Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Acetylcysteine
Phoenix Labs
V03AB; V03AB23
Acetylcysteine
200 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Antidotes; acetylcysteine
Marketed
1993-07-07
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. U Keep this leaflet. You may need to read it again. U If you have any further questions, ask your doctor or nurse. U If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. U In this leaflet, Parvolex 200 mg/ml Concentrate Solution for Infusion will be called Parvolex. IN THIS LEAFLET: 1. What is Parvolex and what it is used for 2. Before you are given Parvolex 3. How you will be given Parvolex 4. Possible side effects 5. How to store Parvolex 6. Further information. 1. WHAT PARVOLEX IS AND WHAT IT IS USED FOR Parvolex contains Acetylcysteine, which is used for the treatment of paracetamol overdose (where you may have taken too much paracetamol). You will be given parvolex if you have taken a potentially harmful amount of paracetamol. Parvolex protects the liver from damage by the high levels of paracetamol. It is very effective when given during the first 8 hours aft er a paracetamol overdose. The effectiveness is reduced as the time interval increases, but it can still help when given up to 24 hours after the overdose. 2. BEFORE YOU ARE GIVEN PARVOLEX THE LEVEL OF PARACETAMOL IN YOUR BLOOD SHOULD BE CHECKED BEFORE TREATMENT IS STARTED. TELL YOUR DOCTOR IF YOU: U suffer from asthma or breathing difficulties U have had an adverse reaction to Acetylcysteine before U are pregnant or breast-feeding IF YOU HAVE ANY DOUBTS ABOUT WHETHER THIS MEDICINE SHOULD BE GIVEN TO YOU, DISCUSS THINGS MORE FULLY WITH THE DOCTOR OR NURSE. TAKING OTHER MEDICINES: Tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription. PREGNANCY AND BREAST-FEEDING: If you are pregnant the doctor will decide if you should receive this medicine. You should not breastfeed during or immediately after being given this medicine. Ask the doctor or nurse if you need further information. EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINERY: I Read the complete document
Health Products Regulatory Authority 04 October 2019 CRN008PF9 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Parvolex 200mg/ml concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 200 mg Acetylcysteine. Excipients : Each 10ml contains 322.6mg sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for Solution for Infusion Clear colourless solution contained in a 10ml clear colourless type 1 glass ampoule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients: a) who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is defined as an overdose where the paracetamol was ingested over a period of 1 hour or more; or b) where there is any doubt over the time of the overdose, irrespective of plasma paracetamol level; or c) who present with a plasma paracetamol level on or above a line joining points of 100mg/L at 4h and 15mg/L at 15h (see below nomogram). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. Continued treatment with acetylcysteine (given at the dose and rate as used in the third infusion) may be necessary depending on the clinical evaluation of the individual patient. 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. Heal Read the complete document