TorbayPharmaceuticalS    Torbay and South Devon h'llPi

NHS Foundation THist

Patient Information Leaflet

Metaraminol 10mg/mL Solution for Injection or Infusion

•    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 any of the side effects get serious, or if you notice side effects £i not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1.    What Metaraminol Solution for Injection or Infusion is and what it is used for

2.    Before you are given Metaraminol Solution for Injection or Infusion

3.    How Metaraminol Solution for Injection or Infusion is used

4.    Possible Side Effects

5.    How to store Metaraminol Solution for Injection or Infusion

6.    Further Information

1. What Metaraminol Solution for Injection or Infusion is and what it is used for

The active substance Metaraminol Tartrate belongs to a group of medicines called vasopressors which work by narrowing the blood vessels causing blood pressure to rise.

It is used to:

• Raise low blood pressure to normal levels in an emergency situation.

2. Before you are given Metaraminol Solution for Injection or Infusion

You will be given this medicine in hospital by a doctor or nurse.

You should not be given this medicine:

•    If you are allergic to metaraminol 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.

Extra care will be taken if you have:

•    Liver disease

•    Heart disease

•    High blood pressure

•    Thyroid disease

•    Diabetes mellitus

•    A history of malaria

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important if you are taking:

•    Digitalis medicines (such as digoxin) which may cause an irregular heartbeat.

Use in children and adolescents

This medicine is not recommended for use in children below the age of 12 years. Pregnancy and breast-feeding

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.

Important information about some of the ingredients in this medicine

This medicine contains

•    Sodium metabisulfite - a preservative which may rarely cause hypersensitivity reactions and bronchospasm. It may also cause skin reactions if spilt on the skin.

•    Sodium - a 1mL ampoule contains 2.26mg sodium. Take into consideration if you are on a low-sodium diet.

Additional information for Healthcare Professionals (as stated on the Summary of Product Characteristics)

Therapeutic indications

For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and as an adjunct to accepted remedial procedures.

Posology and method of administration

Method of Administration For intravenous use.

Posology

Direct intravenous injection in grave emergencies: 0.5 - 5 mg (0.05 - 0.5 mL), followed by an infusion of 15 - 100 mg (1.5 - 10 mL) in 500 mL of infusion liquid.

Particuler care should be taken to use the correct dose when injecting undiluted Metaraminol.

Intravenous Infusion: 15 - 100 mg (1.5 - 10.0 mL) in 500 mL Sodium Chloride Injection or Dextrose 5% Injection, adjusting the rate of infusion to maintain the blood pressure at the desired level. Higher concentrations of Metaraminol have been used when appropriate to the circumstances.

3. How Metaraminol Solution for Injection or Infusion is used

•    A nurse or doctor will give you this medicine.

•    Your doctor will decide the correct dosage for you and how and when the medicine will be given.

If you are given more of this medicine than you should be

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).

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:

•    Shortness of breath

•    Chest pain

•    Slow or irregular heart beat

•    Headaches

•    Feeling sick

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: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metaraminol Solution for Injection or Infusion

•    This medicine will be stored out of the sight and reach of children and below 25°C.

•    Your nurse or doctor will check the expiry date has not passed before giving you this medicine.

6. Further information

What this medicine contains

•    The active ingredient is Metaraminol Tartrate (1.9% w/v), which is equivalent to 1% w/v (10mg/mL) Metaraminol.

•    It also contains the inactive ingredients Sodium Chloride, Sodium Metabisulfite (E223) and Water for Injections.

What this medicine looks like and contents of the pack:

This medicine is a clear, colourless solution in a 1 mL glass ampoule. This medicine is packed into cartons containing 10 ampoules.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust, Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG, UK

This leaflet was last revised in: 10/2015

PL 13079/0011

PIL/11/2

Children: Metaraminol should not be used in children under 12 years of age.

Use in the elderly: The dosage may not require modification for elderly patients; however, geriatric patients may be more sensitive to sympathomimetic agents, therefore particular caution should be taken in this age group.

Incompatibilities

Metaraminol must not be mixed with the following medicinal products due to their additive incompatibilities:

Amphotericin B

Dexamethasone

Prednisolone

Erythromycin

Hydrocortisone

Methicillin

Penicillin G

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