Instructions for T-Choline solution for injection 250 mg/ml ampoule 4 ml No. 3
Composition
active ingredient: choline alfoscerate;
1 ml of solution contains choline alfoscerate (calculated as choline alfoscerate anhydrous) 250 mg;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or yellowish solution contains practically no visible particles.
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 is potentially capable of preventing and correcting 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, has a positive effect on the plasticity of neuronal membranes and the function of receptors. Choline alfoscerate improves cerebral blood circulation, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain and restores consciousness in traumatic brain injury.
Pharmacokinetics. When choline alfoscerate is administered, an average of almost 88% of the dose is absorbed. The drug accumulates mainly in the brain (45% of the drug concentration in the blood), lungs and liver. Elimination 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
Hypersensitivity to the components of the drug.
Psychotic syndrome, severe psychomotor agitation.
Pregnancy or breastfeeding period.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Use during pregnancy or breastfeeding
The drug is contraindicated for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or operate other mechanisms.
Method of administration and doses
In acute conditions, T-CHOLINE should be administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) per day for 15–20 days. Then, after the patient's condition has stabilized, switch to the dosage form in capsules.
Children
There is no experience with the use of the drug T-CHOLINE in children.
Overdose
In case of overdose of the drug T-CHOLINE, which may manifest as nausea, anxiety, agitation, insomnia, the dose should be reduced. Therapy is symptomatic.
Adverse reactions
The drug is usually well tolerated even with prolonged use. Injection site reactions are possible. During the first days or weeks of treatment, the following side effects may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be necessary.
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 when using this 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 pharmacovigilance information system at the following link: https://aisf.dec.gov.ua
Expiration date
4 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility
Do not mix in the same container with other medicines.
Packaging
4 ml in an ampoule, 3 ampoules in a contour blister pack; 1 contour blister pack in a cardboard pack.
Vacation category
According to the recipe.
Producer
K.T. Rompharm Company SRL / SC Rompharm Company SRL
Location of the manufacturer and address of its place of business.
Eroilor St. No. 1A, Otopeni, 075100, Ilfov County, Romania – Romfarm 1 and Romfarm 2 buildings.
Applicant.
LLC "BFC "SALYUTARIS".
Location of the applicant and address of the place of business.
Ukraine, 01042, Kyiv, Druzhby Narodiv Boulevard, 9.
