Metaraminol 0.5mg/mL Solution for Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• A nurse or doctor will give you the injection.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Metaraminol 0.5mg/mL Solution for Injection is and what it is used for
2. What you need to know before you use Metaraminol 0.5mg/mL Solution for Injection
3. How to use Metaraminol 0.5mg/mL Solution for Injection
4. Possible Side Effects
5. How to store Metaraminol 0.5mg/mL Solution for Injection
6. Contents of the pack and other information

Do not use this medicine:

• If you are allergic to metaraminol tartrate or any of the other ingredients in this medicine (listed in section 6).
• With cyclopropane or halothane (anaesthetics) unless your doctor sees a clinical need to do so.

Warnings and Precautions

Talk to your doctor, nurse or pharmacist before using Metaraminol 0.5mg/mL Solution for Injection if you have:

• Liver disease
• Heart disease
• High blood pressure
• Thyroid disease
• Diabetes mellitus
• A history of malaria

Children

This medicine is not recommended for use in children below the age of 12 years.

Other medicines and Metaraminol 0.5mg/mL Solution for Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important if you are taking:

• Digitalis medicines (such as digoxin) which may cause an irregular heartbeat.
• Monoamine oxidase inhibitors which may increase the action of metaraminol.

Pregnancy, breast-feeding and fertility

The effects of this medicine on the unborn baby is unknown. It is not known whether this medicine is present in breast milk. You will only be given this medicine if your doctor sees the clinical need to do so in an emergency situation.

Metaraminol 0.5mg/mL Solution for Injection contains sodium metabisulfite and sodium chloride

This medicine contains

• Sodium metabisulfite – a preservative which may rarely cause severe hypersensitivity reactions and bronchospasm. It may also cause skin reactions if spilt on the skin.
• Sodium – there is less than 1mmol sodium (23mg) per 0.5mg/mL, that is to say essentially ‘sodium - free’.

The recommended dose is:

In the case of an emergency, this medicine is given by direct injection into a vein, which may be followed by an infusion into a vein. The dose will be adjusted by your doctor, but the usual dose is between 0.5 – 5mg (1 – 10mL) injected into the vein, followed by an infusion of 15 – 100mg (30 – 200mL of metaraminol 0.5mg/mL solution for injection).

Metaraminol 0.5mg/mL Solution for Injection is already diluted and ready to use. It should be used without prior dilution.

If you are given more Metaraminol 0.5mg/mL Solution for Injection than you should

It is unlikely that you will receive too much because this medicine will be given to you in hospital. You will be carefully monitored by your doctor for symptoms or severely high blood pressure (see symptoms in Section 4 Possible Side Effects).

Tell your doctor immediately if you experience:

• Sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), feeling that you are going to faint (symptoms of a severe hypersensitivity reaction).
• Pain and/or swelling at the injection site.

The following symptoms may be due to severely high blood pressure. Tell your doctor immediately if you experience:

• Headaches
• High blood pressure (hypertension)
• Slow, or irregular heartbeat
• Shortness of breath
• Feeling sick
• Chest pain
• Abscesses

Tell your doctor as soon as possible if you experience:

• Cold extremities
• Pain in the extremities

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: 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.

What Metaraminol 0.5mg/mL Solution for Injection contains

• The active substance is metaraminol tartrate (0.095%w/v), which is equivalent to 0.05%w/v (0.5mg/mL) metaraminol.
• The other ingredients are: sodium chloride, sodium metabisulfite (E223) and Water for Injections.

What Metaraminol 0.5mg/mL Solution for Injection looks like and contents of the pack:

This medicine is a clear, colourless solution in a 5 mL or 10 mL glass ampoule. This medicine is packed into cartons containing 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Medical enquiries:

[email protected]