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DANTRIUM INTRAVENOUS 20G

Active substance: DANTROLENE SODIUM

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22200401
6
SPCR13/0009 & SPCR13/0015
DANTRIUM IV
23/10/14
UK
PIL
Loxxess
TBC
150x208mm
N/A
306056
n/a

445739A05

PACKAGE LEAFLET: INFORMATION FOR THE USER
Black

Dantrium Intravenous 20 mg
®

Powder for Solution for Injection
Dantrolene sodium

Fonts used:
Arial Rounded MT-Bold
Myriad Pro-Bold
Myriad Pro-Regular
Average Text Size (Body Text):
9.0 pt

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.  efore you are given Dantrium Intravenous
B

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:
-  rugs for high blood pressure and angina
d
called “calcium channel blockers”
- muscular relaxants, like vecuronium
- other intravenous infusion fluids

1.  hat Dantrium Intravenous is and what it
W
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.
306056

22200401
6
SPCR13/0009 & SPCR13/0015
DANTRIUM IV
23/10/14
UK
PIL
Loxxess
TBC
150x208mm
N/A
306056
n/a

445739A05

Black

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.

Fonts used:
Arial Rounded MT-Bold
Myriad Pro-Bold
Myriad Pro-Regular
Average Text Size (Body Text):
9.0 pt

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:
Norgine BV
Hogehilweg 7
1101 CA Amsterdam ZO
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 10/2014

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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