Postponing Menstruation: Choices and Concerns

Total Page:16

File Type:pdf, Size:1020Kb

Postponing Menstruation: Choices and Concerns PERSONAL VIEW J Fam Plann Reprod Health Care: first published as 10.1136/jfprhc-2016-101438 on 25 November 2016. Downloaded from Postponing menstruation: choices and concerns Diana Mansour Consultant, Community BACKGROUND norethisterone a day it is equivalent to Gynaecology and Reproductive Since writing an editorial for this journal taking a 20–30 μg EE combined oral Health Care, New Croft Centre, 1 1 Newcastle upon Tyne, UK in 2014 I have been repeatedly asked contraceptive (COC) pill. As clinicians, about my views on postponing menstru- we need to ask ourselves if we would be Correspondence to: ation. Women in the 21st century want happy prescribing a COC to the women Dr Diana Mansour, Community Gynaecology and Reproductive to avoid periods when on holiday yet requesting a supply of norethisterone? If Health Care, New Croft Centre, have difficulty accepting highly effective, the answer is no, then we should offer a Market Street East, Newcastle reversible forms of contraception which safer alternative. upon Tyne NE1 6ND, UK; provide infrequent bleeding. Authors of a The SPC for norethisterone tablets [email protected] BMJ article published 16 years ago sug- (5 mg) states that “previous idiopathic or Received 1 June 2016 gested that prescribing progestogens to current venous thromboembolism (deep Revised 3 September 2016 delay periods was a lifestyle choice and vein thrombosis, pulmonary embolism), Accepted 7 November 2016 should not be funded by the National active or recent arterial thromboembolic Health Service.2 I am not sure I feel that disease (e.g. angina, myocardial infarc- strongly but I do think women need to tion), the presence or a history of pro- know all options and any potential risks dromi of a thrombosis (e.g. transient or side effects associated with each treat- ischaemic attack, angina pectoris), a high ment – they may think twice. risk of venous or arterial thrombosis or a history of migraine with focal neurological by copyright. symptoms” are contraindications to its NORETHISTERONE use.3 It warns about the potential risk of Only one drug is licensed to postpone VTE in users and advises immediate dis- menstruation in the UK and that is nor- continuation if symptoms of a VTE occur. ethisterone. The Summary of Product Characteristics (SPC) state that at low dose’ (5 mg three times a day) norethis- OTHER OPTIONS terone may be used to treat “metropathia In practice, clinicians have a number of haemorrhagica, premenstrual syndrome, alternatives for those women wishing to postponement of menstruation, dysmen- postpone menstruation. The first is to orrhoea, endometriosis and menorrha- choose a contraceptive method that will gia”.3 There is limited evidence to provide high levels of amenorrhoea. Depot http://jfprhc.bmj.com/ support these indications1 but it does medroxyprogesterone acetate (DMPA), delay the onset of menses. Why has nor- whether it is given intramuscularly or sub- ethisterone been our preferred choice for cutaneously, will result in about 55% of this indication? First, it works; second, it women having no periods over a 90-day is cheap; and third, many women return reference period by the end of the first to our clinics requesting a further supply year of use.4 Levels of amenorrhoea are on September 27, 2021 by guest. Protected year on year when they head off to the lower for other hormonal methods sun in the summer. (Ta b l e 1 ) but rely on women starting these My reservations about the use of nor- methods well in advance of their travels. ethisterone in postponing menstruation What other options are available to are related to safety. There is evidence to those wishing to delay their periods? suggest that taking norethisterone at doses 1 5 mg norethisterone taken three times a day, of 10 mg or more a day may increase a started before the onset of menstruation and JFam To cite: Mansour D. person’s risk of venous thromboembolism continued until menstruation can be toler- Plann Reprod Health Care 1 – Published Online First: [please (VTE). Norethisterone is one of a few ated. Bleeding normally commences 2 3 include Day Month Year] progestogens that can be aromatised to days after discontinuing norethisterone. doi:10.1136/jfprhc-2016- ethinylestradiol (EE).1 Therefore when 2 10 mg DMPA taken three times a day, started 101438 women are taking between 10 and 15 mg before the onset of menstruation and Mansour D. J Fam Plann Reprod Health Care 2016;0:1–2. doi:10.1136/jfprhc-2016-101438 1 Personal view J Fam Plann Reprod Health Care: first published as 10.1136/jfprhc-2016-101438 on 25 November 2016. Downloaded from Table 1 Amenorrhoea achieved with different methods of REFERENCES hormonal contraception 1 Mansour D. Safer prescribing of therapeutic norethisterone for women at risk of venous thromboembolism. J