natgillin/translations-raw huggingface dataset:
Nimesulide hæmmer prostaglandinsyntese enzym cyclo- oxygenase.
Nimesulide is an inhibitor of the prostaglandin synthesis enzyme cyclo-oxygenase.
CPMP/ 3086/ 03- REV. 1
CPMP/ 3086/ 03-REV.1 5.2 Pharmacokinetic properties
Når Nimesulide 3% påføres topisk, er plasmakoncentrationerne af nimesulide meget lave sammenlignet med dem, der opnås efter oral indtagelse.
When Nimesulide 3% is applied topically, plasma concentrations of nimesulide are very low in comparison with those achieved following oral intake.
Efter en enkelt påføring af 200mg nimesulide som gel, blev det højeste plasmaniveau på 9, 77 ng/ ml konstateret efter 24 timer.
After a single application of 200mg of nimesulide, in the gel form, the highest plasma level of 9.77 ng/ ml was noted after 24 hours.
Der blev ikke fundet spor efter det vigtigste stofskifteprodukt 4– hydroxy– nimesulide.
No trace of the main metabolite 4-hydroxy-nimesulide, was detected.
Ved stationærtilstand (dag 8) var plasmakoncentrationerne højere (37, 25 ± 13, 25 ng/ ml), men næsten 100 gange lavere end dem, der blev målt efter gentagen oral indgivelse.
At steady-state (day 8) peak plasma concentrations were higher (37.25 ± 13.25 ng/ ml, but almost 100 times lower than those measured following repeated oral administration.
Det lokale tolerance og irritations – og sensibiliseringspotentiale for Nimesulide 3% er blevet testet i flere anerkendte dyremodeller.
The local tolerance and the irritation and sensitisation potential of Nimesulide 3% have been tested in several recognised animal models.
Resultaterne af disse undersøgelser indicerer, at Nimesulide 3% tåles godt.
The results of these studies indicate that Nimesulide 3% is well tolerated.
De prækliniske data for systemisk indgivet nimesulide viser ingen særlige risici for mennesker baseret på traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, cancerfrembringende potentiale.
Preclinical data for systemically administered nimesulide reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
3086/ 03- REV. 1 30
CPMP/ 3086/ 03-REV.1
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Heiligenstädter Straße 52/ 2/ 8 A- 1190 Wien Østrig
Heiligenstädter Straße 52/ 2/ 8 A-1190 Wien Austria
Merck Sharp & Dohme GmbH Donau - City - Straße 6 A- 1220 Wien Østrig
Merck Sharp & Dohme GmbH Donau - City - Straße 6 A-1220 Wien Austria
Ratiopharm Arzneimittel Vertriebs- GmbH Albert- Schweitzer Gasse 3 A- 1140 Wien Østrig
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 A-1140 Wien Austria
Sandoz GmbH Biochemiestraße 10 A- 6250 Kundl Østrig
Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Austria
Docpharma N. V Ambachtenlaan 13H 3001 Heverlee Belgien
Docpharma N. V Ambachtenlaan 13H 3001 Heverlee Belgium
Socobom N. V Louizalaan 149 B24 1050 Brussel Belgien
Socobom N. V Louizalaan 149 B24 1050 Brussel Belgium
Ratiopharm Belgium S. A Rue St- Lambert 141 1200 Bruxelles Belgien
Ratiopharm Belgium S. A Rue St-Lambert 141 1200 Bruxelles Belgium
Teva Generics Belgium NV Laarstraat 16 2610 Wilrijk Belgien
Teva Generics Belgium NV Laarstraat 16 2610 Wilrijk Belgium
Overtrukket tablet
Coated tablets
Krka, d. d. Novo Mesto Smarjeka cesta 6 8501 Novo mesto Slovenien
Krka, d. d. Novo Mesto Smarjeka cesta 6 8501 Novo mesto Slovenia
Hexal AG Industriestrasse 25, D- 83607 Holzkirchen, Tyskland
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Germany
Merck Sharp & Dohme BV, Waarderweg 39, NL- 2031 BN Haarlem, Holland
Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, The Netherlands
Medochemie Ltd, P. O Box 51409 Lemesos Cypern
Medochemie Ltd, P. O Box 51409 Lemesos Cyprus
