Cetrotide 0.25mg powder and solvent for solution for injection

Product Information *

  • Company:

    Merck
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 28 July 2021

File name

Cetrotide_PIL_Juy2019_1627467980.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Amendment of "United Kingdom" with "United Kingdom (Northern Ireland).
TW1735675.

Updated on 28 July 2021

File name

Cetrotide SPC 0.25 mg UK IE TW1826852 Current V6.0_1627467887.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Amendment of "United Kingdom" with "United Kingdom (Northern Ireland)".
TW1735675.

Updated on 17 September 2019

File name

PIL CETROTIDE 250 MCG (1) - 07-19_1568727120.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to improve clarity and readability

Updated on 23 July 2019

File name

Package leaflet_1535015327.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 17 July 2019

File name

Cetrotide SPC 0.25 mg UK IE TW1826852 Current V6.0_1563365873.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 11 July 2019

File name

Cetrotide SPC 0.25 mg UK IE TW1826852 Current V6.0_1562834835.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text

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

Updated on 23 August 2018

File name

Package leaflet_1535015327.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 23 August 2018

File name

Cetrotide SPC 0.25 mg UK IE TW1735675 Current V5.0_1535015301.pdf

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)

Updated on 31 July 2018

File name

Cetrotide - IFU update - TW1774786 (24.7.18)_1533027967.pdf

Reasons for updating

  • Change to information for healthcare professionals

Updated on 30 July 2018

File name

Cetrotide - IFU update - TW1774786 (24.7.18)_1532958492.pdf

Reasons for updating

  • Change to information for healthcare professionals

Updated on 22 December 2017

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.4       Special precautions for storage - Do not store above 25oC and keep the vials in the outer carton in order to protect from light has been removed and replaced with store in a refrigerator (2°C – 8°C); in the original package in order to protect from light. Also the following text has been added ,the unopened product may be stored in the original package at room temperature (not above 30°C) for up to three months. This product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use. Do not freeze or place next to the freezer compartment or a freezer pack.

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6.6       Special precautions for disposal and other handling - the following text has been added, this product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.

​​

10. Date of revision of the text - has changed from 04/2016 to 12/2017.

Updated on 22 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 19 December 2017

File name

PIL_15324_233.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 December 2017

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 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to other sources of information section

Updated on 20 February 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 15 December 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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 Undesirable effects - how to report a side effect  - was updated with the addition of Malta. Internal Ref: TW1230178.

Updated on 25 October 2016

Reasons for updating

  • Improved presentation of PIL

Updated on 25 May 2016

Reasons for updating

  • 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

There are several changes to Sections 4.3 Contraindications, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction and 4.8 Undesirable effects.

Updated on 25 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 30 September 2014

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

5.1 Pharmacodynamic properties

......

Clinical efficacy and safety

In females, cetrorelix delays the LH surge and consequently ovulation. In women undergoing ovarian stimulation the duration of action of cetrorelix is dose dependent. At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.

Updated on 15 July 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 04 June 2014

Reasons for updating

  • Change of manufacturer

Updated on 26 March 2014

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
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

There are minor editorial changes throughout the SPC.

Updated on 18 March 2014

Reasons for updating

  • Change of distributor details

Updated on 10 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 April 2010

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

Changed to section 10 : Date of Revision of Text

03/2010

Updated on 23 July 2009

Reasons for updating

  • 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

Change to Section 7 - MA Holder

From

Serono Europe Limited

To

Merck Serono Europe Limited

Updated on 30 April 2009

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Changes are widespread throughout document. Changes are minor editorial changes only.

Updated on 16 February 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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 2. Qualitative and quantitative composition: This section has been amended to include “Excipients: 54.80 mg mannitol. For a full list of excipients, see section 6.1.”

 

Section 3. Pharmaceutical form: The following sentence has been added to the end of this section: “The pH of the reconstituted solution is 4.0 – 6.0”.

 

Section 4.2. Posology and method of administration. The last sentence of this section has been amended as follows: “For instructions on preparation for use and handling, see section 6.6.”

 

Section 4.3. Contraindications. The first bullet point of this section has been amended to: “Hypersensitivity to the active substance or any structural analogue of GnRH, extrinsic peptide hormones or to any of the excipients.”

 

Section 4.8. Undesirable effects. This section has been tabulated by system organ class and frequency. No new adverse events added. The following paragraph has been added ‘Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.’

 

Section 5.3. Preclinical safety data. The following paragraph has been added to the beginning of this section: “Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.”

 

Section 6.1. List of Excipients. This section has been amended to “Powder: Mannitol Solvent: Water for injections”

 

Section 6.2. Incompatibilities.  This section has been amended to: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.”

 

Section 6.4. Special precautions for storage. This section has been amended to:

“Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.”

 

Section 10. Date of revision of the text. The data of revision of the text has been amended to October 2006.

Updated on 21 January 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

Updated on 18 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 30 June 2003

Reasons for updating

  • New SPC for new product

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