Parvolex 2g/10ml concentrate for solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetylcysteine

Available from:

Phoenix Labs Ltd

ATC code:

V03AB23

INN (International Name):

Acetylcysteine

Dosage:

200mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 19020700; GTIN: 5015313010566

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
nurse.
• 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.
• 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:
• suffer from asthma or breathing difficulties
• have had an adverse reaction to Acetylcysteine before
• 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 US

Summary of Product characteristics

OBJECT 1
PARVOLEX (ACETYLCYSTEINE) 200 MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 15-Jul-2015 | Phoenix Labs
1. Name of the medicinal product
Parvolex 200 mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Each ml contains Acetylcysteine 200mg
Each 10 ml contains 322.6 mg of sodium
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear colourless solution contained in a 10 ml clear colourless Type I
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.
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.
ADULT N-ACETYLCYSTEINE PRESCRIPTION
(EACH AMPOULE = 200MG/ML N-ACETYLCYSTEINE)
PLEASE CIRCLE APPROPRIATE WEIGHT, DOSE AND
VOLUME.
REGIMEN
DOSE 1
DOSE 2
DOSE 3
FLU