Reasons for adding or updating:

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

Date of revision of text on the SPC: 01-Apr-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Undesirable effects - adverse reaction reporting was updated with the addition of Malta. Internal Ref: TW1230178.

Reasons for adding or 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

Date of revision of text on the SPC: 01-Apr-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Reasons for adding or updating:

• Change to section 5.1 - Pharmacodynamic properties

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:



 

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.

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 - Fertility, pregnancy and lactation
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 5.1 - Pharmacodynamic properties
• 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

Date of revision of text on the SPC: 01-Mar-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

There are minor editorial changes throughout the SPC.

Reasons for adding or updating:

• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Mar-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changed to section 10: Date of Revision of Text

03/2010

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Jul-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to Section 7 - MA Holder

From

Serono Europe Limited

To

Merck Serono Europe Limited

Reasons for adding or updating:

• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.6 - Pregnancy and Lactation
• Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes are widespread throughout SPC. The changes are minor editorial changes only.

Reasons for adding or 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

Date of revision of text on the SPC: 01-Oct-2006

Legal Category:POM

Black Triangle (CHM): NO

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.

 

Reasons for adding or updating:

• Change to section 3 - pharmaceutical form
• Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
• Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

• Addition of Black Triangle

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 4.8 - Undesirable Effects

Reasons for adding or updating:

• Correction of spelling/typing errors

Reasons for adding or updating:

• New SPC for new product