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(12) Patent Application Publication (10) Pub. No.: US 2005/0070488A1 Coelingh Bennik Et Al
US 2005.0070488A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0070488A1 Coelingh Bennik et al. (43) Pub. Date: Mar. 31, 2005 (54) ESTROGENIC COMPOUNDS IN prises the oral administration of an estrogenic component COMBINATION WITH PROGESTOGENIC and a progestogenic component to a mammal in an effective COMPOUNDS IN amount to prevent or treat Symptoms of hypoestrogenism, HORMONE-REPLACEMENT THERAPY wherein the estrogenic component is Selected from the group (76) Inventors: Herman Jan Tijmen Coelingh Bennik, consisting of Substances represented by the above formula in Driebergen (NL); Evert Johannes which formula R, R2, R, R independently are a hydrogen Bunschoten, Heesch (NL); Christian atom, a hydroxyl group or an alkoxy group with 1-5 carbon Franz Holinka, New York, NY (US) atoms; each of Rs, R, R-7 is a hydroxyl group; and no more than 3 of R, R2, R, R are hydrogen atoms; precursors Correspondence Address: capable of liberating a Substance according to the aforemen William Logsdon tioned formula when used in the present method; and Webb Ziesenheim Logsdon Orkin & Hanson mixtures of one or more of the aforementioned Substances 700 Koppers Building and/or precursors. Another aspect of the invention concerns 436 Seventh Avenue a pharmaceutical kit comprising oral dosage units that Pittsburgh, PA 15219-1818 (US) contain the aforementioned estrogenic component and a (21) Appl. No.: 10/495,707 progestogenic component as well as an androgenic compo nent. (22) PCT Filed: May 23, 2002 (86) PCT No.: PCT/NL02/00332 (30) Foreign Application Priority Data Nov. 15, 2001 (EP)........................................ O1204377.4 Feb. -
COVID-19—The Potential Beneficial Therapeutic Effects of Spironolactone During SARS-Cov-2 Infection
pharmaceuticals Review COVID-19—The Potential Beneficial Therapeutic Effects of Spironolactone during SARS-CoV-2 Infection Katarzyna Kotfis 1,* , Kacper Lechowicz 1 , Sylwester Drozd˙ zal˙ 2 , Paulina Nied´zwiedzka-Rystwej 3 , Tomasz K. Wojdacz 4, Ewelina Grywalska 5 , Jowita Biernawska 6, Magda Wi´sniewska 7 and Miłosz Parczewski 8 1 Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland; [email protected] 2 Department of Pharmacokinetics and Monitored Therapy, Pomeranian Medical University, 70-111 Szczecin, Poland; [email protected] 3 Institute of Biology, University of Szczecin, 71-412 Szczecin, Poland; [email protected] 4 Independent Clinical Epigenetics Laboratory, Pomeranian Medical University, 71-252 Szczecin, Poland; [email protected] 5 Department of Clinical Immunology and Immunotherapy, Medical University of Lublin, 20-093 Lublin, Poland; [email protected] 6 Department of Anesthesiology and Intensive Therapy, Pomeranian Medical University in Szczecin, 71-252 Szczecin, Poland; [email protected] 7 Clinical Department of Nephrology, Transplantology and Internal Medicine, Pomeranian Medical University, 70-111 Szczecin, Poland; [email protected] 8 Department of Infectious, Tropical Diseases and Immune Deficiency, Pomeranian Medical University in Szczecin, 71-455 Szczecin, Poland; [email protected] * Correspondence: katarzyna.kotfi[email protected]; Tel.: +48-91-466-11-44 Abstract: In March 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 was declared Citation: Kotfis, K.; Lechowicz, K.; a global pandemic by the World Health Organization (WHO). The clinical course of the disease is Drozd˙ zal,˙ S.; Nied´zwiedzka-Rystwej, unpredictable but may lead to severe acute respiratory infection (SARI) and pneumonia leading to P.; Wojdacz, T.K.; Grywalska, E.; acute respiratory distress syndrome (ARDS). -
Journal Pre-Proof
Journal Pre-proof Steroid hormones in the aquatic environment J.O. Ojoghoro, M.D. Scrimshaw, J.P. Sumpter PII: S0048-9697(21)03377-5 DOI: https://doi.org/10.1016/j.scitotenv.2021.148306 Reference: STOTEN 148306 To appear in: Science of the Total Environment Received date: 19 April 2021 Revised date: 3 June 2021 Accepted date: 3 June 2021 Please cite this article as: J.O. Ojoghoro, M.D. Scrimshaw and J.P. Sumpter, Steroid hormones in the aquatic environment, Science of the Total Environment (2018), https://doi.org/10.1016/j.scitotenv.2021.148306 This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2018 © 2021 Published by Elsevier B.V. Journal Pre-proof Steroid Hormones in the Aquatic Environment Ojoghoro, J.O.a, Scrimshaw, M.D.b* and Sumpter, J.P.b a Department of Botany, Faculty of Science, Delta State University Abraka, Delta State, Nigeria b Division of Environmental Science, Department of Life Sciences, Brunel University London, Uxbridge, Middlesex, UB8 3PH, United Kingdom Abstract Steroid hormones are extremely important natural hormones in all vertebrates. -
Fee-For-Service Preferred Drug List
