PARACETAMOL B. BRAUN SOLUTION FOR INFUSION 10MG/ML [SIN14786P]

Product Info

PARACETAMOL B. BRAUN SOLUTION FOR INFUSION 10MG/ML

[SIN14786P]

4.1 Therapeutic indications

Paracetamol B. Braun is indicated for:

• short-term treatment of moderate pain, especially following surgery,

• short-term treatment of fever,

when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.

4.2 Posology and method of administration

The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg.

The 50 ml bottle is restricted to toddlers and children weighing more than 10 kg and up to 33 kg.

The 10 ml ampoule is restricted to term newborn infants, infants and toddlers weighing up to 10 kg.

Posology:

The dose to be administered and the container size to be used depend exclusively on the patient`s weight. The volume to be administered must not exceed the determined dose. If applicable the desired volume must be diluted in a suitable solution for infusion prior to administration (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or a syringe driver must be used.

Dosing based on patient weight (please see the dosing table here below)

The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.

Severe renal insufficiency:
It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), to reduce the dose and increase the minimum interval between each administration to 6 hours (See section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3 g (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Take care when prescribing and administering Paracetamol B. Braun to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Take care to ensure the dose is measured and administered accurately.

Intravenous use.
The paracetamol solution is administered as a 15-minute intravenous infusion.

Patients weighing ≤10 kg:

• The volume to be administered should be withdrawn from the container and diluted in a sodium chloride 9 mg/ml (0.9 %) solution or glucose 50 mg/ml (5 %) solution or a combination of both solutions up to one tenth (one volume Paracetamol B. Braun into nine volumes diluent) and administered over 15 minutes. See also section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However, this should never exceed 7.5 ml per dose.

Paracetamol B. Braun can be diluted in a 9 mg/ml (0.9 %) sodium chloride solution or 50 mg/ml (5 %) glucose solution or a combination of both solutions up to one tenth (one volume Paracetamol B. Braun into nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).

For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

For single use only. Any unused solution should be discarded.

Before administration, the product should be visually inspected for any particulate matter and discolouration. Only to be used if solution is clear, colourless to slightly pinkish-orangish and the container and its closure are undamaged. Perception of the colour may vary.
As for all solutions for infusion presented in containers with air space inside, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

4.3 Contraindications

• Hypersensitivity to paracetamol, propacetamol hydrochloride (prodrug of paracetamol) 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.

• Cases of severe hepatocellular insufficiency.