Nurofen for Children 100mg/5ml oral suspension orange

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Ibuprofen

Διαθέσιμο από:

Reckitt Benckiser Healthcare (UK) Ltd

Φαρμακολογική κατηγορία (ATC):

M01AE01

INN (Διεθνής Όνομα):

Ibuprofen

Δοσολογία:

20mg/1ml

Φαρμακοτεχνική μορφή:

Oral suspension

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 10010100; GTIN: 5000167092196 5000158100688

Αρχείο Π.Χ.Π.

OBJECT 1
NUROFEN FOR CHILDREN ORANGE BABY
Summary of Product Characteristics Updated 31-Jan-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen for Children Orange
Nurofen for Children Orange Baby
Nurofen for Children 3 months to 9 years Orange
Nurofen for Children Cold, Pain and Fever Orange Flavour 100mg/5mL
Oral Suspension
2. Qualitative and quantitative composition
Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v).
Excipients with known effect:
Maltitol Liquid
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension.
An off-white, orange-flavoured, syrupy suspension.
4. Clinical particulars
4.1 Therapeutic indications
Prescription and OTC: For the fast and effective reduction of fever,
including post immunisation pyrexia
and the fast and effective relief of the symptoms of colds and
influenza and mild to moderate pain, such
as a sore throat, teething pain, toothache, headache, minor aches and
sprains.
4.2 Posology and method of administration
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
For short term use only.
The recommended daily dose of the product is 20 – 30 mg per kg of
body weight, divided into equal
doses, with dosing intervals of 6 to 8 hours. Leave at least 4 hours
between doses and do not take more
than the recommended dose in 24 hours. The recommended dose should not
be exceeded.
Using the spoon or syringe dosing device provided this can be achieved
as follows:
Age
Body weight
(kg)
Recommended Dosage
Infants 3-6 months weighing more
than 5 kg
5-7.6
one 2.5ml dose may be taken 3
times in 24 hours
Infants 6-12 months
7.7-9
one 2.5ml dose may be taken 3 to 4
times in 24 hours
Children 1-3 years
10-16
one 5ml dose may be taken 3 times
in 24 hours
Children 4-6 years
17-20
7.5ml (5ml +2.5ml spoonful) may
be taken 3 times in 24 hours
Children 7-9 years
21-30
two 5ml doses may be taken 3
times in 24 hours
Not suitable for children un