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ACTOVEGIN 40 mg / ml 10 ml 5’s solution for injection in ampoules




The instruction for medical use of ACTOVEGIN medicine the Trade name Actovegin the International unlicensed name Is not present the Dosage form Solution for injections of 40 mg/ml – 2 ml, 5 ml and 10 ml Structure of 1 ml active agent – deproteined hemoderivative of blood of calfs (in terms of dry matter) * contains 40.0 mg. excipient: water for injections * contains about 26.8 mg of sodium of chloride the Description Transparent solution of yellowish color Pharmacotherapeutic group the Drugs influencing a hemopoiesis and blood. Other hematologic drugs. The ATX B06AB code the Pharmacological Pharmacokinetics to Study properties pharmacokinetic characteristics (absorption, distribution, removal) of the drug Actovegin it is impossible as it consists only of physiological components which usually are present at an organism. Actovegin possesses anti-hypoxemic action which begins to be shown the latest in 30 min. after parenteral administration. The maximum effect is noted in 3 hours after parenteral and in 2–6 hours after oral administration. The pharmacodynamics Actovegin is hemoderivative which is received by means of dialysis and ultrafiltration (there take place connections with molecular weight less than 5000 dalton). Aktovegin – the antigipoksant rendering three types of effects: metabolic, neuroprotective and microcirculator. Aktovegin increases the absorption and utilization of oxygen which are a part of drug inositol phospho-oligosaccharides positively influence transport and utilization of glucose that leads to improvement of power metabolism of cells and decrease in formation of a lactate in the conditions of ischemia. The activity of the drug Actovegin is confirmed by measurement of the increased absorption and the increased utilization of glucose and oxygen. Several ways of implementation of the neuroprotective mechanism of effect of drug are considered. Aktovegin interferes with development of the apoptosis induced by peptide of beta amyloid (Aβ25-35). Aktovegin modulates activity of the nuclear factor a kappa In (NF-kB) playing an important role in regulation of processes of apoptosis and inflammation in the central and peripheral nervous system. Other mechanism of action is connected with nuclear enzyme weed (ADF-ribose) – a polymerase (PARP). PARP plays an important role in identification and a reparation of damages of one-chained DNA, however excessive activation of enzyme can start processes of cellular death at such states as cerebrovascular diseases and diabetic polyneuropathy. Aktovegin inhibits activity of PARP that leads to functional and morphological improvement of a condition of the central and peripheral nervous system. The positive effects of the drug Aktovegin influencing processes of microcirculation and an endothelium are increase in speed of a capillary blood-groove, reduction of a perikapillyarny zone, decrease in a myogenetic tone of precapillary arterioles and capillary sphincters, decrease in degree of the arteriolovenulyarny shunting blood-groove with primary blood circulation in a capillary bed and stimulation of function of the endothelial synthase of nitrogen oxide influencing a microcirculation. During various researches it was established that the effect of the drug Aktovegin occurs no later than in 30 minutes after its reception. The maximum effect is noted in 3 hours after parenteral and in 2–6 hours after oral administration. Influence of the drug Actovegin on assimilation and utilization of oxygen and also insulinopodobny activity with stimulation of transport and oxidation of glucose are significant in treatment of diabetic polyneuropathy (DPN). At patients with diabetes and diabetic polyneuropathy Actovegin authentically reduces polyneuropathy symptoms (the pricking pain, burning sensation, parasthesias, numbness in the lower extremities). Objectively sensitivity disorders decrease, the mental health of patients improves. Indications as a part of complex therapy: – symptomatic treatment of cognitive disturbances, including postinsultny cognitive disturbances and dementia. – symptomatic treatment of disturbances of peripheric circulation and their consequences. – symptomatic treatment of diabetic polyneuropathy (DPN). The route of administration and doses Actovegin, solution for injections, is applied intramusculary, intravenously (including in the form of infusions) or vnutriarterialno. IInstruktsiya on use of ampoules with one point of a break: take an ampoule so that the top containing a tag was above. Carefully tapping with a finger and stirring up an ampoule, to allow solution to flow down from a tip of an ampoule down. To break off an ampoule top, pressing on a tag. Depending on severity of a clinical picture, at first it is necessary to enter 10 – 20 ml of drug intravenously or vnutriarterialno daily, for further treatment on 5 ml intravenously or intramusculary slowly, daily or several times a week. For infusional introduction from 10 to 50 ml of drug it is necessary to add to 200–300 ml of the main solution (isotonic solution of sodium of chloride or 5% of solution of glucose). Speed of infusion is about 2 ml/min. For intramuscular injections use no more than 5 ml of drug which should be entered