To USP 39–NF 34, First Supplement the Following Index Is For
Total Page:16
File Type:pdf, Size:1020Kb

Load more
Recommended publications
-
Wo 2009/081169 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date PCT 2 July 2009 (02.07.2009) WO 2009/081169 A2 (51) International Patent Classification: KJELLSON, Fred [SE/SE]; IoPharma Technologies AB, A61K 49/04 (2006.01) Ideon Science Park, Ole Romers Vag 12, SE-223 70 Lund (SE). KLAVENESS, J o [NO/SE]; IoPharma Technologies (21) International Application Number: AB, Ideon Science Park, Ole Romers Vag 12, SE-223 70 PCT/GB2008/004268 Lund (SE). (22) International Filing Date: (74) Agent: KIDD, Sara; Frank B. Dehn 6 Co., St. Bride's 22 December 2008 (22.12.2008) House, 10 Salisbury Square, London EC4Y 8ID (GB). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (26) Publication Language: English AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, (30) Priority Data: EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, 0725070.7 21 December 2007 (21.12.2007) GB IL, IN, IS, IP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (71) Applicant (for all designated States except US): IO- LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, PHARMA TECHNOLOGIES AB [SE/SE]; Ideon MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, Science Park, Ole Romers Vag 12, SE-223 70 Lund (SE). -
Betamethasone Valerate Foam: a Look at the Clinical Data
Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs. -
Constipation: a Parent's Guide
CONSTIPATION: A PARENT’S GUIDE Twenty Questions About Constipation: Answers to Guide Parents and Professionals Constipation is the abnormally delayed or infrequent passage of hard stools. Most children, and many adults, too, become constipated from time to time. Often, the duration is short; occasionally it persists for months, even years. Although constipation can be uncomfortable, may create worry, and sometimes seem serious, fortunately it does not have long-term, troubling effects in most healthy children. This Booklet is designed to help you deal with childhood constipation by answering several questions and outlining management instructions for you to follow. Questions answered are: 1. What are the normal 11. What can we learn from patterns of bowel physical exam results? movements at 12. What is our treatment different ages? program for constipation? 2. What makes up bowel 13. How is the colon movements and how do cleaned out? they travel? 14. How are stools softened? 3. What is constipation? 15. Why is trying to have 4. When is constipation most bowel movements twice likely to occur? a day so important? 5. Why does constipation 16. What are the expected persist in some children? results of the treatment 6. Why would a child hold program? back stool and what 17. What do we do if the happens then? cleansing regimen is 7. How can proper toilet not successful? training help? 18. What is the long-term 8. Why would stool back up program for children in the colon? prone to constipation? 9. Why do some children 19. Does a special diet help have soiling accidents? resolve constipation? 10. -
Albany-Molecular-Research-Regulatory
PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF A Abiraterone Malta • Benztropine Mesylate Cedarburg • Adenosine Rozzano - Quinto de' Stampi • • * Betaine Citrate Anhydrous Bon Encontre • Betametasone-17,21- Alcaftadine Spain Spain • • Dipropionate Sterile • Alclometasone-17, 21- Spain Betamethasone Acetate Spain Dipropionate • • Altrenogest Spain • • Betamethasone Base Spain Amphetamine Aspartate Rensselaer Betamethasone Benzoate Spain * Monohydrate Milled • Betamethasone Valerate Amphetamine Sulfate Rensselaer Spain * • Acetate Betamethasone-17,21- Argatroban Rozzano - Quinto de' Stampi Spain • • Dipropionate • • • Atenolol India • • Betamethasone-17-Valerate Spain • • Betamethasone-21- Atracurium Besylate Rozzano - Quinto de' Stampi Spain • Phosphate Disodium Salt • • Bromfenac Monosodium Atropine Sulfate Cedarburg Lodi * • Salt Sesquihydrate • • Azanidazole Lodi Bromocriptine Mesylate Rozzano - Quinto de' Stampi • • • • • Azelastine HCl Rozzano - Quinto de' Stampi • • Budesonide Spain • • Aztreonam Rozzano - Valle Ambrosia • • Budesonide Sterile Spain • • B Bamifylline HCl Bon Encontre • Butorphanol Tartrate Cedarburg • Beclomethasone-17, 21- Spain Capecitabine Lodi Dipropionate • C • 2 *Please contact our Accounts Managers in case you are interested in this API. 3 PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF Dexamethasone-17,21- Carbimazole Bon Encontre Spain • Dipropionate -
