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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WD , UK
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441/Freephone: 1800 523137
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)1223 436 700/Freephone: 1800 523137
Summary of Product Characteristics last updated on medicines.ie: 21/11/2011
SPC Vectibix

When a pharmaceutical company changes an SPC or PIL, 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 21/11/2011 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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Nov-2011
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 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 4.3 - 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 - Date of revision of the text
Updated on 03/06/2011 and displayed until 21/11/2011
Reasons for adding or 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
Date of revision of text on the SPC:   23-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.4 (special warnings and precautions for use) 

Addition of a paragraph regarding ocular toxicities (including cases of keratitis and ulcerative keratitis)

 

Section 4.8 (undesirable effects)

Inclusion of the adverse reactions keratitis (uncommon) and ulcerative keratitis (rare).   

Addition of a paragraph regarding ocular toxicities (including cases of keratitis and ulcerative keratitis)

 

Section 10 (date of revision of the text)

Date changed to 23 May 2011

Updated on 01/06/2010 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • 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 4.5 - 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
  • Change to section 5.2 - Pharmacokinetic properties
  • 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
Date of revision of text on the SPC:   29-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 addition of warnings concerning cellulitis and also infusion related reactions. The background to the warning on cellulitis is provided. In addition, a warning has been included that Vectibix should not be administered to mCRC patients with mutant KRAS tumours or for whom KRAS status is unknown in combination with oxaliplatin-containing chemotherapy based on the results of a recent trial (also included in Section 4.5).
Section 4.8, amendment of table of adverse reactions, increased information concerning dermatological reactions, infusion-related reactions, cellulitis. angioedema.
Other indicated sections have minor amendments.
Updated on 27/04/2009 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   04/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special Warnings and Precautions for Use), revised wording concerning infusion related reactions, and hypersensitivity and inclusion of warning about late onset reactions.
Strengthened warning about use in combination with bevacizumab containing chemotherapy. New warning about acute renal failure.
In section 4.5 (Interaction), strengthened warning about use in combination with chemotherapy and IFL or bevacizumab.
Section 4.8 (undesirable effects), new warnings concerning dermatitis acneiform, acute renal failure, infusion related reactions and fatal angioedema, revisions in line with new data.
Section 5.1 (Pharmacodynamic Properties), revised text in line with the latest data concerning hazard ratios and survival in the different treatment groups of the PACCE study.
Updated on 21/01/2009 and displayed until 27/04/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In section 4.4, warning concerning hypomagnesaemia has been extended to include reference to hypocalcaemia and hypokalaemia and the details concerning frequency of monitoring these electrolyte disturbances has been modified.
In section 6.3, the precautions to be taken after dilution of the product have been strengthened.
Updated on 26/08/2008 and displayed until 21/01/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 (undesirable effects) vascular disorders: pulmonary embolism has been added to table in this section as a common side effect.
 
section 6.3 the shelf life has been changed from 2 years to 3 years.
Updated on 03/07/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • New SPC for new product

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  Panitumumab