PARACETAMOL ACCORD

Intravenous use. The product is restricted to adults, adolescents and children weighing more than 33 kg. 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.

4). Elderly patients No dose adjustment is usually required in geriatric patients.

Method of administration:

Take care when prescribing and administering Paracetamol 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. 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 pernfusion applies particularly for central route infusions, in order to avoid air embolism.

As with all paracetamol products, adverse drug reactions are common (≥1/100 to <1/10) or rare (>1/10,000 to <1/1,000) or very rare (<1/10,000) or have a not known frequency (cannot be estimated from the available data), they are described below : System Organ Class Frequency Undesirable effects Blood and the lymphatic system disorders Very rare Thrombocytopenia Leucopenia, Neutropenia Immune system disorders Very rare Anaphylactic shock* Hypersensitivity reaction* Metabolism and nutrition disorders Not known High anion gap metabolic acidosis Rare Hypotension Cardiac disorders Not known Tachycardia Hepatobiliary disorders Rare Increased levels of hepatic transaminases Skin and subcutaneous tissue disorders Very rare Rash* Urticaria* Serious skin reactions** Rare Malaise Common Administration site reaction (pain and burning sensation) General disorders and administration site conditions Not known Erythema Flushing Pruritus *Very rare cases of hypersensitivity reactions in the form of anaphylactic shock, urticaria, skin rash have been reported and require discontinuation of treatment.

**Very rare cases of serious skin reactions have been reported 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.

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 (including prescription and nonprescription) administered do not contain either paracetamol or propacetamol.

Doses higher than the recommended entails risk for very serious liver damage. Clinical signs and symptoms 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. This medicinal product contains less than 1mmol sodium (23mg) per 100ml of Paracetamol, that is to say essentially 'sodium free'.

Paracetamol can cause serious skin reactions. Patients should be informed about the early signs of serious skin reactions, and the use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

2). 2), - chronic alcoholism, - chronic malnutrition (low reserves of hepatic glutathione), anorexia, bulimia or cachexia, - dehydration - glucose-6-phosphatase dehydrogenase deficiency (may lead to haemolytic anaemia). 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 (including prescription and nonprescription) administered do not contain either paracetamol or propacetamol. Doses higher than the recommended entails risk for very serious liver damage.

Clinical signs and symptoms 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.