepatitis even without the previous symptoms is in rare instances possible).
Therefore at long-term treatment it is regularly necessary to carry out by drug the analysis of hepatic indicators.
- an alopecia
- developing of hypostases, especially at patients with arterial hypertension or a renal failure
Seldom: (³ 1/10,000 - & lt, 1/1,000)
- hypostasis, necrosis in the place of an injection
- reactions of hypersensitivity to benzyl alcohol meet
seldom Very seldom (& lt, 1/10,000), including isolated cases
- abscess in the place of an injection
- hemopoiesis disturbances (anemia, a leukopenia, thrombocytopenia, a pancytopenia, an agranulocytosis), hemolytic anemia.
- heavy generalized reactions of hypersensitivity: a Quincke's edema (a face edema, a paraglossa, hypostasis internal throats with narrowing of airways, short wind, increase of heart rate, a lowering of arterial pressure, falling of arterial blood pressure to critical level).
- an allergic vasculitis and a pneumonitis
- psychotic reactions, a depression, feeling of alarm, dreadful dreams
- touch disorders, disturbances of flavoring perception, memory, a disorientation, spasms, a tremor
- mental disorders, such as memory disturbance
- a disorder of vision (blurring of sight or a diplopia)
- sonitus, passing disorders of hearing
- heartbeat, hypostases, heart failure, a myocardial infarction
- an arterial hypertension
- an acute disorder of cerebral circulation
- stomatitis, a glossitis, damages of a gullet, the complaint to pain in the lower part of a stomach (for example, bleeding in colitis or aggravation of nonspecific ulcer colitis / Crohn's disease), a constipation, pancreatitis, diafragmopodobny strictures of intestines.
- a dieback, eczema, a multiformny erythema, a photosensitization, a purpura (including an allergic purpura), such bullous reactions as Stephens-Johnson's syndrome and a toxic epidermal necrolysis
- defeat of tissue of kidneys (interstitial nephrite, papillary necrosis) which can be followed by an acute renal failure, a proteinuria and/or a hamaturia, a nephrotic syndrome
- aggravation of inflammatory processes of infectious origin (for example, development of a necrotizing fasciitis), connected with system use of non-steroidal anti-inflammatory drugs. Perhaps, it is connected with the mechanism of action of NPVP.
- symptoms of aseptic meningitis, such as muscle tension of a nape, headache, nausea, vomiting, temperature increase or turbidity of consciousness. Patients with autoimmune diseases are predisposed to emergence of such states (a system lupus erythematosus, mixed collagenoses).
Contraindications
of Dikloberl® N 75 should not be applied in the following cases:
- hypersensitivity to active ingredient or one of other components of drug
- in the presence in the anamnesis of a bronchospasm, asthma, rhinitis or urticaria after intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- at disturbances of a hemopoiesis of the obscure origin, disturbance of a hemostasis and fibrillation
- treatment of postoperative pain after operation of coronary shunting (or uses of the cardiopulmonary bypass)
- inflammatory bowel diseases (Crohn's disease or ulcer colitis)
- in the presence in the present or in the past of a recurrent round ulcer / hemorrhages (two or more separate cases of the confirmed peptic ulcer or bleedings)
- in the presence in the anamnesis of gastrointestinal bleeding or perforation of an ulcer connected with intake of non-steroidal anti-inflammatory drugs
- fresh cerebrovascular or other bleedings
- the established stagnant heart failure (class II-IV NYHA), coronary heart disease, diseases of peripheral arteries or vessels of a brain
- an abnormal liver function or kidneys of heavy degree
- heart failure of heavy degree
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years
Medicinal interactions
Other NPVP, including salicylates:
The accompanying use of some NPVP can increase risk of developing of ulcers and gastrointestinal bleeding owing to synergy effect of drugs. In this regard combined use of diclofenac and other NPVP is not recommended.
Digoxin, Phenytoinum, lithium:
At joint introduction of Dikloberl® N 75 can increase concentration of digoxin, Phenytoinum and lithium in blood. In this regard at treatment by diclofenac control of serumal concentration of lithium is obligatory, and digoxin or Phenytoinum - is recommended.
Diuretics, APF inhibitors and antagonists of angiotensin II:
NPVP can reduce efficiency of diuretics and other antihypertensive drugs (such as beta-blockers, inhibitors of the angiotensin-converting enzyme (ACE)). At some patients with reduced renal function (e.g., in dehydration or at elderly patients with the lowered function of kidneys) at intake of APF inhibitors or antagonists of angiotensin II together with the drug inhibiting cyclooxygenase, perhaps further deterioration in renal function including possible development of an acute renal failure which, however, in most cases has reversible character. In this regard it is necessary to appoint the specified drugs with care in combination with diclofenac, especially at elderly patients. At joint administration of diclofenac and these drugs it is necessary to watch that the patient accepted adequate amount of liquid and also it is necessary - after an initiation of treatment - to control function of kidneys regularly.
The accompanying use of Диклоберла® 75 and kaliysberegayushchy diuretics can lead to development of a hyperpotassemia. In this regard it is recommended to control potassium concentration in blood at joint administration of the specified drugs.
Glucocorticoids:
At joint introduction with diclofenac the risk of developing ulcers and gastrointestinal bleeding increases.
The drugs suppressing aggregation of thrombocytes (for example, acetylsalicylic acid), and selective serotonin reuptake inhibitors (SSRI):
At joint introduction with diclofenac the risk of gastrointestinal bleeding increases.
