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Diprospan® 1 ml 5’s suspension for injection in ampoules

$80.20

a32091d0f502

Description

The instruction for medical use

of Diprospan Torgovoye medicine a name

Diprospan

Mezhdunarodnoye the unlicensed name

Is not present

the Dosage form

Suspension for injections

Structure

1 ml of suspension contains

active agents: betamethasone Dipropionas of 6.43 mg (5.00 mg of betamethasone are equivalent), sodium betamethasone phosphate of 2.63 mg (2.00 mg of betamethasone are equivalent)

excipients: hydrophosphate sodium a dihydrate, sodium chloride, dinatrium edetat, polysorbate 80, benzyl alcohol, methylparahydroxybenzoate, propilparagidroksibenzoat, sodium carboxymethylcellulose, a macrogoal, acid chlorohydrogen, water for injections

the Description

Transparent, from colourless till light yellow color, slightly viscous liquid containing easily suspended particles of white or almost white color,

Pharmacotherapeutic group, free from mechanical inclusions,

Corticosteroids for system use. Glucocorticosteroids. Betamethasone.

The ATX H02AB01 code

the Pharmacological

Betamethasone Pharmacokinetics properties of sodium phosphate – a readily soluble component which is quickly absorbed from the injection site, providing quick start of therapeutic action. Betamethasone Dipropionas – the slightly soluble component which is slowly absorbed from depot which is formed in the place of an injection, and causing long effect of drug.

Linking with proteins of plasma – 62.5%. It is metabolized in a liver. An insignificant part is removed mainly by kidneys, – with bile.

Diprospan’s pharmacodynamics has high glucocorticosteroid activity and insignificant mineralokortikosteroidny activity.

Besides, drug regulates a carbon homeostasis and water and electrolytic balance.

The insignificant sizes of crystals of betamethasone of Dipropionas allow to apply needles of small diameter (to 0.9 mm) to intracutaneous introductions and introductions directly to the defeat center.

Indications

˗ the pseudorheumatism, an osteoarthritis, a bursitis, tendosinoviit, an ankylosing spondylitis, sciatica, a koktsidiniya, a sciatica, a lumbago, a wryneck, a ganglionic cyst, an exostosis, a fasciitis, heavy gout

˗ bronchial asthma (including in complex therapy of the asthmatic status), hay fever, a Quincke’s disease, an allergic bronchitis, seasonal or year-round allergic rhinitis, a medicamentous allergy, a serum disease, reactions to stings of insects

˗ atopic dermatitis (monetovidny eczema), neurodermatitises, contact dermatitis, the profound solar dermatitis, red flat deprive, the insulin lipodystrophy, a nested alopecia, a diskoidny erythematic lupus, psoriasis, keloid cicatrixes, a usual bladderwort, herpetic dermatitis, cystous eels

˗ a system lupus erythematosus, a scleroderma, a dermatomyositis, a nodular periarteritis

˗ palliative therapy of a leukosis and lymphoma at adults, an acute leukosis at children

˗ an adrenogenital syndrome, a hemorrhagic proctocolitis, Crohn’s disease, a spra, kortikosteroidozavisimy diseases of blood, nephrite, a nephrotic syndrome

˗ primary and secondary insufficiency of bark of adrenal glands (at obligatory simultaneous introduction of mineralokortikosteroid)

is recommended to enter the Route of administration and Diprospan’s doses intramusculary in need of system receipt of a glucocorticosteroid into an organism or directly into the struck soft tissue, in the form of intra articulate and periartikulyarny injections in arthritises, in the form of intracutaneous injections in various diseases of skin, in the form of local injections in the defeat center in some diseases of foot.

The mode of dosing and a method of administration establish individually, depending on indications, disease severity and reaction of the patient to treatment. The dose has to be minimum, the use period – the shortest.

The dose has to be picked up for obtaining satisfactory clinical effect. In the absence of satisfactory clinical effect Diprospan it is necessary to cancel and choose alternative therapeutic tactics.

