Dantrium Intravenous 20g
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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
Schawk Link No.: 445739A05
Black
Technical Info Profile
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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
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. Before you are given Dantrium Intravenous
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.
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
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
Norgine Item No.:
Proof No.:
Change Control No.:
Product Name (including flavour):
Date:
Market:
Component Type:
Manufacturing Site:
Technical Drawing No.: Dimensions (mm):
Pharmacode:
Material Number:
On-line print requirements:
22200401
6
SPCR13/0009 & SPCR13/0015 DANTRIUM IV
23/10/14
UK
PIL
Loxxess
TBC
150x208mm
N/A
306056
n/a
Schawk Link No.: 445739A05
Black
Technical Info Profile
Fonts used:
Arial Rounded MT-Bold Myriad Pro-Bold Myriad Pro-Regular
Average Text Size (Body Text):
9.0 pt
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:
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
306056