Antidiabetic drugs:
Clinical trials showed that diclofenac can be applied together with oral antidiabetic drugs, without influencing their action. Nevertheless, there are separate messages about the hypoglycemic and hyper glycemic phenomena which demanded dose adjustment of antidiabetic drugs during treatment by diclofenac. For this reason, as a precautionary measure, at simultaneous use of these drugs it is recommended to carry out regular control of level of glucose to blood.
Methotrexate:
Diclofenac is capable to suppress renal clearance of a methotrexate that leads to increase in its level. At introduction of Dikloberla® N 75 during 24 h to or after introduction of a methotrexate the increase in concentration of a methotrexate in blood and strengthening of its toxic effects is possible.
Cyclosporine:
NPVP (e.g., sodium diclofenac) can strengthen nephrotoxic effect of cyclosporine.
Antibiotics of a hinolonovy row:
It was reported about isolated cases of appearance of spasms which could be caused by simultaneous use of hinolon with NPVS.
Anticoagulants:
NPVP can strengthen effect of anticoagulants, such as warfarin
Sulphonylurea:
There are separate messages about the changes of concentration of glucose in blood after use of diclofenac which demanded dose adjustment of antidiabetic drug. In this regard at joint therapy it is recommended to control concentration of glucose in blood.
Probenetsid and Sulfinpyrazonum:
The medicines containing probenetsid and Sulfinpyrazonum, can delay removal of diclofenac from an organism.
Kolestipol and holestiramin:
These drugs are capable to cause decrease or delay of absorption of diclofenac. For this reason it is recommended to appoint diclofenac, at least, for an hour before reception kolestipola/a holestiramina or 4-6 hours later after it.
Strong CYP2C9 inhibitors:
It is necessary to appoint with care diclofenac along with strong CYP2C9 inhibitors (as, for example Sulfinpyrazonum and vorikonazol) as at their concomitant use the increase in peak concentration of diclofenac in plasma and strengthening of its action in connection with delay of his metabolism is possible.
Special indications
of the Precautionary measure concerning digestive tract
It is necessary to avoid use of the drug Dikloberl® N 75 along with other NPVP, including selection inhibitors of cyclooxygenase-2.
Undesirable effects can be reduced to a minimum by purpose of the smallest effective dose during the smallest period necessary for effective control of pain (gastrointestinal and cardiovascular risks are lower)
Patients of advanced age
At patients of advanced age the frequency of undesirable reactions to NPVP, especially gastrointestinal bleedings and perforation including from the death is increased.
Gastrointestinal bleeding, an ulcer and perforation of an ulcer
Gastrointestinal bleeding, ulceration or perforation, in certain cases and from the death, were noted for all NPVP at any stages of treatment, with or without symptoms harbingers and irrespective of existence or absence in the anamnesis of serious pathology of a GIT.
The risk of gastrointestinal bleeding, development of an ulcer or perforation increases with increase in a dose of non-steroidal anti-inflammatory drug at patients with presence of the ulcer in the anamnesis which is especially complicated by bleeding or perforation. In such cases the treatment should be begun with the smallest possible dose.
For these patients and also for the patients receiving low doses of aspirin or other drugs which increase risk of the undesirable phenomena from a GIT it is necessary to consider the possibility of use of combination therapy using the medicines possessing protective action concerning a GIT (for example, a mizoprostol or inhibitors of the proton pump).
Patients at whom in the anamnesis the toxic phenomena from a GIT took place in particular patients of advanced age, have to report about any unusual symptoms from abdominal organs (especially about gastrointestinal bleedings), it has the greatest value for the initial stages of treatment. The patient needs to be instructed that if at appearance of severe pain in an upper part of a stomach, melenas or vomitings it is necessary to stop immediately intake of medicine and to see a doctor (see side effects).
It is necessary to appoint with care diclofenac to the patients who are at the same time taking the drugs which can increase risk of developing of an ulcer or bleeding oral corticosteroids, anticoagulants, for example, the warfarin, selective serotonin reuptake inhibitors or means suppressing aggregation of thrombocytes (antiagregant), e.g. aspirin belong to such drugs.
At development of gastrointestinal bleeding against the background of treatment of Dikloberlom® N 75, drug should be cancelled.
Patients should appoint non-steroidal anti-inflammatory drugs with care with digestive tract diseases in the anamnesis (nonspecific ulcer colitis, Crohn's disease) in connection with risk of their aggravation.
Diclofenac patients should appoint effects from a cardiovascular system and cerebrovascular blood circulation with care with arterial hypertension and/or dekompensirovanny heart failure from easy to moderate severity in the anamnesis as at treatment of NPVP the delay of liquid and development of hypostases are possible.
According to results of clinical trials and epidemiological data, diclofenac use, especially in high doses (150 mg/days) and for a long time, can be followed by small increase in risk of arterial thromboses (for example, a myocardial infarction or a stroke).
For minimization of the cardiovascular risks connected with dosing and duration of treatment by diclofenac, drug should be used in minimum effective dose during the short period. It is necessary to carry out periodically the repeated assessment of need of patients for relief of symptoms and reaction to therapy.
Patients with uncontrollable arterial hypertension, the stagnant heart failure established by coronary heart disease, a disease of peripheral arteries or vessels of a brain diclofenac should appoint after careful survey.
Patients with considerable risk factors of developing cardiovascular diseases (for example, arterial hypertension, a lipidemia, diabetes, smoking) it is possible to treat diclofenac only after careful survey.
