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Dantrium Intravenous

Last Updated on eMC 09-Nov-2016 View document  | Norgine Limited Contact details

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 09-Nov-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 20-Oct-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



DANTRIUM SPC updates are as follows:

Section 2:  QRD update

 

Section 4.2: Reference to method of administration added

 

Section 4.3: Addition of hypersensitivity to excipients

 

Section 4.4, 4.5 4.6: Grammar and QRD updates

 

Section 4.8: All ADRs corresponding frequencies have been amended to unknown. Addition of Reporting of side effects have been included.  

 

Section 5.1, 5.2 and 5.3: updated to QRD

 

Section 6.1: excipients listed

 

Section 6.6: heading in QRD

 

Section 10: Revision date

 

Updated on 31-Oct-2014 and displayed until 09-Nov-2016

Reasons for adding or updating:

  • 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-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GRNorgine BV.

Hogehilweg 7, 1101CA

1101CA  Amsterdam ZO

The Netherlands

 

 

8.       MARKETING AUTHORISATION NUMBER

 

PL 34413/000320142/0015

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

14/02/1980

 

 

10.     DATE OF REVISION OF THE TEXT

 

06/2010September 2014

Updated on 04-Apr-2011 and displayed until 31-Oct-2014

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-Sep-2010 and displayed until 04-Apr-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-Oct-2008 and displayed until 14-Sep-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-Apr-2006 and displayed until 20-Oct-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-Apr-2006 and displayed until 07-Apr-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-Apr-2006 and displayed until 07-Apr-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-May-2003 and displayed until 07-Apr-2006

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Updated on 30-Sep-2002 and displayed until 27-May-2003

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 25-Jul-2001 and displayed until 30-Sep-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 14-Jun-2000 and displayed until 25-Jul-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 06-Sep-1999 and displayed until 14-Jun-2000

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

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?

Active ingredients

dantrolene sodium

Legal categories

POM - Prescription Only Medicine

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