Panadol Baby suspension oral

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

paracetamol

זמין מ:

Farmaclair

קוד ATC:

N02BE01

INN (שם בינלאומי):

paracetamol

כמות:

120mg/5ml

טופס פרצבטיות:

suspension oral

יחידות באריזה:

glass bottle 100ml and measuring syringe

סוג מרשם:

OTC

מצב אישור:

Registered

תאריך אישור:

2019-01-18

מאפייני מוצר

24.04.2020 GDS 06, France SPC 2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PANADOL BABY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml suspension contains:
Active ingredient: Paracetamol 120mg.
For excipients see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Pink viscous liquid; crystals may present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain from mild to moderate intensity and/or
fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
PANADOL BABY is not recommended for children under the age of 2
months.
PANADOL BABY is indicated for children with a body mass from 4 to 42
kg (approximately up
to 12 years).
The dosing depends on age and body mass of a child.
Approximate single doses, which are determined in accordance with the
age and body mass of a
child, are shown in the table below.
The recommended single dose of paracetamol is 10-15 mg/kg of body
mass. 1ml of the drug
contains 24mg of paracetamol. Give to a child every 4-6 hours, but no
more than four doses in
any 24 hour period. Minimum dosing interval: 4 hour
BODY
MASS
(KG)
AGE
SINGLE DOSE (ML)
MAXIMUM
DAILY
DOSE (ML)
4-7
2-6 months
2,5
15
7-10
6 months - 1 year
2,5-5,0
18-25
10-12
1-2 years
5,0-7,5
25-30
12-16
2-4 years
7,5-10,0
30-40
24.04.2020 GDS 06, France SPC 2017
16-19
4-5 years
10,0
40 -47
20-25
6-7 years
12,0
50-62
26-31
8-9 years
16,0
65-77
32-42
10-12 years
20,0
80-105
The range of maximum daily dose corresponds to the range of body
weight, where lower values
correspond to lower and larger values – to larger.
Maximum daily dosage is 60mg/kg presented in divided doses of 10 - 15
mg/kg throughout the 24
hour period.
The medicine can be taken in pure form or diluted in water, milk or
fruit juice.
Systemic use of the drug avoids severe febrile conditions or changes
in pain intensity.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
Maximum duration of continued use without medical advice: 3 days.
Sho