Summary of Product Characteristics

(欧州の)製品概要

WordNet

1. a chemical substance formed as a result of a chemical reaction; "a product of lime and nitric acid"
2. a consequence of someones efforts or of a particular set of circumstances; "skill is the product of hours of practice"; "his reaction was the product of hunger and fatigue"
3. an artifact that has been created by someone or some process; "they improve their product every year"; "they export most of their agricultural production" (同)production
4. a quantity obtained by multiplication; "the product of 2 and 3 is 6" (同)mathematical product
5. a brief statement that presents the main points in a concise form; "he gave a summary of the conclusions" (同)sum-up

PrepTutorEJDIC

1. 『産物』;製品 / (…の)結果,帰結《+『of』+『名』(do『ing』)》 / (数の)積 / (化学の)生成物
2. 《所有・所属》…『の』,…のものである,…に属する・《材料・要素》…『でできた』,から成る・《部分》…『の』[『中の』] ・《数量・単位・種類を表す名詞に付いて》…の・《原因・動機》…『で』,のために(because of) ・《主格関係》…『の』,による,によって・《目的格関係》…『を』,の・《同格関係》…『という』・《関係・関連》…『についての』[『の』],の点で・《抽象名詞などと共に》…の[性質をもつ] ・《『It is』+『形』+『of』+『名』+『to』 doの形で,ofの後の名詞を意味上の主語として》・《分離》…『から』・《起原・出所》…『から』[『の』](out of) ・《『名』+『of』+『a』(『an』)+『名』の形で》…のような・《『名』+『of』+『mine』(『yours, his』など独立所有格)の形で》…の…・《時》(1)《副詞句を作って》…に《形容詞句を作って》…の・《時刻》《米》…前(to,《米》before)
3. (…の)『要約』,摘要 概要《+of+名》 / 『用約した』,かいつまんだ;手短の / (裁判などか)略式の,即決の
4. OLD French古[代]フランス語

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/05/25 15:49:13」(JST)

wiki en

[Wiki en表示]

The Summary of Product Characteristics is a specific document required within the European Commission before any medicinal product or biocidal product is authorized for marketing. Ths document is required under a number of different European Regulations, e.g. Regulations concerning medicines and Regulations concerning biocidal products. Depending on which Regulation this document is required under the fields contained in the summary may vary. However, in general this summary is the definitive description of the product both in terms of its properties, chemical, hazardardous properties, pharmacological and pharmaceutical etc. and the clinical use or industrial use to which it can put. The EU provide on the use of this document for applicants.

The Summary must be completed and submitted as an application to the European Medicines Agency, the European Chemicals Agency or one of the national competent authorities of the Member States before marketing is authorized. The document is thus an intrinsic part of the authorization and can only be changed after approval by means of an approved Variation.

The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied (Patient information leaflet) with the product contains information from and is drawn up using set out for the purpose.

The summary list is the structure used by a number of organizations when medicine information is delivered from web sites such as the This is not the same structure in use by the British BNF although that organization takes data from the SPC for the products it indexes.

Limitation of data: Data included in the SPC is from the individual companies proposal to MHRA for licensing purposes only, so by its nature will not include speculative information.

The list of headings that organizes the information

• 1. NAME OF THE MEDICINAL PRODUCT
• 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
• 3. PHARMACEUTICAL FORM
• 4. CLINICAL PARTICULARS
• 4.1 Therapeutic indications
• 4.2 Posology and method of administration
• 4.3 Contraindications
• 4.4 Special warnings and precautions for use
• 4.5 Interaction with other medicinal products and other forms of interaction
• 4.6 Pregnancy and lactation
• 4.7 Effects on ability to drive and use machines
• 4.8 Undesirable effects
• 4.9 Overdose
• 5. PHARMACOLOGICAL PROPERTIES
• 5.1 Pharmacodynamic properties
• 5.2 Pharmacokinetic properties
• 5.3 Preclinical safety data
• 6. PHARMACEUTICAL PARTICULARS
• 6.1 List of excipients
• 6.2 Incompatibilities
• 6.3 Shelf life
• 6.4 Special precautions for storage
• 6.5 Nature and contents of container
• 6.6 Special precautions for disposal and other handling
• Administrative Data
• 7. MARKETING AUTHORISATION HOLDER
• 8. MARKETING AUTHORISATION NUMBER(S)
• 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
• 10. DATE OF REVISION OF THE TEXT

References

General

• European Commission (2009): A guideline on summary of product characteristics (SmPC)
• How to prepare and review a summary of product characteristics, Webpage
• electronic Medicines Compendium, SPC explanation of headings
• electronic Medicines Compendium, Patient Information Leaflet

UpToDate Contents

全文を閲覧するには購読必要です。 To read the full text you will need to subscribe.

