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Sertospan 5 mg + 2 mg / ml suspension for injection 1’s




The instruction for medical use of Sertospan Torgovoye medicine a name Sertospan Mezhdunarodnoye the unlicensed name Betamethasone Dosage Form Suspension for injections, 1 ml Structure of 1 ml of drug contains active agents: betamethasone Dipropionas (it is equivalent to betamethasone) 6.43 mg (5.00 mg) and sodium betamethasone phosphate (it is equivalent to betamethasone) 2.63 mg (2.00 mg), excipients: dinatrium edetat, dinatrium hydrophosphate anhydrous, sodium chloride, polysorbate 80, 1 M acid chlorohydrogen, benzyl alcohol, methylparahydroxybenzoate, propilparagidroksibenzoat, sodium of a karmelloz, a macrogoal, water for injections. The description Slightly viscous liquid containing easily suspended particles of white color free from foreign impurity. Pharmacotherapeutic group Hormonal drugs for system use. 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. Sertospan’s pharmacodynamics has high glucocorticosteroid and insignificant mineralokortikosteroidny activity. Also drug affects carbohydrate metabolism and water and electrolytic balance. Indications Rheumatic diseases ˗ pseudorheumatism, osteoarthritis, bursitis, lumbago, sciatica, koktsidiniya, acute gouty arthritis, wryneck, ganglionic cyst, ankylosing spondylitis, sciatica, exostosis, fasciitis. Allergic diseases ˗ bronchial asthma (including in complex therapy of the asthmatic status), seasonal or year-round allergic rhinitis, a heavy allergic bronchitis, contact dermatitis, atopic dermatitis, hay fever, a Quincke’s disease, a medicamentous allergy, a serum disease, allergic reactions to stings of insects. Skin diseases ˗ atopic dermatitis, monetovidny eczema, neurodermatitises, contact dermatitis, a photodermatitis, a small tortoiseshell, red flat deprive, an insulin lipodystrophy, a nested alopecia, a diskoidny lupus erythematosus, psoriasis, keloid cicatrixes, a usual bladderwort, herpetic dermatitis, cystous eels. Collagenic diseases ˗ a system lupus erythematosus (during aggravation or as maintenance therapy), nodular polyarthritis, a scleroderma, a dermatomyositis. Tumoral diseases ˗ palliative therapy of leukoses and lymphoma at adults, an acute leukosis at children. Other diseases ˗ adrenogenital syndrome, nonspecific ulcer colitis, Crohn’s disease, spra, kortikosteroidozavisimy diseases of blood, nephrite, nephrotic syndrome. ˗ primary and secondary insufficiency of bark of adrenal glands (at obligatory simultaneous introduction of mineralokortikosteroid). The route of administration and Sertospan’s doses is recommended to be entered 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 of Sertospan it is necessary to cancel and choose alternative therapeutic tactics. At system therapy the initial dose of the drug Sertospan 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, of enough 1 ml of drug ˗ in diseases of a respiratory system, effect of drug begins within several hours after an intramuscular injection of the drug Sertospan. 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, Sertospan in ampoules is recommended to use. In an acute bursitis (subdeltoid, subscapular, elbow and prepatellar) introduction of 1-2 ml of the drug Sertospan 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 Sertospan 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 Sertospan (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. Disturbance of water and electrolytic balance – 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. Musculoskeletal system diseases – 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). Digestion disturbance – a round ulcer with possible subsequent perforation and bleeding, pancreatitis, a meteorism, perforation of intestines, an ulcer esophagitis, nausea, vomiting. Disturbances from skin – 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. Disturbances from nervous system – spasms, increase in intracranial pressure with a papilledema (usually upon termination of treatment), dizziness, a headache. Disturbances of an endocrine system – 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. Ophthalmologic disturbances – a back subkapsulyarny cataract, increase in intraocular pressure, glaucoma, an exophthalmos. Metabolic disturbances – negative nitrogenous balance (owing to protein catabolism) lipomatoz, increase in weight. Mental disorders – euphoria, change of mood, a heavy depression, psychosis, especially at patients with mental disturbances in the anamnesis, irritability, change of the personality, insomnia. Disturbance from the immune system the Corticosteroids can cause inhibition of skin tests, mask symptoms of an infection and activate latent infection. They can also reduce the resilience to infections, in particular because of mycobacteria, tuberculosis, Candida albicans or viruses. Others – anaphylactic, supersensitive, hypotensive or shocklike reactions to administration of drug. The following side reactions can be observed at parenteral administration of corticosteroids: – 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’s disease. Repeated injections in a joint can increase risk of destruction of a joint. Contraindications ˗ hypersensitivity to betamethasone, other components of drug or to other glucocorticosteroids ˗ system mycoses ˗ Sertospan is not entered intramusculary to patients with an idiopathic or Werlhof’s disease. ˗ children’s age up to 3 years ˗ the lactation period 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 – Century. At 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 anti-coalugating 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 because of a prothrombinopenia. Dose adjustment of antidiabetic drug can be required when assigning corticosteroids sick diabetes. Simultaneous introduction of glucocorticosteroids can suppress Somatotropinum absorption. Corticosteroids can influence the nitroblue tetrazoliyevy test in a bacterial infection and cause false-negative results. The special instructions Sertospan Suspension it is not intended for intravenous or hypodermic administration. 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, tetraplegia, cortical blindness and stroke. About these serious neurologic reactions it was reported irrespective of performing X-ray inspection. Safety and efficiency of epidural introduction of corticosteroids are not established therefore such use of corticosteroids is not recommended. Strict observance of rules of an asepsis is obligatory at drug use. Sertospan contains two active agents – betamethasone derivatives, one of which sodium betamethasone phosphate – quickly gets into a system blood stream. When prescribing the drug Sertospan it is necessary to consider possible systemic action of instant fraction of drug. 