At system therapy the initial dose of the drug Diprospan in most cases makes 1-2 ml. Introduction is repeated if necessary, depending on a condition of the patient. The drug is administered deeply intramusculary in rump. Dosages and frequency of introduction are selected individually taking into account weight of a condition of the patient and a therapeutic response:

˗ at the serious conditions (lupus erythematosus and the asthmatic status) needing emergency measures, the initial dose of drug can make 2 ml

˗ in dermatological diseases, as a rule, enough 1 ml of drug

˗ in diseases of a respiratory system effect of the drug Diprospan begins within several hours after an intramuscular injection of drug. In bronchial asthma, hay fever, an allergic bronchitis and allergic rhinitis the significant improvement of a state is reached after introduction of 1-2 ml of drug

˗ in an acute and chronic bursitis an initial dose for intramuscular introduction makes 1-2 ml of drug. If necessary carry out several repeated introductions.

At local introduction the simultaneous use of mestnoanesteziruyushchy drug is necessary only in isolated cases. At simultaneous administration of the anesthetizing substance Diprospan it can be mixed from 1% or 2% by solution of Procainum of a hydrochloride or lidocaine (in the syringe, not in a bottle), with use of the dosage forms which are not containing parabens. Similar local anesthetics can be also used. Use of anesthetics which contain methylparaben, propylparaben, phenol and other similar substances is not allowed. At use of anesthetic in a combination with the drug Diprospan at first gather in the syringe from a bottle a necessary dose of drug, then in the same syringe gain necessary amount of local anesthetic from an ampoule and stir up during the short span.

In an acute bursitis (subdeltoid, subscapular, elbow and prepatellar) introduction of 1-2 ml of the drug Diprospan to a synovial bag can relieve pain and completely renew mobility within several hours. Treatment of a chronic bursitis is carried out by smaller doses of drug after stopping of a bad attack of a disease.

At sharp tendosinoviita, tendinites and peritendinites one injection of the drug Diprospan facilitates a condition of the patient, at chronic – it is necessary to repeat a drug injection depending on reaction. It is necessary to avoid administration of drug directly in a sinew.

Intra articulate administration of drug in a dose of 0.5-2.0 ml reduces pain, morbidity and rigidity of joints in a pseudorheumatism and an osteoarthritis during 2-4 h after introduction. Duration of therapeutic effect of drug considerably varies and can be 4 and more weeks.

The recommended drug doses at introduction to big joints (a knee, a hip, a shoulder) make 1-2 ml, in averages (elbow, a wrist, an anklebone) – 0.5-1 ml, in small (a foot, a brush, a thorax) – 0.25-0.5 ml.

In some diseases of skin effectively intracutaneous administration of drug directly in the defeat center, the dose makes 0.2 ml/cm2. The place of defeat is evenly cut away by means of the tuberkulinovy syringe and a needle. The total dose of the drug administered to all sites of introduction within 1 week should not exceed 1 ml.

The recommended single doses of the drug Diprospan (once a week):

˗ at a firm callosity – 0.25-0.5 ml (as a rule, 2 injections are effective)

˗ at a spur – 0.5 ml

˗ at rigidity of a thumb of foot – 0.5 ml

˗ in a synovial cyst – from 0.25 to 0.5 ml, at a tendosinoviita – 0.5 ml

˗ in acute gouty arthritis – from 0.5 to 1 ml.

Recommend to use the tuberkulinovy syringe with a needle to introduction.

After achievement of therapeutic effect the maintenance dose is selected by gradual decrease in an initial dose due to reduction of concentration of betamethasone in solution which is entered through certain intervals of time. The dose decline is continued before achievement of a minimal effective dose.

At emergence or threat of emergence of a stressful situation (which is not connected with a disease) there can be a need for increase in a dose of drug.

Drug withdrawal after long therapy should be carried out by a gradual dose decline. Observation of a condition of the patient is carried out, at least, within a year upon termination of long therapy or after use of drug in high doses.

