描述

PARACETAMOL INJECTION 300MG/2ML

Indicatios:

Paracetamol Baxter is indicated for the short-term treatment of moderate pain, especially following surgery and for the 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.

This medicinal product is indicated in adults, adolescents and children weighing more than 33 kg.

Dosage and administration：

Intravenous use.

This medicinal product is restricted to adults, adolescents and children weighing more than 33 kg.

Posology :

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

Patient weight	Dose per administration	Volume per administration	Maximum volume of Paracetamol (10 mg/ml) per administration based on upper weight limits of group (ml)**	Maximum Daily Dose *
> 33 kg to ≤50 kg	15 mg/kg	1.5 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.

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.

In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration: The maximum daily dose must not exceed 3 g.

Severe renal insufficiency: it is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤30 ml/min), to increase the minimum interval between each administration to 6 hours.

Contraindications:

▪ Hypersensitivity to the active substance or to any of the excipients or to propacetamol hydrochloride (prodrug of paracetamol).

▪ in cases of severe hepatocellular insufficiency.

Precautions:

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. Treatment with antidote should be given as soon as possible.

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

Precautions for use

Paracetamol should be used with caution in cases of:

▪ hepatocellular insufficiency, Gilbert’s syndrome,

▪ severe renal impairment ,

▪ chronic alcoholism,

▪ chronic malnutrition (low reserves of hepatic glutathione),

▪ dehydration.

▪ In patients suffering from a genetically caused G-6-PD deficiency (favism) the occurrence of a haemolytic anaemia is possible due to the reduced allocation of glutathione following the administration of paracetamol.

Drug interactions:

Probenecid causes an almost 2-fold reduction in clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction of the paracetamol dose should be considered for concomitant treatment with probenecid,

▪ Salicylamide may prolong the elimination t1/2 of paracetamol,

▪ Caution should be paid to the concomitant intake of enzyme-inducing substances.

▪ Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values. In this case, increased monitoring of INR values should be conducted during the period of concomitant use as well as for 1 week after paracetamol treatment has been discontinued.

Storage:

Do not refrigerate or freeze.

Store the immediate packaging in the outer, over wrap.