Deductible EPO (DEPO) Commercial (Self-Funded Plans) Formulary
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List of Patented Medicines 2018
Patented Medicine Annual Report List 02 Apr 2019 Prices Review Board Protected A DIN Brand Chemical Name ATC Dosage Comments Status ABBVIE 02436027 HOLKIRA PAK 12.5/75/50/250 ombitasvir/paritaprevir/ritonavir/dasabuvir J05AX Oral Solid /Tablet Within Guidelines 02258595 HUMIRA - 40 MG/SYRINGE adalimumab L04AA Parenteral /Solution Within Guidelines 02312301 KALETRA 100/25 MG/TABLET lopinavir/ritonavir J05AE Oral Solid /Tablet Within Guidelines 02285533 KALETRA 200/50 MG/TABLET lopinavir/ritonavir J05AE Oral Solid /Tablet Within Guidelines 02243644 KALETRA 80/20 MG/MILLILITER lopinavir/ritonavir J05AE Oral Liquid /Solution Does Not Trigger 00884502 LUPRON DEPOT - 3.75 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 00836273 LUPRON DEPOT - 7.5 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02239834 LUPRON DEPOT - 11.25 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02230248 LUPRON DEPOT - 22.5 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02239833 LUPRON DEPOT - 30 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02467550 MAVIRET 100/40 MG/TABLET glecaprevir/pibrentasvir J05AP Oral Solid /Tablet Subj. Investigation 02229145 NORVIR - 80 MG/MILLILITER ritonavir J05AE Oral Liquid /Solution Within Guidelines 02357593 NORVIR - 100 MG/TABLET ritonavir J05AE Oral Solid /Tablet Within Guidelines 02481332 ORILISSA - 150 MG/TABLET elagolix -
Human and Recombinat Coagulation Factor VIII
08 July 2016 EMA/PRAC/471535/2016 PRAC List of questions To be addressed by the marketing authorisation holder(s) for human and recombinant coagulation factor VIII containing medicinal products Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1448 Advate EMEA/H/C/0520/A31/0078 Elocta EMEA/H/C/3964/A31/0006 Helixate Nexgen EMEA/H/C/0276/A31/0178 Iblias EMEA/H/C/4147/A31/0002 Kogenate EMEA/H/C/0275/A31/0185 Kovaltry EMEA/H/C/3825/A31/0004 Novoeight EMEA/H/C/2719/A31/0014 Nuwiq EMEA/H/C/2813/A31/0015 Obizur EMEA/H/C/2792/A31/0003 Refacto AF EMEA/H/C/0232/A31/0134 Voncento EMEA/H/C/2493/A31/0022 Active substances: human coagulation factor VIII; efmoroctocog alfa; moroctocog alfa; octocog alfa; simoctocog alfa; susoctocog alfa; turoctocog alfa 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, 2016. Reproduction is authorised provided the source is acknowledged. 1. Background Today’s standard treatment of congenital haemophilia (and acquired haemophilia A) is based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII), either with plasma derived or with recombinant FVIII products. Principally both substance classes may be used for prophylactic treatment as well as for therapeutic treatment in case of spontaneous bleedings. Inhibitor development in haemophilia A patients receiving FVIII products mostly occurs in previously untreated or minimally treated patients (PUPs), who are still within the first 50 days of exposure to the treatment. -
Intravesical Cocktails PBS/IC
International Painful Bladder Foundation Interstitial Cystitis/Painful Bladder Syndrome Anaesthetic intravesical cocktails 1. Anaesthetic cocktail – Robert Moldwin, MD 1:1 mixture of 0.5% Marcaine and 2% Lidocaine jelly – about 40 cc total. To this solution are added: Heparin sulphate 10,000 IU Triamcinolone 40 mg Gentamycin 80 mg or a post-procedural prophylactic antibiotic. Administration: Patients are instructed to hold the solution for about 30 minutes, then to void. When given as a diagnostic test, patients will generally sense relief of pain within 5-10 minutes. The only (rare) problems that we’ve encountered are the following: Patients may experience “rebound” pain once the solution has worn off (within 3-5 hours). This generally resolves with continued instillations. When given as therapy, we usually administer the cocktail on a weekly basis for 8-12 weeks. This is the length of time usually needed to get a prolonged response. Then, the duration between instillations is increased to q 2 weeks to q 3 weeks, etc., ultimately with the goal of discontinuance. Patients may experience urinary retention requiring catheterization. This seems to be particularly a problem in patients who appear to have pre-existing voiding dysfunction, those patients who initially present with a poor urinary flow rate, an interrupted urinary stream, etc. The urinary retention can usually be circumvented by delivering a lower total volume. 2. Marcaine with steroid cocktail – Nagendra Mishra, MD Marcaine 40 ml Heparin sulphate 10,000 IU Dexamethasone 2 cc Sodium bicarbonate 20 ml Administration: This cocktail should be held in the bladder for 20 minutes. It should be administered every 15 days for a total of 6 treatments and then as needed. -
