FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET For medicinal products available without a prescription
Slovenian: NAVODILO ZA UPORABO Za zdravilo, ki se izdaja brez recepta.
English: 45 tablets
Slovenian: 45 tablet
English: - Psychiatric disorders: common: somnolence uncommon: agitation rare: aggression, confusion, depression, hallucination, insomnia very rare: tic
Slovenian: − Psihiatrične motnje: pogosti: zaspanost, občasni: agitacija (motorični nemir), redki: agresivnost, zmedenost, depresija, halucinacije, nespečnost, zelo redki: trzaj.
English: Denmark: Benaday, Zyrtec
Slovenian: Danska: Benaday, Zyrtec
English: Zyrtec oral solution contain methyl (4-hydroxybenzoate) E 218, propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Zyrtec peroralna raztopina vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročita alergijske reakcije (lahko zapoznele).
English: Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg as 10 drops once daily.
Slovenian: Pri bolnikih z zmerno ledvično okvaro je priporočen odmerek 5 mg oz. 10 kapljic enkrat na dan.
English: 5 tablets
Slovenian: 5 tablet
English: Quinta da Fonte 2770-229 PACO DE ARCOS
Slovenian: Maria I, Q 60, piso 1 A Quinta da Fonte 2770-229 PACO DE ARCOS
English: In adults and children 2 year and above:
Slovenian: Odrasli in otroci, stari 2 leti in več
English: Duration of treatment
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full spoons)).
Slovenian: Odrasli in mladostniki, starejši od 12 let: 10 mg enkrat na dan (10 ml peroralne raztopine (2 polni merilni žlički)).
English: What Zyrtec looks like and contents of the pack Zyrtec is supplied as a clear and colorless liquid.
Slovenian: Izgled zdravila Zyrtec in vsebina pakiranja Bistra in brezbarvna tekočina.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Dopolniti lokalno]
English: No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
Slovenian: Med cetirizinom v običajnih odmerkih in alkoholom (pri koncentraciji alkohola v krvi 0,5 promila, kar ustreza 1 kozarcu vina) niso opazili nobenega vidnejšega medsebojnega delovanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablets contains 10 mg cetirizine dihydrochloride Excipients: one film-coated tablet contains 66.40 mg lactose-monohydrate For a full list of excipients, see section 6.1
Slovenian: Pomožne snovi: ena filmsko obložena tableta vsebuje 66,40 mg laktoze monohidrata.
English: Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet).
Slovenian: Odrasli in mladostniki, starejši od 12 let: 10 mg enkrat na dan (1 tableta).
English: The MAH also proposed harmonised Product Information texts for section 4.3 Contraindications reflecting the hypersensitivity to formulation constituents and addressing patients with severe renal impairment.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal tudi usklajena besedila v informacijah o zdravilu za razdelek 4.3.
English: Zyrtec 1 mg/mlorale Lösung oral solution
Slovenian: Zyrtec 1 mg/mlorale Lösung peroralna raztopina
English: 15 tablets
Slovenian: 15 tablet
English: Elderly: Following a single 10 mg oral dose, half-life increased by about 50 % and clearance decreased by 40 % in 16 elderly subjects compared to the normal subjects.
Slovenian: Po enkratnem peroralnem odmerku 10 mg se je pri 16 starejših posameznikih v primerjavi z zdravimi posamezniki razpolovna doba zvečala za okoli 50 %, očistek pa zmanjšal za 40 %.
English: ALERRID 10 MG COMPRIMIDOS RECUBIERTO CON PELICULA
Slovenian: AMERRID 10MG COMPRIMIDOS RECUBIERTOS CON PELICULA
English: FORMISTIN 10mg film-coated tablet
Slovenian: FORMISTIN 10mg filmsko obložene tablete
English: Contains methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sorbitol (E 420), among other substances.
Slovenian: Poleg ostalih pomožnih snovi vsebuje metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), sorbitol (E420).
