Reneiro

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RENEYRO (RENEURO)

Composition:

Active substance: choline alfoscerate;

1 ml of solution contains choline alfoscerate 250 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: a clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group.

Drugs affecting the nervous system. Parasympathomimetics. Other parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

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 that plays a significant role among the pathogenic factors of psychorganic involutional syndrome. Thus, it may influence reduced cholinergic tone and 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 positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, which have deteriorated due to the development of brain involutional pathology.

The mechanism of action is based on the fact that after entering the body, choline alfoscerate is enzymatically hydrolyzed into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the main mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, RENEIRO improves nerve impulse transmission in cholinergic neurons, positively influences neuronal membrane plasticity and receptor function. RENEIRO improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the brain's reticular formation, and restores consciousness in traumatic brain injury.

Pharmacokinetics.

After administration of RENEIRO, approximately 88% of the dose is absorbed. The drug accumulates predominantly in the brain (45% of the plasma concentration), lungs, and liver. Elimination of the drug occurs mainly via the lungs in the form of carbon dioxide (CO₂). Only 15% of the drug is excreted in urine and bile.

Clinical characteristics.

Indications.

Acute period of severe traumatic brain injury with predominantly brainstem level damage (disturbance of consciousness, coma, focal hemispheric symptoms, brainstem injury signs).

Degenerative-involutional cerebral psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive impairments in elderly individuals characterized by memory disturbances, confusion, disorientation, reduced motivation and initiative, decreased concentration ability; emotional and behavioral changes: emotional instability, irritability, indifference towards surroundings; pseudomelancholia in elderly individuals.

Contraindications.

• Known hypersensitivity to the drug or its components;
• psychotic syndrome with severe psychomotor agitation;
• pregnancy and breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Clinically significant interaction of the drug with other medicinal products has not been established.

Special precautions.

Nausea may occur (mainly as a result of dopaminergic stimulation). This does not require discontinuation of therapy; a temporary reduction in dosage is sufficient.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of administration and dosage.

In acute conditions, RENAYRO is administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) per day for 15–20 days. After stabilization of the patient's condition, switch to the oral dosage form of choline alfoscerate.

Children.

There is no experience with the use of the medicinal product RENAYRO in children.

Overdose.

In case of RENAYRO overdose, which may manifest as nausea, the dose of the drug should be reduced. Symptomatic therapy.

Adverse Reactions.

The drug is generally well tolerated even with long-term use. Reactions at the injection site may occur. During the first days or weeks of treatment, the following adverse reactions may appear: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be considered.

Nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache may occur. Abdominal pain and short-term confusion are very rare. In such cases, the administered dose should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioneurotic edema, and skin redness.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Incompatibility.

Do not mix with other medicinal products in the same container.

Packaging.

4 ml in ampoules, 5 ampoules per cassette in a cardboard pack.

Or 4 ml in ampoules, 10 ampoules (5×2) in cassettes in a cardboard pack.

Prescription status.

Prescription only.

Manufacturers.

Private Joint-Stock Company "Lekhim-Kharkiv" (responsible for manufacturing and control/testing of the batch, excluding batch release).

LLC Scientific and Production Firm "MIKROKHIM" (responsible for manufacturing and control/testing of the batch, including batch release).

Manufacturers' addresses and locations of business activities.

Ukraine, 61115, Kharkiv region, Kharkiv, Severyna Pototskoho Street, 36 (Private Joint-Stock Company "Lekhim-Kharkiv").

Ukraine, 93000, Luhansk region, Rubizhne, Lenina Street, 33 (LLC NPF "MIKROKHIM").

Marketing Authorization Holder.

LLC NPF "MIKROKHIM".

Address of the Marketing Authorization Holder.

Ukraine, 01013, Kyiv, Budynstustriyi Street, 5.

To report an adverse event during the use of this medicinal product, please call +38 (050) 309-83-54 (24/7).