Skin reactions
It was reported about exceptional cases of serious skin reactions, sometimes with a lethal outcome, including exfoliative dermatitis, Stephens-Johnson's syndrome and a toxic epidermal necrolysis (Lyell's disease), against the background of treatment of NPVP. The risk of such reactions is highest in an initiation of treatment, the majority of the described phenomena were observed in the first months of therapy. Диклоберл® N 75 has to be cancelled at the first appearance of skin rash, damage of mucous or other signs of hypersensitivity.
Diclofenac patients should appoint effects from a liver with care with an abnormal liver function as against the background of treatment their state can worsen. At emergence of clinical signs of pathology of a liver, drug needs to be cancelled.
Other instructions
For prevention of damage of renal fabric it is necessary to check a condition of function of kidneys regularly.
Appearance of fever, sore throat, superficial wounds in an oral cavity, grippopodobny symptoms, the significant fatigue, nasal bleedings and skin hemorrhages can be the first signs of disturbance of a hemopoiesis (see side effects). At long-term treatment the regular blood test is necessary.
In the following cases of Dikloberl® N 75 it is necessary to appoint only after careful assessment of a ratio advantage risk:
- at congenital disturbances of exchange of porphyrine (for example, at the sharp alternating porphyria),
- at the system lupus erythematosus (SLE) and the mixed collagenoses.
In the following cases especially careful control from the attending physician is necessary:
- at disturbances from digestive tract or in the presence in the anamnesis of chronic inflammatory bowel diseases (nonspecific ulcer colitis, Crohn's disease),
- at the increased arterial blood pressure or heart failure,
- at depression of function of kidneys
- in an abnormal liver function
- right after extensive surgical intervention
- in an allergy to pollen, polyps in a nose and chronic obstructive respiratory diseases as at such patients the risk of emergence of allergic reactions is increased. These reactions can be shown by asthma attacks (so-called analgetikovy asthma), a Quincke's edema or urtikarny rash.
- in an allergy to other substances as at such patients the risk of reactions of hypersensitivity including at treatment of Dikloberlom® N 75 is increased.
Диклоберл® N 75 should not be entered into the center of inflammation or an infection.
Heavy acute reactions of hypersensitivity were very seldom observed (for example, an acute anaphylaxis). At emergence of the first signs of reaction of hypersensitivity of Dikloberl® N 75 it has to be cancelled, and professional treatment according to the developed symptomatology is begun.
For safety reasons at treatment of patients of advanced age it is necessary to show care. In particular, to the weakened patients of advanced age and patients with body underweight drug is appointed in a minimal effective dose.
Diclofenac can temporarily suppress aggregation of thrombocytes. In this regard it is necessary to control a condition of patients with disturbances of blood clotting.
As well as other NPVP, owing to the pharmakodinamichesky properties, diclofenac is capable to mask manifestations and symptomatology of an infection.
For prevention of aggravation of inflammation of the infectious nature which can be connected with the mechanism of effect of non-steroidal anti-inflammatory drugs the patient is recommended to see immediately a doctor if against the background of treatment Диклоберлом® 75 infection symptoms arose again or were aggravated (see side effects).
At long-term treatment by diclofenac it is regularly necessary to check function of a liver, kidneys and the general blood test.
At prolonged use of soothing drugs the developing of a headache is possible. It is not necessary to try to eliminate a headache by increase in a dose of drug.
At prolonged use of sedatives, especially at a combination of several anesthetics of active ingredients, injury of kidneys of steady character with risk of developing of a renal failure (analgetikovy nephropathy) is possible.
At a combination of NPVP and alcohol strengthening of undesirable effects of active ingredient of drug, especially on digestive tract or the central nervous system is possible.
In cases of parenteral administration of diclofenac the patients with bronchial asthma should show extra care as the probability of increase of symptomatology of a disease is not excluded.
Pregnancy and a lactation
Pregnancy
Suppression of synthesis of prostaglandin can adversely influence pregnancy and/or development of an embryo/fruit. According to results of epidemiological researches, in the early stages of pregnancy the use of the drugs suppressing prostaglandin synthesis can increase risk of a misbirth, emergence at a fruit of heart disease and not fusion of an anterior abdominal wall. So, the absolute risk of forming of defects of a cardiovascular system increased from & lt, 1% up to about 1.5%. It is considered that the risk of the specified phenomena increases with increase in a dose of drug and duration of its use.
Prescribing of diclofenac during the first and second trimester of pregnancy is possible only when in it there is an imperative need. In case of prescribing of diclofenac the women planning pregnancy or in the first and second trimester of pregnancy should choose the smallest possible dose and the smallest possible duration of treatment.
In the third trimester of pregnancy all inhibitors of synthesis of prostaglandin can lead to development in a fruit:
- the phenomena of cardiopulmonary toxicity (e.g., premature closing of an arterial channel and hypertensia in the system of a pulmonary artery),
- dysfunctions of kidneys which can progress up to a renal failure with development of an oligoamnios
at the end of pregnancy can bring at mother and a fruit to:
- to lengthening of a bleeding time, anti-aggregation effect which can arise even at use of very low doses of drug,
- to suppression of sokratitelny uterine activity that can lead to delay or delay in patrimonial activity.
A lactation
Active ingredient diclofenac and products of its disintegration in small amounts get to mother's milk.
The fertility
Диклоберл® 75 can reduce female fertility and therefore the women planning pregnancy are not recommended to appoint it. At the women who are experiencing difficulties with conception or undergoing inspection regarding infertility it is necessary to consider the possibility of cancellation of Dikloberla® N 75.
