FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia
Slovenian: Očesne bolezni pogosti očesna bolečina, očesni pruritus, hiperemija veznice občasni roženični infiltrati, obarvanje roženice, zamegljen vid, draženje očesa, suho oko, občutek tujka v očesu, povečano solzenje, astenopija, očesna hiperemija
English: Scleral mononuclear cell infiltrates were present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated with 1.0 mg/ml.
Slovenian: Mononuklearni celični infiltrati v beločnici so bili prisotni pri 1/4 samcev in pri 1/4 samic, zdravljenih z odmerkom 0,5 mg/ml, in pri 2/4 samcev in 1/4 samic, zdravljenih z odmerkom 1,0 mg/ml.
English: Benzalkonium chloride 0.1 mg/ml
Slovenian: Pomožna snov z znanim učinkom: benzalkonijev klorid 0,1 mg/ml
English: What EMADINE contains - The active substance is emedastine 0.5 mg/ml as difumarate.
Slovenian: Kaj vsebuje zdravilo EMADINE - Učinkovina je emedastin 0,5 mg/ml v obliki difumarata.
English: No specific reactions are to be expected with an ocular overdose of the product.
Slovenian: Pri okularnem prevelikem odmerjanju ni pričakovati specifičnih neželenih učinkov.
English: 1 ml of solution contains emedastine 0.5 mg (as difumarate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml raztopine vsebuje 0,5 mg emedastina (v obliki difumarata).
English: Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels
Slovenian: Zdravilu včasih dodamo majhne količine klorovodikove kisline ali natrijevega hidroksida,
English: • Gently press on the base of the bottle to release one drop of EMADINE at a time.
Slovenian: • Nežno pritisnite na dno kapalnega vsebnika, da vsakokrat iztisnete po eno kapljico zdravila
English: Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Slovenian: 6.1 Seznam pomožnih snovi trometamol natrijev klorid hipromeloza klorovodikova kislina/natrijev hidroksid (za prilagoditev pH) prečiščena voda
English: - The other ingredients are trometamol; sodium chloride; hypromellose; purified water.
Slovenian: - Pomožne snovi so trometamol; natrijev klorid; hipromeloza; prečiščena voda.
English: There was no evidence of impaired fertility or decreased reproductive capacity in rats administered oral dosages of Emedastine difumarate of up to 30 mg/kg/day.
Slovenian: Pri podganah, ki so prejemale peroralne odmerke emedastinijevega difumarata do 30 mg/kg/dan, ni bilo dokazov o škodljivih učinkih na plodnost ali zmanjšano sposobnost razmnoževanja.
English: What is in this leaflet
Slovenian: Kaj vsebujenavodilo
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni izpuščaj
English: Manufacturer S.A. Alcon-Couvreur N.V., Rijksweg 14,
Slovenian: Izdelovalec Alcon-Couvreur N.V.
English: Eye drops, solution
Slovenian: kapljice za oko, raztopina
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: • Take the bottle and twist off the cap.
Slovenian: • Vzemite kapalni vsebnik in odvijte zaporko.
English: Always use EMADINE exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila EMADINE natančno upoštevajte navodila zdravnika.
English: Emedastine 0.5 mg/ml as difumarate
Slovenian: Emedastin 0,5 mg/ml v obliki difumarata.
English: - The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose;
Slovenian: - Pomožne snovi so benzalkonijev klorid; trometamol; natrijev klorid; hipromeloza; prečiščena voda.
English: No reproductive toxicity was observed in a study in rabbits.
Slovenian: V študiji na kuncih niso opažali nobenih vplivov na sposobnost razmnoževanja.
English: You may find that your vision is blurred for a time just after you use EMADINE.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Takoj po uporabi zdravila EMADINE bo lahko vaš vid nekaj časa zamegljen.
English: How to store EMADINE
Slovenian: Shranjevanje zdravila EMADINE
English: Ocular corneal infiltrates were reported in conjunction with the use of EMADINE.
Slovenian: Ob uporabi zdravila EMADINE so poročali o očesnih roženičnih infiltratih.
