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More infoSummary of Contraindications Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU are contraindicated in patients with prior hypersensitivity to rhFSH or excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled thyroid, adrenal or pituitary disorders, sex hormone dependent tumors of the reproductive tract/accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin and ovarian cyst or enlargement of undetermined origin. Please scroll for full IMPORTANT RISK INFORMATION or see full Prescribing Information for Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU. * RFF: Revised Formulation Female
Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection) Contraindications:
Warnings and Precautions:
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Patient Counseling: In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF* Redi-ject®, not share the device or reuse needles, and to ask their Healthcare Provider about questions. Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female
Important Risk Information for Gonal-f® Multi-Dose (follitropin alfa for injection) Contraindications:
WARNINGS Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications
Multiple Births
PRECAUTIONS
Adverse Reactions: Indications and Usage:
Prior to treatment complete an evaluation of female to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded. Men
Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection) Contraindications:
WARNINGS For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used. Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications:
Multiple Births
PRECAUTIONS
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female |
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Cetrotide® is contraindicated in women who are pregnant, are nursing, or have severe renal impairment. Cetrotide® is also contraindicated in women who exhibit or have known hypersensitivity to cetrorelix acetate, mannitol, extrinsic peptide hormone, GnRH or any other GnRH analogs. Treatment with Cetrotide® is not advised in women with severe allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions have been reported. Other adverse events reported include ovarian hyperstimulation syndrome, nausea, headache, and local injection site reactions. Multiple births and congenital abnormalities have been reported. Indication
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Important Risk Information for Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) Ovidrel® PreFilled Syringe should only be used by physicians who are experienced with infertility problems, their management and appropriate selection and monitoring of patients. Ovidrel® PreFilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations, mannitol, or one of their other excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled intracranial lesion, abnormal uterine bleeding of an undetermined origin, an ovarian cyst or enlargement of an undetermined origin. Women who are pregnant or nursing should not use Ovidrel® PreFilled Syringe. Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) and ovarian enlargement with or without pulmonary and vascular complications. Adverse reactions reported include injection site reactions, GI disorders, abdominal pain, nausea, vomiting, ovarian cyst, ovarian hyperstimulation, and thromboembolic events. Multiple births and congenital abnormalities have been reported. Indication
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Summary of Contraindications Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU are contraindicated in patients with prior hypersensitivity to rhFSH or excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled thyroid, adrenal or pituitary disorders, sex hormone dependent tumors of the reproductive tract/accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin and ovarian cyst or enlargement of undetermined origin. Please scroll for full IMPORTANT RISK INFORMATION or see full Prescribing Information for Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU. * RFF: Revised Formulation Female
Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection) Contraindications:
Warnings and Precautions:
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Patient Counseling: In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF* Redi-ject®, not share the device or reuse needles, and to ask their Healthcare Provider about questions. Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female
Important Risk Information for Gonal-f® Multi-Dose (follitropin alfa for injection) Contraindications:
WARNINGS Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications
Multiple Births
PRECAUTIONS
Adverse Reactions: Indications and Usage:
Prior to treatment complete an evaluation of female to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded. Men
Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection) Contraindications:
WARNINGS For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used. Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications:
Multiple Births
PRECAUTIONS
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female |
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Cetrotide® is contraindicated in women who are pregnant, are nursing, or have severe renal impairment. Cetrotide® is also contraindicated in women who exhibit or have known hypersensitivity to cetrorelix acetate, mannitol, extrinsic peptide hormone, GnRH or any other GnRH analogs. Treatment with Cetrotide® is not advised in women with severe allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions have been reported. Other adverse events reported include ovarian hyperstimulation syndrome, nausea, headache, and local injection site reactions. Multiple births and congenital abnormalities have been reported. Indication
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Important Risk Information for Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) Ovidrel® PreFilled Syringe should only be used by physicians who are experienced with infertility problems, their management and appropriate selection and monitoring of patients. Ovidrel® PreFilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations, mannitol, or one of their other excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled intracranial lesion, abnormal uterine bleeding of an undetermined origin, an ovarian cyst or enlargement of an undetermined origin. Women who are pregnant or nursing should not use Ovidrel® PreFilled Syringe. Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) and ovarian enlargement with or without pulmonary and vascular complications. Adverse reactions reported include injection site reactions, GI disorders, abdominal pain, nausea, vomiting, ovarian cyst, ovarian hyperstimulation, and thromboembolic events. Multiple births and congenital abnormalities have been reported. Indication
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