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.
Sections 3, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.2, 6.5, 6.6
Updated method of administration/side effects.
Updated side effects (angio-oedema).
Section 4.2: Under the sub-heading "Dosage in adult patients", removal of the sentence "Doses higher than 70 mg daily have not been adequately studied"
Section 4.5: Included paragraph stating "All adult drug-drug interaction studies described above were conducted at a 50 or 70 mg daily caspofungin dose. The interaction of higher doses of caspofungin with other medications has not been formally studied"
Section 4.8: Extensive changes to side effects section. New side effects added. Information about a study which evaluated Cancidas at 150 mg daily has been added.
Section 4.9: 140 mg changed to 400 mg with regards to dosage of caspofungin inadvertently administered in one day (up to 400 mg).
Section 5.1: Paragraph added describing study involving patients with invasive candidiasis receiving daily doses of caspofungin at 50 mg/day (following a 70-mg loading dose on Day 1) or caspofungin at 150 mg/day (see section 4.8).
Section 6.4: Minor typographical correction
Section 10: Revision date updated