Pays: Israël
Langue: anglais
Source: Ministry of Health
IBUPROFEN
GSK CONSUMER HEALTHCARE, ISRAEL LTD
M01AE01
SUSPENSION
IBUPROFEN 100 MG / 5 ML
PER OS
Not required
FAREVA RICHMOND INC, USA
IBUPROFEN
IBUPROFEN
For the reduction of fever and relief of mild to moderate pain. For infants and children aged 3 months to 12 years .
2021-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 Under the age of 6 months use according to a doctor’s prescription only. Over the age of 6 months this medicine is dispensed without a doctor's prescription. CHILDREN'S ADVIL GRAPE FLAVOR SUSPENSION 100 mg/5 mL CHILDREN'S ADVIL FRUIT FLAVOR SUSPENSION 100 mg/5 mL ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 5 mL contains: Ibuprofen 100mg For the list of inactive ingredients and allergens: see section 6 “Additional information” and section 2 “Before using the medicine" – under subsection "Important information about some of the ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Use the preparation according to the instructions in section 3 – “How should you use the medicine?” in this leaflet. Consult the pharmacist if you need more information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 24 hours in infants aged 3-6 months or after 3 days in children aged 6 months and older. THIS MEDICINE IS SUITABLE FOR MOST INFANTS OVER 3 MONTHS OF AGE, CHILDREN AND ADULTS. IN INFANTS AGED 3-6 MONTHS USE ACCORDING TO A DOCTOR’S PRESCRIPTION. REFER TO THE DOCTOR IF YOUR CHILD IS TAKING ASPIRIN AT A DOSAGE ABOVE 75 MG PER DAY, OR IF YOUR CHILD DEVELOPS A RASH, DIFFICULTY BREATHING, DIARRHEA OR INCREASED FATIGUE. 1. WHAT IS THE MEDICINE INTENDED FOR? For the reduction of fever and relief of mild to moderate pain, in infants and children from 3 months to 12 years of age. THERAPEUTIC CLASS: Non-steroidal anti-inflammatory drugs (NSAIDs). 2. BEFORE USING THE MEDICINE This medicine is suitable for most people, but some people should avoid using it. Consult the pharmacist or the doctor if you are uncertain. DO NOT USE THIS MEDICINE IF: • You or your child are sensitive (allergic) to ibuprofen, or to any of the add Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Advil Children's Grape Flavor Advil Children's Fruit Flavor 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 100mg/5ml. Excipients with known effect: Sucrose Sodium Sorbitol Sodium Benzoate Propylene Glycol (Grape Flavor only) Benzyl Alcohol (Fruit Flavor only) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 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. 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 Children's Advil 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. 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 measuring cup or syringe dosing device provided this can be achieved as follows: DOSING CHART WEIGHT AGE DOSAGE NUMBER 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 years 12.5 ml 33 – 43 kg 11 – 12 years 15 ml Doses should be given approximately every 6 to 8 hours, (or with a minimum of 4 hours between each dose if required). For short term use only. If the child's (aged over 6 months) symptoms persist for more than 3 days, consult your doctor. For children aged 3-6 months, medical advice should be sought after 24 Lire le document complet