NUROFEN FOR CHILDREN ORANGE 20 MG\ML SUSPENSION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IBUPROFEN

متاح من:

RECKITT BENCKISER (NEAR EAST) LTD

ATC رمز:

M01AE01

الشكل الصيدلاني:

SUSPENSION

تركيب:

IBUPROFEN 20 MG/ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

RECKITT BENCKISER HEALTHCARE INT. LTD, UK

المجموعة العلاجية:

IBUPROFEN

المجال العلاجي:

IBUPROFEN

الخصائص العلاجية:

For the reduction of fever and relief of mild to moderate pain. For infants and children aged 3 months to 12 years (i.e. weighing about 40 kg).

تاريخ الترخيص:

2014-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS), 1986.
Use in children under 6 month of age is according to a doctor's
prescription only.
Over 6 months of age – this medicine is sold without a doctor's
prescription.
NUROFEN FOR CHILDREN ORANGE FLAVOR 100 MG/5 ML
SUSPENSION
NUROFEN FOR CHILDREN STRAWBERRY FLAVOR 100 MG/5 ML
SUSPENSION
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
EACH 5 ML CONTAINS: IBUPROFEN 100 MG
For list of inactive ingredients, please see section 6. See also
section “Important information about
some of the ingredients of this medicine”.
READ THIS LEAFLET IN ITS ENTIRETY CAREFULLY BEFORE YOU START USING
THIS MEDICINE. The leaflet
contains concise information about this medicine. If you have any
further questions, ask your
doctor or pharmacist.
Use this medicine in accordance with the dosage instructions in this
leaflet. Consult a pharmacist if
you need additional information.
You must refer to a doctor if the signs of the illness (symptoms)
worsen or do not improve after 24
hours in infants between 3-6 months of age, or after 3 days in
6-months-old or older children.
This medicine is intended for most infants over the age of 3 months,
children, and adults. Use in
children between 3-6 months of age is according to a doctor's
prescription.
You must refer to a doctor if your child is taking more than 75 mg of
aspirin a day, or if your child is
developing a rash, breathing difficulties, diarrhea, or increased
fatigue.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For reduction of fever and relief of mild to moderate pain, for
infants and children between 3
months old to 12 years of age (weighing about 40 kg).
THERAPEUTIC GROUP: Non-steroidal anti-inflammatories (NSAIDs).
2. BEFORE USING THIS MEDICINE
This medicine is suitable for most people, but some people should
avoid using it. If you are in any
doubt, consult a doctor or pharmacist.
DO NOT USE THIS MEDICINE IF:

You or your child are hypersensitive (allergic) to ibuprofen or to any
of the additional ingredients t

خصائص المنتج

Page 1 of 11
_ _
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Strawberry
Nurofen for Children Orange
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 20 mg/1 ml (equivalent to 2.0% w/v).
Excipients with known effect
:
Maltitol Liquid : 2226 mg (2.26 g) per 5 ml
Sodium 9.08 mg (0.39 mmol) per 5 ml
Nurofen for Children Orange also contains: Wheat starch 11 mg,
containing no more than
0.225μg gluten per 5 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
An off-white, orange-flavoured, syrupy suspension.
An off-white, strawberry-flavoured, syrupy suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the reduction of fever and relief of mild to moderate pain. For
infants and
children aged 3 months to 12 years (i.e. weighing about 40 kg).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms (see section 4.4).
For pain and fever: The daily dosage of Nurofen for Children aged 6
months to 12
years old is 5 to 10 mg/kg ORALLY every 6 to 8 hours as needed MAX 4
doses/day
and at intervals of at least 4 hours between doses. Do not exceed the
dose of
40mg/kg a day
. The maximum dose above 12 years of age is 1200mg /day.
Infants and children aged 3 -6 months: dosage according to
physician’s prescription
only
.
Children with identical ages can have significantly different weights
. Therefore,
try to obtain the weight of the child and determine the dosage by
weight. Only if you
cannot find the child's weight determine the dosage according to age.
Using the syringe dosing device provided this can be achieved as
follows:
Page 2 of 11
Dosing chart
WEIGHT
AGE
DOSAGE
NUM. OF TIMES
IN 24 HOURS
Under 5 kg
3-6 months
According to physician’s prescription only
5-5.4 kg
2 ml
3-4 times
5.5-8.1 kg
6-11 months
2.5 ml
8.2-10.9 kg
12-23 months
3.75 ml
11-15 kg
2-3 years
5 ml
16-21 kg
4-5 years
7.5 ml
22-26 kg
6-8 years
10 ml
27-32 kg
9-10 y