FrancophonIA/ELRC3.0 huggingface dataset:
English: No data on efficacy and safety are available in women currently treated with hormonal therapy such as: androgens, hormone replacement therapy (oestrogen alone or combined with progestogens).
Slovenian: Za ženske, ki se trenutno zdravijo s hormonsko terapijo, kot so: androgeni ali nadomestno hormonsko zdravljenje (samo estrogeni ali kombinacija s progestogeni), ni na voljo nobenih podatkov o učinkovitosti in varnosti.
English: Cases of abnormal Pap smears corresponding to ASCUS or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported in women treated with the 6.5 mg dose (common frequency).
Slovenian: Pri ženskah, ki so bile zdravljene s 6,5-miligramskim odmerkom (običajna pogostnost) so poročali o primerih nenormalnih brisov PAP, ki so ustrezali ASCUS ali ploščati intraepitelijski leziji nizke stopnje (LSIL-Low Grade Squamous Intraepithelial Lesion).
English: Weight fluctuation
Slovenian: Nihanje telesne mase
English: The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).
Slovenian: HNZ kot pozneje (glejte poglavje 4.8).
English: Intrarosa has not been studied in women with a current hormonal treatment: hormone replacement therapy (oestrogens alone or combined with progestogens) or androgens treatment.
Slovenian: Zdravilo Intrarosa pri ženskah, zdravljenih s hormonskim nadomestnim zdravljenjem (samo z estrogeni ali kombinacijo s progestogeni) ali androgeni ni bilo proučevano.
English: Instructions on how to use Intrarosa How should I use Intrarosa
Slovenian: Kako jemati zdravilo Intrarosa Kako naj jemljem zdravilo Intrarosa
English: Oestrogen only HRT
Slovenian: Samo estrogensko HNZ
English: • You may have vaginal discharge due to melting of the ‘hard fat base' which adds to increased vaginal secretions due to treatment.
Slovenian: • Zaradi topljenja „trde maščobne podlage“, ki med zdravljenjem poveča količino vaginalnih izločkov, se lahko pojavi izcedek iz vagine.
English: • Known, past or suspected breast cancer;
Slovenian: • znan ali pretekli rak dojk ali sum na raka dojk
English: Intrarosa is not meant for women with child-bearing potential.
Slovenian: Zdravilo Intrarosa ni namenjeno za uporabo pri ženskah v rodni dobi.
English: Intrarosa has not been studied in women with current or previous venous thromboembolic disease.
Slovenian: Zdravilo Intrarosa pri ženskah s trenutno ali preteklo vensko trombembolično boleznijo ni bilo proučevano.
English: No cases of endometrial hyperplasia have been reported in women treated for 52 weeks during the clinical studies.
Slovenian: v katerih so ženske zdravili 52 tednov, niso poročali o nobenem primeru hiperplazije endometrija.
English: There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause.
Slovenian: Uporaba zdravila Intrarosa za indikacijo atrofije vulve in vagine zaradi menopavze ne pride v poštev pri deklicah katere koli starosti.
English: • Systemic HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Slovenian: • Sistemski HNZ je povezan z 1,3-3-krat večjim tveganjem nastanka venske trombembolije (VTE),
English: − with a uncommon frequency (may affect up to 1 in 100 people): benign cervical or uterine polyps, benign breast mass.
Slovenian: LGSIL), nihanja telesne mase (bodisi povečanja ali zmanjšanja); - občasnih (ki se lahko pojavijo pri največ 1 od 100 bolnic): benigni polipi na materničnem vratu ali maternici, benigna tvorba v dojki.
English: Package leaflet: Information for the user Intrarosa 6.5 mg pessary prasterone This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo: informacije za uporabnika Intrarosa 6,5 mg vaginalne globule prasteron (prasteron.)
English: Cases of hypertension have been reported in clinical trials with an uncommon frequency and similar incidence rates were observed in both groups (6.5 mg prasterone and placebo).
Slovenian: pri obeh skupinah (prasteron 6,5 mg in placebo) pa so poročali o podobni pojavnosti.
