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Metrorrhagia Management

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1. Metrorrhagia Management

Metrorrhagia Management Metrorrhagia Management Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Metrorrhagia Management Metrorrhagia (...) Management Aka: Metrorrhagia Management , Anovulatory Bleeding Management From Related Chapters II. Indication ( ) III. Goal: Correct Unopposed Estrogen Prevent Prevent Uncoordinated Sloughing IV. Management Switch to containing pill Avoid when is contraindicated (e.g. users over age 35 years) Limit to no more than 35 mcg Lower is not associated with bleeding acetate ( ) 10 mg oral daily for 10-14 days per month (Aygestin) Dose: 5 mg PO tid cycle days 15 to 25 Micronized (Prometrium) Dose: 200 mg PO qd

2018 FP Notebook

2. Metrorrhagia Management

Metrorrhagia Management Metrorrhagia Management Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Metrorrhagia Management Metrorrhagia (...) Management Aka: Metrorrhagia Management , Anovulatory Bleeding Management From Related Chapters II. Indication ( ) III. Goal: Correct Unopposed Estrogen Prevent Prevent Uncoordinated Sloughing IV. Management Switch to containing pill Avoid when is contraindicated (e.g. users over age 35 years) Limit to no more than 35 mcg Lower is not associated with bleeding acetate ( ) 10 mg oral daily for 10-14 days per month (Aygestin) Dose: 5 mg PO tid cycle days 15 to 25 Micronized (Prometrium) Dose: 200 mg PO qd

2015 FP Notebook

3. International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS)

International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018Publication approval The guideline recommendations on pages 16 to 34 of this document were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 2 July 2018 under section 14A of the National Health and Medical Research Council Act 1992 (...) in unaltered form only (retaining this notice) for your personal, non-commercial use, or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Copies of the guideline can be downloaded from monash.edu/medicine/sphpm/mchri/pcos. Suggested citation: International evidence- based guideline for the assessment and management of polycystic ovary syndrome. Copyright Monash University, Melbourne Australia 2018. Publication history Original

2018 European Society of Human Reproduction and Embryology

4. Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation (MAVUFERT) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03656211 Recruitment Status : Completed First Posted : September 3, 2018 Last Update Posted : September 3, 2018 Sponsor: Rennes

2018 Clinical Trials

5. Practical aspects of the two FIGO systems for management of abnormal uterine bleeding in the reproductive years. (Abstract)

Practical aspects of the two FIGO systems for management of abnormal uterine bleeding in the reproductive years. The FIGO systems defining the nomenclature and symptoms of abnormal uterine bleeding (AUB) in the reproductive years (System 1) and the PALM-COEIN classification of causes of AUB (System 2) are designed to facilitate research, education, and the provision of optimum clinical care for affected women. Development of these systems has been the result of a collaborative effort of experts (...) in bench and translational and clinical research from six continents aided by a spectrum of representatives from relevant medical societies, journals, and regulatory bodies. Integral to this development has been a decision to cease the use of poorly defined and inconsistently used terms such as menorrhagia, metrorrhagia, and dysfunctional uterine bleeding, to name a few, and replace them with a set of terms and definitions that are relatively easily understood and translated into the spectrum

2016 Best practice & research. Clinical obstetrics & gynaecology

6. Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women

Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before (...) adding more. Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02705222 Recruitment Status : Completed First Posted : March 10, 2016 Last Update Posted : October 29, 2018 Sponsor: Mohamed Sayed Abdelhafez Information

2016 Clinical Trials

7. The Management of Dysfunctional Uterine Bleeding Full Text available with Trip Pro

The Management of Dysfunctional Uterine Bleeding 13278735 2003 05 01 2018 12 01 0027-9684 48 1 1956 Jan Journal of the National Medical Association J Natl Med Assoc The management of dysfunctional uterine bleeding. 41-3 DIGNAM W J WJ eng Journal Article United States J Natl Med Assoc 7503090 0027-9684 OM Disease Management Female Humans Menorrhagia therapy Metrorrhagia therapy 5629:30876 MENORRHAGIA AND METRORRHAGIA/therapy 1956 1 1 1956 1 1 0 1 1956 1 1 0 0 ppublish 13278735 PMC2641171 Am J

