FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.1: Therapeutic indications [The wording of this section should be read as below] Treatment of postmenopausal osteoporosis.
Slovenian: Poglavje 4.1: Terapevtske indikacije [Besedilo tega poglavja naj se glasi kot je navedeno spodaj] Zdravljenje postmenopavzne osteoporoze.
English: Summary of product characteristic
Slovenian: Povzetek glavnih značilnosti zdravila
English: In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Slovenian: V nekaterih kliničnih študijah se je pokazalo, da alfakalcidol zmanjša tveganje padcev pri starejših.
English: Section 5.1: Pharmacodynamic properties [This section should be amended to reflect the following wording]
Slovenian: Poglavje 5.1: Farmakodinamične lastnosti [To poglavje je treba spremeniti tako, da odraža naslednje besedilo]
English: Alendronic acid reduces the risk of vertebral and hip fractures.
Slovenian: Alendronska kislina zmanjša tveganje zlomov vretenc in kolka.
English: Amendments to be included in the relevant sections of the summary of product characteristic and package leaflet
Slovenian: Spremembe, ki se vključijo v zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
Slovenian: Veljavno navodilo za uporabo je končna različica, dosežena v dogovoru s koordinacijsko skupino, z naslednjimi spremembami:
English: The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
Slovenian: Veljavni povzetek glavnih značilnosti zdravila je končna različica, dosežena v dogovoru s koordinacijsko skupino, z naslednjimi spremembami:
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 January 2018
Slovenian: Datum prve odobritve: 13. marec 2013 Datum zadnjega podaljšanja: 8. januar 2018
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Slovenian: Torej je treba krvni tlak redno meriti, da bi lahko preverili, ali je v normalnem območju.
English: See also information under the heading “Do not take Tolucombi”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Tolucombi”.
English: Influenza-like illness, pain
Slovenian: gripi podobna bolezen, bolečina
English: Both of these substances help to control high blood pressure.
Slovenian: Obe učinkovini pomagata uravnavati visok krvni tlak.
English: - If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Slovenian: - če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
English: Tolucombi can have influence on the ability to drive and use machines.
Slovenian: Zdravilo Tolucombi lahko vpliva na sposobnost vožnje in upravljanja strojev.
English: 3: For further description, please see sub-section “Description of selected adverse reactions”
Slovenian: 3: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
English: Your doctor will normally advise you to stop taking Tolucombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tolucombi.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo Tolucombi prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Tolucombi jemljete drugo zdravilo.
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Slovenian: Navidezen volumen porazdelitve je približno 500 l, kar kaže na dodatno tkivno vezavo.
English: Chloride deficit is generally mild and usually does not require treatment.
Slovenian: Pomanjkanje klorida je običajno blago in ga ni treba zdraviti.
English: The safety and efficacy of Tolucombi in children and adolescents aged below 18 have not been established.
Slovenian: Varnost in učinkovitost zdravila Tolucombi pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: An updated RMP shall be submitted by CHMP agreed deadline.
Slovenian: Posodobljen RMP je treba predložiti do skrajnega roka, ki ga določi CHMP.
English: Tolucombi with food and alcohol
Slovenian: Zdravilo Tolucombi skupaj s hrano in alkoholom
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l-acid glycoprotein.
Slovenian: Telmisartan se obsežno veže na plazemske beljakovine (> 99,5 %), predvsem albumin in kisli glikoprotein alfa-1.
English: Blisters (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 and 100 x 1 tablet in a box.
Slovenian: Pretisni omoti (OPA/Al/PVC folija//Al folija): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 in 100 x 1 tableta, v škatli.
English: Contains lactose monohydrate and sorbitol (E420).
Slovenian: Vsebuje laktozo monohidrat in sorbitol (E420).
English: Holjevca 20/E, 10 450 Jastrebarsko, Croatia
Slovenian: Holjevca 20/E, 10450 Jastrebarsko, Hrvaška
English: Tolucombi contains lactose, sorbitol and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Zdravilo Tolucombi vsebuje laktozo, sorbitol in natrij Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Children and adolescents The use of Tolucombi in children and adolescents up to the age of 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporabe zdravila Tolucombi pri otrocih in mladostnikih do 18. leta ne priporočamo.
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Slovenian: TAD Pharma GmbH Heinz-Lohmann- Straße 5 27472 Cuxhaven Nemčija
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o.,V.
