| Document Date: 2013-11-07 09:13:48
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City Rockland / / Company EMD Serono Inc. / / Continent Europe / / Country Germany / United States / Canada / Australia / Israel / Spain / / Currency pence / / Event Product Recall / Product Issues / / Facility Laboratory Tests / / IndustryTerm rubber stoppers / injection site / large scale cell culture processing / rubber stopper / gonadotropin products / characterized cell bank / drug products / / MedicalCondition Ectopic Pregnancy / pleural effusions / arterial thromboembolism / Ovarian cyst / nausea / hydrothorax / hepatic dysfunction / Sex hormone dependent tumors / abnormal uterine bleeding / endometrial carcinoma / diarrhea / profound LH deficiency / hepatic insufficiency / infertility / abdominal pain / Ovarian Hyperstimulation Syndrome / dyspnea / adrenal dysfunction / Carcinogenesis / ovarian neoplasms / Premature Labor / oliguria / pituitary tumor / pain / vomiting / hemoperitoneum / anovulatory disorders / hypogonadotropic hypogonadism / Prior hypersensitivity / Spontaneous Abortion / syndrome / acute pulmonary distress / FSH deficiency / / MedicalTreatment contraception / ovulation induction / / Organization Administration of Luveris / DOSAGE AND ADMINISTRATION For Subcutaneous Use Only Dosage It / Concomitant administration / hCG administration / / / Position physician / fertility specialist / PRECAUTIONS General / nurse / or pharmacist / diameter Fisher / / Product Suitable injection / Gonal-f / chorionic gonadotropin / Sterile Water for Injection / sterile water / estradiol / LUTROPIN ALFA FOR INJECTION / Luveris / Patients With Events Headache Nausea Ovarian Hyperstimulation Breast Pain Female Abdominal Pain Ovarian Cyst Flatulence Injection / anovulatory women / / ProvinceOrState Massachusetts / / Technology ultrasound / Pharmacokinetics / Pharmacodynamics / /
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distribution (Vss) was approximately 10 L. Mean residence time (MRT) was approximately 6 hours.