Domestic substitute for Copaxone. The drug 'Copaxone-Teva' - instructions for use, description and reviews

A delicious, healthy and appetizing looking breakfast will be a great and positive start to the day. And if for its preparation it was not required a large number of time spent at the stove, or the help of small household members just came in handy - breakfast becomes a holiday. Egg dishes fit perfectly into our concept healthy breakfast, after all, having been charged with the energy of protein food in the morning, the body will be in good shape all day. What can be cooked from eggs, except for the banal scrambled eggs and a light omelette? Let's show imagination, use the products left over from dinner, and let's start.

Ingredients:

• - 4 things.
• - 1 PC.
• - 1 PC.
• - for frying
• , - taste.

Peel and finely chop the onion, cut the pepper into rings (or use the leftovers from the decoration holiday table, then it will turn out more fun if the peppers are different color). Heat the oil in a frying pan, put the circles of peppers, pour onions into each and break one egg at a time, trying not to damage the yolk. Cook over high heat for 2 minutes, add salt and pepper, reduce heat and fry until the yolk is the state you like.

Ingredients:

• - 6 pcs.
• - 6 pcs.
• - 100 gr.
• , - 1/2 bundle
• - 100 gr.
• , - taste.

From every bun sharp knife cut off the top, take out the pulp with a teaspoon and place the buns on a baking sheet covered with baking paper. Carefully break an egg into a bun, add salt, pepper and chopped herbs on top, pour in the cream. Cook in an oven preheated to 190 degrees for 15-20 minutes.

Ingredients:

• - 2 pcs.
• Toast from - 2 pcs.
• Leaves for serving
• - 2 tbsp. l.
• , - taste.

Eat different ways cooking poached eggs, we will share another, quite simple. Pour water into a deep frying pan (3-4 cm), salt well and add vinegar. Boil. While the water boils, break an egg into different cups (bowls, glasses) so that the yolk remains intact. Carefully but quickly pour the eggs into the water, cover and turn off the heat. After 4-5 minutes, put the eggs on toast with lettuce. It is most convenient to get ready-made eggs with a slotted spoon.

Ingredients:

• - 4 things.
• - 2 pcs.
• - for frying
• - taste.

Cut the sausages lengthwise, then make transverse cuts on each half, roll up the resulting fan and chop with a toothpick. Put in a frying pan with heated oil, cook for 2 minutes and carefully break one egg into the middle of the flowers, salt. Fry until the yolks are ready. Garnish with herbs and fresh herbs, if desired.

Solution for subcutaneous injection- 1 ml:

• active substance: glatiramer acetate - 20 mg;
• excipients: mannitol (mannitol) - 40 mg; water for injection - q.s. up to 1 ml.

Solution for subcutaneous administration, 20 mg/ml. In disposable type I (Ph. Eur.) clear glass syringe with plastic plunger and rubber plunger seal, with a fixed needle protected by a double cap, consisting of an inner rubber and an outer hard plastic part, 1 ml. 5 or 7 syringes in a PVC blister pack. 4 or 6 blisters in a carton box.

Packing "in bulk": 7 syringes in a PVC blister pack. 24 blister packs in a carton or 4 blister packs in an unmarked carton pack, 6 carton packs in a carton box.

When secondary packaging on the territory of the Russian Federation: 4 blisters in a carton pack for consumer packaging of chrome or chrome-ersatz subgroups according to GOST 7933-89 or imported, approved for use in the Russian Federation.

Description of the dosage form

Solution: slightly opalescent, colorless to light yellow color.

pharmachologic effect

Immunomodulating.

Pharmacokinetics

Due to the peculiarities chemical structure glatiramer acetate, which is a mixture of polypeptides formed by natural amino acids, as well as low therapeutic dose data on pharmacokinetics are only indicative. Based on them, as well as experimental data, it is believed that after s / c injection of glatiramer acetate is rapidly hydrolyzed at the injection site. Hydrolysis products, as well as a small part of unchanged glatiramer acetate, can enter the lymphatic system and partially reach the vascular bed. The determined concentration of glatiramer acetate or its metabolites does not correlate with therapeutic effect.

