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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. -
Ophthalmic Adverse Effects of Nasal Decongestants on an Experimental
A RQUIVOS B RASILEIROS DE ORIGINAL ARTICLE Ophthalmic adverse effects of nasal decongestants on an experimental rat model Efeitos oftálmicos adversos de descongestionantes nasais em modelo experimental com ratos Ayse Ipek Akyuz Unsal1, Yesim Basal2, Serap Birincioglu3, Tolga Kocaturk1, Harun Cakmak1, Alparslan Unsal4, Gizem Cakiroz5, Nüket Eliyatkın6, Ozden Yukselen7, Buket Demirci5 1. Department of Ophthalmology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 2. Department of Otorhinolaringology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 3. Department of Pathology, Veterinary Faculty, Adnan Menderes University, Aydin, Turkey. 4. Department of Radiology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 5. Department of Medical Pharmacology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 6. Department of Medical Pathology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 7. Department of Pathology, Aydin State Hospital, Aydin, Turkey. ABSTRACT | Purpose: To investigate the potential effects of cause ophthalmic problems such as dry eyes, corneal edema, chronic exposure to a nasal decongestant and its excipients cataracts, retinal nerve fiber layer, and vascular damage in on ocular tissues using an experimental rat model. Methods: rats. Although these results were obtained from experimental Sixty adult male Wistar rats were randomized into six groups. animals, ophthalmologists should keep in mind the potential The first two groups were control (serum physiologic) and ophthalmic adverse effects of this medicine and/or its excipients Otrivine® groups. The remaining four groups received the and exercise caution with drugs containing xylometazoline, Otrivine excipients xylometazoline, benzalkonium chloride, ethylene diamine tetra acetic acid, benzalkonium chloride and sorbitol, and ethylene diamine tetra acetic acid. Medications sorbitol for patients with underlying ocular problems. -
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. -
Study Protocol
RESEARCH PROTOCOL Project Title A multicenter, single blind, randomized controlled trial of virucidal effect of Polyvinylpyrrolidone-Iodine on SARS-CoV-2 as well as safety of its application on nasopharynx & oropharynx of COVID-19 positive patients BMRC Reg. No: 38624012021 Page-1/17 Project Title A multicenter, single blind, randomized controlled trial of virucidal effect of Polyvinylpyrrolidone- Iodine on SARS-CoV-2 as well as safety of its application on nasopharynx & oropharynx of COVID- 19 positive patients. Summary Povidone Iodine (Iodine with water soluble polymer Polyvinylpyrolidone) or PVP-I is a proven and time trusted antiseptic agent having best possible (99.99%) virucidal effect in it‟s only 0.23% concentration, against all viruses including SARS-Co, MERS-CoV; even in SARS-COV-2 due to it‟s nonspecific mode of action for virus killing and having no resistance [1,2]. Corona virus is transmitted by/via respiratory droplets or aerosol, produced from sneezing or coughing of infected persons to healthy individual through mouth and nose mainly [5, 6]. The routes of entry of coronavirus in human body are mouth, nose and eye. PVP-I products for gargling the throat and spraying or washing the nose may have a preventive effect on COVID-19 and if it is proved in this study following human trial, this will be a landmark research in COVID-19 pandemic. In line of this, PVP-I containing oro-nasal spray, proposed Bangasafe, which should be regarded as PONS (Povidone Iodine oro-nasal spray) in this protocol, has been developed and proposed to use against corona virus disease. -
Topical Management of Chronic Rhinosinusitis
Open Access Advanced Treatments in ENT Disorders Review Article Topical Management of chronic rhinosinusitis - A literature review ISSN 1 2 2640-2777 Aremu Shuaib Kayode * and Tesleem Olayinka Orewole 1ENT Department, Federal Teaching Hospital, Ido-Ekiti/Afe Babalola University, Ado Ekiti, Nigeria 2Department of Anaesthesia, Federal Teaching Hospital, Ido Ekiti/Afe Babalola University, Ado Ekiti, Nigeria *Address for Correspondence: Dr. Aremu Shuaib Introduction Kayode, ENT Department, Federal Teaching Chronic rhinosinusitis (CRS) is an inlammatory condition involving nasal passages Hospital, Ido-Ekiti/Afe Babalola University, Ado Ekiti, Nigeria, Tel: +2348033583842; and the paranasal sinuses for 12 weeks or longer [1]. It can be subdivided into three Email: [email protected] types: CRS with nasal polyposis (CRS with NP), CRS without nasal polyposis (CRS Submitted: 08 April 2019 without NP), and Allergic fungal rhinosinusitis (AFRS). To diagnose CRS we require Approved: 25 April 2019 at