Noradrenaline 0.16 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.

The full name of the your medicine is Noradrenaline 0.16 mg/ml solution for infusion. It is referred to as Noradrenaline infusion throughout this leaflet.

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

• if you are allergic (hypersensitive) to noradrenaline preparations or to any of the other ingredients of this medicine (listed in section 6).
• if you are hypotensive (have low blood pressure) that has been caused by hypovolaemia (low blood volume).

Talk to your doctor, pharmacist or nurse before using Noradrenaline infusion

• if you have diabetes
• if you suffer from high blood pressure
• if you have an over-active thyroid
• if you have low levels of oxygen in the blood
• if you have high levels of carbon dioxide in the blood
• if you have clots or obstructions in the blood vessels supplying the heart, intestines or other parts of the body
• if you have low blood pressure following a heart attack
• if you have a type of angina (chest pain) called Prinzmetal’s angina
• if you are elderly
• if you have extravasation risk (risk that your blood or lymph escape from their proper vessels into surrounding tissues)
• if you have major left ventricular dysfunction
• if you have recently had myocardial infarction (a heart attack)
• if you have cardiac rhythm disorders (your heart beats too fast, too slow or irregular), you will need a reduced dose.

During the infusion of noradrenaline, your doctor will check continuously your blood pressure and cardiac frequency (heart rate).

Noradrenaline 0.16 mg/ml solution for infusion is indicated for adults only.

Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

A number of medicines are known to increase the toxic effects of noradrenaline, such as:

• monoamine oxidase inhibitors (antidepressants)
• tricyclic antidepressants
• linezolid (an antibiotic)
• anaesthetics (especially anaesthetic gases)
• adrenergic-serotoninergic medicines, e.g. used in the treatment of asthma and heart conditions.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking any medicine.

Noradrenaline may harm the unborn baby. Your doctor will decide if you should be given noradrenaline infusion.

None stated.

This medicine contains 165.3 mg sodium (main component of cooking/table salt) in each 50 ml vial. This is equivalent to 8.3% of the recommended maximum daily dietary intake of sodium for an adult.

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 of overdose are severe high blood pressure, slow heartbeat, violent headache, light sensitivity, pain in the chest, pale colour, intense sweating and vomiting.

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 website: www.mhra.gov.uk/yellowcard 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 (as noradrenaline tartrate)

Each ml of solution for infusion contains 0.32 mg noradrenaline tartrate equivalent to 0.16 mg noradrenaline base. Each 50 ml vial contains 16 mg of noradrenaline tartrate equivalent to 8 mg of noradrenaline base.

The other ingredients are Sodium Chloride, Hydrochloric acid 1 N (for pH-adjustment), Water for injections.

This medicinal product is presented as solution for infusion. The solution is clear colourless solution.

The medicinal product is available in packs containing 1 vial of solution for infusion.