Pharmacodynamics

Copaxone®-Teva (glatiramer acetate) is an 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 in terms of chemical structure it has elements of similarity with myelin basic protein.

Glatiramer acetate changes course pathological process with a demyelinating disease of the central nervous system - multiple sclerosis, which refers to autoimmune diseases that change the ratio of T-suppressors in the body. Glatiramer acetate has an immunomodulatory effect at the injection site. His therapeutic effect mediated through the systemic distribution of activated T-suppressors. Glatiramer acetate has a specific mechanism of action, which is based on the ability to competitively replace myelin antigens - myelin basic protein, myelin oligodendrocyte glycoprotein and proteolipid protein at binding sites with MHC class 2 molecules located on antigen-presenting cells. Competitive displacement results in 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 enter the CNS. Once in the site of inflammation in the CNS, these T-lymphocytes are reactivated by myelin antigens, which leads to the 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, which leads to the accumulation of specific anti-inflammatory Th2-type cells and inhibition of the pro-inflammatory Th1-cell system.

In addition, glatiramer acetate stimulates the synthesis of the neurotrophic factor by Th2 cells and protects brain structures from damage (neuroprotective effect). Glatiramer acetate does not have a generalized effect on the main links of normal immune reactions body, which fundamentally distinguishes it from non-specific immunomodulators, including beta-interferon preparations. The resulting antibodies to glatiramer acetate long-term use do not have a neutralizing effect, reducing clinical effect drug.

Instruction

1. It is necessary to make sure that everything necessary for the injection is available: a disposable syringe filled with a solution of Copaxone®-Teva, a container for used syringes, a cotton swab moistened with alcohol.
2. Before injection, remove the disposable syringe from the blister pack by removing the protective paper strip.
3. Keep the syringe with the solution at room temperature for at least 20 minutes.
4. Wash your hands thoroughly with soap and water before administering Copaxone®-Teva.
5. Carefully inspect the solution in the syringe. In the presence of suspended particles or changes in the color of the solution, it should not be used.
6. Choose an injection site. Possible areas for injection: arms, thighs, buttocks, abdomen (approximately 5 cm around the navel). Do not inject into painful areas, discolored, reddened areas of the skin, or areas with seals and nodules. By choosing a new location, you can reduce discomfort and pain during injection. There is enough space inside each injection zone for several injections. It is recommended to draw up a map of injection sites and have it with you. For injections into the buttocks and arms, the patient will need the help of another person.
7. Remove the protective cap from the needle.
8. Pre-treat the injection site with a cotton swab moistened with alcohol solution, lightly gather the skin into a fold with your thumb and forefinger.
9. Positioning the syringe needle perpendicular to the injection site, pierce the skin and, evenly pressing on the syringe plunger, inject its contents into the injection site.
10. Remove the needle by moving the syringe perpendicular to the injection site.
11. Place the syringe in a container for used syringes.

If you miss the introduction of the drug Copaxone®-Teva, you need to make an injection immediately, as soon as you remember about it. You can not enter a double dose of the drug. The next syringe with Copaxone®-Teva should be used only after 24 hours.

Indications for use Copaxone-Teva

• clinically isolated syndrome(the only clinical episode of demyelination suggesting multiple sclerosis) with severity inflammatory process requiring the use of intravenous corticosteroids (to slow the transition to clinically significant multiple sclerosis);
• relapsing-remitting multiple sclerosis (to reduce the frequency of exacerbations, slow the development of disabling complications).

Contraindications to the use of Copaxone-Teva

• hypersensitivity to glatiramer acetate or mannitol;
• pregnancy;
• children under 18 years of age (efficacy and safety have not been studied).

With caution: predisposition to the development of allergic reactions; cardiovascular diseases; impaired renal function.

Copaxone-teva Use in pregnancy and children

There are no data on the use of glatiramer acetate during pregnancy. possible risk such use during pregnancy has not been established. The drug Copaxone®-Teva is contraindicated during pregnancy.

During treatment with Copaxone®-Teva, reliable methods of contraception must be used.

It is not known whether glatiramer acetate is excreted from breast milk therefore, if necessary, use during lactation should evaluate the expected benefit of therapy for the mother and the potential risk to the child.

