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Eisai Ltd
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN
Telephone: +44 (0)845 676 1400
Fax: +44 (0)845 676 1486
Medical Information e-mail: Lmedinfo@eisai.net
Out of Hours Telephone: +44 (0)845 676 1400
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Summary of Product Characteristics last updated on the eMC: 15/02/2010
SPC Prialt solution for infusion

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 15/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


In addition to minor formatting changes, please see below a summary of changes:

 

Section 2: Qualitative and quantitative composition

 

“ziconotide” has been deleted from each of the three sections in brackets

 

Section 4.1: Therapeutic indications

 

The wording has been amended to read:

 

“Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.”

 

Section 4.2: Posology and method of administration

 

The following wording has been moved to the end of this section:

 

“Prialt is for intrathecal use only.

 

For instructions for use and handling, see section 6.6.”

 

Section 4.5: Interaction with other medicinal products and other forms of interaction

 

The sixth paragraph has been amended to read:

 

“An increased incidence of somnolence has been observed when ziconotide is administered concomitantly with systemic baclofen, clonidine, bupivacaine or propofol thus for the time being their simultaneous use is discouraged.”

 

 

The date of renewal of the authorisation and revision of text has been updated to 12 January 2010

Updated on 20/04/2009 and displayed until 15/02/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7:
MAH address has been updated

Section 10:
Date of revision is now 17 March 2009
Updated on 21/10/2008 and displayed until 20/04/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The text in section 10 containes a new URL for the EMEA:

Detailed information on this product is available on the website of the European Medicines Agency (EMEA) www.emea.europa.eu
Updated on 03/11/2006 and displayed until 21/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The following sections have changed:
4.8 Undesirable effects
The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical trials.
In clinical trials, 88% of patients experienced adverse drug reactions (ADRs). The most commonly reported ADRs reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%) headache (12%), asthenia (13%), and vomiting (11%) and somnolence (10%). Most ADRs were mild to moderate in severity and resolved over time.

 Psychiatric disorders

Uncommon: thought blocking and abnormal dreams

Nevous system disorders

Very common: somnolence

Common: mental impairment

Gastrointestinal disorders

Uncommon: dyspepsia

Skin and subcutaneous tissue disorders

Uncommon: rash

Musculoskeletal and connective tissue disorders

Uncommon: back pain, muscle twitching and neck pain

General disorders and administration site conditions

Uncommon: difficulty in walking

Investigations
Uncommon: electrocariogram abnormal, body temperature increased, blood creatine phosphokinase MM increased, aspartate aminotransferase increased.
 
Section 7:
Marketing Authorisation holder has changed from Elan to Eisai Ltd
 
Section 10:
Date of revision of text has changed to 13 September 2006
Updated on 27/10/2006 and displayed until 03/11/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects
In the first sentence of the first paragraph, 1000 has changed to 1400.
In the second paragraph, some percentages & details of ADRs have changed:
In the first sentence, 89% has changed to 88%.
In the second sentence, the ADRs have changed as follows: dizziness (changed from 45% to 42%), nausea (changed from 35% to 30%), nystagmus (changed from 27% to 23%), gait abnormal (changed from 18% to 16%), headache (changed from 13% to 12%), vomiting (changed from 13% to 11%) and the following ADR has been added: somnolence (10%).  
Psychiatric disorders

Uncommon: thought blocking and abnormal dreams (moved from common section)

Nevous system disorders

Very common: somnolence (moved from common section)

Common: mental impairment (new ADR)

Gastrointestinal disorders

Uncommon: dyspepsia (new ADR)

Skin and subcutaneous tissue disorders

Uncommon: rash (moved from common section)

Musculoskeletal and connective tissue disorders

Uncommon: back pain, muscle twitching and neck pain (moved from common section)

General disorders and administration site conditions

Uncommon: difficulty in walking (moved from common section)

Investigations
Uncommon: electrocardiogram abnormal (new ADR), body temperature increased, blood creatine phosphokinase MM increased, aspartate aminotransferase increased (all three moved from common section)
 
Section 7. Marketing Authorisation Holder
Changed from Elan to Eisai Ltd, 3 Shortlands, London, W6 8EE, United Kingdom
 
Section 10. Date of revision of the text
Changed to 13 September 2006
Updated on 07/07/2006 and displayed until 27/10/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  ziconotide acetate


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