FrancophonIA/ELRC3.0 huggingface dataset:
English: Cozaar 100 mg filmdragerade tabletter United Kingdom COZAAR 50 MG FILM-COATED TABLETS United Kingdom COZAAR 25 MG FILM-COATED TABLETS United Kingdom COZAAR 100MG FILM-COATED TABLETS Iceland
Slovenian: Velika Britanija COZAAR 50 MG FILM-COATED TABLETS Velika Britanija COZAAR 25 MG FILM-COATED TABLETS
English: General disorders and administration site conditions: common: asthenia/fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije pogoste: astenija/utrujenost
English: Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Slovenian: Vsaka Cozaar 100 mg tableta vsebuje 100 mg kalijevega losartanata.
English: Unless continued losartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Pri bolnicah, ki načrtujejo nosečnost, je treba čimprej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje z losartanom nujno.
English: The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan RENAAL study was a controlled clinical study conducted worldwide in 1513 Type 2 diabetic patients with proteinuria, with or without hypertension.
Slovenian: Študija RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan; Zmanjšanje števila opazovanih dogodkov z antagonistom angiotenzina II losartanom pri od insulina neodvisni sladkorni bolezni) je bila kontrolirana klinična študija.
English: Blue, oval film-coated tablets marked 11 on one side and plain on the other.
Slovenian: Cozaar 12,5 mg tablete Modre, ovalne filmsko obložene tablete, z oznako 11 na eni strani in brez oznake na drugi strani.
English: Skin and subcutanous tissue disorders: uncommon: urticaria, pruritus, rash
Slovenian: Bolezni kože in podkožja pogostnost ni znana: urtikarija, srbenje, izpuščaj
English: Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Slovenian: Losartan prav tako ni priporočljiv pri otrocih z okvaro jeter (glejte tudi poglavje 4.4).
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek 1 - Izpolni država članica]
English: The antihypertensive effect of Cozaar was established in a clinical study involving 177 hypertensive paediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Slovenian: Antihipertenzivni učinek zdravila Cozaar je bil določen v klinični študiji, ki je vključevala 177 hipertenzivnih pediatričnih bolnikov, starih 6 do 16 let, s telesno maso > 20 kg in stopnjo glomerularne filtracije > 30 ml/min/1,73 m2. Bolniki, ki so tehtali >20 kg do < 50 kg, so prejemali 2,5, 25 ali 50 mg losartana dnevno, bolniki, ki so tehtali > 50 kg, pa so prejemali 5, 50 ali 100 mg losartana dnevno.
English: Cozaar is used
Slovenian: Zdravilo Cozaar se uporablja:
English: Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Slovenian: Vsaka Cozaar 12,5 mg tableta vsebuje 12,5 mg losartana (v obliki kalijeve soli).
English: The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Slovenian: Običajni začetni odmerek zdravila Cozaar pri bolnikih s srčnim popuščanjem je 12,5 mg enkrat na dan. Odmerek je običajno treba titrirati tedensko (to je 12,5 mg na dan, 25 mg na dan, 50 mg na dan) do običajnega vzdrževalnega odmerka 50 mg enkrat na dan, glede na to, kako bolnik zdravilo prenaša.
English: Filmcoated tablet Oral use
Slovenian: Filmsko obložena tableta Peroralna uporaba
English: The dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily depending on your blood pressure response.
Slovenian: Zdravljenje se običajno začne s 50 mg losartana (ena tableta Cozaar 50 mg) enkrat na dan. Odmerek se kasneje lahko poveča na 100 mg losartana (dve tableti Cozaar 50 mg) enkrat na dan, glede na odziv krvnega tlaka.
English: The CHMP was concerned that the benefit/risk ratio of this indication could not be adequately established.
Slovenian: - Srčno popuščanje (kot druga izbira, ko zaviralci ACE niso primerni) CHMP je izrazil pomislek, da razmerja med tveganji in koristmi za to indikacijo ni mogoče ustrezno določiti.
English: Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Slovenian: Vsaka Cozaar 12,5 mg tableta vsebuje 12,5 mg kalijevega losartanata.
English: Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
Slovenian: Cozaar 12,5 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 14, 21, 28, 50, 98, 210 ali 500 tablet.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: It is important to tell your doctor before taking Cozaar:
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO COZAAR
English: Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Slovenian: Losartan prav tako ni priporočljiv pri otrocih z okvaro jeter (glejte tudi poglavje 4.2).
