Composition, form of production and packaging
The solution for injections is transparent, yellowish, practically free of particles.
1 ml of 1 amp.
Actovegin Concentrate (in terms of dry deproteinized hemoderate of blood calves) 40 mg 80 mg
Excipients: sodium chloride - 53.6 mg, water d / and - up to 2 ml.
2 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (1) - packs cardboard.
2 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (2) - packs cardboard.
2 ml - ampoules of colorless glass (5) - packings cellular contour plastic (5) - packs cardboard.
The solution for injections is transparent, yellowish, practically free of particles.
1 ml of 1 amp.
Actovegin concentrate (in terms of dry deproteinized hemoderate of blood calves) 40 mg 200 mg
Excipients: sodium chloride - 134 mg, water d / and - up to 5 ml.
5 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (1) - packs cardboard.
5 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (2) - packs cardboard.
5 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (5) - packs cardboard.
The solution for injections is transparent, yellowish, practically free of particles.
1 ml of 1 amp.
Actovegin concentrate (in terms of dry deproteinized hemoderate of blood calves) 40 mg 400 mg
Excipients: sodium chloride - 268 mg, water d / and - up to 10 ml.
10 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (1) - packs cardboard.
10 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (2) - packs cardboard.
10 ml - ampoules of colorless glass (5) - packings of cellular contour plastic (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Antihypoxant. ActoveginВ® is a hemoderivat, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5,000 daltons pass through). It has a positive effect on transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of plasma cell membranes in ischemia and a decrease in lactate formation), thus having an antihypoxic effect that begins to appear at the latest 30 minutes after parenteral administration and reaches a maximum on average after 3 hours (2-6 hours).
Actovegin В® increases the concentration of ATP, ADP, phosphocreatine, as well as amino acids - glutamate, aspartate and GABA.
The effect of ActoveginВ® on the assimilation and utilization of oxygen, as well as insulin-like activity with the stimulation of transport and glucose oxidation, are significant in the treatment of diabetic polyneuropathy.
In patients with diabetes and diabetic polyneuropathy, ActoveginВ® reliably reduces the symptoms of polyneuropathy (stitching, burning sensation, paresthesia, numbness of the lower limbs). Objective disorders are reduced sensitivity, mental well-being of patients improves.
PHARMACOKINETICS
With the help of pharmacokinetic methods it is impossible to study the pharmacokinetic parameters of the drug Actovegin В® , since it consists only of the physiological components that are usually present in the body.
To date, there has been no reduction in the pharmacological effect of hemoderovatives in patients with altered pharmacokinetics (eg, hepatic or renal insufficiency, metabolic changes associated with advanced age, and metabolic peculiarities in newborns).
INDICATIONS
- metabolic and cerebral disorders of the brain (including ischemic stroke, craniocerebral injury);
- peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);
- diabetic polyneuropathy;
- wound healing (ulcers of different etiology, burns, trophic disorders (bedsores), disturbance of wound healing processes);
- prevention and treatment of radiation lesions of the skin and mucous membranes with radiation therapy.
DOSING MODE
In / a, in / in (including and in the form of infusion) and / m. In connection with the potential for the development of anaphylactic reactions, it is recommended to perform the test before the infusion.
Metabolic and cerebral infringements of a brain: from 5 ml to 25 ml (200-1000 mg) in day I / in daily for 2 weeks with the subsequent transition to Actovegin В® in the form of tablets.
Ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml 0.9% solution of sodium chloride or 5% solution of dextrose, in / in the drip daily for 1 week, then 10-20 ml (400-800 mg ) in / in the drip - 2 weeks with the subsequent transition to Actovegin В® in the form of tablets.
Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800-1000 mg) of the drug in 200 ml of 0.9% solution of sodium chloride or 5% solution of dextrose, in / or or / daily; duration of treatment is about 4 weeks.
Diabetic polyneuropathy: 50 ml (2000 mg) a day for IV for 3 weeks, followed by the transition to Actovegin В® in the form of tablets - 2-3 tablets. 3 times / day for at least 4-5 months.
Wound healing: 10 ml (400 mg) IV or 5 ml IM daily or 3-4 times a week, depending on the healing process (in addition to local treatment with ActoveginВ® in topical dosage forms).
Prevention and treatment of radiation lesions of the skin and mucous membranes with radiation therapy: the average dose is 5 ml (200 mg) IV daily in the interruption of radiation exposure.
Radiation cystitis: every day 10 ml (400 mg) is transurethral combined with antibiotic therapy. The rate of administration is about 2 ml / min. The duration of the course of treatment is determined individually according to the symptoms and severity of the disease.
SIDE EFFECT
Allergic reactions: skin rash, skin hyperemia, hyperthermia, up to anaphylactic shock.
CONTRAINDICATIONS
- hypersensitivity to the drug Actovegin В® or similar drugs;
Decompensated heart failure;
- pulmonary edema;
- oliguria, anuria;
- fluid retention in the body.
With caution: hyperchloremia, hypernatremia.
PREGNANCY AND LACTATION
The use of the drug in pregnant women did not cause a negative impact on the mother or fetus. However, when used in pregnant women, the potential risk to the fetus must be considered.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in oliguria, anuria
SPECIAL INSTRUCTIONS
In the case of a / m method of administration, slowly inject no more than 5 ml.
Because of the possible occurrence of an anaphylactic reaction, a trial injection (2 mL IM) is recommended.
Solution for injection has a slightly yellowish tinge. The color intensity can vary from one batch to another, depending on the nature of the raw materials used, but this does not adversely affect the activity of the drug or its tolerability.
Do not use an opaque solution or solution containing particles.
DRUG INTERACTION
It is currently unknown.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, protected from light, at a temperature of no higher than 25 В° C. Shelf life - 5 years.
After opening the ampoule, the solution should not be stored.
