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SpePharm UK Ltd
2B Bankside, Hanborough Business Park, Long Hanborough, Witney, Oxfordshire, OX29 1LJ, UK
Telephone: +44 (0) 844 800 7335
Telephone:
Fax: +44 (0) 844 800 7341
WWW: http://www.spepharm.com
Medical Information Direct Line: 0844 800 7579
Medical Information e-mail: medinfo.uk@spepharm.com
Medical Information Fax: 0844 800 7336

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/04/2011
SPC Dantrium Intravenous

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


6.4     Special precautions for storage

 

Unopened product:  Do not store above 25°C.

Reconstituted solution:  store between 15 and 25°C.  Do not refrigerate or freeze.  Protect from direct light.

 

6.5     Nature and contents of container

 

Type II glass vial with chlorobutyl rubber stopper and aluminium seal.  Twelve vials per carton.

 

 

10.     DATE OF REVISION OF THE TEXT

 

06/2010
Updated on 14/09/2010 and displayed until 04/04/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2     Posology and method of administration

Dantrium Intravenous is not recommended for use in children

4.4     Special warnings and precautions for use (two new paragraphs)


The use of Dantrium Intravenous in the management of malignant hyperthermia is not a substitute for previously known supportive measures. It will be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements and manage the metabolic acidosis. When necessary institute cooling, attend to urinary output and monitor for electrolyte imbalance.

 

Hepatic dysfunction, including hepatitis and fatal hepatic failure, has been reported with dantrolene sodium therapy. Whilst the licensed indications of intravenous dantrolene sodium do not generally necessitate prolonged therapy, the risk of hepatic dysfunction may increase with dose and duration of treatment, based on experience with oral therapy. However in some patients it is of an idiosyncratic or hypersensitivity type, and could occur after a single dose.

4.6     Pregnancy and lactation

The safety of Dantrium intravenous in pregnant women has not been established; it should be given only when the potential benefits have been weighed against the possible risk to mother and child.

7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GR Amsterdam

The Netherlands

8.       MARKETING AUTHORISATION NUMBER

 

PL 34413/0003

10.     DATE OF REVISION OF THE TEXT

 

10/2009
Updated on 20/10/2008 and displayed until 14/09/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated 4.6 section with the following text:

The safety of Dantrium intravenous in pregnant women has not been established.  Dantrolene crosses the placenta, and should be given only when the potential benefits have been weighed against the possible risk to mother and child.

 

Dantrolene has been detected in human milk at low concentrations (less than 2 micrograms per milliliter) during repeat intravenous administration over 3 days.  Dantrium Intravenous should be used by nursing mothers only if the potential benefit justifies the potential risk to the infant.
Updated on 07/04/2006 and displayed until 20/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 07/04/2006 and displayed until 07/04/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 07/04/2006 and displayed until 07/04/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 27/05/2003 and displayed until 07/04/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 30/09/2002 and displayed until 27/05/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/07/2001 and displayed until 30/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 14/06/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 14/06/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  dantrolene sodium