English: happening in 1 in 100 to 1 in 10 patients uncommon happening in 1 in 1,000 to 1 in 100 patients rare:
Slovenian: pojavijo se pri 1 ali več od 1.000 ter manj kot 1 od 100 bolnikov redki:
English: Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/day The usual starting dose is 50 mg once daily.
Slovenian: Bolniki s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo ≥ 0,5 g/dan Običajni začetni odmerek je 50 mg enkrat na dan. Glede na odziv krvnega tlaka lahko po enem mesecu zdravljenja ali kasneje odmerek povečamo na 100 mg enkrat na dan.
English: The side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common:
Slovenian: Neželeni učinki so razvrščeni takole: zelo pogosti:
English: Read all of this leaflet carefully before taking this medicine.
Slovenian: Pred uporabo natančno preberite navodilo!
English: HOW TO STORE Cozaar
Slovenian: SHRANJEVANJE ZDRAVILA COZAAR
English: Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
Slovenian: Vsaka Cozaar 25 mg tableta vsebuje 25 mg kalijevega losartanata.
English: Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
Slovenian: Pretisni omot za Cozaar 12,5 mg filmsko obložene tablete Pretisni omot za Cozaar 50 mg filmsko obložene tablete
English: Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Slovenian: Vsaka Cozaar 25 mg tableta vsebuje 25 mg losartana (v obliki kalijeve soli).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka COZAAR 12,5 mg filmsko obložena tableta vsebuje 12,5 mg kalijevega losartanata.
English: Nervous system disorders: common: dizziness
Slovenian: Bolezni živčevja pogoste: omotica
English: The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Slovenian: Cozaar 12,5 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171), indigo karmin (E132).
English: The following adverse events occurred more often in patients receiving losartan than placebo: Blood and lymphatic system disorders: not known: anaemia
Slovenian: Naslednji neželeni učinki so se pogosteje pojavili pri bolnikih, ki so prejemali losartan, kot pri bolnikih, ki so prejemali placebo:
English: Each Cozaar 50 mg film-coated mg tablet contains 50 mg losartan potassium.
Slovenian: Vsaka COZAAR 50 mg filmsko obložena tableta vsebuje 50 mg kalijevega losartanata.
English: Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Slovenian: Vsaka Cozaar 12,5 mg tableta vsebuje 25,5 mg laktoze monohidrata.
English: LORTAAN 100mg
Slovenian: 100mg
English: Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Slovenian: Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 25 mg kalijevega losartanata.
English: A lower dose should be considered for patients with a history of hepatic impairment.
Slovenian: Pri bolnikih, ki so kdaj imeli okvaro jeter, je treba razmisliti o manjšem odmerku.
English: Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Slovenian: Vsaka Cozaar 50 mg tableta vsebuje 50 mg losartana (v obliki kalijeve soli).
English: • migraine,
Slovenian: • migrena
English: Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Slovenian: Vsaka Cozaar 50 mg tableta vsebuje 25,5 mg laktoze monohidrata.
English: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Slovenian: Luksemburg Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
English: Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Slovenian: Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 100 mg kalijevega losartanata.
English: Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Slovenian: Bolezni prebavil občasne: diareja, navzeja, bruhanje
English: White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Slovenian: Bele, filmsko obložene tablete v obliki kapljice, z oznako 951 na eni strani in brez oznake na drugi strani.
English: Cozaar Startpakke
Slovenian: COZAAR CARDIO START
English: Investigators were instructed to titrate the study medication to 100 mg daily as appropriate; 72 % of patients were taking the 100 mg daily dose for the majority of the time.
Slovenian: Raziskovalci so dobili navodila, naj odmerek preiskovanega zdravila titrirajo do 100 mg enkrat na dan, če je potrebno.
English: • shortness of breath (dyspnoea),
Slovenian: • kratka sapa (dispneja)
English: • nausea,
Slovenian: • bruhanje
English: Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
Slovenian: Vsaka Cozaar 50 mg tableta vsebuje 50 mg kalijevega losartanata.
English: Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Slovenian: Vsaka Cozaar 100 mg tableta vsebuje 100 mg losartana (v obliki kalijeve soli).
English: 751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of a blood lowering pressure.
Slovenian: Namen študije je bil poleg koristi za znižanje krvnega tlaka pokazati še zaščitni učinek kalijevega losartanata na ledvice.
