natgillin/translations-raw huggingface dataset:
Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Bolezni jeter, žolčnika in žolčevodov disfunkcija jeter, ki se prvenstveno kaže s povišanjem vrednosti jetrnih encimov5
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).
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).
Overall, 43%, 47% and 42% of subjects in the rosiglitazone, glibenclamide and metformin groups respectively withdrew due to reasons other than monotherapy failure.
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.
MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 56 TABLET, PAKIRANIH V ŠKATLO)
Î Tell your doctor as soon as possible if you get any of these symptoms.
Î Čimprej obvestite svojega zdravnika, če se pojavi katerikoli od teh simptomov.
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.
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 %.
Hypromellose (E464) Titanium dioxide (E171) Macrogol
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol rdeči železov oksid (E172)
Post-marketing data
Podatki po pridobitvi dovoljenja za promet
PSURs
PSUR-i
Î Contact a doctor immediately if you get any of these symptoms.
Î Nemudoma se posvetujte z zdravnikom, če se pojavi katerikoli od teh simptomov.
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.
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.
General disorders and administration site conditions Oedema
Splošne težave in spremembe na mestu aplikacije edem
Metabolism and nutrition disorders lactic acidosis
Presnovne in prehranske motnje laktacidoza
Individual CL/F in the paediatric population was in the same range as individual adult data.
Pri posameznem otroku je bil navidezni očistek v istem razponu kot podatki za posameznega odraslega bolnika.
Î Contact a doctor immediately if you get these symptoms.
Î Nemudoma se posvetujte z zdravnikom, če opazite te simptome.
Food had no effect on the AUC of rosiglitazone or metformin when AVANDAMET was administered to healthy volunteers.
Pri zdravih prostovoljcih, ki so dobivali AVANDAMET, hrana ni vplivala na AUC rosiglitazona ali metformina.
• nausea and vomiting
• siljenje na bruhanje in bruhanje.
Nervous system disorders dizziness*
Bolezni živčevja omotica* glavobol*
Nervous system disorders metallic taste
Bolezni živčevja okus po kovini
Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common Hyperlipaemia weight increase increased appetite
Presnovne in prehranske motnje hiperholesterolemija1 Pogosti
These may affect up to 1 in 10,000 people:
Pojavijo se lahko pri do 1 od 10.000 bolnikov:
PHARMACEUTICAL FORM AND CONTENTS 112 tablets.
Vsaka enota vsebuje 112 tablet.
Rosiglitazone failed to demonstrate non-inferiority to metformin.
Enakovrednosti rosiglitazona metforminu ni bilo mogoče dokazati.
Î Tell a doctor or pharmacist if you are taking any of these.
Î Obvestite svojega zdravnika, če jemljete katerokoli od teh zdravil.
Therefore, liver enzymes should be checked prior to the initiation of therapy with AVANDAMET in all patients and periodically thereafter based on clinical judgement.
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.
Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required.
Če je potrebno močnejše uravnavanje koncentracije glukoze v krvi, se lahko po 8 tednih odmerek rosiglitazona zveča na 8 mg/dan.
How much to take
Kakšen odmerek zdravila vzeti
These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Pakiranje vsebuje 28, 56, 112, 3x112 ali 360 filmsko obloženih tablet.
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)].
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)].
tell your doctor before you take Avandamet.
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVANDAMET
What Avandamet contains
Kaj vsebuje zdravilo Avandamet
Pruritis
Presnova
Increased monitoring of the patient is recommended if AVANDAMET is used in combination particularly with insulin but also with a sulphonylurea.
Pri uporabi zdravila AVANDAMET v kombinaciji s sulfonilsečnino, še posebej pa v kombinaciji z insulinom, priporočamo skrben nadzor bolnika.
Your kidney function will be checked
Preverjati je treba delovanje ledvic
Rare side effects
Neželen učinek
INFORMATION IN BRAILLE avandamet 1 mg/500 mg
PODATKI V BRAILLOVI PISAVI avandamet 1 mg/500 mg
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Tablete jemljite vsak dan ob približno istem času.
Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
V nadzorovanih kliničnih preskušanjih uporabe rosiglitazona pri bolnikih z AKS niso raziskovali.
• steroids (used to treat inflammation) such as prednisolone or dexamethasone
• kortikosteroidi (uporabljamo jih pri zdravljenju vnetja), kot sta prednizolon ali deksametazon.
INFORMATION IN BRAILLE avandamet 4 mg/1000 mg
PODATKI V BRAILLOVI PISAVI avandamet 4 mg/1000 mg
INFORMATION IN BRAILLE avandamet 2 mg/500 mg
PODATKI V BRAILLOVI PISAVI avandamet 2 mg/500 mg
Multipack comprising 3 packs, each containing 56 film-coated tablets.
Vsaka enota vsebuje 56 filmsko obloženih tablet.
A more pronounced glucose-lowering effect was observed in obese patients.
Pri debelih bolnikih je bil učinek zniževanja glukoze še izrazitejši.
Always take Avandamet tablets exactly as your doctor has told you.
Pri jemanju Avandamet tablet natančno upoštevajte zdravnikova navodila.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
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.
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).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 4 mg rosiglitazona (kot rosiglitazonijev maleat) in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
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.
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.
INFORMATION IN BRAILLE avandamet 2 mg/1000 mg
PODATKI V BRAILLOVI PISAVI avandamet 2 mg/1000 mg
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).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 2 mg rosiglitazona (kot rosiglitazonijev maleat) in 500 mg metforminijevega klorida (kar ustreza 390 mg metformina).
• if you are going to have an X-ray using an injected dye (see ‘While you take
• 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).
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.
Metformin lahko deluje na tri načine: - zmanjšuje nastajanje glukoze v jetrih, tako da inhibira glukoneogenezo in glikogenolizo;
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.
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.
The decision whether to continue the patient on therapy with AVANDAMET should be guided by clinical judgement pending laboratory evaluations.
Dokler ne razpolagamo z rezultati laboratorijskih preiskav, je klinična presoja tista, ki vodi do odločitve o nadaljevanju zdravljenja z zdravilom AVANDAMET.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Component of a multipack comprising 3 packs, each containing 112 film-coated tablets.
Vsaka enota vsebuje 112 filmsko obloženih tablet.
Use only as directed by your doctor.
Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/016
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/016
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ( Z BLUE BOX) (NI ZA PAKIRANJE PO VEČ ENOT)
Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other.
Filmsko obložena tableta Rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "4/1000" na drugi strani.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets
IME ZDRAVILA AVANDAMET 4 mg/1000 mg filmsko obložene tablete
Lactose monohydrate Povidone (E1201) Magnesium stearate.
Jedro tablete: natrijev karboksimetilškrob hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat povidon (E1201) magnezijev stearat
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets
IME ZDRAVILA AVANDAMET 1 mg/500 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (56 TABLETS)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (56 TABLET)
An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
V kliničnih preskušanjih so pri uporabi rosiglitazona v kombinaciji z insulinom poročali o večji pojavnosti srčnega popuščanja.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/015
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/015
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets
IME ZDRAVILA AVANDAMET 2 mg/500 mg filmsko obložene tablete
This risk was increased when rosiglitazone was added to established insulin and in patients receiving nitrates for known ischaemic heart disease.
Pri bolnikih, ki so se že zdravili z insulinom, in bolnikih, ki so prejemali nitrate zaradi znane ishemične bolezni srca, se je to tveganje po dodatni uvedbi rosiglitazona povečalo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 112 TABLET)
EU/1/03/258/010 14 tablets EU/1/03/258/011 28 tablets EU/1/03/258/012 56 tablets EU/1/03/258/022 180 tablets
EU/1/03/258/010 14 tablet EU/1/03/258/011 28 tablet EU/1/03/258/012 56 tablet EU/1/03/258/022 180 tablet
Yellow film-coated tablets marked "gsk" on one side and "1/500" on the other.
Filmsko obložena tableta Rumene filmsko obložene tablete z oznako "gsk" na eni strani in "1/500" na drugi strani.
EU/1/03/258/007-009 EU/1/03/258/013 EU/1/03/258/017 EU/1/03/258/021
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/007-009, EU/1/03/258/013, EU/1/03/258/017, EU/1/03/258/021
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 112 TABLET)
Check with your doctor or pharmacist if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg tablets rosiglitazone/metformin HCl
IME ZDRAVILA AVANDAMET 1 mg/500 mg tablete rosiglitazon/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg tablets rosiglitazone/metformin HCl
IME ZDRAVILA AVANDAMET 2 mg/500 mg tablete rosiglitazon/metforminijev klorid
However, the risk of both fluid related adverse events and hypoglycaemia are increased when AVANDAMET is used in combination with insulin.
Vendar pa pri uporabi zdravila AVANDAMET v kombinaciji z insulinom obstaja večje tveganje tako za pojav neželenih dogodkov povezanih z zastajanjem tekočine, kot za pojav hipoglikemije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (112 TABLETS)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) - SAMO ZA PAKIRANJE PO VEČ ENOT (112 TABLET)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 4 mg rosiglitazona (kot maleat) in 1000 mg metforminijevega klorida.
Pale pink film-coated tablets marked "gsk" on one side and "2/500" on the other.
Filmsko obložena tableta Bledo rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "2/500" na drugi strani.
If you get side effects
V primeru pojava neželenih učinkov
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets
IME ZDRAVILA AVANDAMET 2 mg/1000 mg filmsko obložene tablete
EU/1/03/258/007 14 tablets EU/1/03/258/008 28 tablets EU/1/03/258/009 56 tablets EU/1/03/258/021 180 tablets
EU/1/03/258/007 14 tablet EU/1/03/258/008 28 tablet EU/1/03/258/009 56 tablet EU/1/03/258/021 180 tablet
Yellow film-coated tablets marked "gsk" on one side and "2/1000" on the other.
Filmsko obložena tableta Rumene filmsko obložene tablete z oznako "gsk" na eni strani in "2/1000" na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 2 mg rosiglitazona (kot maleat) in 500 mg metforminijevega klorida.
EU/1/03/258/017, 56 tablets, component of a 168 tablet multipack.
EU/1/03/258/013, 56 tablet, sestavni del pakiranja po več enot s 112 tabletami EU/1/03/258/017, 56 tablet, sestavni del pakiranja po več enot s 168 tabletami
EU/1/03/258/004 28 tablets EU/1/03/258/005 56 tablets EU/1/03/258/006 112 tablets EU/1/03/258/020 360 tablets
EU/1/03/258/004 28 tablet EU/1/03/258/005 56 tablet EU/1/03/258/006 112 tablet EU/1/03/258/020 360 tablet
Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Za režim zdravljenja z rosiglitazonom kot samostojnim zdravilom so neželeni učinki v preglednici, znotraj vsakega organskega sistema, navedeni po padajoči pogostnosti.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 2 mg rosiglitazona (kot maleat) in 1000 mg metforminijevega klorida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 1 mg rosiglitazona (kot maleat) in 500 mg metforminijevega klorida.
EU/1/03/258/001 28 tablets EU/1/03/258/002 56 tablets EU/1/03/258/003 112 tablets EU/1/03/258/019 360 tablets
EU/1/03/258/001 28 tablet EU/1/03/258/002 56 tablet EU/1/03/258/003 112 tablet EU/1/03/258/019 360 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX)
ZUNANJA NALEPKA (Z BLUE BOX)
EU/1/03/258/018, 56 tablets, component of a 168 tablet multipack.
EU/1/03/258/014, 56 tablet, sestavni del pakiranja po več enot s 112 tabletami EU/1/03/258/018, 56 tablet, sestavni del pakiranja po več enot s 168 tabletami
and your dose of Avandamet may need to be changed.
Zdravnik bo preveril vrednost krvnega sladkorja, odmerek zdravila Avandamet pa bo morda moral spremeniti.
Hepatobiliary disorders liver function disorders
Bolezni jeter, žolčnika in žolčevodov motnje v delovanju jeter
HOW TO STORE AVANDAMET Keep out of the reach and sight of children.
SHRANJEVANJE ZDRAVILA AVANDAMET Zdravilo shranjujte nedosegljivo otrokom!
New or worse cases of macular oedema have occurred on rare occasions in people taking Avandamet and similar medicines.
V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avandamet in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 2 mg rosiglitazona (kot rosiglitazonijev maleat) in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 1 mg rosiglitazona (kot rosiglitazonijev maleat) in 500 mg metforminijevega klorida (kar ustreza 390 mg metformina).
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
AVANDAMET 4 mg/1000 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Pri sočasnem dajanju kationskih zdravilnih učinkovin, ki se izločajo preko ledvic s tubulno sekrecijo je torej treba skrbno nadzirati urejenost glikemije, skrbeti za prilagoditev odmerka znotraj priporočenega odmernega intervala in razmisliti o morebitnih spremembah pri zdravljenju sladkorne bolezni.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg tablets rosiglitazone/metformin HCl
AVANDAMET 4 mg/1000 mg tablete rosiglitazon/metforminijev klorid
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high
Stopnja vezave glavnega metabolita (parahidroksisulfata) na proteine je zelo visoka (> 99,99 %).
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
AVANDAMET 2 mg/1000 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
EU/1/03/258/010-012 EU/1/03/258/014 EU/1/03/258/018 EU/1/03/258/022
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/010-012, EU/1/03/258/014, EU/1/03/258/018, EU/1/03/258/022
HOW TO TAKE AVANDAMET
Zdravilo Avandamet
Excipients:
Pomožne snovi:
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg tablets rosiglitazone/metformin HCl
AVANDAMET 2 mg/1000 mg tablete rosiglitazon/metforminijev klorid
Titanium dioxide (E171)
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol rumeni železov oksid (E172)
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 3 packs, each containing 112 film-coated tablets.
112 tablet Sestavni del pakiranja po več enot, ki vsebuje 3 enote.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets rosiglitazone/metformin HCl
AVANDAMET 2 mg/500 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day.
Največji odmerek je 4 mg rosiglitazona in 1.000 mg metformina dvakrat na dan. (Takšen odmerek lahko vzamete tudi v obliki dveh 2 mg/500 mg tablet dvakrat na dan.)
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Pri njuni sočasni uporabi se lahko poveča tveganje za pojav edemov in ishemično bolezen srca.
Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common hyperlipaemia weight increase increased appetite hypoglycaemia
Pogosti hipertrigliceridemija Pogosti hiperlipemija
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets rosiglitazone/metformin HCl
AVANDAMET 1 mg/500 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
What Avandamet looks like and contents of the pack Avandamet 1 mg/500 mg tablets are yellow and marked "gsk" on one side and "1/500" on the other.
Izgled zdravila Avandamet in vsebina pakiranja Avandamet 1 mg/500 mg tablete so rumene barve.
In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)].
s 5,3 %, razmerje tveganj 1,57 (95 % IZ 1,26-1,97)].
Strength Pharmaceutical Form
Farmacevtska oblika
1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads
1 viala + 1 injekcijska brizga + 1 igla + 1 adapter + 2 alkoholna zloženca napolnjena injekcijska brizga (steklo)
(Invented) name
Številka EU Izmišljeno ime Jakost
EU/1/19/1356/001 IDACIO 40 mg/0.8 ml
40 mg/0,8 ml raztopina za injiciranje viala (steklo)
Pack size
Ovojnina
This summary was last updated in 07-2015.
Povzetek je bil nazadnje posodobljen 07-2015.
As a result, patients fall asleep and wake up at unusual times.
Posledično bolniki zaspijo in se zbujajo ob neobičajnih urah.
However, continued treatment would be necessary to maintain the beneficial effects.
Vendar je za vzdrževanje koristnih učinkov nujno potrebno neprekinjeno zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Hetlioz, veljavno po vsej Evropski uniji, izdala 3. julija 2015.
The recommended dose is one capsule per day, taken one hour before bedtime, at the same time every night.
Priporočeni odmerek je ena kapsula na dan, ki jo je treba vsak večer ob istem času vzeti eno uro pred spanjem.