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PARVOLEX 200 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ACETYLCYSTEINE

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Patient Information Leaflet Parvolex 200 mg/ml Concentrate for Solution for Infusion
Acetylcysteine
ACETYLCYSTEINE 200 mg/mL INJECTION FOR INFUSION
ADMINISTRATION INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Read all of this leaflet carefully before you are given this
medicine.

Adults

2. Before you are given Parvolex

Parvolex is given in three stages. During each stage a different
dose of parvolex will be given. You will be given a total dose
of 300 mg parvolex per kg of your body weight, over a period
of 21 hours. Some patients may require longer treatment with
acetylcysteine. The doctor will calculate how much to give you
in each stage.

The level of paracetamol in your blood should be checked
before treatment is started.

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.

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:

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.

Tell your doctor if you are taking or have recently taken other
medicines, including medicines obtained without a
prescription.

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 after 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.

Children
Children will be given parvolex in three stages, like adults.
However, the amount of fluid used to dilute parvolex will be
calculated to take into consideration the age and weight of the
child, as too much fluid can be harmful.
Blood tests may be carried out before, during and after
treatment with this medicine.
Because the injection will be given to you by a nurse or doctor,
it is unlikely that you will be given too much or that you will
miss a dose. However, if you are concerned about your
treatment, please talk to your doctor.

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:
It is unlikely that after using Acetylcysteine Injection, your
ability to drive and use machines will be affected. However, if
you feel unwell you must speak to your doctor before driving
or operating machinery.

3. How Parvolex will be given
Acetylcysteine Injection will be diluted in glucose or sodium
chloride solution and given as an intravenous infusion (a drip
into a vein) by a doctor or nurse.

Adult dosage table

Acetylcysteine   should   be   administered   by   intravenous   infusion   preferably   using  
Glucose   5%   as   the   infusion    f luid.   Sodium   Chloride   0.9%   solution   may   be   used   if  
Glucose   5%   is   not   suitable.  
The  full   course  of  treatment  with   acetylcysteine  comprises  of   3  consecutive  
intravenous  infusions.  Doses   should  be   administered   sequentially   with  no  break  
between  the  infusions.  The  patient  should  receive  a  total  dose  of  300  mg/kg  body  
weight   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.  

Please turn over.

Adult acetylcysteine prescription

Please circle appropriate
weight and volume.

(each ampoule = 200mg/mL acetylcysteine)
Regimen

First Infusion

Second Infusion

Third Infusion

Infusion
fluid

200 mLs 5% glucose or
sodium chloride 0.9%

500 mLs 5% glucose or
sodium chloride 0.9%

1000 mLs 5% glucose or
sodium chloride 0.9%

Duration
of infusion

1 hour

4 hours

16 hours

Drug dose

150 mg/kg

50 mg/kg

100 mg/kg

acetylcysteine

acetylcysteine

acetylcysteine

Adults
Ȉ
Ȉ

Weigh   the   patient   to   determine   the   correct   weight   band.  
Use   the   adult   dosage   table   to   determine   the   appropriate   volume   of  
acetylcysteine   (ampoule   volume)   to   be   added   to   the   infusion  f
  luid   for   each   of  
the   3   infusion   periods.  

First infusion
Add   the   appropriate   volume   of   acetylcysteine   injection   to   200   mL   of   infusioϐŽ—‹†
 
and  infuse   over   1 hour.
Second infusion
Add   the   appropriate   volume   of   acetylcysteine   injection   to   500   mL   of   infusioϐŽ—‹†
 
and  infuse  over  the  next   4 hours.
Third infusion
Add   the   appropriate   volume   of   acetylcysteine   injection   to   1   litre   of   infusioϐŽ—‹†
 
and  infuse   over   the  next   16 hours.

