AmBisome (Liposomal Amphotericin)
- Name:
AmBisome (Liposomal Amphotericin)
- Company:
Gilead Sciences Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/08/20

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Gilead Sciences Ltd

Company Products
When a pharmaceutical company changes any document, 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 August 2020 PIL
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 November 2018 SPC
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 8 October 2018 SPC
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 2 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 2 October 2018 SPC
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 SPC
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 SPC
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
Updated on 11 July 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 11 July 2016 PIL
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 SPC
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 10: Change to the date of revision to January 2015
Updated on 27 January 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 28 May 2013 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 2 January 2013 SPC
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 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 19 December 2012 SPC
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)
Updated on 7 December 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 25 October 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 18 January 2012 PIL
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 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 August 2011 SPC
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
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 9 August 2011 PIL
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 13 July 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 May 2011 SPC
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 9 November 2010 SPC
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
-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 5 November 2010 PIL
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 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 11 August 2009 SPC
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
Updated on 28 October 2008 SPC
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 2
Section 4.2
- Inclusion of adult patients subheading and B following amphotericin.
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
- Amendment to the frequency definitions.
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 of Referral to section 6.3 for storage conditions.
Section 6.5
- Statement on the marketing of pack sizes.
Section 6.6
- Includes statements on unused product and waste disposal.
Section 10
- Date changed for the revision of the text.
Updated on 28 October 2008 PIL
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 1 May 2008 SPC
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
Updated on 1 May 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 29 June 2007 PIL
Reasons for updating
- Change to improve clarity and readability
- Addition of marketing authorisation holder
Updated on 29 June 2007 SPC
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
Updated on 14 March 2007 SPC
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
Updated on 14 March 2007 PIL
Reasons for updating
- New PIL for new product
Updated on 1 September 2003 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)