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Composition and pharmaceutical form:

The active component of this drug is the concentrate of Actovegin (deproteinized hemoderivative obtained from calf blood).

Actovegin is available in various forms: solution for injections 40 mg/ml, 200 mg tablets, ointment, cream, gel.

Indications for use:

Actovegin is an antihypoxant (decreases the intensity of oxygen deficiency of tissues).

The tablets are prescribed for the purpose of:

comprehensive treatment of metabolic/vascular disorders of the brain (head injury, various forms of deficiency of cerebral circulation, dementia);
in peripheral venous/arterial disorders, their consequences (trophic ulcers, angiopathy);
in diabetic polyneuropathy.

The ointment, cream, gel are used for:

various wounds;
dermatitis, mucitis;
burns, including sunscalds, and to contribute to tissue recovery after burns;
skin cuts;
trophic ulcers;
frets, scratches;
ulcers of varicose origin, other weeping ulcers;
bedsores, slowly healing wounds;
bedsore prevention/treatment;
pre-treatment (before transplantation) of wound surfaces;
prevention/treatment of skin responses due to radiation exposure.

The solution for infusions/injections is used:

in metabolic, vascular disorders brain disorders (ischemic stroke, head injury, etc.); 

for faster wound healing (ulcers of various origin, trophic disturbances, burns, bedsores, non-healing wounds);
for prevention/treatment of irradiation injuries of mucous membranes, skin at X-ray therapy;
in peripheral venous/arterial disorders, their consequences (trophic ulcers, angiopathy);
in diabetic polyneuropathy, angiopathy.

Contraindications:

It’s forbidden to prescribe Actovegin of any version in case of intolerance to drug components, an allergic response to similar drugs in the past.

Tablets and solutions aren’t prescribed in cardiac decompensation (exacerbation), pulmonary edema, low urinary excretion (oliguria, anuresis), water retention (hyperhydration).

Care must be taken with taking this drug in case of chloruremia (the excess of chlorides in the blood), hypernatremia (the excess of sodium).

Using during pregnancy and breast-feeding:

The use of Actovegin in pregnant women didn’t cause a negative effect on the health of the mother and child, as well as the normal course of the pregnancy. However, when prescribing to a pregnant woman the doctor should take into account a potential risk to the fetus. The drug is prescribed to pregnant or breast-feeding mothers in standard doses.

Instructions for use and dosage:

Actovegin solution is injected intravenously (including infusively), intraarterially, and also intramuscularly.

Injection speed: slowly (2 ml/minute).

Due to the risk of serious anaphylaxis reactions, it’s recommended to do an allergotest (to inject 2 ml IM).

Dosage depending on indications:

metabolic, vascular brain disorders: 200–100 mg/day (from 5 to 25 ml) IV every day throughout 2 weeks with the further switch to the tableted form of the drug;
ischemic stroke: 800–2000 mg (20-50 ml), added to 200–300 ml of 0,9% NaCl solution or 5% glucose solution, administer IV by drop within 1 week every day, and then by 400–800 mg (10–20 ml) IV by drop within 2 weeks with the further switch to the tableted form;
peripheral (arterial/venous) vascular disorders or their consequences: 800–1000 mg (20-30 ml) of solution added to 200 ml 0,9% NaCl solution or 5% glucose solution, administer IV or IA every day (treatment duration– 4 weeks);
diabetic polyneuropathy: 2000 mg (50 ml) a day IV within 3 weeks with further switch to the tableted form (2–3 tablets х3 times/day) no less than 4–5 months;
non-healing wounds: 400 mg (10 ml) IV or 200 mg (5 ml) IM х3–4 times/week or every day depending on the process of healing (additional treatment with Actovegin dosage forms for spot application is recommended);
prevention/treatment of irradiation injuries of mucous membranes, skin at X-ray therapy: 200 mg (5 ml) IV every day in between radiation exposure;
radiation cystitis: 400 mg (10 ml) every day transurethrally (via the urethra) in combination with antibiotics;

No more than 5 ml is slowly used in case of intramuscular administration.

It’s necessary to rigidly observe the conditions of aseptics since Actovegin solution doesn’t contain preserving agents.

Actovegin tablets are intended for internal use. Standard dose – 1–2 tablets х3 times/day. A whole tablet is swallowed with water before a meal. The course of treatment– 4–6 weeks.

Actovegin dosage forms for external use (ointment, cream, gel) are used for prevention/treatment of irradiation injuries of mucous membranes, skin after X-ray therapy. The gel is used for cleaning, treatment of non-healing wounds, ulcers, burns, irradiation injuries. The gel is applied to the skin in a thin layer. In case of ulcers, the ointment is applied in a thick layer or close with a bandage saturated with the drug (to prevent sticking to the wound). The dressing should be changed every day, in case of weeping ulcers – a few times a day. To treat irradiation injuries in oncologic patients the drug is applied in the form of applications. For prevention/treatment of bedsores dressings with the drug 2-4 times a day (treatment course — 3–60 days) are indicated. The cream is used for better healing of wounds, including weeping ones, as well as for further treatment after the gel. The cream is used 2-3 times a day to prevent bedsores, treat irradiation injuries. The ointment is prescribed for long-term treatment (speeding up of epithelization) of wounds, ulcers.

Overdose:

So far, the information on overdose is limited.

The treatment of possible overdose is symptomatic treatment.

In case of accidental ingestion of the ointment, the cream or the gel digestive disturbances are possible. In this case, it’s necessary to lavage the stomach, use enterosorbents (drugs absorbing harmful substances).

Side effects:

Allergic responses manifesting in hyperaemia (blush) of skin, itch, urticarial rash (hives), skin irritation, contact dermatitis are possible. Quincke's disease (fast emerging oedema of the face or its part, eyes, lips, larynx with breathing problems), anaphylactic shock (strong skin itching, sharp arterial blood pressure fall, vomit, liquid stool, laryngeal edema, noisy and labouring breath, pale/ blue skin, sharp constriction of bronchi and larynx resulting in acute shortness of breath, disorder of vital organs, loss of consciousness) are not excluded.

Storage conditions and shelf-time:

The solution should be stored at a temperature of 18– 25°С. It’s forbidden to store the solution after the opening of vials.

Tablets, ointment, gel, cream should be stored in the original (manufacturer) packing under proper temperature conditions (to 25°C), low humidity, protection against direct sunlight. The shelf life is indicated on the package (to 5 years).

Parents should ensure the children’s security and limit their access to the drug.

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