Instructions for Reneiro injection solution 250 mg/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: transparent, colorless or with a yellowish tinge of color liquid.
Pharmacotherapeutic group
Agents affecting the nervous system. Parasympathomimetics. Choline alfoscerate.
ATX code N07A X02.
Pharmacological properties
Pharmacodynamics
Reneiro is a drug belonging to the group of central cholinomimetics with a predominant effect on the CNS. Choline alfoscerate as a choline carrier and a precursor of phosphatidylcholine has the potential to 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 consists of 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Reneiro 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 enters the body, alfoscerate 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, Reneiro improves the transmission of nerve impulses in cholinergic neurons; positively affects the plasticity of neuronal membranes and the function of receptors. Reneiro 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
When Reneiro is administered, on average, 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 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 with severe psychomotor agitation.
- Pregnancy and breastfeeding.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Application features
Nausea may occur (mainly as a result of dopaminergic activation). Does not require discontinuation of therapy, a temporary reduction in the dose of the drug is sufficient.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect driving and working with other mechanisms.
Method of administration and doses
In acute conditions, Reneiro is 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 stabilizes, they switch to the oral dosage form of choline alfoscerate.
Children
There is no experience with the use of Reneiro in children.
Overdose
In case of overdose of Reneiro, which may manifest as nausea, the dose of the drug should be reduced. Treatment is symptomatic.
Adverse reactions
As a rule, the drug is well tolerated even with long-term use.
On the part of the digestive system:
abdominal pain, nausea (see section "Special warnings and precautions for use").
Nervous system: short-term confusion, anxiety, insomnia, agitation, headache.
On the part of the immune system: with individual hypersensitivity to the drug, allergic reactions may occur.
Possible reactions at the injection site.
Expiration date
3 years.
Storage conditions
Incompatibility.
Do not use in the same container with other medicines.
Packaging
4 ml in ampoules, 5 ampoules in a cassette in a cardboard pack.
Or 4 ml in ampoules, 10 ampoules (5x2) in cassettes in a cardboard pack.
Vacation category
According to the recipe.
Manufacturers
Private Joint-Stock Company "Lekhim-Kharkiv" (responsible for production and control/testing of the series, not including series release).
LLC Scientific and Production Company "MICROCHEM" (responsible for batch release, not including batch control/testing).
Location of manufacturers and their business addresses
Ukraine, 61115, Kharkiv, 17th Party Congress St., 36 (Private Joint-Stock Company "Lekhim-Kharkiv").
Ukraine, 93000, Luhansk region, Rubizhne, Lenina St., 33 (LLC Scientific and Production Company "MICROCHEM").
Applicant
LLC Scientific and Production Company "MICROCHEM".
Location of the applicant and the applicant's representative
Ukraine, 93000, Luhansk region, Rubizhne, Lenina St., 33.
