FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Slovenian: Po mnenju Odbora je malo verjetnosti, da bi bila ta razlika pomembna, prav tako pa ni bil prepričan, da je bila opredeljena podskupina bolnikov, ki bi imeli koristi zaradi dodajanja zdravila Velcade rituksimabu.
English: There are no consequences on the use of Velcade in its authorised indications.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Velcade pri odobrenih indikacijah.
English: It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
Slovenian: Uporablja se tudi samostojno pri bolnikih z napredovalo boleznijo, ki se niso odzvali na vsaj eno drugo zdravljenje in katerim so že presadili kostni mozeg ali pri katerih presaditev kostnega mozga ni mogoča.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade.
Slovenian: Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih uporabe zdravila Velcade.
English: The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients.
Slovenian: Predlagatelj je predstavil rezultate študije, v katero je bilo vključenih 676 bolnikov s folikularnim neHodgkinovim limfomom, ki se je ponovil ali napredoval kljub predhodnim zdravljenjem, in katere namen je bil oceniti učinek uporabe zdravila Velcade v kombinaciji z rituksimabom v primerjavi z uporabo samo rituksimaba pri teh bolnikih.
English: Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Slovenian: Zdravilo Velcade naj bi se uporabljalo tudi za folikularni ne-Hodgkinov limfom (rak limfnega tkiva (dela imunskega sistema), ki prizadene vrsto belih krvnih celic, imenovanih B-limfociti ali B-celice) v kombinaciji z rituksimabom pri bolnikih, pri katerih se je bolezen ponovno pojavila (ponovila po zdravljenju).
English: Velcade is a medicine given by injection that contains the active substance bortezomib.
Slovenian: Velcade je zdravilo za vbrizgavanje, ki vsebuje zdravilno učinkovino bortezomib.
English: It is given in combination with melphalan and prednisone (other medicines for multiple myeloma) to patients who have not been treated before and who are not suitable for high-dose chemotherapy with a bone marrow transplant.
Slovenian: Daje se v kombinaciji z melfalanom in prednizonom (drugima zdraviloma za multipli mielom), in to bolnikom, ki predhodno še niso bili zdravljeni in za katere kemoterapija z visokimi odmerki s sočasno presaditvijo kostnega mozga ni primerna.
English: On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.
Slovenian: je 2. julija 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Velcade, s katerim bi se njegova uporaba razširila na bolnike s ponovljenim folikularnim neHodgkinovim limfomom.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Velcade in the treatment of relapsed follicular non-Hodgkin lymphoma did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Velcade pri zdravljenju ponovljenega folikularnega ne-Hodgkinovega limfoma ne odtehtajo z njim povezanih tveganj.
English: In relapsed follicular non-Hodgkin lymphoma, Velcade was expected to work in the same way as it does in its existing indications.
Slovenian: Pri ponovljenem folikularnem ne-Hodgkinovem limfomu naj bi zdravilo Velcade delovalo enako kot pri sedanjih indikacijah.
English: Based on the review of the data and the company's response to the CHMP's questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Velcade could not have been approved for the treatment of patients with relapsed follicular non-Hodgkin lymphoma.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na vprašanja, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Velcade ni mogoče odobriti za zdravljenje bolnikov s ponovljenim folikularnim ne-Hodgkinovim limfomom.
English: The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.
Slovenian: Zaskrbljen je bil tudi, da kombinacija zdravila Velcade in rituksimaba povzroča več neželenih učinkov kot samo rituksimab.
English: What is happening with Velcade for the treatment of multiple myeloma?
Slovenian: Kakšne so posledice za zdravilo Velcade, indicirano za zdravljenje multiplega mieloma?
English: What was Velcade expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Velcade uporabljalo?
English: How was Velcade expected to work?
Slovenian: Kako naj bi zdravilo Velcade delovalo?
English: It is used to treat patients with multiple myeloma (a cancer of the plasma cells in the bone marrow).
Slovenian: V EU je odobreno od aprila 2004 in se uporablja za zdravljenje bolnikov z multiplim mielomom (rakom plazemskih celic v kostnem mozgu).
English: In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
Slovenian: V primerih, kjer lahko pričakujemo maternalna protitelesa, je morebiti potrebno še tretje injiciranje v starosti od 15 tednov.
English: Date of first authorisation: 06/11/2017.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/11/2017.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki po EXP.
English: After the second injection, and subsequent administrations, this reaction is markedly reduced.,
Slovenian: Po drugem injiciranju in nadaljnjih dajanjih je ta reakcija opazno blažja.
English: Pregnancy and lactation: Do not use in pregnant cats.
Slovenian: Brejost in laktacija: Ne uporabite pri brejih mačkah.
English: Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Slovenian: Prvo cepljenje: - prvo injiciranje mačjih mladičev, starih nad osem tednov - drugo injiciranje 3 ali 4 tedne kasneje.
English: Pharmacotherapeutic group: immunologicals for Felidae, inactivated viral vaccines for cats.
Slovenian: IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: imunološka zdravila za mačke (felidae), inaktivirana virusna cepiva za mačke.
English: Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Slovenian: Ne mešajte z nobenim drugim zdravilomza uporabo v veterinarski medicini, razen z zdravilom FELIGEN CRP ali FELIGEN RCP.
English: A decision to use this vaccine before or after another veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporao tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera do primera.
English: Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Slovenian: Viala iz stekla tipa I, ki vsebuje en odmerek (1 ml) cepiva, zaprta z butil-elastomernim zamaškom, premera 13 mm in zapečatena z aluminijasto zaporko.
English: Box of 10 or 50 vials
Slovenian: ŠKATLA Z 10 ALI 50 VIALAMI
English: Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Slovenian: Dodatki: 3-% gel aluminijevega hidroksida, izražen kot mg Al
English: No adverse reactions were observed after an overdose administration (2 doses) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Slovenian: Po dajanju prevelikega odmerka (2 odmerkov) zdravila za uporabo v veterinarski medicini ni bilo opaženih neželenih učinkov, razen tistih, ki so omenjeni v poglavju 4.6, z izjemo lokalnih reakcij, ki lahko trajajo dlje časa (od 5 do 6 tednov največ).
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Slovenian: Natrijev hidrogenfosfat, brezvodni Kalijev dihidrogenfosfat Aluminijev hidroksid (gel)Quillaja saponaria Voda za injekcije
English: Nobivac LeuFel suspension for injection for cats
Slovenian: Nobivac LeuFel suspenzija za injiciranje za mačke
English: Shake the vial gently and administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Slovenian: Vialo rahlo pretresite in subkutano dajte en odmerek (1 ml) zdravila za uporabo v veterinarski medicini po naslednjem programu cepljenja.
English: Vial label
Slovenian: NALEPKA NA VIALI
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Slovenian: B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z zdravilom FELIGEN CRP ali FELIGEN RCP.
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Slovenian: Odmerek (1 ml) zdravila za uporabo v veterinarski medicini dajte subkutano po naslednjem programu cepljenja.
English: Active substance: Minimum quantity of purified p45 FeLV-envelope antigen 102 µg
Slovenian: Učinkovina: Minimalna količina prečiščenega antigena ovojnice p 45 FeLV 102 µg
English: No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po dajanju prevelikega odmerka zdravila za uporabo v veterinarski medicini ni bilo opaženih neželenih učinkov, razen tistih, ki so omenjeni v poglavju 6, z izjemo lokalnih reakcij, ki lahko trajajo dlje časa (od 5 do 6 tednov največ).
English: The onset of immunity has been demonstrated from 3 weeks after the primary vaccination.
Slovenian: Začetek imunosti je bil dokazan od treh (3) tednov po prvem cepljenju.
English: PSUR submissions for Nobivac LeuFel shall be synchronised and submitted at the same frequency as for LEUCOGEN.
Slovenian: Redna posodobljena poročila o varnosti zdravila (PSUR) se predložijo z enako pogostnostjo kot za cepivo LEUCOGEN.
English: PACKAGE LEAFLET Nobivac LeuFel suspension for injection for cats
Slovenian: NAVODILO ZA UPORABO Nobivac LeuFel suspenzija za injiciranje za mačke
English: After the primary vaccination course, the duration of immunity lasts for one year.
Slovenian: Po prvem cepljenju je trajanje imunosti eno leto.
English: Excipients: Buffered isotonic solution to 1 ml.
Slovenian: Pomožne snovi: Puferna izotonična raztopina do 1 ml
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP and FELIGEN RCP.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z zdravilom FELIGEN CRP ali FELIGEN RCP.
English: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Slovenian: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Luxembourg/Luxemburg INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Slovenian: Luxembourg/Luxemburg INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Marketing authorisation holder and manufacturer responsible for the batch release
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij
English: Slovenská republika INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Slovenian: Slovenská republika INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Slovenian: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: CLINICAL PARTICULARS
Slovenian: Natrijev klorid
English: ivabradine
Slovenian: ivabradin
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Slovenian: Zdravnik mora razmisliti o prenehanju zdravljenja tudi, če ima zdravilo le omejen učinek na zmanjšanje simptomov ali zniževanje srčne frekvence.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Slovenian: Kadar se zdravilo uporablja za angino pektoris, je treba zdravljenje z njim prekiniti, če se simptomi po treh mesecih ne izboljšajo.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Slovenian: Priporočeni začetni odmerek je 5 mg dvakrat na dan ob obroku, kar zdravnik lahko poveča na 7,5 mg dvakrat na dan ali zmanjša na 2,5 mg (pol 5-miligramske tablete) dvakrat na dan, odvisno od bolnikove srčne frekvence in simptomov.
English: The full EPAR for Ivabradine JensonR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ivabradin JensonR je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Slovenian: Kadar je ta tok zaustavljen, se srčna frekvenca zniža, srce pa ima manj dela in potrebuje manj oksigenirane krvi.
English: It is used in combination with standard therapy which can include a beta-blocker.
Slovenian: Uporablja se v kombinaciji s standardnim zdravljenjem, ki lahko vključuje zaviralec adrenergičnih receptorjev beta.
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Slovenian: Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, ki imajo srčno frekvenco vsaj 70 utripov na minuto.
English: Ivabradine JensonR is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Ivabradin JensonR je na voljo v obliki tablet (5 mg in 7,5 mg), predpisuje in izdaja pa se le na recept.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine JensonR.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ivabradin JensonR.
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Slovenian: Simptomi srčnega popuščanja so posledica dejstva, da srce ne črpa dovolj krvi po telesu.
English: Ivabradine JensonR is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Slovenian: Ivabradin JensonR je zdravilo za srce, ki se uporablja za zdravljenje simptomov dolgotrajne stabilne angine pektoris (bolečin v prsnem košu, čeljusti in hrbtu, ki se pojavijo ob telesnem naporu) pri odraslih s koronarno boleznijo ožilja (boleznijo srca, ki jo povzroča zapora krvnih žil, ki dovajajo kri v srčno mišico).
English: The Committee recommended that Ivabradine JensonR be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Ivabradin JensonR odobri za uporabo v EU.
English: Ivabradine JensonR therefore reduces or prevents the symptoms of angina.
Slovenian: Zdravilo Ivabradin JensonR torej zmanjšuje ali preprečuje simptome angine pektoris.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine JensonR has been shown to have comparable quality and to be bioequivalent to Procoralan.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ivabradin JensonR primerljivo raven kakovosti kot zdravilo Procoralan ter da mu je biološko enakovredno.
English: What measures are being taken to ensure the safe and effective use of Ivabradine JensonR?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivabradin JensonR?
English: Because Ivabradine JensonR 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 Ivabradin JensonR generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blockers alone.
Slovenian: Uporablja se pri bolnikih, ki ne morejo jemati zaviralcev adrenergičnih receptorjev beta (druge vrste zdravila za zdravljenje angine pektoris), ali v kombinaciji z zaviralci adrenergičnih receptorjev beta pri bolnikih, pri katerih bolezen samo z zaviralci adrenergičnih receptorjev beta ni dovolj urejena.
English: The symptoms of angina are caused by the heart not receiving enough oxygenated blood.
Slovenian: Simptomi angine pektoris se pojavijo, kadar srce ne prejema dovolj oksigenirane krvi.
English: Ivabradine JensonR is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Slovenian: Zdravilo Ivabradin JensonR se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (stanjem, pri katerem srce ne more črpati dovolj krvi v druge dele telesa) in normalnim srčnim ritmom, ki imajo srčno frekvenco vsaj 75 utripov na minuto.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine JensonR have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ivabradin JensonR upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: By lowering the heart rate, Ivabradine JensonR reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Slovenian: Z zniževanjem srčne frekvence zdravilo Ivabradin JensonR zmanjša obremenitev srca ter tako zaustavi napredovanje srčnega popuščanja in izboljša simptome.
English: For more information about treatment with Ivabradine JensonR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ivabradin JensonR preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Ivabradine JensonR
Slovenian: Ivabradin JensonR
English: Because Ivabradine JensonR is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Procoralan.
Slovenian: Ker je zdravilo Ivabradin JensonR generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Procoralan.
English: For practical information about using Ivabradine JensonR, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ivabradin JensonR naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: This means that Ivabradine JensonR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Procoralan.
English: What are the benefits and risks of Ivabradine JensonR?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ivabradin JensonR?
English: Other information about Ivabradine JensonR
Slovenian: Druge informacije o zdravilu Ivabradin JensonR
English: What is Ivabradine JensonR and what is it used for?
Slovenian: Kaj je zdravilo Ivabradin JensonR in za kaj se uporablja?
English: Ivabradine JensonR contains the active substance ivabradine.
Slovenian: Zdravilo Ivabradin JensonR vsebuje zdravilno učinkovino ivabradin.
English: The active substance in Ivabradine JensonR, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' regulates the heart rate.
Slovenian: Zdravilna učinkovina v zdravilu Ivabradin JensonR, ivabradin, zaustavi „tok If“ v sinusnem vozlu, ki deluje kot naravni „spodbujevalnik“ srčne frekvence.
English: Why is Ivabradine JensonR approved?
Slovenian: Zakaj je bilo zdravilo Ivabradin JensonR odobreno?
English: Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Slovenian: Pri bolnikih, starejših od 75 let, se lahko uporabi manjši začetni odmerek, in sicer 2,5 mg dvakrat na dan. Z zdravljenjem je treba prenehati, če je srčna frekvenca trajno zmanjšana na manj kot 50 utripov na minuto ali če simptomi bradikardije (počasnega bitja srca) ne prenehajo.
English: How does Ivabradine JensonR work?
Slovenian: Kako zdravilo Ivabradin JensonR deluje?
English: How has Ivabradine JensonR been studied?
Slovenian: Kako je bilo zdravilo Ivabradin JensonR raziskano?
English: How is Ivabradine JensonR used?
Slovenian: Kako se zdravilo Ivabradin JensonR uporablja?
English: - if you have impaired liver function (see section 3.
Slovenian: - če imate okvarjeno delovanje jeter (glejte poglavje 3.
English: These gastro-resistant capsules are available in blister packs containing 7, 14, 28, 56 or 98 capsules.
Slovenian: Te gastrorezistentne kapsule so na voljo v pretisnih omotih po 7, 14, 28, 56 ali 98 kapsul.
English: Belgium ratiopharm Belgium Rue Saint-Lambert 14 11200 Bruxelles Belgium
Slovenian: Belgija ratiopharm Belgium Rue Saint-Lambert 14 11200 Bruselj Belgija
English: No further clinical data are needed to substantiate.
Slovenian: Za utemeljitev niso potrebni nadaljnji klinični podatki.