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Cephalon Pharma (Ireland) Ltd
Suite 43, Northwood Court, Northwood Business Campus, Santry, Dublin 9,
Telephone: +353 1 8621600
Fax: +353 1 8621601
Medical Information e-mail: UKMedInfo@cephalon.com
Summary of Product Characteristics last updated on medicines.ie: 27/04/2011
SPC Abelcet

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 27/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   13-Apr-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 of the SPC addition of a new heading of “Infusion Hypersensitivity Reactions” has been added together with a cross-reference to the information on infusion hypersensitivity reactions in section 4.8.

Section 4.8 of the SPC, addition of 3 new adverse events (dermatitis exfoliative, hyposthenuria, renal tubular acidosis) are being added and the frequence for cardiac arrest is being changed from unknown to uncommon.  The categorisation and frequency for abdominal pain has been changed from uncommon under ‘general disorders and administration site conditions’ to common under ‘gastrointestinal disorders’.   In addition, information on infusion hypersensitivity reactions and renal tubular acidosis has been added to section 4.8.
Updated on 08/03/2011 and displayed until 27/04/2011
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   25-Feb-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 6.6.1 of the SmPC (Preparation of the suspension for infusion) has been amended to prevent errors in the dilution of the product.
Updated on 10/08/2010 and displayed until 08/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   24-May-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 7 update MAH from Cephalon Limited to Cephalon UK ltd
Updated on 07/07/2010 and displayed until 10/08/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   29-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 2:  Add 'Abelcet contains 3.6 mg/mL of sodium (0.156 mmol); this represents 71.8 mg of sodium (3.12 mmol) per 20 mL vial'

Section 4.2 - Information on paediatric, elderly, renal imparitment and hepatic impairement is moved from section 4.1 to section 4.2, in line with SmPC guideline.

Section 4.4 - Add 'Since Abelcet is a potentially nephrotoxic drug, monitoring of renal function should be performed before initiating treatment in patients with pre-existing renal disease or who have already experienced renal failure, and regularly during therapy.' & Systemic fungal infections:  Abelcet should not be used for treatment of common or superficial, cliically unapparent fungal infections that are detectable only by positive skin or serologic tests.'

Section 4.5 - Add 'flucytosine' & 'Acute pulmonary toxicity has been reported in patients receiving intravenous conventional amphotericin B and leukocyte transfusions. It is not recommended to administer Abelcet with leukocyte transfusions.'

Section 4.6 - Add information on brest-feeding

Section 4.7 - Additional information on ability to drive & use equipment

Section 4.8 - Add injection site reaction; Rewording & format improvement

Section 4.9 - Additional information on overdose.
Updated on 29/04/2009 and displayed until 07/07/2010
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Section 7 to update MA Holder address details
Updated on 10/01/2007 and displayed until 29/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change of MA holder from Zeneus to Cepahlon
Updated on 14/08/2006 and displayed until 10/01/2007
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 4.9 - Overdose
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Updated Section 4.4 providing Fequency data
Updated on 21/07/2006 and displayed until 14/08/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/07/2006 and displayed until 21/07/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
All updates regarded new standardised terms introduced with the licence renewal
Updated on 16/07/2003 and displayed until 21/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/06/2003 and displayed until 16/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Amphotericin B