Patient
Weight1

Ampoule
volume2

Infusion
Rate

Ampoule
volume2

Infusion
Rate

Ampoule
volume2

Infusion
Rate

kg

mL

mL/h

mL

mL/h

mL

mL/h

40-49

34

234

12

128

23

64

50-59

42

242

14

129

28

64

60-69

49

249

17

129

33

65

70-79

57

257

19

130

38

65

80-89

64

264

22

131

43

65

90-99

72

272

24

131

48

66

100-109

79

279

27

132

53

66

•110

83

283

28

132

55

66

1 Dose   calculations   are   based   on   the   weight   in   the   middle   of   each   band.   If   the   patient   weighs  
less   than   40kg   use   the   paediatric   dosage   table.  
2 Ampoule   volume   has   been   rounded   up   to   the   nearest   whole   number  

4. Possible side effects
Like all medicines Parvolex can cause side effects, although not
everybody gets them.

Tell your doctor or nurse immediately if you notice any of
the following symptoms.
U swelling of the face, lips or tongue
U wheezing, difficulty in breathing
U feeling or being sick
U irritation at the injection site
U skin rash, itching
U flushing (red face or feeling hot)
U low blood pressure resulting in dizziness
U very rarely, rapid heart beat or increased blood pressure.

6. Further information

U a condition called acidosis, which may cause weariness,
vomiting, thirst or restlessness
U anxiety
U joint pain or disease
U bluish skin from low oxygen levels in the blood

What Parvolex contains
The active substance in Parvolex is acetylcysteine. Each millilitre
(ml) of solution contains 200 mg acetylcysteine and each 10 ml
ampoule contains a total of 2 g of acetylcysteine. The other
ingredients are disodium edetate, sodium hydroxide (E524) and
water for injection.

If any of these side effects become serious, or you notice any
side effects not listed in this leaflet tell your doctor or nurse.

What Parvolex looks like
Parvolex is a clear colourless solution and comes in sealed 10 ml clear
glass containers called ampoules. Each ampoule contains 10 ml
solution. Do not use if solution becomes cloudy or if visible particles
or fibres can be seen. When opened the colour of solution may
change to light purple.
Each box of Parvolex contains ten 10 ml ampoules.

Marketing Authorisation Holder
Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park,
Clonee, Co. Meath, Ireland.
Manufacturer
Labiana Pharmaceuticals, S.L.U., C/ Casanova 27-31,
Corbera de Llobregat, Barcelona, (Spain)

These symptoms often happen 15 to 60 minutes after the start
of the infusion, and may be relieved by stopping the infusion.
You may need to be treated with antihistamines. Once the
reaction is under control the infusion can be restarted.

Other rare side effects
U coughing, noisy breathing
U respiratory arrest (stop breathing)
U chest tightness or pain,
U puffy eyes, blurred vision, pain in the face or eyes
U sweating, feeling unwell
U raised temperature, hot, red face and skin
U liver problems
U slow heart beat, cardiac arrest (heart stops beating)
U fainting, collapsing, fits
U reduction in blood platelets, which increases the risk of
bleeding or bruising

This leaflet was approved in

5. How to store Parvolex

If this leaflet is difficult to see or read, or you
would like it in a different format, please contact
Phoenix Labs, Suite 12, Bunkilla Plaza,
Bracetown Business Park,
Clonee, Co. Meath, Ireland.

Your doctor or nurse will make sure your medicine is correctly
stored and disposed of.
Keep out of the reach and sight of children.
Do not use Parvolex after the expiry date on the carton and on the
ampoule label. The expiry date refers to the last day of that month.
Store below 25ºC.
Parvolex must be diluted in an appropriate infusion fluid before
use. Once opened use immediately. Discard after use.
Medicines should not be disposed of via wastewater or
household waste.

