Skip to Content

UK Edition. Click here for US version.

ACETYLCYSTEINE 200 MG/ML INJECTION

Active substance(s): ACETYLCYSTEINE

View full screen / Print PDF » Download PDF ⇩
Transcript
BEFORE YOU ARE GIVEN ACETYLCYSTEINE
INJECTION

ACETYLCYSTEINE 200 mg/ml INJECTION
FOR INFUSION

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 or any of the other
ingredients of Acetylcysteine before (see list of ingredients in Section 6)
• are pregnant or breast-feeding.

ADMINISTRATION INFORMATION FOR THE
HEALTHCARE PROFESSIONAL

2
PACKAGE LEAFLET: INFORMATION FOR THE USER

ACETYLCYSTEINE 200 mg/ml INJECTION
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:
1. What Acetylcysteine Injection is and what it is used for
2. Before you are given Acetylcysteine Injection
3. How Acetylcysteine Injection will be given
4. Possible side effects
5. How to store Acetylcysteine Injection
6. Further information

1

WHAT ACETYLCYSTEINE INJECTION IS
AND WHAT IT IS USED FOR

Acetylcysteine Injection contains Acetylcysteine, which is used for the
treatment of paracetamol overdose (where you may have taken too much
paracetamol).
You will be given Acetylcysteine 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 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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any 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.
Driving and using machines
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 ACETYLCYSTEINE INJECTION 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.
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 300 mg 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 will be given Acetylcysteine Injection in three stages, like adults.
However, the amount of fluid used to dilute Acetylcysteine Injection will be
calculated to take into consideration the age and weight of the child, as too
much fluid can be harmful.

Adult Dosage Table
Adult acetylcysteine prescription
(each ampoule = 200 mg/mL acetylcysteine)

Please circle appropriate
weight and volume.

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.

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%

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.

Duration
of infusion

1 hour

4 hours

16 hours

Drug dose

150 mg/kg
acetylcysteine

50 mg/kg
acetylcysteine

100 mg/kg
acetylcysteine

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.

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

Second infusion
Add the appropriate volume of acetylcysteine injection to
500 mL of infusion fluid and infuse over the next 4 hours.

60-69

49

249

17

129

33

65

70-79

Third infusion
Add the appropriate volume of acetylcysteine injection to 1
litre of infusion fluid and infuse over the next 16 hours.

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

26

132

53

66

≥110

83

283

28

132

55

66

First infusion
Add the appropriate volume of acetylcysteine injection to
200 mL of infusion fluid and infuse over 1 hour.

1

Dose calculations are based on the weight in the middle of each band. If the patient weighs less than 40 kg use the paediatric dosage
table.

2

Ampoule volume has been rounded up to the nearest whole number.

Children

Paediatric Dosage Table

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 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 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 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.

Regimen

First Infusion

Second Infusion

Third Infusion

Infusion

50 mg/mL for 1 hour

6.25 mg/mL for 4 hours

6.25 mg/mL for 16 hours

3 mL/kg/h

Infusion rate

2 mL/kg/h

Total Infusion
Volume

Infusion
Rate

Total Infusion
Volume

Infusion
Rate

kg

mL

mL/h

mL

1

3

3

8

2

6

6

3

9

4
5

Total Infusion
Volume

Infusion
Rate

mL/h

mL

mL/h

2

16

1

16

4

32

2

9

24

6

48

3

12

12

32

8

64

4

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

300

4

1 mL/kg/h

Patient
Weight1

113

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.

Please circle appropriate
weight and volume.

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

75

608

POSSIBLE SIDE EFFECTS

Like all medicines Acetylcysteine Injection can cause side effects particularly
when treatment is first started, although not everybody gets them.
All medicines can cause adverse reactions although not everyone 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
• very rarely, 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. Once the reaction is under control the infusion
can be restarted.

38

1

Dose calculations are based on the weight in the middle of each band. If the patient weighs more than 40 kg use the adult dosage table.
Figures have been rounded up to the nearest whole number.
87816-E

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.

5

HOW TO STORE ACETYLCYSTEINE
INJECTION

Keep Acetylcysteine out of the reach and sight of children.
Do not use Acetylcysteine after the expiry date, which is stated on the
carton.
The expiry date refers to the last day of that month.
Store below 25°C in its carton.
Once diluted, Acetylcysteine should be used immediately.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer needed. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Acetylcysteine Injection contains:
The active substance is acetylcysteine 200 mg/ml. The other ingredients are:
disodium edetate, water for injections and sodium hydroxide.
What Acetylcysteine Injection looks like and contents of the pack
Clear glass ampoules containing 10 ml acetylcysteine 200 mg/ml solution.
10 ampoules are packed per carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
This leaflet was last revised in June 2015
PL 00289/1543

87816-E

Expand view ⇕

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.

Hide