Descripción del producto Modelo: 1g / 4ml, 500mg / 2ml GMP: Contrato de GMP Fabricación: Disponible Paquete del transporte: 5 Ampolas / bandeja / caja Origen: China Registro Dossier para Citicoline: País disponible de Citicoline Inyección: Filipinas, Vietnam, etc. Especificación: 1g / 4ml Código del SA: 3004909099 Finished Drug Citicoline Injection
Información del Producto

Product name:	Citicoline injection
Specification:	1g/4ml
Package:	5 ampoules/tray/box
Shelf life:	36 months
Registration dossiers:	available

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1 What CITICOLINE-REX is and what it is used for

Each ampoule contains Citicoline (in the form of sodium salt) 500 mg (2ml) or 1g (4ml). PHARMACOLOGICAL PROPERTIES: PHARMACODINAMICS Citicoline, being the precursor of key ultrastructural components of a cellular membrane (mainly phospholipids), possesses wide range of activities, promotes restoration of the damaged cell membranes, inhibits action of phospholipases, what prevents excessive formation of free radicals and destruction of cells, affects the mechanisms of apoptosis. In the acute period of stroke it reduces the volume of damaged tissue, improves cholinergic transmition. In head injury it reduces duration of a post-traumatic coma and intensity of neurologic symptoms. Citicoline improves observed during hypoxia symptoms, such as memory impairment, emotional liability, lack of initiative, difficulties at conducting of daily actions and self-service. The drug product does not influence breath, pulse and arterial pressure; therefore long treatment is possible.  PHARMACOKINETICS As Citicoline is natural compound which is found in organism, it is impossible to provide classical pharmacokinetic research in connection with complexity of quantitative analysis of exogenous and endogenous  Citicoline. INDICATIONS: 1. Disturbance of consciousness associated with head injury or brain surgery. 2. Promotion of rehabilitation of the upper extremities in patients with hemiplegia following cerebral apoplexy. 3. Treatment in combination with anticholinergics in the following cases of parkinson's disease, in which tremor is especially severe: - Cases in which adverse reactions have developed under treatment with L-DOPA. - Cases in which the administration of L-DOPA is difficult because of laparotomy or complication. - Cases in which L-DOPA is ineffective. 4.Concomitant therapy with protease inhibitors in the treatment of the following diseases: - Acute pancreatitis. - Acute exacerbation of chronic recurrent pancreatitis. - Acute pancreatitis after surgery.

2 Before you use CITICOLINE-REX

CONTRAINDICATIONS: - Children and teenage age before 18 years (in connection with absence of data); - Hypersensitivity to components of drug. OVERDOSAGE: Taking into account low toxicity of the drug overdosage cases are not described, even in case of excess of therapeutic doses. INTERACTION WITH OTHER DRUG PRODUCTS: Citicoline strengthens effects of L-dihydroxyphenylalanine. Citicoline injection can be applied simultaneously with haemostatic agents, intracranial antihypertensive agents and with usual perfusion liquids.

3 How to use CITICOLINE-REX

DOSAGE AND ADMINISTRATION: Solution for intravenous and intramuscular injections It is prescribed intravenously in the form of a bolus intravenous injection (during 5 minutes) or slow intravenous infusion (40-60 drops per minute) at strokes and head injury in acute period by 1000 - 2000 mg daily, which depends on severity of disease during 3-7 days with the subsequent change to intramuscular administration or oral administration. The intravenous way of administration is more preferable, than intramuscular.  Intramuscularly: 1-2 injections per day. It is necessary to avoid repeated administration of the drug to the same place during intramuscular administration. At long-term impairment of consciousness continuous application of a drug from the first stages of disease is possible. At Parkinson's disease and syndromes the recommended dose of a drug is 500 mg per day during the period of treatment throughout 3-4 weeks with breaks between them.

4 Possible side effects

From CNS and peripheral nervous system: sleeplessness, headache, dizziness, excitation, tremor, numbness in the paralyzed limbs. From digestive system: nausea, appetite decrease, change of activity of hepatic enzymes. Allergic reactions: rash, skin itch, anaphylactic shock. The others: heat; in some cases - short-term hypotensive action, stimulation of parasympathetic nervous system.

5 Storing CITICOLINE-REX

Store in a cool dry place, protected from heat and light. Keep all medicines out of reach of children.

6 Shelf life:3 years

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