FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
Slovenian: Intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo V 5 s placebom kontroliranih študijah so se pljučni dogodki pojavili pri 0,6 % bolnikov v skupini z dronedaronom in pri 0,8 % bolnikov, ki so prejemali placebo.
English: Uncommon (1/1,000 to
Slovenian: Občasni ( 1/1.000 do
English: Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Slovenian: Medsebojna delovanja z zdravili, ki se presnovijo s CYP 2D6
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).
Slovenian: Med obdobjem trženja so bili opisani primeri intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo (pogostnost neznana).
English: • Liver problems including life threatening liver failure.
Slovenian: • Težave z jetri, vključno s smrtno nevarno odpovedjo jeter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of dronedarone (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 400 mg dronedarona (v obliki klorida).
English: The incidence of the primary efficacy endpoint defined as first recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy at 12 months was 75% in the dronedarone group and 59% in the amiodarone group (hazard ratio = 1.59, log-rank p-value <0.0001).
Slovenian: Po 12 mesecih je bila incidenca te primarne končne točke v skupini z dronedaronom 75 % in v skupini z amiodaronom 59 % (razmerje ogroženosti = 1,59, vrednost p za log-rang < 0,0001).
English: Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 400 mg dronedarona (v obliki klorida).
English: Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides (such as erythromycin), terfenadine and Class I and III antiarrhythmics are contraindicated because of the potential risk of proarrhythmia (see section 4.3).
Slovenian: Zaradi možnega tveganja proaritmičnih učinkov so kontraindicirana zdravila, ki inducirajo torsades de pointes, npr. fenotiazini, cisaprid, bepridil, triciklični antidepresivi, nekateri peroralni makrolidi (kot eritromicin), terfenadin in antiaritmiki iz I. in III. skupine (glejte poglavje 4.3).
English: What MULTAQ contains
Slovenian: Kaj vsebuje zdravilo MULTAQ
English: • some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
Slovenian: • nekaterih zdravil za glivične okužbe, npr. ketokonazola, vorikonozola, itrakonazola ali pozakonazola,
English: In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion, - if you have instability (drops) in your blood pressure which can lead to inadequate arterial blood flow to your organs,
Slovenian: Pri permanentni (trajni) AF je AF prisotna že dolgo (vsaj 6 mesecev) in odločeno je bilo, da vašega srčnega ritma ne bodo znova vračali v normalen preddvorni ritem z zdravljenjem, ki ga imenujemo kardioverzija.
English: MULTAQ 400 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MULTAQ 400 mg
English: Dronedarone was not shown to alter fertility in animal studies.
Slovenian: V študijah na živalih dronedaron ni vplival na plodnost.
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical assistance
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikommorda boste potrebovali nujno zdravniško pomoč Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: How to take MULTAQ
Slovenian: Kako jemati zdravilo MULTAQ
English: Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists
Slovenian: Medsebojno delovanje z varfarinom in losartanom (substratoma CYP 2C9)
English: Fatigue Asthenia
Slovenian: Žilne bolezni
English: No interaction was observed between dronedarone and losartan and an interaction between dronedarone and other AIIRAs is not expected.
Slovenian: Losartan in drugi antagonisti receptorjev angiotenzina II (Angiotensin II Receptor Antagonists AIIRA) Medsebojnih delovanj med dronedaronom in losartanom niso opazili in medsebojnih delovanj med dronedaronom in drugimi antagonisti receptorjev angiotenzina II ni pričakovati.
English: • Co-administration with dabigatran
Slovenian: • Sočasno jemanje z dabigatranom.
English: Do not take MULTAQ:
Slovenian: Hkrati z zdravilom MULTAQ ne smete jemati:
English: Take:
Slovenian: Lot:
English: What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side.
Slovenian: Tablete MULTAQ so bele, ovalne filmsko obložene tablete z oznako dvojnega vala na eni strani in kodo "4142" na drugi strani.
English: If ALT levels are confirmed to be ≥3 × ULN, treatment with dronedarone should be withdrawn.
