Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibuprofen
Medical Horizon Ltd
M01AE01
ibuprofen
20mg/ml
suspension oral
glass bottle 100ml and measuring cup
OTC
Registered
2019-05-31
INSTRUCTION FOR MEDICINAL USE (FOR PATIENTS) IBUFENE ORAL SUSPENSION 100 ML TRADE NAME IBUFENE INTERNATIONAL NON-PROPRIETARY NAME (INN) Ibuprofen COMPOSITION Each 5 ml contains active ingredients: 100 mg Ibuprofen, inactive ingredients: Propylene glycol, Glycerine, Methylparaben, Propylparaben, Sunset yellow, Sorbitol liquid, Polysorbate 80, Orange flavour, Saccharose, Aerosol 200, Xanthan, Purified water. DOSAGE FORM Oral paediatric suspension with orange flavour. PARMACOLOGICAL GROUP Nonsteroidal anti-inflammatory drugs ATC CODE M01AE01 PHARMACOLOGOCAL PROPERTIES PHARMACODYNAMIC PROPERTIES Ibuprofen inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors. Ibuprofen is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis, (including juvenile rheumatoid arthritis or still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions, Ibuprofen is indicated in particular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis, and low back pain; Ibuprofen can also be used in soft-tissue injuries such as sprains and strains. Ibuprofen is indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhea, dental and post-operative pain and for the symptomatic relief of headache including migraine headache. Ibuprofen is also indicated for its antipyretic properties especially for children. PHARMACOKINETIC PROPERTIES Ibuprofen is absorbed from the gastrointestinal tract and peak plasma concentrations occur about 1 to 2 hours after ingestion. Ibuprofen is also absorbed following rectal administration. There is some absorption following topical application to the skin. For example, some manufacturers report that percutaneous absorption from topical gel is about 5 % of that obtained following administration of an oral dose Baca dokumen lengkapnya
PRODUCT – IBUFENE ORAL SUSPENSION Page 1 of 6 SUMMARY PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT IBUFENE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 100mg/5ml. For excipients, see 6.1 3. PHARMACEUTICAL FORM Oral Suspension 100ml 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IBUFENE suspension is indicated for children from 6 months to 12 years, but for infants 3-6 month only after medical prescription, taking into account baby’s weight over 5 kg. As antipyretic: acute respiratory diseases, flu, paediatric infections, post-vaccination period, and diseases which proceed with high temperature. As analgesic: mild to moderate pain such as: dentation, headache, toothache, earache, throat ache, traumatic and post-operative pains, neuralgia and migraine. As anti-inflammatory: juvenile rheumatoid arthritis, osteoarthritis, bursitis, tendovaginitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage depends on children age and weight. Single dose of IBUFEN suspension varies between 5-10mg/kg per body weight, maximum daily dose is 30mg/kg per body weight. IBUFEN suspension can be given 3-4 times during 24 hours. The medicine is effective until 8 hours. AGE AVERAGE WEIGHT SINGLE DOSE MAXIMUM DAILY DOSE 3-6 month By medical advise 6 month-1year 7-10 kg 2.5 ml (mg) 200 mg 1-3 year 10-16 kg 2.5-5 ml (50-100 mg) 300 mg 4-6 year 18-22 kg 7.5 ml (150 mg) 450 mg 7-9 year 24-28 kg 10 ml (200 mg) 600 mg 10-12 year 30-36 kg 15 ml (300 mg) 900 mg - It is not recommended to use IBUFEN suspension for more than 5 days as analgesic - And for more than 3 days as antipyretic PRODUCT – IBUFENE ORAL SUSPENSION Page 2 of 6 4.3 CONTRAINDICATIONS - Infants above 3 month - Hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory agents - Bronchial asthma, urticarial - Gastro-intestinal ulcer in children - Gastro-intestinal bleeding - Colon inflammation - Blood disease leucopenia, haemophilia - Liver or kidney insufficiency - Last trimester of pregnancy 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE Care Baca dokumen lengkapnya