Remedica Ltd, P. O Box 51706 Lemesos Cypern
Remedica Ltd, P. O Box 51706 Lemesos Cyprus
1- 10, P. O. Box 51409, CY- 3505 Limassol Cypern
1-10, P. O. Box 51409, CY-3505 Limassol Cyprus
Ratiopharm GmbH Graf- Arco- Strasse 3 D- 89070 Ulm Tyskland
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Germany
Tad Pharma GmbH Heinz- Lohmann Strasse 5, DE- 27472, Cuxhaven Tyskland
Tad Pharma GmbH Heinz-Lohmann Strasse 5, DE-27472, Cuxhaven Germany
Šmarješka cesta 6 8501 Novo mesto Slovenien
Š marješ ka cesta 6 8501 Novo mesto Slovenia
Biogaran 15 Bd Charles de Gaulle 92700 Colombes Frankrig
Biogaran 15 Bd Charles de Gaulle 92700 Colombes France
EG Labo "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex Frankrig
EG Labo "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France
Ivax Pharmaceuticals SAS 1 cours du triangle, Immeuble palatin 1 92936 Paris la Défense cedex Frankrig
Ivax Pharmaceuticals SAS 1 cours du triangle, Immeuble palatin 1 92936 Paris la Défense cedex France
Merck Generiques 34, rue Saint- Romain 69359 Lyon Cedex 08 Frankrig
Merck Generiques 34, rue Saint-Romain 69359 Lyon Cedex 08 France
Laboratoire Qualimed 34, rue Saint- Romain 69008 Lyon Frankrig
Laboratoire Qualimed 34, rue Saint-Romain 69008 Lyon France
5 Medlemsstat
5 Member State
Sandoz 49, avenue Georges Pompidou 92300 Levallois- Perret Frankrig
Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
Socitété Teva Classics Le Palatin 1 1, cours du Triangle 92936 Paris la Défense Cedex Frankrig
Socitété Teva Classics Le Palatin 1 1, cours du Triangle 92936 Paris la Défense Cedex France
Sanofi Aventis France 1/ 13, Bd Romain Rolland 75014 Paris Frankrig
Sanofi Aventis France 1/ 13, Bd Romain Rolland 75014 Paris France
Merck Sharp – Dohme Chibret 3 avenue Hoche 75114 Paris Cedex 08 Frankrig
Merck Sharp – Dohme Chibret 3 avenue Hoche 75114 Paris Cedex 08 France
7 D- 89143 Blaubeuren Tyskland
7 D-89143 Blaubeuren Germany
6 Medlemsstat
6 Member State
Tyskland Tyskland
Germany Germany
27 D- 01309 Dresden Tyskland
27 D-01309 Dresden Germany
CT Arzneimittel GmbH
CT Arzneimittel GmbH
Norflox- CT
Norflox-CT
Lengeder Str.
Lengeder Str.
42 a D- 13407 Berlin Tyskland
42 a D-13407 Berlin Germany
Heumann Pharma GmbH & Co. Generica. KG Südwestpark 50 D- 90449 Nürnberg Tyskland
Heumann Pharma GmbH & Co. Generica. KG Südwestpark 50 D-90449 Nürnberg Germany
11 D- 83607 Holzkirchen Tyskland
11 D-83607 Holzkirchen Germany
11 D- 83607 Holzkirchen
11 D-83607 Holzkirchen
7 Medlemsstat
7 Member State
2- 18 D- 61118 Bad Vilbel Tyskland
2-18 D-61118 Bad Vilbel Germany
5 D- 27472 Cuxhaven Tyskland
5 D-27472 Cuxhaven Germany
Teofarma S. R. L Via F. Iii Cervi 8 I- 27010 Valle Salimbene (PV) Itaien
Teofarma S. R. L Via F. Iii Cervi 8 I-27010 Valle Salimbene (PV) Italy
64 D- 53125 Bonn Tyskland
64 D-53125 Bonn Germany
Paleologou & Perikleous 27, Halandri, 15232 Grækenland
Paleologou & Perikleous 27, Halandri, 15232 Greece
Psychiko, 15451 Grækenland
Psychiko, 15451 Greece
8 Medlemsstat
8 Member State
Vianex S. A Tatoiou Street Nea Erythrea 14671 Grækenland
Vianex S. A Tatoiou Street Nea Erythrea 14671 Greece
Kifissia Grækenland
Kifissia Greece
Overtrukket tablet
coated tablet
Faran Abee Production and Trading Medicines Averof 19A, Athens, 10433 Grækenland
Faran Abee Production and Trading Medicines Averof 19A, Athens, 10433 Greece
Xrispa Alpha Farmaceuticals S. A 16th Km Marathonos Avenue Pallini 15344 Grækenland
Xrispa Alpha Farmaceuticals S. A 16th Km Marathonos Avenue Pallini 15344 Greece
Irakleion 14122 Grækenland
Irakleion 14122 Greece
Medicrom S. A 6 Km Markopoulo- Koropi Avenue Markopoulo Mesogeion 19003 Grækenland