• 1. 血友病患者における第VIIIおよび第IX因子阻害物質 factor viii and factor ix inhibitors in patients with hemophilia
• 2. 一酸化炭素中毒 carbon monoxide poisoning
• 3. 尿毒症性そう痒症 uremic pruritus
• 4. 注入可能軟部組織充填剤：非永久性充填剤 injectable soft tissue fillers temporary agents
• 5. 非HIV感染患者におけるスルホンアミドアレルギー sulfonamide allergy in non hiv infected patients

English Journal

• The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

• Tzogani K1, Straube M, Hoppe U, Kiely P, O'Dea G, Enzmann H, Salmon P, Salmonson T, Pignatti F.Author information 1European Medicines Agency , London.AbstractThe European Commission has recently issued a marketing authorisation valid throughout the European Union for 5-aminolaevulinic acid (Ameluz). The decision was based on the favorable opinion of the CHMP recommending a marketing authorization for 5-aminolaevulinic acid for treatment of actinic keratosis of mild to moderate intensity on the face and scalp. The active substance is a sensitizer used in photodynamic/radiation therapy (ATC code L01XD04). The gel should cover the lesions and approximately 5 mm of the surrounding area with a film of about 1 mm thickness. The entire treatment area should be illuminated with a red light source, either with a narrow spectrum around 630 nm and a light dose of approximately 37 J/cm(2) or a broader and continuous spectrum in the range between 570 and 670 nm with a light dose between 75 and 200 J/cm(2). One session of photodynamic therapy should be administered for single or multiple lesions. Non- or partially responding lesions should be retreated in a second session 3 months after the first treatment. 5-aminolaevulinic acid is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy. In the presence of oxygen, reactive oxygen species are formed which causes damage of cellular components and eventually destroys the target cells. The benefit with 5-aminolaevulinic acid is its ability to improve the complete response rate of actinic keratosis lesions. The most common side effects are reactions at the site of application. The objective of this article is to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics (SmPC), are available on the EMA website (www.ema.europa.eu).
• The Journal of dermatological treatment.J Dermatolog Treat.2014 Oct;25(5):371-4. doi: 10.3109/09546634.2013.789474. Epub 2013 May 21.
• The European Commission has recently issued a marketing authorisation valid throughout the European Union for 5-aminolaevulinic acid (Ameluz). The decision was based on the favorable opinion of the CHMP recommending a marketing authorization for 5-aminolaevulinic acid for treatment of actinic kerato
• PMID 23550714

• PBPK models for the prediction of in vivo performance of oral dosage forms.

• Kostewicz ES1, Aarons L2, Bergstrand M3, Bolger MB4, Galetin A2, Hatley O2, Jamei M5, Lloyd R6, Pepin X7, Rostami-Hodjegan A8, Sjögren E9, Tannergren C10, Turner DB5, Wagner C11, Weitschies W12, Dressman J11.Author information 1Institute of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany. Electronic address: kostewicz@em.uni-frankfurt.de.2Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, The University of Manchester, United Kingdom.3Pharmacometrics Research Group, Department of Pharmaceutical Biosciences, Uppsala University, Sweden.4Simulations Plus, Inc., Lancaster, CA, United States.5Simcyp Limited (a Certara Company), Blades Enterprise Centre, Sheffield, United Kingdom.6Department of Drug Metabolism and Pharmacokinetics, GlaxoSmithKline, Ware, Hertfordshire, United Kingdom.7Department of Biopharmaceutics, Pharmaceutical Sciences R&D, Sanofi, Vitry sur Seine Cedex, France.8Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, The University of Manchester, United Kingdom; Simcyp Limited (a Certara Company), Blades Enterprise Centre, Sheffield, United Kingdom.9Department of Pharmacy, Uppsala University, Uppsala, Sweden.10Medicines Evaluation CVGI, Pharmaceutical Development, AstraZeneca R&D Mölndal, Sweden.11Institute of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany.12Department of Biopharmaceutics, University of Greifswald, Greifswald, Germany.AbstractDrug absorption from the gastrointestinal (GI) tract is a highly complex process dependent upon numerous factors including the physicochemical properties of the drug, characteristics of the formulation and interplay with the underlying physiological properties of the GI tract. The ability to accurately predict oral drug absorption during drug product development is becoming more relevant given the current challenges facing the pharmaceutical industry. Physiologically-based pharmacokinetic (PBPK) modeling provides an approach that enables the plasma concentration-time profiles to be predicted from preclinical in vitro and in vivo data and can thus provide a valuable resource to support decisions at various stages of the drug development process. Whilst there have been quite a few successes with PBPK models identifying key issues in the development of new drugs in vivo, there are still many aspects that need to be addressed in order to maximize the utility of the PBPK models to predict drug absorption, including improving our understanding of conditions in the lower small intestine and colon, taking the influence of disease on GI physiology into account and further exploring the reasons behind population variability. Importantly, there is also a need to create more appropriate in vitro models for testing dosage form performance and to streamline data input from these into the PBPK models. As part of the Oral Biopharmaceutical Tools (OrBiTo) project, this review provides a summary of the current status of PBPK models available. The current challenges in PBPK set-ups for oral drug absorption including the composition of GI luminal contents, transit and hydrodynamics, permeability and intestinal wall metabolism are discussed in detail. Further, the challenges regarding the appropriate integration of results from in vitro models, such as consideration of appropriate integration/estimation of solubility and the complexity of the in vitro release and precipitation data, are also highlighted as important steps to advancing the application of PBPK models in drug development. It is expected that the "innovative" integration of in vitro data from more appropriate in vitro models and the enhancement of the GI physiology component of PBPK models, arising from the OrBiTo project, will lead to a significant enhancement in the ability of PBPK models to successfully predict oral drug absorption and advance their role in preclinical and clinical development, as well as for regulatory applications.
• European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.Eur J Pharm Sci.2014 Jun 16;57C:300-321. doi: 10.1016/j.ejps.2013.09.008. Epub 2013 Sep 21.
• Drug absorption from the gastrointestinal (GI) tract is a highly complex process dependent upon numerous factors including the physicochemical properties of the drug, characteristics of the formulation and interplay with the underlying physiological properties of the GI tract. The ability to accurat
• PMID 24060672