Features of influence of medicine on ability to driving of vehicles and to service by potentially dangerous mechanisms
At treatment of Dikloberlom® N 75 in high doses such side effects from the central nervous system can take place as increased fatigue and dizziness therefore in certain cases at patients the disturbance of reaction and deterioration in ability to active participation in traffic and to service of mechanisms is possible. The specified phenomena amplify at a drug combination to alcohol intake.
Note:
The propylene glycol which is a part of the drug Dikloberl® N 75 can cause the symptoms similar to that, arising after alcohol intake.
Overdose
Symptoms: the overdose of diclofenac can be shown by disorders from the central nervous system, such as headache, dizziness, oglushennost and loss of consciousness (and at children even with myoclonic spasms) and also abdominal pain, nausea and vomiting. Besides, perhaps gastrointestinal bleeding and also abnormal liver function and kidneys. Also at overdose of diclofenac the arterial hypotonia, respiratory depression and cyanosis can be observed.
Symptomatic treatment: there is no specific antidote.
A form of release and packing
On 3 ml in ampoules of colourless glass of I type.
On 5 ampoules together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
Storage conditions
Drug should be stored at a temperature not above 30 °C. For protection against light influence to store drug in original packing.
To store out of children's reach!
A period of storage
3 years
not to apply after an expiration date
Prescription status
According to the prescription
Proizvoditel Berlin-Hemi AG (Menarini Group) Gliniker Weg 125 12489 Berlin
the Owner of the registration certificate and
the Gliniker Veg Berlin-Hemi AG producer (Menarini Group) 125 12489 Berlin Organization Packer A. Menarini Manyufekchering Logistics and Services of Neuter of l., Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers concerning quality of products (goods):
Representative of Berlin-Hemi AG in the Republic of Kazakhstan
ph. +7 727 2446183, 2446184, 2446185
fax: +7 727 2446180
e-mail:
To Develop Kazakhstan@berlin-chemie.com
of Dikloberl medicine N 75
the Trade name
of Dikloberl N 75
the International unlicensed
name Diclofenac Dosage Form Solution for injections of 75 mg / 3мл
Structure
contains In one ampoule:
active agent – diclofenac of sodium, 75 mg
excipients: propylene glycol, benzyl alcohol, Acetylcysteinum, Mannitolum, 1 M hydroxide sodium solution, water for injections
the Description
Transparent colourless or almost colourless solution without visible particles
Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs.
Non-steroidal anti-inflammatory drugs. Acetic acid derivatives. Diclofenac.
The ATX M01AB05 code
the Pharmacological
Pharmacokinetics Later properties of intramuscular administration of drug the maximum concentration about 2.5 mkg/ml (8 µmol/l), in plasma is reached in 10 – 20 minutes, after rectal administration - approximately in 30 minutes.
Right after its achievement the fast decrease in concentration of drug in plasma is observed. The amount of the soaking-up active agent is in linear dependence on drug dose size. Area size under a curve concentration time (AUC) after intramuscular introduction of Dikloberl is approximately twice more, than after its oral or rectal administration as in the last cases about a half of amount of diclofenac is metabolized at the first passing through a liver.
After repeated use of drug the pharmacokinetic indicators do not change. On condition of observance of the recommended intervals between administrations of drug of cumulation it is not noted.
Linking with serum proteins makes 99.7%, it happens, mainly to albumine (99.4%). The approximate volume of distribution is 0.12-0.17 l/kg.
Diclofenac gets into synovial fluid where its maximum concentration is reached at 2-4 o'clock later, than in blood plasma. Approximate elimination half-life makes 3-6 hours of synovial fluid. In 2 hours after achievement of the maximum concentration in plasma the concentration of diclofenac in synovial fluid is higher, than in plasma, and its values remain higher till 12 o'clock.
Metabolism of diclofenac is carried out partially by a glyukuronization of not changed molecule, but, mainly, by means of a single and repeated metoksilirovaniye that leads to formation of several phenolic metabolites (3 '-hydroxy, 4' - hydroxy, 5 '-hydroxy, 4', 5-digidroksi- and 3 '-hydroxies-4 '-metoksidiklofenaka), the majority of which turns into glyukuronidny conjugates. Two of these phenolic a metabolite are biologically active, but in much smaller degree, than diclofenac.
The general system plasma clearance of diclofenac is 263±56 ml/min. Final elimination half-life makes 1-2 hours. Elimination half-life of 4 metabolites, including two pharmacological active, is also short and makes 1-3 hours. One of metabolites, 3 '-hydroxies-4 '-metoksi-diclofenac, has longer elimination half-life, however this metabolite is completely inactive.
About 30% of active ingredient are allocated in the form of metabolites with a stake.
After metabolic transformations in a liver (hydroxylation and conjugation) of about 70% of active ingredient it is removed through kidneys in the form of pharmacological inactive metabolites.
The pharmacokinetics at separate groups of patients
At some patients of advanced age 15-minute intravenous infusion resulted in concentration, higher for 50%, in plasma, than it was observed at young healthy faces.
At patients with a renal failure when assigning DikloberlN 75 in usual single doses of accumulation of diclofenac it was not noted. However eventually metabolites are removed with bile.
At patients with chronic hepatitis or the compensated cirrhosis the indicators of pharmacokinetics of diclofenac are similar to that at patients without liver diseases.
The pharmacodynamics
DikloberlN 75 contains sodium diclofenac, the substance of nonsteroid structure rendering the significant anti-inflammatory, analgetic and febrifugal action. Slowing down of biosynthesis of prostaglandins is considered the main mechanism of effect of diclofenac. Prostaglandins play an important role in genesis of inflammation, pain and fever.
