FrancophonIA/ELRC3.0 huggingface dataset:
English: Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana
Slovenian: Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Slovenija
English: Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Slovenian: Losartan spada v skupino zdravil, imenovanih "antagonisti receptorjev angiotenzina II".
English: Whilst the ELITE I indicated an reduction in risk of mortality due to heart failure in patients taking losartan, as compared to captopril, the ELITE II study was not powered to establish equal efficacy between losartan and captopril.
Slovenian: Medtem ko je preskušanje ELITE I nakazalo zmanjšanje tveganja smrtnosti zaradi srčnega popuščanja pri bolnikih, prejemajočih losartan, v primerjavi s kaptoprilom, študija ELITE II ni zmogla ugotoviti enake učinkovitosti med losartanom in kaptoprilom.
English: For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).
Slovenian: Uporaba pri bolnikih z zmanjšanim intravaskularnim volumnom Pri bolnikih z zmanjšanim intravaskularnim volumnom (npr. tistih, ki se zdravijo z velikimi odmerki diuretikov) je treba razmisliti o začetnem odmerku 25 mg enkrat na dan (glejte poglavje 4.4).
English: About 14% of an intravenously- or orally-administered dose of losartan is converted to its active metabolite.
Slovenian: Približno 14 % intravenskega ali peroralnega odmerka losartana se pretvori v njegov aktivni presnovek.
English: In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
Slovenian: Pri bolnikih s srčnim popuščanjem z okvaro ledvic ali brez obstaja, tako kot pri drugih zdravilih, ki delujejo na sistem renin-angiotenzin, tveganje za hudo arterijsko hipotenzijo in (pogosto akutno) ledvično okvaro.
English: If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Slovenian: Če ste omotični ali zaspani, se, preden se lotite teh aktivnosti, posvetujte z zdravnikom.
English: The efficacy and safety are well established for the indication “treatment of essential hypertension”.
Slovenian: Za indikacijo »zdravljenje esencialne hipertenzije« sta učinkovitost in varnost dobro potrjena.
English: In the ELITE Study carried out over 48 weeks in 722 patients with heart failure (NYHA Class II-IV), no difference was observed between the patients treated with Losartan and those treated with captopril was observed with regard to the primary endpoint of a long-term change in renal function.
Slovenian: V študiji ELITE, ki je trajala 48 tednov in je vključevala 722 bolnikov s srčnim popuščanjem (NYHA razred II-IV), niso opazili nobenih razlik v dolgoročni spremembi ledvične funkcije kot primarnem opazovanem dogodku med bolniki, ki so prejemali losartan, in bolniki, ki so prejemali kaptopril.
English: You must not take losartan if you are breast-feeding.
Slovenian: Losartana ne smete jemati, če dojite.
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9% of patients treated with Losartan tablets developed hyperkalaemia >5.5 mEq/l and 3.4% of patients treated with placebo (see section 4.4, ‘Electrolyte imbalances').
Slovenian: V klinični študiji, izvedeni pri bolnikih s sladkorno boleznijo tipa 2 in z nefropatijo, se je hiperkaliemija > 5,5 mEq/l razvila pri 9,9 % bolnikov, ki so prejemali tablete z losartanom, in pri 3,4 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4, "Elektrolitsko neravnovesje").
English: • feeling of increased heart rate (palpitations),
Slovenian: • občutek pospešenega bitja srca (palpitacije)
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Dodatku III za zdravilo Cozaar in z njim povezana imena (glejte Dodatek I).
English: Treatment with losartan, as compared with placebo, resulted in a 16.1% risk reduction in the number of patients reaching the primary composite endpoint.
Slovenian: Zdravljenje z losartanom je v primerjavi s placebom, z ozirom na število bolnikov, ki so dosegli sestavljeno primarno končno točko, privedlo do 16,1-odstotnega zmanjšanja tveganja.
English: The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take losartan").
Slovenian: Uporabe losartana ne priporočamo za bolnike s hudo okvaro jeter (glejte poglavje "Ne jemljite zdravila Cozaar").