Slovenian: Če je raven ALT potrjeno ≥ 3 × ZMN, je treba zdravljenje z dronedaronom končati.
English: Tell your doctor, he/she will check your lung.
Slovenian: To morate povedati zdravniku, ki bo preveril vaša pljuča.
English: However, clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone were reported in patients taking oral anticoagulants.
Slovenian: Pri bolnikih, ki jemljejo oralne antikoagulante so poročali o klinično signifikantnem zvišanju internacionalnega normaliziranega razmerja (INR) (≥5), običajno v 1 tednu po začetku jemanja dronedarona.
English: If AF reoccurs, discontinuation of dronedarone should be considered.
Slovenian: Če se AF znova pojavi, je treba razmisliti o prenehanju uporabe dronedarona.
English: Their co-administration is contraindicated (see section 4.3).
Slovenian: Sočasno jemanje omenjenih zdravil je kontraindicirano (glejte poglavje 4.3).
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets
Slovenian: IME ZDRAVILA MULTAQ 400 mg filmsko obložene tablete
English: If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued.
Slovenian: Če se pojavi sistolična disfunkcija levega prekata, je treba zdravljenje z dronedaronom ukiniti.
English: If heart failure develops, treatment with dronedarone should be discontinued.
Slovenian: Če se pojavi srčno popuščanje, je treba zdravljenje z dronedaronom ukiniti.
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone
Slovenian: IME ZDRAVILA MULTAQ 400 mg tablete dronedaron
English: Screen patients before treatment initiation Contra indication of Permanent Atrial fibrillation Contra indication of history, or current heart failure or left ventricular systolic dysfunction (LVSD)
Slovenian: Kontraindikacija v primeru stalne atrijske fibrilacije Kontraindikacija v primeru srčnega popuščanja v anamnezi ali trenutnega srčnega popuščanja ali sistolične disfunkcije levega prekata (LVSD) Preprečevanje medsebojnega delovanja zdravil
English: • St John's Wort - a herbal medicine for depression,
Slovenian: • šentjanževko - zeliščno zdravilo proti depresiji,
English: Potent CYP3A4 inducers
Slovenian: Močni induktorji CYP3A4
English: Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold).
Slovenian: Dronedaron (400 mg dvakrat na dan) poveča tudi izpostavljenost kalcijevim antagonistom (izpostavljenost verapamilu za 1,4-krat in nisoldipinu za 1,5-krat).
English: • you have breathlessness or non-productive cough.
Slovenian: - če imate kratko sapo ali kašelj brez izmečka (neproduktiven kašelj).
English: Overall, due to the pharmacokinetic interaction and possible pharmacodynamic interaction, calcium antagonists with depressant effects on sinus and atrio-ventricular node such as verapamil and diltiazem should be used with caution when associated with dronedarone.
Slovenian: Na splošno je treba kalcijeve antagoniste z depresorskim delovanjem na sinusni in atrioventrikularni vozel (npr. verapamil in diltiazem) zaradi farmakokinetičnih in možnih farmakodinamičnih medsebojnih delovanj uporabljati previdno, kadar so uporabljeni obenem z dronedaronom.
English: • Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.
Slovenian: - neprozorni pretisni omoti za enkratni odmerek iz PVC/aluminija v pakiranju po 100 x 1 filmsko obložena tableta.
English: Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone.
Slovenian: V primeru sočasne uporabe z dronedaronom je priporočljivo kontrolirati njuno koncentracijo v plazmi in ustrezno prilagoditi odmerek.
English: Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro tests.
Slovenian: Na podlagi mikrojedrnega testa in vivo pri miših ter štirih testov in vitro dronedaron nima genotoksičnih učinkov.
English: Also contains: lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi: laktozo.
English: No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.
Slovenian: Pri zdravih preiskovankah, ki so dobivale dronedaron (800 mg dvakrat na dan) sočasno s peroralnimi kontraceptivi, niso opazili znižanja etinilestradiola in levonorgestrela.
