Encetron solution for injection 125mg / ml, 4ml No. 5 Solofarm

- Acute period of ischemic stroke (as part of complex therapy).

- The recovery period of ischemic and hemorrhagic strokes.

- Acute traumatic brain injury (as part of complex therapy) and the recovery period.

- Cognitive and behavioral disorders in degenerative and vascular diseases of the brain.

The drug is administered intravenously or intramuscularly.

Intravenously administered in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or intravenous drip (40-60 drops per minute).

The intravenous route of administration is preferred over the intramuscular route. When administered intramuscularly, repeated administration of the drug in the same place should be avoided.

1 ml of the drug contains:

Active ingredient: citicoline sodium - 130.63 mg, in terms of citicoline - 125 mg

Excipients: 1 M hydrochloric acid solution or 1 M sodium hydroxide solution up to pH 6.0-8.0, water for injection up to 1.0 ml

- Hypersensitivity to any component of the drug.

- Severe vagotonia (predominance of the tone of the parasympathetic autonomic nervous system).

- Children under 18 years of age (due to the lack of sufficient clinical data).

Trade name of the drug

Encetron-SOLOpharm

International non-proprietary name

Citicoline

Dosage form

solution for intravenous and intramuscular administration

Composition

1 ml of the drug contains:

Active ingredient: citicoline sodium - 130.63 mg, in terms of citicoline - 125 mg

Excipients: 1 M hydrochloric acid solution or 1 M sodium hydroxide solution up to pH 6.0-8.0, water for injection up to 1.0 ml.

Description

Transparent, colorless or with a yellowish or brownish, or yellowish-brownish tinge liquid.

Pharmacotherapeutic group

Nootropic remedy

ATX code

N06BX06

Pharmacodynamics:

Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to restore damaged cell membranes, inhibits the action of phospholipases, prevents excessive formation of free radicals and also prevents cell death by acting on the mechanisms of apoptosis.

In the acute period of stroke, citicoline reduces the amount of damage to the brain tissue and improves cholinergic transmission.

In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period.

In chronic hypoxia of the brain, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulties in performing daily activities and self-care.

Increases the level of attention and consciousness and also reduces the manifestation of amnesia.

Effective in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics:

Suction

Citicoline is well absorbed when administered intravenously and intramuscularly.

Metabolism

When administered intravenously and intramuscularly, citicoline is metabolized in the liver to form choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly.

Distribution

Citicoline is largely distributed in the structures of the brain with the rapid introduction of the choline fraction into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline enters the brain and is actively incorporated into the cellular cytoplasmic and mitochondrial membranes, forming part of the structural phospholipid fraction.

Withdrawal

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and through the intestines, and about 12% - with exhaled CO2.

In the excretion of citicoline in the urine, 2 phases can be distinguished: the first phase lasting about 36 hours during which the rate of excretion decreases rapidly and the second phase during which the rate of excretion decreases much more slowly. The same is observed in the exhaled CO2 - the rate of excretion decreases rapidly after about 15 hours and then decreases much more slowly.

Indications:

- Acute period of ischemic stroke (as part of complex therapy).

- The recovery period of ischemic and hemorrhagic strokes.

- Acute traumatic brain injury (as part of complex therapy) and the recovery period.

- Cognitive and behavioral disorders in degenerative and vascular diseases of the brain.

Contraindications:

- Hypersensitivity to any component of the drug.

- Severe vagotonia (predominance of the tone of the parasympathetic autonomic nervous system).

- Children under 18 years of age (due to the lack of sufficient clinical data).

Pregnancy and lactation:

There are no sufficient data on the use of citicoline in pregnant women. Although in animal studies, no negative effects have been identified during pregnancy, the drug is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When prescribing the drug during lactation, women should stop breastfeeding since there are no data on the release of citicoline and its metabolites in breast milk. The risk to the child cannot be ruled out.

Method of administration and dosage:

The drug is administered intravenously or intramuscularly.

Intravenously administered in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or intravenous drip (40-60 drops per minute).

The intravenous route of administration is preferred over the intramuscular route. When administered intramuscularly, repeated administration of the drug in the same place should be avoided.