In rheumatic diseases the protivospalitelny and analgetic DikloberlN 75 properties provide the clinical effect which is characterized by considerable reduction of expressiveness of such symptoms and complaints as pain at rest and at the movement, morning constraint and a swelling of joints and also function improvement.
Diclofenac of sodium does not suppress biosynthesis of proteoglycans of cartilaginous tissue.
The considerable analgetic effect of drug at a moderate and severe pain syndrome of not rheumatic genesis is revealed. DikloberlN 75 it is capable to eliminate pain at primary dysmenorrhea.
Diclofenac is non-steroidal anti-inflammatory drug which efficiency was proved in not clinical trials, the mechanism of effect of drug consists in prostaglandin synthesis suppression. Diclofenac reduces the pains, hypostases and the increased temperature caused by inflammatory process. Besides, diclofenac suppresses the aggregation of thrombocytes caused by ADF and collagen.
Indications
Symptomatic treatment in the profound acute pain accompanying:
- acute arthritis (including a gout attack)
- chronic arthritis, in particular a pseudorheumatism (chronic polyarthritis)
- an ankylosing spondylitis (Bekhterev's disease) and other inflammatory diseases of a backbone of the rheumatic nature
- the irritation phenomenon in degenerative diseases of joints and a backbone (arthrosis and a spondylarthrosis)
- inflammatory diseases of soft tissues of the rheumatic nature
- hypostases or posttraumatic inflammation with a pain syndrome
the Note:
Solution for injections is shown only in case especially fast effect is required and also if intake or introduction are not presented in the form of a candle by possible. In such cases, as a rule, treatment is recommended to be carried out only in the form of a single injection - within initial therapy.
Route of administration and doses
Adult:
The injection of Dikloberla® N 75 is carried out once. For continuation of treatment use dosage forms for oral or rectal administration. At the same time, even in day of an injection, the total dose should not exceed 150 mg.
The way and duration of use
of Dikloberl® N 75 enter in oil deeply into the area of a buttock.
Due to the potential risk of development of anaphylactic reactions (up to shock) the patient after introduction of Dikloberla® N 75 should be under observation not less than an hour, at the same time the necessary for rendering emergency aid and serviceable (functioning) medical tools have to be on call. The patient needs to explain the meaning of these measures.
Usually injections of drug are appointed for a period of 1 up to 5 days. Duration of use of drug is defined by the attending physician.
Special groups of patients
Patients of advanced age:
Special dose adjustment is not required. In case of elderly patients more careful control of their state because of possible side effects is necessary.
Depression of function of kidneys and liver:
At depression of function of kidneys and a liver of easy and average extent of reduction of a dose it is not required (recommendations for patients with a heavy renal failure).
Side effects
Very often (≥ 1/10)
- gastrointestinal complaints, such as nausea, vomiting and diarrhea and also insignificant gastrointestinal bleedings, in rare instances with development of anemia
it is frequent (³ 1/100 - & lt, 1/10)
- pseudo anaphylactic reactions
- reactions of hypersensitivity, such as skin rash and itching
- disturbances from the central nervous system, such as headache, dizziness, oglushennost, excitement, irritability or fatigue
- the dispeptitchesky phenomena, a meteorism, gripes in a stomach, lack of appetite and also gastrointestinal ulcers (with risk of bleeding and perforation)
- increase in activity of transaminases in blood serum
- reactions in the place of an injection, pain in the place of an injection, an induration in the place of an injection
- a liquid delay
Sometimes (³ 1/1,000 - & lt, 1/100)
- urticaria
- a hematemesis, a melena or a bloody diarrhea.
- an abnormal liver function, especially at long therapy, an acute hepatitis with jaundice or without it (lightning hepatitis even without the previous symptoms is in rare instances possible).
Therefore at long-term treatment it is regularly necessary to carry out by drug the analysis of hepatic indicators.
- an alopecia
- developing of hypostases, especially at patients with arterial hypertension or a renal failure
Seldom: (³ 1/10,000 - & lt, 1/1,000)
- hypostasis, necrosis in the place of an injection
- reactions of hypersensitivity to benzyl alcohol meet
seldom Very seldom (& lt, 1/10,000), including isolated cases
- abscess in the place of an injection
- hemopoiesis disturbances (anemia, a leukopenia, thrombocytopenia, a pancytopenia, an agranulocytosis), hemolytic anemia.
- heavy generalized reactions of hypersensitivity: a Quincke's edema (a face edema, a paraglossa, hypostasis internal throats with narrowing of airways, short wind, increase of heart rate, a lowering of arterial pressure, falling of arterial blood pressure to critical level).
- an allergic vasculitis and a pneumonitis
- psychotic reactions, a depression, feeling of alarm, dreadful dreams
- touch disorders, disturbances of flavoring perception, memory, a disorientation, spasms, a tremor
- mental disorders, such as memory disturbance
- a disorder of vision (blurring of sight or a diplopia)
- sonitus, passing disorders of hearing
- heartbeat, hypostases, heart failure, a myocardial infarction
- an arterial hypertension
- an acute disorder of cerebral circulation
- stomatitis, a glossitis, damages of a gullet, the complaint to pain in the lower part of a stomach (for example, bleeding in colitis or aggravation of nonspecific ulcer colitis / Crohn's disease), a constipation, pancreatitis, diafragmopodobny strictures of intestines.