English: Since antiarrhythmic medicinal products may be ineffective or may be arrhythmogenic in patients with hypokalaemia, any potassium or magnesium deficiency should be corrected before initiation and during dronedarone therapy.
Slovenian: Antiaritmična zdravila so lahko pri bolnikih s hipokaliemijo neučinkovita ali celo aritmogena.
English: • you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase (which are signs and symptoms of heart failure),
Slovenian: Zdravilo MULTAQ morate prenehati jemati, - če imate otekla stopala ali noge, težko dihanje v leže ali med spanjem, kratko sapo med gibanjem ali povečanje telesne mase (to so znaki in simptomi srčnega popuščanja).
English: In patients already on calcium antagonists at time of dronedarone initiation, an ECG should be performed and the calcium antagonist dose should be adjusted if needed (see section 4.4).
Slovenian: Bolnikom, ki v času uvedbe dronedarona že dobivajo kalcijeve antagoniste, je treba posneti EKG in jim odmerek kalcijevega antagonista prilagoditi, če je treba (glejte poglavje 4.4).
English: Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively.
Slovenian: Dronedaron (dvakrat na dan) je povečal izpostavljenost simvastatinu za 4-krat in simvastatinski kislini za 2-krat.
English: Contact immediately your doctor or the nearest emergency department or hospital.
Slovenian: Če ste vzeli večji odmerek zdravila MULTAQ, kot bi smeli Takoj se posvetujte s svojim zdravnikom, najbližjo ambulanto za nujno medicinsko pomoč ali bolnišnico.
English: No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2).
Slovenian: Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavje
English: EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets
Slovenian: EU/1/09/591/004 100 x 1 filmsko obložena tableta
English: MULTAQ does not usually affect your ability to drive or use machine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo MULTAQ navadno ne vpliva na sposobnost upravljanja vozil in strojev.
English: • skin problems such as rash or itching,
Slovenian: • težave s kožo, npr. izpuščaj ali srbenje,
English: The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution.
Slovenian: Zaviralci adrenergičnih receptorjev beta in kalcijevi antagonisti Previdnost je potrebna v primeru sočasne uporabe zaviralcev adrenergičnih receptorjev beta ali kalcijevih antagonistov z zaviralnim delovanjem na sinusni in atrioventrikularni vozel.
English: Interaction with medicinal products metabolized by CYP 3A4 Dabigatran
Slovenian: Medsebojna delovanja z zdravili, ki se presnovijo s CYP 3A4
English: Other moderate inhibitors of CYP3A4 are also likely to increase dronedarone exposure.
Slovenian: Drugi zmerni/šibki zaviralci CYP 3A4 Verjetnost večje izpostavljenosti dronedaronu obstaja tudi pri drugih zmernih zaviralcih CYP 3A4.
English: Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure.
Slovenian: Medsebojno delovanje s teofilinom (substratom CYP 1A2) Dronedaron 400 mg dvakrat na dan ne poveča izpostavljenosti teofilinu v stanju dinamičnega ravnovesja.
English: Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting.
Slovenian: V obdobju trženja je bila pri bolnikih, ki so prejemali dronedaron, opisana hepatocelularna poškodba jeter, vključno s smrtno nevarno akutno odpovedjo jeter.
English: The incidence of the main safety endpoint defined as the occurrence of thyroid, hepatic, pulmonary, neurological, skin, eye or gastrointestinal specific events or premature study drug discontinuation following any adverse event was reduced by 20% in the dronedarone group compared to the amiodarone group (p = 0.129).
Slovenian: Glavna končna točka varnosti je bila opredeljena kot pojav specifičnih učinkov na ščitnici, jetrih, pljučih, živčevju, koži, očeh ali prebavilih ali predčasno prenehanje uporabe raziskovanega zdravila po neželenem učinku.
English: An increase in plasma creatinine (mean increase 10 μmol/L) has been observed with dronedarone 400 mg twice daily in healthy subjects and in patients.
