Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Reckitt Benckiser Healthcare (UK) Ltd
M01AE01
Ibuprofen
20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5000167092196 5000158100688
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 Pročitajte cijeli dokument