Somazina solution oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

citicoline (citicoline sodium)

Available from:

Ferrer International

ATC code:

N06BX06

INN (International Name):

citicoline (citicoline sodium)

Dosage:

100mg/ml

Pharmaceutical form:

solution oral

Units in package:

30ml glass bottle and measuring syringe

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-04-12

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SOMAZINA 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAZINA 100 mg/ml oral solution is supplied in glass bottles
containing 30 ml of solution. Each ml
contains 100 mg of citicoline (as sodium salt).
Excipients:
Per ml of solution: 0.005 mg of Ponceau 4-R red colour; 0.4 mg of
propyl parahydroxybenzoate; 1.6 mg of
methyl parahydroxybenzoate; 200 mg of sorbitol and other excipients in
q.s.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
SOMAZINA 100 mg/ml oral solution: Glass bottle containing 30 ml of a
transparent and pink-coloured
liquid with strawberry smell and taste.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications

Stroke, acute phase of cerebral circulation disorders and treatment
of complications and
consequences of cerebral circulation disorders.

Traumatic Brain injury and its neurological sequelae

Cognitive and behavioural impairment secondary to chronic vascular and
degenerative cerebral
disorders.
4.2 Posology and method of administration
Adults:
The recommended dose is from 500 to 2,000 mg/day, depending on the
severity of the symptoms to be
treated.
Duration of treatment depending on the severity of the symptoms to be
treated
and
are determined by the
physician individually.
It may be taken directly or dissolved in half a glass of water (120
ml), with the meals or between them.
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See the instructions for preparation in section 6.6.
Elderly:
SOMAZINA does not need any specific dose adjustment for this age
group.
Children:
The experience in children is limited; therefore it may only be
administered when the expected
therapeutically benefit is higher than any possible risk.
4.3 Contraindications
In case of allergy to Citicoline or any excipient
It must not be administered to patients with hyperton