Composition, form of production and packaging
Solution for administration from colorless to slightly yellow, slightly opalescent.
1 ml (1 syringe)
Glatiramer acetate 20 mg
Auxiliary substances: mannitol, water d / and.
1 ml - syringes (1) - packings, cellular outline (28) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
Immunomodulating drug. Glatiramer acetate is an acetic acid salt of synthetic polypeptides formed by four natural amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine, and has chemical similarities to the basic myelin protein.
Has immunomodulatory properties and ability to block myelin-specific autoimmune reactions underlying the pathogenesis of the destruction of the myelin sheath of 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 myelin protein, myelin oligodendrocyte glycoprotein and proteolipid protein at the binding sites with molecules of the main histocompatibility complex of class 2 located on antigen-presenting cells.
The consequence of competitive displacement is two reactions: 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 the central nervous system. When they reach the site of inflammation in the central nervous system, these T-lymphocytes are reactivated with myelin antigens, which leads to the production of anti-inflammatory cytokines (including IL-4, IL-6, IL-10), which reduce local inflammation by suppressing local inflammatory T cell response. This results in the accumulation of specific anti-inflammatory Th2-type cells and inhibition of the pro-inflammatory system of Th 1 -cells.
In addition, the drug has a neuroprotective effect: it stimulates the synthesis of the neurotrophic factor by Th2-type cells and protects the brain structures from damage.
Copaxone В® -Tev does not have a generalized effect on the main links of normal immune reactions of the body, which fundamentally distinguishes it from nonspecific immunomodulators, including interferon-beta preparations.
The resulting antibodies to glatiramer acetate do not have a neutralizing effect, which reduces the clinical effect of the drug.
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, the pharmacokinetics data are only indicative. Based on them, as well as on the experimental data, it is believed that after the SC administration the preparation is rapidly hydrolyzed at the site of administration. Hydrolysis products, as well as a small part of unchanged glatiramer acetate, can enter the lymphatic system and partially reach the vascular bed. Glatiramer acetate performs its immunomodulatory action at the injection site. The therapeutic effect is mediated through the systemic spread of activated T-cell suppressors. The determined concentration of glatiramer acetate or its metabolites in the blood does not correlate with the therapeutic effect.
- Multiple sclerosis of the remitting course (to reduce the frequency of exacerbations and slow the development of disabling complications).
The drug is prescribed to adults daily s / c at a dose of 20 mg (1 filled syringe for injection) 1 time / day, preferably at the same time, for a long time.
Copaxone В® -Tev can not be administered iv and i / m.
Rules of injection
Blister with a filled syringe after storage in the refrigerator should be kept at room temperature for at least 20 minutes.
The solution is administered sc (observing the rules of asepsis and antiseptics) in the area of вЂ‹вЂ‹the forearm, abdomen (stomach area), buttocks or thighs, changing the injection site daily.
Do not inject into painful points, discolored, reddened skin or areas with seals and nodules. It is necessary to constantly change the injection points inside the injection area.
It is recommended to draw up a scheme for changing injection sites and to have it with you. You may need the help of another person for an injection.
In the presence of undissolved particles or discoloration, the solution of the preparation is not subject to use.
Each syringe containing the drug solution is for single use only; The remaining solution of the drug should be destroyed.
Do not mix the solution contained in the syringe, or inject it in parallel with any other drug.
If the drug is administered alone if an injection is missed, the patient should do it immediately, as soon as he remembers it. Do not administer a double dose of the drug. The next injection should be done only after 24 hours.
Do not stop using Copaxone В® -Tev without consulting your doctor.
Administration of the drug
1. Remove the syringe from the individual contour pack, removing the paper label (strip).
2. Take the syringe in the hand that you are writing. Remove the protective cap from the needle.
3. Pre-treated locally with a cotton swab with alcohol solution, lightly fold the skin into the fold with the thumb and forefinger.
4. With the syringe perpendicular to the injection site, insert the needle into the skin at an angle of 90 В°, insert the drug, evenly pressing the syringe piston down to the end (until it is completely emptied).