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}>
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD/MM/LLLL}
English: Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone.
Slovenian: Angiotenzin II se veže na AT1 receptorje, ki se nahajajo v mnogih tkivih (npr. gladkih mišicah žil, nadledvični žlezi, ledvicah in srcu), in sproži več pomembnih bioloških učinkov, vključno z vazokonstrikcijo in s sproščanjem aldosterona.
English: All-cause mortality rate was not significantly different between the two treatment groups.
Slovenian: Celokupna smrtnost se med skupinama ni pomembno razlikovala.
English: • serum creatinine and serum potassium in patients with heart failure,
Slovenian: • povečana količina kreatinina in kalija v serumu pri bolnikih s srčnim popuščanjem
English: Cozaar and associated names (see Annex I) 12.5 mg film-coated tablets Cozaar and associated names (see Annex I) 25 mg film-coated tablets Cozaar and associated names (see Annex I) 50 mg film-coated tablets Cozaar and associated names (see Annex I) 100 mg film-coated tablets
Slovenian: Cozaar in povezana imena (glejte Dodatek I) 12,5 mg filmsko obložene tablete Cozaar in povezana imena (glejte Dodatek I) 25 mg filmsko obložene tablete Cozaar in povezana imena (glejte Dodatek I) 50 mg filmsko obložene tablete Cozaar in povezana imena (glejte Dodatek I) 100 mg filmsko obložene tablete
English: • severe chest pain (angina pectoris),
Slovenian: • huda bolečina v prsnem košu (angina pektoris)
English: In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Slovenian: V študiji LIFE je bila za strategijo na podlagi losartana ugotovljena dodatna korist z vidika kapi, medtem ko so bili z vidika miokarnega infarkta in srčnožilne smrtnosti učinki podobni, nakazujoč, da je dokazani ugodni učinek blokade receptorjev beta na srčnožilno obolevnost in smrtnost nasploh prisoten tudi pri losartanu.
English: Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure.
Slovenian: Losartan preprečuje vezavo angiotenzina II na te receptorje in tako povzroči, da se žile sprostijo in se krvni tlak zniža.
English: Luxembourg COZAAR 100 mg Luxembourg COZAAR 50 MG Luxembourg COZAAR 12,5 mg Luxembourg COZAAR CARDIO START Luxembourg LOORTAN 100 mg Luxembourg LOORTAN 50 mg Luxembourg LOORTAN 12,50 mg Luxembourg LOORTAN CARDIO START
Slovenian: Luksemburg COZAAR 100 mg Luksemburg COZAAR 50 MG Luksemburg COZAAR 12,5 mg Luksemburg COZAAR CARDIO START Luksemburg LOORTAN 100 mg Luksemburg LOORTAN 50 mg Luksemburg LOORTAN 12,50 mg Luksemburg LOORTAN CARDIO START Madžarska Cozaar
English: if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups'),
Slovenian: • če jemljete diuretike (zdravila, ki povečajo izločanje vode skozi ledvice) ali ste na dieti s hrano z zmanjšano količino soli, zaradi česar iz telesa izgubljate večje količine tekočine in soli (glejte poglavje 3 "Odmerjanje pri posebnih skupinah bolnikov").
English: Therefore, the CHMP proposed that the indication should be re-worded to “Treatment of renal disease in patients with hypertension and Type II diabetes mellitus with proteinuria > 0.5g/day as part of an antihypertensive treatment” to reflect the inclusion criteria of the RENAAL study.
Slovenian: Iz tega razloga je CHMP predlagal, da se besedilo indikacije spremeni v „Zdravljenje ledvične bolezni pri bolnikih s hipertenzijo ter s sladkorno boleznijo tipa 2 s proteinurijo > 0,5 g/dan v okviru antihipertenzivnega zdravljenja“, da bi tako odražalo kriterije vključitve študije RENAAL.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, PREDSTAVLJENI S STRANI EMEA
English: Plasma concentrations of Losartan are not altered in patients with a creatinine clearance above 10 ml/minute.