Clomifene Citrate(BANM, Rinnm) ⊗
2086 Sex Hormones and their Modulators Profasi; UK: Choragon; Ovitrelle; Pregnyl; USA: Chorex†; Choron; Gonic; who received the drug for a shorter period.6 No association be- 8. Werler MM, et al. Ovulation induction and risk of neural tube Novarel; Ovidrel; Pregnyl; Profasi; Venez.: Ovidrel; Pregnyl; Profasi†. tween gonadotrophin therapy and ovarian cancer was noted in defects. Lancet 1994; 344: 445–6. Multi-ingredient: Ger.: NeyNormin N (Revitorgan-Dilutionen N Nr this study. The conclusions of this study were only tentative, 9. Greenland S, Ackerman DL. Clomiphene citrate and neural tube 65)†; Mex.: Gonakor. defects: a pooled analysis of controlled epidemiologic studies since the numbers who developed ovarian cancer were small; it and recommendations for future studies. Fertil Steril 1995; 64: has been pointed out that a successfully achieved pregnancy may 936–41. reduce the risk of some other cancers, and that the risks and ben- 10. Whiteman D, et al. Reproductive factors, subfertility, and risk efits of the procedure are not easy to balance.7 A review8 of epi- of neural tube defects: a case-control study based on the Oxford Clomifene Citrate (BANM, rINNM) ⊗ Record Linkage Study Register. Am J Epidemiol 2000; 152: demiological and cohort studies concluded that clomifene was 823–8. Chloramiphene Citrate; Citrato de clomifeno; Clomifène, citrate not associated with any increase in the risk of ovarian cancer 11. Sørensen HT, et al. Use of clomifene during early pregnancy de; Clomifeni citras; Clomiphene Citrate (USAN); Klomifeenisi- when used for less than 12 cycles, but noted conflicting results, and risk of hypospadias: population based case-control study. -
Information for the User ZYTIGA 500 Mg Film-Coated Tablets Abiraterone
Package leaflet: Information for the user ZYTIGA 500 mg film-coated tablets abiraterone acetate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What ZYTIGA is and what it is used for 2. What you need to know before you take ZYTIGA 3. How to take ZYTIGA 4. Possible side effects 5. How to store ZYTIGA 6. Contents of the pack and other information 1. What ZYTIGA is and what it is used for ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy ). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood. -
Efficacy and Tolerability of Quinacrine Monotherapy and Albendazole Plus Chloroquine Combination Therapy in Nitroimidazole-Refractory Giardiasis: a Tropnet Study
Klinik für Infektiologie & Spitalhygiene Efficacy and tolerability of quinacrine monotherapy and albendazole plus chloroquine combination therapy in nitroimidazole-refractory giardiasis: a TropNet study Andreas Neumayr, Mirjam Schunk, Caroline Theunissen, Marjan Van Esbroeck, Matthieu Mechain, Manuel Jesús Soriano Pérez, Kristine Mørch, Peter Sothmann, Esther Künzli, Camilla Rothe, Emmanuel Bottieau Journal Club 01.03.21 Andreas Neumayr Background on giardia treatment: • 1st-line treatment: 5-nitroimidazoles: metronidazole (1957), tinidazole, ornidazole, secnidazole • cure rate of 5NIs in 1st-line treatment: ~90% • in the last decade, an increase of 5NI-refractory giardia cases has been observed in travel medicine clinics across Europe: Hospital for Tropical Diseases, London: 2008: 15% --> 2013: 40% 70% of 5NI-refractory cases imported from India • 2nd-line treatment: effectiveness of a 2nd round with a 5NI: ~17% alternative drugs: albendazole, mebendazole, nitazoxanide, quinacrine, furazolidone, chloroquine, paromomycin 2012 TropNet member survey: 53 centres use 39 different treatment regimens, consisting of 7 different drugs in mono- or combination-therapy in various dosages and durations JC 01.03.21 Nabarro LE et al. Clin Microbiol Infect. 