Drug information for GANIRELIX ACETATE INJECTION

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	EQ 250MCG BASE/0.5ML	Prescription	(Reference Drug)	GANIRELIX ACETATE	ganirelix	ORGANON USA INC	21057 2008-07-02 Letter 2008-06-30 Label 2004-05-27 Review 1999-07-29 Letter 1999-07-29 Label

Drug Adverse Effects information for GANIRELIX ACETATE INJECTION

Role code	Indications	Reaction	# Reports
PS	ASSISTED FERTILISATION	ANAPHYLACTIC SHOCK	1
PS	ASSISTED FERTILISATION	SKIN IRRITATION	1
PS	INFERTILITY	DRUG INTERACTION	3
PS	INFERTILITY	HAEMOGLOBIN DECREASED	3
PS	INFERTILITY	HYPERTENSION	3
PS	INFERTILITY	HYPERTRANSAMINASAEMIA	3
PS	INFERTILITY	OVARIAN HYPERSTIMULATION SYNDROME	3
PS	INFERTILITY	PLATELET COUNT INCREASED	3
PS	INFERTILITY	PROTEINURIA	3
PS	INFERTILITY	TWIN PREGNANCY	3
SS	IN VITRO FERTILISATION	ATAXIA	3
SS	IN VITRO FERTILISATION	CLUMSINESS	3
SS	IN VITRO FERTILISATION	DYSARTHRIA	3
SS	IN VITRO FERTILISATION	HEADACHE	3
SS	IN VITRO FERTILISATION	HEMIPARESIS	3
SS	IN VITRO FERTILISATION	HYPOAESTHESIA	3
SS	IN VITRO FERTILISATION	LIMB DISCOMFORT	3
SS	IN VITRO FERTILISATION	LOSS OF CONSCIOUSNESS	3
SS	IN VITRO FERTILISATION	VISUAL IMPAIRMENT	3
SS	INFERTILITY	OVARIAN HYPERSTIMULATION SYNDROME	4
SS	OOCYTE DONATION	ATAXIA	2
SS	OOCYTE DONATION	CLUMSINESS	2
SS	OOCYTE DONATION	DYSARTHRIA	2
SS	OOCYTE DONATION	HEADACHE	2
SS	OOCYTE DONATION	HEMIPARESIS	2
SS	OOCYTE DONATION	HYPOAESTHESIA	2
SS	OOCYTE DONATION	LOW DENSITY LIPOPROTEIN INCREASED	2
SS	OOCYTE DONATION	MIGRAINE	2
SS	OOCYTE DONATION	NEUROLOGICAL SYMPTOM	2
SS	OOCYTE DONATION	SENSATION OF PRESSURE	2
SS	OOCYTE DONATION	UNEVALUABLE EVENT	2
SS	OOCYTE DONATION	VISUAL ACUITY REDUCED	2
SS	OOCYTE DONATION	VISUAL IMPAIRMENT	2
SS	OVULATION INDUCTION	EFFUSION	2
SS	OVULATION INDUCTION	OVARIAN HYPERSTIMULATION SYNDROME	2
SS	OVULATION INDUCTION	OVARIAN TORSION	2
SS	OVULATION INDUCTION	VOMITING	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	CRYING	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	DIZZINESS	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	EMOTIONAL DISORDER	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	EMOTIONAL DISTRESS	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	FATIGUE	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	2
C	BLOOD FOLLICLE STIMULATING HORMONE	OFF LABEL USE	1
C	BLOOD FOLLICLE STIMULATING HORMONE	SUBCHORIONIC HAEMORRHAGE	1
C	BLOOD FOLLICLE STIMULATING HORMONE	VITAMIN D DEFICIENCY	1
C	BLOOD GONADOTROPHIN ABNORMAL	OFF LABEL USE	1
C	BLOOD GONADOTROPHIN ABNORMAL	SUBCHORIONIC HAEMORRHAGE	1
C	BLOOD GONADOTROPHIN ABNORMAL	VITAMIN D DEFICIENCY	1
C	IN VITRO FERTILISATION	OFF LABEL USE	11
C	IN VITRO FERTILISATION	SUBCHORIONIC HAEMORRHAGE	11
C	IN VITRO FERTILISATION	VITAMIN D DEFICIENCY	11
C	PRODUCT USED FOR UNKNOWN INDICATION	DIZZINESS	7
C	PRODUCT USED FOR UNKNOWN INDICATION	FATIGUE	2
C	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	2
C	PRODUCT USED FOR UNKNOWN INDICATION	FEELING HOT	2
C	PRODUCT USED FOR UNKNOWN INDICATION	HEADACHE	7
C	PRODUCT USED FOR UNKNOWN INDICATION	MOOD SWINGS	5
C	PRODUCT USED FOR UNKNOWN INDICATION	MUSCLE SPASMS	2
C	PRODUCT USED FOR UNKNOWN INDICATION	OFF LABEL USE	6
C	PRODUCT USED FOR UNKNOWN INDICATION	PAIN	2
C	PRODUCT USED FOR UNKNOWN INDICATION	POOR QUALITY SLEEP	2
C	PRODUCT USED FOR UNKNOWN INDICATION	SUBCHORIONIC HAEMORRHAGE	6
C	PRODUCT USED FOR UNKNOWN INDICATION	THINKING ABNORMAL	2
C	PRODUCT USED FOR UNKNOWN INDICATION	VITAMIN D DEFICIENCY	6
C	PROPHYLAXIS OF ABORTION	OFF LABEL USE	1
C	PROPHYLAXIS OF ABORTION	SUBCHORIONIC HAEMORRHAGE	1
C	PROPHYLAXIS OF ABORTION	VITAMIN D DEFICIENCY	1
C	THYROID DISORDER	OFF LABEL USE	1
C	THYROID DISORDER	SUBCHORIONIC HAEMORRHAGE	1
C	THYROID DISORDER	VITAMIN D DEFICIENCY	1
C	VITAMIN D DEFICIENCY	OFF LABEL USE	1
C	VITAMIN D DEFICIENCY	SUBCHORIONIC HAEMORRHAGE	1
C	VITAMIN D DEFICIENCY	VITAMIN D DEFICIENCY	1

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