English: Novartis Farma - Produtos Farmacêuticos, S.A.
Slovenian: Novartis Farma S.p.A.
English: Put the others back in the foil wrapper.
Slovenian: • Odtrgan vsebnik pustite zunaj, druge pa vrnite v folijsko vrečko.
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container emedastine
Slovenian: EMADINE 0,5 mg/ml kapljice za oko, raztopina, enoodmerni vsebnik emedastin
English: (pH levels) normal.
Slovenian: da zagotovimo normalno vrednost kislosti (vrednost pH).
English: BOTTLE LABEL 5 ml & 10 ml
Slovenian: NALEPKA NA KAPALNEM VSEBNIKU, 5 ml in 10 ml
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container.
Slovenian: EMADINE 0,5 mg/ml kapljice za oko, raztopina, enoodmerni vsebnik
English: Corneal limbal mononuclear cell infiltrates were noted in 1/4 male monkeys treated with 0.5 mg/ml and in 4/4 males and 1/4 females treated with1.0 mg/ml.
Slovenian: Pri 1/4 opičjih samcev, zdravljenih z odmerkom 0,5 mg/ml, in pri 4/4 samcev in 1/4 samic, zdravljenih z odmerkom 1,0 mg/ml, so opažali mononuklearne celične infiltrate v limbusu roženice.
English: • Bring the container tip close to the eye. Use the mirror if it helps.
Slovenian: • Vrh vsebnika približajte očesu.
English: 6 Contents of the pack and other information
Slovenian: Shranjevanje zdravila EMADINE Vsebina pakiranja in dodatne informacije
English: EMADINE 0.5 mg/ml eye drops emedastine
Slovenian: EMADINE 0,5 mg/ml kapljice za oko, raztopina
English: It may harm them even if their signs of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: • Bring the bottle tip close to the eye. Use the mirror if it helps.
Slovenian: Če vam to pomaga, uporabite ogledalo.
English: 15 INSTRUCTIONS ON USE
Slovenian: B. NAVODILO ZA UPORABO
English: You must talk to a doctor if you do not feel better or if you feel worse.
Slovenian: Če se znaki vaše bolezni poslabšajo ali ne izboljšajo, se posvetujte z zdravnikom.
English: Foil Pouch
Slovenian: Folijska vrečka
English: Excipient with known effect
Slovenian: Neželen učinek
English: B. CONDITIONS OR RESTRICIONS REGARDING SUPPLY AND USE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: 6 OTHER
Slovenian: DRUGI PODATKI
English: Hypromellose
Slovenian: Dojenje
English: It must also not be used in women who are breastfeeding.
Slovenian: Prav tako zdravila ne smejo uporabljati ženske, ki dojijo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Procysbi on 06.09.2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Procysbi, veljavno po vsej Evropski uniji, odobrila 06.09.2013.
English: The recommended daily dose is calculated according to body surface area, as 1.30 g per m2 divided into 2 doses given every 12 hours.
Slovenian: Priporočen dnevni odmerek se izračuna glede na telesno površino in znaša 1,30 g na m2, daje pa se ga v dveh deljenih odmerkih vsakih 12 ur.
English: Procysbi is available as gastroresistant capsules (25 and 75 mg).
Slovenian: Zdravilo Procysbi je na voljo v obliki gastrorezistentnih kapsul (25 in 75 mg).
English: What measures are being taken to ensure the safe and effective use of Procysbi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Procysbi?
English: Procysbi mercaptamine
Slovenian: Procysbi merkaptamin
English: This is a summary of the European public assessment report (EPAR) for Procysbi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Procysbi.
English: In addition, the company that markets Procysbi will provide educational material to all doctors expected to prescribe the medicine, containing important safety information including the risk that the medicine may be harmful to the unborn child.
Slovenian: Poleg tega bo družba, ki trži zdravilo Procysbi, zagotovila izobraževalno gradivo za vse zdravnike, ki naj bi predpisovali zdravilo, v katerega bodo vključene pomembne informacije o varnosti, vključno z opozorilom, da je lahko zdravilo škodljivo za nerojenega otroka.
