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ACETYLCYSTEINE 200MG/ML INJECTION

Active substance(s): ACETYLCYSTEINE

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Adult acetylcysteine prescription
(each ampoule = 200mg/ml acetylcysteine)

ADMINISTRATION INFORMATION FOR THE
HEALTHCARE PROFESSIONAL
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.
The full course of treatment with acetylcysteine comprises
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.
Adults
• 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 fluid for each of the 3
infusion periods.
First infusion
Add the appropriate volume of acetylcysteine injection to
200 ml of infusion fluid and infuse over 1 hour.

Regimen

First Infusion

Infusion
fluid

200 mls 5% glucose or
sodium chloride 0.9%

Duration
of infusion

1 hour

Drug dose


Please circle appropriate
weight and volume.

Second Infusion

Third Infusion

500 mls 5% glucose or 1000 mls 5% glucose or
sodium chloride 0.9% sodium chloride 0.9%

150 mg/kg
acetylcysteine

4 hours

16 hours

50 mg/kg
acetylcysteine

100 mg/kg
acetylcysteine


Patient Ampoule Infusion Ampoule Infusion Ampoule Infusion
volume2
Rate
volume2 Rate volume2 Rate
Weight1

kg ml ml/h ml ml/h ml ml/h

40-49 34 234

50-59 42 242

60-69 49 249

70-79 57 257

80-89 64 264

90-99 72 272

100-109
79 279
≥110 83 283

12 128 23 64
14 129 28 64
17 129 33 65
19 130 38 65
22 131 43 65
24 131 48 66
27 132 53 66
28 132 55 66

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.
1

The Summary of Product Characteristics should be
referred to for full prescribing information.
Continued overleaf

Second infusion
Add the appropriate volume of acetylcysteine injection to
500 ml of infusion fluid and infuse over the next 4 hours.
Third infusion
Add the appropriate volume of acetylcysteine injection to
1 L of infusion fluid and infuse over the next 16 hours.

If you have any doubts about whether this medicine
should be given to you, discuss things more fully with the
Acetylcysteine 200mg/ml Injection
doctor or nurse.
N-acetylcysteine
Other medicines and Acetylcysteine Injection
(N-acetylcysteine is referred to as Acetylcysteine Injection in this leaflet) Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Read all of this leaflet carefully before you are
given this medicine because it contains important
Pregnancy, breast-feeding and fertility
information for you.
If you are pregnant or breast-feeding, think you may be
• Keep this leaflet. You may need to read it again.
pregnant or planning to have a baby, ask your doctor or
• If you have any further questions, please ask your
nurse for advice before being given this medicine.
doctor or nurse.
Driving and using machines
• If you get any side effects, talk to your doctor or nurse.
It is unlikely that after using Acetylcysteine Injection,
This includes any possible side effects not listed in this
your ability to drive and use machines will be affected.
leaflet. See section 4.
However, if you feel unwell you must speak to your doctor
before driving or operating machinery.
What is in this leaflet
1. What Acetylcysteine Injection is and what it is used for Acetylcysteine Injection contains sodium
This medicinal product contains 32.26mg of sodium per
2. What you need to know before you are given
ml of infusion (a total of 322.6mg of sodium in each 10ml
Acetylcysteine Injection
ampoule for infusion). This amount must be taken into
3. How you will be given Acetylcysteine Injection
consideration by patients on a salt-restricted diet.
4. Possible side effects
5. How to store Acetylcysteine Injection
3. How you will be given Acetylcysteine
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE USER

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Injection
1. What Acetylcysteine Injection is and what it Acetylcysteine Injection will be diluted in glucose or
is used for
sodium chloride solution and given as an intravenous