least two of four of its cardinal signs/symptoms (nasal obstruction, mucopurulent Published: 26 April 2019 discharge, facial pain/pressure, and decreased sense of smell). In addition, direct Copyright: © 2019 Aremu SK, et al. This is visualization or imaging for objective documentation of mucosal inlammation is an open access article distributed under the required. CRS therapy is aimed to reduce its symptoms and improve quality of life as it Creative Commons Attribution License, which cannot be cured in most patients. Thus, the goals of its therapy include the following: permits unrestricted use, distribution, and reproduction in any medium, provided the 1: Control mucosal edema and inlammation of nasal and paranasal sinuses original work is properly cited 2: Maintain adequate sinus ventilation and drainage 3: Treat any infecting or colonizing micro-organisms, if present 4: Reduce the number of acute exacerbations Mucosal remodeling is the most likely underlying mechanism causing irreversible chronic sinus disease, similar to that occur in severe asthma. -
7.Inhalation Testing
Analytical Challenges in Implementing Effective QC/Stability testing of Inhalation Drug Products Wayland Rushing, Ph.D. Director, Scientific Affairs Eurofins BioPharma Product Testing www.Eurofins.com Inhalation Overview Delivery of one or more drug products to the lungs or nasal mucosa Benefits: § Directly targets the lungs § Rapid onset of drug action • Quick absorption into bloodstream § Low doses required § Fewer side effects 2 Drug/Device Combination Devices Orally Inhaled and Nasal Drug Products (OINDP) § Metered Dose Inhaler (pMDI or simply MDI) • HFA propellant Driven § Dry Powder Inhaler (DPI) • Patient driven § Nebulizer • Aerosolizes solutions for constant delivery § Nasal Spray • Liquid or powder delivery to nasal cavity 3 Regulatory Guidance FDA Guidances § Guidance for Container Closure Systems for Packaging Human Drugs and Biologics (1999) § Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993) § Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) (revised 2018) § Nasal Spray and Inhalers Solution, Suspension, and Spray Drug Products (2002) § Drug Products Packaged in Semipermeable Container Closure Systems (2002) USP Chapters § USP <5>: Inhalation and Nasal Drug Products—General Information and Product Quality Tests § USP <601>: Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders— Performance Quality Tests § USP <1602>: Spacers and Valved Holding Chambers Used with Inhalation Aerosols— Characterization Tests § USP <1664.1>: Orally Inhaled and Nasal Drug Products 4 Revise -
Nasal and Sinus Surgery After Care
ENT SURGICAL CONSULTANTS 2201 Glenwood Ave., Joliet, IL 60435 (815) 725-1191, (815) 725-1248 fax Michael G. Gartlan, MD, FAAP, FACS 1890 Silver Cross Blvd, Pavilion A, Suite 435, New Lenox, IL 60451 Rajeev H. Mehta, MD, FACS 815-717-8768 Scott W. DiVenere, MD Sung J. Chung, MD 900 W. Rte 6, Suite 960., Morris, IL 60450 (815) 941-1972 Ankit M. Patel, MD Walter G. Rooney, MD www.entsurgicalillinois.com NASAL & SINUS SURGERY (7/13) Nasal Drainage and Bleeding Immediately after surgery, you will have drainage from your nose. At first, there may be a small amount of bright red bleeding, but do not be alarmed. A small amount is normal and may continue through the first week. A gauze dressing will be place on your upper lip to absorb this drainage. It may be necessary to change this dressing several times on the day of your surgery. Any bright red bleeding that lasts more than ten minutes, orEar, is heavy, Nose &spray Throat two Diseases puffs of over-the-counter Afrin decongestant nasal spray (or generic equivalent) in each nostril every ten minutesOtolaryngology until the bleeding-Head & subsides. Neck Surgery This should only be used for active bleeding. This medication is available. Facial Plastic & Reconstructive Surgery Relax with your head elevated,Thyroid tilt your and headParathyroid forward Surgery and gently pinch your nostrils with an ice pack over the bridge of your nose. Persistent bleeding should be reportedPediatric to Otolaryngologyyour doctor immediately. Old blood, which accumulated during surgery, is dark reddish-brown and will drain for a week or more. -
FLONASE (Fluticasone Propionate) Nasal Spray Bacterial, Viral, Or Parasitic Infection; Ocular Herpes Simplex)
