FrancophonIA/ELRC3.0 huggingface dataset:
English: The only residue depletion study for methylprednisolone after intramuscular injection in cattle is cited in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL).
Slovenian: Edina študija o izločanju ostankov metilprednizolona po intramuskularnem injiciranju pri govedu je citirana v poročilu EPMAR odbora CVMP za metilprednizolon (EMEA/MRL/798/01-FINAL).
English: No information has been found in open databases (e.g. PubMed, Scopus, VetMed Resource, Web of Science) regarding pharmacokinetic and residue data of methylprednisolone hydrogen succinate in edible tissues and at the injection site of cattle.
Slovenian: V odprtih zbirkah podatkov (npr. PubMed, Scopus, VetMed Resource, Web of Science) ni nobenih informacij glede farmakokinetike in podatkov o ostankih metilprednizolonhidrogensukcinata v užitnih tkivih in na mestu injiciranja pri govedu.
English: Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Slovenian: Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung metilprednizolonhidrogensukcinat prašek in vehikel
English: The residue depletion data do not allow a statistically based determination of a withdrawal period.
Slovenian: Podatki o izločanju ostankov ne omogočajo določitve karence, ki bi temeljila na statističnih podatkih.
English: Furthermore, the data from the MRL file on methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological ADI, indicating a serious risk for consumer safety.
Slovenian: Poleg tega podatki dosjeja o najvišjih mejnih vrednostih ostankov za metilprednizolon podpirajo domnevo, da bo morebitna izpostavljenost potrošnikov ostankom na mestu injiciranja nad farmakološko dopustnim dnevnim vnosom, kar kaže na resno tveganje za varnost potrošnikov.
English: Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone.
Slovenian: Metilprednizolonhidrogensukcinat je ester sintetičnega glukokortikoida metilprednizolona.
English: Taking all the information together, it cannot be confirmed from the available data that the withdrawal period of 6 days for cattle (meat and offal) for the reference product Solu-Medrol is safe for the consumer.
Slovenian: Z upoštevanjem vseh informacij iz razpoložljivih podatkov ni mogoče potrditi, da je šestdnevna karenca za govedo (meso in organe) za referenčno zdravilo Solu-Medrol varna za potrošnika.
English: Following a marketing authorisation application to the Federal Office of Consumer Protection and Food Safety of Germany, under Article 13(1) of Directive 2001/82/EC, i.e., a generic application, for the veterinary medicinal product Solupred 125 mg (applicant: CP-Pharma), it appeared that no productspecific residue data are available in support of the cattle meat and offal withdrawal periods of 6 days for the reference products Solu-Medrol 120 mg and Solu-Medrol 500 mg which are authorised in France for use in dogs, cats and cattle (marketing authorisation holder: Zoetis).
Slovenian: Po vložitvi vloge za pridobitev dovoljenja za promet z zdravilom pri nemškem zveznem uradu za varstvo potrošnikov in varnost hrane v skladu s členom 13(1) Direktive 2001/82/ES, tj. generične vloge, za zdravilo Solupred 125 mg za uporabo v veterinarski medicini (predlagatelj: CP-Pharma), se je izkazalo, da v podporo šestdnevni karenci za goveje meso in organe za referenčni zdravili Solu-Medrol 120 mg in Solu-Medrol 500 mg, ki imata dovoljenje za promet v Franciji za uporabo pri psih, mačkah in govedu (imetnik dovoljenja za promet z zdravilom: Zoetis), ni na voljo nobenih za zdravilo specifičnih podatkov o ostankih.
English: • the CVMP considered that a withdrawal period for meat and offal derived from treated cattle cannot be set; the CVMP has recommended the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate as referred in Annex I.
Slovenian: • odbor CVMP je menil, da ni mogoče določiti karence za meso in organe, pridobljene iz zdravljenega goveda; odbor CVMP je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo, za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat, kot je navedeno v Prilogi I.
English: Therefore, the Committee considers that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Slovenian: Zato odbor meni, da razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo metilhidrogensukcinat in so v obliki raztopine za injiciranje za uporabo pri ciljni vrsti govedo, zaradi odsotnosti ustreznih podatkov o izločanju ostankov, ki bi utemeljilo šestdnevno karenco za govedo (meso in organe), ni ugodno.
English: In the absence of residue depletion data it cannot be ensured that residue levels are below the MRLs in all edible tissues at 6 days post-treatment.
Slovenian: Zaradi odsotnosti podatkov o izločanju ostankov ni mogoče zagotoviti, da so ravni ostankov v vseh užitnih tkivih šest dni po zdravljenju pod najvišjimi mejnimi vrednostmi ostankov.
