Kopakson-teva

Roman name

Copaxone # -Teva

The composition and the form of

1 bottle with liofilizirovannam powder for solution to the p / to the introduction of glatiramer acetate 20 mg; together with the solvent (water for injection) in the USD 1 ml, in a package 28 kits.

Characteristics

Glatiramer acetate is uksousnokisloy salt synthetic polipeptidov formed four natural amino acids (L, L-alaninom, L-tirosinom and L-lizinom) and the Chemical Engineering has similarities with the basic myelin protein.

Of drugs

Immunomodulirutee. Competitive replaces myelin antigens is a major myelin protein, mielinovy oligodendrocitarnyi glikoprotein and proteolipidnyi protein in binding to molecules major histocompatibility complex class II on the surface of cells are antigens. This is a stimulation антиген-специфически�� supressornah T (Th2-tipa), and braking �нтиген-специфических �ffectornah T (Th1-tipa). Activated T-supressorne cells come with the system and the ability to penetrate the central nervous system, where it came to the station inflammation, reaguiruyutza myelin antigens, which leads to products противовоспалительны х Cytokines (interleykin 4, interleykin-6, interleykin-10, etc.). These zitokin reduce local inflammation, by the suppression of the local cellular inflammatory response, which leads to the accumulation противовоспалительны х Th2-tipa cells and suppression of provospalitelna Th1.

Pharmacokinetics

Due to the nature of chemical structure, and low therapeutic dose pharmacokinetics study of glatiramer acetate gave approval Rezultata.posle s / c injection medicine quickly hydrolyses in the introduction. Products hydrolysis, as well as a small portion unchanged glatiramer acetate can be the lymphatic system, and partly to achieve vascular bed. An concentration glatiramer acetate or its metabolites in the blood does not match extended therapeutic effects.

Farmakodinamika

Does mielin-specificskie autoimmunity underlying the destruction caused casing conductors CNS distributed in EMG. There is generalized impact on the core normal immune reactions organism. Identified antibody glatiramer azetatu do not have details, reducing clinical effect Preparata.proavlet its immunomodulirutee act in the place of injection. Therapeutic effect mediated through the system activated supressornah T-kletok.v pilot studies had revealed mutagennogo actions and the negative impact on the reproductive system, the development of the embryo and the process of childbirth.

Indications

MS relapsing course (to reduce the frequency of relapses and to slow the development of disabling complications).

Pregnancy and lactation

In the case of pregnancy, only in absolute grounds (controlled safety studies had been conducted). Is not known is whether glatiramer acetate in breast milk, so if you need to apply during the period of breast-feeding should weigh the expected benefits of therapy for the mother and the potential risk to the child.

Contraindications

Гиперчувствительност ь (incl. to mannitu). is not recommended for children under 18 and seniors (special studies of this patient population did not).

Side-Effects

Immediately after the injections can local reactions (pain, redness, swelling, in rare cases, the atrophy of the skin at the injection, abscess, hematoma). System response, a phenomenon vazodilatace, pain in the chest, heart palpitations, anxiety, shortness of breath, difficulty swallowing, urticaria, can be temporary and limited in nature and do not require special intervention; they could begin a few months after the start of Terapii.drugie possible side Reaktion.so the circulatory system and blood (blood, gemostaz) : tachycardia, rarely sincopale state, the AD arrythmia, paleness of skin, varicose veins limfadenopatia very rarely eozinofilia, Splenomegalia.so part of the intestine : constipation, diarrhea, and nausea; very rarely, anorexia, gastroenteritis, disease, dental caries, the Disfagia.so metabolism : very rarely, swelling, loss of body weight, aversion to Alkilu.so the musculoskeletal system : seldom -artralgia, Artrit.so the nervous system and sensory organs : seldom-emotional lability, drowsiness (stalemate), convulsions, anxiety, depression, dizziness, tremor, ataxy, headache Bol.so the respiratory system : rarely showing respiration (giperventilatia); in a few cases, bronhospazm, active bleeding, gipoventilatia change Golos.so the urogenital system : rarely amenorea, gematuria, impotence, menorragia etc. vaginal �ровотечения.Аллергич еские reactions : allergic shock anaphylactoidnye reaction.

Specific guidance

For safe and effective use of the drug, patients must :-provide a doctor of the existence of pregnancy, to have a child or offensive pregnant at the time of treatment; Notify the doctor that feed you her child; is not to change the dose or the introduction and to continue receiving drug without consulting Vrachom.patienta shall be instructed on the use of Antiseptic techniques in a product, its preparation solution and taught how to self-injection. The first injection should be under the supervision of a qualified professional. Understanding the importance of the patient antisepticescoy use of the self-injection and procedures should be periodically monitored. Patients should be advised not reuse needles and syringes, as well as the safe disposal. Before disposal of used needles and syringes should be placed in the firm Upakovku.pri of undiluted particles prepared solution of podljeit not. The contents of bottle is for a single application, the remainder of the solution should be destroyed.

Patient interaction

Studied enough. Not yet identified any drug interactions, including simultaneous application with korticosteroidami for up to 28 days (with the frequency of local reactions may increase).

Precautions

Be wary appoint patients with pathology Serdza.ballam-impaired kidney requires regular monitoring of laboratory performance.

Dosing and Administration

P / to the daily, 20 mg / day one, preferably at the same time, preparations Dlitelno.dl solution attached solvent added to a bottle with sterile syringe with a needle, a bottle gently vesbaltarve and leave at room temperature to dissolve the solid частиц.Приготовленны�� solution recruited sterile syringe with a new needle 112be and introduce e / to the forearms, abdomen or thighs, the daily changing of Wvedenia.rastvor contains no preservatives and should be used immediately after cooking.

Storage conditions

por.liof.d / in. : List B. The temperature of 2-8 ° C. In the refrigerator. - Solvent at room temperature.

Shelf life

por.liof.d / in. : 2 city. Solvent-3 years.

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