Ceraxon solution oral

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

citicoline (citicoline sodium)

Предлага се от:

Ferrer International

АТС код:

N06BX06

INN (Международно Name):

citicoline (citicoline sodium)

дозиране:

100mg/ml

Лекарствена форма:

solution oral

Броя в опаковка:

glass bottle 30ml and measuring syringe, (6) sachets 10ml, (10) sachets 10ml, (30) sachets 10ml

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2024-02-09

Данни за продукта

SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CERAXON 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CERAXON 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: 0.25 mg of propyl parahydroxybenzoate; 1.45 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.
CERAXON 100 mg/ml oral solution: Glass bottle containing 30 ml of a
transparent and colourless liquid
that could occasionally contain whitish crystals with strawberry smell
and taste.
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. Treatment duration depends on cerebral affection degree. The
minimal recommended duration is 45
days.
It may be taken directly or dissolved in half a glass of water (120
ml), with the meals or between them.
See the instructions for preparation in section 6.6.
ELDERLY:
CERAXON 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
Due to Sorbitol, patients with rare hereditary problems of fructose
intolerance should not take this
medicine
.
Due to Propyl parahydroxybenzoate and Methyl parahydroxybenzoate it
may cause allergic react