natgillin/translations-raw huggingface dataset:
Cases of severe hepatotoxicity, including cases with fatal outcome, have been reported with the use of cholic acid. 
Pri zdravljenju s holno kislino so poročali o primerih hude hepatotoksičnosti, vključno s primeri s smrtnim izidom.
Conjugated cholic acid is absorbed in the ileum via transporters , passed back to the liver and enters another cycle of enterohepatic circulation. 
Konjugirana holna kislina se prek prenašalcev absorbira v ileumu, potuje nazaj v jetra in vstopi v še en cikel enteropatičnega obtoka.
A concomitant decrease of urine total bile acids should be observed. 
Opazno mora biti sočasno zmanjšanje skupnih žolčnih kislin v urinu.
Patients with familial hypertriglyceridaemia 
Posebne skupine bolnikov Bolniki z družinsko hipertrigliceridemijo
Drug interactions with cholic acid mainly relate to medicinal products capable of interrupting the enterohepatic circulation of bile acids, such as the sequestering agents cholestyramine, colestipol, or colesevelam. 
Medsebojno delovanje zdravil s holno kislino je večinoma povezano z zdravili, ki lahko ovirajo enterohepatično cirkulacijo žolčnih kislin, kot so vezalci želodčnih kislin holestiramin, holestipol ali holesevelam.
Oestrogens, oral contraceptives and clofibrate (and perhaps other lipid-lowering substances) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of cholic acid. 
Estrogeni, peroralna kontracepcijska sredstva in klofibrat (ter morda druge učinkovine za zniževanje ravni lipidov) povečajo jetrno izločanje holesterola in spodbujajo tvorbo holesterolskih žolčnih kamnov, kar lahko nevtralizira učinkovitost holne kisline.
It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given. 
Pomembno je, da dojenčku ali majhnemu otroku, ki ne more pogoltniti cele kapsule, daste celotno vsebino kapsule.
Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated. 
Ocenjevali so terapevtsko učinkovitost in varnost zdravljenja s holno kislino pri bolnikih s prirojenimi okvarami presnove žolčnih kislin.
Patients with newly diagnosed or a family history of familial hypertriglyceridaemia are expected to poorly absorb cholic acid from the intestine. 
Pri bolnikih z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi je pričakovana slaba absorpcija holne kisline iz črevesja.
This medicinal product has been authorised under ‘exceptional circumstances,' which means that, due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product. 
To pomeni, da zaradi redkosti bolezni in iz etičnih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Of 49 patients with a single enzyme defect treated in Study CAC-91-10-10 and included in the safety analysis, 42 had at least one pre- and one post-treatment assessment for urine bile acids and liver function tests; height and weight and were included in the primary efficacy analysis. 
Od 49 bolnikov z okvaro posamičnega encima, zdravljenih v študiji CAC-91-10-10 in vključenih v analizo varnosti, jih je 42 imelo vsaj eno oceno žolčnih kislin v urinu, preiskav jetrnega delovanja ter telesne višine in mase pred zdravljenjem in eno oceno po njem.
Serum transaminases were below the ULN for 1 patient and elevated (≥2 times the ULN) for 2 patients at baseline, were elevated for 2 patients in the worst postbaseline analysis but were below the ULN for all 3 patients in the best post-treatment analysis. 
Transaminaze v serumu so bile pod vrednostjo ULN za 1 bolnika in zvišane (≥ 2-kratna vrednost ULN) za 2 bolnika ob izhodišču, zvišane za 2 bolnika v analizi najslabših vrednosti po izhodišču, a pod vrednostjo ULN za vse 3 bolnike v analizi najboljših vrednosti po zdravljenju.
Based on clinical trial data, adverse reactions in patients (both adults and children) receiving cholic acid are generally mild to moderate in severity and are provided in the following table. 
Preglednica z neželenimi učinki Glede na podatke iz kliničnih preskušanj je resnost neželenih učinkov pri bolnikih (odraslih in otrocih), ki prejemajo holno kislino, navadno blaga do zmerna, navedeni pa so v spodnji tabeli.
Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases. 
Statistično značilna izboljšanja transaminaz v serumu so opazili tudi v analizi primerjave izhodiščnih vrednosti z najboljšimi vrednosti po izhodišču.
In Study CAC-91-10-10 the efficacy analysis showed that treatment with cholic acid significantly improved (i.e., decreased) urinary bile acid excretion in patients with single enzyme defects. 