Side effects

the Undesirable phenomena, as well as at use of other glucocorticosteroids, are caused by a dose and duration of use of drug. These reactions, as a rule, are reversible and can be reduced by a dose decline:

– a natriyemiya, the increased potassium removal, a gipokaliyemichesky alkalosis, a liquid delay in fabrics, stagnant heart failure at the patients predisposed to this disease, arterial hypertension

– muscle weakness, a myopathy, loss of muscle bulk, deterioration in myasthenic symptoms at a heavy pseudoparalytic myasthenia, osteoporosis, a compression fracture of vertebras, aseptic necrosis of a head of femoral or humeral bones, pathological fractures of tubular bones, ruptures of sinews, instability of joints (after reusable injections)

– a hiccups, a round ulcer with possible subsequent perforation and bleeding, pancreatitis, a meteorism, an ulcer esophagitis

– deterioration in healing of wounds, a skin atrophy, thinning of skin, a petechia and ecchymomas, an erythema of the person, the increased perspiration, decrease in sensitivity of skin tests, dermatitis, rash, a Quincke’s disease

– spasms, increase in intracranial pressure with a papilledema (usually upon termination of treatment), dizziness, a headache

– disturbance of a menstrual cycle, Cushing’s syndrome, an arrest of development of a fruit or growth of the child, secondary adrenocortical and hypophysial unresponsiveness (especially during a stress in an injury, surgical intervention, a disease), disturbance of tolerance to glucose, manifestations of latent diabetes, increase in need for use of injections of insulin or oral anti-diabetic means

– a back subkapsulyarny cataract, increase in intraocular pressure, glaucoma, an exophthalmos

– negative nitrogenous balance (owing to protein catabolism)

– euphoria, change of mood, a heavy depression up to its open manifestations (psychosis), change of the personality, insomnia

– anaphylactic, supersensitive, hypotensive or shocklike reactions to administration of drug

– isolated cases of a disorder of vision, including a blindness which accompany topical administration in a zone of face and head, hyper – or hypopigmentation, a hypodermic and skin atrophy, aseptic abscesses, a post-injection peristatic hyperemia (after intra articulate introduction) and a neurogenetic arthropathy, like Sharko

Protivopokazaniya’s disease

˗ hypersensitivity to betamethasone, other components of drug or to other glucocorticosteroids

˗ system mycoses

˗ the lactation period

˗ children’s age up to 3 years

˗ at intra articulate introduction: the unstable joint, infectious arthritis

˗ Diprospan is not entered intramusculary to patients with an idiopathic or Werlhof’s disease

Medicinal interactions

Simultaneous use of phenobarbital, rifampicin, Phenytoinum or ephedrine can strengthen drug metabolism, reducing at the same time its therapeutic activity.

At simultaneous use of glucocorticosteroids and estrogen the drug dose adjustment can be necessary (because of overdose threat).

The concomitant use of corticosteroids with diuretics can lead to a hypopotassemia. Simultaneous use of glucocorticosteroids and cardiac glycosides increases risk of developing of arrhythmia or digitalis intoxication owing to a hypopotassemia. Corticosteroids can strengthen potassium removal which is caused by intake of Amphotericinum of V.U of all patients accepting any of these medicinal combinations it is necessary to control carefully the level of electrolytes in blood serum, especially potassium level.

The concomitant use of corticosteroids and coumarinic anticoagulants can raise or reduce anticoagulating effects that, will perhaps demand dose adjustment.

At the combined use of glucocorticosteroids with non-steroidal anti-inflammatory drugs or alcohol the increase in frequency of emergence or intensity of erosive cankers of the digestive tract (DT) is possible.

Simultaneous use of glucocorticosteroids can reduce concentration of salicylates in blood plasma. Acetylsalicylic acid has to be appointed with care in a combination with corticosteroids in a prothrombinopenia.

Dose adjustment of antidiabetic drug can be required when assigning corticosteroids sick diabetes.

Simultaneous introduction of glucocorticosteroids can suppress the answer to Somatotropinum.

Corticosteroids can influence the nitroblue tetrazoliyevy test in a bacterial infection and cause false-negative results.

The special

instructions Diprospan Suspension it is not intended for intravenous or hypodermic administration.

Strict observance of rules of an asepsis is obligatory at drug use.

Intramuscular injections of corticosteroids need to be entered deeply into a muscle for prevention of a local atrophy of soft tissues.

Any administration of drug (soft tissues, the defeat center, vnutrisustavno, etc.) can lead to systemic action at the simultaneous significant local action.

