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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

MICAFUNGIN (UNII: R10H71BSWG) (MICAFUNGIN - UNII:R10H71BSWG)

Disponible des:

Hikma Pharmaceuticals USA Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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   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

Resumen del producto:

Micafungin for Injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: Storage Unopened vials of lyophilized material must be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store the reconstituted product at 25°C (77°F) [see Dosage and Administration (2.4)] . Store the diluted solution at 25°C (77°F) [see Dosage and administration (2.4)] . Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA, Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MICAFUNGIN- MICAFUNGIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HIKMA PHARMACEUTICALS USA 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).
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 for injection is contraindicated in persons with known
hypersensitivity to micafungin sodium,
any component of micafungin for injection, or other echinocandins. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions
(including shock) have been
observ