natgillin/translations-raw huggingface dataset:
The narrow therapeutic index means that accidental overdose is a real possibility under normal conditions of use, particularly for patients on certain concomitant medications or when combined with even a small amount of alcohol. 
Ozek terapevtski indeks pomeni, da je nenamerno prekomerno odmerjanje dejansko možno pod normalnimi pogoji uporabe, zlasti pri bolnikih z določenimi sočasno uporabljanimi zdravili ali v kombinaciji z že zelo majhno količino alkohola.
Similarly, proposals to limit supplies for each prescription to at most 15 days, or one month, before review is needed by the prescriber, are unlikely to be of any significant benefit in risk minimisation: the patient will still have access to significant large quantity in excess of the lethal dose. 
Podobno ni verjetno, da bi imeli predlogi za omejitev količine na posamezen recept za največ 15 dni oz. en mesec, preden zdravnik, ki predpisuje zdravilo, zahteva pregled, pomembne koristi pri zmanjševanju tveganja: bolnik bo še vedno imel dostop do količine, ki je bistveno večja od smrtnega odmerka.
Ibuprofen has also shown to be more effective, as a single dose, in the management of severe postoperative pain; tramadol being equally effective in this setting. 
Za ibuprofen so dokazali, da je v enojnem odmerku učinkovitejši pri obvladovanju hude postoperativne bolečine, pri čemer je enako učinkovit tudi tramadol.
One possible risk minimisation measure, a reduced pack size (e.g. to only 10 tablets), is unlikely to be of any significant benefit in risk minimisation as the lethal dose (particularly when taken with alcohol) is under 10 tablets. 
Eden izmed možnih ukrepov za zmanjševanje tveganja - zmanjšana velikost pakiranja (npr. na le 10 tablet) - najverjetneje ne bi pomenil bistvenih koristi za zmanjševanje tveganja, saj je smrtni odmerek (zlasti ob sočasni uporabi z alkoholom) manj kot 10 tablet.
The CHMP reviewed the data submitted by the MAHs to address the above-mentioned concerns as well as the available data from Member States in relation to drug poisoning that involves dextropropoxyphene and the investigation of suspicious deaths in their countries. 
CHMP je pregledal podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili za obravnavo zgoraj omenjenih zadržkov, ter razpoložljive podatke držav članic o zastrupitvah z zdravili, ki vsebujejo dekstropropoksifen, in o preiskavah sumljivih smrtnih primerov v posameznih državah.
Benefit-Risk 
Razmerje med koristmi in tveganji
GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATIONS 
PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILI
Apart from the strengthened warnings, and more extensive contra-indications, proposed by several MAHs, the other proposals for changes in the SPCs and PLs - for example, in relation to indication - reflected the existing variations across Europe and were often not internally consistent: for example, the proposal that chronic pain should be explicitly contra-indicated, in the context of a SPC also having instructions in relation to repeat prescriptions “which should not exceed three months”. 
Poleg okrepljenih opozoril in obsežnejših kontraindikacij, ki so jih predlagali nekateri imetniki dovoljenja za promet z zdravilom, so drugi predlogi sprememb povzetkov glavnih značilnosti zdravil in navodil za uporabo, npr. v zvezi z indikacijo, zadevali obstoječe variacije po Evropi in so bili pogosto notranje neskladni: npr. predlog, da bi morale biti kronične bolečine izrecno kontraindicirane, v kontekstu povzetka glavnih značilnosti zdravil, ki vključuje tudi navodila glede ponovitev receptov, „ki ne smejo presegati treh mesecev“.
Although available meta-analyses mostly included single dose studies, these data also provided further insights in the efficacy of the dextropropoxyphene containing medicinal products. 
Čeprav so bile v razpoložljive metaanalize večinoma vključene študije posameznih odmerkov, pa ti podatki omogočajo dodaten vpogled v učinkovitost zdravil, ki vsebujejo dekstropropoksifen.
