Nurofen for Children

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

IBUPROFEN

Dostopno od:

Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom

Koda artikla:

M01AE01

INN (mednarodno ime):

IBUPROFEN 100 mg/5ml

Farmacevtska oblika:

ORAL SUSPENSION

Sestava:

IBUPROFEN 100 mg/5ml

Tip zastaranja:

OTC

Terapevtsko območje:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status dovoljenje:

Invalid

Datum dovoljenje:

2008-07-09

Lastnosti izdelka

Page 1 of 8 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Nurofen For Children 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

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

3. PHARMACEUTICAL 
FORM 

Oral suspension 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Prescription only: For symptomatic treatment of Juvenile
Rheumatoid 
Arthritis. 

Prescription and OTC: 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, earache,
headache, minor 
aches and sprains. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For pain and fever: The daily dosage of Nurofen For Children is
20-30 mg/kg 
bodyweight in divided doses. Using the spoon or syringe dosing
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. 
Children 4 - 6 years: 7.5ml (5ml +2.5ml spoonful) may be taken 3
times in 24 
hours. 
Children 7 - 9 years: Two 5ml doses may be taken 3 times in 24
hours. 
Children 10 – 12 years: Three 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 unless advised
by your doctor. 

Page 2 of 8 
For Juvenile Rheumatoid Arthritis: The usual daily dosage is 30 to
40 
mg/kg/day in three to four divided doses. 

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 y