FrancophonIA/ELRC3.0 huggingface dataset:
English: Romania Merck Sharp & Dohme Romania S.R.L.
Slovenian: Merck Sharp & Dohme Romania S.R.L.
English: • inflammation of the liver (hepatitis),
Slovenian: • vnetje jeter (hepatitis)
English: The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and
Slovenian: Uporaba losartana je kontraindicirana v 2. in 3. trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders: uncommon: hypotension, including orthostatic hypotension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Slovenian: Srčne bolezni redke: sinkopa, atrijska fibrilacija, možganskožilni dogodek Žilne bolezni občasne: hipotenzija, vključno z ortostatsko hipotenzijo Bolezni dihal, prsnega koša in mediastinalnega prostora občasne: dispneja
English: Patients were randomised to once daily Losartan 50 mg or once daily atenolol 50 mg.
Slovenian: Bolnike so randomizirali tako, da so enkrat na dan dobivali 50 mg losartana ali 50 mg atenolola.
English: - Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Slovenian: - Zdravljenje kroničnega srčnega popuščanja (pri bolnikih, starih 60 let ali več), ko je zdravljenje z zaviralci ACE ocenjeno kot neprimerno zaradi nezdružljivosti, zlasti kašlja, ali kontraindikacij.
English: Losartan therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also 5.3 'Preclinical safety data').
Slovenian: Znano je, da izpostavljenost losartanu v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnija, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkalemija) (glejte poglavje 5.3).
English: - Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Slovenian: - Nosečnost in dojenje morata biti kontraindicirana in ustrezno besedilo je treba vključiti v poglavja 4.3, 4.4 in 4.6 SPC ter v ustrezna poglavja navodila za uporabo.
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Slovenian: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, Nizozemska
English: PVC/aluminum foil/nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
Slovenian: PVC/aluminijasta folija/najlon pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 10, 14 in 28 tablet.
English: Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Slovenian: Nosečnost in dojenje morata biti kontraindicirana in ustrezno besedilo je treba vključiti v poglavja 4.3, 4.4 in 4.6 SPC ter v ustrezna poglavja navodila za uporabo.
English: Cardiac disorders: not known: syncope, palpitations
Slovenian: Srčne bolezni pogostnost ni znana: sinkopa, palpitacije
English: If goal blood pressure (< 140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of Losartan or atenolol was then increased to 100 mg once daily.
Slovenian: Če ciljnega krvnega tlaka (< 140/90 mmHg) niso dosegli, so najprej dodali hidroklorotiazid (12,5 mg), potem pa so, če je bilo potrebno, povečali odmerek losartana ali atenolola na 100 mg enkrat na dan. Za doseg ciljnega krvnega tlaka so, če je bilo potrebno, dodali še druge antihipertenzive, razen zairalcev ACE, antagonistov angiotenzina II ali beta zaviralcev.
English: The active substance is losartan potassium.
Slovenian: Zdravilna učinkovina je kalijev losartanat.
English: HDPE bottles of 100 tablets.
Slovenian: HDPE plastenke po 100 tablet.
English: Plasma clearance of losartan and its active metabolite is about 600 mL/min and 50 mL/min, respectively.
Slovenian: Plazemski očistek losartana je približno 600 ml/min, njegovega aktivnega presnovka pa 50 ml/min.
English: The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders: not known: Anaemia, thrombocytopenia
Slovenian: O naslednjih neželenih učinkih so poročali v okviru izkušenj z zdravilom v obdobju trženja: Bolezni krvi in limfatičnega sistema pogostnost ni znana: anemija, trombocitopenija
English: Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovenian: Hipotenzija in elektrolitsko/tekočinsko neravnovesje Simptomatska hipotenzija, posebej po prvem odmerku in po povečanju odmerka, se lahko pojavi pri bolnikih z zmanjšanim intravaskularnim volumnom in/ali zmanjšano količino natrija zaradi zdravljenja z velikimi odmerki diuretikov, diete z omejitvijo količine soli v hrani, driske ali bruhanja.
English: - Treatment of essential hypertension.
Slovenian: - Zdravljenje esencialne hipertenzije.
English: • debility,
Slovenian: • slabotnost
English: The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients > 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).
Slovenian: Farmakokinetiko losartana so preučevali pri 50 pediatričnih bolnikih s hipertenzijo, starih > 1 mesec do < 16 let, po enkrat dnevni peroralni uporabi približno 0,54 do 0,77 mg/kg losartana (povprečni odmerki).
English: These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see section 4.2).
Slovenian: Pred začetkom zdravljenja z zdravilom Cozaar je treba ta stanja pozdraviti ali pa uporabiti manjši začetni odmerek (glejte poglavje 4.2).