Slovenian: Pri zdravih preiskovancih in pri bolnikih so med uporabo 400 mg dronedarona dvakrat na dan opazili porast kreatinina v plazmi (povprečen porast 10 µmol/l).
English: CYP 3A4 inducers
Slovenian: Induktorji CYP 3A4
English: The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Slovenian: Multicentrična, mednarodna, dvojno slepa, randomizirana, s placebom kontrolirana študija ATHENA je dokazala učinkovitost dronedarona za zmanjšanje tveganja hospitalizaciji, povezanih z AF, pri bolnikih z AF ali anamnezo AF in dodatnimi dejavniki tveganja.
English: International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Slovenian: Po uvedbi dronedarona je treba bolnikom, ki prejemajo antagoniste vitamina K, natančno kontrolirati INR (internacionalno normalizirano razmerje), v skladu z navodili za posamezen antagonist.
English: Talk to your doctor or pharmacist before taking MULTAQ if
Slovenian: • Če dojite, se posvetujte z zdravnikom, preden vzamete zdravilo MULTAQ.
English: • you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).
Slovenian: - če ste starejši od 75 let, - če imate bolezen, pri kateri žile, ki dovajajo kri v srčno mišico, otrdijo in se zožijo (bolezen koronarnih arterij).
English: In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the dose of beta-blocker should be adjusted if needed (see section 4.4).
Slovenian: Bolnikom, ki v času uvedbe dronedarona že dobivajo zaviralce beta, je treba posneti EKG in jim odmerek zaviralca beta prilagoditi, če je potrebno (glejte poglavje 4.4).
English: Heart Failure (including use in patients with unstable hemodynamic conditions with history of, or current heart failure or left ventricular systolic dysfunction, and pre-renal azotemia) Use in Permanent atrial fibrillation defined as an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician Pulmonary-interstitial lung disease (ILD)
Slovenian: Uporaba pri stalni atrijski fibrilaciji (opredeljeni kot AF, ki traja ≥ 6 mesecev, ali njeno trajanje ni znano), pri kateri zdravnik ne predvideva več poskusov za obnovitev sinusnega ritma Pljučna - intersticijska bolezen pljuč (IBP)
English: Titanium dioxide (E171) Carnauba wax (E903)
Slovenian: Obloga tablete hipromeloza (E464) makrogol 6000 titanov dioksid (E171) karnauba vosek (E903)
English: If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds), - if you have a type of atrial fibrillation called permanent atrial fibrillation (AF).
Slovenian: - če vaš EKG (elektrokardiogram) pokaže srčno motnjo, ki jo imenujemo "podaljšan korigirani interval QT" (interval, daljši od 500 milisekund).
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience.
Slovenian: Med obdobjem trženja so bili opisani primeri intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo.
English: Patients with history of, or current heart failure or left ventricular systolic dysfunction
Slovenian: Bolniki s srčnim popuščanjem ali sistolično disfunkcijo levega prekata trenutno ali v anamnezi
English: Beta-blockers that are metabolised by CYP 2D6 can have their exposure increased by dronedarone.
Slovenian: Dronedaron lahko poveča izpostavljenost zaviralcem beta, ki se presnavljajo s CYP 2D6.
English: • History of, or current heart failure or left ventricular systolic dysfunction
Slovenian: • Srčno popuščanje ali sistolična disfunkcija levega prekata trenutno ali v anamnezi.
English: This will give you more details on exactly what medicines you cannot take with MULTAQ), - if you have a severe liver problem, - if you have a severe kidney problem, - if you take dabigatran (see section below on “Other medicines and MULTAQ”).
Slovenian: Tam boste našli več podrobnosti o tem, katerih zdravil ne smete jemati hkrati z zdravilom MULTAQ).
English: In EURIDIS and ADONIS, a total of 1,237 patients with a prior episode of AF or AFL were randomised in an outpatient setting and treated with either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) on top of conventional therapies (including oral anticoagulants, beta-blockers, ACE inhibitors or AIIRAs, chronic antiplatelet agents, diuretics, statins, digitalis, and calcium antagonists).
