FLUCONAZOLE-BAXTER fluconazole 100mg/50mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluconazole, Quantity: 2 mg/mL

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Fluconazole

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

1 x 50mL vial and 6 x 50mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FLUCONAZOLE-BAXTER Intravenous infusion should be used only when fluconazole cannot be administered orally: 1. Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note: Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. 2. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). 3. Treatment of oropharyngeal and oesophageal candidiasis in patients with AIDS and other immunosuppressed patients. 4. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. 5. Vaginal candidiasis, when topical therapy has failed. 6. Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. Note: It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-04-29

Summary of Product characteristics

FLUCONAZOLE-BAXTER (Fluconazole)
Version 2.0
1 of 23
AUSTRALIAN PRODUCT INFORMATION
FLUCONAZOLE-BAXTER (FLUCONAZOLE) INJECTION
FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole-Baxter, Injection for Intravenous Infusion is a clear
colourless infusion containing
2 mg/mL of Fluconazole in 0.9% saline (sodium chloride dissolved in
water for injection)
solution. Each 100 mL of the solution contains 15.4 mmol of sodium.
The pH of the solution is
4.0 – 8.0.
Each 50 mL vial of solution contains 100 mg of fluconazole, each 100
mL vial of solution
contains 200 mg of fluconazole and each 200 mL vial of solution
contains 400 mg of
fluconazole. Vials are for single use only.
3
PHARMACEUTICAL FORM
Injection for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole-Baxter Intravenous Infusion should be used only when
fluconazole cannot be
administered orally.
1.
Treatment of cryptococcal meningitis in patients who are unable to
tolerate amphotericin
B.
NOTE: Data suggest that the clinical efficacy of fluconazole is lower
than that of
amphotericin B in the treatment of the acute phase of cryptococcal
meningitis.
2.
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with AIDS.
3.
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
4.
Secondary prophylaxis of oropharyngeal candidiasis in patients with
HIV infection.
5.
Serious and life-threatening
_Candida_
infections in patients who are unable to tolerate
amphotericin B.
NOTE: It remains to be shown that fluconazole is as effective as
amphotericin B in the
treatment of serious and life-threatening
_Candida_
infections. Until such data are available,
amphotericin B remains the drug of choice.
6.
Vaginal candidiasis, when topical therapy has failed.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Fluconazole is normally administered orally. If oral administration is
not possible, it may be
administered by intraven