Copaxone-teva side effects

Copaxone®-Teva is safe and well tolerated by patients. In some cases, the following adverse reactions may occur.

From the blood and lymphatic system: lymphadenopathy, leukocytosis, leukopenia, splenomegaly, thrombocytopenia, changes in the structure of lymphocytes.

From the side immune system: hypersensitivity reaction, anaphylactoid reaction, angioedema.

From the side endocrine system: hyperthyroidism.

From the side of metabolism: anorexia, weight gain, alcohol intolerance, gout, hyperlipidemia, hypernatremia, decreased serum ferritin concentration.

From the side nervous system: headache, anxiety, depression, euphoria, nervousness, abnormal dreams, psychosis, hallucinations, hostility, mania, personality disorder, suicidal behavior, taste perversion, migraine, syncope, tunnel syndrome, cognitive disorders, tremor, convulsions, dysgraphia, dyslexia, impaired motor functions, myoclonus, neuritis, neuromuscular blockade, paralysis, incl. peroneal nerve, stupor.

On the part of the organ of vision: diplopia, visual field defect, eye movement disorder, cataract, corneal damage, dryness of the sclera and cornea, subconjunctival hemorrhage, eyelid ptosis, mydriasis, nystagmus, atrophy optic nerve, visual impairment.

On the part of the organ of hearing and balance: headache, hearing impairment.

From the CCC: palpitations, tachycardia, extrasystole, sinus bradycardia, paroxysmal tachycardia, increased blood pressure, varicose veins veins.

From the side respiratory system: cough, shortness of breath, seasonal rhinitis, apnea, hyperventilation of the lungs, laryngospasm.

From the side digestive system: nausea, vomiting, swelling of the tongue, constipation, caries, odontogenic periostitis, increase salivary glands, dyspepsia, dysphagia, belching, esophageal ulcer, colitis, enterocolitis, colon polyposis, anorectal disorders, rectal bleeding.

From the side of the liver and biliary tract: cholelithiasis, hepatomegaly.

From the skin and subcutaneous tissues: ecchymosis, hyperhidrosis, skin rash, itching, urticaria, contact dermatitis, erythema nodosum, skin nodules.

From the musculoskeletal system and connective tissue: arthralgia, pain in cervical region spine, back pain, arthritis, bursitis, side pain, muscular atrophy, osteoarthritis.

From the urinary system: imperative urge to urinate, pollakiuria, urinary retention, hematuria, nephrolithiasis.

From the genital organs and mammary glands: amenorrhea, breast enlargement, erectile disfunction, prolapse pelvic organs, deviation of laboratory parameters in smears from the cervical canal, violation menstrual cycle, vulvovaginal disorders.

Infections: otitis, bronchitis, gastroenteritis, exacerbation of diseases caused by Herpes simplex, rhinitis, vaginal candidiasis, inflammation of the subcutaneous fat, furunculosis, pyelonephritis, herpes zoster.

Other: reactions immediately after injection*, asthenia, fatigue, chills, fever, nose bleed, peripheral edema, hangover.

* Reactions immediately after injection: local reactions - pain, redness, swelling, abscess, hematoma, lipoatrophy, skin necrosis; systemic reactions- flushing, chest pain, palpitations, anxiety, shortness of breath, difficulty swallowing, urticaria. These symptoms are temporary and limited and do not require special intervention; they may also begin several months after the start of therapy, the patient may experience this or that symptom sporadically.

drug interaction

Interactions between glatiramer acetate and others medicines insufficiently studied. No drug interactions have been identified, including simultaneous application glatiramer acetate with drugs that are used for therapy multiple sclerosis, incl. with GKS (at combined application up to 28 days). Very rare frequency local reactions may increase.

Dosage of Copaxone-Teva

In the form of injections of 20 mg of the drug Copaxone®-Teva (1 injection syringe filled with a solution of the drug) 1 time per day, daily, preferably at the same time of the day. The treatment is long. The decision to stop therapy should be made by the attending physician.

Each syringe with Copaxone®-Teva is intended for single use only.

Overdose

There are no data on overdose of Copaxone®-Teva. In case of overdose, careful observation and symptomatic treatment are indicated.

