MICAFUNGIN- micafungin sodium injection, powder, lyophilized, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Micafungin sodium (UNII: IS1UP79R56) (Micafungin - UNII:R10H71BSWG)

Saatavilla:

Meitheal Pharmaceuticals Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Micafungin for Injection is indicated for: - Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]. - Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]. - Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. Limitations of Use - Micafungin for Injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida. - The efficacy of Micafungin for Injection against infections caused by fungi other than Candida has not been established. Additional pediatric use information is approved for Astellas Pharma US, Inc.'s MYCAMINE® (micafungin for injection). However, due to Astellas Pharma US, Inc.'s marketi

Tuoteyhteenveto:

Micafungin for Injection is a white to off-white lyophilized powder or cake for reconstitution for intravenous infusion, and is supplied as follows: Storage Unopened vials of lyophilized material must be stored at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store the reconstituted product at 20° to 25°C (68° to 77°F) [ see Dosage and Administration (2.4)]. Store the diluted solution at 20° to 25°C (68° to 77°F) [ see Dosage and Administration (2.4)]. Protect from light. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

MICAFUNGIN- MICAFUNGIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MEITHEAL PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MICAFUNGIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MICAFUNGIN FOR
INJECTION.
MICAFUNGIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Micafungin for Injection is an echinocandin indicated in adult and
pediatric patients for (1):
Treatment of Candidemia, Acute Disseminated Candidiasis, _Candida_
Peritonitis and Abscesses in adult
and pediatric patients 4 months of age and older.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4
months of age and older.
Prophylaxis of _Candida_ Infections in adult and pediatric patients 4
months of age and older undergoing
Hematopoietic Stem Cell Transplantation (HSCT).
Limitations of Use
Micafungin for Injection has not been adequately studied in patients
with endocarditis, osteomyelitis or
meningoencephalitis due to _Candida._ (1)
The efficacy of Micafungin for Injection against infections caused by
fungi other than _Candida_ has not
been established. (1)
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSAGE ADMINISTERED BY INDICATION, WEIGHT AND AGE (2.1,
2.2, 8.4)
ADULT
PEDIATRIC PATIENTS
4 MONTHS AND OLDER
30 KG OR LESS
PEDIATRIC PATIENTS
4 MONTHS AND OLDER
GREATER THAN 30 KG
TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, _CANDIDA
_PERITONITIS AND
ABSCESSES
100 mg daily
2 mg/kg/day
(maximum 100 mg daily)
TREATMENT OF ESOPHAGEAL CANDIDIASIS
150 mg daily
3 mg/kg/day
2.5 mg/kg/day
(maximum 150 mg daily)
PROPHYLAXIS OF _CANDIDA _INFECTIONS IN HSCT RECIPIENTS
50 mg daily
1 mg/kg/day
(maximum 50 mg daily)
Infuse over 1 hour. (2.5)
See Full Prescribing Information for intravenous (IV) preparation and
administration instructions. (2)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg single-dose vial. (3)
For injection: 100 mg single-dose vial. (3)
CONTRAINDICATIONS
Micafungin i