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Prostaglandind2 and Thromboxane A2 Receptor Antagonists Medicine

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Prostaglandind2 and Thromboxane A2 Receptor Antagonists Medicine Revised: OCT 2009（2nd revised edition） Standard Commodity Classification No. of Japan：87449 Medical Interview Form Framed based on the criteria of 2008 IF entry guidelines of Japanese Society of Hospital Pharmacists ProstaglandinD2 and Thromboxane A2 receptor antagonists Medicine for allergic rhinitis Baynas tablets 50 mg Baynas tablets 75 mg Dosage form Film-coating tablets Regulatory classification of Prescription drug（caution-use as directed by physician） formula Baynas tablets 50 mg: includes Ramatroban 50 mg Standard・Content Baynas tablets 75 mg: includes Ramatroban 75 mg Japanese name:ラマトロバン（JAN） Common name Western name:Ramatroban （JAN，INN） Manufacture and sales Date of Manufacture and sales approval: March 10 2000 approval date, Date of listing in NHI reimbursement price: May 02 2000 Date of release: May 23 2000 Listing in NHI reimbursement Nipppon Shinyaku Co. Ltd. Date of release: July 03 2006 price, Date of release(for sale) Development and marketing Manufacturer:Bayer Yakuhin Ltd. authorization holder (import) Sales: Nippon Shinyaku Co., Ltd and licensed seller Contact address of medical representative Nippon Shinyaku Co., Ltd science department, pharmaceutical information department, medical counsellor Inquiry TEL 075-321-9064 FAX 075-321-9061 Home page for medical personnel http://www.nippon-shinyaku.co.jp/medicine/medicine_conts/ This IF is revised based on the listings of the package inserts of revision, June 2009。 Please confirm the newest information on the package inserts at http://www.info.pmda.go.jp/ Supply of Information on Drugs and Medical devices website Summary of guidelines for IF usage -Japanese Society of Hospital Pharmacists 1. The details about framing the Medical Interview Form The packet inserts of the prescription drugs (abbrev. as packet inserts below) are provided as basic information about the prescribed drug. In medical setting where appropriate information about the drug usage is necessary for the daily work for doctors and healthcare workers like pharmacists there are situations in which the packet insert that carrying more detailed information is necessary. In medical setting, it is being handled by completing the information by questioning and demanding information additionally about the particular drug to the medical representative of the manufacturer. In this case, the Interview Form was created as information list to obtain the required information comprehensively. In 1988, the 2nd subcommittee of science, The Japanese Society of Hospital Pharmacists (abbrev. As JSPN below) laid out and determined the IF listing format of the ‘Medical Interview Form’ (abbrev. as IF below). Thereafter, to meet the changes in the drug information needs of the healthcare workers and patients, the revision of IF Entry Guidelines was conducted by the 3rd subcommittee of science, JSHP in September 1998. Now after ten years, in September 2008, the new IF Entry Guidelines were determined by the subcommittee of JSHP by regarding the huge changes in pharmaceutical and medical environment for both the manufacturers who produce the medical information and pharmacists in the medical setting who are the users. 2. IF is Established as ‘a guideline determined by the JSHP as comprehensive discrete drug manual with collective information that supplements the information of package inserts and information required for quality management of drug, prescription formulation, compounding medicine, appropriate use of the drug, pharmaceutical patient care and as a scientific document necessary for the daily work of healthcare workers like pharmacists and that inquires the manufactures about the making and provisions of the particular drug for the purpose of the healthcare workers’. However, the matters related to the Pharmaceutical Affair law and manufacture’s classified information, matters that invalidates the manufacturing efforts of the manufacturers and the matters that has to be evaluated, judged and supported by the pharmacist themselves does not become IF. In other words, the IF supported by the manufacturers is the one with preamble recognizing the evaluation, judgement and clinical adaptation by pharmacists along with required supplementation. IF format 1. The standard is to print in A4 size paper, horizontal writing with font size above 9 points as general rule (excluding charts) and as a one-color print. But when red frames and red letters are used in the package inserts, it is made to support this in digital media. 2. Frame based on the IF Entry Guideline and every item name is listed in Gothic font. 3. The content of Front cover is consolidated, the whole Summary of guidelines for IF usage by JSHP is printed by continuing to the cover page and summarized in 2 pages. Preparation of IF 1. The IF in general is prepared separately for routes of administration (internal drug, injections and external drug) of the formulation. 