- a dieback, eczema, a multiformny erythema, a photosensitization, a purpura (including an allergic purpura), such bullous reactions as Stephens-Johnson's syndrome and a toxic epidermal necrolysis
- defeat of tissue of kidneys (interstitial nephrite, papillary necrosis) which can be followed by an acute renal failure, a proteinuria and/or a hamaturia, a nephrotic syndrome
- aggravation of inflammatory processes of infectious origin (for example, development of a necrotizing fasciitis), connected with system use of non-steroidal anti-inflammatory drugs. Perhaps, it is connected with the mechanism of action of NPVP.
- symptoms of aseptic meningitis, such as muscle tension of a nape, headache, nausea, vomiting, temperature increase or turbidity of consciousness. Patients with autoimmune diseases are predisposed to emergence of such states (a system lupus erythematosus, mixed collagenoses).
Contraindications
of Dikloberl® N 75 should not be applied in the following cases:
- hypersensitivity to active ingredient or one of other components of drug
- in the presence in the anamnesis of a bronchospasm, asthma, rhinitis or urticaria after intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- at disturbances of a hemopoiesis of the obscure origin, disturbance of a hemostasis and fibrillation
- treatment of postoperative pain after operation of coronary shunting (or uses of the cardiopulmonary bypass)
- inflammatory bowel diseases (Crohn's disease or ulcer colitis)
- in the presence in the present or in the past of a recurrent round ulcer / hemorrhages (two or more separate cases of the confirmed peptic ulcer or bleedings)
- in the presence in the anamnesis of gastrointestinal bleeding or perforation of an ulcer connected with intake of non-steroidal anti-inflammatory drugs
- fresh cerebrovascular or other bleedings
- the established stagnant heart failure (class II-IV NYHA), coronary heart disease, diseases of peripheral arteries or vessels of a brain
- an abnormal liver function or kidneys of heavy degree
- heart failure of heavy degree
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years
Medicinal interactions
Other NPVP, including salicylates:
The accompanying use of some NPVP can increase risk of developing of ulcers and gastrointestinal bleeding owing to synergy effect of drugs. In this regard combined use of diclofenac and other NPVP is not recommended.
Digoxin, Phenytoinum, lithium:
At joint introduction of Dikloberl® N 75 can increase concentration of digoxin, Phenytoinum and lithium in blood. In this regard at treatment by diclofenac control of serumal concentration of lithium is obligatory, and digoxin or Phenytoinum - is recommended.
Diuretics, APF inhibitors and antagonists of angiotensin II:
NPVP can reduce efficiency of diuretics and other antihypertensive drugs (such as beta-blockers, inhibitors of the angiotensin-converting enzyme (ACE)). At some patients with reduced renal function (e.g., in dehydration or at elderly patients with the lowered function of kidneys) at intake of APF inhibitors or antagonists of angiotensin II together with the drug inhibiting cyclooxygenase, perhaps further deterioration in renal function including possible development of an acute renal failure which, however, in most cases has reversible character. In this regard it is necessary to appoint the specified drugs with care in combination with diclofenac, especially at elderly patients. At joint administration of diclofenac and these drugs it is necessary to watch that the patient accepted adequate amount of liquid and also it is necessary - after an initiation of treatment - to control function of kidneys regularly.
The accompanying use of Диклоберла® 75 and kaliysberegayushchy diuretics can lead to development of a hyperpotassemia. In this regard it is recommended to control potassium concentration in blood at joint administration of the specified drugs.
Glucocorticoids:
At joint introduction with diclofenac the risk of developing ulcers and gastrointestinal bleeding increases.
The drugs suppressing aggregation of thrombocytes (for example, acetylsalicylic acid), and selective serotonin reuptake inhibitors (SSRI):
At joint introduction with diclofenac the risk of gastrointestinal bleeding increases.
Antidiabetic drugs:
Clinical trials showed that diclofenac can be applied together with oral antidiabetic drugs, without influencing their action. Nevertheless, there are separate messages about the hypoglycemic and hyper glycemic phenomena which demanded dose adjustment of antidiabetic drugs during treatment by diclofenac. For this reason, as a precautionary measure, at simultaneous use of these drugs it is recommended to carry out regular control of level of glucose to blood.
Methotrexate:
Diclofenac is capable to suppress renal clearance of a methotrexate that leads to increase in its level. At introduction of Dikloberla® N 75 during 24 h to or after introduction of a methotrexate the increase in concentration of a methotrexate in blood and strengthening of its toxic effects is possible.
Cyclosporine:
NPVP (e.g., sodium diclofenac) can strengthen nephrotoxic effect of cyclosporine.
Antibiotics of a hinolonovy row:
It was reported about isolated cases of appearance of spasms which could be caused by simultaneous use of hinolon with NPVS.
Anticoagulants:
NPVP can strengthen effect of anticoagulants, such as warfarin
Sulphonylurea:
There are separate messages about the changes of concentration of glucose in blood after use of diclofenac which demanded dose adjustment of antidiabetic drug. In this regard at joint therapy it is recommended to control concentration of glucose in blood.
Probenetsid and Sulfinpyrazonum:
The medicines containing probenetsid and Sulfinpyrazonum, can delay removal of diclofenac from an organism.
Kolestipol and holestiramin:
These drugs are capable to cause decrease or delay of absorption of diclofenac. For this reason it is recommended to appoint diclofenac, at least, for an hour before reception kolestipola/a holestiramina or 4-6 hours later after it.
Strong CYP2C9 inhibitors:
It is necessary to appoint with care diclofenac along with strong CYP2C9 inhibitors (as, for example Sulfinpyrazonum and vorikonazol) as at their concomitant use the increase in peak concentration of diclofenac in plasma and strengthening of its action in connection with delay of his metabolism is possible.