Intra articulate injections have to be carried out only by the qualified medical personnel. It is necessary to carry out the analysis

of intra articulate liquid for an exception of septic process. Not to administer the drug in the presence of an intra articulate infection. Noticeable strengthening of morbidity, puffiness, temperature increase of surrounding fabrics and further restriction of mobility of a joint testify to septic arthritis. At confirmation of the diagnosis it is necessary to appoint antibacterial therapy.

It is not necessary to enter the corticosteroids in an unstable joint infected areas and intervertebral intervals. Repeated injections in a joint in an osteoarthritis can increase risk of destruction of a joint. After successful intra articulate therapy the patient should avoid joint overloads.

As exceptional cases of anaphylactoid reactions met at the patients receiving corticosteroid therapy, it is necessary to take before administration of drug the appropriate measures of precaution, especially if the patient had cases of allergic reactions to administration of medicines.

When assigning a long course of corticosteroid therapy it is necessary to weigh a ratio of potential advantage and risk of administration of medicines and to consider the possibility of transition from parenteral to oral administration.

Change of a dosage during the easing or aggravation of pathological process, individual reaction of the patient to therapy, impact on the patient of an emotional or physical stress in the form of a serious infection, surgical intervention or an injury can be required. After the termination of long or high-dose corticosteroid therapy the medical observation during 1 year after completion of therapy can be necessary.

At use of drug it is necessary to consider that corticosteroids can mask symptoms of an infectious disease and also reduce body resistance.

Prolonged use of corticosteroids can lead to development of a cataract (especially at children), glaucomas with possible damage of an optic nerve, and can contribute to the development of consecutive infection of eyes (fungal or virus). It is necessary to undergo periodically ophthalmologic inspection, especially the patient receiving Diprospan within more than 6 weeks.

Average and high doses of corticosteroids can increase arterial blood pressure, promote a delay of liquid and sodium of chloride in fabrics and to increase in removal of potassium from an organism (that can be shown by hypostases, disturbances in cardiac performance), the diet with restriction of edible salt and additional administration of drugs, containing potassium is recommended. Emergence of such manifestations is improbable / less possibly at use of synthetic derivatives if only they are not used in high doses. All corticosteroids increase calcium removal.

The patients receiving corticosteroids should not do a smallpox inoculation. It is not necessary to carry out other immunization at treatment by corticosteroids (especially in high doses), considering risk of development of neurologic complications and the low immune response (lack of antibody formation). When performing replacement therapy (for example, at primary insufficiency of bark of adrenal glands) carrying out immunization is possible.

Patients who receive Diprospan in the doses suppressing immunity should avoid contact with patients with chicken pox and measles (it is especially important when prescribing drug to children).

Prescribing of drug in active tuberculosis is possible only in cases of lightning or disseminate tuberculosis in combination with adequate antitubercular therapy. For patients with latent tuberculosis or with positive reaction to tuberculine it is necessary to resolve an issue of preventive antitubercular therapy before beginning the Diprospan drug treatment. It is necessary to consider that rifampicin strengthens metabolism of hepatic clearance of corticosteroids and can be required correction of a dosage of corticosteroids.

It is necessary to appoint the smallest possible dose of drug. If necessary the drug dose decline which has to be gradual is possible.

Too fast cancellation of corticosteroids can result in medicinal secondary adrenocortical insufficiency which can be minimized gradual decrease in a dosage. It is necessary to remember also a possibility of development of secondary insufficiency of bark of adrenal glands within several months after the end of therapy. At emergence or threat of emergence of a stressful situation during this period the Diprospan drug treatment should be resumed. If to the patient therapy is already appointed, then the dose of drugs can be increased. Deterioration in secretion of mineralokortikosteroid is possible therefore it is necessary to appoint salt and/or mineralokortikosteroida at the same time.

With care to use drug to patients with a hypothyroidism or cirrhosis, to patients with herpetic damage of eyes (because of risk of perforation of a cornea).

At drug treatment the patients with diabetes can need correction of antihyperglycemic therapy.

