Summary of product characteristics name of the medicinal product



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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Noradrenalin Abcur 1 mg/ml concentrate for solution for infusion.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 2 mg noradrenaline tartrate corresponding to 1 mg noradrenaline.
Excipients with known effect: 0.14 mmol (3.2 mg) sodium per ml.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL form
Concentrate for solution for infusion.
Appearance: Clear colourless solution.
pH 3-4.5

4. Clinical particulars
4.1 Therapeutic indications
Short-term treatment of acute hypotension, such as in septic shock.


    1. Posology and method of administration

Noradrenalin Abcur 1 mg/ml should be diluted before use (see section 6.6) and administered as an intravenous infusion via 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 the entire treatment and the infusion rate should be adjusted to the desired blood pressure.
Posology:

Adults:

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




Infusion rate ml/hour

Body weight

40 kg

50 kg

60 kg

70 kg

80 kg

90 kg

100 kg

110 kg

120 kg

Dose




























0.05 μg/kg/min

3.0

3.8

4.5

5.3

6.0

6.8

7.5

8.3

9.0

0.10 μg/kg/min

6.0

7.5

9.0

10.5

12.0

13.5

15.0

16.5

18.0

0.15 μg/kg/min

9.0

11.3

13.5

15.8

18.0

20.3

22.5

24.8

27.0

0.20 μg/kg/min

12.0

15.0

18.0

21.0

24.0

27.0

30.0

33.0

36.0

0.25 μg/kg/min

15.0

18.8

22,5

26.3

30.0

33.8

37.5

41.3

45.0

0.30 μg/kg/min

18.0

22.5

27,0

31.5

36.0

40.5

45.0

49.5

54.0

0.35 μg/kg/min

21.0

26.3

31,5

36.8

42.0

47.3

52.5

57.8

63.0

0.40 μg/kg/min

24.0

30.0

36,0

42.0

48.0

54.0

60.0

66.0

72.0

0.45 μg/kg/min

27.0

33.8

40,5

47.3

54.0

60.8

67.5

74.3

81.0

0.50 μg/kg/min

30.0

37.5

45,0

52.5

60.0

67.5

75.0

82.5

90.0

Discontinuation of treatment:

Infusion of noradrenaline should be reduced gradually since abrupt withdrawal may cause acute hypotension.


Elderly patients

See section 4.4 Special warnings and precautions for use.


Paediatric population

The efficacy and safety of Noradrenalin Abcur 1 mg/ml in children and adolescents has not been established.


Patients with renal- and hepatic impairment.

There is no experience of treatment with Noradrenalin Abcur 1 mg/ml in patients with renal- and hepatic impairment.


Method of administration

Administered after dilution as an intravenous infusion via a central venous catheter, see above.


Precautions to be taken before handling or administering the medicinal product

The concentrate should not be used without being diluted. For instructions on dilution of the medicinal product before administration, see section 6.6.


4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Noradrenaline should only be used in conjunction with appropriate blood volume replacement.
Noradrenaline should be administered with caution to patients being treated with MAO inhibitors or within 14 days after treatment with MAO inhibitors and in patients treated with tricyclic antidepressants since prolonged hypertension can occur.
Elderly patients may be especially sensitive to the effects of noradrenaline.
Caution should also be exercised in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline may exacerbate the ischemia and enlarge the infarct region. Caution should also be taken in hypotensive patients after myocardial infarction and in patients with angina, especially Prinzmetal´s angina and in patients with diabetes, hypertension or hyperthyroidism.

Noradrenaline should only be administered by healthcare professionals who are well familiar with the use of the product.

Paravenous infusion should be avoided and may cause local tissue necrosis. The infusion site should therefore be monitored frequently and regularly.
Contains sodium. To be taken into consideration by patients on a controlled sodium diet, see section 2.
4.5 Interaction with other medicinal products and other forms of interaction
Noradrenaline should be administered with caution to patients being treated with MAO inhibitors or within 14 days after treatment with MAO inhibitors and in patients treated with tricyclic antidepressants due to the risk of serious, prolonged hypertension.
The use of noradrenaline with cyclopropane, halothane, chloroform, enflurane or other inhalation anesthetics may cause serious cardiac arrhythmias. Due to the increased risk of ventricular fibrillation noradrenaline should be used with caution in patients receiving these agents or other cardiac sensitizing agents or in patients showing hypoxia or hypercapnia.
The effect of noradrenaline may be enhanced by guanethidine, resperpine, methyldopa or tricyclic antidepressants.
Concomitant treatment with maprotiline and digoxin may require dose adjustment.
4.6 Fertility, pregnancy and lactation
Pregnancy

Noradrenaline may impair placental perfusion and induce fetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy. These possible risks to the fetus should therefore be considered against the potential benefit to the mother.


Lactation

There is insufficient information on the effects of noradrenaline during lactation.


4.7 Effects on ability to drive and use machines
Not relevant.


    1. Undesirable effects


Psychiatric disorders

Anxiety
Nervous system disorders

Headache
Cardic disorders:

Hypertension, reflex bradycardia, ventricular arrhytmia


Vascular disorders

Peripheral ischemia with sequential gangrene. Decreased blood volume at prolonged administration.


Respiratory, thoracic and mediastinal disorders

Dyspnea
Noradrenaline is a tissue irritant and must be diluted before use. Extravasation may cause necrosis of the skin and the surrounding tissue. Development of tolerance to the effects of noradrenaline may occur after prolonged use.


Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in

[To be completed nationally]
4.9 Overdose
Overdosage may result in severe hypertension, reflex bradycardia, marked increase in peripheral resistance and decreased cardiac output. This may be accompanied by violent and sudden headache, photophobia, retrosternal pain, pallor, intense sweating and vomiting.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Adrenergic and dopaminergic agents, ATC code: C01CA03
Noradrenaline provides a strong stimulation of alpha receptors in blood vessels at which these are counter-extracted. Noradrenaline also has effect on beta-1 receptors in the heart leading to a positive inotropic and initially positive chronotropic effect. The increase in blood pressure may cause a reflex reduction in heart rate. Vasoconstriction may lead to decreased blood flow in the kidneys, liver, skin and smooth muscle. Local constriction of the vessels may cause hemostasis and/or necrosis.
The pressor effect disappears 1 2 min after terminated infusion.
Development of tolerance to the effects of noradrenaline may occur.
5.2 Pharmacokinetic properties
Up to 16% of an intravenous dose is excreted unchanged in the urine as methylated and deaminated metabolites in free and conjugated forms.
5.3 Preclinical safety data
Most of the undesirable effects can be derived to sympathomimetic results from excessives stimulation of the sympathetic nervous system through the various adrenergic receptors.
Noradrenaline may impair placental perfusion and induce fatal fetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to fatal fetal asphyxia in late pregnancy.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride

Water for injections


6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
2 years
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.
6.4 Special precautions for storage
Do not store above 25°C. Do not freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.




    1. Nature and contents of container

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.
6.6 Special precautions for disposal and other handling
SHOULD BE DILUTED
Dilution with 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 concentrate for infusion (1mg/ml) 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Abcur AB

P.O. Box 1452

251 14 Helsingborg

Sweden
8. MARKETING AUTHORISATION NUMBER(S)


To be completed nationally
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
To be completed nationally
10. DATE OF REVISION OF THE TEXT
2014-12-12



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