5. Remove the syringe with the needle moving vertically upwards, keeping the same angle of inclination.
6. Place the syringe in the disposal container.
Immediately after the injection , the following are possible:
Local reactions: pain, redness, swelling; rarely - atrophy of the skin or subcutaneous tissue at the injection site, abscess, hematoma.
Systemic reactions: hot flushes, chest pain, palpitations, anxiety, shortness of breath, difficulty swallowing, hives. These symptoms may be temporary and limited and do not require special intervention; they can begin several months after the initiation of therapy, the patient may experience a particular symptom occasionally.
Sometimes it can be observed:
From the cardiovascular system: palpitation, vasodilation; rarely - syncopal conditions, increased blood pressure, extrasystole, pallor, varicose veins.
From the digestive system: constipation, diarrhea, nausea; very rarely - anorexia, dysphagia, gastroenteritis, stomatitis, caries.
Allergic reactions: anaphylactic reactions, including shock.
On the part of the blood and lymphatic system: rarely - lymphadenopathy; very rarely - eosinophilia, splenomegaly.
From the side of metabolism: very rarely - swelling, loss of body weight, aversion to alcohol.
From the musculoskeletal system : rarely - arthralgia, arthritis.
From the side of the nervous system: rarely - emotional lability, confusion (stupor), convulsions, anxiety, depression, dizziness, tremor, ataxia, headache.
On the part of the respiratory system: rarely - increased respiration (hyperventilation); in isolated cases - bronchospasm, epistaxis, hypoventilation, change of voice.
On the part of the reproductive system: rarely - amenorrhea, impotence, menorrhagia, vaginal bleeding.
Other: rarely - hematuria.
- hypersensitivity to glatiramer acetate or mannitol.
The drug is not recommended for use in children and adolescents under the age of 18, since adequate and strictly controlled clinical studies of the safety of the drug in this contingent of patients have not been conducted.
PREGNANCY AND LACTATION
Adequate and well-controlled studies of the safety of glatiramer acetate in pregnancy have not been conducted. The use of the drug Copaxone В® -Tev in pregnancy is possible only on absolute indications.
It is not known whether glatiramer acetate is excreted in breast milk, therefore, if the drug is to be used during lactation, the expected benefit of therapy for the mother and the potential risk for the child should be correlated.
In experimental studies on animals, the mutagenic effect of glatiramer acetate and its negative effect on the parameters of the reproductive system, development of the embryo, and the process of delivery have not been revealed.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with renal dysfunction should regularly monitor laboratory indicators.
APPLICATION FOR CHILDREN
The drug is not recommended for use in children and adolescents under the age of 18, because adequate and strictly controlled clinical trials of safety of the drug in this contingent of patients have not been conducted.
With caution should prescribe the drug to patients who are predisposed to allergic reactions and with the pathology of the heart.
Patients with renal dysfunction should regularly monitor laboratory indicators.
The patient should be informed about the method of independent injections for the safe use of Copaxone В® -Teva and obtain instructions on the use of antiseptic methods in the preparation of an injection and its administration. The first injection should be carried out under the supervision of a qualified specialist. 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 re-use of needles and syringes, as well as the procedure for their safe disposal. Used needles and syringes should be put in a firm pack and only after that can be discarded. Patients should be informed of possible adverse reactions associated with the use of the drug.
Impact on the ability to drive vehicles and manage mechanisms
Based on the available data, there is no need for special precautions for persons driving a vehicle or complex equipment.
Data on the overdose of Copaxone В® -Tev is not available.
The interaction between the drug Copaxone В® -Tev and other drugs has not been studied enough. In the process of clinical trials, no significant drug interaction was detected, including the simultaneous use of Copaxone В® -Teva with drugs that are used for the therapy of multiple sclerosis, incl. with corticosteroids (with simultaneous application for up to 28 days). It is extremely rare to increase the frequency of local reactions.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of 2 В° to 8 В° C (in the refrigerator). If there is no possibility of storage in the refrigerator, the drug can be stored at a temperature of 15 В° to 25 В° C, but not more than 1 month. If after this period the product is not used and is in the original packaging, it should be stored in the refrigerator (2 В° -8 В° C). Shelf life - 2 years.