Parvolex 200mg / 10ml Injection
PDF Leaflet Revision Date: 19 July 1984
Clinical Summary
Quick overview from the medicine insert
Indication
Paracetamol overdosage.
Dosage (summary)
Initial: 150 mg/kg IV over 15 mins, then 50 mg/kg over 4 hours, followed by 100 mg/kg over 16 hours.
Special Populations
- Children
- Asthma history
Pregnancy & Breastfeeding
Safety in pregnancy not established.
Contraindications
- Hypersensitivity to any ingredient
Common side effects
- Rash
- Bronchospasm
- Anaphylactoid reactions
Counselling Points
- Monitor plasma potassium concentration
- Not compatible with rubber and metals
Serious warnings
- Ineffective after 15 hours post-overdose
- Risk of hepatic encephalopathy
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Paracetamol overdosage.
4.2 Posology and method of administration
Adults: Initial dose: 150 mg/kg body mass of N-acetylcysteine infused in 200 ml of 5 % dextrose intravenously over 15 minutes, followed by continuous infusion: 50 mg/kg body mass in 500 ml of 5 % dextrose over next 4 hours, followed by 100 mg/kg body mass in 1 litre of 5 % dextrose over 16 hours.
Children: The quantity of intravenous fluid used in children should be modified to take into account age and mass.
4.3 Contraindications
Hypersensitivity to any ingredient in the preparation.
4.4 Special warnings and precautions for use
Administer with caution in asthma or a history of asthma. Rash, bronchospasm and anaphylactoid reactions have been reported. These have occurred between 15 minutes and 1 hour after the start of the infusion. Hypokalaemia and ECG changes have been noted in patients with paracetamol poisoning, irrespective of the treatment given. Monitoring of plasma potassium concentration is therefore recommended. N-acetylcysteine is not compatible with rubber and metals, particularly iron, copper and nickel. Silicone rubber and plastic are satisfactory for use with PARVOLEX. The safety of PARVOLEX in pregnancy has not been established.
4.8 Undesirable effects
Rash, bronchospasm and anaphylactoid reactions have been reported.
4.9 Overdose
There is a theoretical risk of hepatic encephalopathy. There is no specific treatment and general supportive measures should be carried out.