Fam Plann Amenorrhoea achieved over a Reprod Health Care – 90-day reference period (unless 2012;38:148 149. Method of contraception otherwise specified) 2 Shakespeare J, Neve E, Hodder K. Is norethisterone a lifestyle drug? Results of database analysis. BMJ 2000; Jaydess® IUS 11.6% over time5 320:291. ® 6 Mirena IUS 23.6% at 3 years 3 Norethisterone tablets: Summary of Product Characteristics ® 7 Nexplanon 20% over time (revision of text 11.9.2015). https://www.medicines.org.uk/ Depo-Provera® 55% at 12 months4 emc/medicine/7257 [accessed 30 May 2016]. Sayana Press® 56.5% at 12 months8 4 Depo-Provera 150 mg/ml injection: Summary of Product Standard combined hormonal <1%9 Characteristics. https://www.medicines.org.uk/emc/medicine/ contraception given in a 21/7 11121 [accessed 30 May 2016]. regimen 5 Jaydess 13.5 mg intrauterine delivery system: Summary of Estradiol combined pills with 19.4–31% absent withdrawal Product Characteristics. https://www.medicines.org.uk/emc/ shorter hormone-free intervals bleeds over time10 11 medicine/28672 [accessed 30 May 2016]. Desogestrel POP 20% at 12 months12 6 Gemzell-Danielsson K, Schellschmidt I, Apter D. A Traditional POPs 3% at 12 months12 randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing IUS, intrauterine system; POP, progestogen-only pill. intrauterine contraceptive systems and Mirena. Fertil Steril 2012;97:616–622. continued until menstruation can be tolerated. Bleeding nor- 7 Nexplanon 68 mg implant for subdermal use: Summary of mally commences 2–3 days after discontinuing DMPA. It is Product Characteristics. https://www.medicines.org.uk/emc/ not licensed for this indication and there is no published evi- medicine/23824/SPC/Nexplanon+68+mg+implant+for dence to support its use for postponing menstruation, +subdermal+use/ [accessed 30 May 2016]. although it has been shown to reduce heavy menstrual 8 Sayana Press 104 mg/0.65 ml suspension for injection: 13 bleeding at this dose. Anecdotally, it may not be as effect- Summary of Product Characteristics. https://www.medicines. ive as norethisterone in delaying menstrual bleeding. org.uk/emc/medicine/27798 [accessed 30 May 2016]. 3 Starting a combined hormonal contraceptive (CHC) 9 Foidart JM, Wuttke W,Bouw GM, et al. A comparative method such as a monophasic COC or vaginal ring before investigation of contraceptive reliability, cycle control and by copyright. menstruation may delay the next period. Advising tolerance of two monophasic oral contraceptives containing Eur J Contracept Reprod back-to-back administration can also be tried.14 A CHC pro- either drospirenone or desogestrel. Health Care – vides contraception as well as cycle control, although break- 2000;5:124 134. 10 Ahrendt HJ, Makalová D, Parke S, et al. Bleeding pattern and through bleeding is more common in the first few months. cycle control with an estradiol-based oral contraceptive: A number of preparations now have information concerning a seven-cycle, randomized comparative trial of estradiol 15 16 the missing of a withdrawal bleed in their SPCs. valerate/dienogest and ethinyl estradiol/levonorgestrel. 4 If there is some forward planning the timing of the Contraception 2009;80:436–444. period can be altered by either taking 5 mg norethister- 11 Mansour D, Verhoeven C, Sommer W, et al. Efficacy and one twice daily or DMPA 10 mg twice daily for 10 days tolerability of a monophasic combined oral contraceptive to induce a bleed. This should move the date of the sub- containing nomegestrol acetate and 17β-oestradiol in a 24/4 sequent period. regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur http://jfprhc.bmj.com/ CONCLUSIONS J Contracept Reprod Health Care 2011;16:430–443. et al So to conclude, when faced with a mother requesting 12 Korver T, Dieben T, Vree M, . A double-blind study comparing the contraceptive efficacy, acceptability and safety of medication to delay her daughter’s period, or a two progestogen-only pills containing desogestrel 75 μg/day or woman wishing to avoid menstruating while on levonorgestrel 30 μg/day. Collaborative Study Group on the holiday or at a religious festival, we should discuss: Desogestrel-containing Progestogen-only Pill. Eur J Contracept 1 The relevant treatment options. Reprod Health Care 1998;3:169–178. 2 The potential VTE risks associated with CHCs and nor- 13 Fraser IS. Treatment of ovulatory and anovulatory on September 27, 2021 by guest. Protected ethisterone, especially if long-haul flights or prolonged dysfunctional uterine bleeding with oral progestogens. Aust N periods of immobility on coaches or in cars are planned. Z J Obstet Gynaecol 1990;30:353–356. 3 Contraceptive choices that may reduce menstrual blood loss. 14 Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Combined Hormonal Contraception. Competing interests Dr Mansour declares no support from any October 2011. https://www.fsrh.org/documents/ organisation for the submitted work.
