Rx Item-Follistim Aq 600 0.72Ml Cartridge By Merck

FOLLISTIM AQ- follitropin injection, solution
Organon Pharmaceuticals USA

1 INDICATIONS AND USAGE

Follistim� AQ (follitropin beta injection) Cartridge is indicated:

In Women for:

1.1 Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure.
Prior to initiation of treatment with Follistim AQ Cartridge:

Women should have a complete gynecologic and endocrinologic evaluation.
Primary ovarian failure should be excluded.
The possibility of pregnancy should be excluded.
Tubal patency should be demonstrated.
The fertility status of the male partner should be evaluated.
1.2 Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle.


? Prior to initiation of treatment with Follistim AQ Cartridge:

Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility.
The possibility of pregnancy should be excluded
The fertility status of the male partner should be evaluated
In Men for:

1.3 Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure.
Prior to initiation of treatment with Follistim AQ Cartridge:

Men should have a complete medical and endocrinologic evaluation.
Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded.
Serum testosterone levels should be normalized with human chorionic gonadotropin (hCG) treatment.
The fertility status of the female partner should be evaluated.
2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is not clear and colorless or has particles in it, the solution should not be used.
Do not add any other medicines into the Follistim AQ Cartridge.
Follistim AQ Cartridge with the pen injector device delivers on average an 18% higher amount of follitropin beta when compared to reconstituted Follistim delivered with a conventional syringe and needle. When administering Follistim AQ Cartridge, a lower starting dose and lower dose adjustments (as compared to reconstituted Follistim) should be considered. For that purpose the following Dose Conversion Table is provided:

RX ITEM-Follistim Aq 600 0.72Ml Cartridg
NDC 00052-0316-01 UPC/GTIN No.3-00520-31601-9 Mfg.Part No.31601

Follistim Aq 600 0.72Ml Cartridge By Me
BRAND: FOLLISTIM AQ NDC: 00052-0316-01,52031601 UPC: 3-00520-31601-9,300520316019 Merck & Co.

FOLLITROPIN BETA,RECOMB S
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