PASS) Information
Reference Number: RD-SOP-1214 Supplement Version: 14 Post Authorization Safety Study (PASS) Information HA-SAFE: Observational study evaluating long-term safety Acronym/Title of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A Protocol version and date v 1.0, 13 JAN 2020 IMPACT study number 20904 Study type / Study phase Observational, post-approval PASS Joint PASS: YES NO EU PAS register number Study not yet registered Active substance ATC code: B02BD02/Hematological/Damoctocog alfa pegol Medicinal product Jivi EU/1/18/1324/001 Jivi 250 IU; Product reference EU/1/18/1324/002 Jivi 500 IU; EU/1/18/1324/003 Jivi 1000 IU; EU/1/18/1324/004 Jivi 2000 IU; EU/1/18/1324/005 Jivi 3000 IU Procedure number EMEA/H/C/004054 Study Initiator and Funder Bayer Consumer Care AG, Basel, Switzerland Research question and objectives The aim of this study is to characterize in a real-world setting the long-term safety of damoctocog alfa pegol drug usage. The primary objective of this study is to assess the long- term safety of prophylaxis with damoctocog alfa pegol in patients with hemophilia A in the real-world setting through the collection and analysis of adverse events (AEs) of special interest including those potentially indicative of PEG accumulation (hypersensitivity reactions, loss of drug effect, renal impairment, neurocognitive disorders, and inhibitor development), AEs, serious adverse events (SAEs), and adverse reactions (ARs). The secondary objective is to monitor the clinical effects of long-term exposure of prophylaxis damoctocog alfa pegol in 20904; HA-SAFE; v 1.0, 13 JAN 2020 Page 1 of 48 Reference Number: RD-SOP-1214 Supplement Version: 14 patients with hemophilia A, including assessments of kidney and liver function parameters, neurological function and patients’ PEG plasma levels. -
CHMP/565731/2018 Rev.1 Inspections, Human Medicines Pharmacovigilance and Committees Division
21 August 2018 EMA/CHMP/565731/2018 Rev.1 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Agenda of CHMP written procedure* 20-23 August 2018 Chair: Tomas Salmonson – Vice-Chair: Harald Enzmann * Written Procedure - comments on the draft documents should be forwarded to the Product Manager (PM) as identified in the CHMP agenda. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda 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). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. -
Evaluation of Pentosan Polysulfate Sodium in the Postoperative Recovery from Cranial Cruciate Injury in Dogs: a Randomized
See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/6367210 Evaluation of Pentosan Polysulfate Sodium in the Postoperative Recovery from Cranial Cruciate Injury in Dogs: A Randomized... Article in Veterinary Surgery · May 2007 DOI: 10.1111/j.1532-950X.2007.00256.x · Source: PubMed CITATIONS READS 16 103 4 authors, including: Steven C Budsberg Mary Sarah Bergh University of Georgia Iowa State University 129 PUBLICATIONS 3,106 CITATIONS 22 PUBLICATIONS 366 CITATIONS SEE PROFILE SEE PROFILE All content following this page was uploaded by Steven C Budsberg on 11 March 2014. The user has requested enhancement of the downloaded file. Veterinary Surgery 36:234–244, 2007 Evaluation of Pentosan Polysulfate Sodium in the Postoperative Recovery from Cranial Cruciate Injury in Dogs: A Randomized, Placebo-Controlled Clinical Trial STEVEN C. BUDSBERG, DVM, MS, Diplomate ACVS, MARY SARAH BERGH, DVM, LISA R. REYNOLDS, BS, and HEATHER K. STREPPA, DVM, Diplomate ACVS Objective—To evaluate the efficacy of pentosan polysulfate (PPS) for improving the recovery period and mitigate the progression of osteoarthritis (OA) of the canine stifle after extracapsular stabilization of cranial cruciate ligament (CCL) injuries. Study Design—Randomized, blinded, placebo-controlled clinical trial. Animals—Dogs (n ¼ 40) with unilateral CCL instability. Methods—Each dog had an extracapsular stabilization of the stifle with or without partial men- iscectomy. Dogs were divided into 4 groups based on preoperative radiographic assessment and whether a partial meniscectomy was performed. Dogs were randomly assigned to either (3 mg/kg) PPS or placebo treatment in each group, and then injected subcutaneously weekly for 4 weeks. -
Hemorrhoids (1 of 8)