• Profile of Adverse Events in Patients Receiving Treatment for Malaria in Urban Ghana: A Cohort-Event Monitoring Study.

• Dodoo AN1, Fogg C, Nartey ET, Ferreira GL, Adjei GO, Kudzi W, Sulley AM, Kodua A, Ofori-Adjei D.Author information 1Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana Medical School, P.O. Box GP 4236, Accra, Ghana, alex.dodoo@who-pvafrica.org.AbstractBACKGROUND: Antimalarial treatment strategies have changed much in the last 15 years, resulting in an increased variety of medicines available. Active pharmacovigilance methods are important for continued safety surveillance of these medicines, particularly in environments in which there is variability in treatments prescribed and limited confirmatory diagnostic capacity as well as limited ability of spontaneous reporting pharmacovigilance systems to generate much needed safety information quickly and efficiently.
• Drug safety : an international journal of medical toxicology and drug experience.Drug Saf.2014 May 1. [Epub ahead of print]
• BACKGROUND: Antimalarial treatment strategies have changed much in the last 15 years, resulting in an increased variety of medicines available. Active pharmacovigilance methods are important for continued safety surveillance of these medicines, particularly in environments in which there is variabi
• PMID 24788801

Japanese Journal

• P-46 Study on Decomposition Characteristics of Guluronic Acid

• ムハンマド ロジャンティ,秋 庸裕,岡村 好子,田島 誉久,中島田 豊,松村 幸彦
• バイオマス科学会議発表論文集 (10), 139-140, 2015-01-08
• … The ultimate objective of this research is to study the behaviour of guluronic acid (GA) during hydrothermal treatment. … The experimental works started with preparation of GA through partial hydrolysis of alginic acid with hydrochloric acid (HCl). … The separation of GA from its hydrolysate was performed based on solubility at pH 2.85 where GA was collected as insoluble precipitate. …
• NAID 110009926322

• Characterization of the Enzymatic and Structural Properties of Human D-Aspartate Oxidase and Comparison with Those of the Rat and Mouse Enzymes

• Katane Masumi,Kawata Tomonori,Nakayama Kazuki [他],Saitoh Yuki,Kaneko Yuusuke,Matsuda Satsuki,Saitoh Yasuaki,Miyamoto Tetsuya,Sekine Masae,Homma Hiroshi
• Biological and Pharmaceutical Bulletin 38(2), 298-305, 2015
• … Recent studies have implicated D-Asp in the pathophysiology of infertility and N-methyl-D-Asp receptor-related diseases. … Human DDO is considered an attractive therapeutic target, and DDO inhibitors may be potential lead compounds for the development of new drugs against the aforementioned diseases. …
• NAID 130004872265

• 農業資材産業における多国籍アグリビジネスのグローバル戦略(資材価格高止まり・農産物価格低迷下の農業市場と政策課題,2010年度大会シンポジウム報告)

• 久野 秀二
• 農業市場研究 19(3), 4-17, 2010-12-31
• … The recent global "food crisis" and subsequent market fluctuations have revealed clearly the significant role played by a handful transnational agribusiness corporations not just in the grain trading sector as happened in 1970s, but also in agricultural input sectors in a way that these corporations have reaped enormous profits at the expense of farmers worldwide. … This is possible because of an undue exercise of their oligopolistic influence on the agricultural input market. …
• NAID 110009865979

---

★リンクテーブル★

リンク元	「製品概要」
関連記事	「product」「summary」「summary of product characteristics」

「製品概要」

　　[★]

英

Summary of Product Characteristics

同

SmPC, SPC, 製品特性概要

「product」

　　[★]

• n.

• 産物、生成物、製品、結果、成果。(化学)生成物。(数学)積

関

accomplishment、achievement、consequence、outcome、output、result、resultant、sequence

　 　 　 　 　

「summary」

　　[★]

• n.

• 概略、概要、要約、要旨

関

abstract、brief、compendium、outline、overview、proceeding、recapitulate、recapitulation、sum、summarize、synopses、synopsis

　 　

「summary of product characteristics」

　　[★] Summary of Product Characteristics