Somazina solution for injection

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:

125mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(5) ampoules 4ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-01

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SOMAZINA 500 mg solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAZINA 500 mg solution for injection is supplied in 4 ml glass
ampoules. Each
ampoule contains 500 mg citicoline (as sodium salt).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
SOMAZINA 500 mg solution for injection: Clear and colourless water
solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stroke, Acute phase and its neurological sequelae.
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.
It can be administered by intramuscular, slow intravenous route( from
3 to 5 minutes
depending on the administered dose) or in intravenous drop perfusion (
drippin speed:
40-60 drops per minute ).
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
therapeutical 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 hypertonia of the
parasympathetic.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
When administered by intravenous route, the administration must be
slow (from 3 to 5
minutes depending
on the administered dose).
When administered by intravenous drop perfusion, the dripping speed
must be 40-60 drops
per minute.
In case of persistent intracranial haemorrhage, do not exceed the dose
of 1000 mg daily by
very slow
intravenous administration (30 drops per minute).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Citicoline potentiates the effe