PARVOLEX Solution for infusion Ref.[2452] Active ingredients: Acetylcysteine

Acetylcysteine should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.

Adults

The full course of treatment with acetylcysteine comprises 3 consecutive intravenous infusions:

First infusion: Initial loading dose of 150 mg/kg body weight infused in 200 mL over 1 hour.

Second infusion: 50 mg/kg in 500 mL over the next 4 hours.

Third infusion: 100 mg/kg in 1 litre over the next 16 hours.

The patient should therefore receive a total of 300 mg/kg over a 21 hour period.

A ceiling weight of 110 kg should be used when calculating the dosage for obese patients.

Dosage should be calculated using the patient’s actual weight.

Children

Children should be treated with the same doses and regimen as adults; however, the quantity of intravenous fluid used should be modified to take into account age and weight, as fluid overload is a potential danger

N-acetylcysteine should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.

Doses should be administered using an appropriate infusion pump.

The full course of treatment with N-acetylcysteine comprises 3 consecutive intravenous infusions:

First infusion: Initial loading dose of 150 mg/kg infused over 1 hour (150 mg/kg/h).

Given as a 50 mg/mL solution at a rate of 3 mL/kg/h.

Second Infusion: Dose: 50 mg/kg infused over 4 hours (12.5 mg/kg/h).

Given as a 6.25 mg/mL solution at a rate of 2 mL/kg/h.

Third Infusion: Dose: 100 mg/kg infused over 16 hours (6.25 mg/kg/h).

Given as a 6.25 mg/mL solution at a rate of 1 mL/kg/h.

Preparation of the solution

Dose 1

Prepare a 50 mg/mL solution. Dilute each 10mL ampoule of N-acetylcysteine (200 mg/mL) with 30 mL glucose 5% or sodium chloride 0.9% to give a total volume of 40 mL.

Dose 2

Prepare a 6.25 mg/mL solution. Dilute each 10 mL ampoule of N-acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

Dose 3

Prepare a 6.25 mg/mL solution. Dilute each 10 mL ampoule of N-acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

For full instructions on dilution of the product see section 6.6.

Any unused solution should be disposed of in accordance with local requirements.

Administration

Weigh the child.

Determine the total volume of solution to be infused (infusion fluid + N-acetylcysteine prepared as above) into the child from the table. A separate volume will be required for each of the three infusion periods.

For example for a child weighing 12 kg, 38mL of solution is required for Dose 1, 100mL for Dose 2 and 200mL for Dose 3.

Infuse intravenously according to the weight of the child (see table).

For example for a child weighing 12 kg, Dose 1 is infused at 38mL/h over 60 minutes, Dose 2 would be infused at 25mL/h and Dose 3 at 13mL/h.

Doses should be administered sequentially with no break between the doses.

There is a theoretical risk of hepatic encephalopathy. Overdosage of acetylcysteine has been reported to be associated with effects similar to the ‘anaphylactoid’ reactions noted in section 4.8 (Undesirable Effects), but they may be more severe. General supportive measures should be carried out. Such reactions are managed with antihistamines and steroids in the usual way. There is no specific antidote.

3 years.

Store below 25°C.

Clear, Type I glass, 10ml snap ring ampoules. 10 × 10ml ampoules are packed in cartons.

Acetylcysteine to be diluted for intravenous infusion using either 5% dextrose, 0.9% sodium chloride, 0.3% potassium chloride with 5% glucose, or 0.3% potassium chloride with 0.9% sodium chloride. The volumes to be used are as directed in section 4.2.