Someone from the Pregnancy Registry will then contact you to confirm necessary information to complete the curso de vigilante provigil registration process. During these interviews, you will be asked to provide information about your health and your baby’s health. Overall pregnancy outcome consists of any major congenital defects, alterations in fetal growth (including constitutionally small and large for gestational age infants, as well as growth-restricted infants), spontaneous losses, live births, fetal deaths and elective termination. The PROVIGIL Pregnancy Registry has been established to evaluate the safety of PROVIGIL use during pregnancy. In addition, patient support groups or condition-related sources of information may be targeted to raise patient awareness of the Registry. If you are a healthcare professional treating a patient who is taking PROVIGIL and has become pregnant, you are encouraged to enroll the patient in the provigil pregnancy registry Registry. • Eligible patients may include those where the condition of the fetus was already assessed as normal through early prenatal testing to determine the gestational age or viability within 10 weeks or less from registration. To learn more about the PROVIGIL Pregnancy Registry, contact a Registry representative at 1-866-404-4106 (toll-free). If you are pregnant and have taken at least one PROVIGIL tablet within 6 weeks of becoming pregnant or at any time during your pregnancy, you may be eligible to participate in the Registry. The Registry will be posted on the FDA website for pregnancy registries, with a direct link to a Nuvigil/Provigil Registry website. To learn more about the Registry, including how to participate, please click the “Patients” button below. May 2013 • Any woman who is pregnant, and was exposed to provigil and renal failure at least one dose of armodafinil or modafinil within 6 weeks prior to conception and/or during pregnancy • The condition of the fetus has not been assessed through prenatal testing such as targeted ultrasound and amniocentesis. Your participation in the Registry may last throughout your pregnancy and up to provigil rezeptfrei kaufen 12 months after your delivery date. For ongoing awareness, information on the Registry will be included in the prescribing information and in the Medication Guides distributed by the pharmacist at the time of dispensing. Inclusion Criteria: • Reported exposure to Nuvigil (armodafinil) and/or brand or generic formulations of Provigil (modafinil) within 6 weeks of becoming pregnant, or during pregnancy • Able and willing to provide informed consent • Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff Exclusion Criteria: • Patients who refuse to provide oral or written informed consent • Patients not exposed to armodafinil or brand or generic formulation of modafinil • Pregnancy from outside the United States Sleep Apnea, Obstructive Sleep Wake Disorders Parasomnias Narcolepsy Sleep Disorders, Circadian Rhythm Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Disorders of Excessive Somnolence Chronobiology Disorders Occupational Diseases Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs REGISTRATION REQUEST If you are pregnant and have taken at least one PROVIGIL tablet within 6 weeks of becoming pregnant or at any time during your pregnancy, you may be eligible to participate in the Registry. • Adverse fetal outcomes or congenital anomalies [ Time Frame: Baseline and End of Pregnancy ] The Registry is designed for open enrollment of all patients who meet the inclusion criteria. • BY PHONE–Call the Pregnancy Registry at 1-866-404-4106 • ONLINE– “Click” on the Registration Request Button provide your contact information. The function and activities of the Nuvigil/Provigil Pregnancy Registry will be publicized through direct mailings to obstetricians provigil risks and pharmacists. You may be asked to participate in up to 7 telephone interviews (on enrollment, at each trimester of pregnancy, within 2 months after your delivery, and when your baby reaches 6 months and 1 year of age). A toll-free phone line will be established for patient enrollment and a website containing information about the Registry for both physician and patient recruitment will be available. You may register by filling out the information below or by calling the provigil and parkinson's disease Registry at 1-866-404-4106. Drug: Modafinil/armodafinil The primary objective is to characterize the pregnancy, fetal and newborn outcomes associated with Nuvigil (armodafinil) or (modafinil) exposure during provigil a droga da inteligencia pregnancy.

Share