Precautionary measures

At the beginning of treatment with Copaxone®-Teva, the supervision of a neurologist and a doctor with experience in the treatment of multiple sclerosis is necessary.

Patients should be informed of the possibility of adverse reactions, incl. arising immediately after the injection of the drug Copaxone®-Teva. Most of these symptoms are short-lived and resolve spontaneously without sequelae. With the development of serious adverse reactions, you should immediately stop therapy and contact your doctor or call an ambulance medical care. Application decision symptomatic therapy takes the doctor.

Chest pain that occurs immediately after injections is usually transitory nature, lasts a few minutes, has no connection with other symptoms, passes on its own without any clinical consequences. The mechanism by which this symptom develops is unclear.

With prolonged use (within several months) of the drug Copaxone®-Teva, lipoatrophy may develop at the injection sites and in isolated cases- skin necrosis. In order to prevent the development of these local reactions, it is necessary to advise the patient to strictly follow the sequence of injection sites according to the scheme, which should include a mandatory daily change of the injection site.

Patients with impaired renal function or cardiovascular disease should be under medical supervision.

Due to the fact that Copaxone®-Teva is an immunomodulatory drug and is used in the treatment autoimmune disease- multiple sclerosis, its use may be accompanied by changes in the functions of the immune system, and therefore it is necessary to periodically monitor the state of the patient's immune system.

If the patient does not have the opportunity to store syringes with Copaxone®-Teva in the refrigerator, then storage at a temperature of 15–25 ° C is allowed, but not more than 1 month. If the syringes with the drug have not been used within a month and the blister pack has not been opened, then these syringes should be further stored in the refrigerator (2-8 ° C).

Impact on ability to drive vehicles and work with machinery. Based on the available data, there is no need for special measures precautions for persons driving a car or complex machinery.

Immunomodulator. drug used in multiple sclerosis

Release form, composition and packaging

Solution for s / c injection from colorless to light yellow, slightly opalescent.

1 ml of solution contains:

active substance: glatiramer acetate - 20 mg / 40 mg;

Excipients: mannitol, water d / i.

1 ml (20 mg) - syringes (1) - blister packs (28) - cardboard boxes. 1 ml (40 mg) - disposable syringes made of colorless glass (3) - blister packs (4) - cardboard packs.

Indications

Relapsing-remitting multiple sclerosis.

Contraindications

Hypersensitivity to glatiramer acetate or mannitol;

Pregnancy;

Children's and adolescence up to 18 years (efficacy and safety have not been studied).

Carefully: predisposition to the development of allergic reactions, cardiovascular diseases, impaired renal function.

Dosage

Enter s / c in the form of injections of 40 mg (1 injection syringe filled with a solution of the drug) 3 times a week, the minimum interval between injections is 48 hours.

The drug is not intended for intravenous or intramuscular administration.

Currently, there are no data on the duration of the course of treatment. The decision to prescribe a long course of treatment should be made by the attending physician in each case.

Patients are encouraged to receive training in the technique independent holding injections. The first injection (as well as 30 minutes after it) should be supervised qualified specialist. To reduce the risk of irritation or pain at the injection site, the injection site should be changed each time.

elderly patients have not been studied.

The efficacy and safety of the drug have not been studied.

Each Copaxone syringe is for single use only.

1. The patient must make sure that everything necessary for the injection is available: a disposable syringe filled with Copaxone solution, a container for used syringes, a cotton swab moistened with alcohol.

2. Before injection, remove the disposable syringe from the blister pack by removing the protective paper strip.

3. Keep the syringe with the solution at room temperature for at least 20 minutes.

4. Before administering Copaxone, wash your hands thoroughly with soap and water.

5. Carefully inspect the solution in the syringe. In the presence of suspended particles or changes in the color of the solution, it should not be used.

6. Choose an injection site. Possible areas for self-injection: arms, thighs, buttocks, abdomen (approximately 5 cm around the navel). Do not inject into painful areas, discolored, reddened areas of the skin, or areas with seals and nodules. There is enough space inside each injection zone for several injections. It is recommended to draw up a map of injection sites and have it with you. Injections into the gluteal muscle and on the arms may require the assistance of another person.

