DANTRIUM INTRAVENOUS 20G

Active substance: DANTROLENE SODIUM

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22200401 DAN IV GB PIL pf4_Dec2013 06/02/2014 15:24 Page 1

PA C K A G E L E A F L E T : I N F O R M AT I O N F O R T H E U S E R

Dantrium Intravenous 20 mg
®

Powder for Solution for Injection
Dantrolene sodium
Read all of this leaflet carefully before you
start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor.
- This medicine has been prescribed for you.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

2. Before you are given Dantrium® Intravenous

In this leaflet:
1. What Dantrium Intravenous is and what it is
used for
2. Before you are given Dantrium Intravenous
3. How Dantrium Intravenous is given
4. Possible side effects
5. How to store Dantrium Intravenous
6. Further information

Taking other medicines
Please tell your doctor if you are taking or have
recently taken 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”
- muscular relaxants, like vecuronium
- other intravenous infusion fluids

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.

Take special care with 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 find out if you have had a serious reaction to
Dantrium in the past.

Pregnancy and breast-feeding
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 “lightheadedness”. 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.
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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, Dantrium Intravenous 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.
Rare side effects:
- inflammation, sometimes formation of a blood
clot in the vein where Dantrium Intravenous was
injected
- serious liver disorder
- excess fluid in the lungs
- weakness of hand and leg muscles and
lightheadedness in the first 48 hours following
injection.
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® Intravenous
Keep out of the reach and sight of children.
Do not store Dantrium Intravenous 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 Intravenous 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. Further information
What Dantrium® Intravenous contains:
- The active substance is dantrolene sodium
20 mg.
- The other ingredients are mannitol and sodium
hydroxide.
What Dantrium® Intravenous looks like and
contents of the pack
The product is a pale orange-yellow powder for
solution for injection, supplied to hospitals in packs
of 12 and 36 glass vials.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Norgine B.V.
Hogehilweg 7
1101 CA Amsterdam
The Netherlands
Manufacturer:
SpePharm Holding B.V.
Kingsfordweg 151
1043 GR Amsterdam
The Netherlands
DANTRIUM is a registered trademark of the
SpePharm AG group of companies, licensed to the
Norgine group of companies.
Legal Category: POM
PL 20142/0015
This leaflet was last revised in 01/2014

22200401
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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