English: 40 tablets
Slovenian: 40 tablet
English: - Skin and subcutaneous tissue disorders: uncommon: pruritus, rash, rare: urticaria, very rare: oedema, fixed drug eruption
Slovenian: − Bolezni kože in podkožnega tkiva: občasni: srbenje, izpuščaj, redki: koprivnica, zelo redki:edem, z zdravilom povezan izbruh kožnega izpuščaja.
English: Zyrtec and associated names (see Annex I) 1 mg/ml oral solution
Slovenian: Zyrtec in sorodna imena (glejte Dodatek 1) 1 mg/ml peroralna raztopina [Glejte Dodatek 1 - dopolniti lokalno]
English: Body as a whole - general disorders Fatigue
Slovenian: Splošne težave utrujenost
English: - Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
Slovenian: - Cetirizin je indiciran za lajšanje nosnih in očesnih simptomov sezonskega in celoletnega alergijskega rinitisa,.
English: 5 mg once daily
Slovenian: 5 mg enkrat na dan huda ledvična okvara
English: Adults and adolescents over 12 years of age: 10 mg once daily (20 drops).
Slovenian: Odrasli in mladostniki, starejši od 12 let: 10 mg enkrat na dan (20 kapljic).
English: ZIRTEK ORAL SOLUTION 1MG/ML
Slovenian: ZIRTEK PERORALNA RAZTOPINA 1MG/ML
English: 5mg film-coated tablet
Slovenian: 5mg filmsko obložene tablete
English: Austria: Zyrtec 1 mg/ml - orale Lösung
Slovenian: Avstrija: Zyrtec 1 mg/ml - orale Lösung Belgija: Zyrtec
English: • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis
Slovenian: • je cetirizin indiciran za lajšanje nosnih in očesnih simptomov sezonskega ali trajnega alergijskega rinitisa;
English: Italy: Zirtec 1mg/ml soluzione orale
Slovenian: ZIRTEC 1 MG/ML SOLUZIONE ORALE
English: - The other ingredients are microcrystalline cellulose, lactose, macrogol 400, magnesium stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
Slovenian: - Pomožne snovi so: mikrokristalna celuloza, laktoza, makrogol 400, magnezijev stearat,
English: - Glycerol - Propylene glycol - Sodium saccharinate - Methylparahydroxybenzoate (E 218) - Propylparahydroxybenzoate (E 216) - Sodium acetate - Glacial acetic acid - Purified water
Slovenian: - glicerol - propilenglikol - natrijev saharinat - metilparahidroksibenzoat (E218) - propilparahidroksibenzoat (E216) - natrijev acetat - ocetna kislina, koncentrirana; ledocet - prečiščena voda
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: Adults and adolescents above 12 years old: 10 mg once daily as 1 tablet.
Slovenian: Odrasli in mladostniki, starejši od 12 let: 10 mg oz. 1 tableta enkrat na dan.
English: • Adults and adolescents over 12 years of age: 10 mg once daily (20 drops).
Slovenian: • Odrasli in mladostniki, stari 12 let ali več: 10 mg enkrat na dan (20 kapljic).“
English: - The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharine sodium, methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate, acetic acid, purified water.
Slovenian: - Pomožne snovi so: sorbitol (E420), glicerol, propilenglikol, natrijev saharinat, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), aroma, natrijev acetat, ocetna kislina, prečiščena voda.
English: Respiratory system disorders Pharyngitis
Slovenian: Psihiatrične motnje somnolenca Bolezni dihal faringitis
English: 10 mg once daily
Slovenian: 10 mg enkrat na dan zmerna ledvična okvara
English: - General disorders and administration site conditions: uncommon: asthenia (extreme fatigue), malaise, rare: oedema (swelling)
Slovenian: - Splošne težave in spremembe na mestu aplikacije: občasni: astenija (izredna utrujenost), slabo počutje, redki: edem (oteklina).
English: Contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), among other substances.
Slovenian: Poleg ostalih pomožnih snovi vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216).