Against the background of use of the drug Diprospan, disturbances of mentality are possible (especially at patients with emotional instability or tendency to psychoses).

It is necessary to appoint corticosteroids with care in not specific ulcer colitis, perforation threat, abscess or other pustulous infections and also in a diverticulitis, a fresh intestinal anastomosis, an active or latent peptic ulcer of a stomach and a duodenum, a renal failure, arterial hypertension, osteoporosis, a heavy myasthenia, glaucoma, acute psychosis, viral and bacterial infections, lag in growth, tuberculosis, Cushing’s syndrome, diabetes, heart failure, epilepsy hard to cure, tendency to a thrombembolia or thrombophlebitises and pregnancy.

Against the background of use of glucocorticosteroids the change of mobility and quantity of spermatozoa is possible.

As complications of glucocorticosteroid therapy depend on doses, a course and duration of therapy, ratio assessment the advantage/risk is solved individually for each patient.

It was reported about emergence of serious neurologic reactions (sometimes leading to deaths) at epidural injection introduction of corticosteroids. Also it was reported about specific reactions which include (but are not limited to listed): heart attack of a spinal cord, paraplegia, quadriplegia, cortical blindness and stroke. About these serious neurologic reactions it was reported irrespective of carrying out a roentgenoscopic research. Safety and efficiency of epidural introduction of corticosteroids are not established therefore such use of corticosteroids is not recommended.

Use in pediatric practice

As corticosteroids are capable to slow down growth at newborns and children and suppress endogenous products of corticosteroids, if treatment drags on, it is necessary to provide careful control of growth rates and development.

Pregnancy and the period of a lactation

Due to the lack of controlled researches on safety of use of drug for pregnant women, it is necessary to appoint it only in urgent cases, after careful assessment of a ratio advantage/risk for mother and for the fruit/child. The children who were born from mothers receiving considerable doses of corticosteroids at pregnancy need careful medical control (for early identification of signs of insufficiency of bark of adrenal glands).

In need of prescribing of the drug Diprospan&Ograve, in the period of a lactation it is necessary to resolve an issue of the feeding termination by a breast, in view of importance of therapy for mother (because of possible undesirable side effects at children).

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

As a rule, Diprospan does not affect speed of reaction at management of trasportny means or work with difficult mechanisms. However in isolated cases there can be muscle weakness, spasms, disorders of vision, dizziness, a headache, change of mood, a depression (with the significant psychotic reactions), acrimony therefore it is recommended to refrain from control of vehicles or work with difficult mechanisms during drug treatment.

Overdose

Symptoms: the acute overdose of betamethasone does not create life-threatening situations. Introduction within several days of high doses of glucocorticosteroids does not lead to undesirable consequences (except for cases of use of very high doses or in case of use in diabetes, glaucoma, exacerbation of erosive cankers of a GIT or at patients who at the same time undergo therapy by digitalis drugs, indirect anticoagulants or diuretics).

Treatment: careful medical control of a condition of the patient is necessary. It is necessary to support optimum consumption of liquid and to control electrolytic composition of blood plasma and urine (especially balance of sodium and potassium in an organism). At identification of an imbalance of these ions it is necessary to carry out the corresponding therapy.

The form of release and packing

On 1 ml of drug spill in ampoules from glass of I type.

On 5 ampoules place in blister strip packagings.

1 blister strip packaging together with the instruction for medical use in the state and Russian languages is put in a cardboard box

by
Storage conditions

to Store at a temperature from 2 With up to 25 C in the place protected from light.

Not to freeze.

To store out of children’s reach.

A period of storage

2 years

not to apply after an expiration date

Prescription status

According to the prescription

Shering-Plau Labo Producer H. B., Belgium

the Owner of the registration certificate

Shering-Plau Sentral East AG, Switzerland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims of consumers on quality of products (goods): Representative office of Shering-Plau Sentral East AG in Kazakhstan,
Almaty, ave. Dostyk, 38, business center Ken Dala, 5th floor
Ph. +7 (727) 330-42-66, +7 (727) 259-80-84
Fax +7 (727) 259-80-90
e-mail: dpoccis2@merck.com,
pharmacovigilance.ukraine&cis@merck.com

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