natgillin/translations-raw huggingface dataset:
Each mL of solution contains 925 MBq of copper (64Cu) chloride at calibration time (01h00 a.m. 
En ml raztopine vsebuje 925 MBq bakrovega (64Cu) klorida ob času kalibracije (ob 1:00 po srednjeevropskem času), kar ustreza vsaj 0,25 mikrogramom bakra (64Cu).
How the medicine radiolabelled with Cuprymina is used 
Uporaba zdravila, radioaktivno označenega z radiofarmacevtskim predhodnikom Cuprymina,
Medicines radiolabelled with Cuprymina will only be used in special, controlled areas. 
Zdravila, radioaktivno označena z radiofarmacevtskim predhodnikom Cuprymina, se vedno uporabljajo v posebnih,
The pharmacokinetic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled. 
Farmakokinetične lastnosti z bakrom (64Cu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Cuprymina pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označeno.
Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, will be dependent on the specific medicinal product being used. 
Neželeni učinki, ki so posledica intravenskega dajanja zdravil, označenih z bakrom (64Cu) in pripravljenih z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Cuprymina, bodo odvisni od posameznega zdravila, ki bo uporabljeno.
PACKAGE LEAFLET 
SPROŠČANJE SERIJE
Posology 
Splošna opozorila
Breast-feeding 
Cuprymina
For more information concerning paediatric use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product. 
Za več informacij glede uporabe z bakrom (64Cu) označenih zdravil pri otrocih glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo radioaktivno označenega zdravila.
PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution. 
FARMACEVTSKA OBLIKA radionukleotidni predhodnik, raztopina Bistra, brezbarvna raztopina brez trdnih delcev.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. 
IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Liver, gastrointestinal tract and kidney are the target organs for copper toxicity after single and repeated doses administration. 
Tarčni organi za toksičnost bakra po enem ali večkratnem dajanju odmerka so jetra, prebavni trakt in ledvice.
Contact your nuclear medicine doctor if you have any questions. 
Če imate kakršno koli vprašanje, se posvetujte s svojim specialistom nuklearne medicine.
Do not use this medicine after the expiry date and time which are stated on the label after EXP. Cuprymina will be stored in the original package that provides protection from radiation. 
Radiofarmacevtskega predhodnika Cuprymina ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
Cuprymina is not a medicine and it is not intended to be used on its own. 
Kaj je radionukleotidni predhodnik Cuprymina in za kaj ga uporabljamo Radionukleotidni predhodnik Cuprymina ni zdravilo in ni namenjeno samostojni uporabi, je vrsta izdelka, ki ga imenujemo radionukleotidni predhodnik.
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 
Druga zdravila in zdravila, radioaktivno označena z radiofarmacevtskim predhodnikom
The toxicological properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled. 
5.3 Predklinični podatki o varnosti Toksikološke lastnosti z bakrom (64Cu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Cuprymina pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označeno.
(MBq: mega Becquerel, Becquerel is the unit in which radioactivity is measured) - The other ingredients are hydrochloric acid (0.1 N) and water for injections. 
− Druge sestavine so klorovodikova kislina (0,1 M) in voda za injekcije.
- if you drink alcohol excessively (either every day or only from time to time). 
- če prekomerno uživate alkohol (bodisi dnevno ali občasno).
Date of first authorisation: 28/07/2006 Date of latest renewal: 25/04/2016 
Datum prve odobritve: 28/07/2006 Datum zadnjega podaljšanja: 25/04/2016
Your doctor will check whether Competact is working 3 to 6 months after you start taking it. 
Zdravnik bo preveril, če zdravilo Competact deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
- if you have a severe infection or are dehydrated. 
če imate hujšo okužbo ali ste dehidrirani.
Packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180. 
Pakiranja po 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
- if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. 
- če zadržujete vodo (zastajanje tekočine v telesu) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
Take Competact daily as prescribed. 
Zdravilo Competact jemljite vsak dan, kakor vam je predpisano.
Use in children and adolescents under 18 years is not recommended. 
Uporaba tega zdravila pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
- if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na pioglitazon, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
No dose adjustment. 
Brez prilagajanja odmerka.
