Steroid Contraception and Its Effects on Lactation Are a Public Health Dilemma
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Index Vol. 12-15
353 INDEX VOL. 12-15 Die Stichworte des Sachregisters sind in der jeweiligen Sprache der einzelnen Beitrage aufgefiihrt. Les termes repris dans la Table des matieres sont donnes selon la langue dans laquelle l'ouvrage est ecrit. The references of the Subject Index are given in the language of the respective contribution. 14 AAG (Alpha-acid glycoprotein) 120 14 Adenosine 108 12 Abortion 151 12 Adenosine-phosphate 311 13 Abscisin 12, 46, 66 13 Adenosine-5'-phosphosulfate 148 14 Absorbierbarkeit 317 13 Adenosine triphosphate 358 14 Absorption 309, 350 15 S-Adenosylmethionine 261 13 Absorption of drugs 139 13 Adipaenin (Spasmolytin) 318 14 - 15 12 Adrenal atrophy 96 14 Absorptionsgeschwindigkeit 300, 306 14 - 163, 164 14 Absorptionsquote 324 13 Adrenal gland 362 14 ACAI (Anticorticocatabolic activity in 12 Adrenalin(e) 319 dex) 145 14 - 209, 210 12 Acalo 197 15 - 161 13 Aceclidine (3-Acetoxyquinuclidine) 307, 13 {i-Adrenergic blockers 119 308, 310, 311, 330, 332 13 Adrenergic-blocking activity 56 13 Acedapsone 193,195,197 14 O(-Adrenergic blocking drugs 36, 37, 43 13 Aceperone (Acetabutone) 121 14 {i-Adrenergic blocking drugs 38 12 Acepromazin (Plegizil) 200 14 Adrenergic drugs 90 15 Acetanilid 156 12 Adrenocorticosteroids 14, 30 15 Acetazolamide 219 12 Adrenocorticotropic hormone (ACTH) 13 Acetoacetyl-coenzyme A 258 16,30,155 12 Acetohexamide 16 14 - 149,153,163,165,167,171 15 1-Acetoxy-8-aminooctahydroindolizin 15 Adrenocorticotropin (ACTH) 216 (Slaframin) 168 14 Adrenosterone 153 13 4-Acetoxy-1-azabicyclo(3, 2, 2)-nonane 12 Adreson 252 -
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, -
Combined Estrogen–Progestogen Menopausal Therapy
COMBINED ESTROGEN–PROGESTOGEN MENOPAUSAL THERAPY Combined estrogen–progestogen menopausal therapy was considered by previous IARC Working Groups in 1998 and 2005 (IARC, 1999, 2007). Since that time, new data have become available, these have been incorporated into the Monograph, and taken into consideration in the present evaluation. 1. Exposure Data 1.1.2 Progestogens (a) Chlormadinone acetate Combined estrogen–progestogen meno- Chem. Abstr. Serv. Reg. No.: 302-22-7 pausal therapy involves the co-administration Chem. Abstr. Name: 17-(Acetyloxy)-6-chlo- of an estrogen and a progestogen to peri- or ropregna-4,6-diene-3,20-dione menopausal women. The use of estrogens with IUPAC Systematic Name: 6-Chloro-17-hy- progestogens has been recommended to prevent droxypregna-4,6-diene-3,20-dione, acetate the estrogen-associated risk of endometrial Synonyms: 17α-Acetoxy-6-chloro-4,6- cancer. Evidence from the Women’s Health pregnadiene-3,20-dione; 6-chloro-Δ6-17- Initiative (WHI) of adverse effects from the use acetoxyprogesterone; 6-chloro-Δ6-[17α] of a continuous combined estrogen–progestogen acetoxyprogesterone has affected prescribing. Patterns of exposure Structural and molecular formulae, and relative are also changing rapidly as the use of hormonal molecular mass therapy declines, the indications are restricted, O CH and the duration of the therapy is reduced (IARC, 3 C 2007). CH3 CH3 O C 1.1 Identification of the agents CH3 H O 1.1.1 Estrogens HH For Estrogens, see the Monograph on O Estrogen-only Menopausal Therapy in this Cl volume. C23H29ClO4 Relative molecular mass: 404.9 249 IARC MONOGRAPHS – 100A (b) Cyproterone acetate Structural and molecular formulae, and relative Chem. -
Use of Postmenopausal Hormone Therapy and Risk of Alzheimer’S BMJ: First Published As 10.1136/Bmj.L665 on 6 March 2019
RESEARCH Use of postmenopausal hormone therapy and risk of Alzheimer’s BMJ: first published as 10.1136/bmj.l665 on 6 March 2019. Downloaded from disease in Finland: nationwide case-control study Hanna Savolainen-Peltonen,1,2 Päivi Rahkola-Soisalo,1 Fabian Hoti,3 Pia Vattulainen,3 Mika Gissler,4,5,6 Olavi Ylikorkala,1 Tomi S Mikkola1,2 1University of Helsinki and ABSTRACT ratio 1.09, 95% confidence interval 1.05 to 1.14) and Helsinki University Hospital, OBJECTIVES those of oestrogen-progestogen (1.17, 1.13 to 1.21). Obstetrics and Gynecology, To compare the use of hormone therapy between The risk increases in users of oestrogen-progestogen Haartmaninkatu 2, PO Box 140, FIN-00029 HUS, 00029 Finnish postmenopausal women with and without a therapy were not related to different progestogens Helsinki, Finland diagnosis for Alzheimer’s disease. (noreth isterone acetate, medroxyprogesterone 2 Folkhälsan Research Center, DESIGN acetate, or other progestogens); but in women Biomedicum, Helsinki, Finland younger than 60 at hormone therapy initiation, 3 Nationwide case-control study. EPID Research Oy, Espoo, these risk increases were associated with hormone Finland SETTING therapy exposure over 10 years. Furthermore, the 4National Institute for Health Finnish national population and drug register, age at initiation of systemic hormone therapy was and Welfare, Helsinki, Finland between 1999 and 2013. 5Karolinska Institute, not a decisive determinant for the increase in risk Department of Neurobiology, PARTICIPANTS of Alzheimer’s disease. The exclusive use of vaginal Care Sciences and Society, All postmenopausal women (n=84 739) in Finland estradiol did not affect the risk of the disease (0.99, Division of Family Medicine, who, between 1999 and 2013, received a diagnosis of 0.96 to 1.01). -