Slovenian: Równoległa 5, 02-235 Warszawa, Poljska TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija KRKA - FARMA d.o.o.,V.
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Slovenian: Skupna pogostnost neželenih učinkov, o kateri so poročali za telmisartan (41,4 %), je bila večinoma primerljiva s podatki za placebo (43,9 %) v kliničnih preskušanjih, nadzorovanih s placebom.
English: Only on blisters containing 7 tablets MON
Slovenian: Samo na pretisnih omotih po 7 tablet PON
English: It is important that you take Tolucombi every day until your doctor tells you otherwise.
Slovenian: Zdravilo Tolucombi morate jemati vsak dan, dokler vam ga bo zdravnik predpisoval.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Slovenian: označenega telmisartana se je večina odmerka (> 97 %) izločila z blatom po biliarni poti.
English: There are no adequate data from the use of Tolucombi in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Tolucombi pri nosečnicah.
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicinal product initiation.
Slovenian: Simptoma sta akutno poslabšanje ostrine vida ali očesna bolečina, ki se značilno pojavita v nekaj urah do nekaj tednih po začetku jemanja zdravila.
English: Depression
Slovenian: depresija
English: Blisters (OPA/Al/PVC foil//Al foil): 3 years Blisters (OPA/Al/PE foil with desiccant//Al foil): 2 years
Slovenian: Pretisni omoti (OPA/Al/PVC folija//Al folija): 3 leta Pretisni omoti (OPA/Al/PE folija s sušilnim sredstvom//Al folija): 2 leti
English: Other antihypertensive agents Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Slovenian: Drugi antihipertenzivi Telmisartan lahko poveča hipotenzivni učinek drugih antihipertenzivov.
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Slovenian: označenega telmisartana odpade na glukuronid približno 11 % radioaktivnosti, izmerjene v plazmi.
English: Adverse reactions reported in all clinical trials and occurring more frequently (p ≤0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Slovenian: Neželeni učinki, o katerih so poročali v vseh kliničnih preskušanjih in so se pojavljali pogosteje (p ≤ 0,05) pri telmisartanu in hidroklorotiazidu kot pri placebu, so našteti po organskih sistemih.
English: - Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Slovenian: - preobčutljivost na katero koli učinkovino ali katero koli pomožno snov, navedeno v poglavju
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Tolucombi.
Slovenian: Z zdravnikom se morate posvetovati, ali je treba med jemanjem zdravila Tolucombi prilagoditi odmerek vašega drugega zdravila.
English: If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.
Slovenian: Če imate motnje jetrnega delovanja, običajni odmerek ne sme prekoračiti 40 mg/12,5 mg enkrat na dan.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics, ATC code:C09DA07.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na renin-angiotenzinski sistem, antagonisti angiotenzina II in diuretiki, oznaka ATC: C09DA07.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Tolucombi).
Slovenian: O redkih tovrstnih primerih poročajo tudi za antagoniste angiotenzina II (vključno z zdravilom Tolucombi).
English: Possible side effects of Tolucombi:
Slovenian: Možni neželeni učinki zdravila Tolucombi:
English: The effect of Tolucombi may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Slovenian: Učinek zdravila Tolucombi se lahko zmanjša, če jemljete NSAR (nesteroidne antirevmatike, npr. acetilsalicilno kislino ali ibuprofen).
English: - Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Slovenian: - Telmisartan spada v skupino zdravil, ki jo imenujemo antagonisti receptorjev angiotenzina II.
English: In a follow-up trial with the 80 mg/25 mg combination, blood pressure was further decreased (resulting in an overall reduction of 11.5/9.9 mmHg (SBP/DBP).
Slovenian: V nadaljnji raziskavi s kombinacijo 80 mg/25 mg se je krvni tlak nadalje znižal (skupno za 11,5/9,9 mmHg) (SKT/DKT).
English: Angiotensin II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure.
Slovenian: Angiotenzin II je snov, ki nastaja v telesu in povzroča, da se krvne žile zožijo, kar zviša krvni tlak.
English: The concomitant use of Tolucombi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: Sočasna uporaba zdravila Tolucombi in zdravil, ki vsebujejo aliskiren je kontraindicirana pri bolnikih s sladkorno boleznijo ali okvaro ledvic (GFR < 60 ml/min/1,73 m2) (glejte poglavja 4.5 in 5.1).
English: If any of the above applies to you, tell your doctor or pharmacist before taking Tolucombi.