English: Procysbi is a ‘hybrid medicine'.
Slovenian: Procysbi je „hibridno zdravilo“.
English: Gastroresistant means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Slovenian: „Gastrorezistentne“ pomeni, da vsebina kapsul preide skozi želodec v črevesje, ne da bi se pri tem razgradila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Procysbi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Procysbi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Procysbi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 September 2010.
Slovenian: Ker je bolnikov s cistinozo malo, velja ta bolezen za redko, zato je bilo zdravilo Procysbi 20. septembra 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Procysbi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Cystinosis is an inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Slovenian: Cistinoza je dedna bolezen, pri kateri se odvečne količine cistina, tj. aminokisline, ki je naravno prisotna v telesu, kopičijo znotraj celic, zlasti v ledvicah in očeh, ter jih poškodujejo.
English: The most common side effects with Procysbi (which may affect more than 1 in 10 people) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Slovenian: Najpogostejši neželeni učinki zdravila Procysbi (ki lahko prizadenejo več kot 1 osebo od 10) so izguba teka, bruhanje, navzeja (slabost), driska, letargija (pomanjkanje energije) in pireksija (povišana telesna temperatura).
English: A risk management plan has been developed to ensure that Procysbi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Procysbi je bil pripravljen načrt obvladovanja tveganj.
English: Regarding its safety, the CHMP considered that the safety profile of mercaptamine is well established and the safety of Procysbi is expected to be similar to that of the reference medicine.
Slovenian: V zvezi z varnostjo zdravila je CHMP menil, da je varnostni profil merkaptamina že dobro znan in da naj bi bila varnost zdravila Procysbi podobna kot varnost referenčnega zdravila.
English: Levels were 0.51 nmol/mg with Procysbi, compared with 0.44 nmol/mg with Cystagon.
Slovenian: Pri zdravilu Procysbi so bile koncentracije 0,51 nmol/mg, pri zdravilu Cystagon pa 0,44 nmol/mg.
English: The reference medicine for Procysbi is Cystagon.
Slovenian: Referenčno zdravilo za zdravilo Procysbi je Cystagon.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Procysbi is available in a formulation that allows for a delayed release of the active substance in the body.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar pa je zdravilo Procysbi na voljo v obliki pripravka, ki omogoča zapoznelo sproščanje zdravilne učinkovine v telesu.
English: The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs.
Slovenian: Tako se zmanjša količina cistina v organih, s tem pa tudi njihove okvare.
English: What is Procysbi and what is it used for?
Slovenian: Kaj je zdravilo Procysbi in za kaj se uporablja?
English: In a main study involving 43 patients with nephropathic cystinosis, there was no meaningful difference between the average levels of cystine in white blood cells during a 3-week treatment with the two medicines.
Slovenian: V glavni študiji, v katero je bilo vključenih 43 bolnikov z nefropatsko cistinozo, med 3-tedenskim zdravljenjem z omenjenima zdraviloma niso opazili pomembnih razlik med povprečnimi koncentracijami cistina v belih krvnih celicah.
English: Procysbi must not be used in people who are hypersensitive (allergic) to any form of mercaptamine or any of the other ingredients, or to penicillamine.
Slovenian: Zdravila Procysbi ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katero koli obliko merkaptamina, katero koli drugo sestavino zdravila ali penicilamin.
English: The Committee also considered that the gastroresistant formulation, due to its less frequent administration, is expected to increase compliance with treatment and the quality of life of patients with cystinosis.
Slovenian: Poleg tega je odbor menil, da je mogoče pričakovati, da bo gastrorezistenten pripravek zaradi manj pogostega odmerjanja pripomogel k večjemu upoštevanju navodil za zdravljenje in izboljšal kakovost življenja bolnikov s cistinozo.
English: Procysbi can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of cystinosis.
Slovenian: Izdaja zdravila Procysbi je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem cistinoze.
English: For more information about treatment with Procysbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Procysbi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The full EPAR for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Procysbi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Procysbi?