Guidance on Bioequivalence Studies for Reproductive Health Medicines
Medicines Guidance Document 23 October 2019 Guidance on Bioequivalence Studies for Reproductive Health Medicines CONTENTS 1. Introduction........................................................................................................................................................... 2 2. Which products require a bioequivalence study? ................................................................................................ 3 3. Design and conduct of bioequivalence studies .................................................................................................... 4 3.1 Basic principles in the demonstration of bioequivalence ............................................................................... 4 3.2 Good clinical practice ..................................................................................................................................... 4 3.3 Contract research organizations .................................................................................................................... 5 3.4 Study design .................................................................................................................................................. 5 3.5 Comparator product ....................................................................................................................................... 6 3.6 Generic product .............................................................................................................................................. 6 3.7 Study subjects -
Pharmaceutical Appendix to the Tariff Schedule 2
Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9 -
TGA Review of Hgps
A REVIEW TO UPDATE AUSTRALIA’S POSITION ON THE HUMAN SAFETY OF RESIDUES OF HORMONE GROWTH PROMOTANTS (HGPs) USED IN CATTLE Prepared by Chemical Review and International Harmonisation Section Office of Chemical Safety Therapeutic Goods Administration of the Department of Health and Ageing Canberra July 2003 A draft of this report was tabled at the 25th Meeting of the Advisory Committee on Pesticides and Health (ACPH), held in Canberra on the 1st May 2003. The report was subsequently endorsed out-of-session by the ACPH. Hormone Growth Promotants TABLE OF CONTENTS ABBREVIATIONS ................................................................................................................................................................4 EXECUTIVE SUMMARY ..................................................................................................................................................7 INTRODUCTION..................................................................................................................................................................9 HEALTH CONCERNS ASSOCIATED WITH HGP S................................................................................................................9 DIFFICULTIES ASSOCIAT ED WITH ASSESSING THE SAFETY OF HGPS.........................................................................10 RISK ASSESSMENTS OF HGP S .........................................................................................................................................10 PURPOSE OF THE CURRENT -
Studies of Cancer in Experimental Animals
ORAL CONTRACEPTIVES, COMBINED 201 3. Studies of Cancer in Experimental Animals In this section, only relevant studies on oestrogens and progestogens alone and in combination that were published subsequent to or not included in Volume 21 of the IARC Monographs (IARC, 1979) are reviewed in detail. Studies reviewed previously are summarized briefly. 3.1 Oestrogen–progestogen combinations 3.1.1 Studies reviewed previously Mouse The results of studies reviewed previously (Committee on Safety of Medicines, 1972; IARC, 1979) on the carcinogenicity of combinations of oestrogens and proges- togens in mice are as follows: Chlormadinone acetate in combination with mestranol tested by oral administration to mice caused an increased incidence of pituitary adenomas in animals of each sex. Oral administration of chlormadinone acetate in combination with ethinyloestradiol to mice resulted in an increased incidence of mammary tumours in intact and castrated males. After oral administration of ethynodiol diacetate and mestranol to mice, increased incidences of pituitary adenomas were observed in animals of each sex. The combination of ethynodiol diacetate plus ethinyloestradiol, tested by oral administration to mice, increased the incidences of pituitary adenomas in animals of each sex and of malignant tumours of connective tissues of the uterus. Lynoestrenol in combination with mestranol was tested in mice by oral administration. A slight, nonsignificant increase in the incidence of malignant mammary tumours was observed in females which was greater than that caused by lynoestrenol or mestranol alone. The combination of megestrol acetate plus ethinyloestradiol, tested by oral adminis- tration to mice, caused an increased incidence of malignant mammary tumours in animals of each sex. -
Dosage Units of Steroids with a Seal Coating for the Steroids
~™ iiiiiii nun iiiiiiii inn mil mil inn iiiii inn urn mill mi mi m (19) J European Patent Office Office europeen des brevets (11) EP 0 927 556 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication:ation: (51) |nt. ci.6: A61 K 31/565, A61 K 9/28 07.07.1999 Bulletin 1999/27 (21) Application number: 97202908.6 (22) Date of filing: 23.09.1997 (84) Designated Contracting States: (72) Inventor: HARTHOLT GERTJAN PETER AT BE CH DE DK ES Fl FR GB GR IE IT LI LU MC 5406 BD UDEN (NL) NL PT SE (74) Representative: Kraak, Hajo (71) Applicant: Akzo Nobel N.V. N.V. Organon, 6824 BM Arnhem (NL) Postbus 20 5340 BH OSS (NL) (54) Dosage units of steroids with a seal coating for the steroids (57) Dosage units, such as tablet cores and gran- ules, containing a composition comprising a steroid having two hydrogen atoms at position 3 of the steroid skeleton, are coated. While a conventional sugar coat- ing process involves the application of several layers including, as a surface layer, a sugar coat, it was found that a seal coat such as normally used in a sugar coat- ing process can be used as the surface layer for the pur- pose of preventing the transfer of the steroid out of the composition. From this novel use of a seal coat, novel dosage units result. The process is advantageous, as it requires fewer steps than before. < CO LO LO r»- Csl o Q_ LU Printed by Xerox (UK) Business Services 2.16.7/3.6 1 EP 0 927 556 A1 Description ing the dosage unit to coating steps comprising the application of a seal coat. -
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0 -
Effects of Different Add-Back Regimens on Hypoestrogenic Problems by Postoperative Gonadotropin-Releasing Hormone Agonist Treatm
Original Article Obstet Gynecol Sci 2016;59(1):32-38 http://dx.doi.org/10.5468/ogs.2016.59.1.32 pISSN 2287-8572 · eISSN 2287-8580 Effects of different add-back regimens on hypoestrogenic problems by postoperative gonadotropin-releasing hormone agonist treatment in endometriosis Dong-Yun Lee, Hyang Gi Park, Byung-Koo Yoon, DooSeok Choi Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Objective To compare the efficacy of different add-back regimens on hypoestrogenic symptoms during postoperative gonadotropin-releasing hormone (GnRH) agonist treatment in endometriosis patients. Methods This prospective cohort study included reproductive-aged women who underwent conservative laparoscopic surgery for ovarian endometriosis and received add-back therapy during a 6-month course of GnRH agonist therapy after surgery. Participants received one of four different add-back regimens: 1 mg of estradiol valerate, 2.5 mg of tibolone, or a combination of 1 mg of estradiol and 2 mg of drospirenone or 0.5 mg of norethisterone acetate. Changes in quality of life, hypoestrogenic symptoms, and bone mineral density were compared according to add-back regimens. Results A total of 57 participants completed a 6-month course of GnRH agonist and add-back therapy. All components of quality of life did not differ across groups. However, within the same treatment group, social relationship factors decreased significantly with estradiol valerate and tibolone alone, and environmental factors decreased significantly with estradiol valerate alone. Menopausal Rating Scale score did not change significantly, but the incidence of hot flushes significantly decreased with a combination of estradiol and norethisterone acetate. -
Biological Efficacy and Plasma Norethisterone Levels of Orally Administered Norethisterone Enanthate in Rat and Hamster
Indian J Physiol Pharmacol 1998; 42 (4) : 485-490 BIOLOGICAL EFFICACY AND PLASMA NORETHISTERONE LEVELS OF ORALLY ADMINISTERED NORETHISTERONE ENANTHATE IN RAT AND HAMSTER P. RAVINDER, K. MADHAVAN NAIR AND B. SIVAKUMAR* Division of Biophysics. National Institute of Nutrition. (Indian Council of Medical Research) Jamai-Osmania, Hyderabad - 500 007 (Received on September 11, 1997) Abstract: Norethisterone enanthate (NET-En) is a well known intramuscular contraceptive drug. The long acting nature of this prep~ration when administered orally was evalu~ted in female rats and hamsters using fertility inhibition test and from the plasma levels of norethisterone (NET). An oral dose of 20-60 mg NET-En was administered to random groups of six female rats and hamsters and were mated after five and ten days with males of proven fertility. The fertility inhibition rate was determined from vaginal delivery. A dose-dependent reduction in fertility was seen in rats 5 days after oral administration of NET-En. This effect was found to be less pronounced and not significant 10 days after administration of similar doses of NET-En. In hamsters, a similar but less pronounced effect was noted. The decrease in fertility was significant only at the 60 mg dose. The plasma levels of NET estimated by RIA over a period of 15 days, in a different set of treated rats, suggested rapid absorption of NET-En within a day, and drug concentration decreased slowly, the levels on the 4th day ranged from 0.9-2.3 with the 10 mg and 1.0-4.0 ng/ml with the 20 mg dose.