English: Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Slovenian: Zdravilna učinkovina zdravila Zyrtec je cetirizinijev diklorid.
English: Excipients: - one ml of solution contains 1.35 mg methylparahydroxybenzoate
Slovenian: Pomožne snovi: - 1 ml raztopine vsebuje 1,35 mg metilparahidroksibenzoata - 1 ml raztopine vsebuje 0,15 mg propilparahidroksibenzoata
English: Zyrtec and associated names (see Annex I) 10 mg/ml oral drops, solution
Slovenian: Zyrtec in sorodna imena (glejte Dodatek 1) 10 mg/ml peroralne kapljice, raztopina [Glejte Dodatek 1 - dopolniti lokalno]
English: • Children aged from 2 to 6 years: 2.5 mg twice daily (5 drops twice daily).
Slovenian: • Otroci, stari od 2 do 6 let: 2,5 mg dvakrat dnevno (5 kapljic dvakrat dnevno);
English: However, you still need to use Zyrtec carefully to get the best results from it. - Keep this leaflet.
Slovenian: Kljub temu ga morate jemati pazljivo in skrbno, da vam bo kar najbolje koristilo.
English: Bulgaria: Zyrtec
Slovenian: Bulgarija: Zyrtec
English: Do not take Zyrtec - if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); - if you are known to be hypersensitive to the active substance of Zyrtec, to any of its excipients
Slovenian: Ne jemljite zdravila Zyrtec - Če imate hudo ledvično bolezen (huda ledvična odpoved s kreatininskim očistkom manjšim od 10 ml/min).
English: Lithuania: Zyrtec
Slovenian: Litva: Zyrtec
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml solution contain 1 mg of cetirizine dihydrochloride
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml raztopine vsebuje 1 mg cetirizinijevega diklorida.
English: UCB Pharma B.V. Lage Mosten 33
Slovenian: UCB Pharma B.V.
English: - Gastro-intestinal disorders: common: dry mouth, nausea, diarrhoea uncommon:, abdominal pain,
Slovenian: - Bolezni prebavil: pogosti: driska, suha usta, slabost, občasni: bolečina v trebuhu.
English: • Children aged from 6 to 12 years: 5 mg twice daily (10 drops twice daily).
Slovenian: • Otroci, stari od 6 do 12 let: 5 mg dvakrat dnevno (10 kapljic dvakrat dnevno;
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTERS
Slovenian: PVC / ALUMINIJEVI PRETISNI OMOTI
English: Estonia: Zyrtec
Slovenian: Estonija: Zyrtec
English: - The other ingredients are glycerol, propylène glycol, saccharine sodium, methyl (4hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, purified water.
Slovenian: - Pomožne snovi so: glicerol, propilenglikol, natrijev saharinat, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), natrijev acetat, ocetna kislina, prečiščena voda.
English: NAME OF THE MEDICINAL PRODUCT Zyrtec 10 mg film-coated tablets Cetirizine dihydrochloride
Slovenian: Zyrtec 10 mg filmsko obložene tablete [Glejte Dodatek 1 - dopolniti lokalno] cetirizinijev diklorid
English: Netherlands: Zyrtec
Slovenian: Nizozemska: Zyrtec
English: Central and peripheral nervous system disorders Dizziness
Slovenian: Splošne težave utrujenost Bolezni živčevja omotica glavobol
English: 10 ml (equals to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride.
Slovenian: 2 merilni žlički) vsebuje 10 mg cetirizinijevega diklorida.
English: Finland: Zyrtec
Slovenian: Finska: Zyrtec
English: Children aged from 2 to 6 years: 2.5 mg twice daily (5 drops twice daily).
Slovenian: Otroci, stari od 2 do 6 let: 2,5 mg dvakrat na dan (5 kapljic dvakrat na dan).
English: NL-2909 LD Capelle a/d IJsel Nederland
Slovenian: Pfizer Consumer Healthcare BV Rivium Westlaan 142 NL-2909 LD Capelle ann/den IJsel
English: Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus.
