B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML [SIN16467P]

Product Info

B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML

[SIN16467P]

4.1 Therapeutic indications
Ibuprofen B. Braun is indicated in children (≥ 5 kg body weight), adolescents and adults for the short-term symptomatic treatment of acute moderate 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 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.

4.3 Contraindications

• Hypersensitivity to the active substance, to other NSAIDs or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• A history of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with taking acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs);

• Conditions involving an increased tendency or active bleeding such as severe coagulation disorders (e.g. thrombocytopenia);

• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);

• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;

• Cerebrovascular or other active bleeding;

• Severe hepatic or renal insufficiency;

• Severe heart failure (NYHA Class IV);

• Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);

• Pregnancy, in the last trimester (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).