Prescription Drug Program Apple Health Medicaid: Fee-for-Service Preferred Drug List What is new in this version of the preferred drug list? Effective for dates of service on and after October 1, 2018, the Health Care Authority will make the following changes: Change Due to the implementation of the Apple Health Preferred Drug List (PDL), a PDL that applies to fee-for-service (FFS) clients as well as Apple Health managed care enrollees, the following changes have occurred: On the Fee-For-Service only Preferred Drug List • Drug classes that are currently on the Apple Health PDL have been removed. These classes and the drug statuses can be found on the Apple Health Preferred Drug List. On the Apple Health Preferred Drug List • New drug classes have been added. This means drugs not previously on the PDL have been added with preferred and nonpreferred statuses. Some drugs may also have additional prior authorization (PA) requirements. • For existing drug classes, preferred statuses may have changed. Some drugs may have additional PA requirements that did not previously require PA. October 25, 2018 Correction • Two drug classes were erroneously removed and have been added back to the list: Asthma – Leukotriene Modifiers Skeletal Muscle Relaxants (Rev. 10/24/2018) (Eff. 10/1/2018) – 1 – Apple Health Medicaid PDL Prescription Drug Program What is the preferred drug list? The Health Care Authority (the agency) has developed a list of preferred drugs within a chosen therapeutic class that are selected based on clinical evidence of safety, efficacy, and effectiveness. The drugs within a chosen therapeutic class are evaluated by the Drug Use Review Board, which makes recommendations to the agency regarding the selection of the preferred drugs. -
GC-MS Analysis of an Herbal Medicinal
SUPPLEMENT TO October 2014 LCGC North America | LCGC Europe | Spectroscopy GC–MS Analysis of an Herbal Medicine Screening Clandestine Drug Operations with Portable Ambient Sampling MS Targeted Protein Quantifi cation Using MS with Data- Independent Acquisition Determination of Methylxanthines and Cotinine in Human Plasma by SPE and LC–MS-MS magentablackcyanyellow ES501473_SpecCTMS1014_CV1.pgs 09.18.2014 21:10 ADV To Unravel the Proteome, Take an Integrated Approach Solving the complexity of the proteome is far more challenging than ESI-Qq-TOF fi rst imagined. That is why Bruker offers a portfolio of integrated MALDI TOF-TOF complementary technologies that together comprise a multidimensional ESI-ITMS toolbox optimized to unlock the proteome’s complexity. Bottom-up and top-down analyses, intact protein analysis as well as in-depth protein ESI-MALDI-FTMS characterization come together to illuminate a more detailed picture of Bioinformatics the proteome, complete with biological context and confi dence in the quality of your MS data. Contact us for solutions to your proteomics challenges. www.bruker.com Proteomics Innovation with Integrity magentablackcyanyellow ES502017_SPECCTMS1014_CV2_FP.pgs 09.19.2014 19:01 ADV magentablackcyanyellow ES502015_SPECCTMS1014_003_FP.pgs 09.19.2014 19:01 ADV 4 Current Trends in Mass Spectrometry October 2014 www.spectroscopyonline.com PUBLISHING & SALES ® 485F US Highway One South, Suite 210, Iselin, NJ 08830 (732) 596-0276, Fax: (732) 647-1235 Michael J. Tessalone Science Group Publisher, [email protected] Edward Fantuzzi Publisher, [email protected] Stephanie Shaffer East Coast Sales Manager, [email protected] (774) 249-1890 Lizzy Thomas MANUSCRIPTS: To discuss possible article topics or obtain manuscript preparation Account Executive, [email protected] guidelines, contact the editorial director at: (732) 346-3020, e-mail: [email protected]. -
Medicine-Review-Dapoxetine.Pdf
East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast East Anglia Medicines Information Service Medicine Review Medicine / Trade name Dapoxetine / Priligy Manufacturer Menarini Document status Reviewed at Suffolk CCGs D&TC 22 January 2014 and CPG 14 April 2014 Date of last revision 15 January 2014 Traffic light decision Double red – Prescribing not supported in either general practice or secondary/tertiary care Prescribers rating Nothing new Mechanism of action Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI). Human ejaculation is primarily mediated by the sympathetic nervous system. The ejaculatory pathway originates from a spinal reflex centre, mediated by the brain stem, which is influenced initially by a number of nuclei in the brain (medial preoptic and paraventricular nuclei). The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre− and postsynaptic receptors [1]. Licensed indication Dapoxetine is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years [1]. Dosage The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with dapoxetine should not be initiated with the 60 mg dose [1]. Dapoxetine is not intended for continuous daily use. Dapoxetine should be taken only when sexual activity is anticipated dapoxetine must not be taken more frequently than once every 24 hours. If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity. -