English: • the CVMP considered that in the absence of residue depletion data, it cannot be ensured that residue levels are below the MRLs in all edible tissues at 6 days post-treatment;
Slovenian: • odbor CVMP je zaradi odsotnosti podatkov o izločanju ostankov menil, da ni mogoče zagotoviti, da so ravni ostankov v vseh užitnih tkivih šest dni po zdravljenju pod najvišjimi mejnimi vrednostmi ostankov;
English: The aim of the referral procedure was to consider all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated cattle.
Slovenian: Cilj napotitvenega postopka je bil oceniti vse razpoložljive podatke o izločanju ostankov in priporočiti karenco za meso in organe, pridobljene iz zdravljenega goveda.
English: Using the data available in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)2, Germany considered that residues of methylprednisolone at injection sites may lead to intake of amounts of methylprednisolone significantly above the Acceptable Daily Intake (ADI).
Slovenian: Na podlagi podatkov, ki so na voljo v evropskem javnem poročilu o najvišji mejni vrednosti ostankov (EPMAR) za metilprednizolon Odbora za zdravila za uporabo v veterinarski medicini (CVMP) (EMEA/MRL/798/01-FINAL)2), je Nemčija menila, da ostanki metilprednizolona na mestih injiciranja lahko privedejo do vnosa metilprednizolona v količinah, ki znatno presegajo dopustni dnevni vnos.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated cattle.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenco za meso in organe, pridobljene iz zdravljenega goveda.
English: Lyophilisate and diluent for solution for injection
Slovenian: metilprednizolonhidrogensukcinat liofilizat in razredčilo za raztopino za injiciranje
English: As no residue depletion data are available for veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP is not able to recommend withdrawal periods for meat and offal derived from treated cattle.
Slovenian: Ker za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat, ni na voljo nobenih podatkov o izločanju ostankov, odbor CVMP ne more priporočiti karence za meso in organe, pridobljene iz zdravljenega goveda.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation for the target species cattle and for the variation of the existing marketing authorisations in order to remove any reference to the target species cattle
Slovenian: Znanstveni zaključki in podlaga za zavrnitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in za spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo
English: Even if formulation differences and differences between the chemical forms of the active substances (methylprednisolone as free alcohol versus methylprednisolone hydrogen succinate) are taken into account, Germany considered that these data strongly indicate that a withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate containing products might not be sufficient to ensure consumer safety.
Slovenian: Tudi z upoštevanjem razlik med formulacijami in razlik med kemijskimi oblikami zdravilne učinkovine (metilprednizolon v obliki prostega alkohola v primerjavi z metilprednizolonhidrogensukcinatom) je Nemčija presodila, da ti podatki jasno kažejo, da šestdnevna karenca za govedo (meso in organe), zdravljeno z zdravili, ki vsebujejo metilprednizolonhidrogensukcinat, ne zadošča za zagotavljanje varnosti potrošnikov.
English: SOLU-MEDROL 120 MG Methylprednisolone hydrogen succinate
Slovenian: SOLU-MEDROL 120 MG
English: This conclusion applies to the administration of the products via the intramuscular route or the intravenous route.
Slovenian: Ta zaključek se nanaša na intramuskularno in intravensko uporabo zdravil.
English: • the CVMP considered that the data from the MRL file for methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological
Slovenian: • odbor CVMP je menil, da podatki dosjeja o najvišjih mejnih vrednostih ostankov za metilprednizolon podpirajo domnevo, da bo morebitna izpostavljenost potrošnikov ostankom na mestu injiciranja nad farmakološko dopustnim dnevnim vnosom, kar kaže na resno tveganje za varnost potrošnikov;
English: Consequently, the Committee recommends the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Slovenian: Zato odbor priporoča zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo, za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat.
English: SOLU-MEDROL 500 MG Methylprednisolone hydrogen succinate
Slovenian: SOLU-MEDROL 500 MG
English: Grounds for refusal of the granting of the marketing authorisation for the target species cattle and for the variation of the existing marketing authorisations in order to remove any reference to the target species cattle
Slovenian: Podlaga za zavrnitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in za spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo
English: Cattle, cats, dogs
Slovenian: 120 mg per bottle govedo, mačke, psi intramuskularna ali intravenska
English: All references to target species cattle should be deleted from the summary of product characteristics, labelling and package leaflet.
Slovenian: Iz povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo je treba izbrisati vse navedbe za ciljno vrsto govedo.
English: No residue depletion data are available for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Slovenian: Za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednozolonhidrogensukcinat, ni na voljo nobenih podatkov o izločanju ostankov.
