Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
FOLLITROPIN (UNII: 076WHW89TW) (FOLLITROPIN - UNII:076WHW89TW)
Ferring Pharmaceuticals Inc.
FOLLITROPIN
FOLLITROPIN 75 [iU] in 1 mL
PRESCRIPTION DRUG
New Drug Application
BRAVELLE- UROFOLLITROPIN FERRING PHARMACEUTICALS INC. REFERENCE LABEL SET ID: 46F7740F-C879-4A77-9A16-2821FD772641 ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BRAVELLE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRAVELLE BRAVELLE (UROFOLLITROPIN FOR INJECTION, PURIFIED) FOR SUBCUTANEOUS OR INTRAMUSCULAR INJECTION INITIAL U.S. APPROVAL: 2002 INDICATIONS AND USAGE BRAVELLE (urofollitropin for injection, purified) is a gonadotropin indicated for: Induction of ovulation in women who have previously received pituitary suppression – intramuscular and subcutaneous administration (1.1) Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression (1.2) DOSAGE AND ADMINISTRATION _Ovulation Induction (2.2)_ Initial starting 150 International Units per day for 5 days, administered subcutaneously or intramuscularly Individualization of dosing after 5 days Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150 International Units per adjustment Do not administer greater than 450 International Units per day _Assisted Reproductive Technology (ART) (2.3)_ Initial starting dose of the first cycle – 225 International Units per day for 5 days, administered subcutaneously Individualization of dosing after 5 days Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150 International Units per adjustment Do not administer greater than 450 International Units per day DOSAGE FORMS AND STRENGTHS Lyophilized powder for injection: containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting, supplied as lyophilized powder in sterile vials with diluent vials. (3) CONTRAINDICATIONS BRAVELLE is contraindicated in women who exhibit: Prior hypersensitivity to BRAVELLE or urofollitropins (4) High levels of FSH indicating primary o Preberite celoten dokument