Paediatric Dosage Table

Children
Children   are treated   with   the   same   doses   and   regimen   as   adults.   However,   the   quantity   of  
intravenous      f luid   used   has   been   modified   to   take   into   account   age   and   weight,   as      f luid  
overload   is   a   potential   danger.   Doses   should   be   administered   sequentially   using   an  
appropriate    infusion    pump.  
Preparation and administration of paediatric infusions
Ȉ Weigh   the   child   to   determine   the   correct   weight   band.  
Ȉ Read   off   the   table   the   total   infusion   volume   required   for   each   dose   according   to   the  
weight   of   the   child   and   make   up   the   solutions   according   to   the   directions   below.  
First Infusion
Ȉ Prepare   a   50   mg/mL   solution   by   diluting   each   10   mL   ampoule   of   acetylcysteine  
(200   mg/mL)   with   30   mL   glucose   5%   or   sodium   chloride   0.9%   to   give   a   total  
volume   of   40   mL.  
‡ Prepare the appropriate volume for the weight of the child.
Ȉ The  dose  is  infused   over  1 hour at  the  infusion  rate  stated   in  the   table.  
Second Infusion
Ȉ Prepare   a   6.25   mg/mL   solution   by   diluting   each   10   mL   ampoule   of   acetylcysteine  
(200   mg/mL)   with   310   mL   glucose   5%   or   sodium   chloride   0.9%   to   give   a   total  
volume   of   320   mL.  
‡ Prepare the appropriate volume for the weight of the child.
Ȉ The  dose  is  infused   over   4 hours at  the  infusion  rate  stated  in  the  table.  
Third Infusion
Ȉ Prepare   a   6.25   mg/mL   solution   by   diluting   each   10   mL   ampoule   of   acetylcysteine  
(200   mg/mL)   with   310   mL   glucose   5%   or   sodium   chloride   0.9%   to   give   a   total  
volume   of   320   mL.  
‡ Prepare the appropriate volume for the weight of the child.
Ȉ The  dose  is  infused   over  16 hours at   the  infusion   rate   stated  in  the  table.  
For example for a child weighing 12 kg, the first infusion would be 38 mL infused at 38 mL/h over 1 hour, the
second infusion would be 100 mL infused at 25 mL/h over 4 hours and the third infusion would be 208 mL
infused at 13 mL/h over 16 hours.

Paediatric acetylcysteine prescription
(each ampoule = 200mg/mL acetylcysteine)

Please circle appropriate weight
and volume.

Regimen

First Infusion

Second Infusion

Third Infusion

Infusion

50mg/mL for 1 hour

6.25mg/mL for 4 hours

6.25mg/mL for 16 hours

Infusion
rate

3mL/kg/h

2mL/kg/h

1mL/kg/h

Patient
Weight1

Total
Infusion
Volume

Infusion
Rate

Total
Infusion
Volume

Infusion
Rate

Total
Infusion
Volume

Infusion
Rate

kg

mL

mL/h

mL

mL/h

mL

mL/h

1

3

3

8

2

16

1

2

6

6

16

4

32

2

3

9

9

24

6

48

3

4

12

12

32

8

64

4

5

15

15

40

10

80

5

6

18

18

48

12

96

6

7

21

21

56

14

112

7

8

24

24

64

16

128

8

9

27

27

72

18

144

9

10-14

38

38

100

25

208

13

15-19

53

53

140

35

288

18

20-24

68

68

180

45

368

23

25-29

83

83

220

55

448

28

30-34

98

98

260

65

528

33

113

113

300

75

608

38

35-39

1   Dose   calculations   are   based   on   the   weight   in   the   middle   of   each   band.   If   the   patient   weighs   more  
than   40kg   use   the   adult   dosage   table.  
Figures   have  been  rounded   up  to  the  nearest   whole   number  

The Summary of Product Characteristics should be referred to for full prescribing information.
This is available from www.medicines.org.uk; for further information related to this leaflet please
contact Phoenix  Labs,  Suite  12,  Bunkilla  Plaza,  Bracetown  Business  Park,  Clonee,  Co.  Meath,  Ireland

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Further information

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