Slovenian: Če po pomoti vzamete zdravilo, naj to ne bi imelo škodljivega vpliva na plod, vendar pa morate jemanje zdravila nemudoma prekiniti.
English: Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
Slovenian: Otroci, stari od 6 do 12 let: 5 mg dvakrat na dan (polovica tablete dvakrat na dan)
English: Zyrtec 10 mg/mlTropfen oral drops, solution
Slovenian: Zyrtec 10 mg/mlTropfen peroralne kapljice, raztopina
English: Romania: Zyrtec
Slovenian: Romunija: Zyrtec
English: In adults and children aged 2 year and above, Zyrtec is indicated - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
Slovenian: Odrasli in otroci, stari 2 leti in več - Cetirizin je indiciran za lajšanje nosnih in očesnih simptomov sezonskega in celoletnega alergijskega rinitisa.
English: Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral solution twice daily (a half spoon twice daily)).
Slovenian: Otroci, stari od 2 do 6 let: 2,5 mg dvakrat na dan (2,5 ml peroralne raztopine dvakrat na dan (polovica merilne žličke dvakrat na dan)).
English: MG/ML GOCCE ORALI
Slovenian: ZIRTEC 10 MG/ML GOCCE ORALI SOLUZIONE
English: Portugal: Zyrtec
Slovenian: Portugalska: Zyrtec
English: General disorders and administration site conditions: Uncommon: asthenia, malaise Rare: oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije: Občasni: astenija, slabo počutje Redki: edem
English: Nevertheless, the administration of the medicine should be discontinued.
Slovenian: V glavnem so težave odpravljene s prenehanjem jemanja zdravila.
English: 10 mg film-coated tablet
Slovenian: 10mg filmsko obložene tablete
English: Children aged from 6 to 12 years: 5 mg twice daily (10 drops twice daily).
Slovenian: Otroci, stari od 6 do 12 let: 5 mg dvakrat na dan (10 kapljic dvakrat na dan).
English: 10 mg once daily as 10 ml oral solution (2 full measuring spoons) Children between 6 and 12 years old:
Slovenian: 10 mg enkrat na dan v obliki 10 ml peroralne raztopine (2 polni merilni žlički).
English: Czech Republic: Zyrtec
Slovenian: Češka: Zyrtec
English: Dosing adjustments for adult patients with impaired renal function Group
Slovenian: Bolniki z zmerno do hudo ledvično okvaro
English: Children between 6 and 12 years old: 5 mg twice daily as a half tablet twice daily.
Slovenian: Otroci, stari od 6 do 12 let: 5 mg oz. pol tablete dvakrat na dan
English: Patients with rare hereditary problems of fructose intolerance should not take cetirizine 1 mg/ml oral solution.
Slovenian: Bolniki s hudo ledvično okvaro z očistkom kreatinina manj kot 10 ml/min Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila 4.4 Posebna opozorila in previdnostni ukrepi
English: In adults and paediatric patients 6 year and above:
Slovenian: Odrasli in otroci, stari 6 let in več:
English: Oral drops, solution Bottle of 10 ml Bottle of 15 ml Bottle of 20 ml Bottle of 30 ml
Slovenian: Peroralne kapljice, raztopina Steklenička 10 ml
English: Poland: Zyrtec
Slovenian: Polska: Zyrtec
English: Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution bid (a full spoon twice daily).
Slovenian: Otroci, stari od 6 do 12 let: 5 mg dvakrat na dan (5 ml peroralne raztopine dvakrat na dan (polna merilna žlička dvakrat na dan))
English: Gastro-intestinal disorders: Uncommon: diarrhoea
Slovenian: Bolezni prebavil: Občasni: diareja
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo odobreno [Dopolniti lokalno]
English: MG/ML PERORALNA RAZTOPINA
Slovenian: ZYRTEC 1 MG/ML PERORALNA RAZTOPINA
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 10 mg cetirizine dihydrochloride, one drop of solution contains 0.5 mg cetirizine dihydrochloride
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 10 mg cetirizinijevega diklorida.
