Dantrium IV 20 mg powder for solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dantrium® IVs 20 mg

Powder for Solution for Injection

Dantrolene sodium

1. What Dantrium IV is and what it is used for

Dantrium IV is a muscle relaxant. When given by intravenous injection (into a vein), it is useful in controlling malignant hyperthermia. This is a rare reaction to anaesthesia in which the body temperature rises extremely quickly. This serious condition produces a variety of symptoms such as a fast heartbeat and breathing rate, stiff muscles, changes in the acidity of the body and rhythm of the heart as well as high blood pressure. The reaction requires emergency treatment including oxygen, cooling the body, controlling its acidity, stopping the anaesthetic and giving Dantrium IV.

This injection is given to you by a doctor immediately when malignant hyperthermia is recognised.

2. What you need to know before you are given Dantrium IV

Take special care with Dantrium IV. You will probably have been given Dantrium IV before you see this leaflet. The urgent need for treatment will have been more important than anything else at the time. Before you are given this injection, your doctor will try to find out if you have had a serious reaction to Dantrium IV in the past.

3. How Dantrium IV is given

This injection is given to you by a doctor, into a vein. The dose of Dantrium IV is based on body weight; a total dose of up to 10 mg may be given for each kilogram of your body weight.

Care should be taken that Dantrium IV is not mixed with other intravenous infusion fluids.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. Reactions at site of injection may occur.

Immediately inform your health care provider if you have discoloured stool, generalised itch, yellowing of skin and eyes, loss of appetite, feeling sick, or abnormal tests, as this may be signs of a serious liver disorder.

Unknown: frequency cannot be estimated from the available data.

• inflammation around or, sometimes formation of a blood clot in the vein where Dantrium IV was injected
• excess fluid in the lungs
• weakness of hand and leg muscles and light headedness in the first 48 hours following injection.
• dizziness, tiredness, alteration of speech, convulsions (fits)
• change in heart rate
• excess fluid in the lungs or around the lungs
• difficulty breathing
• abdominal pain, nausea, vomiting, bleeding in the gut
• excessive sweating
• crystals in the urine and discoloured urine
• pain, redness, rash or inflammation around the vein where Dantrium IV was injected

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 to store Dantrium IV

Keep out of the sight and reach of children. Do not store Dantrium IV above 25°C.

The solution for injection should be stored between 15 and 25°C, not be refrigerated or frozen, protected from direct light and used within 6 hours of being made up.

Do not use Dantrium IV after the expiry “EXP” date which is stated on the label.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

If you need the information on this leaflet in an alternative format such as large print, please ring from the UK 0800 198 5000.