1956 Journal of the National Medical Association

8. Tadalafil - Pulmonary Hypertension

2.4.4. Post marketing experience 23 2.4.5. Discussion on clinical aspects 23 2.4.6. Conclusions on clinical aspects 24 2.5. Risk management plan 24 2.6. PSUR submission 25 2.7. Pharmacovigilance 25 2.8. Product information 25 2.8.1. User consultation 25 3. Benefit-risk balance 25 4. Recommendation 26 EMA/803097/2016 Page 3/26 List of abbreviations 6MWT 6-minute walk test ADR Adverse Drug Reaction AE Adverse event AESI AEs of special interest ALK1 Activin receptor-like kinase type 1 ALP Alkaline (...) of 80.00-125.00%. EMA/803097/2016 Page 24/26 2.4.6. Conclusions on clinical aspects A summary of the literature with regard to clinical data of tadalafil and two bioequivalence studies were provided to demonstrate that the active substance does not differ significantly in properties with regards to safety and efficacy of the reference product and was accepted by the CHMP. 2.5. Risk management plan Safety concerns Summary of safety concerns Important identified risks • Priapism (MedDRA PT: Priapism

2017 European Medicines Agency - EPARs

9. Baricitinib (Olumiant) - rheumatoid arthritis

by the CHMP with all information of a commercially confidential nature deleted. EMA/13493/2017 Page 2/132 Table of contents 1. Background information on the procedure 9 1.1. Submission of the dossier 9 1.2. Steps taken for the assessment of the product 10 2. Scientific discussion 11 2.1. Problem statement 11 2.1.1. Disease or condition 11 2.1.2. Epidemiology 11 2.1.3. Clinical presentation 11 2.1.4. Management 11 2.1.5. Introduction 15 2.1.6. Active Substance 16 2.1.7. Finished Medicinal Product 19 2.1.8 (...) . Introduction 44 2.3.2. Pharmacokinetics 48 2.3.3. Pharmacodynamics 53 2.3.4. Discussion on clinical pharmacology 57 2.3.5. Conclusions on clinical pharmacology 59 2.4. Clinical efficacy 60 2.4.1. Dose response studies 60 2.4.2. Main studies 60 Clinical studies in special populations 82 2.4.3. Discussion on clinical efficacy 82 2.4.4. Conclusions on the clinical efficacy 85 2.5. Clinical safety 85 2.5.1. Discussion on clinical safety 108 2.5.2. Conclusions on the clinical safety 111 2.6. Risk Management

2017 European Medicines Agency - EPARs

10. Monoclonal antibodies to prevent migraine headaches

the Canadian commercialization rights of erenumab to Novartis (Geoff Sprang, Executive Director, Value & Access, Amgen Canada, Mississauga, ON: personal communication, 2017 Sep 11). Fremanezumab: Teva announced the submission of a BLA to the FDA for fremanezumab on October 17, 2017. 14 Submissions to other regulatory agencies will follow at a later date. (Christine Poulin, General Manager, Teva Canada Innovation, Montreal, QC: personal communication, 2017 Sep 13). Galcanezumab : Eli Lilly has submitted (...) of anti-CGRP therapy. 8,25 Current Practice Existing therapies for migraine management focus on both the acute and the preventive management of symptoms. 1,24 5HT 1B/1D agonists, known as triptans, are the mainstay for the treatment of acute migraine episodes and are available in a number of formulations. 1,24 Other pharmacologic options for treating acute migraines include analgesics (acetaminophen) and nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, and ASA). 24 Patients who suffer from

2018 CADTH - Issues in Emerging Health Technologies

11. CRACKCAST E121 – Anemia, Polycythemia, and White Blood Cell Disorders

History Nature and time of injury Estimated blood loss Non-trauma History Skin: petechiae, bruising Respiratory: hemoptysis, epistaxis Gastrointestinal: hematemesis, hematochezia, melena, peptic ulcer Genitourinary: LMP, menorrhagia (bleeding in-between expected periods), metrorrhagia (excessive bleeding during periods), hematuria Physical Exam Serial Vital signs (including orthostatic vitals), level/content of consciousness Skin: pallor (conjunctival, palmar creases highest LHR), diaphoresis (...) sequestration, cholestasis Gallbladder – increased bilirubin gallstone production Spleen – acute sequestration Urinary – hematuria, hyposthenuria Genital – decreased fertility, impotence, priapism Skeletal – bone infarcts, osteomyelitis, aseptic necrosis Placenta – insufficiency with fetal wastage Leukocytes – relative immunodeficiency Erythrocytes – chronic hemolysis [21] Describe the management of a sickle cell pain crisis Acute: analgesia (patient dependent/directed) with opioids +/- NSAIDS Chronic

2017 CandiEM

12. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline Full Text available with Trip Pro

be compelling reasons to initiate sex hormone treatment prior to age 16 years, although there is minimal published experience treating prior to 13.5 to 14 years of age. For the care of peripubertal youths and older adolescents, we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them (...) 13.5 to 14 years. As with the care of adolescents ≥16 years of age, we recommend that an expert multidisciplinary team of medical and MHPs manage this treatment. (1 |⊕○○○) 2.6. We suggest monitoring clinical pubertal development every 3 to 6 months and laboratory parameters every 6 to 12 months during sex hormone treatment. (2 |⊕⊕○○) 3.0 Hormonal therapy for transgender adults 3.1. We recommend that clinicians confirm the diagnostic criteria of GD/gender incongruence and the criteria

2017 Pediatric Endocrine Society

13. Addyi - Flibanserin

for Reproductive Health Drugs, draft transcript/recommendations from the June 4, 2015 joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee, and the following FDA reviews: ? Primary clinical review (Dr. Catherine Sewell for efficacy and Dr. Olivia Easley for safety, DBRUP) ? Statistical review (Dr. Kate Dwyer, Office of Biometrics) Reference ID: 3807993 (b) (4)Cross-Discipline Team Leader Review NDA 022526 (...) Flibanserin Oral Tablet 100 mg Page 8 of 52 ? Clinical pharmacology review (Dr. LaiMing Lee, Division of Clinical Pharmacology 3, DCP3, Office of Clinical Pharmacology/Office of Translational Science, OTS) and the Supervisory Memo (Dr. Dennis Bashaw, DCP3) ? Risk evaluation and mitigation strategy review (Dr. Somya Dunn, Division of Risk Management, DRISK/Office of Medication Error Prevention and Risk Management, OMEPRM/Office of Surveillance and Epidemiology, OSE) ? Pharmacology/toxicology reviews

2015 FDA - Drug Approval Package

14. Akynzeo (netupitant / palonosetron)

on clinical pharmacology 74 2.5. Clinical efficacy 74 2.5.1. Dose response studies 76 2.5.2. Main studies 76 2.5.3. Discussion on clinical efficacy 115 2.5.4. Conclusions on the clinical efficacy 118 2.6. Clinical safety 118 2.6.1. Discussion on clinical safety 143 2.6.2. Conclusions on the clinical safety 145 2.7. Pharmacovigilance 145 2.8. Risk Management Plan 146 2.9. Product information 149 2.9.1. User consultation 149 EMA/236963/2015 Page 4/153 3. Benefit-Risk Balance 149 4. Recommendations 152 EMA

2015 European Medicines Agency - EPARs

15. Cosentyx - secukinumab

. Pharmacodynamics 48 2.4.4. Discussion on clinical pharmacology 52 2.4.5. Conclusions on clinical pharmacology 54 2.5. Clinical efficacy 54 2.5.1. Dose response studies 54 2.5.2. Main studies 57 2.5.3. Discussion on clinical efficacy 116 2.5.4. Conclusions on the clinical efficacy 121 2.6. Clinical safety 121 2.6.1. Discussion on clinical safety 145 2.6.2. Conclusions on the clinical safety 150 2.7. Pharmacovigilance 151 2.8. Risk Management Plan 151 2.9. Product information 156 2.9.1. User consultation 156 (...) Report was circulated to all CHMP members on 7 February 2014. • During the meeting on 6 March 2014 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted the PRAC Advice on the submitted Risk Management Plan. • During the meeting on 20 March 2014, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. The final consolidated List of Questions was sent to the applicant on 20 March 2014. • The applicant submitted the responses to the CHMP consolidated List

2015 European Medicines Agency - EPARs

16. Bacterial vaginosis

or recur after initial treatment: Adherence with initial treatment should be checked. The diagnosis of BV should be reconsidered. Continued exposure to contributing factors should be checked. Adequate management of the current episode should be ensured. Have I got the right topic? Have I got the right topic? From age 12 years onwards (Female). This CKS topic covers the management of bacterial vaginosis. This CKS topic does not cover the diagnosis and management of other causes of vaginal discharge (...) to the recommendations. January 2008 — minor update. Text changed in line with the National Guideline for the Management of Bacterial Vaginosis (2006) published by the British Association for Sexual Health and HIV (BASHH). Issued in February 2008. October to December 2005 — reviewed. Validated in March 2006 and issued in May 2006. This guidance has been reviewed and updated following a full literature review. The recommendation to treat asymptomatic pregnant women has slightly changed, and the guidance now advises

2018 NICE Clinical Knowledge Summaries

20. Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice. Full Text available with Trip Pro

for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain

2019 BMC Women's Health

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