Medicrom S. A 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Genepharm A. E 18th Km Marathonos Avenue, Pallini Attikis, 15351 Grækenland
Genepharm A. E 18th Km Marathonos Avenue, Pallini Attikis, 15351 Greece
Biospray Abee 18th Km Marathonos Avenue, Pallini, 15344 Grækenland
Biospray Abee 18th Km Marathonos Avenue, Pallini, 15344 Greece
9 Medlemsstat
9 Member State
Coup Abee Agias Varvaras 53- 55, Dafni, Athens, 17235 Grækenland
Coup Abee Agias Varvaras 53-55, Dafni, Athens, 17235 Greece
Viofar Epe Ethnikis Antistaseos & Trifyllias, Aharnai, 13671 Grækenland
Viofar Epe Ethnikis Antistaseos & Trifyllias, Aharnai, 13671 Greece
Sandoz GmbH, Kundl, Austria Biochemiestrasse 10, A- 6520, Kundl Østrig
Sandoz GmbH, Kundl, Austria Biochemiestrasse 10, A-6520, Kundl Austria
5 Ungarn
5 Hungary
AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u. 27 Ungarn
AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Hungary
10 Medlemsstat
10 Member State
36/ a Ungarn
36/ a Hungary
Tad Pharma GmbH, Heinz- Lohmann- Strasse 5 27472 Cuxhaven Tyskland
Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 27472 Cuxhaven Germany
Corso Vittorio Emanuele II, 72 Torino Italien
Corso Vittorio Emanuele II, 72 Torino Italy
Actavis Italy SpA V. Jose' Escrivia De Balaguer, 6 21047 Saronno (VA) Italien
Actavis Italy SpA V. Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italy
Via Pavia, 6 20136 Milano Italien
Via Pavia, 6 20136 Milano Italy
Viale Città d’ Europa 681 - 00144 Roma Italien
Viale Città d’ Europa 681 - 00144 Roma Italy
Fleming 2 - 37135 Verona Italien
Fleming 2 - 37135 Verona Italy
11 Medlemsstat
11 Member State
Via Egadi, 7 - 20144 Milano Italien
Via Egadi, 7 - 20144 Milano Italy
Fabbroni, 6 - 00191 Roma Italien
Fabbroni, 6 - 00191 Roma Italy
Pliva Pharma S. p. A. via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italien
Pliva Pharma S. p. A. via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italy
Largo Umberto Boccioni, 1 21040 – Origgio (VA) Italien
Largo Umberto Boccioni, 1 21040 – Origgio (VA) Italy
Tad Pharma Italia S. r. l. via Felice Casati, 16 – 20124 Milano Italien
Tad Pharma Italia S. r. l. via Felice Casati, 16 – 20124 Milano Italy
12 Medlemsstat
12 Member State
Francia Farmaceutici Industria Farmaco Biologica Srl - Via dei Pestagalli 7 Milano Italien
Francia Farmaceutici Industria Farmaco Biologica Srl - Via dei Pestagalli 7 Milano Italy
Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli 7 Milano Italien
Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli 7 Milano Italy
Pliva Pharma S. p. A via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italien
Pliva Pharma S. p. A via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italy
Cipla (UK) Ltd Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS Storbritannien
Cipla (UK) Ltd Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS United Kingdom
13 Medlemsstat
13 Member State
Smarješka cesta 6, Sl- 8501 Novo mesto Slovenien
Smarješ ka cesta 6, Sl-8501 Novo mesto Slovenia
Juran XXIII, 15- 19, 3a planta ES- 08950, Esplugas de Llobregat, Barcelona Spanien
Juran XXIII, 15-19, 3a planta ES-08950, Esplugas de Llobregat, Barcelona Spain
Krka d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
Krka d. d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
House, 97/ 107 Uxbridge Road, Ealing London W5 5TL, Storbritannien
House, 97/ 107 Uxbridge Road, Ealing London W5 5TL, United Kingdom
Merck Sharp & Dohme Chaussée de Waterloo 1135 B- 1180 Bruxelles Belgien
Merck Sharp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Belgium
Eurogenerics Esplanade Heysel, B. 22 B- 1020 Bruxelles Belgien
Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Belgium
14 Medlemsstat
14 Member State
Merck, Sharp & Dohme Hertford Road Hoddesdon Hertfordshire EN11 9BU Storbritannien
Merck, Sharp & Dohme Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
K Paleologou & Perikleous 153 32 Halandri Athens Grækenland
K Paleologou & Perikleous 153 32 Halandri Athens Greece
Nieuwe Donk 9, 4879 AC Etten- Leur, Holland
Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
Sandoz B. V., Veluwezoom 22, 1327 AH Almere, Holland
Sandoz B. V., Veluwezoom 22, 1327 AH Almere, The Netherlands
15 Medlemsstat
15 Member State
Krka d. d., Novo mesto, Słowenia, 8501, Novo Mesto, Smarjeska Cesta 6 Slovenien
Krka d. d., Novo mesto, Sł owenia, 8501, Novo Mesto, Smarjeska Cesta 6 Slovenia
Piłsudskiego 5 95- 200 Pabianice Polen
Pił sudskiego 5 95-200 Pabianice Poland
Mamede do Coronado,
Mamede do Coronado, Portugal
16 Medlemsstat
16 Member State
Portugal Rumænien
Romania
Victor Babes nr. 50, Baia Mare, Jud Maramures, zip code; 430092 Rumænien
Victor Babes nr.50, Baia Mare, Jud Maramures, zip code; 430092 Romania
060044 Rumænien
060044 Romania
Krka d. d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenien
Krka d. d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
400640 Cluj Napoca, Rumænien
400640 Cluj Napoca, România
17 Medlemsstat
17 Member State
Ilfov, Rumænien
Ilfov, România
Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
P. O. Box 51409, Limassol, CY – 3505 Cypern
P. O. Box 51409, Limassol, CY – 3505 Cyprus
Novo mesto, Šmarješka cesta 6 8501 Novo mesto Slovenien
Novo mesto, Š marješ ka cesta 6 8501 Novo mesto Slovenia
Sharp & Dohme, S. A Josefa Valcárcel, 38 28027 Madrid Spanien
Sharp & Dohme, S. A Josefa Valcárcel, 38 28027 Madrid Spain
C / Valle de Tobalina, 16 Nave 3, 28021 Madrid Spanien
C/ Valle de Tobalina, 16 Nave 3, 28021 Madrid Spain
18 Medlemsstat
18 Member State
Spanien Spanien
Spain
28023 Aravaca Madrid Spanien
28023 Aravaca Madrid Spain
Inkeysa, S. A, Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Spanien
Inkeysa, S. A, Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Spain
Biosarto, S. A Foc, 68- 82, 08038 Barcelona, Spanien
Biosarto, S. A Foc, 68-82, 08038 Barcelona, Spain
Almirall Prodesfarma S. A Ronda General Mitre, 151, 08022 Barcelona, Spanien
Almirall Prodesfarma S. A Ronda General Mitre, 151, 08022 Barcelona, Spain
Alacan S. A Capricornio, 5, 03006 Alicante, Spanien
Alacan S. A Capricornio, 5, 03006 Alicante, Spain
Quimifar, S. A Comadran, 37, 08210 Barbera del Valles, Spanien
Quimifar, S. A Comadran, 37, 08210 Barbera del Valles, Spain
Qualigen Avda, Barcelona, 69 08970 Sant Joan Despi Barcelona Spanien
Qualigen Avda, Barcelona, 69 08970 Sant Joan Despi Barcelona Spain
19 Medlemsstat
19 Member State
Stada Arzneimittel Stadastrasse 2- 18 DE- 61118 Bad Vilbel Tyskland
Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Germany
Recip AB Box 906 170 09 Solna Sverige
Recip AB Box 906 170 09 Solna Sweden
Krka Sverige AB Göta Ark 175 Medborgarplatsen 25 118 72 Stockholm Sverige
Krka Sverige AB Göta Ark 175 Medborgarplatsen 25 118 72 Stockholm Sweden
Oralt
Oral Use
20 Medlemsstat
20 Member State
Tyskland Storbritannien
United Kingdom
TAD Pharma GmbH, Heinz- Lohmann- Strasse 5, Cuxhaven, D- 27472 Tyskland
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472 Germany
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR FJERNELSEN AF DEN TERAPEUTISKE INDIKATION "AKUT OG KRONISK KOMPLICERET PYELONEFRITIS" FREMLAGT AF EMEA FAGLIGE KONKLUSIONER
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS” PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