Recommended publications
  • Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
    Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment.
    [Show full text]
  • How to Select Pharmacologic Treatments to Manage Recidivism Risk in Sex Off Enders
    How to select pharmacologic treatments to manage recidivism risk in sex off enders Consider patient factors when choosing off -label hormonal and nonhormonal agents ® Dowden Healthex offenders Media traditionally are managed by the criminal justice system, but psychiatrists are fre- Squently called on to assess and treat these indi- CopyrightFor personalviduals. use Part only of the reason is the overlap of paraphilias (disorders of sexual preference) and sexual offending. Many sexual offenders do not meet DSM criteria for paraphilias,1 however, and individuals with paraphil- ias do not necessarily commit offenses or come into contact with the legal system. As clinicians, we may need to assess and treat a wide range of sexual issues, from persons with paraphilias who are self-referred and have no legal involvement, to recurrent sexual offenders who are at a high risk of repeat offending. Successfully managing sex offenders includes psychological and pharmacologic interven- 2009 © CORBIS / TIM PANNELL 2009 © CORBIS / tions and possibly incarceration and post-incarceration Bradley D. Booth, MD surveillance. This article focuses on pharmacologic in- Assistant professor terventions for male sexual offenders. Department of psychiatry Director of education Integrated Forensics Program University of Ottawa Reducing sexual drive Ottawa, ON, Canada Sex offending likely is the result of a complex inter- play of environment and psychological and biologic factors. The biology of sexual function provides nu- merous targets for pharmacologic intervention, in- cluding:2 • endocrine factors, such as testosterone • neurotransmitters, such as serotonin. The use of pharmacologic treatments for sex of- fenders is off-label, and evidence is limited. In general, Current Psychiatry 60 October 2009 pharmacologic treatments are geared toward reducing For mass reproduction, content licensing and permissions contact Dowden Health Media.
    [Show full text]
  • Northern Ireland Prescription Code Book Drugs Section September 2021
    Family Practitioner Services, Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 9053 5613, Fax No. 028 9053 2963 Northern Ireland Prescription Code Book Drugs section September 2021 Page 1 of 587 Effective for prescriptions dispensed September 2021 BSO Code dm+d Pack Description Code Number Special ZD Of Container 38960 4SURE beta-ketone testing strips 4S-810-4183401-001 (Nipro Diagnostics (UK) Ltd) 10 strip strips 38961 4SURE testing strips (Nipro Diagnostics (UK) Ltd) 50 strip strips 4144 AAA 1.5mg/dose sore throat spray (Manx Healthcare Ltd) 60 dose [BSO pack = 1] BSO Unit Of Measure Code No. devices dispensed 70598 (DT) Abacavir 600mg / Lamivudine 300mg tablets 30 tablet tablets 9154 Abasaglar 100units/ml solution for injection 3ml cartridges (Eli Lilly and Company Ltd) 5 cartridge cartridges ZD 9038 Abasaglar KwikPen 100units/ml solution for injection 3ml pre-filled pens (Eli Lilly and Company Ltd) 5 pre- injections ZD filled disposable injection 70088 (DT) Abatacept 125mg/1ml solution for injection pre-filled disposable devices 4 pre-filled disposable injections ZD injection 70089 (DT) Abatacept 125mg/1ml solution for injection pre-filled syringes 4 pre-filled disposable injection injections ZD 70144 Abelcet 100mg/20ml concentrate for suspension for infusion vials (Teva UK Ltd) 10 vial vials Hospital Only 3303 Abidec Multivitamin drops (Omega Pharma Ltd) 25 ml mls 4043 Abilify 10mg orodispersible tablets (Otsuka Pharmaceuticals (U.K.) Ltd) 28 tablet 4 x 7 tablets tablets 3006 Abilify 10mg tablets (Otsuka
    [Show full text]
  • Pp375-430-Annex 1.Qxd
    ANNEX 1 CHEMICAL AND PHYSICAL DATA ON COMPOUNDS USED IN COMBINED ESTROGEN–PROGESTOGEN CONTRACEPTIVES AND HORMONAL MENOPAUSAL THERAPY Annex 1 describes the chemical and physical data, technical products, trends in produc- tion by region and uses of estrogens and progestogens in combined estrogen–progestogen contraceptives and hormonal menopausal therapy. Estrogens and progestogens are listed separately in alphabetical order. Trade names for these compounds alone and in combination are given in Annexes 2–4. Sales are listed according to the regions designated by WHO. These are: Africa: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Togo, Uganda, United Republic of Tanzania, Zambia and Zimbabwe America (North): Canada, Central America (Antigua and Barbuda, Bahamas, Barbados, Belize, Costa Rica, Cuba, Dominica, El Salvador, Grenada, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Puerto Rico, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago), United States of America America (South): Argentina, Bolivia, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Guyana, Paraguay,