Patient Group Direction for CLARITHROMYCIN (Version 03) Valid from 1 October 2019 – 30 September 2021
Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021 Version Control This PGD has been FCMS agreed by the following PDS Medical organisations Doncaster CCG East Lancashire CCG Change history 28/08/17 V02 Review. Adjusted dose and duration to match local guidance. Minor editing changes. 18/09/17 V02 Adjust inclusion criteria to match local guidance. 21/09/17 V02 Adjustments to treatment duration to match local guidance. 29/05/2019 V03 Revalidated 30/05/2019 Page 1 of 9 Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021 CLINICAL CONTENT OF PATIENT GROUP DIRECTION Staff Characteristics Qualifications Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Specialist competencies Received training to undertake administration and supply of medicines or qualifications under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. Continuing training and The practitioner should be aware of any change to the recommendations for education the medicine listed. It is the responsibility of the individual to keep up to date with continued professional development and to work within the limitations of individual scope or practice. Clinical Details Indication Treatment of skin, soft tissue or wound infections, acute bronchitis, community acquired pneumonia or exacerbations of COPD. Antibiotic alternative for patients hypersensitive to penicillins or cephalosporins or where these are unsuitable. Inclusion criteria Patients with skin, soft tissue or wound infections: Consider whether wound infections are clinically necessary to treat. -
Rezolsta, INN-Darunavir Cobicistat
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT REZOLSTA 800 mg/150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg of darunavir (as ethanolate) and 150 mg of cobicistat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. Genotypic testing should guide the use of REZOLSTA (see sections 4.2, 4.4 and 5.1). 4.2 Posology and method of administration Therapy should be initiated by a healthcare provider experienced in the management of HIV infection. Posology ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food. ART-experienced patients One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products, but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l (see section 4.1). * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used. -
Guidance for the Format and Content of the Protocol of Non-Interventional
PASS information Title Metformin use in renal impairment Protocol version identifier Version 2 Date of last version of 30 October 2013 protocol EU PAS register number Study not registered Active substance A10BA02 metformin Medicinal product Metformin Product reference N/A Procedure number N/A Marketing authorisation 1A Farma, Actavis, Aurobindo, Biochemie, Bluefish, holder(s) Hexal, Mylan, Orifarm, Pfizer, Sandoz, Stada, Teva Joint PASS No Research question and To assess the use and safety of metformin in patients objectives with and without renal insufficiency in current clinical practice in at least two EU Member States. Country(-ies) of study Denmark, United Kingdom Author Christian Fynbo Christiansen, MD, PhD Page 1/214 Marketing authorisation holder(s) Marketing authorisation N/A holder(s) MAH contact person N/A Page 2/214 1. Table of Contents PASS information .......................................................................................................... 1 Marketing authorisation holder(s) .................................................................................... 2 1. Table of Contents ...................................................................................................... 3 2. List of abbreviations ................................................................................................... 4 3. Responsible parties .................................................................................................... 5 4. Abstract .................................................................................................................. -
Progesterone 7K77 49-3265/R3 B7K770 Read Highlighted Changes Revised April, 2010 Progesterone