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. 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 Sertospan drug treatment should be resumed. If to the patient therapy is already appointed, then the dose of drugs can be increased. After the termination of long or high-dose corticosteroid therapy the medical observation during 1 year after completion of therapy can be necessary. Treat symptoms of insufficiency of bark of adrenal glands: discomfort, muscle weakness, mental disturbances, a lethargy, muscle and bones pain, peeling of skin, an asthma, nausea, vomiting, heat, a hypoglycemia, hypotonia, dehydration and even a lethal outcome after the sharp termination of treatment. Treatment of insufficiency of bark of adrenal glands consists in administration of adrenal hormones, corticosteroids, mineralokortikoid, waters, sodium of chloride and glucose. 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 in the anamnesis. 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. 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 boleznennost
, 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. It is necessary to avoid injections of corticosteroids directly in sinews as in the subsequent the sinew can become torn. 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. Special groups At drug treatment, patients with diabetes can need correction of antihyperglycemic therapy. 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. Against the background of use of the drug Sertospan, disturbances of mentality, especially at patients with emotional instability or tendency to psychoses are possible. It is necessary to appoint corticosteroids with care at: – not specific ulcer colitis, perforation threat, abscess or other pustulous infections – a diverticulitis – an intestinal anastomosis – a 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 – an Icenco-Cushing syndrome – diabetes – heart failure – epilepsy hard to cure – tendency to a thrombembolia or thrombophlebitises – pregnancies. 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. 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 Sertospan 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 Sertospan 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 Sertospan 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. Against the background of use of glucocorticosteroids the change of mobility and quantity of spermatozoa is possible. Sertospan contains benzyl alcohol which can cause toxic reactions and anaphylactic reactions in babies and children 3 years are younger. Not to appoint to premature children or newborns. Sertospan contains methylparahydroxybenzoate and propilparagidroksiben-zoat which can cause allergic reactions (perhaps slowed down type) and, in special cases, the complicated breath. Use in pediatric practice As corticosteroids are capable to slow down growth at newborns, 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 Pregnancy 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. In certain cases it is necessary to continue treatment by corticosteroids during pregnancy and even to increase a dose, for example, at replacement corticosteroid therapy. Intramuscular administration of betamethasone causes considerable decrease in frequency of an asthma in a fruit at administration of drug more than in 24 hours prior to childbirth (to 32 weeks of pregnancy). The published data show that preventive use of corticosteroids after 32 weeks of pregnancy still is disputable. Therefore the doctor has to weigh advantage and potential risks for mother and a fruit when assigning corticosteroids after 32 weeks of pregnancy. Corticosteroids are not appointed for treatment of a hyaline membrane disease after the birth. At preventive treatment of a hyaline membrane disease at premature babies not to enter corticosteroids to pregnant women with a preeclampsia or an eclampsia, or with signs of defeats of a placenta. 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. When injections of betamethasone were entered to mothers before childbirth, babies show a growth inhibition of a fruit and, presumably, hypophyseal hormones regulating production of steroids in the main and embryonic zones of adrenal glands of an embryo. However, the inhibition of an embryonic hydrocortisone does not interfere with hypophysial and adrenal reactions to a stress after the birth. As corticosteroids easily get through a placental barrier, the newborns and babies born by mothers receiving corticosteroids during the most part of pregnancy have to undergo careful inspection for the purpose of detection of possible, though very rare, congenital cataract. The women receiving corticosteroids during pregnancy have to be controlled carefully in time and after the pains, at childbirth for the purpose of detection of insufficiency of bark of adrenal glands because of the stress caused by childbirth. The lactation period Corticosteroids get through a placental barrier and are allocated with breast milk. In need of prescribing of the drug Sertospan 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). The feature of influence of medicine on ability to run the vehicle or potentially dangerous Sertospan mechanisms does not affect speed of reaction at control of vehicles 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 driving 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. A form of release and packing On 1 ml of drug in ampoules from colourless glass. On 1 ampoule without blister strip packaging. On 5 ampoules in blister strip packaging. 1 ampoule without blister strip packaging together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. On 5 ampoules one blister strip packaging together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. Storage conditions In the place protected from light at a temperature not over 25 of 0C. Not to freeze. To store out of children’s reach! Period of storage 3 years. Not to apply after expiry date. Prescription status According to the prescription the Producer Zentiva Saglyk Yuryunleri Sanayi ve A.Sh. Tidzharet, Merkez Sokak, No.: 223/A, 39780 Byuyyukkaryshtyran, Lyuleburgaz, Turkey ph. +90 (288) 4271000, fax: +90 (288) 4271455-56 The owner of the registration certificate Other Sertus Ilach Sanayi ve Tidzharet Limited of Shirketi, Istanbul, Turkey the Name, the address and a contact information of the organization, the accepting claim (offer) from consumers on quality of medicine in the territory of Republic of Kazakhstan Republic of Kazakhstan, Almaty, Turksibsky district, Suyunbaya Ave., 222 b. Ph. / fax: 8 (7272) 529090, the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222 b. Cellular ph. +7 701 786 33 98 (24-hour access), e-mail:
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