Special indications
of the Precautionary measure concerning digestive tract
It is necessary to avoid use of the drug Dikloberl® N 75 along with other NPVP, including selection inhibitors of cyclooxygenase-2.
Undesirable effects can be reduced to a minimum by purpose of the smallest effective dose during the smallest period necessary for effective control of pain (gastrointestinal and cardiovascular risks are lower)
Patients of advanced age
At patients of advanced age the frequency of undesirable reactions to NPVP, especially gastrointestinal bleedings and perforation including from the death is increased.
Gastrointestinal bleeding, an ulcer and perforation of an ulcer
Gastrointestinal bleeding, ulceration or perforation, in certain cases and from the death, were noted for all NPVP at any stages of treatment, with or without symptoms harbingers and irrespective of existence or absence in the anamnesis of serious pathology of a GIT.
The risk of gastrointestinal bleeding, development of an ulcer or perforation increases with increase in a dose of non-steroidal anti-inflammatory drug at patients with presence of the ulcer in the anamnesis which is especially complicated by bleeding or perforation. In such cases the treatment should be begun with the smallest possible dose.
For these patients and also for the patients receiving low doses of aspirin or other drugs which increase risk of the undesirable phenomena from a GIT it is necessary to consider the possibility of use of combination therapy using the medicines possessing protective action concerning a GIT (for example, a mizoprostol or inhibitors of the proton pump).
Patients at whom in the anamnesis the toxic phenomena from a GIT took place in particular patients of advanced age, have to report about any unusual symptoms from abdominal organs (especially about gastrointestinal bleedings), it has the greatest value for the initial stages of treatment. The patient needs to be instructed that if at appearance of severe pain in an upper part of a stomach, melenas or vomitings it is necessary to stop immediately intake of medicine and to see a doctor (see side effects).
It is necessary to appoint with care diclofenac to the patients who are at the same time taking the drugs which can increase risk of developing of an ulcer or bleeding oral corticosteroids, anticoagulants, for example, the warfarin, selective serotonin reuptake inhibitors or means suppressing aggregation of thrombocytes (antiagregant), e.g. aspirin belong to such drugs.
At development of gastrointestinal bleeding against the background of treatment of Dikloberlom® N 75, drug should be cancelled.
Patients should appoint non-steroidal anti-inflammatory drugs with care with digestive tract diseases in the anamnesis (nonspecific ulcer colitis, Crohn's disease) in connection with risk of their aggravation.
Diclofenac patients should appoint effects from a cardiovascular system and cerebrovascular blood circulation with care with arterial hypertension and/or dekompensirovanny heart failure from easy to moderate severity in the anamnesis as at treatment of NPVP the delay of liquid and development of hypostases are possible.
According to results of clinical trials and epidemiological data, diclofenac use, especially in high doses (150 mg/days) and for a long time, can be followed by small increase in risk of arterial thromboses (for example, a myocardial infarction or a stroke).
For minimization of the cardiovascular risks connected with dosing and duration of treatment by diclofenac, drug should be used in minimum effective dose during the short period. It is necessary to carry out periodically the repeated assessment of need of patients for relief of symptoms and reaction to therapy.
Patients with uncontrollable arterial hypertension, the stagnant heart failure established by coronary heart disease, a disease of peripheral arteries or vessels of a brain diclofenac should appoint after careful survey.
Patients with considerable risk factors of developing cardiovascular diseases (for example, arterial hypertension, a lipidemia, diabetes, smoking) it is possible to treat diclofenac only after careful survey.
Skin reactions
It was reported about exceptional cases of serious skin reactions, sometimes with a lethal outcome, including exfoliative dermatitis, Stephens-Johnson's syndrome and a toxic epidermal necrolysis (Lyell's disease), against the background of treatment of NPVP. The risk of such reactions is highest in an initiation of treatment, the majority of the described phenomena were observed in the first months of therapy. Диклоберл® N 75 has to be cancelled at the first appearance of skin rash, damage of mucous or other signs of hypersensitivity.
Diclofenac patients should appoint effects from a liver with care with an abnormal liver function as against the background of treatment their state can worsen. At emergence of clinical signs of pathology of a liver, drug needs to be cancelled.
Other instructions
For prevention of damage of renal fabric it is necessary to check a condition of function of kidneys regularly.
Appearance of fever, sore throat, superficial wounds in an oral cavity, grippopodobny symptoms, the significant fatigue, nasal bleedings and skin hemorrhages can be the first signs of disturbance of a hemopoiesis (see side effects). At long-term treatment the regular blood test is necessary.
In the following cases of Dikloberl® N 75 it is necessary to appoint only after careful assessment of a ratio advantage risk:
- at congenital disturbances of exchange of porphyrine (for example, at the sharp alternating porphyria),
- at the system lupus erythematosus (SLE) and the mixed collagenoses.
In the following cases especially careful control from the attending physician is necessary:
- at disturbances from digestive tract or in the presence in the anamnesis of chronic inflammatory bowel diseases (nonspecific ulcer colitis, Crohn's disease),
- at the increased arterial blood pressure or heart failure,
- at depression of function of kidneys
- in an abnormal liver function
- right after extensive surgical intervention
- in an allergy to pollen, polyps in a nose and chronic obstructive respiratory diseases as at such patients the risk of emergence of allergic reactions is increased. These reactions can be shown by asthma attacks (so-called analgetikovy asthma), a Quincke's edema or urtikarny rash.