HIGHLIGHTS OF PRESCRIBING INFORMATION • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, These highlights do not include all the information needed to use contact dermatitis, rash) have been reported after administration of FLONASE safely and effectively. See full prescribing information for FLONASE nasal spray. Discontinue FLONASE nasal spray if such FLONASE. reactions occur. (5.3) • Potential worsening of infections (e.g., existing tuberculosis; fungal, FLONASE (fluticasone propionate) nasal spray bacterial, viral, or parasitic infection; ocular herpes simplex). Use with Initial U.S. Approval: 1994 caution in patients with these infections. More serious or even fatal course --------------------------- RECENT MAJOR CHANGES --------------------------- of chickenpox or measles can occur in susceptible patients. (5.4) • Hypercorticism and adrenal suppression may occur with very high Warnings and Precautions, Glaucoma and Cataracts (5.2) 1/2019 dosages or at the regular dosage in susceptible individuals. If such --------------------------- INDICATIONS AND USAGE ---------------------------- changes occur, discontinue FLONASE nasal spray slowly. (5.5) FLONASE nasal spray is a corticosteroid indicated for the management of the • Monitor growth of pediatric patients. (5.7) nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients ------------------------------ ADVERSE REACTIONS ------------------------------ aged 4 years and older. (1) The most common adverse reactions (>3%) are headache, pharyngitis, ----------------------- DOSAGE AND ADMINISTRATION ----------------------- epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, For intranasal use only. Recommended starting dosages: and cough. (6.1) • Adults: 2 sprays per nostril once daily (200 mcg per day). (2.1) To report SUSPECTED ADVERSE REACTIONS, contact • Adolescents and children aged 4 years and older: 1 spray per nostril once GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or daily (100 mcg per day). -
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). -
Sodium Chloride | Memorial Sloan Kettering Cancer Center
PATIENT & CAREGIVER EDUCATION Sodium Chloride This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Brand Names: US 4-Way Saline [OTC]; Afrin Saline Nasal Mist [OTC]; Altachlore [OTC]; Altamist Spray [OTC]; Atrapro Dermal Spray; Ayr Nasal Mist Allergy/Sinus [OTC]; Ayr Saline Nasal Drops [OTC]; Ayr Saline Nasal Gel [OTC]; Ayr Saline Nasal Neti Rinse [OTC]; Ayr Saline Nasal No-Drip [OTC]; AYR Saline Nasal Rinse [OTC]; Ayr Saline Nasal [OTC]; Ayr [OTC]; Baby Ayr Saline [OTC]; Deep Sea Nasal Spray [OTC]; DiaB Klenz [OTC] [DSC]; Entsol Nasal [OTC]; Humist [OTC] [DSC]; HyperSal; Liquivida Hydration [DSC]; MicroKlenz Wound Cleanser [OTC] [DSC]; Muro 128 [OTC]; Na- Zone [OTC] [DSC]; Nasal Moist [OTC]; Nebusal [DSC]; Ocean Complete Sinus Rinse [OTC]; Ocean for Kids [OTC]; Ocean Nasal Spray [OTC]; Ocean Ultra Saline Mist [OTC]; Pretz Irrigation [OTC]; Pretz Natur Moist Nasal Spray [OTC]; Pretz [OTC]; PulmoSal [DSC]; RadiaKlenz [OTC] [DSC]; Remedy 4-in-1 Body Cleanser [OTC] [DSC]; Rhinaris [OTC] [DSC]; Safe Wash [OTC]; Saline Flush ZR [DSC]; Saline Mist Spray [OTC]; Saljet Rinse [OTC]; Saljet [OTC]; Sea-Clens Wound Cleanser [OTC] [DSC]; Sochlor [OTC] [DSC]; SwabFlush Saline Flush [DSC]; Ultra- Klenz [OTC]; Wound Wash Saline [OTC] Brand Names: Canada Addipak Sodium Chloride; Aquapak; Ballard Unit Dose; Sodium Chlorure [DSC] Sodium Chloride 1/9 What is this drug used for? Injection and tablet: It is used to treat low sodium levels. Injection: It is used to treat fluid loss. -
The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection
March 27, 2020 The use of Povidone Iodine nasal spray and mouthwash during the current COVID-19 pandemic may protect healthcare workers and reduce cross infection. J Kirk-Bayley MRCP FRCA EDIC FFICM, Consultant Intensivist & Anaesthetist, Royal Surrey County Hospital S Challacombe, PhD, FRCPath, FDSRCS, FMedSci, DSc(h.c), FKC, Martin Rushton Professor of Oral Medicine, KCL VS Sunkaraneni LLM FRCS(2019), Consultant Rhinologist, Royal Surrey County Hospital J Combes FDS FRCS (OMFS), Lt Col RAMC, Consultant Advisor (ARMY) in OMFS, Defence Medical Services Abstract In late 2019 a novel coronavirus, SARS-CoV-2 causing Coronavirus disease 2019 (COVID-19) appeared in Wuhan China, and on 11th March 2020 the World Health Organisation declared it to have developed pandemic status. Povidone-iodine (PVP-I) has a better anti-viral activity than other antiseptics, and has already been proven to be an effective virucide in vitro against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS- CoV). Povidone iodine has been shown to be a safe therapy when inhaled nasally or gargled. We propose that a protocolised nasal inhalation and oropharyngeal wash of PVP-I should be used in the current COVID-19 pandemic to limit the spread of SARS-CoV-2 from patients to healthcare workers (and vice versa) and thus reduce the incidence of COVID-19. There should be regular use in patients with COVID-19 to limit upper respiratory SARS-CoV-2 contamination, but also use by healthcare workers prior to treating COVID 19 patients or performing procedures in and around the mouth/ nose during the pandemic, regardless of the COVID 19 status of the patient.