English: The veterinary medicinal product that has been used in the residue depletion study for the establishment of maximum residue limits (MRLs) for methylprednisolone is a combination product containing methylprednisolone (as free
Slovenian: Zdravilo za uporabo v veterinarski medicini, uporabljeno v tej študiji o izločanju ostankov za ugotavljanje najvišjih mejnih vrednosti ostankov za metilprednizolon, je bilo kombinirano zdravilo, ki je vsebovalo metilprednizolon (v obliki prostega alkohola) in dve antibiotični učinkovini (neomicin in benzilpenicilin).
English: This is relevant for administration of the products via the intramuscular route as well as administration via the intravenous route.
Slovenian: To je pomembno pri intramuskularni in intravenski uporabi zdravil.
English: Even if formulation differences and differences between the chemical forms of the active substances (methylprednisolone as free alcohol versus methylprednisolone hydrogen succinate) are taken into account, these data strongly indicate that a withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products is insufficient to ensure consumer safety.
Slovenian: Prva časovna točka, ko so bili vsi podatki pod najvišjo mejno vrednostjo ostankov, je bil 21. dan. Tudi z upoštevanjem razlik med formulacijami in razlik med kemijskimi oblikami zdravilne učinkovine (metilprednozolon v obliki prostega alkohola v primerjavi z metilprednizolonhidrogensukcinatom) ti podatki jasno kažejo, da šestdnevna karenca za govedo (meso in organe), zdravljeno z zdravili, ki vsebujejo metilprednizolonhidrogensukcinat, ne zadošča za zagotavljanje varnosti potrošnikov.
English: No product specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate are available.
Slovenian: Podatki o izločanju ostankov v govejem mesu in organih Za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednozolonhidrogensukcinat, ni na voljo nobenih za zdravilo specifičnih podatkov o izločanju ostankov ali drugih informacij o ostankih.
English: 500 mg per bottle
Slovenian: 500 mg per bottle govedo, mačke, psi intramuskularna ali intravenska
English: The referral procedure was then started on 20 September 2007.
Slovenian: Napotitveni postopek se je začel 20. septembra 2007.
English: This could indeed be done through a type II variation at national level.
Slovenian: To pa se lahko izvede s spremembo tipa II na nacionalni ravni.
English: Benefit/risk
Slovenian: Korist/tveganje
English: This request was based on the following reasons:
Slovenian: Zahteva je utemeljena na naslednjih razlogih:
English: It is currently authorised in the EU under the different names referred in Annex I.
Slovenian: Trenutno ima dovoljenje za promet v EU pod različnimi imeni, navedenimi v Dodatku I.
English: - There are other alternative treatments available for the above-mentioned indication.
Slovenian: - Za zdravljenje navedenih indikacij so na voljo tudi druga zdravila.
English: Therefore the CHMP remained of the opinion that this indication should be withdrawn.
Slovenian: Zato je Odbor za zdravila za uporabo v humani medicini še naprej menil, da je to indikacijo treba umakniti.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing norfloxacin;
Slovenian: • je Odbor preučil napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo norfloksacin;
English: Medborgarplatsen 25 118 72 Stockholm Sweden
Slovenian: Medborgarplatsen 25 118 72 Stockholm Švedska
English: Production and Trading Medicines Averof 19A, Athens, 10433 Greece
Slovenian: Production and Trading Medicines Averof 19A, Athens, 10433 Grčija
English: - Pyelonephritis is often associated with bacteraemia.
Slovenian: - Pielonefritis je pogosto povezan z bakteremijo.
English: I-27010 Valle Salimbene (PV) Italy
Slovenian: I-27010 Valle Salimbene (PV) Italija
English: Most of the Marketing Authorisation Holders (MAHs) involved in the referral did not provide any answer to the list of questions adopted by the CHMP in September 2007, when the procedure was initiated.
Slovenian: Večina imetnikov dovoljenj za promet z zdravilom, ki so sodelovali v napotitvenem postopku, ni predložila nobenih odgovorov na seznam vprašanj, ki jih je Odbor za zdravila za uporabo v humani medicini sprejel septembra 2007 ob sprožitvi postopka.
English: AstraZeneca AB 151 85 Södertälje Sweden
Slovenian: AstraZeneca AB 151 85 Södertälje Švedska
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NORFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO NORFLOKSACIN (glejte Dodatek I)
English: Overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the SPC.
Slovenian: Gledano v celoti so predloženi odgovori vsebovali bibliografske podatke in predlog za posodobitev poglavja 5.1 v Povzetku glavnih značilnosti zdravila.
English: Alternova AB Vallgatan 11 170 67 Solna Sweden
Slovenian: Alternova AB Vallgatan 11 170 67 Solna Švedska
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: London W5 5TL, United Kingdom
Slovenian: London W5 5TL, Velika Britanija
English: D-53125 Bonn Germany
Slovenian: D-53125 Bonn Nemčija
English: 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Slovenian: 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Grčija
English: Korinthou 12, N. Psychiko, 15451 Greece
Slovenian: Korinthou 12, N. Psychiko, 15451 Grčija
English: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Greece
Slovenian: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Grčija
English: 15 Bd Charles de Gaulle 92700 Colombes France
Slovenian: 15 Bd Charles de Gaulle 92700 Colombes Francija
English: Avgis & Gallinis 15, N. Kifissia Greece
Slovenian: Avgis & Gallinis 15, N. Kifissia Grčija
English: - Complicated pyelonephritis can be treated orally or intravenously (according to local treatment policy and diagnostic criteria used for defining complicated infection).
Slovenian: - Zapleteni pielonefritis se lahko zdravi peroralno ali intravenozno (v skladu z lokalno politiko zdravljenja in diagnostičnimi merili za določanje zapletenih okužb).
English: D-01309 Dresden Germany
Slovenian: D-01309 Dresden Nemčija
English: 2790-221 Carnaxide, Portugal
Slovenian: 2790-221 Carnaxide, Portugalska
English: Laboratoire RPG 4 place Louis Armand 75012 Paris France
Slovenian: Laboratoire RPG 4 place Louis Armand 75012 Paris Francija
English: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Greece
Slovenian: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Grčija
English: 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.
Slovenian: Kljub temu pa je Odbor za zdravila za uporabo v humani medicini zahteval natančnejši pregled vseh ustreznih podatkov, zlasti o odpornosti na običajne sečne patogene in možnih posledicah na poglavje 5.1 Povzetka glavnih značilnosti zdravila, pred sprejetjem končne odločitve, ki bi lahko pripeljala do sprejetja seznama odprtih vprašanj.
English: Via Mario Lalli, 8 - 56127 Pisa Italy
Slovenian: Via Mario Lalli, 8 - 56127 Pisa Italija
English: Via A. Fleming 2 - 37135 Verona Italy
Slovenian: Via A. Fleming 2 - 37135 Verona Italija
English: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italy
Slovenian: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italija
English: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italy
Slovenian: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italija
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Slovenian: 49, avenue Georges Pompidou 92300 Levallois-Perret Francija
English: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630 Espoo, Finland
Slovenian: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630 Espoo, Finska
English: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgium
Slovenian: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgija
English: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, The Netherlands
Slovenian: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, Nizozemska
English: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Hungary
Slovenian: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Madžarska
English: Alacan S.A Capricornio, 5, 03006 Alicante, Spain
Slovenian: Alacan S.A Capricornio, 5, 03006 Alicante, Španija
English: 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.
Slovenian: Imetniki dovoljenj za promet z zdravilom, ki so na zastavljena vprašanja odgovorili, niso mogli navesti nobenih neobjavljenih znanstvenih podatkov, nekateri, razen dveh imetnikov dovoljenj za promet z zdravilom, pa so predlagali umik te indikacije.
English: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Hungary
Slovenian: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Madžarska
English: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italy
Slovenian: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italija
English: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Germany
Slovenian: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Nemčija
English: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgium
Slovenian: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgija
English: Merck Sharp & Dohme, Lda., Quinta da Fonte Edifício Vasco da Gama, 19 - Porto Salvo, 2770-192 Paço d' Arcos Portugal
Slovenian: Merck Sharp & Dohme, Lda., Quinta da Fonte Edifício Vasco da Gama, 19 - Porto Salvo, 2770-192 Paço d' Arcos Portugalska
English: Labesfal - Laboratórios Almiro, S.A. 3465-051Campo de Besteiros, Portugal
Slovenian: Labesfal - Laboratórios Almiro, S.A. 3465-051Campo de Besteiros, Portugalska
English: 7 - 20144 Milano Italy
Slovenian: 7 - 20144 Milano Italija
English: Vianex S.A Tatoiou Street Nea Erythrea 14671 Greece
Slovenian: Vianex S.A Tatoiou Street Nea Erythrea 14671 Grčija
English: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgium
Slovenian: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgija
English: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS United Kingdom
Slovenian: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS Velika Britanija
English: Via Pavia 6, 20131 Milano Italy
Slovenian: Via Pavia 6, 20131 Milano Italija
English: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Spain
Slovenian: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Španija
English: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Slovenian: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, Nizozemska