NUROFEN FOR CHILDREN SUPPOSITORIES 60 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IBUPROFEN

متاح من:

RECKITT BENCKISER (NEAR EAST) LTD

ATC رمز:

M02AA13

الشكل الصيدلاني:

SUPPOSITORIES

تركيب:

IBUPROFEN 60 MG

طريقة التعاطي:

RECTAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

RECKITT BENCKISER HEALTHCARE INT. LTD, UK

المجموعة العلاجية:

IBUPROFEN

المجال العلاجي:

IBUPROFEN

الخصائص العلاجية:

For the symptomatic treatment of mild to moderate pain. For the symptomatic treatment of fever.

تاريخ الترخيص:

2015-02-28

نشرة المعلومات

CUSTOMER INFO:
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1100(27)
31051633
3P Famar Greece
N/A
0199202/0199201
Nurofen
Paediatric
Suppositories
60mg_125mg
60 125mg
RB492082
Please note that any low resolution paper Canon colour copies
associated with this job should be referred to for content, layout
and colour separation only.
STUDIO USE ONLY
v2.0
Sm•Art check results:
Cutter
Guides
Technical & Non Printing Items
Cutter 2 (if applicable)
Guides 2 (if applicable)
Paperpack (Athens , Greece)
N-Lft-Famar-D0314038-160x475mm
TR2294205
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Israel
28/04/22
F
rashmi jegadeesan
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G=0; O=4; R=5; - RJ - 28/04/22 13:11:31
RB Artwork and
Print Specification
D0314038
Artwork Type:
BW Commercial
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RBH Contact:
Bar Yaron
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: [phone]
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
PATIENT PACKAGE INSERT ACCORDING TO THE
PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
The medicine is sold without a doctor's prescription
NUROFEN FOR CHILDREN
SUPPOSITORIES 60 MG
NUROFEN FOR CHILDREN
SUPPOSITORIES 125 MG
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each suppository of NUROFEN FOR CHILDREN
SUPPOSITORIES 60 MG contains: Ibuprofen 60 mg
Each suppository of NUROFEN FOR CHILDREN
SUPPOSITORIES 125 MG contains: Ibuprofen 125 mg
For the list of inactive ingredients, see section

خصائص المنتج

_1_
_ _
_ _
PHYSICIAN'S PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Suppositories 60 mg
Nurofen for Children Suppositories 125 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nurofen for Children Suppository 60 mg contains 60 mg ibuprofen.
Each Nurofen for Children Suppository 125 mg contains 125 mg
ibuprofen.
For the full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Suppositories
Nurofen for Children Suppositories 60 mg- Torpedo Shaped, unbroken,
almost white to white
smooth suppository
Nurofen for Children Suppositories 125 mg- Torpedo Shaped, unbroken,
white to yellowish white
smooth suppository
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
.
For the symptomatic treatment of mild to moderate pain, and for the
symptomatic treatment of fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rectal use.
Use in children under 6 months of age requires prescription.
POSOLOGY
For short term use only.
Do not use this product in children under 3 months of age without
medical advice.
Do not use this product in children weighing less than 6 Kg.
Nurofen for children suppositories 125 mg are not suitable for infants
weighing less than 12.5 kg
(approximately 2 years of age), as suppositories containing less
active substance are needed (see also
section 4.3).
The maximum total daily dose of the product is 20 - 30 mg per kg of
body weight, divided into 3-4 single
doses. This can be achieved as follows:
AGE
BODY WEIGHT (KG)
RECOMMENDED DOSAGE
Infants 3-9 months weighing
more than 6 kg
6-8
60 mg up to 3 times in 24 hours,
leaving 6-8 hours between doses
9 months-2 years
8-12.5
60 mg up to 4 times in 24 hours,
leaving 6 hours between doses
Children 2-4 years
12.5-17
125 mg up to 3 times in 24 hours,
leaving 6-8 hours between doses
_2_
Children 4-6 years
17-20.5
125 mg up to 4 times in 24 hours,
leaving 6 hours between doses
For infants aged 3-5 months, medical advice should be sought if
symptoms worsen or not later than 24
hours if symptoms persist. If in children aged from 6 mon