Cancidas

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Caspofungin acetate 60.6mg equivalent to 50 mg caspofungin anhydrous free base

Beschikbaar vanaf:

Merck Sharp & Dohme (New Zealand) Limited

INN (Algemene Internationale Benaming):

Caspofungin acetate 60.6 mg (equivalent to 50 mg caspofungin anhydrous free base)

Dosering:

50 mg

farmaceutische vorm:

Powder for infusion

Samenstelling:

Active: Caspofungin acetate 60.6mg equivalent to 50 mg caspofungin anhydrous free base Excipient: Glacial acetic acid Mannitol Sodium hydroxide Sucrose Water for injection

Eenheden in pakket:

Vial, glass, single dose, 10 ml, 10 mL

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Merck Sharp & Dohme Corp

therapeutische indicaties:

· Empirical therapy for presumed fungal infections in febrile, neutropaenic patients ·Treatment of Invasive Candidiasis, including candidaemia, in neutropaenic and non-neutropaenic patients ·Treatment of Oesophageal Candidiasis · Treatment of Oropharyngeal Candidiasis ·Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies.

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, single dose, 10 ml - 50 mg - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisatie datum:

2000-09-18

Productkenmerken

S-WPC-MK0991-IV-102016
Page 1 of 16
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
CANCIDAS 50 mg Powder for infusion
CANCIDAS 70 mg Powder for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial contains either 50 mg or 70 mg of caspofungin free
base.
CANCIDAS contains, as the active ingredient, caspofungin acetate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
CANCIDAS is a sterile, lyophilised product for intravenous infusion.
Each vial contains a solid
white to off white cake.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CANCIDAS is indicated for:
• Empirical therapy for presumed fungal infections in febrile,
neutropaenic patients
• Treatment of Invasive Candidiasis, including candidaemia, in
neutropaenic and non-
neutropaenic patients
• Treatment of Oesophageal Candidiasis
• Treatment of Oropharyngeal Candidiasis
• Treatment of Invasive Aspergillosis in patients who are refractory
to or intolerant of other
therapies.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
GENERAL RECOMMENDATIONS IN ADULT PATIENTS
CANCIDAS should be administered in adults (≥18 years of age) by slow
intravenous infusion
over approximately 1 hour.
Empirical Therapy
A single 70 mg loading dose should be administered on Day 1, followed
by 50 mg daily
thereafter. Duration of treatment should be based on the patient’s
clinical response. Empirical
therapy should be continued until resolution of neutropaenia. Patients
found to have a fungal
infection should be treated for a minimum of 14 days; treatment should
continue for at least 7
days after both neutropaenia and clinical symptoms are resolved. If
the 50 mg dose is well
tolerated but does not provide an adequate clinical response, the
daily dose can be increased
S-WPC-MK0991-IV-102016
Page 2 of 16
to 70 mg. Although an increase in efficacy with 70 mg daily has not
been demonstrated, safety
data suggest that an increase in dose to 70 mg daily is well
tolerated.
Invasive Candidiasis
A single 70-mg loading dose should be admi