Ganirelix Acetate Injection 250 mcg/0.5mL

Ganirelix Acetate Injection

INDICATION FOR USE

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

IMPORTANT SAFETY INFORMATION

Ganirelix acetate injection is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components, Known hypersensitivity to GnRH or any other GnRH analog, Known or suspected pregnancy.
Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with ganirelix acetate, pregnancy must be excluded. Safe use of ganirelix acetate during pregnancy has not been established.
Special care should be taken in women with signs and symptoms of active allergic conditions.
Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during postmarketing surveillance. In the absence of clinical experience, ganirelix acetate treatment is not advised in women with severe allergic conditions.
The packaging of this product contains natural rubber latex which may cause allergic reactions.
Most commonly reported adverse reactions (≥ 1%) reported in clinical trials were: Abdominal Pain (gynecological), Death Fetal, Headache, Ovarian Hyperstimulation Syndrome, Vaginal Bleeding, Injection Site Reaction, Nausea, Abdominal Pain (gastrointestinal).
During post marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose.
Major and minor congenital abnormalities have been reported in clinical follow-up studies of newborns of women administered ganirelix acetate injection. The causal relationship between these congenital anomalies and ganirelix acetate is unknown.

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Please see full Prescribing Information.

Control the LH surge during ovarian hyperstimulation¹

Reference

Ganirelix Acetate Injection

INDICATION FOR USE

IMPORTANT SAFETY INFORMATION

Ganirelix Acetate Injection

INDICATION FOR USE

IMPORTANT SAFETY INFORMATION