English: Intrarosa has not been studied in women with active or past breast cancer.
Slovenian: Zdravilo Intrarosa pri ženskah z aktivnim ali preteklim rakom ni bilo proučevano.
English: • changes in the nipple;
Slovenian: • vdolbinice v koži; • spremembe bradavice;
English: • ovarian cancer;
Slovenian: • sladkorna bolezen;
English: Abnormal Pap smear (mostly ASCUS or LGSIL)
Slovenian: ASCUS ali LGSIL)
English: How to use Intrarosa
Slovenian: Kako uporabljati zdravilo
English: For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
Slovenian: 2.000 uporabnicami (tj. približno en dodaten primer).
English: Breast cancer
Slovenian: - Bolezni žolčnika
English: • Estrogen is a metabolite of prasterone.
Slovenian: Hiperplazija in rak endometrija • Estrogen je presnovek prasterona.
English: • The use of oestrogen-only and oestrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Slovenian: • Uporaba samo estrogenskega in estrogensko-progestagenskega zdravljenja je povezana z do
English: The plunger of the applicator should be pressed to release the pessary.
Slovenian: Pritisnite na bat aplikatorja, da sprostite globulo.
English: How Intrarosa works
Slovenian: placeba Intrarosa
English: Stroke
Slovenian: KORAK
English: Intrarosa 6.5 mg pessary.
Slovenian: Intrarosa 6,5 mg vaginalne globule
English: Dyspareunia
Slovenian: A- prasterona
English: 28 pessaries.
Slovenian: vaginalne globule 28 vaginalnih globul.
English: The additional risk becomes clear within a few years.
Slovenian: Pojav takega dogodka je verjetnejši v prvem letu
English: Other adverse reactions have been reported in association with oestrogen/progestagen treatment: - Gall bladder disease.
Slovenian: V zvezi z zdravljenjem z estrogenom in kombinacijo estrogena in progestagena so poročali tudi o drugih neželenih učinkih:
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Slovenian: Odbor CHMP soglaša z znanstvenimi zaključki, ki jih je sprejel odbor PRAC.
English: , headache (especially at the beginning of treatment)
Slovenian: , glavobol (zlasti na začetku zdravljenja)
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Slovenian: AUC je pri starejših (>65 let) 50 % večja kot pri mladih osebah.
English: The safety of Rasilamlo has been evaluated in studies of up to one year duration.
Slovenian: Varnost zdravila Rasilamlo so ocenjevali v študijah, ki so trajale do eno leto.
English: Clinical monitoring and dose adjustment may thus be required.
Slovenian: Morda bo potrebno klinično spremljanje in prilagajanje
English: , exfoliative dermatitis
Slovenian: , eksfoliativni dermatitis
English: The cumulative review retrieved 187 cases out of which 57 were sufficiently documented, in 8 of these cases a causal relationship could not be ruled out.
Slovenian: V kumulativni pregled so zajeli 187 primerov, od katerih je bilo 57 ustrezno dokumentiranih, v 8 od teh primerov pa niso mogli izključiti vzročne povezanosti z zdravilom.
English: Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Slovenian: Pri nosečnicah je uporaba priporočena samo v primeru, da ni na voljo nobene varnejše možnosti, bolezen sama pa pomeni večje tveganje tako za mater kot za plod.
English: Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
Slovenian: Aliskiren so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri
English: The blood pressure reductions with the combination were maintained throughout the entire 24-hour dose interval.
Slovenian: Znižanje krvnega tlaka pri uporabi kombinacije se je ohranilo skozi celoten 24-urni interval odmerjanja.
English: The adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po pogostnosti, najpogostejši najprej, pri čemer je uporabljen naslednji dogovor: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you experience this symptom, do not drive or use tools or machines.
Slovenian: Če ste omotični ali zaspani, ne vozite in ne uporabljajte orodja ali strojev.
