Copaxone 20 solution for subcutaneous injection of 20mg ml syringe 1ml N28
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Active ingredients
Glatiramer Acetate
Release form
Solution
Composition
1 ml (1 syringe) of the solution contains: Active substance: Glatiramer acetate 20 mg. Auxiliary substances: mannitol, water d / and.
Pharmacological effect
Immunomodulatory drug. Glatiramer acetate is an acetic acid salt of synthetic polypeptides formed by 4 natural amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine and by chemical structure has elements of similarity with the main myelin protein. It has immunomodulatory properties and the ability to block myelin -specific autoimmune reactions underlying the pathogenesis of destruction of the myelin sheath of the CNS nerve conductors in multiple sclerosis. Glatiramer acetate has a specific mechanism of action, which is based on the ability to competitively replace myelin antigens - the main protein of myelin, myelin oligodendrocyte glycoprotein and proteolipid protein in the sites of binding to class 2 histocompatibility molecules located on antigen-presenting cells. Two reactions are caused by competitive exclusion: stimulation of antigen-specific suppressor cells lymphocytes (Th2-type) and inhibition of antigen-specific effector T-lymphocytes (Th1-type). Activated T-suppressor lymphocytes enter the systemic circulation and enter the central nervous system. Getting into the site of inflammation in the central nervous system, these T-lymphocytes are reactivated by myelin antigens, which leads to their production of anti-inflammatory cytokines (including IL-4, IL-6, IL-10), which reduce local inflammation by suppressing local inflammatory T cell response. This leads to the accumulation of specific anti-inflammatory Th2-type cells and inhibition of the pro-inflammatory system of Th1-cells. In addition, the drug has a neuroprotective effect: stimulates the synthesis of neurotrophic factor by Th2-type cells and protects brain structures from damage.Copaxone; -Teva does not have a generalized effect on the main links of the body’s normal immune responses, which fundamentally distinguishes it from non-specific immunomodulators, including interferon-beta drugs. Antibodies to g atiramera acetate do not have a neutralizing effect that reduces the clinical effect of the drug.
Pharmacokinetics
Due to the peculiarities of the chemical structure of Glatiramer acetate, which is a mixture of polypeptides formed by natural amino acids, as well as a low therapeutic dose, data on pharmacokinetics are only indicative. Based on them, as well as on experimental data, it is believed that after s / c administration the drug is rapidly hydrolyzed at the injection site. The products of hydrolysis, as well as a small part of the unchanged Glatiramer acetate, can enter the lymphatic system and partially reach the vascular bed. Glatiramer acetate performs its immunomodulatory effects at the injection site. The therapeutic effect is mediated through the systemic proliferation of activated suppressor T-cells. The determined concentration of Glatiramer acetate or its metabolites in the blood does not correlate with the therapeutic effect.
Indications
It is used to treat multiple sclerosis of the remitting course (to reduce the frequency of exacerbations, slow down the development of disability).
Contraindications
- hypersensitivity to Glatiramer acetate or mannitol. The drug is not recommended for use in children and adolescents under the age of 18 years, since adequate and strictly controlled clinical studies of the safety of the drug in this cohort of patients have not been conducted.
Precautionary measures
The drug is intended for single use only. Unused drug or waste must be destroyed.
Use during pregnancy and lactation
Adequate and well-controlled studies of the safety of using Glatiramer acetate during pregnancy have not been conducted. Use of the drug Copaxone-Tev in pregnancy is possible only by absolute indications. It is not known whether Glatiramer acetate is excreted in breast milk, so if you need to use the drug during lactation, you should correlate the expected benefit of therapy for the mother and the potential risk to the baby. The mutagenic action of Glatiramer acetate and its negative effect on the parameters of the reproductive system, the development of the embryo and the process of childbirth.
Dosage and administration
The drug is prescribed to adults daily at a dose of 20 mg (1 filled syringe for injection) 1 time / day, preferably at the same time, for a long time. Kopakson-Teva can not be administered in / and in / m.
Side effects
Immediately after the injection are possible: Local reactions: pain, redness, swelling; rarely - atrophy of the skin or subcutaneous tissue at the injection site, abscess, hematoma. Systemic reactions: flushing, chest pain, heart palpitations, anxiety, shortness of breath, difficulty swallowing, urticaria. These symptoms may be temporary and limited and do not require special intervention; they may begin several months after the start of therapy, the patient may experience this or that symptom occasionally. Sometimes it can be observed: From the side of the cardiovascular system: heartbeat, vasodilation; rarely - syncopal conditions, increased blood pressure, beats, pallor, varicose veins. On the digestive system: constipation, diarrhea, nausea; very rarely - anorexia, dysphagia, gastroenteritis, stomatitis, caries. Allergic reactions: anaphylactic reactions, including shock. From the blood and lymphatic system: rarely - lymphadenopathy; very rarely - eosinophilia, splenomegaly. Metabolism: very rarely - edema, weight loss, aversion to alcohol. From the musculoskeletal system: rarely - arthralgia, arthritis. From the nervous system: rarely - emotional lability, dullness of consciousness (stupor), convulsions, anxiety, depression, dizziness, tremor, ataxia, headache. On the respiratory system: rarely - increased breathing (hyperventilation); in isolated cases - bronchospasm, nasal bleeding, hypoventilation, voice change. From the reproductive system: rarely - amenorrhea, impotence, menorrhagia, vaginal bleeding. Other: rarely - hematuria.
Overdose
A few cases of Copaxone overdose have been reported (with up to 300 mg of Glatiramer Acetate). These cases were not accompanied by the occurrence of other reactions than those listed in the “Adverse Reactions” section. In the event of an overdose, it is necessary to monitor patients and prescribe appropriate symptomatic and supportive therapy.
Interaction with other drugs
The interaction between Copaxone 40 and other drugs has not been studied enough. There is no data on interaction with beta interferon. An increased frequency of reactions at the injection site of Copaxone 40 was observed. An increase in the frequency of local reactions was reported in patients receiving corticosteroid therapy. In vitro studies indicate that Glatiramer acetate in the blood binds to plasma proteins, but it is not replaced and does not replace phenytoin or carbamazepine. However, since theoretically Copaxone 40 has the ability to influence the distribution of protein-related substances, it is necessary to carefully monitor the concomitant use of such drugs.
special instructions
Precautions should be prescribed to patients predisposed to allergic reactions and with heart disease. Patients with impaired renal function should be regularly monitored laboratory indicators. The patient should be informed about the method of self-injection for the safe use of the drug Copaxon-Teva and receive instructions for using antiseptic when preparing the injection solution and its introduction. The first injection should be carried out under the supervision of a qualified technician. It is necessary to periodically monitor the patient's understanding of the importance of using antiseptic treatment for self-injection. Patients should be informed about the inadmissibility of the reuse of needles and syringes, as well as the procedure for their safe disposal. Used needles and syringes should be put in a hard package and only then can be discarded. Patients should be informed about possible adverse reactions associated with the use of the drug. Effect on the ability to drive vehicles and control mechanisms. Based on the available data, there is no need for special precautions for those driving a car or a complicated vehicle.