English: One ml (equals to 20 drops) contains 10 mg of cetirizine dihydrochloride.
Slovenian: 20 kapljic) vsebuje 10 mg cetirizinijevega diklorida.
English: UCB Pharma S.A. Avenida de Barcelona 239
Slovenian: UCB Pharma S.A. 21, Rue de Neuilly F-92003 Nanterre
English: In adults and children aged 6 year and above, Zyrtec is indicated - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
Slovenian: Pri odraslih in otrocih, starih 6 let in več, se zdravilo Zyrtec uporablja za: - lajšanje nosnih in očesnih simptomov sezonskega in celoletnega alergijskega rinitisa - lajšanje kronične koprivnice (kronična idiopatska urtikarija)
English: (other constituents), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
Slovenian: - Če ste alergični na (preobčutljivi za) zdravilno učinkovino zdravila Zyrtec, katerokoli pomožno snov (druge sestavine zdravila), hidroksizin ali derivate piperazina (blizu sorodne zdravilne učinkovine drugih zdravil).
English: INFORMATION IN BRAILLE Zyrtec 1 mg/ml oral solution
Slovenian: PODATKI V BRAILLOVI PISAVI Zyrtec 1 mg/ml peroralna raztopina
English: Denmark: Zyrtec
Slovenian: Danska: Zyrtec
English: Cyprus: Zyrtec
Slovenian: Ciper: Zyrtec
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of cetirizine dihydrochloride
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 10 mg cetirizinijevega diklorida.
English: Norway: Zyrtec
Slovenian: Norveška: Zyrtec
English: Gastro-intestinal system disorders Diarrhoea
Slovenian: Bolezni prebavil diareja
English: Czech Republic UCB Pharma SA (BRAINE) Chemin du Foriest
Slovenian: UCB Pharma SA (BRAINE) Chemin du Foriest Braine-l'Alleud B-1420 Belgija
English: NAME OF THE MEDICINAL PRODUCT Zyrtec 10 mg/ml oral drops, solution Cetirizine dihydrochloride
Slovenian: NAVODILO ZA UPORABO Zyrtec 10 mg/ml peroralne kapljice, raztopina [Glejte Dodatek 1 - dopolniti lokalno] cetirizinijev diklorid
English: NAME OF THE MEDICINAL PRODUCT Zyrtec 1 mg/ml oral solution Cetirizine dihydrochloride
Slovenian: Zyrtec 1 mg/ml peroralna raztopina [Glejte Dodatek 1 - dopolniti lokalno] cetirizinijev diklorid
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Dopolniti lokalno]
English: Menstruation is no contraindication.
Slovenian: Menstruacija ni kontraindikacija.
English: No further interaction studies have been performed.
Slovenian: Nadaljnjih študij medsebojnega delovanja niso izvedli.
English: 75 patients were randomised into the study and 62 of those completed the study.
Slovenian: 75 bolnikov je bilo randomiziranih v študijo in 62 od njih je študijo zaključilo.
English: Your doctor will discuss with you whether the treatment should be continued.
Slovenian: Z zdravnikom se boste pogovorili, ali naj se zdravljenje nadaljuje.
English: Open date: ……………………
Slovenian: Datum odprtja: ……………………
English: In such situations, treatment cessation should be considered.
Slovenian: V teh primerih je treba razmisliti o prekinitvi zdravljenja.
English: • need to urinate more frequently than usual
Slovenian: • potreba po pogostejšem uriniranju kot običajno;
English: In addition positive effects were observed on the voiding profile, although the observed differences were not statistically significant:
Slovenian: Dodatno so pozitivne učinke opazili pri profilu praznjenja, čeprav opažene razlike niso bile statistično značilne:
English: Dispose any remaining capsules after this period.
Slovenian: Po tem obdobju morebitne preostale kapsule zavrzite.
English: After first opening: use within 45 days.
Slovenian: Po prvem odprtju uporabite v 45 dneh.