Recommended dosage regimen

Acute period of ischemic stroke and traumatic brain injury (HMG) : 1000 mg every 12 hours from the first day after diagnosis, the duration of treatment is at least 6 weeks. 3-5 days after the start of treatment (if the swallowing function is not impaired), it is possible to switch to oral forms of the drug.

The recovery period of ischemic and hemorrhagic strokes The recovery period of TBI cognitive and behavioral disorders in degenerative and vascular diseases of the brain : 500-2000 mg per day.

Dosage and duration of treatment depending on the severity of the symptoms of the disease.

If you suspect ongoing intracranial bleeding, it is recommended not to exceed the dose of 1000 mg per day, the drug is administered intravenously at a rate of 30 drops per minute.

Elderly patients

When prescribing the drug to elderly patients, dose adjustment is not required.

Solution in ampoule is intended for single use. It must be used immediately after opening the ampoule.

The drug is compatible with all types of intravenous isotonic solutions and dextrose solutions.

The procedure for working with a polymer ampoule:

1. Take the ampoule and shake it while holding the neck.

2. Squeeze the ampoule with your hand, while there should be no release of the drug and rotate and separate the valve with rotating movements.

3. Immediately connect the syringe to the ampoule through the hole formed.

4. Turn the ampoule over and slowly draw its contents into the syringe.

5. Put the needle on the syringe.

Side effects:

Classification of the incidence of side effects according to the World Health Organization (WHO): very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10000 to <1/1000); very rare (from <1/10000 including isolated cases); the frequency is unknown (the frequency cannot be estimated from the available data).

The frequency of adverse reactions is very rare:

Allergic reactions : rash, itching, anaphylactic shock.

Others : feeling of heat, edema, shortness of breath.

From the side of the central and peripheral nervous system: insomnia, headache, dizziness, tremors, numbness in the paralyzed limbs, stimulation of the parasympathetic nervous system.

From the side of mental disorders: hallucinations, excitement.

From the side of the cardiovascular system : short-term changes in blood pressure.

From the digestive system: nausea, decreased appetite, vomiting, diarrhea, changes in the activity of liver enzymes.

Overdose:

Given the low toxicity of the drug, overdose cases have not been described.

In case of accidental overdose - symptomatic treatment.

Interaction:

Citicoline enhances the effect of levodopa.

Should not be administered concurrently with medicinal products containing meclofenoxate.

Special instructions:

The drug is injected intravenously in a stream slowly (3-5 minutes, depending on the dose). With intravenous drip, the infusion rate should be 40-60 drops per minute.

In case of persistent intravenous hemorrhage, it is recommended not to exceed the dose of the drug 1000 mg / day, the drug is injected intravenously at a rate of 30 drops per minute.

Impact on the ability to drive vehicles. Wed and fur .:

During the treatment period, care should be taken when performing potentially hazardous activities that require special attention and speed of reactions (driving and other vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Release form / dosage:

Solution for intravenous and intramuscular administration of 125 mg / ml and 250 mg / ml.

Packaging:

4 ml in ampoules made of low density polyethylene (Politvist) with a twisting cap for without a needle intake of the drug or in ampoules made of colorless glass.

3 5 or 10 ampoules of low density polyethylene together with instructions for use in a carton box.

3 or 5 ampoules from colorless glass in a blister strip made of polyvinyl chloride or polyethylene terephthalate film with polymer film or varnished aluminum foil or without polymer film and varnished aluminum foil or in the form of cardboard with cells for packing ampoules.

1 blister or a form of cardboard with 3 or 5 ampoules or 2 blisters or forms of cardboard with 5 ampoules together with instructions for use and an ampoule scarifier or without it in a cardboard box.

Storage conditions:

Store in a dark place at a temperature not exceeding 30 ? C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Vacation conditions

On prescription

Manufacturer

Limited Liability Company 'Grotex' (LLC 'Grotex'), 195279, St. Petersburg, Industrialny prospect, 71, bldg. 2, lit. A, Russia

Marketing Authorization Holder / Organization Receiving Consumer Claims:

LLC 'Grotex'.