Translation of the instruction Mose

ALTsMERAT solution for injections of 250 mg

Instruction

On medical use of medicine

Altsmerat

(alzhmerat)

Ingredients:

Active ingredient: choline alfoscerate;

250 mg contain

1 ml of solution sincaline of the alfostserat;

excipient: water for injections.

Dosage form.

Solution for injections.

Main physical and chemical properties: colourless or yellowish transparent liquid.

Pharmacotherapeutic group.

Means, influencing nervous system. parasympathomimetics. sincaline alfostserat. code atkh n07a x02.

Pharmacological properties.

Pharmacodynamics. altsmerat is means which belongs to group of the central cholinomimetics with primary influence on central nervous system. altsmerat as the carrier of sincaline and the previous agent of phosphatidylsincaline has potential ability to prevent and adjust biochemical lesions which are of particular importance among pathogenic factors of a psychoorganic involutional syndrome that is can influence the lowered cholinergic tone and the changed phospholipidic structure of covers of neurons. for 40.5% medicament consists of metabolic protected sincaline. metabolic protection is provided by release of sincaline in a brain. altsmerat positively influences functions of memory and informative abilities and also indicators of an emotional state and behavior which deterioration was caused by development of involutional pathology of a brain.

Mechanism of action is based by

on what at hit in a sincaline organism alfostserat is split under the influence of enzymes on sincaline and glycerophosphate: sincaline takes part in biosynthesis of acetylcholine — one of the main mediators of nervous excitement; glycerophosphate is a predecessor of phospholipids (phosphatidylsincaline) of a neural membrane. Thus, Altsmerat improves transfer of nervous impulses in cholinergic neurons; positively affects plasticity of neuronalny membranes and function of receptors. Altsmerat improves a cerebral blood stream, strengthens metabolic processes in a brain, activates structures of a reticular formation of a brain and restores consciousness at traumatic injury of a brain.

Pharmacokinetics. At introduction about 88% of a dose are on average absorbed. Drug collects mainly in a brain (45% of concentration of medicament in blood), lungs and a liver. Removal of medicament happens mainly through lungs in the form of carbon dioxide (TO ₂ ). Only 15% are removed with urine and bile.

Clinical characteristics.

Indication.

Acute period of a severe craniocereberal injury with mainly stem level of damage (consciousness disturbance, coma, focal polusharny symptomatology, symptoms of damage of a brainstem).

Degenerative and involutional brain psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, that is primary and secondary disturbances of mental activity at elderly people who are characterized by memory disturbance, confusion of consciousness, a disorientation, decrease in motivation and initiative, decline in the ability to concentration; changes in the emotional sphere and sphere of behavior: emotional instability, irritability, indifference to the environment; pseudo-melancholy at elderly people.

Contraindication.

Hypersensitivity to medicament or to its components.

Period of pregnancy and feeding by a breast.

Psychotic syndrome, with heavy psychomotor excitement.

Interaction with other medicines and other types of interactions.

Clinically significant interaction of medicament with other medicines is not established to

.

Feature of use.

Use during pregnancy or feeding by a breast.

Drug is contraindicated to

at pregnancy and during feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

Drug does not influence control of vehicles and work with other mechanisms.

Route of administration and doses.

At acute conditions altsmerat is entered intramusculary or intravenously (slowly) on 1 g (1 ampoule) within 15 — 20 days. then, after stabilization of a condition of the patient, pass to a dosage form of medicament in capsules.

Children.

Experience of use of the altsmerat to children is absent.

Overdose.

At sincaline overdose alfostseraty which can be shown by nausea, it is necessary to reduce a medicament dose. symptomatic therapy.

Side reactions.

As a rule, medicament is well transferred even at prolonged use. developing of nausea (which mainly is a consequence of secondary dopaminergic activation) is possible, abdominal pain and short-term confusion of consciousness are very seldom possible. in that case it is necessary to reduce a medicament dose.

reactions in the injection site Are possible

. During the first days or weeks of treatment there can be such manifestations of side reactions: alarm, agitation, insomnia. These symptoms are temporary and do not demand the treatment termination, but perhaps temporary dose decline.

reactions of hypersensitivity, including rash, an itching, urticaria, a Quincke's disease, erubescence Are possible

.

Expiration date.

3 years.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C. to store out of children's reach.

Incompatibility.

should not be applied in one container with other medicines.

Packing.

On 4 ml in an ampoule; on 5, 10 or 100 ampoules in a pack, or on 5 ampoules in the blister; on 1 or 2 blisters in a pack.

Category of release.

According to the prescription.

Producer.

Private joint-stock company lekkhim-Kharkiv.

Location of the producer and its address of the place of implementation of activity.

Ukraine, 61115, Kharkiv Region, city of Kharkiv, street Severina Pototskogo, house 36.