English: : 60 % of the dose in the liver, 7.7 % in the spleen; 3 h post dosing: 60 % in the liver plus spleen, and 13 % in the bladder).
Slovenian: : 60 % odmerka v jetrih, 7,7 % v vranici; 3 h po odmerjanju: 60 % v jetrih in vranici ter 13 % v mehurju).
English: Side effects have been observed with the following frequencies:
Slovenian: Neželeni učinki so bili opaženi z naslednjo pogostnostjo:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: The used scale for the investigators assessment included the categories “worse”, “no change”, “fair”, “good”, “very good”, and “excellent”.
Slovenian: Uporabljena lestvica za oceno preiskovalcev je vključevala kategorije „slabše“, „ni spremembe“, „sprejemljivo“, „dobro“, „zelo dobro“ in „odlično“.
English: The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.
Slovenian: Kapsule je treba vzeti z vodo najmanj eno uro pred obrokom ali dve uri po obroku.
English: No dose adjustment is recommended for these patients.
Slovenian: Za te bolnike ni priporočil o prilagajanju odmerka.
English: • allergic reactions, increased sensitivity to light
Slovenian: • alergijske reakcije, povečana občutljivost na svetlobo;
English: 4.7 Effects on ability to drive and use machines
Slovenian: Vpliv na sposobnost vožnje in upravljanja strojev
English: • lack of blood platelets, red or white blood cells
Slovenian: • pomanjkanje trombocitov, rdečih ali belih krvnih celic;
English: Blister 21 months
Slovenian: pretisni omot 21 mesecev
English: • ringing or buzzing in the ears
Slovenian: • zvonjenje ali brnenje v ušesih;
English: EXP After first opening: use within 45 days.
Slovenian: EXP Po prvem odprtju uporabite v 45 dneh.
English: • bleeding (other than menstrual bleeding)
Slovenian: • če krvavite (razen menstrualne krvavitve).
English: Date of first authorisation: 2 June 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 02. junij 2017
English: • bleeding, including small bleeding beneath the skin
Slovenian: • krvavitve, vključno z majhno krvavitvijo pod kožo;
English: White opaque capsules size 2.
Slovenian: Bele neprosojne kapsule velikosti 2.
English: The patients were asked whether they felt improved overall since the start of treatment, and if so, whether the improvement was “slight” 25%, “moderate “50%, “great” 75% or “complete cure” 100%.
Slovenian: Bolnike so vprašali, ali čutijo splošno izboljšanje od začetka zdravljenja, in če da, ali je izboljšanje „neznatno“ 25 %, „zmerno“ 50 %, „dobro“ 75 % ali „popolna ozdravitev“ 100 %.
English: • The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171).
Slovenian: • Druge sestavine zdravila so mikrokristalna celuloza, magnezijev stearat, želatina, titanov dioksid (E171).
English: Stop taking elmiron if side effects occur, until they disappear.
Slovenian: Prenehajte jemati zdravilo elmiron, če nastopijo neželeni učinki, vse dokler ti ne izginejo.
English: Take the capsules whole with one glass of water, at least 1 hour before or 2 hours after meals.
Slovenian: Kapsule vzemite cele s kozarcem vode najmanj eno uro pred obrokom ali dve uri po obroku.
English: 81479 Munich GERMANY
Slovenian: 81479 München NEMČIJA
English: The secondary efficacy endpoints included the investigators evaluation of improvement.
Slovenian: Sekundarni cilji študije učinkovitosti so vključevali oceno izboljšanja, ki so jo navedli preiskovalci.
English: Children and adolescents elmiron is not recommended in children under 18 years as safety and efficacy have not been established in this group.
Slovenian: Zdravilo elmiron ni priporočljivo pri otrocih, mlajših od 18 let, saj varnost in učinkovitost v tej skupini nista bili ugotovljeni.
English: Titanium dioxide (E171)
Slovenian: Ovoj kapsule želatina titanov dioksid (E171)