Slovenian: Kakšna tveganja so povezana z zdravilom Procysbi?
English: Procysbi given every 12 hours has been shown to be at least as effective as Cystagon given every 6 hours at maintaining the amount of cystine in white blood cells at acceptable levels (less than 1 nmol hemicystine per mg of white blood cell protein).
Slovenian: Zdravilo Procysbi, ki so ga dajali vsakih 12 ur, je bilo vsaj tako učinkovito kot zdravilo Cystagon, ki so ga dajali vsakih 6 ur, pri ohranjanju sprejemljivih koncentracij cistina v belih krvnih celicah (manj kot 1 nmol hemicistina na mg beljakovin belih krvnih celic).
English: What benefits of Procysbi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Procysbi izkazalo v študijah?
English: Other information about Procysbi
Slovenian: Druge informacije o zdravilu Procysbi
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Procysbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Procysbi vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It is not intended to provide practical advice on how to use Procysbi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: It is used in patients with nephropathic (kidney) cystinosis.
Slovenian: Uporablja se pri bolnikih z nefropatsko (ledvično) cistinozo.
English: The CHMP noted that Procysbi was shown to be at least as effective as Cystagon at maintaining the amount of cystine in white blood cells at acceptable levels.
Slovenian: CHMP je upošteval, da je bilo zdravilo Procysbi vsaj tako učinkovito kot zdravilo Cystagon pri ohranjanju sprejemljivih koncentracij cistina v belih krvnih celicah.
English: Procysbi is a medicine that contains the active substance mercaptamine (also known as cysteamine).
Slovenian: Procysbi je zdravilo, ki vsebuje zdravilno učinkovino merkaptamin (ki ga imenujemo tudi cisteamin).
English: Why is Procysbi approved?
Slovenian: Zakaj je bilo zdravilo Procysbi odobreno?
English: The active substance in Procysbi, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Slovenian: Zdravilna učinkovina v zdravilu Procysbi, merkaptamin, reagira s cistinom, pri čemer nastane druga aminokislina, imenovana cistein, in spojina, imenovana cistin-cisteaminova sol.
English: For practical information about using Procysbi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Procysbi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Procysbi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Procysbi, glejte navodilo za uporabo.
English: Cystine levels in white blood cells (which are measured as nmol hemicystine per mg white blood cell protein), or alternatively mercaptamine concentration in the blood, should be monitored and used to adjust the dose, which should never exceed 1.95 g per m2 per day.
Slovenian: (ki se izmeri kot nmol hemicistina na mg beljakovin belih krvnih celic) ali koncentracijo merkaptamina v krvi in na podlagi rezultatov prilagoditi odmerek, ki pa v nobenem primeru ne sme biti večji od 1,95 g na m2 na dan. Za več informacij glejte navodilo za uporabo.
English: How is Procysbi used?
Slovenian: Kako se zdravilo Procysbi uporablja?
English: How does Procysbi work?
Slovenian: Kako zdravilo Procysbi deluje?
English: Get medical help immediately.
Slovenian: Takoj poiščite zdravniško pomoč.
English: Hepatitis that may be serious.
Slovenian: Hepatitis, ki je lahko resen.
English: The more active you are, the higher your calorie target.
Slovenian: Bolj ko ste dejavni, višja je vaša ciljna vrednost kalorij.
English: However, any possible risk should be avoided (see section 6.6).
Slovenian: Kljub temu se je potrebno izogibati kakršnemkoli tveganju (glejte poglavje 6.6).
English: See section 2, warnings and precautions.
Slovenian: Glejte poglavje 2, Opozorila in previdnostni ukrepi.
English: Eating fewer than 1200 calories per day is not recommended.
Slovenian: Uživanje manj kakor 1200 kalorij na dan ni priporočljivo.
English: The amount of weight you lose may vary from week to week.
Slovenian: Telesna masa, ki jo boste izgubili, se lahko spreminja od tedna do tedna.
English: - Do not take 2 tablets at the same time to make up for a forgotten tablet.
Slovenian: - Ne vzemite dveh tablet sočasno da bi nadomestili pozabljen odmerek.