Slovenian: Plazemske koncentracije losartana se pri bolnikih s kreatininskim očistkom nad 10 ml/min ne razlikujejo.
English: Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2 : Pharmacokinetic properties).
Slovenian: Na voljo je le malo farmakokinetičnih podatkov za otroke s hipertenzijo starosti nad en mesec (glejte 5.2: Farmakokinetične lastnosti).
English: Because of the potential for adverse effects on the nursing infant, losartan is contraindicated during breast-feeding (see section 4.3).
Slovenian: Zaradi možnih neželenih učinkov na dojenčka, je losartan v času dojenja kontraindiciran (glejte poglavje 4.3).
English: The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg.
Slovenian: Farmakokinetiki losartana in njegovega aktivnega presnovka sta linearni za peroralne odmerke kalijevega losartanata do 200 mg.
English: if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
Slovenian: • če imate primarni hiperaldosteronizem (sindrom povezan s povečanim izločanjem hormona aldosterona iz nadledvične žleze zaradi okvare znotraj železe).
English: This results in an increase in blood pressure.
Slovenian: Na ta način se krvni tlak zviša.
English: In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).
Slovenian: Pri bolnikih z blago do zmerno alkoholno jetrno cirozo so bile plazemske koncentracije losartana oz. njegovega aktivnega presnovka po peroralni aplikaciji 5- oz. 1,7-krat višje od tistih pri mladih moških prostovoljcih (glejte poglavji 4.2 in 4.4).
English: Neopharmed SpA Via G. Fabbroni 6, 00191 Rome, Italy
Slovenian: Neopharmed SpA Via G. Fabbroni 6, 00191 Rim, Italija
English: Post-marketing experience
Slovenian: Izkušnje z zdravilom v obdobju trženja
English: Investigations: common: hypoglycaemia, hyperkalaemia
Slovenian: Preiskave pogoste: hipoglikemija, hiperkaliemija
English: Treatment of intoxication
Slovenian: Zdravljenje zastrupitve
English: When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Slovenian: Če se antagonisti angiotenzina II uporabljajo sočasno z nesteroidnimi antirevmatiki (NSAR) (npr. selektivnimi zaviralci COX-2, acetilsalicilno kislino v protivnetnih odmerkih in neselektivnimi NSAR-i) se lahko antihipertenzivni učinek zmanjša.
English: • if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias.
Slovenian: • če imate srčno popuščanje z okvaro ledvic ali brez ali sočasne hude življensko nevarne srčne aritmije.
English: -Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy” (“LIFE indication”)”
Slovenian: -Zmanjšanje tveganja srčnožilne obolevnosti in smrtnosti pri hipertenzivnih bolnikih s hipertrofijo levega prekata« (»indikacija LIFE«)
English: Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Slovenian: Po peroralnem zaužitju se losartan dobro absorbira in je podvržen presnovi prvega prehoda, kjer nastajajo aktivni karboksikislinski presnovki in drugi neaktivni presnovki.
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Slovenian: Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
English: In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
Slovenian: V izjemnih primerih je mogoče odmerek prilagoditi do največ 100 mg enkrat dnevno.
English: The difference in blood pressure increase as compared to placebo was largest in the middle dose group (6.70 mm Hg middle dose vs. 5.38 mmHg high dose).
Slovenian: Razlika v povečanju krvnega tlaka v primerjavi s placebom je bila največja v skupini s srednjim odmerkom (6,70 mmHg za srednji odmerek napram 5,38 mmHg za visoki odmerek).
English: The long-term efficacy of antihypertensive therapy with losartan in childhood to reduce cardiovascular morbidity and mortality has also not been established.
Slovenian: Dolgoročne učinkovitosti antihipertenzivnega zdravljenja z losartanom v otroštvu za zmanjšanje obolevnosti in smrtnosti zaradi srčno-žilnih vzrokov prav tako niso preučevali.
English: Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Slovenian: Losartan je treba pri bolnikih z bilateralno stenozo ledvične arterije ali stenozo ledvične arterije ob solitarni ledvici uporabljati previdno.
