Parvolex 200mg/ml concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetylcysteine

Available from:

Phoenix Labs

ATC code:

V03AB; V03AB23

INN (International Name):

Acetylcysteine

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antidotes; acetylcysteine

Authorization status:

Marketed

Authorization date:

1993-07-07

Patient Information leaflet

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

Summary of Product characteristics

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