English: Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
Slovenian: Zmanjšanje tveganja za možgansko kap pri hipertenzivnih bolnikih s hipertrofijo levega prekata, potrjeno z EKG-jem
English: HOW TO TAKE Cozaar
Slovenian: KAKO JEMATI ZDRAVILO COZAAR
English: Vascular disorders: not known: orthostatic hypotension
Slovenian: Žilne bolezni pogostnost ni znana: ortostatska hipotenzija
English: Take special care with Cozaar
Slovenian: Bodite posebno pozorni pri jemanju zdravila Cozaar
English: Cozaar 25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Slovenian: Cozaar 25 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7 ali 28 tablet.
English: Use in patients with hepatic impairment:
Slovenian: Uporaba pri bolnikih z jetrno okvaro
English: • Treatment of essential hypertension.
Slovenian: • Zdravljenje esencialne hipertenzije.
English: Losartan tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Slovenian: Tablete z losartanom se lahko jemljejo skupaj z drugimi zdravili za zniževanje krvnega tlaka (npr. diuretiki, zaviralci kalcijevih kanalčkov, alfa ali beta zaviralci in zdravili, ki delujejo na centralno živčevje), kot tudi z insulinom in drugimi običajno uprabljenimi zdravili za zmanjševanje količine glukoze v krvi (npr. sulfonilsečnino, glitazoni, zaviralci glukozidaze).
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 tablet.
English: No difference in exposure was found with concomitantly treatment with fluvastatin (weak inhibitor of CYP2C9).
Slovenian: Pri sočasnem zdravljenju s fluvastatinom (šibek zaviralec CYP2C9) niso ugotovili nobenih razlik v izpostavljenosti.
English: • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Slovenian: • Zmanjšanje tveganja za možgansko kap pri hipertenzivnih bolnikih s hipertrofijo levega prekata, potrjeno z EKG-jem (glejte poglavje 5.1: Študija LIFE, Rasa).
English: Chronic heart failure
Slovenian: Kronično srčno popuščanje
English: in patients with high blood pressure and a thickening of the left ventricle, COZAAR has been shown to decrease the risk of stroke (“LIFE indication”).
Slovenian: • Pri bolnikih z visokim krvnim tlakom in zadebeljenim levim prekatom zdravilo Cozaar zmanjša tveganje za možgansko kap.
English: - Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG ( See section 5.1 Life Study, Race)
Slovenian: - Zmanjševanje tveganja kapi pri hipertenzivnih bolnikih s hipertrofijo levega prekata, dokazano z EKG-jem (glejte poglavje 5.1 Študija Life, rasa)
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 filmsko obloženih tablet.
English: Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Slovenian: Bolniki s srčnim popuščanjem, katerih stanje je bilo stabilizirano z zaviralcem ACE, naj ne prehajajo na losartan.
English: Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects, rash.
Slovenian: Žilne bolezni občasne: simptomatska hipotenzija (posebej pri bolnikih z zmanjšanim intravaskularnim volumnom, npr. bolnikih s hudim srčnim popuščanjem ali bolnikih, ki se zdravilo z velikimi odmerki diuretikov), od odmerka odvisni ortostatski učinki, izpuščaj
English: Cozaar may be administered with or without food.
Slovenian: Zdravilo Cozaar se lahko zaužije s hrano ali na tešče.
English: If you experience the following, stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Slovenian: Tablete z losartanom takoj prenehajte jemati in se posvetujte z zdravnikom ali pa takoj pojdite na urgenco, če se pri vas pojavi kaj od sledečega:
English: LORTAAN IC- Titulação
Slovenian: LORTAAN ICTitulação
English: Pediatric Hypertension
Slovenian: Pediatrična hipertenzija
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Slovenian: Razmisliti je treba o kontroli delovanja ledvic takoj po začetku zdravljenja in občasno tekom zdravljenja.
English: INSTRUCTIONS ON USE [To be completed nationally] [For referral procedures]
Slovenian: NAVODILA ZA UPORABO [Izpolni država članica]
English: The usual starting and maintenance dose is 50 mg once daily for most patients.
Slovenian: Za večino bolnikov je običajen začetni in vzdrževalni odmerek 50 mg enkrat na dan.
English: At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dose-dependent manner.
Slovenian: Po treh tednih je dajanje losartana enkrat dnevno krvni tlak ob izteku učinka znižalo v odvisnosti od odmerka.
English: Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Slovenian: Zato se losartan ne sme uporabljati pri bolnikih s hudo jetrno okvaro (glejte poglavja 4.2, 4.3 in 5.2).
English: Do not take Cozaar
Slovenian: Ne jemljite zdravila Cozaar:
English: Cozaar may be taken with or without food.
Slovenian: Zdravilo Cozaar lahko vzamete s hrano ali na tešče.