English: Should exposure to losartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: V primeru izpostavljenosti losartanu od drugega trimesečja nosečnosti dalje se priporoča ultrazvočni pregled lobanje in delovanja ledvic.
English: LIST OF EXCIPIENTS Lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI Laktoza monohidrat.
English: Bulgaria Merck Sharp & Dohme Bulgaria EOOD
Slovenian: Merck Sharp & Dohme Bulgaria EOOD
English: • low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
Slovenian: • nizek krvni tlak (posebno po veliki izgubi vode iz telesa in zato tudi iz krvnih žil, npr. pri bolnikih s hudim srčnim popuščanjem ali pri bolnikih, zdravljenih z velikimi odmerki diuretikov)
English: Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Slovenian: Vsaka tableta vsebuje naslednje pomožne snovi: mikrokristalna celuloza (E460) laktoza monohidrat predgelirani koruzni škrob magnezijev stearat (E572) hidroksipropilceluloza (E463) hipromeloza (E464)
English: The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i.e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only.
Slovenian: Študija LIFE je bila ocenjena v preteklosti in to je pripeljalo do registracije širše indikacije, namreč zmanjševanje srčnožilne obolevnosti in smrtnosti (merjeno s kombinirano incidenco srčnožilne smrti, kapi in miokardnega infarkta).
English: In both comparator-controlled (not placebo-controlled) clinical studies on patients with heart failure the tolerability of Losartan was superior to that of captopril, measured on the basis of a significantly lower rate of discontinuations of therapy on account of adverse events and a significantly lower frequency of cough.
Slovenian: V obeh s primerjalnim zdravilom primerjanih (ne s placebom primerjanih) kliničnih študijah pri bolnikih s srčnim popuščanjem so bolniki losartan veliko bolje prenašali kot kaptopril, kar so določili na podlagi pomembno manjšega deleža prekinitev zdravljenja na račun neželenih učinkov in pomembno manjšo pojavnostjo kašlja.
English: However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people.
Slovenian: Vendar pa lahko losartan tako kot tudi veliko drugih zdravil za zdravljenje visokega krvnega tlaka pri nekaterih bolnikih povzroči omotico ali zaspanost.
English: Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist.
Slovenian: Losartan je sintetični peroralno učinkovit antagonist angiotenzina II (tipa AT1).
English: The adverse experience profile for paediatric patients appears to be similar to that seen in adult patients.
Slovenian: Zdi se, da je profil neželenih dogodkov pri pediatričnih bolnikih podoben kot pri odraslih bolnikih.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Slovenian: O reverzibilnih zvišanjih koncentracij litija v serumu in toksičnosti so poročali pri sočasni uporabi litija in zaviralcev ACE.
English: In a controlled clinical trial on patients with cardiac insufficiency, increase in blood urea, serum creatinine and serum potassium has been reported.
Slovenian: V kontroliranem kliničnem preizkušanju pri bolnikih s srčno insuficienco so poročali o povečani količini sečnine v krvi, zvišanem kreatininu in kaliju v serumu.
English: • changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
Slovenian: • spremenjeno delovanje ledvic (ki se po prekinitvi zdravljenja lahko popravi), vključno z ledvično odpovedjo
English: Special warnings and precautions for use (SPC section 4.4) The CHMP considered that the following warnings needed to be included in the SPC for Cozaar in all MSs: Hypersensitivity; Angioedema; Surgery; Anaesthesia; Haemodialysis; Kidney transplant; Black patients; Obstructive valvular disease.
Slovenian: Posebna opozorila in previdnostni ukrepi (poglavje 4.4) CHMP je menil, da je treba v SPC za zdravilo Cozaar v vseh državah članicah vključiti naslednja opozorila: preobčutljivost; angioedem; operacija; anestezija; hemodializa; presaditev ledvic; bolniki črne rase; obstruktivna bolezen zaklopk.
English: In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
Slovenian: V izjemnih primerih je mogoče odmerek povečati do največ 50 mg enkrat dnevno.
English: The patients should have a left ventricular ejection fraction equal to or greater than 40% and should be stabilised under the treatment of the chronic heart failure.
Slovenian: Bolniki morajo imeti iztisno frakcijo levega prekata enako ali večjo od 40 % ter jih je treba stabilizirati v okviru zdravljenja kroničnega srčnega popuščanja.
English: These results were confirmed during period II of the study where patients were randomized to continue losartan or placebo, after three weeks of treatment.
Slovenian: Ti rezultati so bili potrjeni med obdobjem II študije, v katerem so bili bolniki po osmih tednih zdravljenja naključno izbrani za nadaljevanje zdravljenja bodisi z losartanom bodisi placebom.
English: Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively.
Slovenian: Po peroralnem zaužitju plazemske koncentracije losartana in njegovega aktivnega presnovka padajo polieksponentno, pri čemer je končni razpolovni čas losartana približno 2 uri, njegovega aktivnega presnovka pa 6-9 ur.
English: This applies particularly when losartan is given in the presence of other conditions (fever, dehydratation) likely to impair renal function.
Slovenian: To velja še posebej, če se losartan daje ob prisotnosti drugih stanj (povišana telesna temperatura, dehidracija), za katere je verjetno, da bodo okrnila ledvično funkcijo.
English: The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg).
Slovenian: Razmerje med odmerkom in odzivom je bilo zelo očitno pri primerjavi med skupino z nizkim in skupino s srednjim odmerkom (obdobje I: -6,2 mmHg napram -11,65 mmHg), medtem je bila povezava pri primerjavi skupine s srednjim odmerkom s skupino z visokim odmerkom šibkejša (obdobje I: -11.65 mmHg napram -12.21 mmHg).
English: Cozaar is supplied in the following pack sizes:
Slovenian: Zdravilo Cozaar je na voljo v naslednjih pakiranjih:
English: In a controlled clinical trial in patients with cardiac insufficiency the following adverse events were reported:
Slovenian: V kontroliranem kliničnem preizkušanju pri bolnikih s srčno insuficienco so poročali o naslednjih neželenih učinkih:
English: Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes
Slovenian: Losartan upočasni pešanje ledvic pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
English: For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg.
Slovenian: Za bolnike, ki lahko pogoltnejo tablete, je priporočeni odmerek 25 mg enkrat dnevno pri bolnikih s telesno maso >20 do <50 kg.
English: The CHMP considered that the following contra-indications needed to be included in the SPC for Cozaar in all MSs: Pregnancy and lactation; Severely reduced liver function; Angina pectoris; Myocardial infraction; Cerebrovascular disease; Renal artery stenosis; Kidney transplant patients.
Slovenian: CHMP je menil, da je treba v SPC za zdravilo Cozaar v vseh državah članicah vključiti naslednje kontraindikacije: nosečnost in dojenje; hudo zmanjšana jetrna funkcija; angina pektoris; miokardni infarkt; rerebrovaskularna bolezen; stenoza ledvične arterije; bolniki s presajenimi ledvicami.
English: Discontinuation of Losartan in hypertensive patients did not result in an abrupt rise in blood pressure (rebound).
Slovenian: Prekinitev jemanja losartana pri bolnikih s hipertenzijo ni povzročila nenadnega povratnega dviga krvnega tlaka.
English: The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.
Slovenian: Profil neželenih učinkov za pediatrične bolnike je podoben tistemu za odrasle bolnike.
English: 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6)
Slovenian: Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
English: • too much potassium in the blood (hyperkalaemia).
Slovenian: • preveč kalija v krvi (hiperkaliemija)
English: • itching (pruritus),
Slovenian: • srbenje (pruritus)
English: If you become pregnant while on losartan, tell your doctor immediately.
Slovenian: Če jemljete losartan in zanosite, se takoj posvetujte z zdravnikom.
English: The following wording has been added to SPC Section 4.4 Special warnings and precautions for use:
Slovenian: Naslednje besedilo je bilo dodano v poglavje 4.4 SPC „Posebna opozorila in previdnostni ukrepi“: