Prialt solution for infusion

  • Name:

    Prialt solution for infusion

  • Company:
    info
  • Active Ingredients:

    Ziconotide acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 22/10/2019

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Intrapharm Laboratories Limited

Intrapharm Laboratories Limited

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Medicine Name Mydrilate 0.5% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Mydrilate 1.0% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray Active Ingredients Glyceryl Trinitrate
Medicine Name Prialt solution for infusion Active Ingredients Ziconotide acetate
1 - 0 of 5 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 22 October 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 revised to reflect latest EMA QRD PI template convention regarding reporting of adverse events in Ireland.

Updated on 21 October 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Change to adverse event reporting information for Ireland; change to manufacturer (batch release site).

N.b. PIL mock-up has replaced PIL text version on medicines.ie.

Updated on 17 July 2018 PIL

Reasons for updating

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

Updated on 17 July 2018 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The marketing authorisation granted by Decision C(2005)461 of 21 February 2005 to Eisai Limited for the medicinal product "Prialt - ziconotide", entered in the Community register of medicinal products under No EU/1/04/302, was transferred to RIEMSER Pharma GmbH on 2nd July 2018.

Updated on 22 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 November 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • Improved presentation of PIL

Updated on 7 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 March 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Documented changes

Sections of the SPC

Changes/updates

Section 4.4

Under hypersensitivity reactions, addition of the following wording:

“and spontaneous reports of anaphylactic reactions have been received”

Section 4.8

Under tabulated list of adverse reactions, addition of the following wording:
“Unless otherwise noted the table shows the incidence rates of adverse reactions…“Within each frequency grouping undesirable effects are presented in order of decreasing frequency.”

Addition of “Not known (cannot be estimated from the available data)” to the frequency categories for tabulated adverse reactions.

Addition of “Immune system disorders” as system organ class in tabulated adverse reactions and “Anaphylactic reaction” as adverse reaction in table

Section 10

The Date of revision of text has been updated

 

Updated on 2 March 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 October 2014 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to improve clarity and readability
  • Change due to harmonisation of SPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Documented changes

Sections of the SPC

Changes/updates

General

Updated in line with EMA SPC presentation guidelines

Section 3

“Free of visible particles” removed

Section 4.8

Definition of adverse reaction frequencies added. Adverse event reporting address has been amended.

 

Section 5.3

“Environmental Risk Assessment” removed

Section 6.3

“Unopened vial” mention removed

Section 6.6

Addition of referral to pump manufacturer and disclaimer for pump choice.

Section 9

Date of latest renewal updated

Section 10

Date of revision of text updated

Updated on 22 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Change due to harmonisation of PIL
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 5 February 2014 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 5 February 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 April 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 November 2012 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • In section 4.4 under cognitive and neuropsychiatric adverse reaction the following wording has been added It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide
  • The same wording has alos been added to section 4.8

Updated on 11 August 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Aggressiveness has been added to section 4.4 and 4.8 under uncommon psychiatric disorders

Updated on 8 August 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 16 February 2010 PIL

Reasons for updating

  • Change of active ingredient
  • Change to, or new use for medicine
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 15 February 2010 SmPC

Reasons for 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 renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 April 2009 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7:
MAH address details have been updated
 
Section 10:
Date of revision of text is now 17 March 2009

Updated on 20 April 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder address

Updated on 23 October 2008 PIL

Reasons for updating

  • Change to further information section

Updated on 22 October 2008 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 4 February 2008 PIL

Reasons for updating

  • Removal/change of distributor
  • Change to date of revision

Updated on 28 November 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 29 August 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  4.8  Undesirable effects

 The first sentence has been updated as follows (changes in bold): "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."

The next paragraph has been updated with figures changed in bold as follows: "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%)."

 

Psychiatric disorders

 

The following have moved from uncommon to common in frequency: thought blocking, abnormal dreams

Nervous system disorders

 

The following has moved from common to uncommon in frequency: somnolence

"mental impairment" has been removed from common in frequency

 

Gastrointestinal disorders

 

The following has been moved from common to uncommon: dyspepsia

Skin and subcutaneous tissue disorders

The following has been moved from common to uncommon: rash

 

Musculoskeletal and connective tissue disorders

 

The following has been moved from common to uncommon: back pain, muscle twitching, neck pain

 

General disorders and administration site conditions

 

The following has been moved from common to uncommon: difficulty in walking

 

Investigations

 

The following has been added as a common side effect: weight decreased

The following has been added/moved from common to uncommon: electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased

 

  7.        MARKETING AUTHORISATION HOLDER

 The MAH has been changed to: Eisai Ltd, 3 Shortlands, London, W6 8EE,United Kingdom

 

Updated on 3 August 2006 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 August 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)