Last Updated on eMC 17-09-2012 View medicine  | Ferring Pharmaceuticals Ltd Contact details

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.

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:30-11-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of black triangle

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:30-12-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

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

Date of revision of text on the SPC:02-09-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 4.2 & 4.4: inclusion of the following instruction: "administration slowly over 1 minute"

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

Date of revision of text on the SPC:02-09-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:


Additional text added to sec.4.2 & 4.4;

4.2 - PABAL must be administered slowly, over 1 minute only after delivery of the infant by Caesarean section.

4.4 - It must be administered slowly over 1 minute.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.2. Posology and method of administration  - A single dose of carbetocin has been removed.
 
4.3. Contraindications - Ferring propose to use the standard term in the QRD template, no text changes.
 
4.6. Pregnancy and lactation - Ferring propose to further emphasize that the product must not be used for induction of labour.
 
4.8. Undesirable effects - Ferring propose to re-arrange the order of the  tabular presentation of the undesirable effects according to MedDRA. And also to remove the empty row referring to Cardiac disorders.
 
5.3 Preclinical safety data - Ferring propose to revise and simplify the section to comply with the guideline. The following text has been deleted;
Compared to oxytocin, carbetocin has reduced milk-ejecting and milk-let down effects in animals. Animal studies by the intravenous route have shown carbetocin to possess negligible haemodynamic effects and an antidiuretic activity of approximately one third that of oxytocin.  The LD50 could not be determined in acute toxicity studies. Doses of up to 7000 times that of the therapeutic dose of carbetocin were well tolerated. No toxic effects were observed during four-week toxicity studies in rats and dogs at doses of up to 1 mg/kg/day, which are about 700 times higher than the therapeutic dose.
 
Added:
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology and genotoxicity.
 
6.4. Special precautions for storage - Ferring propose to use the standard term.
 
6.5. Nature and contents of container - Ferring propose to add the pack size.
 
 
 

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 
Section 1: Ferring propose to write the strength per ml instead of in 1ml.
 
section 4.2: Ferring propose to emphasize the single dose use of PABAL. The statement is replaced within the paragraph.
 
section 4.3: Ferring propose to use the standard term in the QRD template, (or to any of the excipients).
 
section 4.4: Ferring propose to correct a typing error, (vasopressor to vasopressin). 
 
section 4.6: Ferring propose to further emphasize that the product must not be used for induction of labour.
 
section 4.8: Ferring propose to re-arrange the order of the  tabular presentation of the undesirable effects according to MedDRA. For readability we have not highlighted the changes in the current text.  Also Ferring propose to remove the empty row referring to Cardiac disorders.
 
section 5.3: Ferring propose to revise and simplify the section to comply with the guideline; delete paragraphs 1,2,3,5 and add the following;
 
"Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology and genotoxicity".
 
section 6.4: Ferring propose to use the standard term for storage condition, to delete 'at' from the following storage cond. sentance;
Store in a refrigerator at (2°C to 8°C).
 
section 6.5: Ferring propose to add the pack size, -  "Packs of 5 ampoules"

Reasons for adding or updating:

  • Extra statutory information

Date of revision of text on the SPC:01-08-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC updated inline with MRP.

Reasons for adding or updating:

  • New SPC for new product