FrancophonIA/ELRC3.0 huggingface dataset:
English: The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history) This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history respectively; and 3.8% versus 1.4% with clopidogrel.
Slovenian: Porast ventrikularnih pavz v akutni fazi ACS je bil izrazitejši pri bolnikih, ki so dobivali tikagrelor in so imeli anamnezo kongestivnega srčnega popuščanja (9,2 % v primerjavi s 5,4 % med bolniki brez takšne anamneze; pri bolnikih, ki so dobivali klopidogrel, 4,0 % pri tistih z anamnezo kongestivnega srčnega popuščanja in 3,6 % pri tistih brez takšne anamneze.
English: On a background of daily ASA, ticagrelor 90 mg twice daily showed superiority to 75 mg daily clopidogrel in preventing the composite endpoint of cardiovascular [CV] death, myocardial infarction [MI], or stroke, with the difference driven by CV death and MI.
Slovenian: Ob vsakodnevnem jemanju ASA je bil tikagrelor v odmerku 90 mg dvakrat na dan superioren od 75 mg klopidogrela na dan pri preprečevanju sestavljenega opazovanega dogodka (kardiovaskularna [KV] smrt, miokardni infarkt [MI] ali možganska kap), pri čemer sta bila glavna dejavnika razlike KV smrt in MI. Bolniki so dobili 300-mg polnilni odmerek klopidogrela (600-mg odmerek je bil možen v primeru PCI) ali 180 mg tikagrelorja.
English: Possia 90 mg tablets ticagrelor
Slovenian: IME ZDRAVILA Possia 90 mg tablete tikagrelor
English: No data are available on concomitant use of Possia with potent P-glycoprotein (P-gp) inhibitors (e.g. verapamil, quinidine, cyclosporin) that may increase ticagrelor exposure.
Slovenian: Podatkov o sočasni uporabi zdravila Possia z močnimi zaviralci P-glikoproteina (P-gp) (npr. z verapamilom, kinidinom, ciklosporinom), ki lahko povečajo izpostavljenost tikagrelorju, ni.
English: The safety of Possia in patients with acute coronary syndromes (UA, NSTEMI and STEMI) was evaluated in the pivotal large phase 3 PLATO ([PLATelet Inhibition and Patient Outcomes] study, 18,624 patients), which compared patients treated with Possia (loading dose of 180 mg of Possia and a maintenance dose of 90 mg twice daily) to patients treated with clopidogrel (300-600 mg loading dose followed by 75 mg once daily maintenance dose) both given in combination with acetylsalicylic acid (ASA) and other standard therapies.
Slovenian: Primerjala je bolnike, zdravljene z zdravilom Possia (polnilni odmerek 180 mg in vzdrževalni odmerek 90 mg dvakrat na dan), in bolnike, zdravljene s klopidogrelom (polnilni odmerek od 300 do 600 mg in potem vzdrževalni odmerek 75 mg enkrat na dan).
English: As a precautionary measure, the use of ticagrelor in patients with uric acid nephropathy is discouraged.
Slovenian: Iz previdnosti zato tikagrelorja ni priporočljivo uporabljati pri bolnikih z urično nefropatijo.
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Higher exposures to ticagrelor and the active metabolite were observed in women compared to men.
Slovenian: Pri ženskah so v primerjavi z moškimi ugotovili večjo izpostavljenost tikagrelorju in njegovemu aktivnemu presnovku.
English: However no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g., 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil, and 4% digoxin) (see section 4.5).
Slovenian: Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % zaviralci adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov (glejte poglavje 4.5).
English: This can be
Slovenian: Ελλάδα
English: Of these AEs 0.05% for ticagrelor vs. 0.02% for clopidogrel were considered causally related by investigators.
Slovenian: Od teh neželenih učinkov so raziskovalci kot vzročno povezane ocenili 0,05 % pri tikagrelorju in 0,02 % pri klopidogrelu.
English: No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are
Slovenian: Med sočasno uporabo levonorgestrela in etinilestradiola z zdravilom Possia ni pričakovati klinično pomembnega vpliva na učinkovitost peroralnih kontraceptivov.
English: However no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g., 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil, and 4% digoxin).
Slovenian: Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % zaviralci adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov.
