Dantrium Intravenous 20 mg Powder for Solution for Injection

  • Name:

    Dantrium Intravenous 20 mg Powder for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Dantrolene Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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Norgine Limited

Norgine Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dantrium Capsules 100mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Capsules 25mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Intravenous 20 mg Powder for Solution for Injection Active Ingredients Dantrolene Sodium
Medicine Name MOVICOL 13.8g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Medicine Name Movicol Liquid Orange Flavour Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVIPREP Orange, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name MOVIPREP, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name NORMACOL Granules Active Ingredients Sterculia
Medicine Name NORMACOL PLUS Granules Active Ingredients Frangula, Sterculia
Medicine Name Plenvu powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name TARGAXAN 550mg film-coated tablets Active Ingredients Rifaximin
1 - 0 of 12 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 May 2019 PIL

Reasons for updating

  • Change to further information section

Updated on 15 May 2019 SmPC

Reasons for 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 January 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 July 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

General QRD updates.
Section 4.8 has been updated with:
Cardiac disorders - Cardiac failure, bradycardia

Gastrointestinal disorders - gastrointestinal bleeding
Respiratory, thoracic and mediastinal disorders - respiratory failure
Hepatobiliary disorders - jaundice, hepatitis

Updated on 6 July 2017 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

General QRD updates.
Section 4.8 has been updated with:
Cardiac disorders - Cardiac failure, bradycardia

Gastrointestinal disorders - gastrointestinal bleeding
Respiratory, thoracic and mediastinal disorders - respiratory failure
Hepatobiliary disorders - jaundice, hepatitis

Updated on 29 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 May 2017 SmPC

Reasons for updating

  • Previous version of SPC reinstated

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Previous version reinstated

Updated on 12 May 2017 PIL

Reasons for updating

  • Previous version of SPC reinstated

Free text change information supplied by the pharmaceutical company

Previous version reinstated

Updated on 30 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following changes have been made:

QRD update throughout the SPC

 

Section 4.8 updated in a tabulated format and to include unknown ADRs

 

Revision date

Updated on 30 December 2016 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Free text change information supplied by the pharmaceutical company

The following changes have been made:

QRD update throughout the SPC

 

Section 4.8 updated in a tabulated format and to include unknown ADRs

 

Revision date

Updated on 28 October 2014 PIL

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company



 

4.2      Posology and method of administration

As soon as the malignant hyperthermia  (MH) MH reaction is recognised, all anaesthetic agents should be discontinued; the administration of 100 % oxygen is recommended.  Dantrium IV should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.


4.4         Special warnings and precautions for use

The use of Dantrium IV in the management of a MH crisis is not a substitute for previously known supportive measures.  These measures must be individualised, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.

 

Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v.IV dantrolene sodium preoperatively should have vital signs monitored.

 

If patients judged MH-susceptible (with MHS) are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard MHS regimen, including the avoidance of known triggering agents.  Monitoring for early clinical and metabolic signs of MH is indicated because attenuation of MH, rather than prevention, is possible.  These signs usually call for the administration of additional i.v.IV dantrolene sodium.

 

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.

 

4.6      Pregnancy Fertility, pregnancy and lactation

 

4.8 Undesirable effects

 

 

Vasular Vascular disorders:

Less common: Labile blood pressure

4.9      Overdose

Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea  diarrhoea, and crystalluria.

 

 

6.1      List of excipients

Mannitol

Sodium hydroxide (for pH adjustment)

6.3      Shelf life

Unopened: 3 years.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 6 hours between 15 and at 25°Cc.  From a microbiological point of view, the product should be used immediately.

6.4      Special precautions for storage

Unopened product:  Do not store above 25°C.

Reconstituted solution:  Do not store above 25°C. Do not refrigerate or freeze.  Protect from direct light. Reconstitution should take place in controlled and validated aseptic conditions.

 

6.5         Nature and contents of container

Clear 70- ml vials, glass type Type I (Ph. Eur.), with siliconised chlorobutyl lyophilisation stoppers Type I (Ph. Eur.). The vials are sealed with aluminium caps with polypropylene flip-off disks.  Supplied in packs of 12 or 36 vials.

 

6.6      Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Each vial of Dantrium IV should be reconstituted by adding 60 ml of waterWater for injection Injection Ph. Eur. and shaking until the solution is clear.  Any unused portion of the reconstituted solution should be discarded.  There are no special requirements relating to the disposal of the container or contents.

 

 

7.        MARKETING AUTHORISATION HOLDER

 

SpePharm Holding Norgine B.V.

Kingsfordweg 151

1043 GR Hogehilweg 7

1101CA  Amsterdam ZO

The Netherlands

 

 

8.        MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/3 1336/004/003

 

9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 022nd December 1980

Date of last renewal: 022nd December 20052010

 

10.      DATE OF REVISION OF THE TEXT

 

December 2011 September 2014 

Updated on 28 October 2014 SmPC

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



 

4.2      Posology and method of administration

As soon as the malignant hyperthermia  (MH) MH reaction is recognised, all anaesthetic agents should be discontinued; the administration of 100 % oxygen is recommended.  Dantrium IV should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.