INSTRUCTION

for medical use of the medicinal product

RENEURO

(RENEURO)

Composition:

Active ingredient: choline alfoscerate;

1 ml of solution contains choline alfoscerate 250 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical characteristics: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group.

Medicinal products affecting the nervous system. Parasympathomimetics. Other parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

RENAYRO 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, has the potential to prevent biochemical damage that plays a significant role among the pathogenic factors of psychorganic involutional syndrome, and to correct such damage; thus, it can influence reduced cholinergic tone and 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. RENAYRO positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, which have deteriorated due to the development of brain involutional pathology.

The mechanism of action is based on the fact that after entering the body, choline alfoscerate is enzymatically hydrolyzed into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the main mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, RENAYRO improves nerve impulse transmission in cholinergic neurons, positively influences neuronal membrane plasticity and receptor function. RENAYRO improves cerebral blood flow, enhances metabolic processes in the brain, activates structures of the brain's reticular formation, and restores consciousness following traumatic brain injury.

Pharmacokinetics.

After administration of RENAYRO, approximately 88% of the dose is absorbed. The drug accumulates predominantly in the brain (45% of the plasma concentration), lungs, and liver. Elimination of the drug occurs mainly via the lungs in the form of carbon dioxide (CO₂). Only 15% of the drug is excreted in urine and bile.

Clinical characteristics.

Indications.

Acute period of severe traumatic brain injury with predominantly brainstem level damage (impaired consciousness, coma, focal hemispheric symptoms, brainstem injury signs).

Degenerative involutional cerebral psycho-organic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive impairments in elderly patients characterized by memory disturbances, confusion, disorientation, reduced motivation and initiative, decreased ability to concentrate; emotional and behavioral sphere alterations: emotional instability, irritability, indifference to surroundings; pseudomelancholia in elderly patients.

Contraindications.

• Known hypersensitivity to the drug or its components;
• psychotic syndrome with severe psychomotor agitation;
• pregnancy and breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Clinically significant interaction of the drug with other medicinal products has not been established.

Special precautions.

Nausea may occur (mainly as a result of dopaminergic stimulation). Therapy need not be discontinued; temporary reduction of the drug dosage is sufficient.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

In acute conditions, RENAYRO is administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) daily for 15–20 days. Then, after stabilization of the patient's condition, switch to the oral dosage form of choline alfoscerate.

Children.

There is no experience with the use of the medicinal product RENAYRO in children.

Overdose.

In case of overdose of RENAYRO, which may manifest as nausea, the dose of the drug should be reduced. Symptomatic therapy.

Adverse Reactions

The drug is generally well tolerated, even during prolonged use. Reactions at the injection site are possible. During the first days or weeks of treatment, the following adverse reactions may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment; however, a temporary dose reduction may be considered.

Nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, and very rarely abdominal pain and short-term confusion may occur. In such cases, the administered dose should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioedema, and skin redness.

Shelf Life

3 years.

Storage Conditions

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Incompatibility

Do not mix with other medicinal products in the same container.

Packaging

4 ml in ampoules, 5 ampoules per cassette in a cardboard pack.

Or 4 ml in ampoules, 10 ampoules (5×2) in cassettes in a cardboard pack.

Prescription Status

Prescription only.

Manufacturers

JSC "Halychpharm" (responsible for manufacturing and batch control/testing, excluding batch release).

LLC NVP "MIKROKHEM" (responsible for batch release, excluding batch control/testing).

Manufacturer Addresses

6/8 Opryshkovska Street, Lviv, Lviv Oblast, 79024, Ukraine (JSC "Halychpharm").

5 Budynsturiyi Street, Holosiivskyi District, Kyiv, 01013, Ukraine (LLC NVP "MIKROKHEM").

Marketing Authorization Holder

LLC NVP "MIKROKHEM".

Address of Marketing Authorization Holder

5 Budynsturiyi Street, Kyiv, 01013, Ukraine.