Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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PARVOLEX® Injection SCHEDULING STATUS : S2 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. PHARMACOLOGICAL CLASSIFICATION: Category A 34 other. PHARMACOLOGICAL ACTION: In paracetamol poisoning, N-acetylcysteine protects the liver, possibly by 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. PARVOLEX INTRAVENOUS INFUSION DOSAGE GUIDE PATIENTS BODY MASS INITIAL SECOND THIRD TOTAL PARVOLEX (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 (mL) 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: 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 Read the complete document