Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IBUPROFEN
ABBOTT INDONESIA - Indonesia
IBUPROFEN
100 MG
SUSPENSI
DUS, 1 BOTOL @ 60 ML
ABBOTT INDONESIA - Indonesia
2019-08-29
1 BRUFEN® IBUPROFEN 100 MG/5 ML NAME OF THE MEDICINAL PRODUCT Ibuprofen 100 mg/5 mL oral suspension QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 100 mg/5 mL oral suspension The suspension contains 100 mg/5 mL ibuprofen. Excipients with known effect: Sucrose, sorbitol, sunset yellow, methyl parahydroxybenzoate, propyl parahydroxybenzoate. PHARMACEUTICAL FORM Ibuprofen 100 mg/5 mL oral suspension Oral suspension Yellow with orange flavor CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • To reduce fever in children. • To relief mild to moderate pain, such as dental pain or dental extraction pain, headache, postoperative pain, pain in rheumatic conditions of bones and joints, pain in association with sprains. POSOLOGY AND METHOD OF ADMINISTRATION Recommended dose for: ADULT To relief pain: 3 to 4 times of 10 ml a day._ _ _ _ CHILDREN To relief fever and pain: AGE DOSE FREQUENCY 1 to 2 years 2.5 ml 3 to 4 times a day 3 to 7 years 5 ml 3 to 4 times a day 8 to 12 years 10 ml 3 to 4 times a day CONTRAINDICATIONS - Patients with severe and active ulcus pepticum (gastric and duodenal ulceration). - Patients with history of hypersensitivity to ibuprofen and other non-steroidal anti-inflammatory drugs. - Patients with polyps in the nose, angioedema and patients who develop asthma symptoms, rhinitis or urticaria when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. - Last trimester in pregnancy. Disetujui oleh BPOM: 18/02/2021 ID REG: EREG100346VR12000182 2 - Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake) SPECIAL WARNINGS AND PRECAUTIONS FOR USE General Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (_see section Posology and method of administration_, _and gastrointestinal _ _and cardiovascular effects below_). As with other NSAIDs, ibuprofen may mask the signs of infection. On prolonged use of any painkillers, headache may occur that must not be treated with increased doses of t Lees het volledige document