Paracetamol Kabi

Composition:
Each vial contains either 50 ml or 100 ml solution for infusion equivalent to 500 mg or 1,000 mg paracetamol. 

Therapeutic Indications:
Paracetamol Kabi is indicated for short-term treatment of moderate pain, especially following surgery, or 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. 

Glass bottle 50ml & 100ml

Body weight or age	Single dose	Maximum daily dose (taking all medicinal products containing paracetamol into account)
Pre-term newborn infants	No safety and efficacy data are available for pre-term newborn infants.	No safety and efficacy data are available for pre-term newborn infants.
Term newborn infants, infants, toddlers and children weighing up to 10 kg (up to approximately 1 year old)	7.5 mg/kg paracetamol per administration, i.e. 0.75 ml solution per kg	• Up to four times a day • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 30 mg/kg
Children weighing more than 10 kg (approximately 1 year old) and up to 33 kg	15 mg/kg paracetamol per administration, i.e. 1.5 ml solution per kg	Up to four times a day • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 60 mg/kg (i.e. maximum daily dose 2 g)
Children weighing more than 33 kg (approximately 11 years old), adolescents and adults weighing up to 50 kg	15 mg/kg paracetamol per administration, i.e. 1.5 ml solution per kg	Up to four times a day • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 60 mg/kg (i.e. maximum daily dose 3 g)
Adolescents and adults weighing more than 50 kg	1 g paracetamol per administration, i.e. one 100 ml vial	Up to four times a day • The minimum interval between each administration must be 4 hours • The maximum daily dose must not exceed 4 g

 

Severe renal impairment:
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.

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

Method of administration:
For single use only. Any unused solution should be discarded.
Paracetamol Kabi solution for infusion can be diluted in sodium chloride 9 mg/ml (0.9 %) solution or 50 mg/ml glucose (5 %) solution up to one tenth. Before administration, the product should be visually inspected for any particulate matter and discolouration. The paracetamol solution is administered as a 15-minute intravenous infusion.