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Glyceryl Trinitrate (Sterile Concentrate)

Glyceryl Trinitrate 5 mg/ml

Sterile Concentrate

Glyceryl Trinitrate (Sterile Concentrate)1. WHAT GLYCERYL TRINITRATE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR

Glyceryl Trinitrate Sterile Concentrate is a vasodilator (a medicine that widens the blood vessels).

Glyceryl trinitrate is used for the control of blood pressure during operations or to improve blood flow during and after heart operations. It can also be given to you after you have had a heart attack or to control angina attacks (sudden pains in the chest) when other medicines have not worked.

2. BEFORE GLYCERYL TRINITRATE STERILE CONCENTRATE IS USED

Glyceryl Trinitrate Sterile Concentrate should not be used

• if you have shown signs of hypersensitivity (severe allergy) to glyceryl trinitrate or medicines of the same group (organic nitrates) in the past

• if you have low blood pressure or a low blood volume (e.g. if you have had severe blood loss)

• if you suffer from increased intracranial pressure (high pressure within the skull)

• a ‘bleed’ on the brain

• if you have inflammation of the outer lining of the heart or compression of the heart due to the collection of fluid around the heart

• if you are very anaemic (low iron content in your blood)

• if you have low oxygen levels in your blood

• if you have severe anaemia (low levels of red blood cells)

If possible, tell your doctor if you think any of the above applies to you before this medicine is used.

Special care needs to be taken with Glyceryl Trinitrate Sterile Concentrate

• if you are undernourished

• if your thyroid is not working properly

• if you have a low body temperature

• if you have severe liver or kidney problems

• if you have an eye condition called ‘closed angle glaucoma’ or you have a higher than normal risk of getting it

If possible, tell your doctor if you think any of the above applies to you before this medicine is used.

The use of this medicine is not recommended in children or the elderly.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with glyceryl trinitrate. For example, it is important that glyceryl trinitrate and sildenafil (a medicine taken to correct erectile dysfunction in men) are not used together because they can cause blood pressure to fall too low.

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

  • Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

  • Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. dizziness) which may lessen your ability to do so.

Important information about some of the ingredients of Glyceryl Trinitrate Sterile Concentrate

This medicinal product contains 30% vol ethanol (alcohol), i.e. up to 2.4 g per 50 mg/10 ml ampoule, equivalent to 86 ml of a 3.5% vol beer or 21 ml of a 14% vol wine. Harmful to those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

In addition, this medicinal product contains propylene glycol, which can increase alcohol-like symptoms.

3. HOW GLYCERYL TRINITRATE STERILE CONCENTRATE IS USED

The medicine will be diluted in a suitable infusion solution and given as an infusion (drip) into a vein.

Dose

Your doctor will work out the correct dose of glyceryl trinitrate for you and how often it must be given.

The dose of medicine given to you will depend upon your medical condition. An initial dose will be given and depending on how your body reacts, this may be gradually increased.

The infusion rate is typically between 10 and 200 microgram/min.

Treatment should not last more than three days.

Your blood pressure and pulse will be measured often whilst you are being given this medicine.

If you are given too much or too little Glyceryl Trinitrate Sterile Concentrate

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

Like all medicines, glyceryl trinitrate can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

•low blood pressure (you may feel dizzy or faint, particularly when standing up or getting out of bed)

• abnormal or fast or slow heart beats

•feeling sick or retching

•feeling apprehensive

•muscle twitching

•pain behind the breast bone

•pain in your abdomen

•headache

•restlessness

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW GLYCERYL TRINITRATE STERILE CONCENTRATE IS STORED

Keep out of the reach and sight of children

  • Expiry

This medicine must not be used after the expiry date which is stated on the ampoule and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

  • Storage

The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 25°C.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours in a refrigerator. Storage for longer periods may be possible provided the infusion has been prepared in a way to exclude microbial contamination.

  • Visible signs of deterioration

Glyceryl Trinitrate Sterile Concentrate and the prepared infusion should be clear and practically colourless. Discoloured solutions should not be used.

6. FURTHER INFORMATION

  • What Glyceryl Trinitrate Sterile Concentrate contains

The active substance is glyceryl trinitrate. Each millilitre (ml) of solution contains 5 milligrams (mg) of glyceryl trinitrate.

The other ingredients are ethanol, propylene glycol and Water for Injections. See section 2 for further information regarding ethanol and propylene glycol.

What Glyceryl Trinitrate Sterile Concentrate looks like and contents of the pack Glyceryl Trinitrate Sterile Concentrate is a clear, practically colourless concentrate for solution for infusion which comes in glass containers called ampoules.

It may be supplied in packs containing:

• 5 x 25 mg/5 ml ampoules

• 5 x 50 mg/10 ml ampoules

Not all packs may be marketed.

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