Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
IBUPROFEN
RECKITT BENCKISER (NEAR EAST) LTD
M02AA13
SUPPOSITORIES
IBUPROFEN 125 MG
RECTAL
Not required
RECKITT BENCKISER HEALTHCARE INT. LTD, UK
IBUPROFEN
IBUPROFEN
For the symptomatic treatment of muld to moderate pain. For the symptomatic treatment of fever.
2015-02-28
CUSTOMER INFO: Minimum Point Size = 7.00pt N/A N/A N/A N/A N/A N/A N/A N/A BARCODE INFO Barcode Type: Barcode Number: Magnification: Truncated By: Full Height: Bar Height (Smallest Bar): BWR: Encoded Data: Trident Reference No: ZEN Ref: Action: Brand: Category: Segment Group: Segment: Pack Size: Market/Country: Date: Component Code (2D if applicable) : 2 nd Component Code (if applicable) : Parent Technical Packaging Specification: Finished Goods Code: Supply Point: 3rd Party Code Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: 1100(27) 31051633 3P Famar Greece N/A 0199202/0199201 Nurofen Paediatric Suppositories 60mg_125mg 60 125mg RB492082 Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only. STUDIO USE ONLY v2.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items Cutter 2 (if applicable) Guides 2 (if applicable) Paperpack (Athens , Greece) N-Lft-Famar-D0314038-160x475mm TR2294205 Paper Israel 28/04/22 F rashmi jegadeesan 3218077 N/A G=0; O=4; R=5; - RJ - 28/04/22 13:11:31 RB Artwork and Print Specification D0314038 Artwork Type: BW Commercial 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 1 LTH Process Black Colours (Leaflet) RBH Contact: Bar Yaron Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. PATIENT PACKAGE INSERT ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is sold without a doctor's prescription NUROFEN FOR CHILDREN SUPPOSITORIES 60 MG NUROFEN FOR CHILDREN SUPPOSITORIES 125 MG THE ACTIVE INGREDIENT AND ITS QUANTITY: Each suppository of NUROFEN FOR CHILDREN SUPPOSITORIES 60 MG contains: Ibuprofen 60 mg Each suppository of NUROFEN FOR CHILDREN SUPPOSITORIES 125 MG contains: Ibuprofen 125 mg For the list of inactive ingredients, see section Læs hele dokumentet
_1_ _ _ _ _ PHYSICIAN'S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Nurofen for Children Suppositories 60 mg Nurofen for Children Suppositories 125 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Nurofen for Children Suppository 60 mg contains 60 mg ibuprofen. Each Nurofen for Children Suppository 125 mg contains 125 mg ibuprofen. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Suppositories Nurofen for Children Suppositories 60 mg- Torpedo Shaped, unbroken, almost white to white smooth suppository Nurofen for Children Suppositories 125 mg- Torpedo Shaped, unbroken, white to yellowish white smooth suppository 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS . For the symptomatic treatment of mild to moderate pain, and for the symptomatic treatment of fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rectal use. Use in children under 6 months of age requires prescription. POSOLOGY For short term use only. Do not use this product in children under 3 months of age without medical advice. Do not use this product in children weighing less than 6 Kg. Nurofen for children suppositories 125 mg are not suitable for infants weighing less than 12.5 kg (approximately 2 years of age), as suppositories containing less active substance are needed (see also section 4.3). The maximum total daily dose of the product is 20 - 30 mg per kg of body weight, divided into 3-4 single doses. This can be achieved as follows: AGE BODY WEIGHT (KG) RECOMMENDED DOSAGE Infants 3-9 months weighing more than 6 kg 6-8 60 mg up to 3 times in 24 hours, leaving 6-8 hours between doses 9 months-2 years 8-12.5 60 mg up to 4 times in 24 hours, leaving 6 hours between doses Children 2-4 years 12.5-17 125 mg up to 3 times in 24 hours, leaving 6-8 hours between doses _2_ Children 4-6 years 17-20.5 125 mg up to 4 times in 24 hours, leaving 6 hours between doses For infants aged 3-5 months, medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 mon Læs hele dokumentet