FrancophonIA/ELRC3.0 huggingface dataset:
English: Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
Slovenian: V primerjavi z odraslimi bolniki s sladkorno boleznijo tipa 2 pri otrocih pri zdravljenju z rosiglitazonom niso zaznali dodatnih težav z varnostjo.
English: AVANDAMET should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin), due to the effect on rosiglitazone pharmacokinetics (see section 4.5).
Slovenian: V primeru sočasnega dajanja zaviralcev CYP2C8 (npr. gemfibrozil) ali induktorjev CYP2C8 (npr. rifampicin) in zdravila AVANDAMET je slednjega, zaradi učinka na farmakokinetiko rosiglitazona, potrebno uporabljati previdno (glejte poglavje 4.5).
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija.
English: These may affect more than 1 in 10 people:
Slovenian: Pojavijo se lahko pri več kot 1 od 10 bolnikov:
English: Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Slovenian: Zdravljenje z rosiglitazonom je povezano z od odmerka odvisnim zmanjšanjem koncentracije hemoglobina.
English: These may affect up to 1 in 1,000 people:
Slovenian: Pojavijo se lahko pri do 1 od 1.000 bolnikov:
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Slovenian: V primeru oslabljene funkcijske sposobnosti ledvic se ledvični očistek zmanjša v sorazmerju s kreatininskim in tako se razpolovna doba izločanja podaljša, kar vodi v zvečanje vrednosti metformina v plazmi.
English: The doctor will check your kidney function before restarting treatment.
Slovenian: Pred nadaljevanjem zdravljenja bo zdravnik preveril delovanje ledvic.
English: Avandamet contains lactose
Slovenian: Zdravilo Avandamet vsebuje laktozo
English: Blood and the lymphatic system disorders Anaemia granulocytopaenia
Slovenian: Bolezni krvi in limfatičnega sistema anemija
English: After oral administration, metformin absorption is saturable and incomplete.
Slovenian: Po peroralnem odmerku je absorpcija metformina nepopolna in poteka do zasičenja.
English: Î Tell your doctor as soon as possible if you get these symptoms.
Slovenian: Î Čimprej obvestite svojega zdravnika, če se pojavijo ti simptomi.
English: The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride.
Slovenian: Običajni začetni odmerek zdravila AVANDAMET je 4 mg/dan rosiglitazona in 2000 mg/dan metforminijevega klorida.
English: Therapy with AVANDAMET should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Slovenian: Pri bolnikih z zvišanimi osnovnimi vrednostmi jetrnih encimov (ALT > 2,5-krat od zgornje meje normalne vrednosti) ali s katerimi koli drugimi znaki jetrnega obolenja se zdravljenje z zdravilom AVANDAMET ne sme uvesti.
English: An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Slovenian: Pri 197 otrocih (starih od 10 do 17 let) s sladkorno boleznijo tipa 2 je bilo izvedeno 24-tedensko z učinkovino nadzorovano klinično preskušanje (rosiglitazon do 8 mg na dan ali metformin do 2.000 mg na dan).
English: Gastrointestinal disorders gastrointestinal symptoms6
Slovenian: Bolezni prebavil prebavni simptomi6
English: The frequency of adverse reactions identified from clinical trial data with rosiglitazone Adverse reaction
Slovenian: Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj rosiglitazona
English: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
Slovenian: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS Velika Britanija
English: No statistically significant difference was observed between the absorption characteristics of rosiglitazone and metformin from the AVANDAMET tablet and those obtained from rosiglitazone maleate and metformin hydrochloride tablets, respectively.
Slovenian: AVANDAMET Absorpcija Značilnost absorpcije rosiglitazona in metformina v zdravilu AVANDAMET se statistično značilno ne razlikuje od posamičnih absorpcij rosiglitazonijevega maleata in metforminijevega klorida.
English: • lower blood sugar than normal (hypoglycaemia)
Slovenian: • prekomerno znižanje vrednosti krvnega sladkorja (hipoglikemija).
English: • rapid and excessive weight gain caused by fluid retention
Slovenian: • hitro in močno povečanje telesne mase zaradi kopičenja tekočine v telesu.
English: Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Slovenian: Bolezni imunskega sistema (glejte Bolezni kože in podkožja) anafilaktična reakcija
English: - hypersensitivity to rosiglitazone, to metformin hydrochloride or to any of the excipients - cardiac failure or history of cardiac failure (New York Heart Association (NYHA) stages I to IV) - an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure - recent myocardial infarction - shock - hepatic impairment - acute alcohol intoxication, alcoholism (see section 4.4) - diabetic ketoacidosis or diabetic pre-coma - renal failure or renal dysfunction e.g. serum creatinine levels > 135 µmol/l in males and > 110 µmol/l in females and/or creatinine clearance < 70 ml/min (see section 4.4) - acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - intravascular administration of iodinated contrast agents (see section 4.4) - lactation.
Slovenian: - oslabljenem delovanju jeter; - akutni zastrupitvi z alkoholom, alkoholizmu (glejte poglavje 4.4); - diabetični ketoacidozi ali diabetični komi; - ledvični odpovedi ali ledvični disfunkciji, npr. koncentracija kreatinina v serumu > 135 μmol/l pri moških ter serumska koncentracija kreatinina > 110 μmol/l pri ženskah in/ali očistek kreatinina < 70 ml/min (glejte poglavje 4.4); - akutnih stanjih, ki lahko spremenijo delovanje ledvic: - dehidracija - hude okužbe - šok - intravaskularna uporaba jodiranih kontrastnih sredstev (glejte poglavje 4.4);
English: These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
Slovenian: Pakiranje vsebuje 14, 28, 56, 2x56, 3x56 ali 180 filmsko obloženih tablet.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Slovenian: Analize teh rezultatov pri bolnikih s čezmerno telesno maso, ki so bili po neuspešnem zdravljenju samo z dieto zdravljeni z metforminom, kažejo: - značilno zmanjšanje absolutnega tveganja za katero koli s sladkorno boleznijo povezano komplikacijo v skupini bolnikov, ki so se zdravili z metforminom (29,8 primerov/1.000 bolnikov letno), v primerjavi s skupino bolnikov, ki je imela predpisano zgolj dieto (43,3 primerov/1.000 bolnikov letno), p = 0,0023 ter v primerjavi s skupino, ki se je kombinirano zdravila s sulfonilsečnino, in skupino, ki je imela monoterapijo z insulinom (40,1 primerov/1.000 bolnikov letno), p = 0,0034; - značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin - 7,5 primerov/1.000 bolnikov letno, samo dieta - 12,7 primerov/1.000 bolnikov
English: The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis,
Slovenian: Incidenco laktacidoze je možno in tudi potrebno zmanjševati z oceno drugih povezanih dejavnikov tveganja, kot so slabo nadzorovana sladkorna bolezen, ketoza, dolgotrajno stradanje, čezmerno uživanje alkohola, jetrna insuficienca in katera koli stanja, povezana s hipoksijo.
English: Cardiac disorders cardiac failure2
Slovenian: Srčne bolezni srčno popuščanje2
English: Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET.
Slovenian: Preden se bolnika preusmeri na zdravljenje z zdravilom AVANDAMET, se lahko najprej pretehta možnost uravnavanja odmerka rosiglitazona (dodajanje k optimalnemu odmerku metformina).
English: The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Slovenian: Pogostnost neželenih učinkov na osnovi podatkov po pridobitvi dovoljenja za promet rosiglitazona
English: Don't take Avandamet.
Slovenian: Ne jemljite zdravila Avandamet.
English: Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Slovenian: Rosiglitazon pri miših in podganah ni spodbujal izločanja insulina iz trebušne slinavke ali sprožil hipoglikemije.
