PARACETAMOL-AFT SOLUTION FOR INFUSION 10MG/ML [SIN14692P]

Product Info

PARACETAMOL-AFT SOLUTION FOR INFUSION 10MG/ML

[SIN14692P]

INDICATIONS
PARACETAMOL-AFT 10 mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

DOSAGE AND ADMINISTRATION
Intravenous route

PARACETAMOL-AFT 10 mg/mL, solution for infusion should not be mixed with other medicinal products.

Dosage:
Adults
The recommended dose in patients weighing more than 50kg is:
Paracetamol 1g per administration, i.e. one 100 mL vial, up to four times a day.

The recommended dose in patients weighing less than 50kg and more than 33kg is:
Paracetamol 15mg/kg per administration (1.5mL solution per kg) up to four times a day.

The minimum interval between each administration must be 4 hours in patients without hepatic or renal impairment. In patients with renal and/or hepatic impairment, the minimum interval between doses must not be less than 6 hours.

For adults weighing from 33 to 50kg, the maximum daily dose from all sources of paracetamol must not exceed 60mg/kg.

Use of 100mL vial is restricted to adults, adolescents and children weighing more than 33kg.

Hepatic Impairment
In patients with chronic or compensated active hepatic disease, especially those with hepatocellular insufficiency, chronic malnutrition (low reserves of hepatic glutathione), and dehydration, the dose should not exceed 3g/day.

Method of administration
The paracetamol solution is administered as a 15-minute intravenous infusion; it contains no antimicrobial agent, and is for single use in one patient only.

PARACETAMOL-AFT 10mg/mL solution for infusion can also be diluted in a 0.9% Sodium Chloride or 5% Glucose solution up to one-tenth. In this case, use the diluted solution within the hour following its preparation (infusion time included).

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 the administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.

It is recommended that for the administration of PARACETAMOL-AFT 10mg/mL solution for infusion a syringe or giving set with a diameter equal to or below 0.8mm should be used for solution sampling. In addition, it is recommended that the bung is pierced at the location specifically designed for needle introduction (where the thickness of the bung is the lowest). If these recommendations are not adhered to, the likelihood of bung fragmentation or the bung being forced into the vial is increased.

Overdose
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. Poisoning may be fatal in these cases. Acute overdose with paracetamol may also lead to acute renal tubular necrosis.

Symptoms generally appear within the first 24 hours and comprise of nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults or 140 mg/kg of body weight in a single administration in children, causes cytolytic hepatitis likely to induce complete and irreversible hepatic necrosis, resulting in acute or fulminant hepatic failure, hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death.

Simultaneously, increased levels of hepatic transaminases (AST, 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.

The Rummack-Matthews nomogram relates plasma levels of paracetamol and the time after oral ingestion to the predicted severity of liver injury. The relation of parental paracetamol levels in overdose to liver toxicity has not been examined. Advice or treatment protocols based on oral paracetamol overdoses may not accurately predict the incidence of liver toxicity or need for antidote therapy in PARACETAMOL-AFT overdose.

Emergency measures

• Immediate hospitalisation.

• Before beginning treatment, take blood for plasma paracetamol assay, as soon as possible after the overdose.

• Treatment of paracetamol overdose may include the antidote N-acetyl cysteine (NAC) by the IV or oral route. In overdoses of oral paracetamol, NAC is administered, if possible, before 10 hours but may give some degree of protection from liver toxicity even after this time. The optimal time for administration of NAC and necessary duration of therapy have not been established for overdoses of PARACETAMOL-AFT.

• 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 the liver function. In very severe cases, however, liver transplantation may be necessary.

CONTRAINDICATIONS
PARACETAMOL-AFT 10 mg/mL, solution for infusion is contraindicated:

• in cases of hypersensitivity to paracetamol or to propacetamol hydrochloride (prodrug of paracetamol) or to any of the excipients

• in cases of severe hepatocellular insufficiency

• in patients with hepatic failure or decompensated 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 entail a risk of very serious liver damage. Clinical symptoms and signs of liver damage are usually seen first after two days with a maximum usually after 4 to 6 days. Treatment with antidote should be given as soon as possible (see DOSAGE AND ADMINISTRATION).