English: 24018, 1700 Λευκωσία
Slovenian: 24018, 1700 Λευκωσία Tηλ.
English: Calories are a measurement of the energy your body needs.
Slovenian: Kalorije so merilo energije, ki jo vaše telo potrebuje.
English: • if you are under 18 years old.
Slovenian: • če ste mlajši od 18 let
English: This does not mean that the capsules are not working.
Slovenian: To ne pomeni, da kapsule ne delujejo.
English: 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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je definirana kot: 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 možno oceniti iz razpoložljivih podatkov).
English: All comparisons against placebo were statistically significant.
Slovenian: Vse primerjave so bile v primerjavi s placebom statistično značilne.
English: If you are unsure which level you are, choose Low activity.
Slovenian: Če niste prepričani, katera stopnja je za vas ustrezna, izberite stopnjo z majhno telesno dejavnostjo.
English: It may be necessary to discontinue treatment.
Slovenian: Morda bo treba prenehati zdravljenje.
English: Choose your start date
Slovenian: Izberite začetni dan
English: This does not mean that the tablets are not working.
Slovenian: To ne pomeni, da tablete ne delujejo.
English: Choose the level that most closely fits your daily routine.
Slovenian: Izberite stopnjo, ki najbolj ustreza vaši vsakodnevni rutini.
English: 4.5 Interaction with other medicinal products and other forms of interaction Ciclosporin
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ciklosporin
English: 190 11 Avlona, Greece
Slovenian: 190 11 Avlona, Grčija
English: They generally occurred early in treatment (within 3 months) and most patients experienced only one episode.
Slovenian: Večinoma so se pojavili na začetku zdravljenja (v prvih 3 mesecih), večina bolnikov pa je imela le eno epizodo neželenih učinkov.
English: Date of first authorisation: 23rd July 2007 Date of latest renewal: 29th June 2017
Slovenian: Datum prve odobritve: 23. julij 2007 Datum zadnjega podaljšanja: 29. junija 2017
English: This could potentially lead to a decrease of immunosuppressive efficacy.
Slovenian: To bi lahko zmanjšalo imunosupresivno učinkovitost.
English: The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Slovenian: Dnevni vnos maščob, ogljikovih hidratov in beljakovin mora biti razdeljen med tri glavne obroke.
English: This pack includes:
Slovenian: Pakiranje vsebuje:
English: Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Slovenian: Zato je pred začetkom zdravljenja z orlistatom potrebna skrbna obravnava možnega vpliva na te bolnike.
English: In the event of an overdose, medical advice should be sought.
Slovenian: V primeru zaužitja prevelikega odmerka je treba poiskati zdravniški nasvet.
English: They are sometimes called kilocalories or kcal. Energy may also be measured in kilojoules, which you may also see on food labels.
Slovenian: Energijo lahko prav tako merimo v kilojoulih, kar lahko prav tako opazite na oznakah hrane.
English: A realistic goal is to lose between 5 % to 10 % of your starting weight.
Slovenian: Realistični cilj je izguba 5 do 10 % vaše izhodiščne telesne mase.
English: Some fatal cases or cases requiring liver transplantation have been reported.
Slovenian: Poročali so o nekaterih smrtnih primerih ali primerih, kjer je bila potrebna presaditev jeter.
English: The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown.
Slovenian: Klinični pomen tega učinka pri bolnikih, ki se zdravijo z amiodaronom, ni poznan.
English: These conditions may not cause you to feel unwell so you should see your doctor for a general health check.
Slovenian: Te okoliščine pri vas ne bodo povzročile slabega počutja, zato vam svetujemo splošen zdravstveni pregled pri svojem zdravniku.
English: Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.
Slovenian: Dnevniki prehranjevanja so učinkoviti, ker ste bolj pozorni kaj in koliko ste jedli ter vam služijo kot osnova za spremembe.
English: Excipient(s) with known effect
Slovenian: Pomožna(-e) snov(-i) z znanim učinkom
English: Elderly (>65 years old)
Slovenian: Starostniki (starejši od 65 let)