Copaxone-Teva, 20 mg/ml 1 ml syringes 28 pcs

Copaxone-Teva (glatiramer acetate) is the acetic acid salt of a mixture 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 similar to the main myelin protein.

Glatiramer acetate reverses the course of the pathological process in the demyelinating CNS disease multiple sclerosis, which is an autoimmune disease that changes the ratio of T-suppressors in the body. Glatiramer acetate has an immunomodulatory effect at the injection site. Its therapeutic effect is mediated through systemic distribution of activated T-suppressors.

Glatiramer acetate has a specific mechanism of action based on the ability to competitively displace myelin antigens – myelin basic protein, myelin oligodendrocytic glycoprotein and proteolipid protein in the binding sites with molecules of the main histocompatibility complex class 2, located on antigen-presenting cells. The consequence of competitive displacement is two responses: stimulation of antigen-specific suppressor T lymphocytes (Th2-type) and inhibition of antigen-specific effector T lymphocytes (Th1-type). Activated T-suppressor lymphocytes enter the systemic circulation and penetrate into the CNS.

Once at the site of inflammation in the CNS, these T-lymphocytes are reactivated by myelin antigens, resulting in their production of anti-inflammatory cytokines (including IL-4, IL-6, IL-10). These cytokines reduce local inflammation by suppressing the local inflammatory T-cell response, leading to the accumulation of specific anti-inflammatory Th2-type cells and inhibition of the pro-inflammatory Th1-cell system.

In addition, glatiramer acetate stimulates synthesis of neurotrophic factor by Th2 cells and protects brain structures from damage (neuroprotective effect). Glatiramer acetate has no generalized effect on the main parts of the normal immune reactions of the body, which distinguishes it in principle from nonspecific immunomodulators, including beta-interferon drugs. Formed antibodies to glatiramer acetate do not have a neutralizing effect during long-term use, which reduces the clinical effect of the drug.

Indications

• clinically isolated syndrome (a single clinical episode of demyelination suggestive of multiple sclerosis) with a severity of inflammation requiring the use of IV GCS (to slow the transition to clinically reliable multiple sclerosis);
• relapsing-remitting multiple sclerosis (to reduce the frequency of exacerbations, slow the development of disabling complications).

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Active ingredient

Glatiramer acetate

How to take, the dosage

The drug is administered to adults daily by injection in a dose of 20 mg (1 filled syringe for injection) once a day, preferably at the same time, for a long time.

Copaxone-Teva should not be administered by IV or IM.

Injection rules

The blister with the filled syringe should be kept at room temperature for at least 20 minutes after storage in the refrigerator.

The solution is administered by injection (observing aseptic and antiseptic rules) in the forearm, abdomen (stomach area), buttock or thigh, changing the injection sites daily.

Injections should not be made in painful spots, discolored, reddened skin areas or areas with lumps and nodules. The injection sites within the injection area should be changed constantly.

It is recommended that you make a chart of the injection site changes and have it with you. You may need the help of another person to administer the injection.

If there are undissolved particles or color changes, the drug solution should not be used.

Each syringe containing drug solution is for single use only; the remaining drug solution must be destroyed.

The solution in the syringe should not be mixed or injected in conjunction with any other product.

If self-administered, if an injection is missed, the patient should give the injection immediately as soon as he or she remembers it. It is not permitted to administer a double dose of the drug. The next injection should not be given until 24 hours later.

The use of Copaxone-Teva should not be discontinued without consulting a physician.

Injection of the drug

1. Take out the syringe from the individual contour cell pack by removing the paper label (strip).

2. Hold the syringe in the hand you are writing with. Remove the protective cap from the needle.

3. Pre-treating the injection site with a cotton swab with an alcohol solution, gently gather the skin into a crease with your thumb and forefinger.

4. Positioning the syringe perpendicular to the injection site, insert the needle into the skin at an angle of 90°, inject the drug, pressing the syringe piston down evenly until it stops (until it empties completely).

5. Retrieve the syringe with the needle in a vertical upward motion, maintaining the same angle of inclination.

6. place the syringe in a container for disposal.

Interaction

The interaction between the drug Copaxone-Teva and other medicinal products has not been sufficiently studied.

In clinical trials no significant drug interactions have been found, including concomitant use of Copaxone-Teva with drugs used for therapy of multiple sclerosis, including corticosteroids (when used simultaneously for up to 28 days).

In extremely rare cases, the frequency of local reactions may increase.

Special Instructions

Caution should be exercised when prescribing the drug in patients prone to allergic reactions and with cardiac pathology.

Patients with impaired renal function should have their laboratory values monitored regularly.

The patient must be informed about the technique of self-injection for safe use of Copaxone-Teva and be instructed on the use of antiseptic methods when preparing the injection solution and its administration. The first injection should be performed under the supervision of a qualified specialist.

The patient’s understanding of the importance of using antiseptic treatment for self-injections should be periodically monitored. Patients should be informed that needles and syringes should not be reused and that they should be disposed of safely. Used needles and syringes should be placed in a solid container and only then discarded. Patients should be informed about possible adverse reactions associated with the use of the drug.

Impact on driving and operating machinery

Based on available data, there is no need for special precautions for persons driving a vehicle or operating complex machinery.

Copaxone-Teva is compatible with corticosteroid hormones.

Contraindications

• hypersensitivity to glatiramer acetate or mannitol;
• pregnancy;
• children under 18 years (effectiveness and safety are not studied).

With caution: predisposition to allergic reactions; cardiovascular disease; impaired renal function.

Side effects

Immediately after injection there may be:

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

Systemic reactions: hot flashes, chest pain, palpitations, anxiety, shortness of breath, difficulty in swallowing, urticaria. These symptoms may be temporary and limited in duration, and do not require special intervention; they may start months after therapy begins, or a patient may experience a symptom occasionally.

Sometimes they can be observed:

Cardiovascular system: palpitations, vasodilation; rarely, syncope, increased BP, extrasystole, pallor, varicose veins.

In the digestive system: constipation, diarrhea, nausea; very rare – anorexia, dysphagia, gastroenteritis, stomatitis, dental caries.

Allergic reactions: anaphylactic reactions, including shock.

The blood and lymphatic system: rare – lymphadenopathy; very rare – eosinophilia, splenomegaly.

Metabolism disorders: very rarely – edema, weight loss, aversion to alcohol.

Muscular system: rare – arthralgia, arthritis.

Nervous system disorders: rarely – emotional lability, mental confusion (stupor), convulsions, anxiety, depression, dizziness, tremor, ataxia, headache.

Respiratory system: rarely – rapid breathing (hyperventilation); in single cases – bronchospasm, nasal bleeding, hypoventilation, voice changes.

As for the sexual system: rarely – amenorrhea, impotence, menorrhagia, vaginal bleeding.

Others: rare – hematuria.

Overdose

There are no data on overdose of Copaxone-Teva.