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.
Updated method of administration / side effects
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 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