English: Lithuania UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
Slovenian: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Litva
English: Muscoskeletal and connective tissue disorders: not known: back pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogostnost ni znana: bolečine v hrbtu
English: Cozaar may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Slovenian: Zdravilo Cozaar se lahko jemlje skupaj z drugimi antihipertenzivnimi zdravili (npr. diuretiki, zaviralci kalcijevih kanalčkov, alfa ali beta zaviralci ter antihipertenzivi z delovanjem na centralni živčni sistem) pa tudi z insulinom in drugimi običajnimi antidiabetičnimi zdravili (npr. sulfonilsečnine, glitazoni in zaviralci glukozidaze).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Izpolni država članica]
English: White, oval film-coated tablets marked 952 on one side and scored on the other.
Slovenian: Bele, ovalne filmsko obložene tablete z oznako 952 na eni strani in z razdelilno zarezo na drugi strani.
English: In elderly hypertensive patients the plasma concentrations of losartan and its active metabolite do not differ essentially from those found in young hypertensive patients.
Slovenian: Plazemske koncentracije losartana in njegovega aktivnega presnovka pri starejših hipertonikih niso pomembno drugačne kot pri mladih hipertonikih.
English: - Treatment of essential hypertension
Slovenian: - Zdravljenje esencialne hipertenzije
English: Use in patients with renal impairment and haemodialysis patients: No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Slovenian: Uporaba pri bolnikih z ledvično okvaro in bolnikih na hemodializi Pri bolnikih z ledvično okvaro in bolnikih na hemodializi začetnega odmerka ni treba prilagoditi.
English: • increase in blood urea,
Slovenian: • povečana količina sečnine v krvi
English: 21 film-coated tablets of 12.5 mg and 7 film-coated tablets of 50 mg losartan potassium.
Slovenian: 21 filmsko obloženih tablet z 12,5 mg in 7 filmsko obloženih tablet s 50 mg kalijevega losartanata.
English: Liver Function Impairment
Slovenian: Okvara ledvične funkcije
English: Nervous system disorders: uncommon: dizziness, headache rare: paraesthesia
Slovenian: Bolezni živčevja občasne: omotica, glavobol redke: parestezija
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
English: • if your liver function is severely impaired,
Slovenian: • če imate hudo okvaro jeter.
English: Treatment with losartan resulted in a 13.0% risk reduction (p=0.021, 95 % confidence interval 0.77-0.98) compared with atenolol for patients reaching the primary composite endpoint.
Slovenian: Zdravljenje z losartanon je v primerjavi z atenololom tveganje za primarni sestavljeni opazovani dogodek zmanjšalo za 13,0 % (p = 0,021; 95-odstotni interval zaupanja 0,77-0,98).
English: Vascular disorders: common: hypotension
Slovenian: Žilne bolezni pogoste: hipotenzija
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Pretisni omot shranjujte v škatli.
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Slovenian: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Velika Britanija
English: Use in pediatric patients with renal function impairment Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Slovenian: Uporaba pri pediatričnih bolnikih z okvaro ledvične funkcije Losartana ne priporočamo za uporabo pri otrocih, ki imajo hitrost glomerulne filtracije < 30 ml/min/1,73 m2, ker ni na voljo nobenih podatkov (glejte poglavje 4.2).
English: happening in 1 in 10,000 to 1 in 1,000 patients very rare:
Slovenian: pojavijo se pri 1 ali več od 10.000 ter manj kot 1 od 1.000 bolnikov zelo redki:
English: not known:
Slovenian: Pogostnost ni znana:
English: • somnolence,
Slovenian: • zaspanost
English: What Cozaar contains
Slovenian: Kaj vsebuje zdravilo Cozaar
English: The following wording has been added to the Package Leaflet Section 2 Before you take Cozaar: Use in children and adolescents <COZAAR> has been studied in children.
Slovenian: Naslednje besedilo je bilo dodano v poglavje 2 navodil za uporabo „Kaj morate vedeti, preden boste vzeli zdravilo Cozaar“:
English: 21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
Slovenian: 21 filmsko obloženih tablet z 12,5 mg in 14 filmsko obloženih tablet s 50 mg kalijevega losartanata.
English: General disorders and administration site conditions: not known: flu-like symptoms
Slovenian: Splošne težave in spremembe na mestu aplikacije pogostnost ni znana: gripi podobni simptomi
English: Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg losartan (one tablet Cozaar 50 mg) once daily, according to your condition.
Slovenian: Zdravljenje se običajno začne z 12,5 mg losartana (ena tableta Cozaar 12,5 mg) enkrat na dan. Večinoma je treba odmerek povečati glede na vaše stanje, postopoma, tedensko (tj. 12,5 mg dnevno prvi teden, 25 mg dnevno drugi teden, 50 mg dnevno tretji teden) do običajnega vzdrževalnega odmerka 50 mg losartana (ena tableta Cozaar 50 mg) enkrat na dan.