English: Table 2 -Kaplan-Meier estimate of bleeding rates by treatment
Slovenian: Kaplan-Meierjeva ocena deleža krvavitev glede na zdravilo Possia (%/leto) n = 9235
English: - This medicine has been prescribed for you only.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Confusion b,
Slovenian: Preglednica 2.
English: Caution should be exercised when administering ticagrelor to patients with history of hyperuricaemia or gouty arthritis.
Slovenian: Pri bolnikih z anamnezo hiperurikemije ali uričnega artritisa je treba tikagrelor uporabljati previdno.
English: • non-steroidal anti-inflammatory drugs (abbreviated as NSAIDs) often taken as pain killers such as ibuprofen and naproxen.
Slovenian: • nesteroidna protivnetna zdravila (s kratico: NSAID), ki se pogosto uporabljajo proti bolečinam,
English: • Diarrhoea or indigestion
Slovenian: • slabost v želodcu ali bruhanje
English: See a doctor straight away if you notice any of the following - you may need urgent medical
Slovenian: Če opazite kaj od naslednjega, nemudoma pojdite do zdravnika.
English: Possia contains ticagrelor a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is a selective adenosine diphosphate (ADP) receptor antagonist acting on the P2Y12
Slovenian: Zdravilo Possia vsebuje tikagrelor, učinkovino iz kemične skupine ciklopentiltriazolopirimidinov (CPTP).
English: Ticagrelor is a mild CYP3A4 inhibitor.
Slovenian: Tikagrelor blago zavira CYP3A4.
English: Paraesthesia
Slovenian: Dispneja
English: Wound haemorrhage, Traumatic haemorrhage
Slovenian: Ušesne bolezni, vključno z motnjami labirinta ušesna krvavitev, vrtoglavica
English: The superiority of ticagrelor over clopidogrel in reducing major CV events was not significantly affected by patient CYP2C19 or ABCB1 genotype.
Slovenian: Genotip CYP2C19 ali ABCB1 ni bistveno vplival na superiornost tikagrelorja v primerjavi s klopidogrelom za zmanjšanje hudih KV dogodkov.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Hyperuricaemia, Blood uric acid increased
Slovenian: Bolezni prebavil gastrointestinalna krvavitevd hematemeza,
English: Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study.
Slovenian: Bolniki tikagrelor dobro prenašajo v enkratnih odmerkih do 900 mg.
English: Biotransformation
Slovenian: FARMACEVTSKA OBLIKA
English: Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast
Slovenian: Če ste noseči ali dojite, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: Ticagrelor has not been studied in patients with moderate or severe hepatic impairment and its use in these patients is contraindicated
Slovenian: Tikagrelor ni raziskan pri bolnikih z zmerno ali hudo okvaro jeter in njegova uporaba pri teh bolnikih je kontraindicirana (glejte poglavji 4.3 in 4.4).
English: ARR
Slovenian: Dojenje
English: Cerebral haemorrhage, Haemorrhage intracranial, Haemorrhagic stroke, Dyspnoea, Dyspnoea exertional, Dyspnoea at rest, Nocturnal dyspnoea Gastrointestinal haemorrhage, Rectal haemorrhage, Intestinal haemorrhage, Melaena, Occult blood Gastrointestinal ulcer haemorrhage, Gastric ulcer haemorrhage, Duodenal ulcer haemorrhage, Peptic ulcer
Slovenian: a hiperurikemija, zvišanje sečne kisline v krvi b možganska krvavitev, intrakranialna krvavitev, hemoragična možganska kap c dispneja, dispneja med naporom, dispneja v mirovanju, nočna dispneja d gastrointestinalna krvavitev, krvavitev iz danke, intestinalna krvavitev, melena, okultna kri e gastrointestinalna razjeda/krvavitev, želodčna razjeda/krvavitev, razjeda/krvavitev na dvanajstniku, peptična razjeda/krvavitev f podkožni hematom, kožna krvavitev, subkutana krvavitev, petehije g kontuzija, hematom, ekhimoze, večja nagnjenost h krvavitvam, travmatski hematom h hematurija, kri v urinu, krvavitev v sečila i krvavitev na mestu punktiranja žile, hematom na mestu punkcije žile, krvavitev na mestu injiciranja, krvavitev na mestu punktiranja, krvavitev na mestu katetra V kraku študije PLATO s tikagrelorjem (n = 9235) niso zabeležili neželenih učinkov s hemartrozo; pogostnost je bila izračunana z uporabo zgornje meje 95 % intervala zaupanja za točkovno oceno (na podlagi 3/X, pri čemer X predstavlja velikost celotnega vzorca, npr. 9235).
English: Hyperuricaemia a
Slovenian: Induktorji CYP3A
English: What Possia is and what it is used for
Slovenian: Kaj je zdravilo Possia in za kaj ga uporabljamo
English: Table 1 - Adverse reactions by frequency and System Organ Class (SOC)
Slovenian: Neželeni učinki po pogostnosti in organskih sistemih
English: Possia 90 mg film coated tablets
Slovenian: IME ZDRAVILA Possia 90 mg filmsko obložene tablete
English: Musculoskeletal and connective tissue disorders
Slovenian: Organski sistem Presnovne in prehranske motnje hiperurikemijaa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: Tell your doctor or pharmacist if you are taking any of the following medicines: • more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high
Slovenian: • več kot 40 mg simvastatina ali lovastatina na dan (zdravili za zdravljenje visokega holesterola)
English: Offset of Action
Slovenian: Mehanizem delovanja
English: Medicinal products known to induce bradycardia
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM AstraZeneca AB
English: Subcutaneous haematoma, Skin haemorrhage, Haemorrhage subcutaneous, Petechiae Contusion, Haematoma, Ecchymosis, Increased tendency to bruise, Traumatic haematoma Haematuria, Blood urine present, Haemorrhage urinary tract Vessel puncture site haemorrhage, Vessel puncture site haematoma, Injection site haemorrhage, Puncture site haemorrhage, Catheter site haemorrhage
Slovenian: Bolezni kože in podkožja podkožne ali kožne krvavitvef, podpludbe g izpuščaj, srbenje Bolezni mišično-skeletnega sistema in vezivnega tkiva hemartroza#
English: • Abdominal pain
Slovenian: • bolečine v trebuhu
English: Check with your doctor or pharmacist
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: - coughing up or bringing up blood (uncommon) - vaginal bleeding that is heavier, or happens at different times, to your normal period
Slovenian: Povečajo se lahko številne različne vrste krvavitev, na primer: - krvavitev iz nosu (pogosto) - kri v urinu (občasno) - črno blato ali kri v blatu (pogosto) - kri v očesu (občasno) - izkašljevanje ali izpljuvanje krvi (občasno) - krvavitev iz nožnice, ki je močnejša ali se pojavi ob drugem času kot normalna
English: CARTON OF 90 mg FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 90-mg FILMSKO OBLOŽENIMI TABLETAMI
English: Possia (%/year) N=9235
Slovenian: Klopidogrel bolnikov z dogodkom) n = 9291
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Possia in vsebina pakiranja
English: This will help to protect the environment.
Slovenian: Takšni ukrepi pomagajo varovati okolje.
English: Risk Management Plan
Slovenian: Načrt upravljanja tveganja
English: In addition, an updated RMP should be submitted:
Slovenian: Razen tega je dopolnjen RMP treba predložiti:
English: The potential risk for humans is unknown.
Slovenian: Kakšno je potencialno tveganje za človeka, ni znano.
English: • OTHER CONDITIONS
Slovenian: • DRUGI POGOJI
English: Diagnosis:
Slovenian: Diagnoza:
English: • loss of appetite
Slovenian: • izguba apetita.
English: • allergic reactions
Slovenian: • alergijske reakcije.
English: See ‘Conditions you need to look out for' in Section 4.
Slovenian: Glejte ‘Stanja na katere morate biti pozorni' v poglavju 4.
English: Just take your next dose at the usual time.
Slovenian: Vzemite le naslednji predvideni odmerek ob običajnem času.
English: Avoid consumption of alcohol and medicinal products containing alcohol.
Slovenian: Uživanju alkohola in zdravilom, ki vsebujejo alkohol, se je potrebno izogibati.
English: This food-effect is not considered clinically significant.
Slovenian: Takšen vpliv hrane se ne šteje za klinično pomembnega.
English: At the request of the EMEA.
Slovenian: • na zahtevo Evropske agencije za zdravila (EMEA).
English: After about 8 weeks your doctor may need to increase your dose.
Slovenian: Po približno 8 tednih zdravljenja bo zdravnik morda moral odmerek povečati.
English: These small changes are not clinically significant and, therefore, it is not necessary to administer rosiglitazone at any particular time in relation to meals.
Slovenian: Te majhne spremembe niso klinično pomembne in potemtakem ni potrebno jemati rosiglitazona v posebej določenem času glede na obroke.
English: In very rare cases, a fatal outcome has been reported.
Slovenian: zelo redkih primerih so poročali tudi o smrtnih izidih.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: 56 tablets.
Slovenian: 56 tablet
English: Very rare hepatitis
Slovenian: Zelo redki hepatitis
English: The mean duration of diabetes in these patients was approximately 7 years.
Slovenian: Sladkorna bolezen je pri teh bolnikih v povprečju trajala približno 7 let.
English: Conditions you need to look out for
Slovenian: Stanja na katera morate biti pozorni
English: The total daily dose of AVANDAMET should be given in two divided doses.
Slovenian: Celokupni dnevni odmerek zdravila AVANDAMET je treba dati v dveh ločenih odmerkih.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.ema.europa.eu/.
English: • if you have severe breathing difficulties
Slovenian: • če imate hude težave z dihanjem.
English: • getting tired easily after light physical activity such as walking
Slovenian: • hitro utrujenost po lahki telesni aktivnosti, kot je hoja.
English: • collapse.
Slovenian: • kolaps.
English: − When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.
Slovenian: • če se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali dejavnosti za zmanjševanje tveganja.
English: Signs include:
Slovenian: Znaki vključujejo:
English: Food decreases the extent and slightly delays the absorption of metformin.
Slovenian: Hrana zmanjša obseg in rahlo zakasni absorpcijo metformina.
English: This is more likely if you are also taking other medicines for your diabetes (like insulin), if you have kidney problems, or if you are over 65.
Slovenian: Verjetnost za to je večja, če že jemljete druga zdravila za zdravljenje sladkorne bolezni (kot je insulin), če imate težave z ledvicami ali če ste starejši od 65 let.
English: Similar effects have been seen with other thiazolidinediones.
Slovenian: O podobnih učinkih poročajo tudi pri drugih tiazolidindionih.
English: • swollen ankles or feet.
Slovenian: • oteklino gležnjev ali nog.
English: The ingredients may pass into breast milk and so may harm your baby.
Slovenian: Sestavine zdravila lahko prehajajo v materino mleko in tako škodijo dojenemu otroku.
English: It is not known whether breast-feeding will lead to exposure of the infant to the medicinal product.
Slovenian: Ni znano, če ima dojenje za posledico izpostavljenost dojenčka zdravilu.
English: Combination requiring precautions for use
Slovenian: Kombinacije, ki zahtevajo previdnost pri uporabi
English: WHAT AVANDAMET IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO AVANDAMET IN ZA KAJ GA UPORABLJAMO
English: Certain medicines are especially likely to affect the amount of sugar in your blood:
Slovenian: Nekatera zdravila lahko še posebej vplivajo na vrednost krvnega sladkorja:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: • if you are very dehydrated or have a severe infection (see ‘While you take
Slovenian: • če ste zelo dehidrirani ali imate hudo okužbo (glejte ‘Med jemanjem zdravila
English: AVANDAMET is not recommended for use in children and adolescents below 18 years of age as there are no data available on its safety and efficacy in this age group (see sections 5.1 and 5.2).
Slovenian: Uporaba zdravila AVANDAMET pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva, saj podatki o njegovi varnosti in učinkovitosti v tej starostni skupini niso na voljo (glejte poglavji 5.1 in 5.2).
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami CHMP o sistemih za upravljanje tveganja za zdravila za uporabo v humani medicini je treba dopolnjen RMP predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
English: The chances of this happening may be higher in people, particularly women, taking rosiglitazone for more than one year.
Slovenian: Verjetnost, da se to zgodi, je lahko večja pri tistih osebah, zlasti ženskah, ki jemljejo zdravilo Avandamet več kot eno leto.
English: Randomised Treatment†
Slovenian: Randomizirano zdravljenje†
English: Plasma protein binding is negligible.
Slovenian: Vezava na plazemske proteine je zanemarljiva.
English: If you stop taking Avandamet, your blood sugar will not be controlled, and you may become unwell.
Slovenian: Če prenehate jemati zdravilo Avandamet, krvni sladkor ne bo več nadzorovan, vaše zdravstveno stanje pa se lahko poslabša.
English: In the event of an overdose, it is recommended that appropriate supportive treatment is initiated as dictated by the patient's clinical status.
Slovenian: V primeru prevelikega odmerjanja je priporočeno uvesti ustrezno podporno zdravljenje, kot ga pač zahteva klinično stanje bolnika.
English: • rifampicin (used to treat tuberculosis and other infections)
Slovenian: • rifampicin (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb).
English: These two medicines are used to treat type 2 diabetes.
Slovenian: Ti dve zdravilni učinkovini uporabljamo za zdravljenje sladkorne bolezni tipa 2.
English: 1995.5 (682.6) mg *Similar relative effective doses (i.e approximately half maximal dose) for other sulphonylureas (glibenclamide and glicazide).
Slovenian: 1995,5 (682,6) mg *Podobni relativno učinkoviti odmerki (tj. približno pol največjega odmerka) za druge sulfonilsečnine (glibenklamid in gliklazid).
English: AVANDAMET has no or negligible influence on the ability to drive and use machines.
Slovenian: AVANDAMET nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: These can lead to severe loss of water (dehydration).
Slovenian: V teh primerih lahko pride do močnejše izgube vode iz telesa (dehidracija).
English: No metabolites have been identified in humans.
Slovenian: Metabolitov pri ljudeh niso ugotovili.
English: For the different dosage regimens, AVANDAMET is available in appropriate strengths.
Slovenian: Za različne režime odmerjanja je AVANDAMET na voljo v primernih jakostih.
English: The most common are breaks in feet, hands and arms.
Slovenian: Najpogostejši so zlomi nog in rok.
English: Overall, these increases were generally mild to moderate and usually did not require discontinuation of treatment.
Slovenian: Povišanja so bila, gledano v celoti, blaga do zmerna in zaradi njih običajno zdravljenja ni bilo treba prekiniti.
English: If you have been diagnosed with angina (chest pain), or peripheral arterial disease (reduced blood flow to the legs):
Slovenian: Če so vam ugotovili angino pektoris (bolečina v prsih) ali bolezen perifernih arterij (zmanjšan pretok krvi v noge):
English: Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit yearly PSURs until otherwise decided by the CHMP.
Slovenian: Po podaljšanju dovoljenja za promet, bo imetnik dovoljenja za promet letno predložil PSUR dokler CHMP ne določi drugače.
English: 1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone
Slovenian: 1 O hiperholesterolemiji so poročali pri do 5,3 % bolnikov, ki so se zdravili z rosiglitazonom
English: This check may be repeated at intervals.
Slovenian: Takšne preiskave lahko ponavlja v rednih časovnih presledkih.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Slovenian: Glavna pot izločanja je z urinom, s katerim se izločita približno dve tretjini zaužitega odmerka, medtem ko izločanje s fecesem predstavlja približno 25 % zaužitega odmerka.
English: The adjudicated primary endpoint was cardiovascular hospitalisation (which included hospitalisations for heart failure) or cardiovascular death.
Slovenian: Vnaprej določena primarna končna točka je bila kardiovaskularna hospitalizacija (ki je vključevala sprejem v bolnišnico zaradi srčnega popuščanja) ali kardiovaskularna smrt.
English: Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Slovenian: Pri bolnikih, starejših od 75 let, je zaradi pomanjkljivih izkušenj pri tej starostni skupini potrebna previdnost.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Slovenian: Metformin povečuje transportno zmožnost specifičnih tipov membranskih transporterjev za glukozo (GLUT-1 in GLUT-4).
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 <1/1000) and very rare (<1/10,000 including isolated reports).
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) in zelo redki (< 1/10.000 vključno s posameznimi primeri).
English: The rosiglitazone dose may need to be increased.
Slovenian: Odmerek rosiglitazona bo morda potrebno povečati.
English: • if you are going to have an operation under general anaesthetic.
Slovenian: • če imate predviden kirurški poseg v splošni anesteziji.