2015;21:791-6. • by 2013, there were only 13 reports of 2nd-line therapy for giardiasis (8 case series, 5 individual case reports): n=110 Cure rates Albendazole 6/32 18.7% Paromomycin 5/17 29.4% Nitazoxanide 2/5 40.0% Albendazole + 5-NI 42/53 79.2% Quinacrine 19/21 90.5% Quinacrine + 5-NI 14/14 100% Quinacrine + Paromomycin 2/2 100% • 2013: TropNet "GiardiaREF" study kick-off: Study on efficacy and tolerability of two 2nd-line regimens in nitroimidazole-refractory giardiasis: Quinacrine JC 01.03.21 Meltzer E et al. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Pharmacy Reengineering (PRE) V.0.5 Pre-Release Implementation
PHARMACY REENGINEERING (PRE) Version 0.5 Pre-Release Implementation Guide PSS*1*129 & PSS*1*147 February 2010 Department of Veterans Affairs Office of Enterprise Development Revision History Date Revised Patch Description Pages Number 02/2010 All PSS*1*147 Added Revision History page. Updated patch references to include PSS*1*147. Described files, fields, options and routines added/modified as part of this patch. Added Chapter 5, Additive Frequency for IV Additives, to describe the steps needed to ensure correct data is in the new IV Additive REDACTED 01/2009 All PSS*1*129 Original version REDACTED February 2010 Pharmacy Reengineering (PRE) V. 0.5 Pre-Release i Implementation Guide PSS*1*129 & PSS*1*147 Revision History (This page included for two-sided copying.) ii Pharmacy Reengineering (PRE) V. 0.5 Pre-Release February 2010 Implementation Guide PSS*1*129 & PSS*1*147 Table of Contents Introduction ................................................................................................................................. 1 Purpose ....................................................................................................................................1 Project Description ....................................................................................................................1 Scope ........................................................................................................................................3 Menu Changes ..........................................................................................................................4 -
Abiraterone Acetate for Chemotherapy-Naive
Fan et al. BMC Urology (2018) 18:110 https://doi.org/10.1186/s12894-018-0416-6 RESEARCHARTICLE Open Access Abiraterone acetate for chemotherapy- naive metastatic castration-resistant prostate cancer: a single-centre prospective study of efficacy, safety, and prognostic factors Liancheng Fan†, Baijun Dong†, Chenfei Chi†, Yanqing Wang†, Yiming Gong†, Jianjun Sha, Jiahua Pan, Xun Shangguan, Yiran Huang, Lixin Zhou* and Wei Xue* Abstract Background: To evaluate the efficacy and safety of abiraterone acetate (AA) plus prednisone compared with prednisone alone in Asian patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), and to identify predictive factors. Methods: We reviewed the medical records of 60 patients with chemotherapy-naive mCRPC at Renji Hospital who were treated with AA plus prednisone (n = 43) or prednisone alone (n = 17). All patients were assessed for prostate- specific antigen (PSA) response, PSA progression-free survival (PSA PFS), radiographic progression-free survival (rPFS), and overall survival (OS). The ability of several parameters to predict PSA PFS, rPFS, and OS was studied. Results: The median follow-up time was 14.0 months (range 7.0–18.5 months), at which time 19 death events had been reported: 11 in the AA + prednisone group and 8 in the prednisone group. The AA + prednisone group had significantly longer median PSA PFS (10.3 vs 3.0 months, P < 0.001), rPFS (13.9 vs 3.9 months, P < 0.001), and OS (23. 3 vs 17.5 months, P = 0.016) than the prednisone-alone group. The most frequently reported grade 3 or 4 adverse event in both the AA + prednisone and prednisone-alone groups was elevated alanine aminotransferase level in 5 of 43 patients (11.6%) and 2 of 17 patients (11.8%), respectively. -
