Dantrium Intravenous 20 mg Powder for Solution for Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dantrium® Intravenous 20 mg

Powder for Solution for Injection

Dantrolene sodium

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

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

What is in this leaflet:

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

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

3. How Dantrium Intravenous is given

4. Possible side effects

5. How to store Dantrium Intravenous

6. Contents of the pack and other information

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

Dantrium is a muscle relaxant. When given by intravenous injection, 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 Intravenous. 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 Intravenous

You will probably have been given Dantrium Intravenous 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 Intravenous in the past.

Do not take Dantrium Intravenous if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)

Other medicines and Dantrium Intravenous Tell your doctor if you are taking, have recently taken or might use any other medicines, including medicines obtained without a prescription. The following medicines affect the way Dantrium Intravenous works:

• drugs for high blood pressure and angina called “calcium channel blockers”
• muscle relaxants, like vecuronium
• other intravenous infusion fluids

Your doctor will also exercise caution if you are taking tranquilizing medicines.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or breastfeeding. Dantrium Intravenous should not be given unless considered essential.

Driving and using machines

For a period of up to 48 hours after you have been given Dantrium Intravenous, your hand and leg muscles may be weak and you may also have a feeling of “light headedness”. If you are affected in this way, do not drive or operate machinery during this time.

3. How Dantrium Intravenous is given

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

Based on experience to date, the dose for children is the same as for adults. Care should be taken that Dantrium Intravenous 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.

The following side effects were observed:

Not known (Frequency cannot be estimated from the available data):

·      anaphylaxis, allergic reactions,

·      drowsiness, dizziness, general weakness, somnolence, speech disorder, headache, convulsion,

·      heart failure,

·      slowed heartbeat (bradycardia), accelerated heartbeat (tachycardia),

·      thrombophlebitis,

·      fluid collection in the chest (pleural effusion),

·      fluid in the lung (possible difficulty breathing),

·      breathing that is too slow and shallow (respiratory depression),

·      difficulty breathing (respiratory failure),

·      high blood potassium levels (hyperkaliemia), which can cause tiredness, muscle weakness feeling sick and heart rhythm disturbances,

·      gastrointestinal complaints such as nausea, vomiting, diarrhoea, abdominal pain/cramps, gastrointestinal bleeding,

·      yellow eyes and skin (jaundice), and/or changes in blood test of liver function (signs of liver problems),

·      liver damage due to inflammation (hepatitis), liver failure,

·      skin redness/itchy rash,

·      increased sweat secretion (hyperhidrosis),

·      muscle tiredness,

·      accumulation of crystals in urine sediment (crystalluria),

·      weak contraction when giving birth (uterine hypotonia),

·      tiredness,

. reactions at the administration site.

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 HPRA Pharmacovigilance Website: www.hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dantrium Intravenous

Before opening and after reconstitution, the product should not be stored above 25°C.

After reconstitution it should not be refrigerated or frozen and should be protected from direct light.

The reconstituted solution should be prepared in controlled and validated aseptic conditions and be used within six hours.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiry date refers to the last day of the month.

Do not use this medicine if you notice that the pack is damaged.

Keep this medicine out of the sight and reach of children.

Do not throw away any medicines 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

What Dantrium Intravenous contains 20 mg dantrolene sodium, as active substance.

• 3000 mg mannitol and a small amount of sodium hydroxide, as other ingredients.

What Dantrium Intravenous looks like and contents of the pack:

Dantrium Intravenous is a pale orange-yellow powder for solution for injection, supplied to hospitals in packs of 12 or 36 glass vials.

Each vial is provided with a single-use filtration device.

Marketing Authorisation Holder and Manufacturer:

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

The Netherlands

If you need further information, on this leaflet in an alternative format, please ring Medical Information on +44 (0)1895 826 606.

Revision date

Thsi leaflet was last revision in 10/2024

The following information is intended for healthcare professionals only:

Information on reconstituting and filtering of Dantrium IV

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1) Add a sterile neddle to a syringe and fill with 60 mL of Water for Injecton.

2) Take one vial of Dantrium IV and reconstitute with the water in the syringe. Gently swirl until the powder if dissolved. Discard the needle.

3) Remove the safety cap and insert the spike of the single-use filration device into the vial

4) Connect syringe and withdraw all o the 60ml reconstituted solution from the vial into the syringe and then discard the filtration device.

5) attach the syringe containing the filtered reconsitituted solution, directly to the patients intravenous cannula or giving set. The product may be administered immediatley or as an infusion manually/via a pump depending on the clinicla need. Refer to section 3 for maximum dose.

6) Do not use the filtration device in the transfer of the filtered solution from the syringe to the giving set or the cannula.