V študiji CAC-91-10-10 je analiza učinkovitosti pokazala, da je zdravljenje s holno kislino pomembno izboljšalo (tj. zmanjšalo), izločanje žolčne kisline v urinu pri bolnikih z okvarami posamičnih encimov.
Silicified microcrystalline cellulose 
Vsebina kapsule silicizirana mikrokristalna celuloza magnezijev stearat
The cholic acid dose for patients with familial hypertriglyceridaemia will have to be established and adjusted as necessary; an elevated dose may be required in order to suppress urinary bile acids (see section 4.4). 
Pri bolnikih z družinsko hipertrigliceridemijo je treba določiti odmerek holne kisline in ga po potrebi prilagoditi; morda bo za zaviranje žolčnih kislin v urinu potreben povečan odmerek (glejte poglavje 4.4).
Of the 41 patients described above that were treated in Study CAC-002-01, 13 patients discontinued: 8 due to AEs, 1 for lack/loss of efficacy, 1 was lost to follow-up, and 3 withdrew consent. 
Od 41 bolnikov, opisanih zgoraj, zdravljenih v študiji CAC-002-01, je 13 bolnikov zdravljenje prekinilo: 8 zaradi neželenega učinka, 1 zaradi pomanjkanja/izgube učinkovitosti, pri 1 je bilo pridobivanje podatkov neuspešno, 3 pa so preklicali svoje soglasje.
The use of cholic acid may be considered during pregnancy if your doctor considers that the benefits to you outweigh any possible risk. 
Holna kislina se lahko uporabi med nosečnostjo, če zdravnik meni, da so koristi za vas večje od morebitnega tveganja.
Marketing Authorisation Holder Retrophin Europe Limited Palmerston House Fenian Street 
Imetnik dovoljenja za promet z zdravilom Retrophin Europe Limited Palmerston House
Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as via its pharmacodynamics by inhibiting cholesterol 7α-hydroxylase. 
Ciklosporin spremeni farmakokinetiko holne kisline z zaviranjem jetrnega privzema in hepatobiliarnega izločanja žolčnih kislin ter tudi s farmakodinamiko z zaviranjem holesterol7α-hidroksilaze.
Cholic acid will pass to the liver in the portal blood, in which it is moderately bound to albumin. 
Holna kislina s portalno krvjo, v kateri se zmerno veže na albumin, potuje do jeter.
MARKETING AUTHORISATION NUMBER EU/1/13/895/001 
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/13/895/001
Conjugated cholic acid is secreted into bile and will pass into the small intestine where, in association with other components of bile, it will perform its principal digestive function. 
Konjugirana holna kislina se izloči v žolč in preide v tanko črevo, kjer skupaj z drugimi sestavinami žolča opravi svojo prvotno prebavno funkcijo.
Elderly Cholic acid has not been studied for safety and effectiveness in people over 65 years of age. 
Varnosti in učinkovitosti holne kisline niso preučevali pri osebah, starejših od 65 let.
The majority of patients with inborn errors of bile acid metabolism presented with some degree of hepatic impairment at the time of diagnosis; in most patients, the hepatic impairment improved or resolved with treatment. 
Ob postavitvi diagnoze ima večina bolnikov s prirojenimi okvarami presnove žolčnih kislin tudi jetrno okvaro različnih stopenj; pri večini bolnikov se jetrna okvara omili ali izgine z zdravljenjem.
Return any unused medicine to your pharmacist for disposal 
Neuporabljeno zdravilo vrnite farmacevtu, ki ga bo ustrezno zavrgel.
Cholic acid can be used during breastfeeding if the doctor considers that the benefits to the patient outweigh the possible risk. 
Holna kislina se lahko uporabi med dojenjem, če zdravnik meni, da so koristi za bolnico večje od morebitnega tveganja.
Efficacy was demonstrated in two ways: (a) treatment with cholic acid leads to an improvement in liver function as demonstrated by improved liver function test values, (b) Fast Atom Bombardment-Mass Spectrometry (FAB-MS) data demonstrated efficacy by showing that cholic acid treatment led to a suppression of the abnormal urine bile acids that initially led to the diagnosis. 
(a) zdravljenje s holno kislino izboljša jetrno funkcijo, kar so pokazali z izboljšanimi vrednostmi pri preiskavah jetrne funkcije, (b) podatki masne spektrometrije bombardiranja s hitrimi atomi FAB-MS (Fast Atom Bombardment-Mass Spectrometry) so pokazali učinkovitost, saj je zdravljenje s holno kislino povzročilo zaviranje nenormalnih žolčnih kislin v urinu, na podlagi katerih je bila postavljena prvotna diagnoza.
Of the 53 patients treated, 41 (77%) presented with disorders in primary bile acid synthesis including sterol 27-hydroxylase deficiency (presenting as CTX; n=8) and AMACR deficiency (n=1). 
Od teh 53 zdravljenih bolnikov jih je imelo 41 (77 %) motnje v sintezi primarnih žolčnih kislin, vključno s pomanjkanjem sterol 27-hidroksilaze (ki se kaže kot CTX) (n = 8) in pomanjkanje AMACR (n = 1).
Patients with newly diagnosed, or a family history of, familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine. 
Družinska hipertrigliceridemija Bolniki z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi imajo lahko slabo absorpcijo holne kisline iz črevesja.
Orally administered cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract. 
Peroralna holna kislina se absorbira s pasivno difuzijo po celi dolžini prebavil.
MARKETING AUTHORISATION NUMBER EU/1/13/895/002 
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/13/895/002
Driving and using machines This medicine is not expected to affect your ability to drive or use machines. 
Ni pričakovati, da bi to zdravilo vplivalo na sposobnost vožnje in upravljanja strojev.
Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172) 
Tiskarsko črnilo šelak (E904) propilenglikol (E1520) koncentrirana raztopina amonijaka (E527) kalijev hidroksid (E525) črni železov oksid (E172)
The concentrations of the abnormal bile acid metabolites synthesised subsequently should be determined. 
Določiti je treba koncentracije nenormalnih sintetiziranih presnovkov žolčnih kislin.
• heartburn (gastric reflux) 
• zgaga (želodčni refluks),
The use of cholic acid may be considered during pregnancy if the doctor considers that the benefits to the patient outweigh the possible risk. 
Holna kislina se lahko uporabi med nosečnostjo, če zdravnik meni, da so koristi za bolnico večje od morebitnega tveganja.
This leaflet was last revised in DDmonthYYYY. 
Navodilo je bilo nazadnje revidirano dne DD. mesec LLLL.
Mean total bilirubin values remained stable in the baseline to worst post-baseline value analysis and decreased in the baseline to best post-baseline analysis. 
Povprečne vrednosti celokupnega bilirubina so pri analizi primerjave izhodiščnih vrednosti in najslabših vrednosti po izhodišču ostale stabilne in so se zmanjšale v analizi primerjave vrednosti ob izhodišču z najboljšo vrednostjo po izhodišču.
Treatment with oral cholic acid stimulates bile flow and secretion, inhibits production and accumulation of hepatotoxic and cholestatic bile acid precursors and facilitates fat absorption without toxic side effects at therapeutic doses. 
Zdravljenje s peroralno holno kislino pri terapevtskih odmerkih spodbuja pretok in izločanje žolča, zavira tvorbo ter kopičenje hepatotoksičnih in holestatskih prekurzorjev žolčnih kislin in omogoča absorpcijo maščob brez toksičnih neželenih učinkov.
Children Cholic acid has not been studied for safety and effectiveness in babies under one month of age. 
Varnosti in učinkovitosti holne kisline niso preučevali pri dojenčkih, mlajših od enega meseca.
Once absorbed, exogenous cholic acid will enter into the body's bile acid pool and will undergo multiple cycles of enterohepatic circulation. 
Ko se eksogena holna kislina absorbira, vstopi v telesno zalogo žolčnih kislin in opravi več ciklov v enterohepatičnem obtoku.
The 50 mg capsules are orange (black imprint “ASK001” and “50mg”). 
50-miligramske kapsule so oranžne (s črnima odtisnjenima oznakama "ASK001" in "50 mg").
Urinary bile acids were normal for all patients (100%) at baseline and worst post-baseline assessments, and for most patients (88%) at the best post-baseline assessment; 1 patient (12%) had a slight elevation of urinary bile acids at best post-baseline assessment. 
Žolčne kisline v urinu so bile v oceni vrednosti ob izhodišču in najslabših vrednosti po izhodišču za vse bolnike normalne (100 %), za večino bolnikov (88 %) pa so bile normalne v oceni najboljših vrednosti po izhodišču; 1 bolnik (12 %)
Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments. 
Poročila o napredku vključevanja v register bodo predložena skupaj s poročili
Study CAC-002-01, (an open-label, single-centre, non-randomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-9110-10 and started on 1 Jan 2010. 
nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis) je bila nadaljevanje študije CAC-91-10-10 in se je začela 1. januarja 2010.
If administration of ciclosporin is considered necessary, serum and urinary bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly. 
Če je uporaba ciklosporina nujna, je treba pozorno spremljati ravni žolčnih kislin v serumu in urinu ter ustrezno prilagoditi odmerek holne kisline.
• yellowing of the skin (jaundice) 
• rumena koža (zlatenica),
Kolbam contains a substance called cholic acid. 
Zdravilo Kolbam vsebuje učinkovino, imenovano holna kislina.
The recommended dosage for cholic acid in the treatment of inborn errors of primary bile acid synthesis is 10-15 mg/kg per day, either as a single daily dose or in divided doses, for both adult and paediatric patients. 
10-15 mg/kg na dan, v enkratnem dnevnem odmerku ali v razdeljenih odmerkih, kar velja za odrasle in pediatrične bolnike.
Kolbam 250 mg: Each capsule contains 250 mg of cholic acid. 
Kolbam 250 mg: ena kapsula vsebuje 250 mg holne kisline.
The 250 mg capsules are white (black imprint “ASK002” and “250mg”). 
250-miligramske kapsule so bele (s črnima odtisnjenima oznakama "ASK002" in "250 mg").
Do not take Kolbam - If you are allergic to cholic acid or to any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na holno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če jemljete fenobarbital (zdravilo za zdravljenje epilepsije).
The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3). 
Omejeni podatki iz študij na živalih niso pokazali neposrednega vpliva na sposobnost razmnoževanja
Preferred Term Frequency 
Organski sistem po MedDRA Priporočeni izraz Pogostnost
The cholic acid dose for patients with familial triglyceridaemia will have to be established and adjusted as necessary (see section 4.2). 
Pri bolnikih z družinsko hipertrigliceridemijo je treba določiti odmerek holne kisline in ga po potrebi prilagoditi (glejte poglavje 4.2).
250 mg capsule: Size number 0 capsule with a white cap (black imprint “ASK002”) and white body (black imprint “250mg”). 
250-miligramska kapsula: kapsula velikosti številka 0 z belim pokrovčkom (s črno odtisnjeno oznako "ASK001") in telesom (s črno odtisnjeno oznako "250 mg").
Patients that have previously been treated with other bile acids or other cholic acid preparations should be closely monitored in the same manner during the initiation of treatment with Kolbam. 
Bolnike, ki so se predhodno zdravili z drugimi žolčnimi kislinami ali drugimi pripravki holne kisline,
The safety and efficacy of cholic acid in neonates less than one month of age has not been established. 
Pediatrična populacija Varnosti in učinkovitosti holne kisline niso ugotovili pri novorojenčkih, mlajših od enega meseca.
HOW TO STORE KOLBAM 
KAKO JEMATI ZDRAVILO KOLBAM
Kolbam 50 mg: Each capsule contains 50 mg of cholic acid. 
Kolbam 50 mg: ena kapsula vsebuje 50 mg holne kisline.
50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”). 
50-miligramska kapsula: kapsula velikosti številka 2 z rjavo-oranžnim pokrovčkom (s črno odtisnjeno oznako "ASK001") in telesom (s črno odtisnjeno oznako "50 mg").
Diarrhoea is also known to occur in cases of excessive dosing with cholic acid. 
Znano je, da se pri čezmernem odmerjanju holne kisline pojavi tudi diareja.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KOLBAM Ne jemljite zdravila Kolbam:
Mild peripheral neuropathy 
Bolezni živčevja blaga periferna nevropatija pogosti
No data regarding cholic acid treatment are available in patients with inborn errors of bile acid metabolism with hepatic impairment unrelated to their primary disease. 
Pri bolnikih s prirojenimi okvarami presnove žolčnih kislin in jetrno okvaro, nepovezano s primarno boleznijo, ni na voljo nobenih podatkov o zdravljenju s holno kislino.
Mild nausea Mild reflux Moderate diarrhoea 
Bolezni prebavil diareja pogosti blaga navzea blag refluks zmerna diareja pogosti pogosti pogosti refluksni ezofagitis pogosti
Study CAC-002-01, (an open-label, single-centre, nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-9110-10 and started on 1 Jan 2010. 
Študija CAC-002-01 (odprta, enocentrična, nerandomizirana nadaljevalna študija kapsul holne kisline pri bolnikih s prirojenimi okvarami sinteze žolčnih kislin - an open-label, single-centre,
• feeling out of sorts (malaise) 
• siljenje na bruhanje (blaga slabost),
Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol. 
V študijah z večkratnimi odmerki, pri katerih se je holna kislina dajala sočasno s holesterolom, so poročali o povečani masi jeter in žolčnih kamnih.
NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules. 
IME ZDRAVILA Kolbam 50 mg trde kapsule
Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid 
Kolbam 250 mg trde kapsule holna kislina
Kolbam'. 
Ne žvečite.
Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters. 
Po zmanjšanju odmerka so klinični znaki izginili,
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content 
6.1 Seznam pomožnih snovi
DATE OF REVISION OF THE TEXT 
DATUM ZADNJE REVIZIJE BESEDILA <{DD. mesec LLLL}>
Titanium dioxide (E171) 
Ovojnica kapsule: - želatina - titanov dioksid (E 171)
NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules. 
IME ZDRAVILA Kolbam 250 mg trde kapsule
- The other ingredients are: Capsule content: Silicified microcrystalline cellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Kolbam 50 mg also contains Red iron oxide (E172). 
- Druge sestavine zdravila so: Vsebina kapsule: - silicizirana mikrokristalna celuloza - magnezijev stearat
• sickness (mild nausea) 
• mravljinčenje (blaga periferna nevropatija).
Titanium dioxide (E171) Red iron oxide (E172) 
rdeči železov oksid (E 172)
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO
CONTENTS OF THE PACK AND OTHER INFORMATION What Kolbam contains - The active substance is cholic acid. 
VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Kolbam
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of cholic acid. 
Ena trda kapsula vsebuje 250 mg holne kisline.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cholic acid. 
Ena trda kapsula vsebuje 50 mg holne kisline.
50 mg Capsule shell Gelatin 
Kolbam 50 mg trde kapsule holna kislina
PHARMACEUTICAL FORM AND CONTENTS Hard capsule. 
Zdravilo Kolbam je na voljo v obliki trdih kapsul.
• Gallstones 
Fenian Street
Jaundice Increased serum transaminases Gallstones 
transaminaz in koncentracij žolčnih kislin v serumu.
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije splošno slabo počutje pogosti
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
(ODGOVORNI) ZA SPROŠČANJE SERIJ
Packaging Content (concentration) 
Ovojnina Vsebina Velikost pakiranja
Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015 
Datum prve odobritve: 4. marec 2011 Datum zadnjega podaljšanja: 19. november 2015
The volume of distribution for irbesartan is 53-93 litres. 
Porazdelitveni volumen irbesartana je 53 do 93 litrov.
Ifirmacombi should be taken at least one hour before or four hours after these medications; 
Zdravilo Ifirmacombi je treba jemati vsaj eno uro pred jemanjem teh zdravil ali štiri ure kasneje.
What Ifirmacombi is and what it is used for 
Kaj je zdravilo Ifirmacombi in za kaj ga uporabljamo
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
Tablete morate pogoltniti z zadostno količino tekočine (npr. s kozarcem vode).
It is important that you continue to take Ifirmacombi until your doctor tells you otherwise. 
Pomembno je, da zdravilo Ifirmacombi jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
See also information under the heading “Do not take Ifirmacombi”. 
Glejte tudi informacije pod naslovom "Ne jemljite zdravila Ifirmacombi".
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. 
Največji učinek na znižanje krvnega tlaka se običajno pojavi v 6 do 8 tednih po začetku zdravljenja.
During the 8-week treatment period, there were no reported cases of syncope in either treatment group. 
Med 8-tedenskim zdravljenjem v nobeni skupini niso poročali o pojavu sinkope.
The frequency of adverse reactions listed below is defined 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) 
Pogostost neželenih učinkov je v nadaljevanju navedena v skladu z naslednjim dogovorom: - 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), - neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Children and adolescents Ifirmacombi should not be given to children and adolescents (under 18 years). 
Otroci in mladostniki Zdravila Ifirmacombi otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
See section 2 "Ifirmacombi contains sodium". 
Glejte poglavje 2 "Zdravilo Ifirmacombi vsebuje natrij".
However the terminal half-life was not significantly altered. 
Končna razpolovna časa se bistveno ne razlikujeta.
Primary aldosteronism: 
Primarni aldosteronizem
If you take more Ifirmacombi than you should If you accidentally take too many tablets, contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila Ifirmacombi, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
You should discontinue Ifirmacombi treatment and seek medical attention. 
Prenehajte z jemanjem zdravila Ifirmacombi in poiščite zdravniško pomoč.