| 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.
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