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Ganirelix (Ganirelix Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

DOSAGE AND ADMINISTRATION

After initiating FSH therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Ganirelix Acetate should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome).

Directions for Using Ganirelix Acetate Injection

  1. Ganirelix Acetate Injection is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only.
  2. Wash hands thoroughly with soap and water.
  3. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh.
  4. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding.
  5. With syringe held upward, remove needle cover.
  6. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection.
  7. The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface.
  8. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes.
  9. Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged.
  10. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
  11. Use the sterile, prefilled syringe only once and dispose of it properly.

HOW SUPPLIED

Ganirelix Acetate Injection is supplied in:

Disposable, sterile, ready for use, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubber piston that does not contain latex. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge × ½-inch needle closed by a needle shield of natural rubber latex and is blister-packed. (See PRECAUTIONS, General.)

Single syringe NDC 0052-0301-51

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany

For patent information: www.merck.com/product/patent/home.html

Copyright © 1999, 2008 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 12/2013

uspi-mk8761-soi-1312r003

Rx only

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