7. Remove the protective cap from the needle.

8. Having previously treated the injection site with a cotton swab moistened with an alcohol solution, lightly gather the skin into a fold with your thumb and forefinger.

9. Positioning the syringe needle perpendicular to the injection site, pierce the skin and, evenly pressing on the syringe plunger, inject its contents into the injection site.

10. Remove the needle by moving the syringe perpendicular to the injection site.

11. Place the syringe in a container for used syringes.

If patients forget to administer Copaxone, the injection should be given immediately as soon as they remember this. You can not enter a double dose of the drug.

Overdose

Symptoms: There have been several reports of overdose (up to 300 mg of glatiramer acetate). No adverse reactions other than those listed above were observed.

Treatment: in case of overdose, careful observation, symptomatic and supportive therapy is indicated.

drug interaction

Interactions between Copaxone and other medicinal products have not been separately evaluated. There are no data on interaction with interferon beta.

An increase in cases of reactions at the injection site was revealed with the simultaneous administration of Copaxone with GCS.

An in vitro study suggested that glatiramer acetate has a high degree of plasma protein binding and is not displaced from plasma protein binding by itself, as well as by phenytoin or carbamazepine. However, since the drug Copaxone has a potential effect on protein-binding substances, it is necessary to control its simultaneous use with other drugs.

Side effects

Infections and infestations: infections, influenza, bronchitis, gastroenteritis, otitis media, infections caused by Herpes simplex, rhinitis, periodontal abscess, vaginal candidiasis, abscess, inflammation of the subcutaneous fat, furunculosis, pyelonephritis, infections caused by Herpes zoster.

Neoplasms: benign neoplasms of the skin, neoplasms; infrequently - skin cancer.

From the hematopoietic and lymphatic system: lymphadenopathy, leukocytosis, leukopenia, splenomegaly, thrombocytopenia, changes in the morphology of lymphocytes.

From the immune system: hypersensitivity reactions.

From the endocrine system: goiter, hyperthyroidism.

From the side of metabolism: anorexia, weight gain, alcohol intolerance, gout, hyperlipidemia, hypernatremia, decreased serum ferritin concentration.

Mental disorder: anxiety, depression, nervousness, abnormal dreams, psychosis, euphoria, hallucinations, aggressiveness, mania, personality disorders, suicidal attempts.

From the nervous system: headache, taste perversion, muscle hypertonicity, migraine, speech disorders, syncope, tremor, carpal tunnel syndrome, cognitive impairment, convulsions, dysgraphia, dyslexia, dystonia, motor dysfunction, myoclonus, neuritis, neuromuscular blockade, nystagmus, paralysis, peroneal paralysis nerve, stupor, visual field defect.

From the side of the organ of vision: diplopia, visual impairment, cataract, corneal damage, dryness of the sclera and cornea, eye hemorrhage, eyelid ptosis, mydriasis, optic nerve atrophy.

From the organ of hearing and balance: hearing impairment.

From the side of cardio-vascular system: vasodilation, palpitations, tachycardia, extrasystole, sinus bradycardia, paroxysmal tachycardia, varicose veins.

From the respiratory system: shortness of breath, cough, seasonal rhinitis, apnea, feeling of suffocation, epistaxis, hyperventilation of the lungs, laryngospasm, pulmonary disorders.

From the digestive system: nausea, anorectal disorders, constipation, caries, dyspepsia, dysphagia, incontinence stool, vomiting, colitis, enterocolitis, colon polyposis, belching, peptic ulcer esophagus, periodontitis, rectal bleeding, salivary gland enlargement.

From the side of the liver and biliary tract: deviation of indicators of liver tests; cholelithiasis, hepatomegaly.

From the side of the skin and subcutaneous fat: skin rash, ecchymosis, hyperhidrosis, pruritus, skin diseases, urticaria, angioedema, contact dermatitis, erythema nodosum, skin nodules.

From the side musculoskeletal system: arthralgia, back pain, neck pain, arthritis, bursitis, flank pain, muscle atrophy, osteoarthritis.

