For short-term treatment of moderate pain, especially following surgery, and for the short term treatment of fever, when administered 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.

 

- In patients with hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol prodrug) or to any of the excipients.

- In case of severe hepatocellular insufficiency.

 

It's recommended that a suitable analgesic oral treatment be used as soon as this route of administration is possible.

In order to avoid the risk of overdose, check that other medicines administered do not contain paracetamol.

Doses higher than those recommended entail the risk of very serious liver damage.

Paracetamol should be used with caution in the following cases:

- Hepatocellular insufficiency

- Severe renal Insufficiency  

- Chronic alcoholism

- Chronic malnutrition  

- Dehydration

 

Clinical experience of the intravenous administration of paracetamol is limited. However, epidemiological data from the use of oral therapeutic doses indicate no undesirable effect on pregnancy or on the health of the foetus. Paracetamol infusion should be used during pregnancy only if there is potential benefit to the mother.

After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, paracetamol infusion may be used in breast-feeding women.

 

As with all paracetamol products there are rare adverse drug reactions: hypotension, increased levels of hepatic transaminase, leucopenia, thrombocytopenia, neutropenia.

Frequent adverse reaction at injection site have been reported during clinical trials (pain and burning sensation).

 

- Probencid causes reduction in clearance of paracetamol by inhibiting conjugation with glucoronic acid.

- Salicylamide may prolong the elimination t½ of paracetamol.

 

- Adolescent and Adults weighing more than 50 kg: Paracetamol 1g per administration i.e. 100 ml of solution, up to four times a day. The minimum interval between each administration must be four hours. The maximum daily dose must not exceed 4g.

- Children weighing more than 33 kg (approximately 11 years old), adolescent and adults weighing less than 50 kg: Pracetamol 15 mg/kg per administration, i.e. 1.5 ml of solution/kg up to 4 times a day.  The minimum interval between each administration must be four hours. The maximum daily dose must not exceed 60 mg/kg (without exceeding 3 g).

- Children weighing more than 10 kg (approximately 1 years old) and weighing less than 33 kg: Paracetamol 15 mg/kg per administration, i.e. 1.5 ml of solution/kg up to 4 times a day. The minimum interval between each administration must be four hours. The maximum daily dose must not exceed 60 mg/kg (without exceeding 2 g).

- Term newborn, infants and children weighing less than 10 kg (up to approximately 1 years old): Paracetamol 7.5 mg/kg per administration, i.e. 0.75 ml of solution/kg up to 4 times a day. The minimum interval between each administration must be four hours. The maximum daily dose must not exceed 30 mg/kg.

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

 

There is a risk of liver injury (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Overdosing may be fatal in these cases.

 

PARACETAMOL ELSaad – Solution for IV Infusion: A pack of 1 glass vial of 50 or 100mL. Each 1 mL of the sterile solution contains 10 mg Paracetamol.

 

Do not store PARACETAMOL ELSaad – Solution for IV Infusion at temperature above 30°C. Do not refrigerate.