Belgien indledte en henvisningsprocedure den 14. september 2007 og anmodede CHMP om at give en udtalelse om, hvorvidt markedsføringstilladelserne for perorale formuleringer af lægemidler, der indeholder norfloxacin, til behandling af akut eller kronisk kompliceret eller ukompliceret pyelonefritis skulle opretholdes, ændres, suspenderes eller trækkes tilbage i hele Den Europæiske Union efter revurderingen af benefit/ risk- forholdet for norfloxacin.
Belgium triggered a referral procedure on 14 September 2007 and requested the CHMP to give its opinion on whether the marketing authorisations for oral formulations of products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the re- assessment of norfloxacin benefit/ risk balance.
Lægemidler, der indeholder norfloxacin, og som kun
Norfloxacin containing medicinal products,
er tilgængelige i en peroral formulering, giver ikke tilstrækkelige serumniveauer til behandling af samtidig bakteriæmi.
which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Andengenerations -
Second
fluoroquinoloner såsom ciprofloxacin, ofloxacin og levofloxacin giver højere serumkoncentrationer og langt bedre fordeling i væv end norfloxacin.
generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
- Kompliceret pyelonefritis kan behandles peroralt eller intravenøst (afhængigt af den lokale
- Complicated pyelonephritis can be treated orally or intravenously (according to local treatment
behandlingspolitik og de diagnostiske kriterier, der anvendes til bestemmelse af en kompliceret infektion).
policy and diagnostic criteria used for defining complicated infection).
Ved peroral behandling andengenerations- fluoroquinoloner bedre end norfloxacin, fordi de giver højere niveauer i serum og væv.
In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
Kun to indehavere af markedsføringstilladelse foreslog ikke at trække indikationen tilbage.
The MAHs that answered to the questions were unable to provide unpublished scientific data, and some proposed to withdraw this indication, at the exception of 2 MAHs.
Som svar til CHMP foreslog de fleste indehavere af markedsføringstilladelse at trække den pågældende indikation tilbage, men nogle indehavere af markedsføringstilladelse indsendte dog bibliografiske data, idet de ikke var i besiddelse af ikke- publicerede data fra kliniske undersøgelser.
As a response to CHMP, most of the MAHs proposed to withdraw the indication in question, while some MAHs chose to submit bibliographic data, because no unpublished data from clinical trials were available to them.
Det er dog allerede kendt, at andengenerations- fluoroquinoloner (ciprofloxacin, ofloxacin og levofloxacin) giver højere serumkoncentrationer og en mere fordelagtig vævsfordeling end norfloxacin.
It is though known that the second generation fluoroquinolones (ciprofloxacin, ofloxacin and levofloxacin) show higher serum concentrations and a more favourable tissue distribution than norfloxacin.
I forlængelse af drøftelsen i maj 2008 vedtog CHMP, at andengenerations- fluoroquinolonerne giver højere serumkoncentrationer end norfloxacin.
Further to the discussion held in May 2008, the CHMP agreed that the second generation of fluoroquinolones result in higher serum concentrations than norfloxacin.
Dette førte til vedtagelsen af en liste over uafklarede spørgsmål.
However the CHMP requested a more detailed review of all relevant data specifically on resistance to common urinary pathogens and the possible consequences on the section 5.1 of the SPC before the final conclusion could be made, which lead to the adoption of a List of Outstanding Issues.
