Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Ibuprofen
B. BRAUN SINGAPORE PTE LTD
INFUSION, SOLUTION
Ibuprofen 4mg/ml
INTRAVENOUS
Prescription Only
B. Braun Medical S.A
ACTIVE
2022-04-04
626/12628808/0322 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen B. Braun 4 mg/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 4 mg of ibuprofen. Each 50 ml bottle contains 200 mg of ibuprofen. Each 100 ml bottle contains 400 mg of ibuprofen. Excipient with known effect: Each ml of solution contains 9.10 mg of sodium chloride (3.58 mg of sodi- um). Each 50 ml bottle contains 455 mg of sodium chloride (179 mg of sodi- um). Each 100 ml bottle contains 910 mg of sodium chloride (358 mg of sodi- um). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear and colourless to pale yellow solution for infusion, without any par- ticulate matter. pH: 6.8–7.8 Osmolarity: 310–360 mOsm/L 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibuprofen B. Braun is indicated in children (≥ 5 kg body weight), adoles- cents and adults for the short-term symptomatic treatment of acute mod- erate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified, when other routes of administration are not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest effective dose should be used for the shortest duration neces- sary to relieve symptoms (see section 4.4.). This may minimise undesirable effects. Use should be limited to situations where oral administration is inappro- priate. Patients must switch to oral treatment as soon as this is possible. Adequate hydration of the patient should be maintained to minimize the risk of possible adverse reactions at renal level. _Adults_ The recommended dose is 400 mg of ibuprofen, every 6–8 hours as nec- essary. The recommended maximum daily dose of 2400 mg and should not be exceeded. _Paediatric patients_ The recommended ibuprofen dose in children and adolescents is based on the body weight or age. As a general rule, the recommended daily dose is 20–30 mg/kg of body weight divided into three to four single doses (5 Les hele dokumentet