4.4         Special warnings and precautions for use

The use of Dantrium IV in the management of a MH crisis is not a substitute for previously known supportive measures.  These measures must be individualised, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.

 

Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v.IV dantrolene sodium preoperatively should have vital signs monitored.

 

If patients judged MH-susceptible (with MHS) are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard MHS regimen, including the avoidance of known triggering agents.  Monitoring for early clinical and metabolic signs of MH is indicated because attenuation of MH, rather than prevention, is possible.  These signs usually call for the administration of additional i.v.IV dantrolene sodium.

 

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.

 

4.6      Pregnancy Fertility, pregnancy and lactation

 

4.8 Undesirable effects

 

 

Vasular Vascular disorders:

Less common: Labile blood pressure

4.9      Overdose

Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea  diarrhoea, and crystalluria.

 

 

6.1      List of excipients

Mannitol

Sodium hydroxide (for pH adjustment)

6.3      Shelf life

Unopened: 3 years.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 6 hours between 15 and at 25°Cc.  From a microbiological point of view, the product should be used immediately.

6.4      Special precautions for storage

Unopened product:  Do not store above 25°C.

Reconstituted solution:  Do not store above 25°C. Do not refrigerate or freeze.  Protect from direct light. Reconstitution should take place in controlled and validated aseptic conditions.

 

6.5         Nature and contents of container

Clear 70- ml vials, glass type Type I (Ph. Eur.), with siliconised chlorobutyl lyophilisation stoppers Type I (Ph. Eur.). The vials are sealed with aluminium caps with polypropylene flip-off disks.  Supplied in packs of 12 or 36 vials.

 

6.6      Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Each vial of Dantrium IV should be reconstituted by adding 60 ml of waterWater for injection Injection Ph. Eur. and shaking until the solution is clear.  Any unused portion of the reconstituted solution should be discarded.  There are no special requirements relating to the disposal of the container or contents.

 

 

7.        MARKETING AUTHORISATION HOLDER

 

SpePharm Holding Norgine B.V.

Kingsfordweg 151

1043 GR Hogehilweg 7

1101CA  Amsterdam ZO

The Netherlands

 

 

8.        MARKETING AUTHORISATION NUMBER(S)

 

PA 1556/1/3 1336/004/003

 

9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 022nd December 1980

Date of last renewal: 022nd December 20052010

 

10.      DATE OF REVISION OF THE TEXT

 

December 2011 September 2014 

Updated on 14 August 2012 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Clear 70-ml vials, glass type I (Ph. Eur.) (used to be type II)

Updated on 14 August 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Clear 70-ml vials, glass type I (Ph. Eur.) (used to be type II)

Updated on 25 March 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

The use of Dantrium IV in the management of a MH crisis is not a substitute for previously known supportive measures.  These measures must be individualised, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.

 

Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.

 

If patients judged MH-susceptible (MHS) are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard MHS regimen, including the avoidance of known triggering agents.  Monitoring for early clinical and metabolic signs of MH is indicated because attenuation of MH, rather than prevention, is possible.  These signs usually call for the administration of additional i.v. dantrolene sodium.

 

When mannitol is used to prevent or treat the renal complications of malignant hyperthermia, the mannitol content in the Dantrium vial, i.e. 3000 milligrams of mannitol per 20mg of dantrolene sodium, should be taken into consideration.

 

Because of the high pH of Dantrium IV and potential for tissue necrosis, care must be taken to prevent extravasation of the intravenous solution into the surrounding tissues.

 

In some subjects as much as 10mg/kg of dantrolene sodium has been needed to reverse the crisis.  In a 70-kg man this dose would require approximately 36 vials.  Such a volume has been administered in approximately one and a half hours.

 

Information for Patients

Based upon data in human volunteers, it will sometimes be appropriate to tell patients who receive dantrolene sodium intravenous that decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected postoperatively.  In addition, symptoms such as "lightheadedness" may be noted.  Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time.  Caution is also indicated at meals on the day of administration because difficulty in swallowing and choking has been reported. Caution should be exercised in the concomitant administration of tranquilizing agents.

 

Hepatotoxicity seen with dantrolene sodium capsules

Dantrolene has a potential for hepatotoxicity, and symptomatic hepatitis, sometimes fatal, has been reported. Factors that may be related to a poorer prognosis include higher daily doses, female gender, and increasing patient age. Spontaneous reports also suggest a higher proportion of hepatic events with fatal outcome in elderly patients.

 

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.

 

 Evaluation of hepatic function should be done before initiating treatment, and hepatic function should be monitored at appropriate intervals throughout treatment. If monitoring reveals abnormal liver function, or if signs or symptoms of hepatotoxicity occur during therapy, dantrolene should be withdrawn. If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.


