B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Therapeutic

Prescription Only

INFUSION, SOLUTION

**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. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). This may minimise undesirable effects. Use should be limited to situations where oral administration is inappropriate. 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 necessary. 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 (5–10 mg/kg): Children weighing 5 kg – 39 kg: up to 10 mg/kg of body weight of ibuprofen not exceeding a maximum daily dose of 30 mg/kg of body weight. Adolescents weighing 40 kg or more: single dose up to 400 mg of ibuprofen not exceeding a maximum daily dose of 1200 mg. Not recommended for children under 5 kg or 3 months. The respective dosing interval should be chosen in line with the symptomatology and the maximum daily dose. The interval between doses should not be below 6 hours. The recommended maximum daily dose should not be exceeded. _Elderly patients_ Like with all non-steroidal anti-inflammatory drugs (NSAIDs), precautions should be taken when treating elderly patients, as they are generally more prone to adverse effects (see section 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), and are more likely to have renal, hepatic and cardiovascular dysfunction, and to be using concomitant medications. Specifically, it is recommended to administer the lowest effective dose for the shortest duration necessary to control symptoms for this population. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. _Renal insufficiency_ Precautions should be taken when NSAIDs are used in patients with renal insufficiency. In patients with mild or moderate renal impairment the initial dose should be reduced and be kept as low as possible for the shortest duration necessary to control symptoms and renal function monitored. This medicinal product is contraindicated in patients with severe renal insufficiency (see section 4.3). Hepatic insufficiency Precautions should be taken when NSAIDs are used in this population although differences in the pharmacokinetic profile have not been observed. Patients with mild or moderate hepatic insufficiency should start the treatment with reduced doses, the dose should be kept as low as possible for the shortest duration necessary and they should be carefully monitored. This medicinal product is contraindicated in patients with severe hepatic insufficiency (see section 4.3). **Method of administration** For intravenous use. Ibuprofen B. Braun is prescribed by a doctor and should only be administered by qualified healthcare professionals in an environment where appropriate equipment is available (during treatment). The solution should be administered as an intravenous infusion over 30 minutes.