Noradrenalin Abcur
Package leaflet: Information for the user
Noradrenalin Abcur 1 mg/ml concentrate for solution for infusion
Noradrenaline
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or nurse.
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This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Noradrenalin Abcur is and what it is used for
2. What you need to know before you use Noradrenalin Abcur
3. How to use Noradrenalin Abcur
4. Possible side effects
How to store Noradrenalin Abcur
6. Contents of the pack and other information
What Noradrenalin Abcur is and what it is used for
Noradrenalin Abcur is used in emergency care in conditions that require an immediate increase in the blood pressure to normal level, as noradrenaline acts as a vasoconstrictor.
What you need to know before you use Noradrenalin Abcur
Do not use Noradrenalin Abcur
- if you are allergic to noradrenaline or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before using Noradrenalin Abcur:
- if you are taking or recently have taken antidepressants (MAO inhibitors or tricyclic antidepresssants)
- if your are taking medicines for Parkinson´s disease
- if you have heart problems
- if you have diabetes
- if you have hyperthyroidism
- when you are elderly, since elderly persons may be escpecially sensitive to noradrenaline.
Other medicines and Noradrenalin Abcur
Tell your doctor or pharmacistif you are taking or have recently taken any other medicines.
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MAO inhibitors, used to treat depression or Parkinsons disease
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Certain types of anesthetics, may together with noradrenaline cause serious heart rythm disorders
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Certain medicines may increase the effect of noradrenaline (methyldopa, tricyclic antidepressants)
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Concomitant treatment with maprotiline (against depression) and digoxin (medicine against heart disease) may reqiure dose adjustment.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Noradrenaline can effect the heart rythm of the fetus and contracts the uterus.
Driving and using machines
This medicine is used in emergency situations when the patient should not operate machinery or drive.
How to use Noradrenalin Abcur
Noradrenalin Abcur is used only in emergancy care and will be given to you by health care professionals.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:High blood pressure, slow heart rate, heart disorders, headache, anxiety, shortness of breath, tissue death, local irritation at the injection site.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
[To be completed nationally]
5. How to store Noradrenalin Abcur
Keep this medicine out of the sight and reach of children.
Do not store above 25° C. Do not freeze.
Do not use this medicin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Noradrenalin Abcur contains
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The active substance is noradrenaline as noradrenaline tartrate. 1 ml concentrate contains noradrenaline tartrate corresponding to 1 mg noradrenaline.
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The other ingredients are sodium chloride and water for injections.
What Noradrenalin Abcur looks like and contents of the pack
Clear, colourless solution.
1 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
2 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
4 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
5 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
8 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
10 ml in clear glass ampoules (type I): packsizes of 10, 20, 50 or 100 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Abcur AB
P.O. Box 1452
251 14 Helsingborg
Sweden
Manufacturer
[To be completed nationally]
This leaflet was last revised in 2014-12-12
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The following information is intended for medical or healthcare professionals only:
SHOULD BE DILUTED
Noradrenalin Abcur 1 mg/ml should be diluted before use and administered as an intravenous infusionvia a central venous catheter. The infusion should be at a controlled rate using either a syringe pump or an infusion pump.
The patient should be closely monitored during the entire treatment. The blood pressure should be monitored during entire treatment and the infusion rate should be adjusted to the desired blood pressure.
Dilutionwith 50 mg/ml (5 %) glucose solution, 9 mg/ml (0.9%) sodium chloride, 9 mg/ml (0.9 %) sodium chloride with 50 mg/ml (5 %) glucose solution, 50 mg/ml (5 %) glucose solution and 9 mg/ml (0.9%) sodium chloride(50:50): 4 ml of 1 mg/ml concentrate for infusion is diluted with 96 ml of the dilution solution to a concentration of 40 microgram/ml. The solution for infusion should be used immediately after dilution.
The chemical and physical stability of the solution after dilution is 24 hours when stored at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Posology: Initially, usually between 0.05-0.15 microgram/kg/min.
Titration of dose:The dose is titrated in steps of 0.05-0.1 microgram/kg/min until adequate blood pressure is achieved (usually mean arterial blood pressure > 75-80 mmHg). The dose should be adjusted according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain the desired blood pressure.
Maximum recommended dose is 2.5 microgram/kg/min.
Dosage table: Reconstituted solution of Noradrenalin Abcur 40 microgram/ml
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Infusion rate ml/hour |
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Body weight |
40 kg |
50 kg |
60 kg |
70 kg |
80 kg |
90 kg |
100 kg |
110 kg |
120 kg |
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Dose |
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0.05 μg/kg/min |
3.0 |
3.8 |
4.5 |
5.3 |
6.0 |
6.8 |
7.5 |
8.3 |
9.0 |
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0.10 μg/kg/min |
6.0 |
7.5 |
9.0 |
10.5 |
12.0 |
13.5 |
15.0 |
16.5 |
18.0 |
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0.15 μg/kg/min |
9.0 |
11.3 |
13.5 |
15.8 |
18.0 |
20.3 |
22.5 |
24.8 |
27.0 |
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0.20 μg/kg/min |
12.0 |
15.0 |
18.0 |
21.0 |
24.0 |
27.0 |
30.0 |
33.0 |
36.0 |
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0.25 μg/kg/min |
15.0 |
18.8 |
22,5 |
26.3 |
30.0 |
33.8 |
37.5 |
41.3 |
45.0 |
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0.30 μg/kg/min |
18.0 |
22.5 |
27,0 |
31.5 |
36.0 |
40.5 |
45.0 |
49.5 |
54.0 |
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0.35 μg/kg/min |
21.0 |
26.3 |
31,5 |
36.8 |
42.0 |
47.3 |
52.5 |
57.8 |
63.0 |
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0.40 μg/kg/min |
24.0 |
30.0 |
36,0 |
42.0 |
48.0 |
54.0 |
60.0 |
66.0 |
72.0 |
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0.45 μg/kg/min |
27.0 |
33.8 |
40,5 |
47.3 |
54.0 |
60.8 |
67.5 |
74.3 |
81.0 |
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0.50 μg/kg/min |
30.0 |
37.5 |
45,0 |
52.5 |
60.0 |
67.5 |
75.0 |
82.5 |
90.0 |
Discontinuation: Infusion of noradrenalin should be reduced gradually since abrupt withdrawal may cause acute hypotension.
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