    [Show full text]
  • Exposure to Female Hormone Drugs During Pregnancy
    British Journal of Cancer (1999) 80(7), 1092–1097 © 1999 Cancer Research Campaign Article no. bjoc.1998.0469 Exposure to female hormone drugs during pregnancy: effect on malformations and cancer E Hemminki, M Gissler and H Toukomaa National Research and Development Centre for Welfare and Health, Health Services Research Unit, PO Box 220, 00531 Helsinki, Finland Summary This study aimed to investigate whether the use of female sex hormone drugs during pregnancy is a risk factor for subsequent breast and other oestrogen-dependent cancers among mothers and their children and for genital malformations in the children. A retrospective cohort of 2052 hormone-drug exposed mothers, 2038 control mothers and their 4130 infants was collected from maternity centres in Helsinki from 1954 to 1963. Cancer cases were searched for in national registers through record linkage. Exposures were examined by the type of the drug (oestrogen, progestin only) and by timing (early in pregnancy, only late in pregnancy). There were no statistically significant differences between the groups with regard to mothers’ cancer, either in total or in specified hormone-dependent cancers. The total number of malformations recorded, as well as malformations of the genitals in male infants, were higher among exposed children. The number of cancers among the offspring was small and none of the differences between groups were statistically significant. The study supports the hypothesis that oestrogen or progestin drug therapy during pregnancy causes malformations among children who were exposed in utero but does not support the hypothesis that it causes cancer later in life in the mother; the power to study cancers in offspring, however, was very low.
    [Show full text]
  • 209627Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D.
    [Show full text]
  • Determination of 17 Hormone Residues in Milk by Ultra-High-Performance Liquid Chromatography and Triple Quadrupole Mass Spectrom
    No. LCMSMS-065E Liquid Chromatography Mass Spectrometry Determination of 17 Hormone Residues in Milk by Ultra-High-Performance Liquid Chromatography and Triple Quadrupole No. LCMSMS-65E Mass Spectrometry This application news presents a method for the determination of 17 hormone residues in milk using Shimadzu Ultra-High-Performance Liquid Chromatograph (UHPLC) LC-30A and Triple Quadrupole Mass Spectrometer LCMS- 8040. After sample pretreatment, the compounds in the milk matrix were separated using UPLC LC-30A and analyzed via Triple Quadrupole Mass Spectrometer LCMS-8040. All 17 hormones displayed good linearity within their respective concentration range, with correlation coefficient in the range of 0.9974 and 0.9999. The RSD% of retention time and peak area of 17 hormones at the low-, mid- and high- concentrations were in the range of 0.0102-0.161% and 0.563-6.55% respectively, indicating good instrument precision. Method validation was conducted and the matrix spike recovery of milk ranged between 61.00-110.9%. The limit of quantitation was 0.14-0.975 g/kg, and it meets the requirement for detection of hormones in milk. Keywords: Hormones; Milk; Solid phase extraction; Ultra performance liquid chromatograph; Triple quadrupole mass spectrometry ■ Introduction Since 2008’s melamine-tainted milk scandal, the With reference to China’s national standard GB/T adulteration of milk powder has become a major 21981-2008 "Hormone Multi-Residue Detection food safety concern. In recent years, another case of Method for Animal-derived Food - LC-MS Method", dairy product safety is suspected to cause "infant a method utilizing solid phase extraction, ultra- sexual precocity" (also known as precocious puberty) performance liquid chromatography and triple and has become another major issue challenging the quadrupole mass spectrometry was developed for dairy industry in China.
