Each 100 mL contains: Paracetamol 1000 mg.
Pharmacology: Paracetamol Infusion provides onset of pain relief within 5 - 10 minutes after the start of administration.The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 - 6 hours. Paracetamol Infusion reduces fever within 30 minutes after the start of administration with a duration of the antipyretic effect of at least 6 hours.
CETAMOL infusion 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.
Intravenous route: The 50 mL bottle is restricted to children weighing from 10 kg (approximately one year old) to 33 kg. The 100 mL bottle is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old).
Posology: Adolescents and adults weighing more than 50 kg: CETAMOL 1 g per administration, i.e. one 100 mL bottle, 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.
Children weighing more than 33 kg (approximately 11 years old), adolescents and adults weighing less than 50 kg: CETAMOL 15 mg/kg 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 (without exceeding 3 g).
Children weighing more than 10 kg (approximately1 year old) and weighing less than 33 kg: CETAMOL 15 mg/kg 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 (without exceeding 2 g).
Severe renal insufficiency: It is recommended, when giving CETAMOL to patients with severe renal impairment (creatinine clearance ≤30 mL/min), to increase the minimum interval between each administration to 6 hours.
Method of Administration: CETAMOL solution is administered as a 15-minute intravenous infusion. It can also be diluted in a 0.9% Sodium Chloride solution or a 5% Glucose solution up to one tenth. In this case, use the diluted solution within the hour following its proportion (infusion time included). As for all solutions for infusion presented in glass bottle, it is reminded that a close monitoring is needed notably at the end of the infusion, regardless the administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid embolism.
There is a risk of poisoning, 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.
Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain.
Overdose, 7.5 g or more of Paracetamol in a singlea dministration in adults and 140 mg/kg of body weight in a single administration in children, causes hepatic cytolysis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST and ALT), Lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12 to 48 hours after administration. Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days.
Emergency measures: Immediate hospitalization.
Before beginning treatment, take a tube of blood for plasma Paracetamol assay, as soon as possible after overdose.
The treatment includes administration of the antidote, N-acetylcystein (NAC), by the i.v. or oral route, if possible before the 10th hour. NAC can, however, give some degree protection even after 10th hour, but in these cases prolonged treatment is given.
Symptomatic treatment.
Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in one to two weeks with full restitution of liver function. In very severe cases, however, liver transplantation may be necessary.
Hypersensitivity to Paracetamol or to Propacetamol hydrochloride (prodrug of Paracetamol) or to any of the excipients.
Severe hepatocellular insufficiency.
Patients with hepatic failure or active liver disease.
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 Paracetamol.
Doses higher than the recommended entails risk for very serious liver damage.
Clinical symptoms and signs on liver damage are usually seen first after two days with a maximum usually after 4 - 6 days. Treatment with antidote should be given as soon as possible (see Overdosage).
Paracetamol should be used with caution in cases of: Hepatocellular insufficiency; Severe renal insufficiency (creatinine clearance ≤30 ml/min); Chronic alcoholism; Chronic malnutrition (low reserves of hepatic glutathione); Dehydration.
Use in pregnancy: Paracetamol should only be used during pregnancy after a carefully benefit-risk assessment. In this case, the recommended posology and duration must be strictly observed.
Use in lactation: After oral administration, Paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol may be used in breast-feeding women.
Pregnancy: Paracetamol should only be used during pregnancy after a carefully benefit-risk assessment. In this case, the recommended posology and duration must be strictly observed.
Lactation: After oral administration, Paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol may be used in breast-feeding women.
Dizziness, headache, dystonia, nausea, vomiting, constipation.
Simple skin rash or urticaria to anaphylactic shock have been occurred and require discontinuation of treatment.
Malaise.
Hypersensitivity reaction.
Hypotension.
Increased level of hepatic transaminases.
Thrombocytopenia, leucopenia, neutropenia.
Do not use if the solution is cloudy, changes colour, containing visible solid particles, also if the container is damaged and leaking.
Incompatibilities: Paracetamol infusion should not be mixed with other medicinal product.
Store below 30°C, away from light. Do not refrigerate or freeze. Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. The product should be used immediately after opening and any unused solution should be discarded. If diluted in 0.9% Sodium Chloride or 5% Glucose, the solution should be used immediately. However, if the solution is not used immediately, store below one hour (infusion time included).
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Cetamol infusion 1,000 mg/100 mL
1's (Rp61,500/botol)
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