PARACETAMOL UNI-PHARMA

Intravenous route. The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg. 5mL/kg 75 mL 60mg/kg not exceeding 3g >50kg with additional risk factors for hepatotoxicity 1g 100mL 100mL 3g >50 kg and no additional risk factors for hepatotoxicity 1g 100mL 100mL 4g *Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

**Patients weighing less will require smaller volumes. 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. 2). 4).

Method of administration:

Take care when prescribing and administering Paracetamol Uni-Pharma to avoid dosing errors due to confusion between milligram (mg) and millilitre (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. The paracetamol solution is administered as a 15-minute intravenous infusion.

As all paracetamol products, adverse drug reactions are Rare (>1/10,000, <1/1,000) or Very Rare (<1/10,000), these are described below: System Organ Class Rare >1/10,000, <1/1,000 Very rare <1/10,000 General disorders and administration site conditions Malaise Hypersensitivity reaction Cardiac disorders Hypotension Hepatobiliary disorders Increased levels of hepatic transaminases Blood and lymphatic system disorders Thrombocytopenia, Leucopenia, Neutropenia Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation).

Very rare cases of serious skin reactions have been reported. Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment.

Cases of erythema, flushing, pruritus and tachycardia have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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2). It is recommended to use a suitable analgesic oral treatment as soon as this administration route is possible. In order to avoid the risk of overdose, check that other medicines administered do not contain either paracetamol or propacetamol.

Doses higher than the recommended entails risk for very serious liver damage. Clinical symptoms and signs of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually first seen after two days of drug administration with a peak seen usually after 4 – 6 days.

9). g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. 9 mmol (or 250 mg) of sodium per 100ml of Paracetamol Uni-Pharma. To be taken into consideration by patients on a controlled sodium diet.

1. • in cases of severe hepatocellular insufficiency.