Brulium

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

domperidone

可用日期:

Brupharmexport sprl

INN（国际名称）:

domperidone

剂量:

1mg/ml

药物剂型:

suspension oral

处方类型:

Prescription

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
BRULIUM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of suspension:
Active substance:
Domperidone 1 mg/ml
Excipients with known effect:
Sorbitol solution (E420) at 70%
455 mg/ml
Methyl para-hydroxybenzoate (E218)
1.8 mg/ml
Propyl para-hydroxybenzoate (E216)
0.2 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
White suspension with sweet taste.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults: relief of symptoms of nausea and vomiting, feeling of gastric
fullness, discomfort of the
upper quadrants of the abdomen and regurgitation of gastric contents.
Children: relief of symptoms of nausea and vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The initial duration of treatment is four weeks. Patients must be
reassessed after four weeks, in
order to decide on the need to continue treatment.
1
Adults and adolescents (older than 12 and weighing more than 35 kg):
10 ml (2 measuring spoons)
to 20 ml (4 measuring spoons) of oral suspension, 3 to 4 times per
day, in a maximum dose of 80
mg per day.
PAEDIATRIC POPULATION
Children aged 2 to 12: 2.5 ml (½ measuring spoon) to 5.0 ml (1
measuring spoon) of oral
suspension per 10 kg of body weight (
⇔
0.25 - 0.5 mg/kg of weight), 3 to 4 times per day, up to the
maximum daily dose of 80 mg.
METHOD OF ADMINISTRATION
If you use the dosing pipette, slide the ring up to the mark
corresponding to the child's weight, in
kilograms,
and
administer
the
measured
volume.
If
necessary,
in
order
to
obtain
the
dose
corresponding to the child's weight, repeat the measurement and
administer again.
Instruction for the use of the dosing pipette (administration to
children):
For more comfort and dose control, mainly in children, use the dosing
pipette provided in the pack.
In order to use it correctly, proceed as follows:
1. Shake the bottle with the suspension before each use.
2. Insert the tip of the pipette in the suspension.
3. For a correct measu