Noradrenaline (Norepinephrine) 0.08 mg/ml, solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.
• 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.

1. What Noradrenaline Solution for infusion is and what it is used for
2. What you need to know before you are given Noradrenaline Solution for infusion
3. How you are given Noradrenaline Solution for infusion
4. Possible side effects
5. How to store Noradrenaline Solution for infusion
6. Contents of the pack and other information

• administered via peripheral cannula and/or peripheral vein,
• if you are allergic to noradrenaline or any of the other ingredients of this medicine (listed in section 6),
• if you are taking some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat).

Talk to your doctor, pharmacist, or nurse before you are given Noradrenaline Solution for infusion if you:

• have major left ventricular dysfunction (a heart condition),
• have coronary (blood clot inside a blood vessel of the heart), mesenteric (blood clot in a vein that drains blood from the intestine), or peripheral vascular thrombosis (blood clot in the vein of arm or leg),
• have hypotension (low blood pressure) following myocardial infarction (heart attack),
• have Prinzmetal’s variant angina,
• have heart rhythm disorders during your treatment,
• have hyperthyroidism (thyroid gland problem),
• have diabetes mellitus.

Additional monitoring tests that you may be required to undergo during treatment:

Your blood pressure and heart rate will be checked frequently during your treatment to avoid hypertension (high blood pressure).

In cases where it is necessary to administer Noradrenaline at the same time as blood or plasma transfusion, the latter will be administered in a separate drip.

The safety and efficacy of norepinephrine in children less than 18 years of age has not been established. Therefore, use in children is not recommended.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines may influence the effect of Noradrenaline Solution for infusion:

• Halothane, cyclopropane, chloroform, enflurane or other halogenated anaesthetics are contraindicated (see section 2 of this leaflet, subsection “you must not be given”): these medicines are anaesthetics, they cause insensibility to pain and are used before some operations. If you are taking these medicines as well as noradrenaline (norepinephrine) this may increase the risk of irregular heart beat.
• Amitriptiline, imipramine, trimipramine, moclobemide, iproniazide, phenelzine, fluoxetine, sertraline, desipramine: these medicines are used for treatment of depression. Taking any of these medicines together with noradrenaline (norepinephrine) can dangerously increase its concentration in the blood and therefore its pressor action.
• Digitalis glycosides may occasionally cause irregular heart beat.
• Levodopa may enhance the effects of noradrenaline (norepinephrine).
• Non-selective MAO inhibitors (or within 14days of cessation of such therapy): increase in the pressor action of the sympathomimetic which is usually moderate. Should only be used under close medical supervision.
• Selective MAO-A inhibitors: by extrapolation from non-selective MAO inhibitors, risk of increase in the pressor action. Should only be used under close medical supervision.
• Linezolid (an antibiotic), (medicine used to treat infections caused by bacteria and other microorganisms), can dangerously increase noradrenaline (norepinephrine) concentration in the blood and therefore its pressor action, when taken together.
• Methylene Blue (methemoglobinemia antidote).
• Alpha 1 agonists (e.g. midodrine): if you are taking these medicines as well as noradrenaline (norepinephrine) this may increase the risk of pronounced hypertension (high blood pressure).
• Alpha 1 blockers (e.g. prazosine, terazosine or doxazosine): if you are taking these medicines as well as noradrenaline (norepinephrine) this may reduce the pressure action of norepinephrine.
• Beta-blockers: if you are taking these medicines as well as noradrenaline (norepinephrine) this may increase the risk of severe hypertension (high blood pressure).
• Thyroid hormones: if you are taking these medicines as well as noradrenaline (norepinephrine) this may cause increased cardiac (heart) effects.
• Ergot alkaloids specifically those with relevant alpha1-agonistic action (e.g. ergotamine, dihydroergotamine, methylergometrine): may enhance the vasopressor and vasoconstrictive (increasing blood pressure) effects.
• Lithium decreases the effect of noradrenaline (norepinephrine).
• Reserpine, amphetamine: may enhance the effects of noradrenaline (norepinephrine).

If you are pregnant or breast-feeding, ask your doctor or nurse for advice before using this medicine.

If you are pregnant, your doctor will decide if you should be given this medicine, as noradrenaline may harm the unborn baby.

No information is available on the use of noradrenaline during lactation.

This medicine contains 177.3 mg sodium (main component of cooking/table salt) in each 50 ml vial. This is equivalent to 8.9 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine will be given to you in a hospital, by a doctor or nurse.

This medicine will be administered by intravenous infusion (into a vein). The dose of this medicine will depend on your condition. Your doctor will know the best dose to use.

It is unlikely that you will receive too much as this medicine will be given to you in hospital. However, talk to your doctor or nurse if you have any concerns.

Symptoms that may occur if you are given too much noradrenaline are severe high blood pressure, slow heartbeat, violent headache, light sensitivity, pain in the chest, bleeding in the brain, pallor, fever, intense sweating and vomiting, fluid in the lungs causing breathlessness.

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 via the national reporting system:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is noradrenaline (norepinephrine).
  Each mL of solution contains 0.16 mg noradrenaline (norepinephrine) tartrate equivalent to 0.08 mg noradrenaline (norepinephrine) base. Each 50 mL vial contains 8 mg noradrenaline (norepinephrine) tartrate, equivalent to 4 mg noradrenaline (norepinephrine) base.
• The other ingredients are: sodium chloride, disodium edetate, hydrochloric acid or sodium hydroxide (pH adjustment) and water for injections.

Clear colourless or slightly yellow solution for infusion packaged in a clear glass vial of 50 mL.

Pack sizes of 1, 10 and 25 vials.

Not all pack sizes may be marketed.

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