Aksoglatiran FS

Aksoglatiran FS – immunomodulatory drug.

Form of release and structure

Dosage form – solution for hypodermic (п / to) introductions: slightly opalescent or transparent, colourless or with a yellowish shade liquid (on 1 ml in glass sterile syringes of single use with the pasted needle, the inserted piston and a protective cap in a blister strip packaging, in a cardboard pack 1 packaging, on 28 or 30 packs in a cardboard box).

Active ingredient of Aksoglatiran of FS – a glatiramer acetate, in 1 ml of solution – 20 mg.

Auxiliary components: D-Mannitolum, water for injections.

Indications to use

• Clinically isolated syndrome with the expressed inflammatory process demanding intravenous administration of glucocorticosteroids (for delay of development of clinically reliable multiple sclerosis);
• Recurrent ремиттирующий multiple sclerosis (for delay of processes of disabling complications and decrease in frequency of aggravations).

Contraindications

• Age up to 18 years;
• Pregnancy period;
• Hypersensitivity to drug components.

With care it is necessary to appoint drug sick with predisposition to allergic reactions, at cardiovascular diseases, a renal failure, during breastfeeding (it is necessary to compare the expected effect of therapy for mother and potential threat for the child).

Route of administration and dosage

Aksoglatiran's solution of FS is intended for п / to introduction.

The syringe should be got from the refrigerator in 20 minutes prior to an injection for acquisition of room temperature by it.

The drug is administered with observance of rules of an asepsis and antiseptics, changing the place for each following administration of drug. П / to an injection it is necessary to make in places of the minimum risk of injury of nerves and blood vessels, with easy capture of skin pleated (the stomach (about 5 cm around a navel), the outside surface of a shoulder, the front surface of a hip, buttock belongs to them).

The recommended dosing mode: on 1 ml (20 mg of drug) of 1 times a day, it is desirable in at one time, daily. The doctor appoints a use course individually, treatment usually long.

It is not necessary to apply solution in the presence in it suspended particles or discoloration.

At accidental delay of introduction of the next dose, the injection should be made at once as soon as remembered, but it should not be simultaneous introduction of a double dose.

Side effects

• Immune system: hypersensitivity reaction, anaphylactoid reaction, Quincke's disease;
• Nervous system: nervousness, headache, depression, alarm, euphoria, psychosis, pathological dreams, hallucinations, mania, faint, hostility, frustration of the personality, food faddism, suicide behavior, cognitive frustration, migraine, tunnel syndrome, tremor, spasms, dyslexia, dysgraphia, myoclonus, disturbance of motor functions, neuromuscular blockade, neuritis, paralysis (including fibular nerve), stupor;
• Lymphatic system and circulatory system: leukocytosis, lymphadenopathy, leukopenia, thrombocytopenia, change of structure of lymphocytes, splenomegaly;
• Endocrine system: hyperthyroidism;
• Cardiovascular system: heart consciousness, increase in arterial pressure, tachycardia, sinus bradycardia, premature ventricular contraction, Bouveret's disease, varicosity;
• Metabolism: increase in body weight, anorexia, gout, intolerance of alcohol, hypernatremia, lipidemia, decrease in level of content in ferritin blood serum;
• Respiratory system: cough, seasonal rhinitis, asthma, apnoea, laryngospasm, hyperventilation of lungs;
• Organ of sight: dryness of a sclera and cornea, defect of fields of vision, diplopia, disturbance of the movement of eyes, defeat of a cornea, ptosis of a century, subconjunctival hemorrhage, mydriasis, atrophy of an optic nerve, nystagmus, vision disorder, cataract;
• Acoustic organ and balances: hearing disorder, headache;
• Digestive tract: paraglossa, nausea, vomiting, increase in sialadens, eructation, lock, caries, dyspepsia, dontogenous periostitis, dysphagy, colitis, coloenteritis, gullet ulcer, anorectal disturbances, polyposes of a large intestine, rectal bleeding;
• Gepatobiliarny system: hepatomegalia, cholelithiasis;
• Musculoskeletal system: pain in cervical department of a backbone, an arthralgia, a dorsodynia, a bursitis, arthritis, a stitch, an osteoarthritis, a muscular atrophy;
• Mammary glands and generative organs: increase in mammary glands, an amenorrhea, erectile dysfunction, disturbance of indicators of laboratory researches of smears from the channel of a neck of uterus, a prolapse of pelvic bodies, vulvovaginal disturbances, failure of a menstrual cycle;
• Urinary system: a pollakiuria, an imperative desire to an urination, an ischuria, a nephrolithiasis, a hamaturia;
• Dermatological reactions: skin rash, itch, hyperhidrosis, ecchymoma, small tortoiseshell, knotty erythema, contact dermatitis, skin small knots;
• Infections: bronchitis, otitis, a gastroenteritis, the vaginal candidiasis, rhinitis, pyelonephritis, an inflammation of a hypodermic fatty tissue surrounding herpes, a furunculosis, an exacerbation of the diseases caused by a herpes simplex;
• Local reactions: after injections – pain, reddening, a hematoma, hypostasis, a lipoatrophia, abscess, a skin necrosis;
• Others: fatigue, fervescence, fever, adynamy, nasal bleeding, condition of a hangover, peripheral hypostases.

Besides, the patient can incidentally test symptoms of system reactions in the form of a stethalgia, rushes of blood, asthmas, a heart consciousness, conditions of alarm, a small tortoiseshell, the complicated swallowing.

Usually Aksoglatiran's use by FS is well transferred by patients, the listed side effects meet in some cases.

Special instructions

It is necessary to begin Aksoglatiran's use with FS under observation of the neurologist and specialist in the field of treatment of multiple sclerosis.

At purpose of drug it is necessary to inform the patient on possible emergence of system side reactions and undesirable effects of a direct injection.

In case of development of heavy side reactions therapy should be stopped immediately and to ask for medical care as the doctor has to appoint use of symptomatic therapy.

Emergence after an injection of a stethalgia usually lasts not for long, has passing character and takes place independently.

For prevention of development of local reactions (a lipoatrophia, a skin necrosis) the patient has to observe strictly the sequence of places for injections, daily changing them.

Patients with functional disorder of kidneys or pathologies of cardiovascular system need to provide regular control of the doctor.

Patients of childbearing age during reception of a glatiramer of acetate have to use reliable methods of contraception.

Treatment by drug demands periodic control of a condition of immune system.

Immunomodulator does not exert impact on ability of the patient to control of difficult mechanisms and vehicles.

Medicinal interaction

Clinically significant interaction of Aksoglatiran of FS at simultaneous use with other means it is not established.

Terms and storage conditions

To protect from children.

To store in the place protected from light at a temperature up to 8 °C, not to freeze.

Period of validity – 2 years.