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.
Section 6.5 – Inclusion of a 20 ml sterile, Type I glass vial presentation Date changed for the revision of the text (Section 10)
- Addition of a paragragh on the interference with Phosphorus Chemistry Assays.
- 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.
Section 2
Section 4.2
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
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
Section 6.5
- Statement on the marketing of pack sizes.
Section 6.6
Section 10
- Date changed for the revision of the text.