slowly as solution is hypertensive. Postinsultny cognitive disturbances In an acute period of an ischemic stroke, since 5 – 7 in the afternoon, on 2000 mg a day intravenously by drop infusion up to 20 infusions with transition to the tableted form on 2 tablets 3 times a day (1200 mg/day). The general duration of treatment is 6 months. Dementia On 2000 mg a day intravenously by drop infusion up to 4 weeks. Disturbances of peripheric circulation and their consequence On 800 – 2000 mg a day vnutriarterialno or intravenously by drop infusion. Duration of treatment is up to 4 weeks. Diabetic polyneuropathy On 2000 mg a day intravenously by drop infusion 20 infusions with transition to the tableted form on 3 tablets 3 times a day (1800 mg/day) duration from 4 to 5 months. Side effects the Frequency of side effects was defined according to classification of Council of the international medical scientific organizations (CIOMS): very often (≥ 1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥ 1/1000 to & lt, 1/100), is rare (≥ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is not known (it cannot be estimated on the available data). Disturbances from the immune system Seldom: allergic reactions (medicinal fever, shock symptoms). Disturbances from skin and hypodermic cellulose Seldom: small tortoiseshell, sudden reddening. Disturbances from a skeletal and muscular system and connective tissues: It is unknown: myalgia. Contraindications – hypersensitivity to drug Actovegin components – the general contraindications to infusional therapy: dekompensirovanny heart failure, a fluid lungs, an oliguria, an anury, an overhydratation – children’s age up to 18 years. Medicinal interactions are not established Special instructions Parenteral administration of drug should be carried out in sterile conditions. Because of possibility of anaphylactic reaction it is recommended to carry out a trial injection (hypersensitivity test). In case of electrolytic disorders (such as hyperchloremia and hypernatremia), the specified states have to be appropriately corrected. Solution for injections has slightly yellowish shade. The intensity of coloring can vary from one party to another depending on features of the used starting materials, however it has not an adverse effect on activity of drug or its shipping. Do not use the opaque solution or solution containing particles. After opening of an ampoule, solution cannot be stored. Clinical data In multicenter randomized double blind placebo – the controlled research ARTEMIDA (NCT01582854) which purpose was a studying therapeutic effect of the drug Actovegin concerning cognitive disturbances at 503 patients with an ischemic stroke the general frequency of the serious undesirable phenomena and death was identical in both groups of treatment. Though the frequency of repeated ischemic strokes was within expected in this population of patients, the bigger number of cases in the group taking the drug Actovegin in comparison with group of placebo was recorded, however this distinction was statistically not significantly. To interrelation between cases of a repeated stroke and the studied drug it was not established. Use for patients of children’s age Now data on use of the drug Actovegin for persons of children’s age are absent therefore its use for this group of persons is not recommended. Influence on ability of driving and other mechanisms is not established. Use at pregnancy and in the period of a lactation Actovegin should be applied only when the therapeutic advantage exceeds potential risk for a fruit or the child. The overdose Is not present data whenever possible of overdose by the drug Actovegin. On the basis of pharmacological data no additional undesirable effects are expected. A form of release and packing On 2, 5 or 10 ml of drug in colourless glass ampoules with a break point. On 5 ampoules put in plastic blister strip packaging. On 1 (for 5 ml and 10 ml) or 5 (for 2 ml) blister strip packagings together with the instruction for use in the state and Russian languages place in a cardboard pack. On a pack paste transparent protective stickers of round shape with holographic inscriptions and control of the first opening. For ampoules of 2 ml and 5 ml marking is applied on the surface of glass of an ampoule or on the label which is pasted on an ampoule. For ampoules of 10 ml the marking is applied on the label which is pasted on an ampoule. To Store storage conditions in the place protected from light at a temperature not over 25C. To store out of children’s reach! A period of storage 3 years not to use drug after an expiration date Prescription status According to the prescription the Producer and packer Takeda Austria GmbH., Austria of St. St. Petersburg Strasse 25, 4020 Linz, Austria / St. Peter-Strasse 25, 4020 Linz, Austria the Owner of the registration certificate of LLC Takeda Pharmasyyutikals, Russia, 119048, Moscow, Usachev St., 2, building 1 of “Takeda Pharmaceuticals” LLC, 2, Bl.1, Usacheva street, Moscow, 119048, Russia the Address of the organization accepting in the territory of the Republic of Kazakhstan a claim (offer) from consumers on quality of medicine and responsible for post-registration observation of safety of medicine of Takeda Kazakhstan LLP Almaty, Shashkin St. 44
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