    [Show full text]
  • State of the Science Report | 19Th Annual PCF Scientific Retreat 2 Session 9 the Good, the Bad and the Ugly of Preclinical and Observational Research
    STATE OF Highlights from the 19th Annual PCF THE SCIENCE Scientific Retreat REPORT October 2012 Provided with the compliments of the Prostate Cancer Foundation Table of Contents Introduction ......................................................................................................................... 4 Special lecture Tumor Heterogeneity: Clonality and Consequences ..................................................................... 5 Session 1 Field Cancerization & the Tumor Microenvironment ..................................................................... 7 Special Lecture Cancer Interception & Metabolic Transformation ........................................................................ 10 Session 2 Role of Growth Factor and Signal Transduction Alterations in Prostate Cancer Initiation, Progression and Therapy Resistance .......................................................................................................... 12 Session 3 Advances in Molecular Imaging of Prostate Cancer .................................................................... 17 Breakthrough Lecture Organoids: A Profound New Prostate Cancer Model System ........................................................ 23 PCF-StandUpToCancer Dream Team Overview 1 ............................................................... 25 PCF-StandUpToCancer Dream Team Overview 2 ............................................................... 28 Exceptional Progress Report – PCF Young Investigator Integrated Molecular Analysis of Circulating Tumor Cells:
    [Show full text]
  • Etats Rapides
    List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate
    [Show full text]
  • Pharmacology on Your Palms CLASSIFICATION of the DRUGS
    Pharmacology on your palms CLASSIFICATION OF THE DRUGS DRUGS FROM DRUGS AFFECTING THE ORGANS CHEMOTHERAPEUTIC DIFFERENT DRUGS AFFECTING THE NERVOUS SYSTEM AND TISSUES DRUGS PHARMACOLOGICAL GROUPS Drugs affecting peripheral Antitumor drugs Drugs affecting the cardiovascular Antimicrobial, antiviral, Drugs affecting the nervous system Antiallergic drugs system antiparasitic drugs central nervous system Drugs affecting the sensory Antidotes nerve endings Cardiac glycosides Antibiotics CNS DEPRESSANTS (AFFECTING THE Antihypertensive drugs Sulfonamides Analgesics (opioid, AFFERENT INNERVATION) Antianginal drugs Antituberculous drugs analgesics-antipyretics, Antiarrhythmic drugs Antihelminthic drugs NSAIDs) Local anaesthetics Antihyperlipidemic drugs Antifungal drugs Sedative and hypnotic Coating drugs Spasmolytics Antiviral drugs drugs Adsorbents Drugs affecting the excretory system Antimalarial drugs Tranquilizers Astringents Diuretics Antisyphilitic drugs Neuroleptics Expectorants Drugs affecting the hemopoietic system Antiseptics Anticonvulsants Irritant drugs Drugs affecting blood coagulation Disinfectants Antiparkinsonian drugs Drugs affecting peripheral Drugs affecting erythro- and leukopoiesis General anaesthetics neurotransmitter processes Drugs affecting the digestive system CNS STIMULANTS (AFFECTING THE Anorectic drugs Psychomotor stimulants EFFERENT PART OF THE Bitter stuffs. Drugs for replacement therapy Analeptics NERVOUS SYSTEM) Antiacid drugs Antidepressants Direct-acting-cholinomimetics Antiulcer drugs Nootropics (Cognitive
    [Show full text]
  • Referral Support Service Gynaecology
    Referral Support Service Gynaecology GY11 Heavy Menstrual Bleeding (Menorrhagia and Polymenorrhagia) Definitions Menorrhagia: Excessive menstrual blood loss which interferes with the woman’s physical, emotional, social and material quality of life and which can occur alone or in combination with other symptoms. Polymenorrhagia: Frequent heavy bleeding, with shortening of menstrual cycle (eg < K- 5/21) for more than 3 cycles. Most cases are due to Dysfunctional uterine bleeding (DUB), however, this is a diagnosis of exclusion. Exclude Red Flag Symptoms Postmenopausal Bleeding (PMB) i.e. bleeding >12 months after last period over age 55 Persistent Intermenstrual bleeding (IMB): if >45 or other risk factors for endometrial cancer (eg obesity, PCOS unopposed oestrogen, tamoxifen) Treatment failure in women aged 45 years or over Significant anaemia- Hb< 8- consider admission for transfusion/ urgent referral Suspicious USS features General Points History: Sudden change in bleeding pattern? Recent childbirth? Recent change in contraception? Family history/ onset of HMB from puberty- consider von Willebrand Disease. Examination: Consider infection (especially if under 25 or change in partner) Abdominal examination/ Pelvic examination (is there pain, is there an enlarged uterus?) Investigations: Bloods: FBC, TFTs.(check for vWF if onset of HBM from puberty) Consider USS if enlarged uterus or new change in bleeding pattern. Refer for hysteroscopy if any suspected polyps or thickened endometrium on USS. How to Reduce Sudden/New onset
    [Show full text]
  • Minutes of PRAC Meeting on 09-12 July 2018
    6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018.
    [Show full text]