English: Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Slovenian: Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet z razdelilno zarezo, ki vsebujejo 50 mg kalijevega losartanata.
English: happening in less than 1 in 10,000 patients not known
Slovenian: pojavijo se pri manj kot 1 od 10.000 bolnikov neznana pogostnost: (iz razpoložljivih podatkov se ne da oceniti)
English: Cosaar 100 mg - Filmtabletten 100 mg
Slovenian: Cosaar 100 mg - Filmtabletten
English: Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Slovenian: Vsaka Cozaar 25 mg tableta vsebuje 12,75 mg laktoze monohidrata.
English: What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Slovenian: Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 12,5 mg kalijevega losartanata.
English: In the LIFE-Study black patients treated with Losartan had a higher risk of suffering the primary combined endpoint, i.e. a cardiovascular event (e.g. cardiac infarction, cardiovascular death) and especially stroke, than the black patients treated with atenolol.
Slovenian: V študiji LIFE so imeli bolniki črne rase, zdravljeni z losartanom, večje tveganje za primarni sestavljeni opazovani dogodek, t.j.
English: • Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
Slovenian: • Zdravljenje bolezni ledvic pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 12,5 mg
English: Film-coated tablets
Slovenian: Filmsko obložene tablete.
English: White, oval unscored film-coated tablets marked 951 on one side and plain on the other.. Cozaar 50 mg tablet
Slovenian: Bele, ovalne filmsko obložene tablete brez razdelilne zareze, z oznako 951 na eni strani in brez oznake na drugi strani.
English: Cozaar contains lactose monohydrate.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Cozaar Zdravilo Cozaar vsebuje laktozo monohidrat.
English: The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Slovenian: Cozaar 100 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
English: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Slovenian: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 100 mg HDPE Bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 100 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 50 mg HDPE bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 50 mg
English: COZAAR IC - Titulação
Slovenian: COZAAR ICTitulação
English: MARKETING AUTHORISATION HOLDER [To be implemented nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Slovenian: Cozaar 50 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 ali 500 tablet.
English: Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135
Slovenian: Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 12,5 mg kalijevega losartanata.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see section 4.4)
Slovenian: Kot posledico zaviranja sistema renin-angiotenzin-aldosteron so pri bolnikih s tveganjem poročali o spremembah ledvične funkcije, vključno z ledvično odpovedjo.
English: NAME OF THE MEDICINAL PRODUCT Cozaar 25 mg film-coated tablets Losartan
Slovenian: Cozaar 25 mg filmsko obložene tablete losartan
English: Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Slovenian: Cozaar 100 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
English: Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Slovenian: Cozaar 100 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 ali 280 tablet.
English: Batch
Slovenian: Ciper
English: Finland Merck Sharp & Dohme B.V. Waarderweg 39
Slovenian: Merck Sharp & Dohme B.V.
English: LORTAAN IC- Titulação 12.5 mg + 50 mg
Slovenian: Cozaar Startpakke 12,5 mg + 50 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 12,5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 25 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za Cozaar 25 mg
English: The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Slovenian: Cozaar 50 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
English: The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Slovenian: Cozaar 25 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Slovenian: Zgibanka za Cozaar 12,5 mg in 50 mg (pretisni omoti za titracijsko odmerjanje)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 25 mg kalijevega losartanata.
English: OTHER
Slovenian: Presnova
English: The dose may be increased to 100 mg once daily based on blood pressure response from one month after initiation of therapy onwards.
Slovenian: V izjemnih primerih se odmerek lahko poveča do največ 50 mg enkrat na dan. Odmerek je treba prilagoditi glede na odziv krvnega tlaka.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 100 mg blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 100 mg
English: Ear and labyrinth disorders: common: vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta pogoste: vrtoglavica
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 50 mg
English: NAME OF THE MEDICINAL PRODUCT Cozaar 100 mg film-coated tablets Losartan
Slovenian: Cozaar 100 mg filmsko obložene tablete losartan
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 50 mg kalijevega losartanata.
English: NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Losartan
Slovenian: Cozaar 12,5 mg filmsko obložene tablete losartan
English: The following wording has been added to SPC Section 5.1.Pharmacodynamic Properties:
Slovenian: Naslednje besedilo je bilo dodano v poglavje 5.1.
English: Cozaar film-coated tablets losartan potassium
Slovenian: NAVODILO ZA UPORABO Cozaar filmsko obložene tablete kalijev losartanat
English: Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten.