Hemorrhoids (1 of 8) 1 Patient presents w/ symptoms of hemorrhoids 2 DIAGNOSIS No ALTERNATIVE Hemorrhoids confi rmed & other DIAGNOSIS causes of rectal bleeding excluded? Yes Internal or external External TREATMENT hemorrhoids? hemorrhoids See page 3 Internal hemorrhoids 3 GRADE HEMORRHOIDS A Dietary modifi cation & supportive measures B Pharmacological therapy Grade I - II Grade III Grade IV Yes Response to C Ablative offi ce procedures therapy? D Surgical hemorrhoidectomy CONTINUE No TREATMENT C Ablative offi ce procedures Yes Response to No D Surgical hemorrhoidectomy ©therapy? MIMS B1 © MIMS 2019 Hemorrhoids (2 of 8) 1 SYMPTOMS ATTRIBUTED TO HEMORRHOIDS • Rectal bleeding - Most common presenting symptom - Bright red blood which may drip or squirt into the toilet bowl or scanty amounts may be seen on toilet tissue • Discomfort due to rectal protrusion or lump • Anal pain • HEMORRHOIDS Anal itching 2 DIAGNOSIS Medical History • Assess nature, duration & severity of symptoms - Ask about bleeding, its amount & frequency - Ask about presence of prolapsing tissue, its timing & reproducibility • Elicit possible risk factors for development of hemorrhoidal symptoms - Low-fi ber diets cause small-caliber stools, resulting in straining during defecation & engorgement of hemorrhoids - Prolonged sitting on a toilet which may cause a problem in the venous return in the perianal area - Pregnancy - Advanced age • Th e signs & symptoms of hemorrhoids are not specifi c to the disease, so care must be taken to avoid missing other causes of pathology • Obtain -
Management of Joint Disease in the Sport Horse
1 MANAGEMENT OF JOINT DISEASE IN THE SPORT HORSE Management of Joint Disease in the Sport Horse C. WAYNE MCILWRAITH Colorado State University, Ft. Collins, Colorado INTRODUCTION The joint is an organ, and there are a number of ways in which traumatic damage occurs, ultimately resulting in degradation of articular cartilage. It was recognized in 1966 that articular cartilage change that accompanied osteochondral fragmentation could also be associated with concurrent traumatic damage to the attachment of the joint capsule and ligaments (Raker et al., 1966). However, there was little association made between primary disease in the synovial membrane and fibrous joint capsule and the development of osteoarthritic change in the articular cartilage until an experimental study demonstrated that cartilage degradation could occur in the horse in the absence of instability or trau- matic disruption of tissue and that loss of glycosaminoglycan (GAG) staining was associated with early morphologic breakdown at the surface of the cartilage (McIlwraith and Van Sickle, 1984). Surveys have confirmed that approximately 60% of lameness problems are related to osteoarthritis (National Animal Health Monitoring Systems, 2000; Caron and Genovese, 2003). Rapid resolution of synovitis and capsuli- tis is a critical part of the medical treatment of joint disease because of the principal role of synovitis in causing cartilage matrix breakdown. The goal of treatment of traumatic entities of the joint is twofold: (1) returning the joint to normal as quickly as possible, and (2) preventing the occurrence or reduction of the severity of osteoarthritis. In other words, treatment is intended to (1) reduce pain (lameness), and (2) minimize progression of joint deterioration. -
PRAC Draft Agenda of Meeting 4 -7 March 2013
4 March 2013 EMA/PRAC/141813/2013 Pharmacovigilance Risk Assessment Committee (PRAC) Pharmacovigilance Risk Assessment Committee (PRAC) Agenda of the meeting on 4-7 March 2013 Explanatory notes The Notes give a brief explanation of relevant agenda items and should be read in conjunction with the agenda. EU Referral procedures for safety reasons: Urgent EU procedures and Other EU referral procedures (Items 2 and 3 of the PRAC agenda) A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). For further detailed information on safety related referrals please see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid =WC0b01ac05800240d0 Signals assessment and prioritisation (Item 4 of the PRAC agenda) A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks. The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient. -
Final Program N