EU/1/06/354/011 2x98 tablets 
EU/1/06/354/011 2x98 tablet
If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy. 
vzemite primerno kontracepcijo, da preprečite možnost nenačrtovane nosečnosti.
Ask your doctor or pharmacist for more information if you are not sure how to recognise this. 
Vprašajte zdravnika ali farmacevta za več informacij, če ne prepoznavate teh simptomov.
- if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision. 
- če imate posebno obliko diabetične očesne bolezni, imenovano makularni edem (otekanje zadnjega dela očesa); pogovorite se z zdravnikom, če opazite kakršno koli spremembo vida.
Animal studies have not revealed teratogenic effects. 
Študije na živalih niso pokazale teratogenih učinkov.
If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination. 
Če ni na voljo ustrezna jakost zdravila Competact, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
What Competact is and what it is used for 
Kaj je zdravilo Competact in za kaj ga uporabljamo
Competact has no or negligible influence on the ability to drive and use machines. 
Zdravilo Competact nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
What you need to know before you take Competact Do not take Competact: 
Kaj morate vedeti, preden boste vzeli zdravilo Competact Ne jemljite zdravila Competact:
What Competact is and what it is used for What you need to know before you take Competact How to take Competact 
Kaj je zdravilo Competact in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Competact Kako jemati zdravilo Competact
Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3). 
Študije na živalih niso pokazale teratogenih učinkov, vendar pa so pokazale fetotoksičnost, vezano na farmakološko delovanje (glejte poglavje 5.3).
Other medicines and Competact 
Druga zdravila in zdravilo Competact
When starting or using such products in combination with Competact, close monitoring of renal function is necessary. 
Ob uvedbi ali uporabi teh zdravil v kombinaciji z Competact je potrebno skrbno spremljanje delovanja ledvic.
There have been no formal interaction studies for Competact. 
Formalne študije interakcij za zdravilo Competact niso bile narejene.
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4). 
Metformin povečuje transportno zmožnost specifičnih tipov membranskih transporterjev za glukozo (GLUT-1 in
If you take more Competact than you should 
Če ste vzeli večji odmerek zdravila Competact, kot bi smeli
- you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. 
Nosečnost in dojenje - Svojemu zdravniku morate povedati, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
Women of childbearing potential / Contraception in males and females Competact is not recommended in women of childbearing potential not using contraception. 
Ženske v rodni dobi / Kontracepcija pri moških in ženskah Zdravilo Competact ni priporočljivo pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Competact pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Competact helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. 
Zdravilo Competact pomaga nadzorovati raven sladkorja v krvi, če imate sladkorno bolezen tipa 2, in sicer tako, da telesu pomaga bolje izkoristiti insulin, ki ga izdela.
In case of suspected symptoms, the patient should stop taking Competact and seek immediate medical attention. 
Ob sumu na simptome mora bolnik prenehati z jemanjem Competact in takoj poiskati zdravniško pomoč.
As Competact contains metformin hydrochloride,it must be discontinued at the time of surgery under general, spinal or epidural anesthesia. 
Ker zdravilo Competact vsebuje metformin hidroklorid, je treba jemanje le-tega prekiniti v času operativnega posega pod splošno, spinalno ali epiduralno anestezijo.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. 
Če po nesreči zaužijete preveč tablet ali če kdo drug ali otrok zaužije vaša zdravila, o tem nemudoma obvestite svojega zdravnika ali farmacevta.
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%. 
Raziskava pri sedmih zdravih prostovoljcih je pokazala, da je cimetidin, ki ga je bolnik prejemal v odmerku 400 mg dvakrat na dan, povečal sistemsko izpostavljenost metforminu (AUC) za 50% in Cmax za 81%.
Competact with alcohol 
Zdravilo Competact skupaj z alkoholom
Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin. 
Jemanje zdravila Competact med obrokom ali neposredno po njem lahko ublaži gastrointestinalne simptome, ki so povezani z metforminom.
If this happens you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. 
V tem primeru morate prenehati jemati zdravilo Competact in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact. 
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Competact.
Contents of the pack and other information What Competact contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Competact
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects. 
Starejši Farmakokinetiki stanja dinamičnega ravnovesja sta pri bolnikih, starih 65 let in več, ter mladih osebah podobni.
