Land: Israël
Taal: Engels
Bron: Ministry of Health
IBUPROFEN
RECKITT BENCKISER (NEAR EAST) LTD
M01AE01
SUSPENSION
IBUPROFEN 20 MG/ML
PER OS
Not required
RECKITT BENCKISER HEALTHCARE INT. LTD, UK
IBUPROFEN
IBUPROFEN
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).
2014-10-31
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 Lees het volledige document
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 Lees het volledige document