Slovenian: Veže se na receptorje v krvnih žilah in tako povzroči, da se zožijo.
English: • cough,
Slovenian: • kašelj
English: Nervous system disorders: not known: migraine
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogostnost ni znana: mialgija, artralgija
English: Severe hepatic impairment
Slovenian: Bolezni ledvic
English: Patients who weighted >20kg to < 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily.
Slovenian: Antihipertenzivni učinek zdravila Cozaar so dokazali v klinični študiji, ki je zajela 177 hipertenzivnih pediatričnih bolnikov, starih 6 do 16 let, s telesno maso > 20 kg in hitrostjo glomerulne filtracije > 30 ml/min/1,73 m2. Bolniki, ki so tehtali > 20 kg do < 50 kg, so prejemali bodisi 2,5, 25 ali 50 mg losartana na dan, bolniki, ki so tehtali > 50 kg, pa so prejemali bodisi 5, 50 ali 100 mg losartana na dan.
English: NAME OF THE MEDICINAL PRODUCT Cozaar 50 mg film-coated tablets Losartan
Slovenian: Cozaar 50 mg filmsko obložene tablete losartan
English: Cosaar 100 mg - Filmtabletten Belgium COZAAR 100 mg Belgium COZAAR 50 MG Belgium COZAAR 12,5 mg Belgium COZAAR CARDIO START Belgium LOORTAN 100 mg Belgium LOORTAN 50 mg Belgium LOORTAN 12,50 mg Belgium LOORTAN CARDIO START Bulgaria
Slovenian: Portugalska COZAAR Portugalska COZAAR 100 mg Portugalska COZAAR IC Portugalska COZAAR IC - Titulação Portugalska LORTAAN IC Portugalska LORTAAN IC- Titulação Portugalska LORTAAN Portugalska LORTAAN 100mg Romunija
English: You may need to read it again.
Slovenian: Morda ga boste ţeleli ponovno prebrati.
English: Open here
Slovenian: Odprite tukaj
English: How much and how often to take?
Slovenian: Koliko in kako pogosto se uporablja?
English: You will hear a loud click, which means the injection has started.
Slovenian: Slišali boste glasen klik, kar pomeni, da se je injiciranje začelo.
English: Age over 65 years
Slovenian: Starejši od 65 let
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan tega meseca.
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je treba predloţiti:
English: 1.2 You will also need (Figure A):
Slovenian: 1.2 Potrebovali boste tudi (Slika A):
English: • You did not inject the full dose or
Slovenian: • niste injicirali celotnega odmerka ali
English: 1.4 You will also need following supplies that are not included in the kit:
Slovenian: 1.4 Potrebovali boste tudi naslednje pripomočke, ki niso priloţeni v kompletu:
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Slovenian: Posebna pozornost glede tveganja okuţb je potrebna pri zdravljenju starejših.
English: • Properly labeled to warn of hazardous waste inside the container.
Slovenian: • je pravilno označen za opozorilo pred nevarnimi odpadki, ki jih vsebuje.
English: Clinical studies in patients suffering hidradenitis suppurativa in this section are merely included for public health reasons.
Slovenian: Klinične študije pri bolnikih, ki trpijo za hidradenitis suppurativo, so v tem poglavju vključeni samo zaradi javno zdravstvenih razlogov.
English: Minimum, median and maximum dose
Slovenian: Najmanjši, srednji in največji odmerek
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 web-portal.
Slovenian: Zahteve glede predloţitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti ime in številka serije uporabljenega zdravila jasno zabeleţena.
English: 6.6 The needle is now covered and is safe.
Slovenian: 6.6 Injekcijska igla je sedaj pokrita in varna.
English: 61352 Bad Homburg v.d.Höhe Germany
Slovenian: 61352 Bad Homburg v.d.Höhe Nemčija
English: Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Slovenian: Opomba: Z vajo boste ugotovili, kakšen kot (od 45° do 90°) je najudobnejši za vas in otroka.
English: However, please note that Kromeya is neither intended nor authorized for treatment of hidradenitis suppurativa.
Slovenian: Vendar upoštevajte, da Kromeya ni namenjena, niti pooblaščena za zdravljenje hidradenitis suppurative.
English: If you do not have a sharps disposal container, you may use a household container that is:
Slovenian: Če nimate zbiralnika za ostre predmete, lahko uporabite koš za gospodinjske odpadke, ki: