INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PARVOLEX® (injection)

SCHEDULING STATUS :
S3

PROPRIETARY NAME
(and dosage form):

PARVOLEX® (injection)

COMPOSITION :
Each mL contains
N-acetylcysteine 200 mg i.e. each 10 mL ampoule contains 2 g N-
acetylcysteine
Dextrose free.

PHARMACOLOGICAL CLASSIFICATION:
A34 other.

PHARMACOLOGICAL ACTION:
In paracetamol poisoning, N-acetylcysteine protects the liver, possibly restoring depleted hepatic-reduced glutathione or by acting as an alternative substrate for the toxic paracetamol metabolite.

INDICATIONS:
Paracetamol overdosage.

CONTRA-INDICATIONS:
Hypersensitivity to any ingredient in the preparation.
PARVOLEX is ineffective 15 hours after paracetamol overdosage and its use after this time may be associated with harmful effects.

DOSAGE AND DIRECTIONS FOR USE:
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.

PATIENTS
BODY
MASS
INITIAL
SECOND
THIRD
TOTAL
PARVOLEX
(mL)
(kg) 150 mg/kg in 200 mL of 5% dextrose over 15 mins 50 mg/kg in 500 mL of 5% dextrose over 4 hours 100 mg/kg in 1 litre of 5% dextrose over 16 hours 
  PARVOLEX (mL) PARVOLEX (mL) PARVOLEX (mL) 
50 37,5 12,5 25 75
60 45,0 15,0 30 90
70 52,5 17,5 35 105
80 60,0 20,0 40 120
90 67,5 22,5 45 135
x 0,75x 0,25x 0,5x 1,5x

If the patient’s body mass is x kg then the infusion volumes of PARVOLEX in mL will be:
Initial infusion        0,75x        PARVOLEX contains 200 mg
Second infusion        0,25x        N-acetylcysteine in each mL
Third infusion        0,5x        i.e. each 10 mL ampoule
Total        1,5x        contains 2 g N-acetylcysteine

Children:
The quantity of intravenous fluid used in children should be modified to take into account age and mass.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT :
There is a theoretical risk of hepatic encephalopathy. There is no specific treatment and general supportive measures should be carried out.

IDENTIFICATION:
A clear, colourless solution, free from visible particulates.

PRESENTATION:
Cartons of 10 x 10 mL ampoules.

STORAGE INSTRUCTIONS:
Store below 25° C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
NX/34/156

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 July 1984

        51723965

Updated on this site: April 2014
Pharmaceutical Industry

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