From the urinary system: urgency, pollakiuria, urinary retention, hematuria, nephrolithiasis, diseases of the urinary tract, deviations from laboratory standards for urinalysis.

From the reproductive system: spontaneous abortion, breast engorgement, erectile dysfunction, pelvic organ prolapse, priapism, prostate disease, laboratory abnormalities in cervical smears, testicular dysfunction, vaginal bleeding, vulvovaginal disorders.

Other: asthenia, chest pain, injection site reactions, pain, chills, facial swelling, injection site atrophy, local reactions, peripheral edema, edema, fever, hypothermia, immediate post-injection reaction, inflammation, cyst, hangover syndrome, diseases of the mucous membranes, post-vaccination syndrome, necrosis at the injection site.

special instructions

The initiation of treatment with Copaxone should be carried out under the supervision of a neurologist and a physician experienced in the treatment of multiple sclerosis. The drug is not indicated for the treatment of primary or secondary progressive multiple sclerosis.

Patients should be informed about the possibility of adverse reactions, incl. arising immediately after the injection of the drug Copaxone. Most of these symptoms are short-lived and resolve spontaneously without sequelae. With the development of serious adverse reactions, you should immediately stop therapy and contact your doctor or call an ambulance. The decision to use symptomatic therapy is made by the doctor.

There is no evidence that certain groups of patients are more at risk for such reactions. However, patients with cardiovascular disease should be under the supervision of a physician throughout the entire period of treatment.

Several cases of seizures and/or anaphylactoid or allergic reactions have been identified. Serious hypersensitivity reactions (bronchospasm, anaphylactic reaction or urticaria) may also rarely occur. In case of severe reactions, it is necessary to prescribe appropriate treatment and stop taking the drug.

In the blood serum of patients, antibodies to glatiramer acetate were detected. After a course of treatment average duration 3-4 months, their maximum concentration was recorded, which subsequently decreased and stabilized at a level slightly above the baseline. There is no evidence that antibodies to glatiramer acetate have a neutralizing effect or affect clinical efficacy drug.

If the patient does not have the opportunity to store Copaxone syringes in the refrigerator, then storage at a temperature of 15-25 ° C is allowed, but not more than 1 month. If within a month the syringes with the drug were not used, and at the same time the blisters were not opened, then these syringes should be further stored in the refrigerator (from 2 ° to 8 ° C).

For impaired renal function

The efficacy and safety of the drug in patients with kidney failure have not been studied. In these patients, renal function should be monitored, although no hard evidence that deposition immune complexes affects glomerular filtration.

Influence on the ability to drive vehicles and control mechanisms

Studies on the effect on the ability to drive vehicles and mechanisms have not been conducted.

Pregnancy and lactation

Copaxone is contraindicated in pregnancy. During treatment, it is necessary to use reliable methods of contraception.

It is not known whether glatiramer acetate is excreted in breast milk, therefore, if it is necessary to use Copaxone during lactation, the expected benefit of therapy for the mother and the potential risk to the child should be assessed.

Application in childhood

Use in the elderly

The efficacy and safety of the drug in elderly patients have not been studied.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature of 2° to 8°C. Do not freeze. Shelf life - 2 years.

Teva Pharmaceutical Enterprise Co., Ltd.

Country of origin

Israel

Product group

Immunomodulatory drugs and immunosuppressants

Immunomodulating agent

Release form

• 28 syringes with a solution of 1.0 ml per package

Description of the dosage form

• Colorless to slightly yellow, slightly opalescent solution

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 low therapeutic dosage data on pharmacokinetics are only indicative. Based on them, as well as on experimental data, it is believed that after subcutaneous injection the drug is rapidly hydrolyzed at the injection site. 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 exerts its immunomodulatory action at the injection site. Its therapeutic effect is mediated through the systemic distribution of activated suppressor T cells. The determined concentration of glatiramer acetate or its metabolites in the blood does not correlate with the therapeutic effect.