XXII Congress The International Society on Thrombosis and Haemostasis B July 11-16 2009 O 55th Annual Meeting S of the Scientific and Standardization Committee of the ISTH T O Final Program N Boston - July 11-16 2009 XXII Congress of the International Society on Thrombosis and Haemostasis 2009 Table ISTH of Contents Venue and Contacts 2 Wednesday 209 Welcome Messages 3 – Plenary Lectures 210 Committees 7 – State of the Art Lectures 210 Congress Awards and Grants 15 – Abstract Symposia Lectures 212 Other Meetings 19 – Oral Communications 219 – Posters 239 ISTH Information 20 Program Overview 21 Thursday 305 SSC Meetings and – Plenary Lectures 306 Educational Sessions 43 – State of the Art Lectures 306 – Abstract Symposia Lectures 309 Scientific Program 89 – Oral Communications 316 Monday 90 – Posters 331 – Plenary Lectures 90 Nursing Program 383 – State of the Art Lectures 90 Special Symposia 389 – Abstract Symposia Lectures 92 Satellite Symposia 401 – Oral Communications 100 – Posters 118 Technical Symposia Sessions 411 Exhibition and Sponsors 415 Tuesday 185 – Plenary Lectures 186 Exhibitor and Sponsor Profiles 423 – State of the Art Lectures 186 Congress Information 445 – Abstract Symposia Lectures 188 Map of BCEC 446 – Oral Communications 196 Hotel and Transportation Information 447 ISTH 2009 Congress Information 452 Boston Information 458 Social Events 463 Excursions 465 Authors’ Index 477 1 Venue & Contacts Venue Boston Convention & Exhibition Center 415 Summer Street - Boston, Massachusetts 02210 - USA Phone: +1 617 954 2800 - Fax: +1 617 954 3326 The BCEC is only about 10 minutes by taxi from Boston Logan International Airport. The 2009 Exhibition is located in Hall A and B of the Exhibit Level of the BCEC, along with posters and catering. -
Justification
Justification to the Resolution of the Federal Joint Committee (G-BA) on an Amendment of the Pharmaceuticals Directive (AM ‑ RL): Annex XII – Resolutions on the Benefit Assessment of Medicinal Products with New Active Ingredients in Accordance with Section 35a SGB V Damoctocog alfa pegol From 20 June 2019 Contents 1. Legal basis ................................................................................................................ 2 2. Key points of the resolution ..................................................................................... 2 2.1 Additional benefit of the medicinal product in relation to the appropriate comparator therapy ..................................................................................................... 3 2.1.1 Approved therapeutic indication of damoctocog alfa pegol (Jivi®) in accordance with the summary of product characteristics ............................................ 3 2.1.2 Appropriate comparator therapy ................................................................... 3 2.1.3 Extent and probability of the additional benefit .............................................. 5 2.1.4 Summary of the assessment ........................................................................ 6 2.2 Number of patients or demarcation of patient groups eligible for treatment ...... 6 2.3 Requirements for a quality-assured application ................................................ 7 2.4 Treatment costs .............................................................................................. -
Medicines/Pharmaceuticals of Animal Origin V3.0 November 2020
Medicines/pharmaceuticals of animal origin V3.0 November 2020 Medicines/pharmaceuticals of animal origin - This guideline provides information for all clinical staff within Hospital and Health Services (HHS) on best practice for avoidance of issues related to animal products. Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Published by the State of Queensland (Queensland Health), November 2020 This document is licensed under a Creative Commons Attribution 3.0 Australia licence. To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au © State of Queensland (Queensland Health) 2020 You are free to copy, communicate and adapt the work, as long as you attribute the State of Queensland (Queensland Health). For more information contact: Medication Services Queensland, Queensland Health, GPO Box 48, Brisbane QLD 4001, email [email protected] An electronic version of this document is available at https://www.health.qld.gov.au/__data/assets/pdf_file/0024/147507/qh-gdl-954.pdf Disclaimer: The content presented in this publication is distributed by the Queensland Government as an information source only. The State of Queensland makes no statements, representations or warranties about the accuracy, completeness or reliability of any information contained in this publication. The State of Queensland disclaims all responsibility and all liability (including without limitation for liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate