AMBISOME

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMPHOTERICIN B

Available from:

GILEAD SCIENCES ISRAEL LTD

ATC code:

J02AA01

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR INFUSION

Composition:

AMPHOTERICIN B 50 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GILEAD SCIENCES IRELAND UC, IRELAND

Therapeutic group:

AMPHOTERICIN B

Therapeutic area:

AMPHOTERICIN B

Therapeutic indications:

Antifungal antibiotic for the treatment of severe systemic and/or deep mycoses where toxicity precludes the use of conventional systemic amphotericin B in effective dosages. This drug should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests. Ambisome is also indicated for the treatment of systemic fungal infections in immunocompromised patients (e.g. patients with AIDS or cancer). Ambisome is also indicated for the primary therapy of visceral leishmaniasis in immunocompetent patients and immunocompromised patients (e.g. HIV positive). Empirical treatment of presumed fungal infection in febrile neutropenic patients.

Authorization date:

2015-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
AMBISOME
®
1.
NAME OF THE MEDICINAL PRODUCT
AmBisome Liposomal Amphotericin B 50mg Powder for concentrate for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of amphotericin B (50,000 units) encapsulated
in
liposomes
After reconstitution, the concentrate contains 4 mg/mL amphotericin B.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liposomal Amphotericin B 50mg Powder for concentrate for infusion.
A sterile, yellow lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AmBisome is indicated:
In the treatment of severe systemic and/or deep mycoses where toxicity
(particularly nephrotoxicity) precludes the use of conventional
systemic
amphotericin B in effective dosages.
This drug should not be used to treat the common clinically inapparent
forms
of fungal disease which show only positive skin or serologic tests.
In the treatment of systemic fungal infections in immuno-compromised
patients (e.g. patients with AIDS or Cancer).
As the primary therapy of visceral leishmaniasis in immunocompetent
patients and immunocompromised patients (e.g. HIV Positive).
In the empirical treatment of presumed fungal infection in febrile
neutropenic
patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
AmBisome should be administered by intravenous infusion over a 30 - 60
minute period. For doses greater than 5 mg/kg/day, intravenous
infusion over
a 2 hour period is recommended (see section 4.4). The recommended
concentration for intravenous infusion is 0.20 mg/ml to 2.00 mg/ml
amphotericin B as AmBisome.
TREATMENT OF SYSTEMIC MYCOSES AND VISCERAL LEISHMANIASIS
Therapy is usually instituted at a daily dose of 1.0 mg/kg of body
weight, and
increased stepwise to 3.0 mg/kg, as required. Dosage of amphotericin B
as
AmBisome must be adjusted to the specific requirements of each
patient.
A cumulative dose 1.0 – 3.0 g of AmBisome over 3-4 weeks has been
typical
of the treatment necessary for the resolution of mycoses.
EMPIRICA