Expiration date: 05/2026

Active substance: deproteinized calves blood gemoderivat. 

Pharmachologic effect

Mode of action - metabolic.

Pharmacodynamics

Antihypoxants. Actovegin® gemoderivat is that obtained by dialysis and ultrafiltration (tested compound with a molecular weight less than 5000 Da).

Positively affects the transport and utilization of glucose stimulated oxygen consumption (which leads to stabilization of the plasma membranes of cells during ischemia and reduce lactate) has thus antihypoxic action, which begins to appear at the latest 30 minutes after parenteral administration and reaches a peak in average of 3 hours (2-6 hours).

Actovegin® increasing concentrations of ATP, ADP, phosphocreatine, and amino acids - glutamate, aspartate and GABA.

Influence Actovegin® on absorption and utilization of oxygen, as well as insulin-like activity with the stimulation of glucose transport and oxidation are important in the treatment of diabetic polyneuropathy (DPN).

In patients with diabetes and DPN Actovegin® significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness in the lower extremities).

Objectively reduced sensitivity disorders, improves mental health patients.

Pharmacokinetics

Using methods impossible pharmacokinetic study Actovegin® pharmacokinetic drug because it consists only of physiological components that normally present in the body.

So far not found to decrease gemoderivat pharmacological effect in patients with altered pharmacokinetics (eg liver or kidney failure, changes in metabolism associated with old age, and especially in newborns metabolism).

Testimony

• metabolic and cerebrovascular disorders (including ischemic stroke, TBI);
  
• healing wounds (ulcers of various etiologies, burns, trophic disorders (bedsores), violation of the healing process);
  
• prevention and treatment of radiation skin lesions and mucous membranes with radiation therapy;
  
• peripheral (arterial and venous) vascular disorders and their consequences (angiopathy, trophic ulcers);
  
• diabetic polyneuropathy.
  

Contraindications

• Actovegin® hypersensitivity to the drug or similar drugs.
  
• decompensated heart failure;
  
• pulmonary edema;
  
• oliguria;
  
• anuria;
  
• fluid retention.
  

Precautions: hyperchloremia, hypernatremia.

Precautions: diabetes mellitus (. 1 vial contains 7.75 g of dextrose).

Pregnancy and breast-feeding

Use of the drug in pregnant women caused no adverse effects on the mother or fetus. However, when used in pregnant women should take into account the potential risk to the fetus.

Side effects

Allergic reactions (skin rash, skin redness, hyperthermia), up to anaphylactic shock.

Interaction

It is currently unknown.

Dosing and Administration

For Actovegin solution for injection, in addition

Radiation cystitis. A transurethral, ??daily, 10 ml of solution for injection (400 mg) in combination with antibiotic therapy. introduction rate - about 2 ml / min.

Duration of treatment is determined individually according to the symptoms and severity of the disease.

Instructions for use ampoules with breaking point

1. Place the tip of the ampule breaking point upwards.

2. Gently tapping his finger and shaking the vial to give a solution from the tip of the ampule to flow down.

3. Break off the tip of the ampoule at fault movement from itself.

Release Form

Injection, 40 mg / ml. 2, 5, 10 ml of the product in colorless glass vials (Type I according to European Pharmacopoeia) from the fault point. On 5 amp. in a plastic contour cellular packaging. By 1 or 5 contour cell packages in a carton box. In a pack of transparent protective paste stickers round shape with holographic inscriptions and control of the first opening.

Manufacturer

Injection

"Nycomed Austria GmbH", Austria. Art. Peter Strasse 25, A-4020 Linz, Avctriya.

In the case of packaging of "Takeda Pharmaceuticals", Russian "Nycomed Austria GmbH", Austria. Art. Peter Strasse 25, A-4020 Linz, Avctriya.

Packer / producing quality control, "Takeda Pharmaceuticals" LLC. 150066, Russia, Yaroslavl, ul. Technopark, 9.

www.takeda.com.ru, www.actovegin.ru

Storage conditions

In the dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

The shelf life: 5 years.

Do not use beyond the expiration date printed on the package.