On the basis of the available data sources, the CHMP was of the opinion that spontaneous reporting was significantly underestimating the number of reported deaths associated with dextropropoxyphene. 
CHMP je na osnovi razpoložljivih virov podatkov menil, da spontana poročila bistveno podcenjujejo število objavljenih smrti, povezanih z dekstropropoksifenom.
In view of the complex context in which cases of fatal overdose occurred under normal conditions of use and in view of the narrow therapeutic index and the potential for rapid death, the CHMP was of the opinion that the above proposed risk minimisation activities of narrowing the indication, reducing the pack sizes and/or introducing further safety warnings and contraindications (including those beyond the Product Information) would not be able to reduce the risks to an acceptable level. 
Zaradi zapletenega ozadja primerov prevelikega odmerjanja s smrtnim izidom pod normalnimi pogoji uporabe ter ozkega terapevtskega indeksa in možnosti hitre smrti je CHMP menil, da zgoraj predlagani ukrepi zmanjšanja tveganja, npr. zoženje indikacije, zmanjšanje velikosti pakiranja in/ali uvedba dodatnih varnostnih opozoril ter kontraindikacij (vključno s takimi, ki niso našteti v informacijah o zdravilu), ne bi zmanjšali tveganja na sprejemljivo raven.
However, the key safety concern with dextropropoxyphene is that it has a very narrow therapeutic index under normal conditions of use: following overdose, cardiac arrhythmias (which cannot be reversed using naloxone) and opioid side effects (such as respiratory depression) are rapid in onset and often fatal - there is evidence that the case fatality rate is higher than, for example, for tricyclic antidepressants. 
Vendar je ključni varnostni pomislek glede dekstropropoksifena ta, da ima dekstropropoksifen pod normalnimi pogoji uporabe zelo ozek terapevtski indeks: po prevelikem odmerjanju se srčne aritmije (ki jih ni mogoče odpraviti z naloksonom) in neželeni učinki opioidov (na primer depresija dihanja) pojavijo hitro in so pogosto smrtni - dokazano je, da je število smrtnih primerov višje kot na primer pri tricikličnih antidepresivih.
In chronic pain, other combinations of paracetamol and an opioid (such as a fixed-dose combination of paracetamol and codeine phosphate), or a combination of a non-steroidal anti-inflammatory drug (NSAID) and an opioid other than dextropropoxyphene have been shown to be at least as effective as the fixed combination of dextropropoxyphene and paracetamol. 
Pri kronični bolečini pa so za druge kombinacije paracetamola in opioida (kot je fiksna kombinacija odmerkov paracetamola in kodein fosfata) ali kombinacijo nesteroidnega protivnetnega zdravila (NSAID) in opioida, ki ni dekstropropoksifen, dokazali, da so vsaj tako učinkovite kot fiksna kombinacija dekstropropoksifena in paracetamola.
After considering the CHMP's major concerns over the toxicity of dextropropoxyphene, given its narrow therapeutic index and its adverse effects on the cardio - respiratory system as well as the lack of information in relation to the use of single component dextropropoxyphene medicinal products, the European Commission agreed on 31 March 2009 to the extension of the scope of the referral to also include authorised medicinal products containing only dextropropoxyphene. 
Po obravnavi poglavitnih zadržkov CHMP glede toksičnosti dekstropropoksifena in ob upoštevanju ozkega terapevtskega indeksa ter njegovih neželenih učinkov na srčno-dihalni sistem ter pomanjkanja podatkov o uporabi zdravil z dekstropropoksifenom kot edino sestavino, se je Evropska komisija dne 31. marca 2009 odločila razširiti obseg napotitvenega postopka z vključitvijo odobrenih zdravil, ki vsebujejo le dekstropropoksifen.
A substantial proportion of the fatal overdoses are accidental - occurring under normal conditions of use, for the licensed indication of painand there is a significant public health impact in relation to these cases alone. 
Velik delež prevelikih odmerkov s smrtnim izidom je nenameren in se zgodi pod normalnimi pogoji uporabe za odobreno indikacijo bolečine, poleg tega obstaja velik vpliv teh primerov samih na javno zdravje.
Prolonged-release capsule, hard 
Kapsula s podaljšanim sproščanjem, trda
In particular, more comprehensive mortality data at a national level from France, notably forensic toxicology results, provided evidence of a significantly greater number of deaths associated with the use of dextropropoxyphene-containing products than had previously been estimated. 
Zlasti obsežnejši podatki o umrljivosti na nacionalni ravni iz Francije, predvsem forenzični toksikološki rezultati, so pokazali bistveno večje število smrti zaradi uporabe zdravil, ki vsebujejo dekstropropoksifen, kot so ocenjevali dotlej.
Based on the limited efficacy and the significant risk of fatal overdose (in particular accidental overdose), the CHMP was of the opinion that the benefit/risk balance of dextropropoxyphene containing medicinal products was negative. 
Na osnovi omejene učinkovitosti in pomembnega tveganja prevelikega odmerjanja s smrtnim izidom (zlasti nenamerni primeri prevelikega odmerjanja) je CHMP menil, da je razmerje med koristmi in tveganji zaradi zdravil z dekstropropoksifenom negativno.
Because of this, the most reliable data come from forensic analysis and national mortality statistics, and complete review of the fatal overdoses associated with dextropropoxyphene (alone and in combination with paracetamol/caffeine) supported the major concern over the fatal toxicity of dextropropoxyphene containing products under normal conditions of use due to their narrow therapeutic index. 
Zaradi tega najbolj zanesljivi podatki izhajajo iz forenzičnih analiz in nacionalnih statistik umrljivosti, popoln pregled primerov prevelikih odmerkov s smrtnim izidom, povezanih z dekstropropoksifenom (samim ali v kombinaciji s paracetamolom/kofeinom), pa podpira poglavitni zadržek, ki zadeva smrtno toksičnost zdravil, ki vsebujejo dekstropropoksifen, pod normalnimi pogoji uporabe zaradi njihovega ozkega terapevtskega indeksa.
While some patients find these products helpful in managing pain, results from clinical trials do not provide evidence for the superior efficacy of dextropropoxyphene alone or in combination with paracetamol, when compared with normal therapeutic doses of simple analgesics. 
Čeprav nekaterim bolnikom ta zdravila koristijo pri obvladovanju bolečine, pa rezultati kliničnih preskušanj ne dokazujejo, da bi bila učinkovitost samega dekstropropoksifena, ali v kombinaciji s paracetamolom, večja v primerjavi z običajnimi terapevtskimi odmerki preprostih analgetikov.
In acute pain, the fixed combination of dextropropoxyphene and paracetamol appeared to be an effective analgesic; this is to be expected, as paracetamol alone is an effective analgesic. 
Pokazalo se je, da je za akutno bolečino fiksna kombinacija dekstropropoksifena in paracetamola učinkovit analgetik; to je pričakovano, saj je paracetamol tudi sam učinkovit analgetik.
Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality. 
Čeprav so spontana poročila kazala, da varnostni signal v zvezi s prevelikim odmerjanjem ni pomemben, so drugi, popolnejši podatki, zlasti iz forenzičnih centrov in nacionalnih statistik umrljivosti, potrdili, da je tveganje nenamernega prevelikega odmerka s smrtnim izidom v normalnih pogojih uporabe povezano z zdravili z dekstropropoksifenom, poglaviten zadržek, zlasti zaradi ozkega terapevtskega indeksa in visoke smrtnosti ob uporabi teh zdravil.
The CHMP, having considered the matter as set out in the appended referral assessment report recommended the withdrawal of all the Marketing Authorisations for all oral/rectal medicinal products referred to in Annex I to be effective within the next 15 months after Commission Decision in order to allow switching patients to safer alternatives in particular, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States. 
CHMP je po obravnavi zadeve, kakor je navedena v priloženem ocenjevalnem poročilu napotitvenega postopka, priporočil umik vseh dovoljenj za promet z vsemi zdravili, navedenimi v Dodatku I, kar se izvede v naslednjih 15 mesecih po sprejetju sklepa Komisije, s čimer bo bolnikom omogočen prehod na varnejša alternativna zdravila zlasti ob upoštevanju obsežne klinične rabe zdravil, ki vsebujejo dekstropropoksifen, in velike izpostavljenosti bolnikov v določenih državah članicah.
Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States. 
Zato je CHMP z večino glasov zaključil, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo dekstropropoksifen, negativno, da mnenja o zdravilih, ki vsebujejo dekstropropoksifen za peroralno/rektalno uporabo z dne 25. junija 2009 ni potrebno ponovno pregledati in je priporočil, da se dovoljenja za promet z zdravilom umakne v naslednjih 15 mesecih po sprejetju sklepa Komisije, da se bolnikom omogoči prehod na varnejša alternativna zdravila upoštevajoč obsežno klinično uporabo zdravil, ki vsebujejo dekstropropoksifen, in veliko število bolnikov, ki so temu zdravilu izpostavljeni v državah članicah.
However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death. 
Potrebi po nacionalnih podatkih o umrljivosti, zlasti podatkih o forenzični patologiji, za zagotovitev učinkovitosti ukrepov za zmanjševanje tveganj, ni bilo namenjene posebne pozornosti: zaradi bistveno premajhnega poročanja o resnih neželenih dogodkih, vključno s smrtjo, rutinsko zbranih (spontanih) podatkov ni mogoče uporabiti za oceno učinkovitosti ukrepov za zmanjševanje tveganj.
After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels. 
CHMP je po pregledu vseh razpoložljivih podatkov menil, da so različne številke iz virov podatkov (spontana poročila, forenzični centri, centri za zastrupitve, nacionalne statistike umrljivosti) pokazale skupno pomembno število smrti, pri katerih je dekstropropoksifen prisoten v toksičnih ravneh.
The different figures provided by the available data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels. 
Različne številke iz razpoložljivih virov podatkov (spontanih poročil, forenzičnih centrov, centrov za zastrupitve, nacionalnih statistik umrljivosti) so skupno pokazale precejšnje število smrti, pri katerih je dekstropropoksifen prisoten v toksičnih ravneh.
Available data showed only limited efficacy of the dextropropoxyphene medicinal products in the symptomatic treatment of pain. 
Iz razpoložljivih podatkov je razvidna le omejena učinkovitost zdravil z dekstropropoksifenom pri simptomatskem zdravljenju bolečine.
- The Committee concluded, in view of the available data, that the risk of accidental fatal overdose associated with the use of dextropropoxyphene containing medicinal products in the symptomatic treatment of pain outweigh the limited benefits. 
- zaradi razpoložljivih podatkov je Odbor zaključil, da tveganje nenamernega prevelikega odmerjanja s smrtnim izidom povezano z uporabo zdravil, ki vsebujejo dekstropropoksifen, za simptomatsko zdravljenje bolečine, odtehta omejene koristne učinke.
- The Committee considered that dextropropoxyphene containing medicinal products showed only limited efficacy in the symptomatic treatment of pain; 
- Odbor je menil, da je za zdravila, ki vsebujejo dekstropropoksifen, dokazana le omejena učinkovitost pri simptomatskem zdravljenju bolečine;
Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index. 
Odbor CHMP je po proučitvi podrobnih razlogov za ponovno presojo, ki so jih pisno in z ustno razlago navedli imetniki dovoljenja za promet, menil, da je bila zasnova predlagane klinične študije, ki bi dokazala večjo učinkovitost kombinacije dekstropropoksifena in paracetamola v primerjavi s paracetamolom, napačna in da zaradi ozkega terapevtskega indeksa niti dobro zasnovana študija ne bi spremenila razmerja med koristmi in tveganji pri zdravilih, ki vsebujejo dekstropropoksifen.
- The Committee also considered that a significant number of deaths have been reported in which dextropropoxyphene is present at toxic levels confirming that the risk of accidental fatal overdose associated with dextropropoxyphene containing medicinal products and their narrow therapeutic index is of major concern; 
- Odbor je tudi menil, da precejšnje število sporočenih smrti, pri katerih so bile prisotne toksične ravni dekstropropoksifena, dokazujejo tveganje nenamernega prevelikega odmerjanja s smrtnim izidom, ki je povezano z zdravili z dekstropropoksifenom, ter da je njihov ozek terapevtski indeks poglavitni zadržek;
However, there is no clear evidence from clinical trials of superiority of efficacy of the combination of dextropropoxyphene and paracetamol compared with normal therapeutic doses of paracetamol alone, the trials which have suggested superiority to paracetamol alone have used sub-therapeutic doses of paracetamol. 
Vendar iz kliničnih preskušanj ni jasnega dokaza, da je kombinacija dekstropropoksifena in paracetamola učinkovitejša od običajnih terapevtskih odmerkov samega paracetamola; v preskušanjih, ki so pokazala večjo učinkovitost od samega paracetamola, so uporabljali subterapevtske odmerke paracetamola.
Dextropropoxyphene containing medicinal products with Marketing Authorisation in the European Union 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo dekstropropoksifen
Member State Marketing Authorisation Holder Product Name 
Država članica Imetnik dovoljenja za promet z zdravilom
Prolonged-release capsule Oral use 
Kapsula s podaljšanim sproščanjem
Modified release capsule Oral use 
Kapsula s prirejenim sproščanjem
Domperidone DIGESTIVO GIULIANI 
DIGESTIVO GIULIANI
150 00 Praha 5 - Smíchov Czech Republic domperidone Motilium 
150 00 Praha 5 - Smíchov Czech Republic
10 mg capsule, hard 
10 mg kapsula, trda
Germany betapharm Arzneimittel GmbH Kobelweg 95 
Slovenija betapharm Arzneimittel GmbH Kobelweg 95
Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia domperidone Motilium 
Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia
McNeil Healthcare (Ireland) Limited Airton Road 
McNeil Healthcare (Ireland) Limited
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil 
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Domperidone DOMPERIDONE DR. REDDY'S 
DOMPERIDONE DR. REDDY'S
Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet 
Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal
Domperidone DOMPERIDONE TEVA 
DOMPERIDONE TEVA
Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal domperidone Domperidona Labesfal 
Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
20092 Cinisello Balsamo - MilanoItaly 
20092 Cinisello Balsamo - Milano - Italy
LABORATORIOS DR. ESTEVE, S.A. Avda. 
LABORATORIOS DR. ESTEVE, S.A.
Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis 
Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidone Domperidona Ratiopharm 
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal
Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed 
Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidone Domperidona Generis 
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Domperidone DOMPERIDONE PENSA 
DOMPERIDONE PENSA
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France domperidone DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé 
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
1314 SJ Almere 
1314 SJ Almere The Netherlands
Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidone Domperidona Baldacci 
Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Domperidone DOMPERIDONE DOC GENERICI 
DOMPERIDONE DOC GENERICI
United Kingdom Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate 
Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN
Domperidone Domperidona Gamir 10 mg cápsulas duras 
Domperidona Gamir mg cápsulas duras
Belgium domperidone Motilium-10 supp. 
Motilium-10 supp.
MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus domperidone COSTI TABLETS 10MG 
MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus
Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom 
Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex
3460 Birkeroed Denmark domperidone Motilium 
3460 Birkeroed Denmark
Domperidone DOMPERIDONE ALTER 
DOMPERIDONE ALTER
20 mg / 15 mg tablet 
20 mg/15 mg tableta
Belgium domperidone Motilium Domperidone Base 
Motilium Domperidone Base
Domperidone Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten 
Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
B-2340, Beerse Belgium domperidone motilium 10mg film coated tablets 
B-2340, Beerse Belgium motilium 10mg film coated tablets
B-2340, Beerse Belgium domperidone motilium 1mg/ml oral suspension 
B-2340, Beerse Belgium motilium 1mg/ml oral suspension
AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé 
AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France