Chemical Compounds As Carcinogenic Agents Second Supplementary Report: Literature of 1938 and 1939 Biological Considerations
CHEMICAL COMPOUNDS AS CARCINOGENIC AGENTS SECONDSUPPLEMENTARY REPORT: LITERATURE OF 1938 AND 1939 J. W. COOK AND E. L. KENNAWAY (From the Royal Cancer Hospital (Free), London, and the University of Glasgow) BIOLOGICALCONSIDERATIONS (Continued from page 428, Jitly 1940) II. Action of Carcinogenic Compounds in Difierent Species and Tissues A number of reports of the action of carcinogenic compounds on human tis- sues have appeared. Klar (601) developed a nodule on the forearm after completion of a series of experiments with 3:4-benzpyrene. He applied a solution of the hydrocarbon (0.25 per cent in benzol) to the skin of mice with a paint brush and for at least part of the period wore rubber gloves. He also conducted experiments, of which no description is given, with the powdered hydrocarbon contained in a glass vessel. Three months after the completion of the experiments a small nodule appeared on the dorsum of the left forearm, This was excised in May 1938 and described by Professor Huckel as a “ so- called benign calcifying epithelioma.” The growth extended into the subcu- taneous fatty tissue; the connection with the superficial epithelium is not described nor is it evident in the two photomicrographs which illustrate the report. The author does not state his age. Gordonoff and Walthard (562) record the occurrence of a tumor in a labo- ratory assistant, aged forty-two, engaged in applying methylcholanthrene (0.3 per cent in benzol) to the skin of mice. The site was in the nasolabial fold, at a spot often touched by the patient when smoking. The microscopic ap- pearance was that of a “ still well delimited stage of an incipient squamous- cell sarcoma.” Cottini and Mazzone (479) deliberately applied 3 :4-benzpyrene ( 1 per cent in benzene) to the skin, generally of the arm or thigh, of 26 patients with various cutaneous diseases, usually daily for periods up to 120 days. -
Jos Journal 2
POST-OPERATIVE AUDIT OF G6PD-DEFICIENT MALE CHILDREN WITH OBSTRUCTIVE ADENOTONSILLAR ENLARGEMENT AT UNIVERSITY COLLEGE HOSPITAL, IBADAN, NIGERIA. John EN1, Totyen EL1, Jacob N2, Nwaorgu OGB1 1 .Department of ENT/Head and Neck Surgery, University College Hospital, Ibadan, Nigeria 2. Department of paediatrics, University College Hospital, Ibadan, Nigeria All correspondences and request for reprint to Dr John EN, Department of ENT/Head and Neck Surgery, University College Hospital, Ibadan, Nigeria Email: [email protected] Telephone: +2348036240109 Abstract Background: G6PD deficiency ranks among the commonest hereditary enzyme deficiency worldwide and notable as a predisposing condition to haemolyticcrises. The fear of possible untoward effects is often expressed by parents of G6PD deficient male children scheduled for surgery after obtaining an informed and understood consent. The parental perception of obstructive adenotonsillar enlargement in this condition was also appraised. Methods: A retrospective chart review of all G6PD deficient male children between ages 1 to 7years who had adenotonsillectomy over a 3year period at University college Hospital, Ibadan, Nigeria. Results: The patients comprised of 22 G6PD deficient male children diagnosed shortly after birth upon development of neonatal jaundice. Fifteen(68.2%) and 6(27.3%) of the patients subsequently developed episodes of drug- induced haemolysis and non-haemolytic drug reactions prior to undergoing adenotonsillectomy by the otolaryngologists. None of the patients was observed to develop haemolytic crises up to 2weeks post-adenotonsillectomy. From the parental perception and responses in the follow-up period,all 22(100%) patient had resolution of noisy breathing, 20(91%) had improvement of snoring and apnoeic spells. Only 15 (68%) were reported to stop mouth-breathing.