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AmBisome (Liposomal Amphotericin)

*
Pharmacy Only: Prescription

  • Company:

    Gilead Sciences Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Amphotericin B

    *Additional information is available within the SPC or upon request to the company

Updated on 15 April 2024

File name

AmBisome Ireland PIL April 2024.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 15 April 2024

File name

AmBisome Ireland SPC April 2024.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 09 February 2023

File name

AmBisome Ireland SPC - September 2018.pdf

Reasons for updating

  • Document format updated

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

Updated on 27 August 2020

File name

AmBisome Ireland PIL - June 2020.pdf

Reasons for updating

  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

  • Removal of printed SmPC from the pack – this is to be replaced by the Instructions for Use (IU) being added to the Patient Information Leaflet.
  • Inclusion of Instructions for Use in the pack instead of the SmPC – this IU is intended for healthcare professionals and will be an integral part of the PIL, that is removable.
  • Inclusion of pictures of reconstitution in the IU for clearer and visual instructions for healthcare professionals

Updated on 30 November 2018

File name

AmBisome Ireland PIL - September 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 30 November 2018

File name

AmBisome Ireland SPC - September 2018.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 08 October 2018

File name

AmB Ireland SPC - September 2018.pdf

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 02 October 2018

File name

AmB Ireland PIL - September 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 02 October 2018

File name

AmB Ireland SPC - September 2018.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 27 July 2016

Reasons for updating

  • New SPC for new product

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

Updated on 27 July 2016

Reasons for 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 4.6 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

$0-Update to Section4.2 (Posology and method of administration) to include to include a dosingrecommendation for mucormycosis.$0$0- Whole SPC has undergone changes to bring in line with the latest version of the QRD template$0

Updated on 11 July 2016

File name

PIL_11863_556.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 July 2016

Reasons for updating

  • Change of active ingredient
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 28 January 2015

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)

Free text change information supplied by the pharmaceutical company

• Section 7: Minor correction of the name of the marketing authorisation holder to Gilead Sciences International Ltd
• Section 10: Change to the date of revision to January 2015

Updated on 27 January 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 28 May 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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- Each vial contains 213 mg of hydrogenated soy phosphatidylcholine (HSPC) and a small amount of sodium

·         Section 4.3- Addition of statement ‘AmBisome contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product’

·         Section 4.4- Inclusion of statement ‘This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’

·         Section 10- Date changed for the revision of the text

Updated on 24 May 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 02 January 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3- Shelf life extension from 36 to 48 months

Section 6.4- Removal of the statement “Do not Freeze” for the storage of the finished product

Section 10- Date changed for the revision of the text to December 2012

Updated on 20 December 2012

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 19 December 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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


- Musculoskeletal pain (arthralgia, back pain or bone pain) listed as a symptom of less frequent infusion related reactions (Section 4.8)
- Date changed for the revision of the text (Section 10)

Updated on 07 December 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 October 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 January 2012

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Change due to harmonisation of PIL

Updated on 12 October 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 17 August 2011

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

The amendment to the SPC is as follows:

Section 6.5 –  Inclusion of a 20 ml sterile, Type I glass vial presentation

Date changed for the revision of the text (Section 10)

Updated on 09 August 2011

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 13 July 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 May 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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


  • Clarifying the dosing and reconstitution information in sections 6.3 (shelf life) and 6.6 (special precautions for disposal and other handling)
  • In section 10: Date of the revision of the text- changed to May 2011

Updated on 09 November 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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

Section 1

-Wording changed to AmBisome liposomal amphotericin B 50mg powder for concentrate for dispersion for infusion.

Section 4.2

- Addition of hepatic impairment statement which states no data are available on which to make a dose recommendation for patients with hepatic impairment.

- Removal of the statement in this section that AmBisome is not physically compatible with saline solutions and should not be mixed with other drugs or electrolytes.

Section 4.8

- Addition of the following under musculoskeletal and connective tissue disorders:- Not Known: rhabdomyolysis (associated with hypokalemia).

- Addition of a paragragh on the interference with Phosphorus Chemistry Assays.

Section 6.6

- Addition of statement that AmBisome is NOT interchangeable with other amphotericin products.

- Addition of statement- AmBisome must be reconstituted using Sterile Water for Injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%, 10% or 20%) for infusion only.

- Addition of a section preparation of AmBisome for infusion. This also shows an example of the preparation of AmBisome at a dose of 3 mg/kg/day in dextrose 5%.

Section 10

- Date of the revision of the text changed to October 2010.

Updated on 05 November 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 26 August 2009

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 11 August 2009

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

In section 10, the date of the revision of the text has been amended to March 2008

Updated on 28 October 2008

Reasons for 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 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 6.3 - 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)

Free text change information supplied by the pharmaceutical company

Section 1
 
- Name amended to AmBisome 50 mg lyophilisate for solution for infusion.

Section 2

The following statement added:
 
- After reconstitution, the concentrate contains 4 mg/mL amphotericin B.
 
Section 3
 
- Rewording of dosage form.

Section 4.2

- Information added regarding the recommended duration of intravenous infusion in doses greater than 5mg/kg/day.
- Inclusion of adult patients subheading and B following amphotericin.
- Statement that AmBisome is not recommended for use in children below 1 month.
- Statement alteration in elderly patients section.

Section 4.3

- Amendment to contraindication statement.

Section 4.4

- Changes to this section with additional information included with regards special warnings and precautions.

Section 4.5

- Changes to this section with additional information included with regards to interaction.

Section 4.7

- Statement alteration on the effects of AmBisome on the ability to drive/or use machines.

Section 4.8

- Changes with additional information on undesirable effects.
- Amendment to the frequency definitions.
- Addition of not known incidences in the disorders section.

Section 4.9

- Inclusion of the word acute to overdose.

Section 5.1

- Addition of a subheading and B after amphotericin.

Section 5.3

- Statement amendments to doses in dogs, rabbits and rats and non-mutagenic in bacterial and mammalian systems.

Section 6.1

- Excipients listed.

Section 6.2

- Statement alteration with regards incompatibility and mixing with other drugs and electrolytes.

Section 6.3

- Minor amendments with shelf life information.

Section 6.4

- Statement Keep container in outer carton added.
- Statement of Referral to section 6.3 for storage conditions.

Section 6.5

- Statement on the marketing of pack sizes.

Section 6.6

- Addition of yellow dispersion after reconstitution with water for injections statement.
- Includes statements on unused product and waste disposal.

Section 10

- Date changed for the revision of the text.

Updated on 28 October 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to, or new use for medicine
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 01 May 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Type II update to section 4.4.

Updated on 01 May 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 June 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

All sections of SmPC updated in line with company core safety information.

Updated on 29 June 2007

Reasons for updating

  • Change to improve clarity and readability
  • Addition of marketing authorisation holder

Updated on 14 March 2007

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

General updates in line with current SmPC requirements. 
 
Further clarification of Sections 1, 2, 3, 6.1, 6.3, 6.4, 6.5 and 6.6. 
 
Section 1 update in line with standard terms.
 
Section 6.4 - removal of requirement to protect AmBisome from light.
 
Section 9 - Date of renewal
 
Section 10 - Date of revision of the text.

Updated on 14 March 2007

Reasons for updating

  • New PIL for new product

Updated on 01 September 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 25 June 2003

Reasons for updating

  • New SPC for medicines.ie

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