Samlet set omfattede de indkomne svar vedlagte bibliografiske data og et forslag om opdatering af produktresuméets afsnit 5. 1.
Overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the SPC.
CHMP var dog imødekommende over for idéen om at opdatere de MIC breakpoints, der er angivet i produktresuméets afsnit 5. 1, således at dette afsnit også inkluderer de kliniske MIC breakpoints, der er fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST), da disse breakpoints ikke kun vedrører de patogener, der optræder ved kompliceret pyelonefritis, men også almindelige urinpatogener, som findes i forbindelse med andre indikationer relateret til urinvejene.
However the CHMP welcomed the idea to update the MIC breakpoints in section 5.1 of the SPC to include the clinical MIC breakpoints as defined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) in section 5.1 of the SPC as these breakpoints are not only related to the pathogens found in complicated pyelonephritis, but to common urinary pathogens found in other urinary indications.
Dette kunne gøres gennem en type II- ændring på nationalt niveau.
This could indeed be done through a type II variation at national level.
Benefit/ risk
Benefit/ risk
CHMP anbefalede derfor at fjerne den terapeutiske indikation "akut og kronisk kompliceret pyelonefritis" for lægemidler, der indeholder norfloxacin, i hele Europa.
Therefore, the CHMP recommended the removal of the therapeutic indication “ acute and chronic complicated pyelonephritis” for products containing norfloxacin throughout Europe.
BEGRUNDELSER FOR FJERNELSE AF DEN TERAPEUTISKE INDIKATION "AKUT OG KRONISK KOMPLICERET PYELONEFRITIS"
GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS”
Ud fra følgende betragtninger: • CHMP behandlede den indbringelse, der havde fundet sted i henhold til artikel 31 i direktiv 2001/ 83/ EF, som ændret, for lægemidler, som indeholder norfloxacin,
Whereas • The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing norfloxacin;
• CHMP konkluderede, at den perorale anvendelse af lægemidler, der indeholder norfloxacin, til behandling af akut eller kronisk kompliceret pyelonefritis fremkaldt af bakterier, som er følsomme over for norfloxacin, ikke længere kan understøttes, • CHMP konkluderede følgelig, at benefit/ risk- forholdet for perorale lægemidler, der indeholder norfloxacin, er negativt ved ovennævnte indikation.
• The Committee concluded that the oral use of norfloxacin containing medicinal products in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms could no longer be supported; • The Committee, as a consequence, concluded that the benefit/ risk balance of oral norfloxacin containing medicinal products is negative in the above indication.
anbefaler CHMP fjernelse af den terapeutiske indikation "akut og kronisk kompliceret pyelonefritis" for lægemidler, der indeholder norfloxacin, og som tages oralt (se listen over lægemidler i
The CHMP has recommended the removal of the therapeutic indication “ acute and chronic complicated pyelonephritis” for the medicinal products containing norfloxacin taken orally (referred to medicinal products listed in Annex I).
13. januar 2009 EMEA/ CHMP/ 89938/ 2009
13 January 2009 EMEA/ 660192/ 2008
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
Lægemidler indeholdende norfloxacin
Norfloxacin containing medicinal products
Internationalt fællesnavn (INN): norfloxacin
International non-proprietary name (INN): norfloxacin
Den 14. september 2007 indbragte Belgien en sag for EMEA i henhold til artikel 31 i direktiv 2001/ 83/ EF og anmodede CHMP om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for perorale formuleringer af lægemidler indeholdende norfloxacin til behandling af akut eller kronisk kompliceret eller ukompliceret pyelonefritis skulle opretholdes, ændres, suspenderes eller trækkes tilbage i hele Den Europæiske Union efter revurderingen af benefit/ risk- forholdet for norfloxacin.
On 14 September 2007, Belgium referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC and asked the CHMP to give its opinion on whether the marketing authorisations for oral formulations of medicinal products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the re-assessment of norfloxacin benefit/ risk balance.
Ved peroral behandling virker andengenerations- fluoroquinoloner bedre end norfloxacin, fordi de giver højere serum - og vævsniveauer.
In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
Den udpegede rapportør og medrapportør var henholdsvis dr.
Dr.
Ondřej Slanař og dr.
Ondř ej Slanař and Dr.
Pieter Neelsy.
Pieter Neels, respectively.