PARACETAMOL

5 ml/kg 75 ml 60 mg/kg not exceeding 3 g >50 kg with additional risk factors for hepatotoxicity 1 g 100 ml 100 ml 3 g > 50 kg and no additional risk factors for hepatotoxicity 1 g 100 ml 100 ml 4 g *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. No more than 4 doses to be given in 24 hours. The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

2). 2). 4).

Method of administration:

Take care when prescribing and administering Paracetamol 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. The paracetamol solution is administered as a 15-minute intravenous infusion. 8 mm needle (21 gauge needle) and vertically perforate the stopper at the spot specifically indicated.

As for all solutions for infusion presented in glass vials, 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 infusion, in order to avoid air embolism.

6.

The following definitions apply to the incidence of the undesirable effects:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class Common Rare Very rare Frequency not known Blood and lymphatic system disorders Thrombocytopenia, leucopenia, neutropenia Immune system disorders Anapahylactic shock*, hypersensitivity reaction* Metabolism and nutrition disorders High anion gap metabolic acidosis System organ class Common Rare Very rare Frequency not known Cardiac disorders Tachycardia Vascular disorders Hypotension Hepatobiliary disorders Hepatic transaminases increased Skin and subcutaneous tissue disorders Serious skin reactions**, Rash*, Urticaria* Erythema, pruritus, flushing General disorders and administration site conditions Reactions at injection site (pain and burning sensation) Malaise * Very rare cases of hypersensitivity reactions such as anaphylactic shock, urticaria and skin rash have been reported and require discontinuation of treatment.

** Very rare cases of serious skin reactions have been reported (acute generalised exanthematous pustulosis, toxic epidermal necrolysis and Stevens-Johnson syndrome) and require discontinuation of treatment. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

RISK OF MEDICATION ERRORS

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, it should be checked that other medicines administered do not contain either paracetamol or propacetamol.

Doses higher than the recommended entail 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 administration of the medicinal product with a peak seen usually after 4-6 days.

9). Paracetamol can cause serious skin reactions. Patients should be informed of early signs of serious skin reactions. The use of paracetamol should be discontinued if signs of rash or other symptoms of hypersensitivity appear. 2). 2) - chronic alcoholism - low reserves of hepatic glutathione as a result of chronic malnutrition, anorexia, bulimia or cachexia - dehydration.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, that is to say essentially 'sodium free'.

1. - In cases of severe hepatocellular insufficiency