2. The items and arrangement used in the IF should be based on the IF Entry Guideline established by JSHP. 3. The necessary information that is in line with the motive of IF to supplement the contents of the package insert is given. 4. The matters related to the manufacturer’s classified information, the matters that invalidates the manufacturer’s manufacturing efforts and the matters that are to be evaluated, judged and supported by healthcare workers and pharmacists will not be given. 5. With the support in digital media as foundation, the IF framed according to the ‘Medical Interview Form Entry Guideline 2008’ (abbrev. as ‘IF Entry Guideline 2008’ below), is used by the pharmacists by printing from digital media (PDF) depending upon the need. Industrial binding is not required. Publication of IF 1. ‘IF Entry Guideline 2008’ will be adapted from the products that were approved after April, 2009. 2. The making and provision by ‘IF Entry Guideline 2008’ is not enforceable for the drug aside from those mentioned above. 3. IF will be revised when revision of caution during usage, the time when the re-examination and re- evaluation results (clinical re-evaluation) are officially announced as well as the expansion of indications are made and when the is contents that ought to be mentioned changes hugely. Summary of guidelines for IF usage -Japanese Society of Hospital Pharmacists 3.In using the IF The ‘IF Entry Guideline 2008’ has provision in digital media through PDF files as its basis, rather than in MR based paper medium which was used widely so far. Pharmacists who uses the information, with principle of using the information by printing from the digital, depending on the IT setting of the medical institution, can also request provision of printing in MR to meet the requirement. A publishing place has been set up in Supply of Information on Drugs and Medical devices website of Pharmaceutical and Medical Device Agency about the digital medium IF. The manufacturers follow ‘Guidelines for making Medical Interview Form’ for the making and providing, but based on the origin of the IF, the increase in usefulness of the IF is necessary as the pharmacists are made to complete the contents about the information insufficient in the medical setting and the information that cannot be entered at the time of making the IF through the manufacturers’ MR based Interview． And regarding the entries related to Caution during usage that are revised occasionally, in the period until the IF is revised, the pharmacists has to provide themselves through the package insert and notice provided by the particular drug’s manufacturer or through the Pharmaceutical and Medical Devices Information Distribution services along with confirmation of new package insert on Supply of Information on Drugs and Medical devices website depending up on the usage of IF. Also, the entries related to ‘clinical results’ and ‘important conditions for selling in foreign country’ mentioned from point of securing the safety and proper usage are related to the approval. Hence sufficient attention has to be paid in handling. 4. Points to remember during use Use the IF as vital source of drug information for the daily work of the Pharmacists. But, because of the regulations by the Pharmaceutical Affairs Law and medical drug promotion code, there is a natural limit in the range of information that can be provided by the manufacturer as drug information. From the fact that IF complies with the entry guidelines of JSHP and is made and provided by the particular drug’s manufacturer, it should be recognized that the listing and expressions must comply the constraints. And there is a need for the manufacturer to use the information with the understanding that IF being a material that supplements the package insert and hereupon also based on the openness on the internet, is made carefully so as not to contradict the advertising regulation of Pharmaceutical Affairs Law. (September 2008) Table of Contents Ⅰ． Entries related to summary········································································1 1. Development details············································································1 2. Therapeutic and pharmaceutical traits of the product··································1 Ⅱ．Name related entry···················································································2 1. Brand name·······················································································2 2. Western name····················································································2 3. Structural formula and Rational formula···················································2
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