en system Progesterone 7K77 49-3265/R3 B7K770 Read Highlighted Changes Revised April, 2010 Progesterone Customer Service: Contact your local representative or find country specific contact information on www.abbottdiagnostics.com Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Key to symbols used List Number Calibrator (1,2) In Vitro Diagnostic Medical Control Low, Medium, High Device (L, M, H) Lot Number Reagent Lot Expiration Date Reaction Vessels Serial Number Sample Cups Septum Store at 2-8°C Replacement Caps Consult instructions for use Warning: May cause an allergic reaction Contains sodium azide. Contact Manufacturer with acids liberates very toxic gas. See REAGENTS section for a full explanation of symbols used in reagent component naming. 1 NAME REAGENTS ARCHITECT Progesterone Reagent Kit, 100 Tests INTENDED USE NOTE: Some kit sizes are not available in all countries or for use on all ARCHITECT i Systems. Please contact your local distributor. The ARCHITECT Progesterone assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of progesterone in ARCHITECT Progesterone Reagent Kit (7K77) human serum and plasma. • 1 or 4 Bottle(s) (6.6 mL) Anti-fluorescein (mouse, monoclonal) fluorescein progesterone complex coated Microparticles SUMMARY AND EXPLANATION OF TEST in TRIS buffer with protein (bovine and murine) and surfactant Progesterone is produced primarily by the corpus luteum of the ovary stabilizers. Concentration: 0.1% solids. Preservatives: sodium azide in normally menstruating women and to a lesser extent by the adrenal and ProClin. cortex.1 At approximately the 6th week of pregnancy, the placenta 2-5 • 1 or 4 Bottle(s) (17.0 mL) Anti-progesterone (sheep, becomes the major producer of progesterone. -
Not for Publication United States District Court For
Case 3:10-cv-00603-PGS-DEA Document 289 Filed 06/29/12 Page 1 of 47 PageID: <pageID> NOT FOR PUBLICATION UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY TEVA WOMEN’S HEALTH, INC., Civil Action No.: Plaintiff, 10-603 (PGS) v. OPINION LUPIN, LTD. et al., Defendants. SHERIDAN, U.S.D.J. This case is a patent infringement action arising under the Hatch-Waxman Act involving Teva Women’s Health, Inc.’s (Teva) oral contraceptive (OC) Seasonique.1 Teva owns the patent-in-suit, U.S. Patent No. 7,320,969 (“the ’969 patent”). The ’969 patent, entitled “Oral contraceptives to prevent pregnancy and diminish premenstrual symptomology,” was issued on January 22, 2008. Teva’s predecessors-in-interest to the ’969 patent include Duramed and Barr.2 Teva alleges that defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) and defendants Mylan Inc., Mylan Pharmaceuticals, Inc., and Famy Care Ltd. (collectively, “Mylan”) infringed on Claim 19 of the ’969 patent. Claim 19 of the ’969 patent discloses an extended OC regimen that administers unopposed estrogen during the traditionally hormone free 1 While Seasonique and similar FDA-approved products are trademarked, in this opinion the Court refrains from using such marks for the sake convenience. 2 There is a lawsuit captioned Duramed Pharmaceuticals v. Watson Laboratories, Case No. 08-116 (D. Nev.) which involves the same patent and remains pending in Nevada. Although the parties knew of this other case, none of the parties sought to consolidate matters. Case 3:10-cv-00603-PGS-DEA Document 289 Filed 06/29/12 Page 2 of 47 PageID: <pageID> interval (HFI). -
Validated Stability -Indicating UPLC Method
A tica nal eu yt c ic a a m A r a c t Soliman et al., Pharm Anal Acta 2017, 8:12 h a P Pharmaceutica DOI: 10.4172/2153-2435.1000571 Analytica Acta ISSN: 2153-2435 Research Article Open Access Validated Stability -Indicating UPLC Method for Determination of Dapoxetine and Fluoxetine: Characterization of Their Hydrolytic Degradation Products, Kinetic Study and Application in Pharmaceutical Dosage Forms Suzan Mahmoud Soliman1*, Heba MY El-Agizy1 and Abd El Aziz El Bayoumi2 1National Organization for Drug Control and Research (NODCAR), Giza, Egypt 2Analytical Chemistry Departments, Faculty of Pharmacy, Cairo University, Cairo, Egypt Abstract New isocratic stability-indicating reversed phase UPLC method was developed for determination of two antidepressant drugs dapoxetine hydrochloride (DAP) and fluoxetine hydrochloride (FLX) in the presence of their hydrolytic degradation products namely; (+)-N, N-dimethyl-1-phenyl-3-propanolamine (DAP Deg I), N-methyl- 3-hydroxy-3-phenyl propyl amine (FLX DegI), α, α, α-Trifluorotoluene (FLX Deg II) and application in their pharmaceutical dosage forms. UPLC method using small sub-1.8 µm particle was developed for separation and determination of the selected drugs using Agilent Eclipse XDB C18 (50 mm x 2.1 mm i.d., 1.8 µm) column. Upon using UPLC, the run time could be reduced 5-fold and the solvents consumption decreased 10 tims. Quantification is achieved by detection wavelength at 210 nm, based on peak area. The linear ranges were 0.05-100 μg/mL and 0.30-100 μg/mL with LOD of 0.01 and 0.09 μg mL-1 and mean recoveries of 99.41 ± 1.02 and 100.05 ± 0.89 for DAPand FLX, respectively, the developed method was successfully applied to analysis of DAP and FLX in bulk powder, laboratory-prepared mixtures containing different percentages of degradation products and pharmaceutical dosage forms.