SIENEF

INSTRUCTIONS FOR MEDICAL USE

SIENF

SIENF

Trade name of the drug: Cienef

Active ingredient (INN): citicoline

Dosage form : solution for injection

Composition:

Each 1 ml of solution contains:

active substance : sodium citicoline in terms of citicoline – 250 mg.

excipients : methylparaben, propylparaben, sodium chloride, benzyl alcohol, water for injection.

Description: transparent, colorless liquid, odorless and foreign inclusions

Pharmacotherapeutic group: nootropic agent

Code ATX: N06BX06

pharmachologic effect

Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action — it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In the acute period of stroke, citicolitine reduces the volume of brain tissue damage and improves cholinergic transmission. In case of 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 cerebral hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

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

Removal

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and about 12% by exhaled CO ₂ .

The excretion of citicoline in urine can be divided into 2 phases: a first phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and a second phase, during which the rate of excretion decreases much more slowly. The same thing is observed in exhaled CO ₂ — the rate of elimination decreases rapidly after about 15 hours, and then decreases much more slowly. The same thing is observed in exhaled CO ₂ — the rate of elimination decreases rapidly after about 15 hours, and then decreases much more slowly.

Indications for use

— acute period of ischemic stroke (as part of complex therapy);

— recovery period of ischemic and hemorrhagic strokes;

— traumatic brain injury, acute (as part of complex therapy) and recovery period;

— cognitive and behavioral disorders in degenerative and vascular diseases of the brain.

Directions for use and doses

The drug is prescribed intravenously or intramuscularly.

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

The intravenous route of administration is preferable to 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 (TBI): 1000 mg every 12 hours from the first day after diagnosis, treatment duration is at least 6 weeks. 3-5 days after the start of treatment (if swallowing function is not impaired), it is possible to switch to oral forms of the drug Cienef.

Recovery period of ischemic and hemorrhagic strokes, recovery period of head injury, 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. It is possible to use oral forms of the drug Cienef.

Elderly patients

When prescribing Cienef to elderly patients, no dose adjustment is required. The solution in the 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.

Side effects

Allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes . In some cases, Cienef may stimulate the parasympathetic system and also produce a short-term change in blood pressure.

If any of the side effects indicated in the instructions get worse, or any other side effects not listed in the instructions are noticed, you should inform your doctor.

Contraindications

— hypersensitivity to any of the components of the drug;

— pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);

— rare hereditary diseases associated with fructose intolerance;

— children under 18 years of age (due to the lack of sufficient clinical data).

Drug interactions

Citicoline enhances the effectiveness of levodopa.

Cienef should not be prescribed concomitantly with medications containing meclofenoxate.

special instructions

Use during pregnancy and breastfeeding

There are no sufficient data on the use of citicoline in pregnant women. Although animal studies have not revealed any negative effects, during pregnancy the drug Cienef is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When prescribing Cienef during lactation, women should stop breastfeeding, since there is no data on the excretion of citicoline in human milk.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, patients should be careful when performing potentially hazardous activities that require special attention and speed of psychomotor reactions (including driving a car and other vehicles, working with moving mechanisms, working as a dispatcher and operator).

Overdose

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

Release form

2 ml and 4 ml of solution in glass ampoules. 5 ampoules in a cardboard box with instructions for medical use.

Food conditions

Store at a temperature not exceeding 25ºС in the original packaging.

Keep out of the reach of children.

Best before date

3 years.

Do not use after expiration date.

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

Ankur Drugs and Pharma Limited (Unit-II)

Vill. Makhnumajra, PO Bhud,

Nalagarth, Distt. Solan (HP), India.

Tel : +91-22-40682301

Fax : +91-22-40682323 / 40682333

Manufactured for Avison Pharmaceuticals Pvt. Ltd., India.

Name and address of the organization accepting claims (suggestions) regarding the quality of medicines in the territory of the Republic of Uzbekistan

ООО «SHAYANA FARM»

Republic of Uzbekistan, city Tashkent 700057, st. Usta Shirin house-117,

Phone: 99(871) 2281692(93/94)

Fax: 99 (871) 2281695