Slovenian: Bolniki so dobivali bodisi dronedaron 400 mg dvakrat na dan (n = 828) ali placebo (n = 409) poleg konvencionalnih zdravil (vključno s peroralnimi antikoagulansi, zaviralci beta,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg dronedarone (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 400 mg dronedarona (v obliki klorida).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: Datum zadnjega podaljšanja:
English: MULTAQ contains lactose
Slovenian: Zdravilo MULTAQ vsebuje laktozo
English: Diarrhoea Vomiting Nausea
Slovenian: Bolezni živčevja dizgevzija agevzija
English: Prevention of drug-drug interaction
Slovenian: Medsebojno delovanje zdravil
English: tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I
Slovenian: • Zdravila, ki inducirajo torsades de pointes, npr. fenotiazini, cisaprid, bepridil, triciklični antidepresivi, terfenadin in nekateri peroralni makrolidi (kot eritromicin), antiaritmiki iz I. in III. skupine (glejte poglavje 4.5).
English: - if you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6), - if you have a problem with the nerves in your heart (heart block).
Slovenian: Ne uporabljajte zdravila MULTAQ - če ste alergični na dronedaron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Potent CYP 3A4 inhibitors
Slovenian: Močni zaviralci CYP 3A4
English: PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets
Slovenian: 20 filmsko obloženih tablet
English: Drug interaction
Slovenian: Zaviralci beta
English: Other moderate/weak CYP 3A4 Inhibitors
Slovenian: Zmerni/šibki zaviralci CYP 3A4:
English: Rare (1/10,000 to disorders test abnormalities liver injury, including life-threatening acute liver failure (see section 4.4)
Slovenian: Redki ( 1/10.000 do odpovedjo jeter (glejte poglavje
English: How to store MULTAQ
Slovenian: Shranjevanja zdravila MULTAQ
English: sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Slovenian: • Atrioventrikularni blok druge ali tretje stopnje, popolni kračni blok, distalni blok, disfunkcija sinusnega vozla, atrijske prevodne motnje, ali bolezen sinusnega vozla (razen če ima bolnik delujoč srčni spodbujevalnik).
English: MULTAQ.
Slovenian: Pogosti
English: • Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking
Slovenian: • Če med jemanjem zdravila MULTAQ zanosite, nehajte jemati tablete in se takoj posvetujte z zdravnikom.
English: • Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo.
Slovenian: V kliničnih študijah so ta neželeni učinek opažali podobno pogosto med bolniki, ki so dobivali zdravilo MULTAQ, in med bolniki, ki so dobivali placebo.
English: • Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole,
Slovenian: • Sočasna uporaba z močnimi zaviralci citokroma P 450 (CYP) 3A4, npr. ketokonazolom, itrakonazolom, vorikonazolom, pozakonazolom, telitromicinom, klaritromicinom, nefazodonom ali ritonavirjem (glejte poglavje 4.5).
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost astenija
English: • one tablet with the evening meal.
Slovenian: Vzeti ga je treba kot eno tableto z jutranjim obrokom in eno tableto z večernim obrokom.
English: You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around, - if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction), - if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems, - if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”.
Slovenian: - če jemljete zdravila za okužbe (vključno z glivičnimi okužbami ali aidsom), alergije, težave z bitjem srca, depresijo ali po presaditvi (glejte spodaj, poglavje "Druga zdravila in zdravilo MULTAQ ".
English: • Severe hepatic impairment
Slovenian: • Huda okvara jeter.
English: • you have a problem that gives you a low level of potassium or magnesium in your blood.
Slovenian: Pred začetkom jemanja zdravila MULTAQ se posvetujte z zdravnikom ali s farmacevtom - če imate kakšno težavo, zaradi katere imate v krvi majhno koncentracijo kalija ali magnezija.
English: The European Commission issued a decision on 16 December 2011.
Slovenian: Evropska komisija je odločbo izdala dne 16. decembra 2011.
English: What is the background to the current investigation?
Slovenian: Kakšno je ozadje sedanje preiskave?