infusion (a drip into a vein) by a doctor or nurse.
Adults:
Acetylcysteine Injection is given in three stages. During
each stage a different dose of Acetylcysteine will
be given. You will be given a total dose of 300mg of
Acetylcysteine per kg of your body weight, over a period
of 21 hours. The doctor will calculate how much to give
you in each stage.
Children:
Children should be given Acetylcysteine Injection in three
stages, like adults. However, the amount of fluid used to
dilute Acetylcysteine Injection will be calculated to take
2. What you need to know before you are
into consideration the age and weight of the child, as too
given Acetylcysteine Injection
much fluid can be harmful.
The level of paracetamol in your blood should be checked Blood tests may be carried out before, during and after
treatment with this medicine.
before treatment is started.
If you receive more Acetylcysteine Injection than you
Warnings and precautions
should
Talk to your doctor or nurse before using Acetylcysteine
Acetylcysteine Injection will be given to you by a doctor
Injection if:
or nurse, therefore it is unlikely that you will be given
• you suffer from asthma or breathing difficulties
too much or that you will miss a dose. However, if you
• you have had an adverse reaction to Acetylcysteine
are concerned about your treatment, please talk to your
before
doctor.
• you are pregnant or breast-feeding
Continued overleaf
Acetylcysteine Injection is used for the treatment of
paracetamol overdose (where you may have taken too
much paracetamol).
You will be given Acetylcysteine Injection if you have
taken a potentially harmful amount of paracetamol.
Acetylcysteine protects the liver from damage by the
high levels of paracetamol. It is very effective when given
during the first 8 hours following 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 are treated with the same doses and regimen as
adults. However, the quantity of intravenous fluid used
has been modified to take into account age and weight,
as fluid overload is a potential danger. Doses should be
administered sequentially using an appropriate infusion
pump.
Preparation and administration of paediatric infusions
• Weigh the child to determine the correct weight band.
• 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
• Prepare a 50 mg/ml solution by diluting each 10 ml
ampoule of N-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.
• The dose is infused over 1 hour at the infusion rate stated
in the table.
Second Infusion
• Prepare a 6.25 mg/ml solution by diluting each 10 ml
ampoule of N-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.
• The dose is infused over 4 hours at the infusion rate
stated in the table.
Third Infusion
• Prepare a 6.25 mg/ml solution by diluting each 10 ml
ampoule of N-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.
• 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 is 208 ml infused at 13 ml/h over 16 hours.

Paediatric Dosage Table
Paediatric acetylcysteine prescription
( each ampoule = 200mg/ml acetylcysteine)
Regimen

First Infusion

Infusion

50mg/ml for 1 hour

Please circle appropriate
weight and volume.

Second Infusion

Third Infusion

6.25mg/ml for 4 hours 6.25mg/ml for 16 hours

Infusion
3ml/kg/h 2ml/kg/h 1ml/kg/h
rate

Total
Total
Total
Patient
Infusion
Infusion
Infusion

1
Infusion
Infusion Infusion
Weight
Rate
Rate
Rate
Volume Volume Volume


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
35-39
113
113
300
75
608
38

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

1

The Summary of Product Characteristics should be
referred to for full prescribing information.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd., T/A Martindale Pharma,
Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom.
Marketing Authorisation Number: PL 12064/0026
This leaflet was last revised in: April 2016

Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom

D03335

Acetylcysteine 200mg/ml Injection
Acetylcysteine

Children

Adult Dosage Table

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4. Possible side effects

5. How to store Acetylcysteine Injection

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or nurse immediately if you notice any
of the following:
• swelling of the face, lips or tongue
• wheezing, difficulty in breathing
• feeling or being sick
• irritation at the injection site
• skin rash, itching
• flushing (red face or feeling hot)
• low blood pressure resulting in dizziness
• rapid heart beat or increased blood pressure.
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
or corticosteroids. Once the reaction is under control the
infusion can be restarted.
Other rare side effects:
• coughing, noisy breathing
• respiratory arrest (stop breathing)
• chest tightness or pain,
• puffy eyes, blurred vision, pain in the face or eyes
• sweating, feeling unwell
• raised temperature, hot, red face and skin
• liver problems
• slow heart beat, cardiac arrest (heart stops beating)
• fainting, collapsing, fits
• reduction in blood platelets, which increases the risk of
bleeding or bruising
• a condition called acidosis, which may cause weariness,
vomiting, thirst or restlessness
• anxiety
• joint pain or disease
• bluish skin from low oxygen levels in the blood
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.
Do not use Acetylcysteine Injection after the expiry date
which is stated on the label. The expiry date refers to the
last day of that month. The doctor or nurse will check that
the product has not passed this date.
Once diluted according to directions, start using within 3
hours.
Do not store above 25ºC. Store ampoules in the original
container until use.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

100mm Measurement Verification Bar

6. Contents of the pack and other information
What Acetylcysteine Injection contains
The active ingredient is Acetylcysteine 200 mg/1 ml.
The other ingredients are disodium edetate, nitrogen
gas, sodium hydroxide and water for injection.
What Acetylcysteine Injection looks like and contents
of the pack:
Acetylcysteine Injection is a clear colourless solution for
infusion.
The product is available in (Type I) clear glass ampoules in
pack sizes of 10x 10ml, 10x 20ml or 5x 20ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation
Holder:
Manufacturer:
Aurum
Rotexmedica GmBH,
Pharmaceuticals Ltd.,
Azneimittelwerk,
T/A Martindale Pharma,
Bunsenstrasse 4,
Bampton Road,
D-22946 Trittau,
Harold Hill,
Germany
Romford,
RM3 8UG, UK.

Product Licence Number: PL 12064/0026
This leaflet was last revised in: April 2016

Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom

D03335

PROFESSIONAL LEAFLET

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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