natgillin/translations-raw huggingface dataset:
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
Zdravljenje ledvične bolezni pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo > 0, 5 g/ dan kot del antihipertenzivnega zdravljenja
Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (See section 5.1 Life Study, Race)
Zmanjševanje tveganja kapi pri hipertenzivnih bolnikih s hipertrofijo levega prekata, dokazano z EKG- jem (glejte poglavje 5. 1 Študija Life, rasa)
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.
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.
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure
Bolniki morajo imeti iztisno frakcijo levega prekata enako ali večjo od 40% ter jih je treba stabilizirati v okviru zdravljenja kroničnega srčnega popuščanja.
- Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections
- Nosečnost in dojenje morata biti kontraindicirana in ustrezno besedilo je treba vključiti v poglavja
4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
4. 3, 4. 4 in 4. 6 SPC ter v ustrezna poglavja navodila za uporabo.
- The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of
- Uporabo losartana pri pediatričnih bolnikih je treba vključiti v poglavja 4. 2, 4. 4, 4. 8, 5. 1 in 5. 2 SPC
the SPC, and the relevant sections of the Package Leaflet.
ter v ustrezna poglavja navodila za uporabo.
22 ANNEX III
18 DODATEK III
23 SUMMARY OF PRODUCT CHARACTERISTICS
19 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
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
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
Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Vsaka Cozaar 12, 5 mg tableta vsebuje 12, 5 mg losartana (v obliki kalijeve soli).
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Vsaka Cozaar 12, 5 mg tableta vsebuje 25, 5 mg laktoze monohidrata.
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Vsaka Cozaar 25 mg tableta vsebuje 12, 75 mg laktoze monohidrata.
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Vsaka Cozaar 50 mg tableta vsebuje 25, 5 mg laktoze monohidrata.
Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Vsaka Cozaar 100 mg tableta vsebuje 51, 0 mg laktoze monohidrata.
Cozaar 12,5 mg tablet Blue, oval film-coated tablets marked 11 on one side and plain on the other.
Cozaar 12, 5 mg tablete Modre, ovalne filmsko obložene tablete, z oznako 11 na eni strani in brez oznake na drugi strani.
Cozaar 25 mg tablet White, oval unscored film-coated tablets marked 951 on one side and plain on the other..
Cozaar 25 mg tablete Bele, ovalne filmsko obložene tablete brez razdelilne zareze, z oznako 951 na eni strani in brez oznake na drugi strani.
Cozaar 50 mg tablet White, oval film-coated tablets marked 952 on one side and scored on the other .< The tablet can be divided into equal halves .>
Tableta se lahko deli na enaki polovici.
Cozaar 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Cozaar 100 mg tablete Bele, filmsko obložene tablete v obliki kapljice, z oznako 951 na eni strani in brez oznake na drugi strani.
• Treatment of essential hypertension. • 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.
• Zdravljenje esencialne hipertenzije. • Zdravljenje bolezni ledvic pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo ≥ 0, 5 g/ dan kot del antihipertenzivnega zdravljenja.
25 • 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.
21 • Zdravljenje kroničnega srčnega popuščanja (pri bolnikih ≥ 60 let) kadar zdravljenje z zaviralci ACE ne velja za primerno zaradi inkompatibilnosti, posebno kašlja, ali kontraindikacije.
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure. • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Študija LIFE, Rasa).
Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients.
Hipertenzija Za večino bolnikov je običajen začetni in vzdrževalni odmerek 50 mg enkrat na dan.
The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
Največji antihipertenzivni učinek dosežemo 3- 6 tednov po začetku zdravljenja.
Cozaar may be administered with other antihypertensive agents, especially with diuretics (e. g. hydrochlorothiazide).
Zdravilo Cozaar se lahko jemlje skupaj z drugimi antihipertenzivnimi zdravili, še posebej z diuretiki (npr. hidroklorotiazidom).
Pediatric hypertension There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1:
Pediatrična hipertenzija Podatkov o učinkovitosti in varnosti losartana za zdravljenje hipertenzije pri otrocih in mladostnikih, starih 6 do 16 let, je malo (glejte poglavje 5. 1 "Farmakodinamične lastnosti").
Pharmacokinetic properties).
Farmakokinetičnih podatkov pri otrocih s hipertenzijo, starih več kot en mesec, je malo na voljo (glejte poglavje 5. 2 "Farmakokinetične lastnosti").
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg.
Za bolnike, ki tablete lahko pogoltnejo in so težki 20 – 50 kg, je priporočeni odmerek 25 mg enkrat na dan.