6.3     Shelf life

 

Unopened: 3 years.

 

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 6 hours between 15 and 25°C.  From a microbiological point of view, the product should be used immediately.



6.4     Special precautions for storage

 

Unopened product:  Do not store above 25°C.

 

Reconstituted solution:  Do not store above 25°C. Do not refrigerate or freeze.  Protect from direct light. Reconstitution should take place in controlled and validated aseptic conditions.

 

6.5         Nature and contents of container

 

Clear 70-ml vials, glass type III treated for type II (Ph. Eur.), with siliconised chlorobutyl lyophilisation stoppers Type I (Ph. Eur.). The vials are sealed with aluminium caps with polypropylene flip-off disks.  Twelve vials per carton.

7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GR Amsterdam

The Netherlands

 

8.       MARKETING AUTHORISATION NUMBER

 

PA 1556/1/3

10.     DATE OF REVISION OF THE TEXT

 

April 2010

Updated on 25 March 2011 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

The use of Dantrium IV in the management of a MH crisis is not a substitute for previously known supportive measures.  These measures must be individualised, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.

 

Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.

 

If patients judged MH-susceptible (MHS) are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard MHS regimen, including the avoidance of known triggering agents.  Monitoring for early clinical and metabolic signs of MH is indicated because attenuation of MH, rather than prevention, is possible.  These signs usually call for the administration of additional i.v. dantrolene sodium.

 

When mannitol is used to prevent or treat the renal complications of malignant hyperthermia, the mannitol content in the Dantrium vial, i.e. 3000 milligrams of mannitol per 20mg of dantrolene sodium, should be taken into consideration.

 

Because of the high pH of Dantrium IV and potential for tissue necrosis, care must be taken to prevent extravasation of the intravenous solution into the surrounding tissues.

 

In some subjects as much as 10mg/kg of dantrolene sodium has been needed to reverse the crisis.  In a 70-kg man this dose would require approximately 36 vials.  Such a volume has been administered in approximately one and a half hours.

 

Information for Patients

Based upon data in human volunteers, it will sometimes be appropriate to tell patients who receive dantrolene sodium intravenous that decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected postoperatively.  In addition, symptoms such as "lightheadedness" may be noted.  Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time.  Caution is also indicated at meals on the day of administration because difficulty in swallowing and choking has been reported. Caution should be exercised in the concomitant administration of tranquilizing agents.

 

Hepatotoxicity seen with dantrolene sodium capsules

Dantrolene has a potential for hepatotoxicity, and symptomatic hepatitis, sometimes fatal, has been reported. Factors that may be related to a poorer prognosis include higher daily doses, female gender, and increasing patient age. Spontaneous reports also suggest a higher proportion of hepatic events with fatal outcome in elderly patients.

 

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.

 

 Evaluation of hepatic function should be done before initiating treatment, and hepatic function should be monitored at appropriate intervals throughout treatment. If monitoring reveals abnormal liver function, or if signs or symptoms of hepatotoxicity occur during therapy, dantrolene should be withdrawn. If a decision is made to restart treatment after recovery from hepatic dysfunction, liver function should be monitored and the drug discontinued if abnormal values are observed.


6.3     Shelf life

 

Unopened: 3 years.

 

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 6 hours between 15 and 25°C.  From a microbiological point of view, the product should be used immediately.



6.4     Special precautions for storage

 

Unopened product:  Do not store above 25°C.

 

Reconstituted solution:  Do not store above 25°C. Do not refrigerate or freeze.  Protect from direct light. Reconstitution should take place in controlled and validated aseptic conditions.

 

6.5         Nature and contents of container

 

Clear 70-ml vials, glass type III treated for type II (Ph. Eur.), with siliconised chlorobutyl lyophilisation stoppers Type I (Ph. Eur.). The vials are sealed with aluminium caps with polypropylene flip-off disks.  Twelve vials per carton.

7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GR Amsterdam

The Netherlands

 

8.       MARKETING AUTHORISATION NUMBER

 

PA 1556/1/3

10.     DATE OF REVISION OF THE TEXT

 

April 2010

Updated on 26 August 2008 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 
Update to Section 4.4:

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.
 
Update to Section 4.6:
 
The safety of Dantrium IV 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.
 
Update to Section 4.8:
 Local injection site reactions are commonly observed. 
 
Update to Section 10:
 June 2008

Updated on 26 August 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 
Update to Section 4.4:

Hepatic dysfunction, including fatal hepatic failure, can occur with dantrolene use, and appears to be related to dose and duration of therapy. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may also occur with dantrolene sodium therapy.
 
Update to Section 4.6:
 
The safety of Dantrium IV 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.
 
Update to Section 4.8:
 Local injection site reactions are commonly observed. 
 
Update to Section 10:
 June 2008

Updated on 2 March 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 2 March 2006 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Updated on 18 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 August 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie