FrancophonIA/ELRC3.0 huggingface dataset:
English: Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Slovenian: Zdravilo Stalevo 150 mg/37,5 mg/200 mg so rjavkaste ali sivkasto-rdeče, podolgovate filmsko obložene tablete v obliki elipse brez zareze, z oznako »LCE 150« na eni strani.
English: Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
Slovenian: Da bi se izognili morebitnim neželenim učinkom, vedno pustite, da preteče med jemanjem prejšnje in naslednje tablete zdravila Stalevo vsaj ena ura.
English: Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Stalevo 75 mg/18,75 mg/200 mg je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Stalevo.
Slovenian: - Med dolgotrajnejšim zdravljenjem z zdravilom Stalevo je priporočljivo občasno testirati delovanje jeter, srčno-žilnega sistema in ledvic.
English: Stalevo 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Stalevo 75 mg/18,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: According to this daily carbidopa dose, the maximum recommended daily dose of Stalevo 175 mg/43.75 mg/200 mg is 8 tablets per day and Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.
Slovenian: 175 mg/43,75 mg/200 mg je 8 tablet na dan in zdravila Stalevo 200 mg/50 mg/200 mg 7 tablet dnevno.
English: Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Stalevo 125 mg/31,25 mg/200 mg tablete je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: - Coadministration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section 4.5).
Slovenian: MAO-B) (npr. fenelzin, tranilcipromin) - sočasna uporaba selektivnega zaviralca MAO-A in selektivnega zaviralca MAO-B (glejte poglavje 4.5) - nevroleptični maligni sindrom (NMS) in/ali netravmatska rabdomioliza v preteklosti
English: Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Slovenian: Zdravilo Stalevo 125 mg/31,25 mg/200 mg: svetlorjavkasto rdeče, ovalne tablete z oznako »LCE 125« na eni strani.
English: Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Slovenian: Zdravilo Stalevo 75 mg/18,75 mg/200 mg: svetlorjavkasto rdeče, ovalne filmsko obložene tablete z oznako »LCE 75« na eni strani.
English: Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Slovenian: Zdravilo Stalevo 50 mg/12,5 mg/200 mg so rjavkaste ali sivkasto-rdeče, okrogle, konveksne filmsko obložene tablete brez zareze, z oznako »LCE 50« na eni strani.
English: Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Slovenian: Zdravilo Stalevo 175 mg/43,75 mg/200 mg tablete je na razpolago v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: Stalevo contains sucrose (1.9 mg/tablet).
Slovenian: Zdravilo Stalevo vsebuje saharozo (1,9 mg/tableto).
English: Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Slovenian: Zdravilo Stalevo 200 mg/50 mg/200 mg so na voljo v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
English: The doses of other antiparkinsonian medicinal products may need to be adjusted when Stalevo treatment is substituted for a patient currently not treated with entacapone.
Slovenian: Kadar zdravilo Stalevo nadomešča terapijo pri bolniku, ki trenutno ne prejema entakapona, bo odmerke drugih antiparkinsonskih zdravil morda treba ustrezno prilagoditi.
English: - Each Stalevo 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 125 mg/31,25 mg/200 mg vsebuje 125 mg levodope, 31,25 mg karbidope in 200 mg entakapona.
English: Stalevo contains sucrose (1.6 mg/tablet).
Slovenian: Zdravilo Stalevo vsebuje saharozo (1,6 mg/tableto).
English: How to store Stalevo
Slovenian: Shranjevanje zdravila Stalevo
English: - Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 75 mg/18,75 mg/200 mg vsebuje 75 mg levodope, 18,75 mg karbidope in 200 mg entakapona.
English: - Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 175 mg/43,75 mg/200 mg vsebuje 175 mg levodope, 43,75 mg karbidope in 200 mg entakapona.
English: - Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 150 mg/37,5 mg/200 mg vsebuje 150 mg levodope, 37,5 mg karbidope in 200 mg entakapona.
English: Stalevo contains sucrose (1.2 mg/tablet).
Slovenian: Zdravilo Stalevo vsebuje saharozo (1,2 mg/tableto).
English: Stalevo 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Stalevo 50 mg/12,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Stalevo contains sucrose (1.4 mg/tablet).
Slovenian: Zdravilo Stalevo vsebuje saharozo (1,4 mg/tableto).
English: - Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 100 mg/25 mg/200 mg vsebuje 100 mg levodope, 25 mg karbidope in 200 mg entakapona.
English: Stalevo 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Stalevo 175 mg/43,75 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: - Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 50 mg/12,5 mg/200 mg vsebuje 50 mg levodope, 12,5 mg karbidope in 200 mg entakapona.
English: Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Slovenian: Zdravilo Stalevo 175 mg/43,75 mg/200 mg: svetlorjavkasto rdeče, ovalne tablete z oznako »LCE 175« na eni strani.
English: Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Stalevo 150 mg/37,5 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Stalevo 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Stalevo 100 mg/25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Stalevo 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Slovenian: Stalevo 125 mg/31,25 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: EU/1/03/260/024 10 film-coated tablets EU/1/03/260/025 30 film-coated tablets EU/1/03/260/026 100 film-coated tablets EU/1/03/260/027 130 film-coated tablets EU/1/03/260/028 175 film-coated tablets
Slovenian: EU/1/03/260/024 10 filmsko obloženih tablet EU/1/03/260/025 30 filmsko obloženih tablet EU/1/03/260/026 100 filmsko obloženih tablet EU/1/03/260/027 130 filmsko obloženih tablet EU/1/03/260/028 175 filmsko obloženih tablet
English: Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Slovenian: Zdravilo Stalevo 100 mg/25 mg/200 mg so rjavkaste ali sivkasto-rdečkaste filmsko obložene ovalne tablete brez zareze, z oznako »LCE 100« na eni strani.
English: Stalevo 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Slovenian: Stalevo 200 mg/50 mg/200 mg filmsko obložene tablete levodopa/karbidopa/entakapon
English: Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Slovenian: Zdravilo Stalevo 200 mg/50 mg/200 mg: temnorjavkast rdeče ovalne filmsko obložene tablete brez zareze z oznako „LCE 200“ na eni strani.
English: - Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Slovenian: - Ena tableta zdravila Stalevo 200 mg/50 mg/200 mg vsebuje 200 mg levodope, 50 mg karbidope in 200 mg entakapona.
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Slovenian: To pomeni, da znaša maksimalni odmerek 10 tablet na dan zdravila Stalevo jakosti 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg in 150 mg/37,5 mg/200 mg.
English: EU/1/03/260/029 10 film-coated tablets EU/1/03/260/030 30 film-coated tablets EU/1/03/260/031 100 film-coated tablets EU/1/03/260/032 130 film-coated tablets EU/1/03/260/033 175 film-coated tablets
Slovenian: EU/1/03/260/029 10 filmsko obloženih tablet EU/1/03/260/030 30 filmsko obloženih tablet EU/1/03/260/031 100 filmsko obloženih tablet EU/1/03/260/032 130 filmsko obloženih tablet EU/1/03/260/033 175 filmsko obloženih tablet
English: Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Slovenian: Filmska obloga pri 50/12,5/200 mg, 100/25/200 mg, 150/37,5/200 mg: glicerol (85 odstotkov) (E422) hipromeloza (E464) magnezijev stearat polisorbat 80 (E433) rdeči železov oksid (E172) saharoza titanov dioksid (E171) rumeni železov oksid (E172)
English: EU/1/03/260/034 10 film-coated tablets EU/1/03/260/035 30 film-coated tablets EU/1/03/260/036 100 film-coated tablets EU/1/03/260/037 130 film-coated tablets EU/1/03/260/038 175 film-coated tablets
Slovenian: EU/1/03/260/034 10 filmsko obloženih tablet EU/1/03/260/035 30 filmsko obloženih tablet EU/1/03/260/036 100 filmsko obloženih tablet EU/1/03/260/037 130 filmsko obloženih tablet EU/1/03/260/038 175 filmsko obloženih tablet
English: EU/1/03/260/005 10 film-coated tablets EU/1/03/260/006 30 film-coated tablets EU/1/03/260/007 100 film-coated tablets EU/1/03/260/008 250 film-coated tablets EU/1/03/260/014 175 film-coated tablets EU/1/03/260/017 130 film-coated tablets
Slovenian: EU/1/03/260/005 10 filmsko obloženih tablet EU/1/03/260/006 30 filmsko obloženih tablet EU/1/03/260/007 100 filmsko obloženih tablet EU/1/03/260/008 250 filmsko obloženih tablet EU/1/03/260/014 175 filmsko obloženih tablet EU/1/03/260/017 130 filmsko obloženih tablet
English: EU/1/03/260/009 10 film-coated tablets EU/1/03/260/010 30 film-coated tablets EU/1/03/260/011 100 film-coated tablets EU/1/03/260/012 250 film-coated tablets EU/1/03/260/015 175 film-coated tablets EU/1/03/260/018 130 film-coated tablets
Slovenian: EU/1/03/260/009 10 filmsko obloženih tablet EU/1/03/260/010 30 filmsko obloženih tablet EU/1/03/260/011 100 filmsko obloženih tablet EU/1/03/260/012 250 filmsko obloženih tablet EU/1/03/260/015 175 filmsko obloženih tablet EU/1/03/260/018 130 filmsko obloženih tablet
English: EU/1/03/260/019 10 film-coated tablets EU/1/03/260/020 30 film-coated tablets EU/1/03/260/021 100 film-coated tablets EU/1/03/260/022 130 film-coated tablets EU/1/03/260/023 175 film-coated tablets
Slovenian: EU/1/03/260/019 10 filmsko obloženih tablet EU/1/03/260/020 30 filmsko obloženih tablet EU/1/03/260/021 100 filmsko obloženih tablet EU/1/03/260/022 130 filmsko obloženih tablet EU/1/03/260/023 175 filmsko obloženih tablet
English: EU/1/03/260/001 10 film-coated tablets EU/1/03/260/002 30 film-coated tablets EU/1/03/260/003 100 film-coated tablets EU/1/03/260/004 250 film-coated tablets EU/1/03/260/013 175 film-coated tablets EU/1/03/260/016 130 film-coated tablets
Slovenian: EU/1/03/260/001 10 filmsko obloženih tablet EU/1/03/260/002 30 filmsko obloženih tablet EU/1/03/260/003 100 filmsko obloženih tablet EU/1/03/260/004 250 filmsko obloženih tablet EU/1/03/260/013 175 filmsko obloženih tablet EU/1/03/260/016 130 filmsko obloženih tablet
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Slovenian: 1 Člen 29(4) Direktive 2001/83/ES, kot je bila spremenjena.
English: London, 11 July 2007 EMEA/CHMP/75066/2007
Slovenian: London, 11. julij 2007 EMEA/CHMP/75066/2007
English: The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
Slovenian: Referenčna država članica je bila Nizozemska, zadevne države članice pa Avstrija, Nemčija, Irska, Italija in Združeno kraljestvo.
English: Hikma Farmaceutica Lda.
Slovenian: Podjetje Hikma Farmaceutica Lda.
English: A positive opinion was adopted by on 24 January 2007.
Slovenian: Pozitivno mnenje je bilo sprejeto 24. januarja 2007.
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
Slovenian: Poročevalec je bil dr. Ian Hudson, soporočevalec pa dr. Bengt Ljungberg.
English: The Mutual Recognition Procedure started on 28 January 2006.
Slovenian: Postopek medsebojnega priznavanja se je pričel 28. januarja 2006.
English: The final opinion was converted into a Decision by the European Commission on 11 July 2007.
Slovenian: Končno mnenje je Evropska komisija dne 11. julija 2007 spremenila v odločbo.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Te države članice niso uspele doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država članica.
English: The Netherlands referred the reasons for disagreement to the EMEA on 7 July 2006.
Slovenian: Nizozemska je agenciji EMEA posredovala razloge za nesoglasje dne 7. julija 2006.
English: The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Slovenian: Postopek arbitraže se je pričel 27. julija 2006 s sprejemom seznama vprašanj.
English: Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Slovenian: Ugotovljene so bile pomembne razlike v zvezi z odmerkom za okužbe sečil in največjim dnevnim odmerkom za odrasle.
English: The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je posredoval pisno razlago 20. oktobra 2006.
English: In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev.1).
Slovenian: Poleg tega je bilo ocenjeno, da bi moral predlagatelj v povzetek glavnih značilnosti zdravila (poglavje 5.1) vključiti organizme, naštete v mejnih vrednostih in tabeli občutljivosti, ki se nanašajo na indikacije, kot je bilo določeno v navodilih za vrednotenje zdravil, indiciranih za zdravljenje bakterijskih okužb (Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections, CPMP/EWP/558/95 rev.1).
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim povzetkom glavnih značilnosti zdravila v Dodatku III.
English: submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
Slovenian: je predložilo vloge za medsebojno priznavanje dovoljenja za zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ml raztopino za infundiranje, na podlagi dovoljenja za promet, podeljenega na Nizozemskem 12. aprila 2005.
English: During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem januarja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ciprofloxacin Hikma in z njim povezana imena ugodno, da naj podani ugovori ne preprečijo podelitve dovoljenja za promet z zdravilom ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names International Non-Proprietary Name (INN): Ciprofloxacin BACKGROUND INFORMATION Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Slovenian: Zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ml raztopina za infundiranje, je antibiotik, ki sodi v družino kinolonov in je in vitro učinkovit proti številnim po Gramu negativnim aerobnim bakterijam kakor tudi proti nekaterim po Gramu pozitivnim organizmom.
English: Januvia is taken at a dose of 100 mg once a day.
Slovenian: Zdravilo Januvia se jemlje v odmerku 100 mg enkrat na dan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Januvia on 21 March 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Januvia, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2007.
English: Other information about Januvia
Slovenian: Druge informacije o zdravilu Januvia
English: The full EPAR for Januvia 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 Januvia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Januvia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Januvia.
English: What benefit has Januvia shown during the studies?
Slovenian: Kakšne koristi je zdravilo Januvia izkazalo med študijami?
English: For more information about treatment with Januvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Januvia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Januvia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Slovenian: Zdravila Januvia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin ali katero koli drugo sestavino zdravila.
English: In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.
Slovenian: Pri bolnikih z delno ali močno okrnjenim delovanjem ledvic je treba odmerek zdravila Januvia zmanjšati.
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 Januvia.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Januvia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Slovenian: Če se zdravilo Januvia jemlje s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina znižati, da se zmanjša tveganje za hipoglikemijo (nizko koncentracijo sladkorja v krvi).
English: Januvia is a medicine that contains the active substance sitagliptin.
Slovenian: Januvia je zdravilo, ki vsebuje zdravilno učinkovino sitagliptin.
English: What is the risk associated with Januvia?
Slovenian: Kakšna tveganja so povezana z zdravilom Januvia?
English: The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Slovenian: Zdravilna učinkovina zdravila Januvia je sitagliptin, ki je zaviralec dipeptidil peptidaze-4 (DPP-4).
English: In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide.
Slovenian: V študijah, v katerih so zdravilo Januvia primerjali z drugimi zdravili, je bila učinkovitost dodajanja zdravila Januvia metforminu podobna kot pri dodajanju glipizida.
English: Januvia was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Slovenian: Zdravilo Januvia je bilo raziskano v devetih glavnih študijah, ki so vključevale skoraj 6 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ravni glukoze v krvi niso bile zadostno nadzorovane:
English: • two studies compared Januvia with other antidiabetes medicines.
Slovenian: • v dveh študijah so zdravilo Januvia primerjali z drugimi zdravili proti sladkorni bolezni.
English: Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Slovenian: Zdravilo Januvia je bilo učinkovitejše od placeba, ko so ga bolniki jemali kot samostojno zdravilo ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
English: The CHMP decided that Januvia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Januvia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Why has Januvia been approved?
Slovenian: Zakaj je bilo zdravilo Januvia odobreno?
English: Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Slovenian: Med resnimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Januvia so pankreatitis (vnetje trebušne slinavke) in preobčutljivostne (alergijske) reakcije.
English: In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Slovenian: Pri bolnikih, ki so jemali samo zdravilo Januvia so se ravni HbA1c zmanjšale za približno 8 % na začetku študij, za 0,48 % po 18 tednih in za 0,61 % po 24 tednih.
English: Januvia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Slovenian: Zdravilo Januvia se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnjo glukoze (sladkorja) v krvi.