Slovenian: Če imate katero od naštetih stanj, povejte svojemu zdravniku ali farmacevtu, preden boste vzeli zdravilo Tolucombi.
English: Experience with Tolucombi is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Slovenian: Z zdravilom Tolucombi je malo izkušenj pri bolnikih z blago do zmerno zmanjšanim ledvičnim delovanjem, zato so priporočljivi periodični kontrolni pregledi serumskih ravni kalija, kreatinina in sečne kisline.
English: Very rare: Interstitial lung disease
Slovenian: kašelj Zelo redki: intersticijska pljučna bolezen
English: Patients weighing 58.8 kg or less with hereditary fructose intolerance (HFI) should not take this medicinal product.
Slovenian: Bolniki, ki tehtajo 58,8 kg ali manj in imajo dedno intoleranco za fruktozo, ne smejo jemati tega zdravila.
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Tolucombi, minimal or no effects were reported.
Slovenian: Z zdravljenjem s tiazidnimi diuretiki povezujejo povečanje ravni holesterola in trigliceridov, vendar za odmerek po 12,5 mg, ki ga vsebuje zdravilo Tolucombi, poročajo le o minimalnih ali nikakršnih tovrstnih učinkih.
English: Periodic monitoring of renal function is advised (see section 4.4).
Slovenian: Priporočamo periodične kontrolne preglede ledvičnega delovanja (glejte poglavje 4.4).
English: What Tolucombi is and what it is used for
Slovenian: Kaj je zdravilo Tolucombi in za kaj ga uporabljamo
English: Tolucombi is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Tolucombi med nosečnostjo ne priporočajo; ne smete pa ga jemati, ko boste noseči več kot 3 mesece, ker lahko po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: Elimination Telmisartan: Following either intravenous or oral administration of
Slovenian: Izločanje Telmisartan: Po intravenskem ali peroralnem dajanju s C
English: You can take Tolucombi with or without food.
Slovenian: Zdravilo Tolucombi lahko jemljete s hrano ali brez nje.
English: Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Slovenian: sepsa* (pogosto poimenovana tudi »zastrupitev krvi«) je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva, hitro otekanje kože in sluznice (angioedem); mehurje in luščenje vrhnjega kožnega sloja (toksična epidermalna nekroliza) ti neželeni učinki so redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) ali neznane pogostnosti (toksična epidermalna nekroliza), toda zelo resni, zato morajo bolniki takoj prenehati z jemanjem zdravila in nemudoma poiskati zdravniško pomoč.
English: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Slovenian: povečana raven kreatinina v krvi, povečana raven kreatin-fosfokinaze v krvi, povečana raven jetrnih encimov
English: In addition, Tolucombi should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Slovenian: Zdravilo Tolucombi moramo previdno dajati tudi bolnikom z motnjami jetrnega delovanja ali napredujočo jetrno boleznijo, ker lahko že manjše spremembe ravnovesja tekočin in elektrolitov povzročijo jetrno komo.
English: Coadministration of lithium and Tolucombi is not recommended (see section 4.4).
Slovenian: Sočasnega dajanja litija in zdravila Tolucombi ne priporočamo (glejte poglavje 4.4).
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking Tolucombi.
Slovenian: Če boste operirani ali boste dobili anestetike, morate zdravniku povedati, da jemljete zdravilo Tolucombi.
English: Based on modest experience in patients with mild to moderate renal impairment (creatinine clearance of 30 - 60 ml/min, mean about 50 ml/min) no dosage adjustment is necessary in patients with decreased renal function.
Slovenian: Redke izkušnje pri bolnikih z blago do zmerno ledvično okvaro (s kreatininskim očistkom 30 do 60 ml/min in srednjo vrednostjo približno 50 ml/min) kažejo, da bolnikom z zmanjšanim ledvičnim delovanjem odmerka ni treba prilagajati.
English: Tolucombi once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Slovenian: Zdravilo Tolucombi v enem odmerku na dan učinkovito in enakomerno znižuje krvni tlak v celotnem razponu odmerjanja.
English: Hydrochlorothiazide: Following oral administration of Tolucombi peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Slovenian: Hidroklorotiazid: Po peroralnem dajanju zdravila Tolucombi doseže hidroklorotiazid največjo koncentracijo v plazmi približno v 1,0 do 3,0 urah.
English: Tolucombi is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Uporaba zdravila Tolucombi v zgodnjem obdobju nosečnosti ni priporočljiva, če ste noseči več kot 3 mesece, pa ga ne smete jemati, ker lahko v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
English: Tolucombi must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Slovenian: Zdravila Tolucombi ne smemo dajati bolnikom z močno zmanjšanim ledvičnim delovanjem (kreatininskim očistkom < 30 ml/min) (glejte poglavje 4.3).
English: Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Slovenian: Neželeni učinki neznane pogostnosti, o katerih so poročali med samostojno uporabo hidroklorotiazida:
English: Tolucombi is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Slovenian: Zdravilo Tolucombi je kombinacija dveh učinkovin, telmisartana in hidroklorotiazida v eni tableti.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Tolucombi.
Slovenian: Oba sta lahko tudi simptoma zvišanega očesnega tlaka, ki se pojavita nekaj ur do nekaj tednov po začetku jemanja zdravila Tolucombi.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Slovenian: Redko (≥1/10.000 do <1/1.000) se lahko pojavi resen angioedem.
English: Tolucombi may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Slovenian: Zdravilo Tolucombi lahko poveča antihipertenzivni učinek drugih zdravil, ki znižujejo krvni tlak, ali zdravil z možnim antihipertenzivnim učinkom (npr. baklofen, amifostin).
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Slovenian: Njegova absolutna biološka uporabnost je bila po dajanju odmerkov po 40 mg in 160 mg 42- oz. 58odstotna.
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Slovenian: Če ste vzeli večji odmerek zdravila Tolucombi, kot bi smeli Če pomotoma vzamete preveč tablet, se lahko pojavijo simptomi, kot so nizek krvni tlak in pospešen srčni utrip.
English: An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the angiotensin II evoked blood pressure increase.
Slovenian: Pri zdravih prostovoljcih odmerek telmisartana po 80 mg skoraj povsem zavre povečanje krvnega tlaka, ki ga povzroča angiotenzin II.
English: As with all other angiotensin II receptor antagonists telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Slovenian: Kaže, da telmisartan, tako kot drugi antagonisti receptorjev angiotenzina II, manj učinkovito znižuje krvni tlak pri črni kot pri drugih rasah, kar je verjetno posledica večje razširjenosti stanj z manjšo količino renina pri osebah črne rase, ki imajo hipertenzijo.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Slovenian: Enako kot pri vseh bolnikih, ki se zdravijo z diuretiki, so potrebni periodični kontrolni pregledi ravni elektrolitov v serumu v ustreznih časovnih razmikih.
English: Such conditions should be corrected before the administration of Tolucombi.
Slovenian: Tovrstna stanja je treba uravnati pred zdravljenjem z zdravilom Tolucombi.
English: Very rare side effects (may affect up to 1 in 10,000 people): Increased pH (disturbed acid-base balance) due to low blood chloride level.
Slovenian: Zelo redki neželeni učinki (lahko se pojavijo pri največ 1 od 10.000 bolnikov): povišan pH (porušeno kislinsko-bazično ravnovesje) zaradi nizke ravni klorida v krvi.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Slovenian: Nesteroidna protivnetna zdravila (acetilsalicilna kislina v odmerkih, ki učinkujejo protivnetno, zaviralci ciklooksigenaze 2 in neselektivna nesteroidna protivnetna zdravila) lahko zmanjšajo diuretične, natriuretične in antihipertenzivne učinke tiazidnih diuretikov ter antihipertenzivne učinke antagonistov receptorjev angiotenzina II.
English: If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Tolucombi may be less effective in lowering the blood pressure in black patients.
Slovenian: Zdravilo Tolucombi lahko pri črni rasi manj učinkovito znižuje krvni tlak.
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased.
Slovenian: Simpatikomimetiki (npr. noradrenalin) Njihov učinek se lahko zmanjša.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Tolucombi Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Tolucombi should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
Slovenian: Zdravila Tolucombi ne smemo dajati bolnikom s holestazo, z obolenji z zaporo žolčevoda ali močno zmanjšanim jetrnim delovanjem (glejte poglavje 4.3), ker se telmisartan v glavnem izloča z žolčem.
English: Because no information is available regarding the use of Tolucombi during breast-feeding, Tolucombi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Ker o uporabi zdravila Tolucombi med dojenjem ni podatkov, ga ne priporočajo, zato je treba med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane.
English: The use of Tolucombi during breast feeding is not recommended.
Slovenian: Uporabe zdravila Tolucombi med dojenjem ne priporočajo.