English: • swelling (oedema) due to water retention
Slovenian: • oteklina (edem) zaradi zastajanja vode v telesu.
English: Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Slovenian: O edemih in srčnem popuščanju so pogosteje poročali tudi pri starostnikih in pri bolnikih z blago do zmerno odpovedjo ledvic.
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Slovenian: Bolezni jeter, žolčnika in žolčevodov disfunkcija jeter, ki se prvenstveno kaže s povišanjem vrednosti jetrnih encimov5
English: An increase in the rosiglitazone component to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see sections 4.4 and 4.8).
Slovenian: Pred tem je treba opraviti ustrezen klinični pregled in oceniti bolnikovo ogroženost za pojav neželenih učinkov, povezanih z zastajanjem tekočine (glejte poglavji 4.4 in 4.8).
English: Overall, 43%, 47% and 42% of subjects in the rosiglitazone, glibenclamide and metformin groups respectively withdrew due to reasons other than monotherapy failure.
Slovenian: Zaradi drugih razlogov, ne zaradi neuspeha monoterapije, se je v celoti umaknilo 43 % preiskovancev v skupini z rosiglitazonom, 47 % v skupini z glibenklamidom in 42 % v skupini z metforminom.
English: MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
Slovenian: SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 56 TABLET, PAKIRANIH V ŠKATLO)
English: Î Tell your doctor as soon as possible if you get any of these symptoms.
Slovenian: Î Čimprej obvestite svojega zdravnika, če se pojavi katerikoli od teh simptomov.
English: The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus sulphonylurea dual therapy.
Slovenian: V obsežni dvojno slepi študiji pri peroralnem zdravljenju s tremi zdravili je bila incidenca srčnega popuščanja 1,4 %, pri režimu zdravljenja z dvema zdraviloma (metformin in sulfonilsečnina) pa 0,4 %.
English: Hypromellose (E464) Titanium dioxide (E171) Macrogol
Slovenian: Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol rdeči železov oksid (E172)
English: Post-marketing data
Slovenian: Podatki po pridobitvi dovoljenja za promet
English: PSURs
Slovenian: PSUR-i
English: Î Contact a doctor immediately if you get any of these symptoms.
Slovenian: Î Nemudoma se posvetujte z zdravnikom, če se pojavi katerikoli od teh simptomov.
English: ADOPT (A Diabetes Outcome Progression Trial) was a multicentre, double-blind, controlled trial with a treatment duration of 4-6 years (median duration of 4 years), in which rosiglitazone at doses of 4 to 8 mg/day was compared to metformin (500 mg to 2000 mg/day) and glibenclamide (2.5 to 15 mg/day) in 4351 drug naive subjects recently diagnosed (≤3 years) with type 2 diabetes.
Slovenian: V tem preskušanju so rosiglitazon v odmerkih 4 do 8 mg/dan primerjali z metforminom (500 mg do 2000 mg/dan) in glibenklamidom (2,5 do 15 mg/dan) pri 4351 preiskovancih z nedavno odkrito ( ≤3 leta) sladkorno boleznijo tipa 2, ki pred tem še niso dobivali zdravil.
English: General disorders and administration site conditions Oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije edem
English: Metabolism and nutrition disorders lactic acidosis
Slovenian: Presnovne in prehranske motnje laktacidoza
English: Individual CL/F in the paediatric population was in the same range as individual adult data.
Slovenian: Pri posameznem otroku je bil navidezni očistek v istem razponu kot podatki za posameznega odraslega bolnika.
English: Î Contact a doctor immediately if you get these symptoms.
Slovenian: Î Nemudoma se posvetujte z zdravnikom, če opazite te simptome.
English: Food had no effect on the AUC of rosiglitazone or metformin when AVANDAMET was administered to healthy volunteers.
Slovenian: Pri zdravih prostovoljcih, ki so dobivali AVANDAMET, hrana ni vplivala na AUC rosiglitazona ali metformina.
English: • nausea and vomiting
Slovenian: • siljenje na bruhanje in bruhanje.
English: Nervous system disorders dizziness*
Slovenian: Bolezni živčevja omotica* glavobol*
English: Nervous system disorders metallic taste
Slovenian: Bolezni živčevja okus po kovini
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common Hyperlipaemia weight increase increased appetite
Slovenian: Presnovne in prehranske motnje hiperholesterolemija1 Pogosti
English: These may affect up to 1 in 10,000 people:
Slovenian: Pojavijo se lahko pri do 1 od 10.000 bolnikov:
English: PHARMACEUTICAL FORM AND CONTENTS 112 tablets.
Slovenian: Vsaka enota vsebuje 112 tablet.
English: Rosiglitazone failed to demonstrate non-inferiority to metformin.
Slovenian: Enakovrednosti rosiglitazona metforminu ni bilo mogoče dokazati.
English: Î Tell a doctor or pharmacist if you are taking any of these.
Slovenian: Î Obvestite svojega zdravnika, če jemljete katerokoli od teh zdravil.
English: Therefore, liver enzymes should be checked prior to the initiation of therapy with AVANDAMET in all patients and periodically thereafter based on clinical judgement.
Slovenian: Pri bolnikih z zvišanimi vrednostmi jetrnih encimov (ALT > 2,5-krat od zgornje meje normalne vrednosti) so izkušnje z rosiglitazonom omejene, zato je pred pričetkom zdravljenja z zdravilom AVANDAMET pri vseh bolnikih potrebno preveriti jetrne encime in jih nato na osnovi klinične presoje preverjati periodično.
English: Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required.
Slovenian: Če je potrebno močnejše uravnavanje koncentracije glukoze v krvi, se lahko po 8 tednih odmerek rosiglitazona zveča na 8 mg/dan.
English: How much to take
Slovenian: Kakšen odmerek zdravila vzeti
English: These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Slovenian: Pakiranje vsebuje 28, 56, 112, 3x112 ali 360 filmsko obloženih tablet.
English: In an update to this retrospective analysis that included 10 further studies that met the criteria for inclusion, but were not available at the time of the original analysis, the overall incidence of events typically associated with cardiac ischaemia was not statistically different for rosiglitazone containing regimens, 2.21% versus combined active and placebo comparators, 2.08% [HR 1.098 (95% CI 0.809 - 1.354)].
Slovenian: Ta posodobitev je pokazala, da se celotna incidenca dogodkov, tipično povezanih s srčno ishemijo pri bolnikih , ki so prejemali rosiglitazon (2,21 %) ni statistično značilno razlikovala od incidence pri bolnikih, ki so prejemali primerjalno učinkovino ali placebo (2,08 %) [razmerje ogroženosti 1,098 (95 % IZ 0,809-1,354)].
English: tell your doctor before you take Avandamet.
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVANDAMET
English: What Avandamet contains
Slovenian: Kaj vsebuje zdravilo Avandamet
English: Pruritis
Slovenian: Presnova
English: Surgery
Slovenian: Kirurgija
English: Increased monitoring of the patient is recommended if AVANDAMET is used in combination particularly with insulin but also with a sulphonylurea.
Slovenian: Pri uporabi zdravila AVANDAMET v kombinaciji s sulfonilsečnino, še posebej pa v kombinaciji z insulinom, priporočamo skrben nadzor bolnika.
English: Your kidney function will be checked
Slovenian: Preverjati je treba delovanje ledvic
English: Rare side effects
Slovenian: Neželen učinek
English: INFORMATION IN BRAILLE avandamet 1 mg/500 mg
Slovenian: PODATKI V BRAILLOVI PISAVI avandamet 1 mg/500 mg
English: Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Slovenian: Tablete jemljite vsak dan ob približno istem času.
English: Very rare side effects
Slovenian: Zelo redki neželeni učinki
English: Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Slovenian: V nadzorovanih kliničnih preskušanjih uporabe rosiglitazona pri bolnikih z AKS niso raziskovali.
English: • steroids (used to treat inflammation) such as prednisolone or dexamethasone
Slovenian: • kortikosteroidi (uporabljamo jih pri zdravljenju vnetja), kot sta prednizolon ali deksametazon.
English: INFORMATION IN BRAILLE avandamet 4 mg/1000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI avandamet 4 mg/1000 mg
English: INFORMATION IN BRAILLE avandamet 2 mg/500 mg
Slovenian: PODATKI V BRAILLOVI PISAVI avandamet 2 mg/500 mg
English: Multipack comprising 3 packs, each containing 56 film-coated tablets.
Slovenian: Vsaka enota vsebuje 56 filmsko obloženih tablet.
English: A more pronounced glucose-lowering effect was observed in obese patients.
Slovenian: Pri debelih bolnikih je bil učinek zniževanja glukoze še izrazitejši.
English: Always take Avandamet tablets exactly as your doctor has told you.
Slovenian: Pri jemanju Avandamet tablet natančno upoštevajte zdravnikova navodila.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Slovenian: Med spremljanjem tiazolindionov, vključno z rosiglitazonom, po pridobitvi dovoljenja za promet so poročali o primerih na novo nastalega diabetičnega edema makule z zmanjšano ostrino vida ali njegovega poslabšanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 4 mg rosiglitazona (kot rosiglitazonijev maleat) in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Slovenian: Zaradi kompeticije za ledvične tubulne transportne sisteme se lahko med kationskimi zdravilnimi učinkovinami, ki se izločajo preko ledvic s tubulno sekrecijo (npr. cimetidin) in metforminom pojavi medsebojno delovanje.
English: INFORMATION IN BRAILLE avandamet 2 mg/1000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI avandamet 2 mg/1000 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 2 mg rosiglitazona (kot rosiglitazonijev maleat) in 500 mg metforminijevega klorida (kar ustreza 390 mg metformina).
English: • if you are going to have an X-ray using an injected dye (see ‘While you take
Slovenian: • če imate predvideno rentgensko preiskavo pri kateri vam bodo v žilo vbrizgali kontrastno sredstvo (glejte ‘Med jemanjem zdravila Avandamet morate obvestiti svojega zdravnika' v nadaljevanju poglavja 2).
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
Slovenian: Metformin lahko deluje na tri načine: - zmanjšuje nastajanje glukoze v jetrih, tako da inhibira glukoneogenezo in glikogenolizo;
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Slovenian: Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedene v preglednici 2.
English: The decision whether to continue the patient on therapy with AVANDAMET should be guided by clinical judgement pending laboratory evaluations.
Slovenian: Dokler ne razpolagamo z rezultati laboratorijskih preiskav, je klinična presoja tista, ki vodi do odločitve o nadaljevanju zdravljenja z zdravilom AVANDAMET.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Component of a multipack comprising 3 packs, each containing 112 film-coated tablets.
Slovenian: Vsaka enota vsebuje 112 filmsko obloženih tablet.
English: Use only as directed by your doctor.
Slovenian: Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/016
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/016
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ( Z BLUE BOX) (NI ZA PAKIRANJE PO VEČ ENOT)
English: Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other.
Slovenian: Filmsko obložena tableta Rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "4/1000" na drugi strani.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets
Slovenian: IME ZDRAVILA AVANDAMET 4 mg/1000 mg filmsko obložene tablete
English: Lactose monohydrate Povidone (E1201) Magnesium stearate.
Slovenian: Jedro tablete: natrijev karboksimetilškrob hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat povidon (E1201) magnezijev stearat
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets
Slovenian: IME ZDRAVILA AVANDAMET 1 mg/500 mg filmsko obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (56 TABLETS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (56 TABLET)