Copaxone-TEVA

Active material: Glatiramer acetate
When ATH: L03AX13
CCF: Immunomodulator. Preparation, primenâemyj at rasseânnom sclerosis
ICD-10 codes (testimony): G35
When CSF: 02.12
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Pharmaceutical form, composition and packaging

The solution for the p / to the introduction colorless to slightly yellow, slightly opalescent.

Excipients: mannitol, water d / and.

1 ml – syringes (1) – packings Valium planimetric (28) – cardboard boxes.

Pharmacological action

Immunomodulatory drugs. Glatiramer acetate is an acetic acid salt of synthetic polypeptides, educated 4 natural amino acids: L-glutamic acid, L-аланином, L-tyrosine and L-lysine and chemical structure has similarities to myelin basic protein.

It has immunomodulatory properties and capable of blocking myelin-specific autoimmune reactions, underlying the pathogenesis of destruction of the myelin sheath of nerve conductors CNS in multiple sclerosis.

Glatiramer acetate has a specific mechanism of action, which is based on the ability to competitively replace myelin antigens – myelin basic protein, myelynovыy olyhodendrotsytarnыy glycoprotein and proteolypydnыy proteyn in place svyazыvanyya with complex molecules hlavnoho hystosovmestymosty class 2, located on antigen-presenting cells.

The consequence of the competitive displacement are two reactions: stimulation of antigen-specific suppressor T-lymphocytes (Th2-типа) and inhibition of antigen-specific effector T lymphocytes (Th1-типа). Activated T-suppressor lymphocytes enter the systemic circulation and enter the CNS. Getting to the site of inflammation in the CNS, These T cells are reactivated myelin antigens, which leads to the production of inflammatory cytokines (incl. IL-4, IL-6, IL-10), that reduce local inflammation by suppressing local inflammatory T-cell response. This leads to the accumulation of inflammatory cells specific Th₂-type and inhibition of pro-inflammatory Th₁-cell.

Besides, the drug has a neuroprotective effect: It stimulates the synthesis of a neurotrophic factor Th cells₂-types and protects against damage to brain structures.

Copaxone^®-Teva does not have a generalized effect on the main elements of the normal immune response of the organism, that distinguishes it from non-specific immunomodulators, including preparations of beta-interferons.

The resulting antibodies to glatiramer acetate do not have the effect of neutralizing, reducing the clinical effect of the drug.

Pharmacokinetics

Due to the nature of the chemical structure of glatiramer acetate, which is a mixture of polypeptides, formed by natural amino acids, and the low therapeutic dose pharmacokinetic data are only indicative value. Based on these, as well as the experimental data, believe, after s / to the introduction of the drug is rapidly hydrolyzed at the injection site. The hydrolysis products, as well as a small portion of unchanged glatiramer acetate, can enter the lymphatic system and partly to achieve vascular bed. Glatiramer acetate exerts its immunomodulatory effects at the injection site. The therapeutic effect is mediated through the systemic spread of activated T-cell suppressor. Determines the concentration of glatiramer acetate or its metabolites in the blood is not correlated with the therapeutic effect.

Testimony

- Relapsing-remitting multiple sclerosis flow (to reduce the frequency of relapses and slowing the progression of disabling complications).

Dosage regimen

The drug is prescribed for adults daily n / a dose of 20 mg (1 filled syringe for injection) 1 times / day, preferably at the same time, protractedly.

Copaxone^®-Teva should not be administered in / in / m.

Terms of injection

Blister with filled syringes after storage in the refrigerator should be kept at room temperature for at least 20 m.

The solution was injected s / c (observing the rules of aseptic and antiseptic) in the forearm, life (the stomach), buttocks or thighs, daily changing the injection site.

It should not be injected into the painful points, bleached, reddened skin, or the fate of the region with seals and nodules. It is constantly changing in terms of injections within the injection area.

In the presence of undissolved particles of the drug solution is not subject to the use of.

Each syringe, containing solution formulation, intended for single use only; the remaining solution of the drug should be destroyed.

Do not mix the solution, contained in the syringe, or introducing it in parallel with any other drug.

With self-administered the drug in case of missing injections, the patient should do it immediately, as soon as remember it. It is not allowed to enter a double dose. The next injection should be done only through 24 no.