English: Lowering the blood pressure to a normal level reduces the risk
Slovenian: Zniževanje krvnega tlaka na normalne vrednosti zmanjšuje tveganje, da bi prišlo do
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Via Provinciale Schito 131 IT-80058 Torre Annunziata Italy
Slovenian: Via Provenciale Schito 131 I-80058 Torre Annunziata/NA Italija
English: Rasilamlo with food and drink
Slovenian: Zdravilo Rasilamlo skupaj s hrano in pijačo
English: What you need to know before you take Rasilamlo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Rasilamlo
English: Your doctor will normally advise you to stop taking Rasilamlo before you become pregnant and will advise you to take another medicine instead of Rasilamlo.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Rasilamlo še preden zanosite in vam bo svetoval jemanje drugega zdravila namesto zdravila Rasilamlo.
English: See also information under the heading “Do not take Rasilamlo”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Rasilamlo”.
English: If your blood pressure is not controlled after 4 to 6 weeks, your doctor may adjust your dose.
Slovenian: Če po 4 do 6 tednih vaš krvni tlak ne bo urejen, vam bo zdravnik morda spremenil odmerek.
English: , arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Slovenian: , aritmija (vključno z bradikardijo, ventrikularno tahikardijo in atrijsko fibrilacijo)
English: No mortality or significant toxicity was observed.
Slovenian: Pri njih niso opažali smrtnosti ali pomembnega toksičnega delovanja zdravila.
English: Do not take this medicine if you are pregnant (see section Do not take Rasilamlo).
Slovenian: Če ste noseči, ne jemljite tega zdravila (glejte poglavje Ne jemljite zdravila Rasilamlo).
English: It is unknown whether aliskiren and/or amlodipine are excreted in human milk.
Slovenian: Ni znano, ali se aliskiren in/ali amlodipin izločata v materino mleko.
English: Since there is insufficient/limited information on the excretion of aliskiren and amlodipine in human or animal breast milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ker je na voljo le malo oziroma ni dovolj podatkov o izločanju aliskirena in amlodipina v materino oziroma živalsko mleko, ni mogoče izključiti tveganja za novorojenčka/dojenega otroka.
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Slovenian: Skupno so randomizirali 33.357 hipertenzivnih bolnikov in jih spremljali povprečno 4,9 leta.
English: The safety and efficacy of Rasilamlo in children below age 18 have not been established.
Slovenian: Varnost in učinkovitost zdravila Rasilamlo pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: During your treatment, your doctor may adjust your dose depending on your blood pressure response.
Slovenian: Zdravnik vam bo v času zdravljenja morda spremenil odmerek glede na odziv vašega krvnega tlaka.
English: • skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects
Slovenian: • kožni izpuščaj (to je lahko tudi znak alergijskih reakcij ali angioedema - glejte "Redki"
English: A single dose study was conducted in juvenile rats aged 14, 21, 24, 28, 31 or 36 days post-partum.
Slovenian: Študijo z enkratnim odmerkom so izvedli na podganjih mladičih, ki so bili stari 14, 21, 24, 28, 31 oziroma 36 dni.
English: ***Including one case of “liver failure fulminant” reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
Slovenian: ***vključno z enim primerom “fulminantne odpovedi jeter”, o katerem so poročali med izkušnjami v obdobju trženja zdravila in pri katerem vzročne povezanosti z aliskirenom ni mogoče izključiti
English: If you take more Rasilamlo than you should If you have accidentally taken too many Rasilamlo tablets, talk to a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Rasilamlo, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Rasilamlo, kot bi smeli, se takoj posvetujte z zdravnikom.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of
Slovenian: Pri zdravih prostovoljcih je uporaba aktivnega oglja do dve uri po zaužitju amlodipina 10 mg zmanjšala absorpcijo amlodipina.
English: Angiotensin II causes vasoconstriction and sodium and water reabsorption.
Slovenian: Angiotenzin II sicer povzroča vazokonstrikcijo in reabsorpcijo natrija in vode.
English: difficulty breathing, dizziness (rare: may affect up to 1 in 1,000 people).