Special conditions

Influence on the ability to drive vehicles and control mechanisms Based on the available data, there is no need for special precautions for persons driving a car or complex machinery. To ensure safe and effective use Copaxone®-Teva, patients should: 1. Inform the doctor about the presence of pregnancy, the desire to have a child, or the onset of pregnancy while taking the drug. 2. Tell your doctor if you are breastfeeding your baby. 3. Do not change the dose or mode of administration of the drug without consulting a doctor. 4. Do not stop taking the drug without consulting a doctor. The drug should be used with caution in patients predisposed to allergic reactions and with heart disease. Patients with impaired renal function should regularly monitor laboratory parameters. In the presence of undissolved particles, the prepared solution of the drug should not be used. The contents of the syringe are for single use only; the remaining solution of the drug should be destroyed. Patients should be instructed in the use of antiseptic methods when administering the drug and trained in the technique of self-injection. The first injection must be carried out under the supervision of a qualified specialist. Understanding by the patient of the importance of using antiseptic treatment with independent injections and procedures should be monitored periodically. Patients should be informed about the inadmissibility of reusing needles and syringes, as well as about the procedure for their safe disposal. The patient can dispose of used needles and syringes only after they have been previously placed in a solid package. If the patient does not have the opportunity to store syringes with the drug in the refrigerator, then storage at a temperature of 15-25 ° C is allowed, but not more than one month. If within a month the syringes have not been used, and at the same time the blister pack has not been opened, then these syringes should be further stored in the refrigerator (2-8 ° C). Patients should be informed about possible adverse reactions associated with the use of the drug.

Compound

• 1 ml of solution contains:
• active substance: glatiramer acetate - 20 mg
• excipients: mannitol (mannitol) water for injection.

Copaxone indications for use

• relapsing-remitting multiple sclerosis (to reduce the frequency of exacerbations, slow down the development of disabling complications

Copaxone contraindications

• hypersensitivity to glatiramer acetate or mannitol;
• not recommended for use in children under 18 years of age and the elderly, since specially organized studies have not been conducted in these patient populations;
• Pregnancy and lactation
• Controlled safety studies of glatiramer acetate during pregnancy have not been conducted. Application is possible only by absolute indications.
• It is not known whether glatiramer acetate is excreted in breast milk, therefore, if necessary, use during lactation should weigh the expected benefit of therapy for the mother and the potential risk to the child. In experimental studies, no mutagenic effect of glatiramer acetate and its negative influence on reproductive system, development of the embryo and the process of childbirth.

Copaxone dosage

• 20 mg/ml

Copaxone side effects

• Copaxone®-Teva is safe and well tolerated by patients. Possible reactions immediately after injection:
• Local reactions: pain, redness, swelling, rare cases- skin atrophy or subcutaneous tissue at the injection site, abscess, hematoma.
• Systemic reactions: flushing, chest pain, 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 sporadically.
• Other side effects can sometimes include:
• from the side of the cardiovascular system: palpitations, vasodilation, rarely syncope, increased blood pressure, extrasystole, blanching, varicose veins;
• from the digestive system: constipation, diarrhea, nausea; very rarely - anorexia, dysphagia, gastroenteritis, stomatitis, caries;
• allergic reactions: allergic shock and anaphylactoid reactions.
• from the blood and lymphatic system: rarely - lymphadenopathy, very rarely - eosinophilia, splenomegaly;
• metabolic and nutritional: very rare - edema, weight loss, aversion to alcohol;
• from the musculoskeletal system: rarely - arthralgia, arthritis;
• from the nervous system: rarely - emotional instability, clouding of consciousness (stupor), convulsions, anxiety, depression, dizziness, tremor, ataxia, headache;
• from the respiratory system: rarely - increased respiration (hyperventilation). In isolated cases: bronchospasm, epistaxis, hypoventilation, voice change;
• from the side genitourinary system: rarely - amenorrhea, hematuria, impotence, menorrhagia, vaginal bleeding.

drug interaction

Interactions between Copaxone®-Teva and others medicines insufficiently studied. No identified drug interaction, including the simultaneous use of Copaxone®-Teva with drugs that are used to treat multiple sclerosis, including corticosteroids (with combined use for up to 28 days). Very rarely, the frequency of local reactions may increase.

Overdose

There are no data on overdose of Copaxone®-Teva.

Storage conditions

• Keep cold (t 2 - 5)
• keep away from children

Information provided