English: Always take Cozaar exactly as your doctor has instructed you.
Slovenian: Pomembno je, da nadaljujete z jemanjem zdravila Cozaar tako dolgo, kot vam je predpisal zdravnik.
English: Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108
Slovenian: Luksemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Bruselj, Belgija
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 in 500 tablet.
English: It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Slovenian: Uporaba ni priporočljiva pri otrocih s stopnjo glomerularne filtracije < 30 ml/ min / 1,73 m2, saj za to skupino podatki niso na voljo (glejte tudi poglavje 4.4).
English: The Losartan Intervention For Endpoint Reduction in Hypertension [LIFE] study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECGdocumented left-ventricular hypertrophy.
Slovenian: Vključevala je 9.193 hipertenzivnih bolnikov, starih od 55 do 80 let, z EKG-jem potrjeno hipertrofijo levega prekata.
English: There was also a significant risk reduction for doubling of the serum creatinine and for end-stage renal failure in the patient group treated with losartan.
Slovenian: V skupini bolnikov, zdravljenih z losartanom, je bilo ugotovljeno tudi signifikantno zmanjšanje tveganja za podvojitev serumskega kreatinina ter za napredovanje do končnega stadija ledvične bolezni.
English: Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Zato je uporaba losartana pri bolnikih s hudo okvaro jeter kontraindicirana (glejte poglavji 4.3 in 4.4).
English: • liver function abnormalities,
Slovenian: • nenormalno delovanje jeter
English: Common: dizziness, vertigo Uncommon: somnolence, headache, sleep disorders
Slovenian: Bolezni živčevja pogoste: omotica, vrtoglavica občasne: zaspanost, glavobol, motnje spanja
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations' and ‘Post-marketing experience - Investigations' Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/ min should be closely monitored.
Slovenian: V klinični študiji pri bolnikih s sladkorno boleznijo tipa 2 in nefropatijo je bila pojavnost hiperkaliemije večja v skupini, ki je prejemala zdravilo Cozaar, kot v skupini, ki je prejemala placebo (glejte poglavje 4.8: "Hipertenzija in sladkorna bolezen tipa 2 z boleznijo ledvicPreiskave" in "Izkušnje z zdravilom v obdobju trženja - Preiskave").
English: If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan .
Slovenian: Če je srčno popuščanje stabilno ob zdravljenju z zaviralcem ACE, vam zdravnik zdravila ne sme zamenjati za losartan.
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6
Slovenian: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Dunaj, Avstrija
English: Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Slovenian: Losartan ni priporočljiv pri otrocih s stopnjo glomerularne filtracije < 30ml/ml/min/1,73 m2, saj o taki uporabi ni na voljo nobenih podatkov (glejte poglavje 4.2).
English: Cozaar 25 mg tablet
Slovenian: Cozaar 25 mg tablete
English: Renal and urinary disorders: not known: urinary tract infections
Slovenian: Bolezni sečil pogostnost ni znana: okužbe urinarnega trakta
English: • numbness or tingling sensation (paraesthesia),
Slovenian: • odrevenelost ali mravljinčenje (parestezija)
English: Hepatobiliary disorders: rare: hepatitis not known: liver function abnormalities
Slovenian: Bolezni jeter, žolčnika in žolčevodov redke: hepatitis pogostnost ni znana: nenormalno delovanje jeter
English: Ireland Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Slovenian: Velika Britanija Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Velika Britanija
English: INFORMATION IN BRAILLE [To be completed nationally] [For referral procedures]
Slovenian: PODATKI V BRAILLOVI PISAVI [Izpolni država članica]
English: Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Slovenian: Vsaka Cozaar 100 mg tableta vsebuje 51,0 mg laktoze monohidrata.
English: Respiratory, thoracic and mediastinal disorders: not known: cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogostnost ni znana: kašelj
English: A low dose of hydrochlorothiazide should be added and/ or the dose of Cozaar should be increased to 100 mg once daily based on blood pressure response.
Slovenian: Običajni začetni odmerek je 50 mg zdravila Cozaar enkrat na dan. Glede na odziv krvnega tlaka je treba dodati majhen odmerek hidroklorotiazida in/ali odmerek zdravila Cozaar povečati na 100 mg enkrat na dan.
English: Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites.
Slovenian: K izločanju losartana in njegovih presnovkov prispevata tako izložanje z žolčem kot izložanje preko ledvic.
English: • muscle and joint pain,
Slovenian: • bolečine v mišicah in sklepih
English: Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive 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 AIIA-jem nujno.
English: Gastrointestinal disorders: not known: diarrhoea
Slovenian: Bolezni prebavil pogostnost ni znana: diareja
English: Store Cozaar in the original package.
Slovenian: Zdravilo Cozaar shranjujte v originalni ovojnini.