Instructions for use Reinix solution for injection 1000 mg/4 ml ampoule 4 ml No. 10
Composition
active ingredient: choline alfoscerate;
1 ml of solution contains choline alfoscerate 250 mg;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Agents affecting the nervous system. Parasympathomimetics. Choline alfoscerate. ATX code N07A X02.
Pharmacological properties
Pharmacodynamics.
Choline alfoscerate is a drug belonging to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Choline alfoscerate as a choline carrier and a precursor of phosphatidylcholine can potentially prevent and correct biochemical damage, which is of particular importance among the pathogenic factors of psychoorganic involutional syndrome, i.e. it can affect the reduced cholinergic tone and the altered phospholipid composition of nerve cell membranes. The drug contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Choline alfoscerate has a positive effect on memory functions and cognitive abilities, as well as on indicators of emotional state and behavior, the deterioration of which was caused by the development of involutional brain pathology.
The mechanism of action is based on the fact that when choline alfoscerate enters the body, it is broken down by enzymes into choline and glycerophosphate: choline takes part in the biosynthesis of acetylcholine, one of the main mediators of nervous excitation; glycerophosphate is a precursor of phospholipids (phosphatidylcholine) of the neuronal membrane. Thus, choline alfoscerate improves the transmission of nerve impulses in cholinergic neurons; it has a positive effect on the plasticity of neuronal membranes and the function of receptors. Choline alfoscerate improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain and restores consciousness in traumatic brain injury.
Pharmacokinetics.
On average, almost 88% of the administered dose of choline alfoscerate is absorbed. The drug accumulates mainly in the brain (45% of the drug concentration in the blood), lungs and liver. Elimination of the drug occurs mainly through the lungs in the form of carbon dioxide (CO2). Only 15% of the drug is excreted in the urine and bile.
Indication
Acute period of severe traumatic brain injury with predominantly brainstem level of damage (impaired consciousness, comatose state, focal hemispheric symptoms, symptoms of brainstem damage).
Degenerative-involutional cerebral psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary disorders of mental activity in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased ability to concentrate; changes in the emotional and behavioral spheres: emotional instability, irritability, indifference to the environment; pseudomelancholia in the elderly.
Contraindication
Known hypersensitivity to the drug or its components.
Psychotic syndrome, severe psychomotor agitation.
Pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Application features
Use during pregnancy or breastfeeding.
The drug is contraindicated during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
The drug does not affect the ability to drive vehicles and work with complex mechanisms.
Method of administration and doses
In acute conditions, administer intramuscularly or intravenously (slowly) 1 g (4 ml) per day for a period of 15 to 20 days. After stabilization of the patient's condition, switch to the oral dosage form of choline alfoscerate.
Children.
Due to the lack of sufficient experience with the use of the drug in children, it should not be used in pediatric practice.
Overdose
In case of an overdose of choline alfoscerate, which may manifest as nausea, anxiety, agitation, and insomnia, the dose of the drug should be reduced. Therapy is symptomatic.
Side effects
The drug is usually well tolerated even with prolonged use. During the use of the drug, reactions at the injection site are possible. During the first days or weeks of treatment, the following may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction is possible.
Hypersensitivity reactions are possible, including rash, itching, urticaria, angioedema, and skin redness.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
In original packaging, does not require special storage conditions.
Keep out of reach of children.
Incompatibility.
Do not use in the same container with other medicines.
Packaging
5 ampoules in a cassette. 2 cassettes in a pack.
Vacation category
According to the recipe.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and address of its place of business.
Ukraine, 03134, Kyiv, Myru St., 17.