Slovenian: oteženo dihanje, omotičnost (redki: lahko se pojavijo pri največ 1 od 1.000 ljudi),
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rasilamlo in all subsets of the paediatric population in essential hypertension (see section 4.2 for
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Rasilamlo za vse podskupine pediatrične populacije pri esencialni hipertenziji (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Slovenian: Aliskiren se zmerno veže na proteine v plazmi (47-51 %) in sicer neodvisno od
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or
Slovenian: Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1
English: The CHMP recommends that the terms of the Marketing Authorisations should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenj za promet z zdravilom.
English: Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
Slovenian: Obstrukcija iztočnega kanala levega prekata (npr. huda aortna stenoza).
English: Clearance in rats aged 8 or 14 days was similar, but at these ages the clearance was only about 23% of clearance in rats aged 21 days and 16% of clearance in rats aged 28 days.
Slovenian: Pri 8 dni starih in 14 dni starih podganah je bil očistek približno enak, a je znašal samo približno 23 % očistka pri 21 dni starih podganah in 16 % očistka pri 28 dni starih podganah.
English: The recommended dose of Rasilamlo is one tablet per day.
Slovenian: Priporočeni odmerek zdravila Rasilamlo je ena tableta na dan.
English: Rasilamlo should be taken with a light meal once a day, preferably at the same time each day.
Slovenian: Zdravilo Rasilamlo je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: Rasilamlo has been administered to more than 2,800 patients in completed clinical trials, including 372 patients for one year or more.
Slovenian: V okviru že zaključenih kliničnih študij je zdravilo Rasilamlo prejemalo več kot 2.800 bolnikov, med njimi 372 bolnikov eno leto ali več.
English: Women of child-bearing potential/contraception in males and females Healthcare professionals prescribing Rasilamlo should counsel women of childbearing potential about the potential risk during pregnancy.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Zdravstveni delavci, ki predpisujejo zdravilo Rasilamlo, morajo ženskam v rodni dobi razložiti možna tveganja uporabe zdravila med nosečnostjo.
English: Do not take a double dose (two tablets at once) to make up for a
Slovenian: Ne vzemite dvojnega odmerka (dveh tablet naenkrat), če ste pozabili vzeti prejšnjo tableto.
English: Rasilamlo is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Slovenian: Jemanje zdravila Rasilamlo med zgodnjo nosečnostjo ni priporočljivo, ko pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti povzroči resno
English: However, the use of aliskiren is not recommended in patients with severe
Slovenian: Kljub temu pa uporaba aliskirena ni priporočena pri bolnikih s hudo okvaro
English: The use of combined treatment with aliskiren and amlodipine arises from the actions of these two medicinal products on different but complementary systems that regulate blood pressure.
Slovenian: Izbira kombinacije zdravljenja z aliskirenom in amlodipinom izhaja iz delovanja teh dveh učinkovin na različna, a komplementarna sistema, ki uravnavata krvni tlak.
English: If anaphylactic reactions or angioedema occur, Rasilamlo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Slovenian: Če pride do anafilaktične reakcije ali angioedema, je treba zdravljenje z zdravilom Rasilamlo takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi niso v celoti in trajno odpravljeni.
English: - if your urine flow has decreased markedly for 24 hours or more and/or if you have serious kidney problems (e.g. require dialysis) or a narrowing or blockage of the arteries that supply
Slovenian: - če se vam je v obdobju 24 ur ali več izrazito zmanjšalo izločanje urina in/ali imate resne težave z ledvicami (če na primer potrebujete dializo) ali če imate zoženje ali zaporo arterij, ki s krvjo
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Slovenian: Možen mehanizem je lahko nasičenost prenašalcev na mestu absorpcije ali pri izločanju
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA PRIPOROČILO SPREMEMBE POGOJEV DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: If blood pressure remains uncontrolled after 4 to 6 weeks of therapy, the dose may be titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine.
Slovenian: Če po 4 do 6 tednih zdravljenja krvni tlak še vedno ni urejen, je mogoče odmerek zvišati na največ 300 mg aliskirena/10 mg amlodipina.
English: A few patients have experienced these serious side effects.
Slovenian: Do teh resnih neželenih učinkov je prišlo le pri majhnem številu bolnikov.
English: If you experience these, tell your doctor immediately.
Slovenian: Če pride do tega, takoj obvestite svojega zdravnika.
English: The antihypertensive effect is manifested within 1 week and the effect is near maximal at around 4 weeks.
Slovenian: Antihipertenzivno delovanje je opazno v 1 tednu, večji del učinka pa se razvije po približno 4 tednih.
English: 85 to 90% of the maximal blood-pressure-lowering effect was observed after 2 weeks.
Slovenian: Po dveh tednih so opažali izraženost 85 do 90 % največjega učinka zniževanja krvnega tlaka.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local irritation potential or the expected pharmacological effects of aliskiren.
Slovenian: Rezultati toksikoloških študij ponovljenih odmerkov na živalih so bili skladni z znano možnostjo draženja ali s pričakovanimi farmakološkimi učinki
English: Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasilamlo.
Slovenian: Omedlevica in/ali stemnitev pred očmi zaradi nizkega krvnega tlaka, do česar lahko prihaja na začetku zdravljenja z zdravilom Rasilamlo.
English: The concomitant use of CYP3A4 inducers (e.g. rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine.
Slovenian: Sočasna uporaba induktorjev CYP3A4 (npr. rifampicin, Hypericum perforatum) lahko povzroči znižanje plazemske koncentracije amlodipina.
English: For the surviving juvenile rats, no effects on behavioural or reproductive performance were observed.
Slovenian: Pri preživelih podganjih mladičih niso opažali nobenega vpliva na vedenje in sposobnost
English: When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilamlo.
Slovenian: Pri vožnji in upravljanju s stroji je treba upoštevati, da lahko med jemanjem zdravila Rasilamlo občasno pride do omotičnosti in zaspanosti.
English: With cessation of treatment, blood pressure gradually returned towards baseline levels over a period of several weeks, with no evidence of a rebound effect for blood pressure or PRA.
Slovenian: Po prenehanju zdravljenja se je krvni tlak v obdobju nekaj tednov postopoma vrnil na izhodiščne vrednosti, pri tem ni bilo nobenih znakov za povratni učinek niti glede krvnega tlaka niti glede
English: Very rare (may affect up to 1 in 10,000 people): • low level of white blood cells and blood platelets
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 ljudi): • znižano število levkocitov in trombocitov
English: • increased sensitivity of the skin to sun
Slovenian: • prekomerna občutljivost kože na sončno svetlobo
English: Mutagenicity studies revealed no effects related to the medicinal product at either the gene or
Slovenian: Študije mutagenosti niso pokazale nobenih z zdravilom povezanih učinkov niti na ravni genov niti na
English: When clinically appropriate and in line with the above-mentioned posology, direct change from monotherapy to the fixed combination may be considered.
Slovenian: Kadar je to klinično primerno in v skladu z zgoraj omenjenimi priporočili za odmerjanje, velja razmisliti tudi o neposrednem prehodu z monoterapije na že pripravljeno kombinacijo zdravila.
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see interaction with organic anion transporting polypeptide (OATP) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Slovenian: Ker pa so dokazali, da je aliskiren substrat polipeptidnega prenašalca organskih anionov 1A2 (OATP1A2) (glejte možnost medsebojnega delovanja z zaviralci polipeptidnega prenašalca organskih anionov), obstaja možnost, da aliskiren z oviranjem procesa absorpcije znižuje
English: , increased urinary frequency
Slovenian: , povečana pogostnost uriniranja impotenca
English: Intravenous calcium gluconate may be beneficial in reversing the
Slovenian: Intravenska uporaba kalcijevega glukonata lahko koristi za odpravljanje
English: Renin inhibitors suppress the enzymatic activity of renin, and thereby block the formation of Angiotensin II, the major effector molecule of the renin-angiotensin-aldosterone system (RAAS).
Slovenian: Zaviralci renina zavirajo encimsko aktivnost renina in s tem preprečujejo nastajanje angiotenzina II, ki je glavna efektorska molekula sistema renin-angiotenzin-aldosteron (sistema RAAS).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rasilamlo therapy taking into account the benefit of breast-feeding for the child and the benefit of
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Rasilamlo, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.