Nurofen for Children Orange; Nurofen for Children Orange Baby; Nurofen for Children 3 months to 9 years Orange

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

IBUPROFEN

Dostopno od:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

Koda artikla:

M01AE01

INN (mednarodno ime):

IBUPROFEN

Farmacevtska oblika:

ORAL SUSPENSION

Sestava:

IBUPROFEN milligram(s)/5 millilitre

Tip zastaranja:

OTC

Terapevtsko območje:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2010-08-30

Navodilo za uporabo

Reckitt Benckiser
P0002 MA936-00101 MoM-Spec-Excipients-UCP
1.3.1 Package Leaflet
NfC National 2pc Orange
Page 1
Mockups for the packing at BCM
Reckitt Benckiser
P0002 MA936-00101 MoM-Spec-Excipients-UCP
1.3.1 Package Leaflet
NfC National 2pc Orange
Page 2
TR525250E - Dimensions 420x148mm - Minimum point size: 10pt
Reckitt Benckiser
P0002 MA936-00101 MoM-Spec-Excipients-UCP
1.3.1 Package Leaflet
NfC National 2pc Orange
Page 3
Mockups for the packing at
Reckitt Benckiser
Reckitt Benckiser
P0002 MA936-00101 MoM-Spec-Excipients-UCP
1.3.1 Package Leaflet
NfC National 2pc Orange
Page 4
TR486201B - Dimensions 420x148mm - Minimum point size 10pt

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Nurofen for Children Orange 
Nurofen for Children Orange Baby 
_NUROFEN FOR CHILDREN 3 MONTHS TO 9 YEARS ORANGE _

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v). 

For excipients, see 6.1. 

3. 
PHARMACEUTICAL FORM 

Oral suspension. 
An off-white, orange-flavoured, syrupy suspension. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
For the fast and effective reduction of fever,
including post immunisation pyrexia and the 
fast and effective relief of mild to moderate pain, such as a
sore throat, teething pain, 
toothache, headache, minor aches and sprains. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral administration. 

For post immunisation pyrexia: One 2.5 ml dose followed
by one further 2.5 ml dose 6 
hours later if necessary. No more than two 2.5ml doses in 24
hours. If the fever is not 
reduced, consult your doctor. Not suitable for children under 3
months of age. 

For pain and fever: The daily dosage of Nurofen For Children
is 20-30 mg/kg bodyweight in 
divided doses. Using the dosing syringe device provided this can
be achieved as follows: 

Infants 3 - 6 months weighing more than
5kg: One 2.5ml dose may be taken 3 times in 24 
hours. 
Infants 6 - 12 months: One 2.5ml dose may be taken 3 to 4
times in 24 hours. 
Children 1 - 3 years: One 5ml dose may be taken 3 times in
24 hours. 
Page 1 of 11 
Children 4 - 6 years: 7.5ml (5ml +2.5ml) may be taken 3
times in 24 hours. 
Children 7 - 9 years: Two 5ml doses may be taken 3 times in
24 hours. 

Doses should be given approximately every 6 to 8 hours, (or with
a minimum of 4 hours 
between each dose if required). 

Not suitable for children under 3 months of age. 
For