The introduction of the drug

1. Take the syringe from the individual blisters, Remove the paper marking (strip).

2. Take a syringe in his hand, who writes. Remove the protective cap from the needle.

3. Pretreated local injection cotton cloth with an alcohol solution, gently raise the skin in the fold between thumb and forefinger.

4. With a syringe perpendicular to the injection site, inserting a needle into the skin at an angle of 90 °, enter drug, uniformly pressing the plunger of the syringe down to the end (until complete emptying).

5. Remove the syringe and needle movement vertically upwards, maintaining the same angle of inclination.

6. Place the syringe in container for disposal.

Side effect

Cardio-vascular system: heartbeat, vasodilation, hot flushes, chest pain; rarely – syncope, increased blood pressure, arrythmia, paleness, phlebeurysm.

From the digestive system: constipation, diarrhea, nausea; rarely – anorexia, dysphagia, gastroenteritis, stomatitis, caries.

From the central and peripheral nervous system: anxiety state; rarely – emotional lability, pomrachnenie consciousness (stupor), convulsions, depression, dizziness, tremor, ataxia, headache.

From the blood and lymphatic system: rarely – lymphadenopathy; rarely – eozinofilija, splenomegaly.

Metabolism: rarely – swelling, weight loss, aversion to alcohol.

On the part of the musculoskeletal system: rarely – arthralgia, arthritis.

The respiratory system: rarely – shortness of breath (hyperventilation); in a few cases – bronchospasm, nose bleed, gipoventilyatsiya, voice alteration.

On the part of the reproductive system: rarely – amenorrhea, impotence, menorragija, vaginal bleeding.

Allergic reactions: hives, anaphylactic reactions, including shock.

Local reactions: pain, redness, edema; rarely – atrophy of the skin or the subcutaneous tissue at the injection site, abscess, hematoma.

Other: rarely – hematuria.

Contraindications

- Hypersensitivity to glatiramer acetate or mannitol.

The drug is not recommended for use in children and adolescents under the age of 18 years, as adequate and well-controlled clinical studies on the safety of the drug in these patients has not been.

Pregnancy and lactation

Adequate and well-controlled studies of the safety of glatiramer acetate in pregnancy have not been conducted. Use of the drug Copaxone^®-Teva during pregnancy is possible only if absolutely indicated.

Unknown, whether it is allocated glatiramer acetate in breast milk, therefore, if necessary, use during lactation should be related to the expected benefit of therapy for the mother and the potential risk for the baby.

IN experimental studies in animals revealed no mutagenic effect of glatiramer acetate and its negative impact on the parameters of the reproductive system.

Cautions

Precautions should be prescribed to patients, prone to allergic reactions and heart disease.

Patients with impaired renal function should be regularly monitoring of laboratory parameters.

The patient should be informed about the self-injection technique for the safe use of Copaxone^®-Teva and get instructions on how to use antiseptic techniques in the preparation of injectable solution and administered. The first injection should be supervised by an experienced physician. It is necessary to periodically monitor the patient's understanding of the importance of using antiseptic treatment at separate injections. Patients should be informed about the inadmissibility of re-use of needles and syringes, as well as the procedure for their safe disposal. Used needles and syringes should be placed in a hard pack and only field that can be thrown away. Patients should be informed of the possibility of adverse reactions, associated with drug.

Effects on ability to drive vehicles and management mechanisms

Based on the available data there is no need for special precautions for persons, drive or sophisticated technology.

Overdose

Data on overdose of Copaxone^®-Teva is available not.

Drug Interactions

Interaction between Copaxone^®-Teva and other medicines understudied. During clinical trials no significant drug interactions have been identified, including the simultaneous use of Copaxone^®-Teva with preparations, are used for the treatment of multiple sclerosis, incl. with corticosteroids (while the application for up to 28 days). Very rarely can increase the frequency of local reactions.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored at 2 ° to 8 ° C (in a refrigerator). If it is impossible to refrigerate the drug can be stored at a temperature of from 15 ° to 25 ° C., but not more 1 of the month. If after this period, the drug is not used and is in its original packaging, Further it should be stored in the refrigerator (2° -8 ° C). Shelf life – 2 year.