In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
V izjemnih primerih se odmerek lahko poveča do največ 50 mg enkrat na dan.
In patients > 50 kg, the usual dose is 50 mg once daily.
Pri bolnikih > 50 kg je običajni odmerek 50 mg enkrat na dan.
In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
V izjemnih primerih se odmerek lahko prilagodi do največ 100 mg enkrat na dan.
Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Odmerki nad 1, 4 mg/ kg (ali nad 100 mg) na dan pri pediatričnih bolnikih niso bili preizkušani.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
Uporabe losartana ne priporočamo pri otrocih, mlajših od 6 let, ker je razpoložljivih podatkov za to starostno skupino malo.
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).
Losartana ne priporočamo za uporabo pri otrocih, ki imajo hitrost glomerulske filtracije < 30 ml/ min/ 1, 73 m2, ker ni na voljo nobenih podatkov (glejte tudi poglavje 4. 4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Losartana ne priporočamo tudi za uporabo pri otrocih z jetrno okvaro (glejte tudi poglavje 4. 4).
Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/ day The usual starting dose is 50 mg once daily.
Bolniki s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo ≥ 0, 5 g/ dan Običajni začetni odmerek je 50 mg enkrat na dan.
The dose may be increased to 100 mg once daily based on blood pressure response from one month after initiation of therapy onwards.
Glede na odziv krvnega tlaka lahko po enem mesecu zdravljenja ali kasneje odmerek povečamo na 100 mg enkrat na dan.
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).
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).
Heart Failure The usual initial dose of Cozaar in patients with heart failure is 12.5 mg once daily.
Srčno popuščanje Običajni začetni odmerek zdravila Cozaar pri bolnikih s srčnim popuščanjem je 12, 5 mg enkrat na dan.
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.
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.
26 Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG The usual starting dose is 50 mg of Cozaar once daily.
22 Zmanjšanje tveganja za možgansko kap pri hipertenzivnih bolnikih s hipertrofijo levega prekata, potrjeno z EKG- jem Običajni začetni odmerek je 50 mg zdravila Cozaar enkrat na dan.
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.
Glede na odziv krvnega tlaka je treba dodati majhen odmerek hidroklorotiazida in/ ali odmerek zdravila Cozaar povečati na 100 mg enkrat na dan.
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).
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).
A lower dose should be considered for patients with a history of hepatic impairment.
Uporaba pri bolnikih z jetrno okvaro Pri bolnikih, ki so kdaj imeli okvaro jeter, je treba razmisliti o manjšem odmerku.
Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Zato je uporaba losartana pri bolnikih s hudo okvaro jeter kontraindicirana (glejte poglavji 4. 3 in 4. 4).
Use in Elderly Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Uporaba pri starejših bolnikih Za bolnike, starejše od 75 let, je treba razmisliti o začetku zdravljeja s 25 mg odmerkom, vendar pa prilagoditev odmerjanja pri starejših običajno ni potrebna.
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavji 4. 4 in 6. 1).
2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6) Severe hepatic impairment
Huda okvara jeter.
Hypersensitivity Angiooedema.
Preobčutljivost Angioedem.
Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Bolnike, ki so kdaj imeli angioedem (otekanje obraza, ustnic, žrela in/ ali jezika) je treba pozorno spremljati (glejte poglavje 4. 8).
Hypotension and Electrolyte/ Fluid Imbalance 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.
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.
These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see section 4.2).
Pred začetkom zdravljenja z zdravilom Cozaar je treba ta stanja pozdraviti ali pa uporabiti manjši začetni odmerek (glejte poglavje 4. 2).
Electrolyte imbalances Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Elektrolitsko neravnovesje Pri bolnikih z okvaro ledvic, s sladkorno boleznijo ali brez nje, so pogosta elektrolitska neravnovesja, ki jih je treba urediti.
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.
Zato je treba pozorno spremljati plazemske koncentracije kalija ter kreatininski očistek, še posebej pri bolnikih s srčnim popuščanjem in kreatininskim očistkom 30- 50 ml/ min.
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
Sočasne uporabe diuretikov, ki varčujejo kalij, kalijevih dodatkov in nadomestkov soli, ki vsebujejo kalij, ter losartana ne priporočamo (glejte poglavje 4. 5).
27 Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
Okvara jetrne funkcije Glede na farmakokinetične podatke, ki kažejo pomembno zvišanje plazemskih koncentracij losartana pri bolnikih s cirozo, je treba pri bolnikih, ki so kdaj imeli okvaro jeter, razmisliti o manjšem odmerku.
There is no therapeutic experience with losartan in patients with severe hepatic impairment.
23 Izkušenj z zdravljenjem z losartanom pri bolnikih s hudo jetrno okvaro ni.
Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Zato se losartan ne sme uporabljati pri bolnikih s hudo jetrno okvaro (glejte poglavja 4. 2, 4. 3 in 5. 2).
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Losartana ne priporočamo tudi za uporabo pri otrocih z okvaro jeter (glejte poglavje 4. 2).
Renal Function Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Okvara ledvične funkcije Kot posledico inhibicije sistema renin- angiotenzin so poročali o spremembah ledvične funkcije, vključno z ledvično odpovedjo (še posebej pri bolnikih, katerih ledvična funkcija je odvisna od sistema renin- angiotenzin- aldosteron, kot je pri bolnikih s hudo srčno insuficienco ali že obstoječo ledvično disfunkcijo).
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Te spremembe ledvične funkcije so po ukinitvi zdravljenja lahko reverzibilne.
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).
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).
Primary hyperaldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Primarni hiperaldosteronizem Bolniki s primarnim hiperladosteronizmom se na zdravljenje z antihipertenzivi, ki zavirajo sistem renin- angiotenzin, večinoma ne odzovejo.
Heart failure 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.
Srčno popuščanje 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.
The combination of losartan with a beta-blocker should be used with caution (see section 5.1).
Kombinacijo losartana in beta zaviralca je treba previdno uporabljati (glejte poglavje 5. 1).
Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze, malabsorpcija glukoze - galaktoze Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze- galaktoze tega zdravila ne smejo jemati.
28 Pregnancy Losartan should not be initiated during pregnancy.
24 Nosečnost Zdravljenja z losartanom se ne sme začeti med nosečnostjo.
When pregnancy is diagnosed, treatment with losartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Ko se ugotovi nosečnost, je treba zdravljenje z losartanom takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4. 3 in 4. 6).
Other warnings and precautions As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Druga opozorila in previdnostni ukrepi Tako kot so opazili pri zaviralcih angiotenzinske konvertaze, so tudi losartan in drugi antagonisti angiotenzina pri črncih očitno manj učinkoviti za zniževanje krvnega tlaka kot pri drugih rasah, verjetno zaradi večje pojavnosti nizkih vrednosti renina pri črnski populaciji hipertonikov.
In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%.
V kliničnem preizkušanju so ugotovili, da flukonazol (zaviralec CYP2C9) zmanjšuje izpostavljenost aktivnemu presnovku za približno 50%.
It was found that concomitant treatment of losartan with rifampicine (inducer of matabolism enzymes) gave a 40% reduction in plasma concentration of the active metabolite.
Ugotovili so, da je pri sočasnem zdravljenju z losartanom in rifampicinom (induktor presnovnih encimov) plazemska koncentracija aktivnega presnovka manjša za 40%.
As with other drugs that block angiotensin II or its effects, concomitant use of other drugs which retain potassium (e. g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e. g. heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
Kot pri drugih zdravilih, ki zavirajo angiotenzin II ali njegove učinke, lahko sočasna uporaba drugih zdravil, ki zadržujejo kalij (npr. diuretikov, ki varčujejo kalij, amilorida, triamterena, spironolaktona) ali lahko povečajo količino kalija (npr. heparin), dodatkov kalija ali nadomestkov soli, ki vsebujejo kalij, povzroči zvišanje vrednosti kalija v serumu.
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.
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.
Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Sočasna uporaba antagonistov angiotenzina II ali diuretikov in NSAR- ov lahko poveča tveganje za poslabšanje ledvične funkcije, vključno z možno akutno ledvično odpovedjo, ter poveča količino kalija v serumu, še posebej pri bolnikih z že obstoječim slabim delovanjem ledvic.
Pregnancy The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4).
Nosečnost Uporaba losartana v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4. 4).
The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
Uporaba losartana je kontraindicirana v 2. in 3. trimesečju nosečnosti (glejte poglavji 4. 3 in 4. 4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk 29 cannot be excluded.
Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavlejnei zaviralcem ACE,, vendar pa majhnega povečanja tveganja ni možno izključiti.
Unless continued ARB 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.
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
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 ').
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).
Infants whose mothers have taken losartan should be closely observed for hypotension (see also section 4.3 and 4.4).
Otroke, katerih matere so prejemale losartan, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
Because of the potential for adverse effects on the nursing infant, losartan is contraindicated during breast-feeding (see section 4.3).
Zaradi možnih neželenih učinkov na dojenčka, je losartan v času dojenja kontraindiciran (glejte poglavje 4. 3).