The decision whether to continue the patient on therapy with Competact should be guided by clinical judgement pending laboratory evaluations. 
Odločitev o tem, ali zdravljenje bolnika z zdravilom Competact nadaljevati, naj do laboratorijskih vrednotenj temelji na klinični presoji.
During treatment with Competact, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. 
Med zdravljenjem z zdravilom Competact bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice. 
Priporočeno je, da imate pri sebi nekaj kock sladkorja, sladkarije, piškote ali sladki sadni sok.
However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively). 
Vendar sta bila po obroku v primeru metformina povprečna AUC in Cmax nižja (13% in
EU/1/06/354/001 14 tablets EU/1/06/354/002 28 tablets EU/1/06/354/003 30 tablets EU/1/06/354/004 50 tablets EU/1/06/354/005 56 tablets EU/1/06/354/006 60 tablets EU/1/06/354/007 90 tablets EU/1/06/354/008 98 tablets EU/1/06/354/010 112 tablets EU/1/06/354/009 180 tablets EU/1/06/354/012 60 x 1 tablets 
EU/1/06/354/001 14 tablet EU/1/06/354/002 28 tablet EU/1/06/354/003 30 tablet EU/1/06/354/004 50 tablet EU/1/06/354/005 56 tablet EU/1/06/354/006 60 tablet EU/1/06/354/007 90 tablet EU/1/06/354/008 98 tablet EU/1/06/354/010 112 tablet EU/1/06/354/009 180 tablet EU/1/06/354/012 60 x 1 tableta
Following initiation of therapy with Competact, it is recommended that liver enzymes be monitored periodically according to clinical judgement. 
Po uvedbi zdravljenja z zdravilom Competact je priporočeno, da jetrne encime spremljate redno po klinični presoji.
Individual cartons not to be sold separately. 
Posameznih škatel se ne izdaja posebej.
If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately. 
Če imate resno alergijsko reakcijo, ki vključuje koprivnico in otekanje obraza, ustnic, jezika ali žrela, kar lahko povzroči težave pri dihanju ali požiranju, takoj prenehajte z jemanjem tega zdravila in nemudoma poiščite zdravniško pomoč.
If you stop taking Competact 
Če ste prenehali jemati zdravilo Competact
5 How to store Competact Contents of the pack and other information 
5 Shranjevanje zdravila Competact Vsebina pakiranja in dodatne informacije
If ALT levels are increased to 3 x upper limit of normal during Competact therapy, liver enzyme levels should be reassessed as soon as possible. 
Če se med zdravljenjem z zdravilom Competact ravni ALT zvišajo do 3-kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible. 
Tudi, če že imate zamegljen vid in se simptomi poslabšajo, se nemudoma posvetujte s svojim zdravnikom.
If you forget to take Competact 
Če ste pozabili vzeti zdravilo Competact
Competact may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. 
Zdravilo Competact lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
Before you start taking Competact you will have a blood sample taken to check your liver function. 
Pred začetkom jemanja zdravila Competact vam bodo odvzeli vzorec krvi, da se preveri delovanje jeter.
Stop taking Competact for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. 
Za kratek čas prenehajte jemati zdravilo Competact, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
Frequencies are defined as: 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). 
(≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The following statements reflect the pharmacokinetic properties of the individual active substances of Competact. 
Sledeče ugotovitve odražajo farmakokinetične lastnosti individualnih zdravilnih učinkovin v zdravilu
However if you miss a dose, skip the missed dose and just carry on with the next dose as normal. 
Če ste pozabili vzeti odmerek, izpustite pozabljeni odmerek in nadaljujte z naslednjim odmerkom kot sicer.
They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets. 
Na voljo so v aluminij/aluminij pretisnih omotih in pakiranjih po 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, večkratnih pakiranjih po 196 (2 paketa po 98) tablet ali v aluminij/aluminij perforiranih enoodmernih pretisnih omotih po 60 x 1 tableta.
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision. 
To zdravilo ne vpliva na sposobnost upravljanja vozil in strojev, vendar pa bodite pozorni v primeru pojava težav z vidom.
- do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”). 
- Zdravila Competact ne smete jemati, če dojite ali nameravate dojiti (glejte poglavje “Ne jemljite zdravila Competact”.
Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4). 
Laktacidoza je resen neželen učinek, ki se lahko pojavi zelo redko (< 1/10.000) (glejte poglavje 4.4), drugi neželeni učinki, kot so zlomi kosti, povečanje telesne mase in edem pa se lahko pojavijo pogosto (≥ 1/100 do < 1/10) (glejte poglavje 4.4).
In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Competact should be temporarily discontinued and contact with a health care professional is recommended. 
V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje Competact začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
comprising 2 packs, each containing 98 film-coated tablets. 
Sestavni del večkratnega pakiranja sta 2 pakiranji, vsako vsebuje 98 filmsko obloženih tablet.
- if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties. 
- če ste pred kratkim doživeli srčni infarkt, imate hujše težave s krvnim obtokom, če ste doživeli šok ali imate težave z dihanjem.
If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again. 
Če se pri vas pojavijo simptomi hipoglikemije, kot so oslabelost, omotica, povečano znojenje, hiter srčni utrip, težave z vidom ali težave s koncentracijo, pojejte nekaj sladkega, da znova dvignete raven sladkorja v krvi.
- if you have a problem with your liver. 
- če imate težave z jetri.
FOR CALENDARISED PACKS: 7 Tablet blister 
ZA KOLEDARSKA PAKIRANJA: Pretisni omot s 7 tabletami
When clinically appropriate, direct change from metformin monotherapy to Competact may be considered. 
Če je klinično sprejemljivo, se sme razmisliti o neposredni zamenjavi iz monoterapije z metforminom na zdravljenje z zdravilom Competact.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema. 
Ker sta tako insulin kot pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje insulina in zdravila Competact poveča tveganje za edeme.
Both pioglitazone and metformin have been shown to be present in the milk of lactating rats. 
Tako pioglitazon kot metformin so dokazali v mleku doječih podgan.
Competact must therefore not be used in women who are breast-feeding (see section 4.3). 
Zdravila Competact se torej ne sme uporabljati pri ženskah, ki dojijo (glejte poglavje 4.3).
If you are following a special diet for diabetes, you should continue with this while you are taking Competact. 
Če ste na posebni dieti za sladkorno bolezen, morate z dieto med jemanjem zdravila Competact nadaljevati.
Maximum daily dose is 45 mg 
Največji dnevni odmerek je 45 mg
The European Medicines Agency has waived the obligation to submit the results of studies with Competact in all subsets of the paediatric population in type 2 diabetes mellitus. 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Competact za vse skupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1). 
Izvedli so klinična preskušanja s tabletami zdravila Competact in sočasnim dajanjem pioglitazona in metformina (glejte poglavje 5.1).
ACE inhibitors may decrease the blood glucose levels. 
Zaviralci ACE lahko zmanjšajo koncentracijo glukoze v krvi.
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4). 
Zaradi izločanja metformina skozi ledvice in zaradi starostnega nagnjenja k zmanjšanju ledvičnega delovanja je pri starejših bolnikih, ki jemljejo zdravilo Competact, potrebno redno spremljati delovanje ledvic (glejte poglavji 4.3 in 4.4).
Your doctor will decide when you must stop and when to restart your treatment with Competact. 
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Competact prenehati in kdaj lahko nadaljujete.
Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets. 
Biokvivalenčne študije pri zdravih prostovoljcih so pokazale, da je zdravilo Competact bioekvivalentno sočasnemu jemanju pioglitazona in metformina kot dveh posameznih tablet.
On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal. 
Na tej podlagi je delež učinkovitosti M-IV enak približno trikratniku deleža pioglitazona,
- if you have severely reduced kidney function. 
- če imate hudo oslabljeno delovanje ledvic.
Small clinical trials have not revealed metformin to have malformative effects. 
Neobsežna klinična preskušanja niso pokazala negativnih učinkov metformina.
In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator. 
V 3,5-letni PROactive študiji je 44/870 (5,1%, 1,0 zloma na 100 bolnik-let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5%, 0,5 zloma na 100 bolnik-let) žensk, zdravljenih s primerjalnim zdravilom.
Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients. 
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja z zdravilom Competact.
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4). 
Zdravila Competact pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavji 4.3 in 4.4).