FrancophonIA/ELRC3.0 huggingface dataset:
English: MabThera is available as a concentrate that is made up into the solution for infusion and as a readymade solution for the injection under the skin.
Slovenian: Zdravilo MabThera je na voljo v obliki koncentrata za pripravo raztopine za infundiranje in v obliki pripravljene raztopine za injiciranje v podkožje.
English: • two inflammatory conditions of blood vessels known as granulomatosis with polyangiitis (GPA or
Slovenian: • dveh vnetnih stanj krvnih žil, znanih kot granulomatoza s poliangiitisom (GPA ali Wegenerjeva granulomatoza) in mikroskopski poliangiitis (MPA);
English: How is MabThera used?
Slovenian: Kako se zdravilo MabThera uporablja?
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Slovenian: • folikularnega limfoma in difuznega velikoceličnega B ne-Hodgkinovega limfoma (dveh vrst ne
English: • In a study of 198 patients with GPA or MPA, 64% of patients given MabThera were in complete remission after six months, compared with 55% given cyclophosphamide, a comparator medicine.
Slovenian: • v študiji s 198 bolniki z Wegenerjevo granulomatozo ali mikroskopskim poliangiitisom je bilo po šestih mesecih v popolni remisiji 64 % bolnikov, ki so prejemali zdravilo MabThera, v primerjavi s 55 % tistih, ki so prejemali primerjalno zdravilo ciklofosfamid.
English: In patients whose disease had come back after previous treatment, those receiving MabThera lived for 30.6 months without their disease getting worse, compared with 20.6 months in those receiving chemotherapy alone.
Slovenian: Pri bolnikih, pri katerih se je bolezen po predhodnem zdravljenju ponovila, so tisti, ki so prejemali zdravilo MabThera, brez poslabšanja bolezni živeli 30,6 meseca, v primerjavi z 20,6 meseca pri bolnikih, ki so prejemali le kemoterapijo;
English: How does MabThera work?
Slovenian: Kako zdravilo MabThera deluje?
English: • In a studies of MabThera given on its own (203 patients), 48% of the patients with follicular lymphoma who had failed previous treatment responded to MabThera.
Slovenian: • v študijah uporabe zdravila MabThera kot samostojnega zdravila (203 bolniki) se je na zdravilo MabThera odzvalo 48 % bolnikov s folikularnim limfomom, pri katerih predhodno zdravljenje ni bilo uspešno;
English: • In a maintenance study in patients whose follicular lymphoma had come back after previous treatment, patients who received MabThera alone lived for an average of 42.2 months without the disease getting worse, compared with 14.3 months in patients who did not receive the medicine.
Slovenian: • v vzdrževalni študiji pri bolnikih, pri katerih se je folikularni limfom po predhodnem zdravljenju ponovil, so bolniki, ki so prejemali samo zdravilo MabThera, živeli brez poslabšanja bolezni v povprečju 42,2 meseca, v primerjavi s 14,3 meseca pri bolnikih, ki tega zdravila niso prejeli.
English: MabThera is given as an infusion (drip) into a vein.
Slovenian: Zdravilo MabThera se daje z infundiranjem (kapalno infuzijo) v veno.
English: • severe rheumatoid arthritis (an inflammatory condition of the joints);
Slovenian: • hudega revmatoidnega artritisa (vnetne bolezni sklepov);
English: MabThera contains the active substance rituximab.
Slovenian: Zdravilo MabThera vsebuje zdravilno učinkovino rituksimab.
English: • In a study of 399 patients with diffuse large B-cell lymphoma, patients adding MabThera to chemotherapy lived for an average of 35 months without the disease getting worse or the need for a change in treatment, compared with 13 months in those receiving chemotherapy alone.
Slovenian: • v študiji s 399 bolniki z difuznim velikoceličnim B limfomom so bolniki po dodajanju zdravila MabThera kemoterapiji živeli brez poslabšanja bolezni ali potrebe po menjavi zdravljenja v povprečju 35 mesecev, bolniki, ki so prejemali le kemoterapijo, pa 13 mesecev;
English: • In a follicular lymphoma study involving 322 patients, patients receiving MabThera in addition to chemotherapy lived for an average of 25.9 months without the disease coming back, compared with 6.7 months in those receiving chemotherapy alone.
Slovenian: • v študiji folikularnega limfoma, ki je vključevala 322 bolnikov, so bolniki, ki so prejemali zdravilo MabThera kot dodatek kemoterapiji, v povprečju živeli 25,9 meseca brez ponovnega pojava bolezni, bolniki, ki so prejemali samo kemoterapijo, pa 6,7 meseca;
English: • In a study of 817 patients with CLL, patients who had not been treated before lived for an average of 39.8 months without their disease getting worse when they received MabThera in addition to chemotherapy, compared with 32.2 months in patients receiving chemotherapy alone.
Slovenian: • v študiji z 817 bolniki s kronično limfocitno levkemijo so predhodno nezdravljeni bolniki po prejemanju zdravila MabThera kot dodatka kemoterapiji brez poslabšanja bolezni živeli 39,8 meseca, v primerjavi z 32,2 meseca pri bolnikih, ki so prejemali le kemoterapijo.
English: The final opinion was converted into a Decision by the European Commission on 14 July 2008.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 14. julija 2008.
English: The Member States' competent authorities will continue to keep the product under regular review.
Slovenian: Pristojne oblasti držav članic bodo zdravilo še naprej redno nadzorovale.
English: London, 14 August 2008 EMEA/CHMP/524135/2008
Slovenian: London, 14. avgust 2008 EMEA/CHMP/524128/2008
English: The tablets have to be taken orally once daily for up to 10 days, depending on the indication.
Slovenian: Tablete je treba jemati peroralno enkrat dnevno do 10 dni, odvisno od indikacije.
English: Actira was initially approved in June 1999.
Slovenian: Zdravilo Actira so prvič odobrili junija 1999.
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Slovenian: V kliničnih preizkušanjih so tablete raziskovali do največ 14 dni zdravljenja.
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 19 March 2008.
Slovenian: ∗ Opombe: Informacije, podane v tem dokumentu in njegovih dodatkih, odražajo le mnenje CHMP z dne 19. marca 2008.
English: Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 January 2008 and 27 February 2008.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili pisna pojasnila 18. januarja 2008 in 27. februarja 2008.
English: The arbitration procedure was discussed by the CHMP at its plenary meeting in November 2007 and a Rapporteur (Dr Harald Enzmann) and Co-Rapporteur (Dr. Pieter Neels) were appointed.
Slovenian: CHMP je razpravljal o arbitražnem postopku na plenarnem zasedanju novembra 2007, kjer je bil za poročevalca imenovan dr. Harald Enzmann, za soporočevalca pa dr. Pieter Neels.
English: At the end of the mutual recognition procedure there was a discrepancy between different EU Member States regarding the wording of the indication that should adequately reflect the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by Belgium to the CHMP on 19 October
Slovenian: Na koncu postopka medsebojnega priznavanja se je med različnimi državami članicami EU pojavila neskladnost glede besedila indikacije, ki naj bi primerno odražalo klinične podatke, ki jih je predložila družba, Belgija pa je dne 19. oktobra 2007 obvestila CHMP o uradni napotitvi na arbitražo v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003, kakor je bila spremenjena.
English: On 19 March 2008, the CHMP recommended the variation to the Marketing Authorisations to include this indication.
Slovenian: CHMP je dne 19. marca 2008 priporočil spremembo dovoljenja za promet z zdravilom, ki vključuje to indikacijo.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Actira and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6(12) ZA ZDRAVILO Actira in povezana imena Mednarodno nelastniško ime (INN): moksifloksacin OSNOVNE INFORMACIJE*
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Slovenian: Zdravilo Actira, filmsko obložene tablete, vsebuje 400 mg moksifloksacina v obliki hidroklorida.
English: In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
Slovenian: Glede varnosti pri daljšem zdravljenju so se pojavili zadržki glede tveganja učinkov na hrustanec pri mladih bolnikih in glede tveganja podaljšanja intervala QT.
English: The Committee further considered that the benefit/risk balance concerning the use of moxifloxacin up to 14 days in the PID indication remains positive, and that information and recommendations on the use of moxifloxacin, and the measures that should be taken before it is prescribed, are adequately addressed in the ‘contraindications' and ‘special warnings and precautions for use' sections of the EU SPC.
Slovenian: Odbor je tudi menil, da razmerje med koristmi in tveganji ob uporabi moksifloksacina do 14 dni pri pelvični vnetni bolezni ostaja pozitivno ter da so podatki in priporočila o uporabi moksifloksacina z ukrepi, ki jih je treba izvesti pred predpisovanjem tega zdravila, primerno obdelani v poglavjih Kontraindikacije ter Posebna opozorila in previdnostni ukrepi za uporabo v Povzetku glavnih značilnosti zdravila za EU.
English: The Referral procedure was initiated on 15 November with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Slovenian: Napotitveni postopek se je začel 15. novembra s sprejemom seznama vprašanj odbora CHMP, na katera so morali odgovoriti imetniki dovoljenja za promet z zdravilom.
English: This Referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Slovenian: Napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi s spremembo tipa II za novo indikacijo, ki bo vključevala zdravljenje blage do zmerne pelvične vnetne bolezni, tj. okužb zgornjega dela genitalnih organov, vključno s salpingitisom in endometritisom.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, dopolnjeni povzetek glavnih značilnosti zdravila pa v Dodatku III.
English: The main unresolved areas of concern identified by Belgium were in terms of efficacy the emergence of moxifloxacin-resistant strains of N. gonorrhoeae and the feasibility of the treatment in the proposed indication in clinical practice.
Slovenian: Glavna nerešena sporna področja, ki jih je navedla Belgija, so se nanašala na učinkovitost, pojavnost sevov bakterije N. gonorrhoeae, ki so odporni na moksifloksacin, in izvedljivost zdravljenja za predlagano indikacijo v klinični praksi.
English: In view of the data provided on efficacy and safety, the benefit/risk of the proposed extended indication “mild to moderate pelvic inflammatory disease” was therefore considered to be positive by the CHMP as the initially proposed wording was adequately revised to reflect the current knowledge.
Slovenian: CHMP je menil, da je razmerje med koristmi in tveganji za predlagano indikacijo „blage do zmerne pelvične vnetne bolezni“ na podlagi priskrbljenih podatkov o učinkovitosti in varnosti pozitivno, saj je bilo prvotno predlagano besedilo primerno popravljeno, tako da odraža trenutno znanje.
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: acute exacerbation of chronic bronchitis; community acquired pneumonia, except severe cases; acute bacterial sinusitis (adequately diagnosed).
Slovenian: Zdravilo je odobreno za zdravljenje spodaj naštetih bakterijskih okužb, če jih povzročajo bakterije, ki so občutljive na moksifloksacin: akutno poslabšanje kroničnega bronhitisa, izvenbolnišnično pridobljena pljučnica, ki pa ne vključuje hudih primerov, akutni bakterijski sinusitis (ustrezno diagnosticiran).
English: The CHMP considered that moxifloxacin cannot be used in the setting of PID in empirical monotherapy due to the increasing incidence of fluoroquinolone-resistant N. gonorrhoeae, unless a resistant strain can be excluded.
Slovenian: CHMP je menil, da moksifloksacina ni mogoče uporabljati pri pelvični vnetni bolezni v empirični monoterapiji zaradi povečane pojavnosti sevov N. gonorrhoeae, odpornih na fluorokinolon, razen če je mogoče pojavljanje takih sevov izključiti.
English: Moxifloxacin should therefore be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) for the treatment of mild to moderate PID, unless moxifloxacin-resistant N. gonorrhoeae can be excluded.
Slovenian: Moksifloksacin je zaradi tega treba za zdravljenje blage do zmerne pelvične vnetne bolezni dajati v kombinaciji z drugim primernim protibakterijskim zdravilom (npr. cefalosporinom), razen če se lahko izključi prisotnost sevov N. gonorrhoeae, odpornih na moksifloksacin.
English: Immediate Packaging
Slovenian: Farmacevtska oblika
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Giovanni Ogna E Figli S.p.A. Viale Zara 23
Slovenian: Giovanni Ogna E Figli S.p.A.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Slovenian: Uporablja se pri bolnikih, ki so v preteklosti imeli težave zaradi krvnih strdkov (kot so denimo bolezen srca, kap ali arterijsko obolenje) ali imajo sladkorno bolezen tipa 2, zaradi katere so utrpeli poškodbo organa (npr. oči, srca ali ledvic).
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: Izraz „esencialna“ pomeni, da visok krvni tlak nima očitnega vzroka.
English: For more information about treatment with Telmisartan Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Telmisartan Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the benefits and risks of Telmisartan Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Telmisartan Teva?
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Slovenian: Hkrati omogoča, da lahko srce lažje črpa kri po telesu, kar pripomore k zmanjšanju tveganja za pojav srčno-žilnih težav v prihodnosti.
English: This means that Telmisartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Micardis.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Telmisartan Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva on 26 January 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Telmisartan Teva, veljavno po vsej Evropski uniji, izdala 26. januarja 2010.
English: Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Telmisartan Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Telmisartan Teva.
English: The active substance in Telmisartan Teva, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Telmisartan Teva, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu zavira delovanje hormona, imenovanega angiotenzin II.
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Teva, and may decide to adjust the patient's blood pressure-lowering medication.
Slovenian: Zdravnik mora ob začetku zdravljenja z zdravilom Telmisartan Teva skrbno spremljati bolnikov krvni tlak in se po potrebi odločiti za prilagoditev bolnikovega odmerka zdravila za zniževanje krvnega tlaka.
English: Telmisartan Teva is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Slovenian: Zdravilo Telmisartan Teva se uporablja tudi za preprečevanje srčno-žilnih težav (težav s srcem in ožiljem), kot sta srčni napad ali kap.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Telmisartan Teva primerljivo raven kakovosti kot zdravilo Micardis ter da mu je biološko enakovredno.
English: reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Slovenian: vrednost krvnega tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je denimo hidroklorotiazid.
English: Telmisartan Teva is a ‘generic medicine'.
Slovenian: Telmisartan Teva je „generično zdravilo“.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Slovenian: Posledica tega je znižanje krvnega tlaka, zaradi česar se zmanjšajo tveganja, povezana z visokim krvnim tlakom, kot sta srčni napad ali kap.
English: For the treatment of essential hypertension, the recommended dose of Telmisartan Teva is 40 mg once a day, but some patients may benefit from using a 20 mg dose.
Slovenian: Za zdravljenje esencialne hipertenzije znaša običajni priporočeni odmerek zdravila Telmisartan Teva 40 mg enkrat dnevno, vendar za nekatere bolnike zadostuje že 20-miligramski odmerek.
English: Telmisartan Teva is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Telmisartan Teva se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: Because Telmisartan Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Slovenian: Ker je zdravilo Telmisartan Teva generično zdravilo, so bile študije omejene na preskuse pri ljudeh za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Micardis.
English: Telmisartan Teva is a medicine that contains the active substance telmisartan.
Slovenian: Telmisartan Teva je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
English: The Committee recommended that Telmisartan Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Telmisartan Teva odobri dovoljenje za promet.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Slovenian: Za preprečevanje srčno-žilnih težav je priporočeni odmerek 80 mg enkrat na dan.
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Micardis, odtehtajo znana tveganja.
English: Other information about Telmisartan Teva
Slovenian: Druge informacije o zdravilu Telmisartan Teva:
English: The full EPAR for Telmisartan Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Slovenian: Bolniki s hudo okvaro delovanja ledvic morajo prejemati nižji začetni 20-miligramski odmerek enkrat na dan. Bolniki z blago do zmerno okvaro delovanja ledvic ne smejo prejemati odmerkov, višjih od 40 mg na dan.
English: Why has Telmisartan Teva been approved?
Slovenian: Zakaj je bilo zdravilo Telmisartan Teva odobreno?
English: How has Telmisartan Teva been studied?
Slovenian: Kako je bilo zdravilo Telmisartan Teva raziskano?
English: What is Telmisartan Teva?
Slovenian: Kaj je zdravilo Telmisartan Teva?
English: What is Telmisartan Teva used for?
Slovenian: Za kaj se zdravilo Telmisartan Teva uporablja?
English: How is Telmisartan Teva used?
Slovenian: Kako se zdravilo Telmisartan Teva uporablja?
English: How does Telmisartan Teva work?
Slovenian: Kako zdravilo Telmisartan Teva deluje?
English: Further information on Vantobra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vantobra
Slovenian: Dodatne informacije o zdravilu Vantobra so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/vantobra
English: After a 28-day course of treatment, the patient stops treatment for 28 days, before starting another 28-day course.
Slovenian: Po 28 dneh zdravljenja bolnik to za 28 dni prekine, čemur ponovno sledi 28-dnevno zdravljenje.
English: Vantobra1 (tobramycin)
Slovenian: Vantobra1 (tobramicin)
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Slovenian: Priporočeni odmerek je ena ampula dvakrat na dan, najbolje v razmaku 12 ur.
English: Vantobra is therefore easier to use and might help patients to stick to their treatment.
Slovenian: Zdravilo Vantobra je zato lažje uporabljati in lahko pomaga bolnikom, da se držijo zdravljenja.
English: The European Medicines Agency decided that Vantobra's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je sklenila, da so koristi zdravila Vantobra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Treatment courses may be repeated for as long as the doctor considers the patient to be benefiting from treatment.
Slovenian: Cikli zdravljenja se lahko ponavljajo, dokler to bolniku po zdravnikovi presoji koristi.
English: What measures are being taken to ensure the safe and effective use of Vantobra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vantobra?
English: 1 Previously known as Tobramycin PARI.
Slovenian: 1 Prej znano kot Tobramycin PARI
English: The Agency noted that safety profile of inhaled tobramycin was well known.
Slovenian: Agencija je ugotovila, da je varnostni profil tobramicina, ki se vdihava, dobro znan.
English: As for all medicines, data on the use of Vantobra are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vantobra stalno spremljajo.