- in an allergy to other substances as at such patients the risk of reactions of hypersensitivity including at treatment of Dikloberlom® N 75 is increased.
Диклоберл® N 75 should not be entered into the center of inflammation or an infection.
Heavy acute reactions of hypersensitivity were very seldom observed (for example, an acute anaphylaxis). At emergence of the first signs of reaction of hypersensitivity of Dikloberl® N 75 it has to be cancelled, and professional treatment according to the developed symptomatology is begun.
For safety reasons at treatment of patients of advanced age it is necessary to show care. In particular, to the weakened patients of advanced age and patients with body underweight drug is appointed in a minimal effective dose.
Diclofenac can temporarily suppress aggregation of thrombocytes. In this regard it is necessary to control a condition of patients with disturbances of blood clotting.
As well as other NPVP, owing to the pharmakodinamichesky properties, diclofenac is capable to mask manifestations and symptomatology of an infection.
For prevention of aggravation of inflammation of the infectious nature which can be connected with the mechanism of effect of non-steroidal anti-inflammatory drugs the patient is recommended to see immediately a doctor if against the background of treatment Диклоберлом® 75 infection symptoms arose again or were aggravated (see side effects).
At long-term treatment by diclofenac it is regularly necessary to check function of a liver, kidneys and the general blood test.
At prolonged use of soothing drugs the developing of a headache is possible. It is not necessary to try to eliminate a headache by increase in a dose of drug.
At prolonged use of sedatives, especially at a combination of several anesthetics of active ingredients, injury of kidneys of steady character with risk of developing of a renal failure (analgetikovy nephropathy) is possible.
At a combination of NPVP and alcohol strengthening of undesirable effects of active ingredient of drug, especially on digestive tract or the central nervous system is possible.
In cases of parenteral administration of diclofenac the patients with bronchial asthma should show extra care as the probability of increase of symptomatology of a disease is not excluded.
Pregnancy and a lactation
Pregnancy
Suppression of synthesis of prostaglandin can adversely influence pregnancy and/or development of an embryo/fruit. According to results of epidemiological researches, in the early stages of pregnancy the use of the drugs suppressing prostaglandin synthesis can increase risk of a misbirth, emergence at a fruit of heart disease and not fusion of an anterior abdominal wall. So, the absolute risk of forming of defects of a cardiovascular system increased from & lt, 1% up to about 1.5%. It is considered that the risk of the specified phenomena increases with increase in a dose of drug and duration of its use.
Prescribing of diclofenac during the first and second trimester of pregnancy is possible only when in it there is an imperative need. In case of prescribing of diclofenac the women planning pregnancy or in the first and second trimester of pregnancy should choose the smallest possible dose and the smallest possible duration of treatment.
In the third trimester of pregnancy all inhibitors of synthesis of prostaglandin can lead to development in a fruit:
- the phenomena of cardiopulmonary toxicity (e.g., premature closing of an arterial channel and hypertensia in the system of a pulmonary artery),
- dysfunctions of kidneys which can progress up to a renal failure with development of an oligoamnios
at the end of pregnancy can bring at mother and a fruit to:
- to lengthening of a bleeding time, anti-aggregation effect which can arise even at use of very low doses of drug,
- to suppression of sokratitelny uterine activity that can lead to delay or delay in patrimonial activity.
A lactation
Active ingredient diclofenac and products of its disintegration in small amounts get to mother's milk.
The fertility
Диклоберл® 75 can reduce female fertility and therefore the women planning pregnancy are not recommended to appoint it. At the women who are experiencing difficulties with conception or undergoing inspection regarding infertility it is necessary to consider the possibility of cancellation of Dikloberla® N 75.
Features of influence of medicine on ability to driving of vehicles and to service by potentially dangerous mechanisms
At treatment of Dikloberlom® N 75 in high doses such side effects from the central nervous system can take place as increased fatigue and dizziness therefore in certain cases at patients the disturbance of reaction and deterioration in ability to active participation in traffic and to service of mechanisms is possible. The specified phenomena amplify at a drug combination to alcohol intake.
Note:
The propylene glycol which is a part of the drug Dikloberl® N 75 can cause the symptoms similar to that, arising after alcohol intake.
Overdose
Symptoms: the overdose of diclofenac can be shown by disorders from the central nervous system, such as headache, dizziness, oglushennost and loss of consciousness (and at children even with myoclonic spasms) and also abdominal pain, nausea and vomiting. Besides, perhaps gastrointestinal bleeding and also abnormal liver function and kidneys. Also at overdose of diclofenac the arterial hypotonia, respiratory depression and cyanosis can be observed.
Symptomatic treatment: there is no specific antidote.
A form of release and packing
On 3 ml in ampoules of colourless glass of I type.
On 5 ampoules together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
Storage conditions
Drug should be stored at a temperature not above 30 °C. For protection against light influence to store drug in original packing.
To store out of children's reach!
A period of storage
3 years
not to apply after an expiration date
Prescription status
According to the prescription
Proizvoditel Berlin-Hemi AG (Menarini Group) Gliniker Weg 125 12489 Berlin
the Owner of the registration certificate and
the Gliniker Veg Berlin-Hemi AG producer (Menarini Group) 125 12489 Berlin Organization Packer A. Menarini Manyufekchering Logistics and Services of Neuter of l., Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers concerning quality of products (goods):
Representative of Berlin-Hemi AG in the Republic of Kazakhstan
ph. +7 727 2446183, 2446184, 2446185
fax: +7 727 2446180
e-mail:
To Develop Kazakhstan@berlin-chemie.com
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