natgillin/translations-raw huggingface dataset:
It cannot be excluded that other inducers (e.g. phenytoin, carbamazepine, phenobarbital, St John's wort) may also affect rosiglitazone exposure.
Vpliva drugih induktorjev (npr. fenitoina, karbamazepina, fenobarbitala, šentjanževke) ni mogoče izključiti.
An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVAGLIM or if it occurred at a higher frequency than that listed for a component part.
Neželeni učinki kombinacije v fiksnem odmerku so navedeni le, če pri posamezni zdravilni učinkovini zdravila AVAGLIM niso bili ugotovljeni, oziroma je bila njihova pogostnost večja od pogostnosti pri
The usual starting dose is one combined tablet (4 mg rosiglitazone and 4 mg glimepiride), taken once
Običajni začetni odmerek je ena kombinirana tableta (4 mg rosiglitazona in 4 mg glimepirida) enkrat
Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient's risk of developing
Pred uvedbo terapije z AVAGLIMOM je treba ustrezno klinično oceniti bolnikovo ogroženost s hipoglikemijami (glejte
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor
Študije in vitro so pokazale, da se rosiglitazon pretežno presnavlja s CYP2C8, ob manjšem prispevku
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.
O edemih in srčnem popuščanju so pogosteje poročali tudi pri starejših bolnikih in bolnikih z blago ali zmerno odpovedjo ledvic.
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with
Po hkratni uporabi z rosiglitazonom niso opazili klinično pomembnega medsebojnega delovanja z digoksinom, substratom CYP2C9 varfarinom in substrati CYP3A4 nifedipinom, etinilestradiolom oz.
Each tablet contains either: 4 mg or 8 mg rosiglitazone and 4 mg glimepiride.
Ena tableta vsebuje: 4 mg ali 8 mg rosiglitazona in 4 mg glimepirida.
Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Zdravljenje z rosiglitazonom spremlja z odmerkom povezano znižanje koncentracije hemoglobina.
Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68,
Med študijo (do 72 mesecev zdravljenja) je zdravljenje z rosiglitazonom statistično značilno zmanjšalo tveganje odpovedi monoterapije (glukoza v plazmi na tešče > 10,0 mmol/l) za 63 % v primerjavi z glibenklamidom (razmerje ogroženosti 0,37, interval zaupanja 0,30-0,45) in za 32 % v primerjavi z metforminom (razmerje ogroženosti 0,68, interval zaupanja 0,55-0,85).
Therefore, AVAGLIM should not be used during lactation.
Zato AVAGLIMA ne smete uporabljati med obdobjem dojenja.
phenylbutazone, azapropazon and oxyfenbutazone,
fenilbutazon, azapropazon ali oksifenbutazon,
Reproduction toxicology findings may be related to the pharmacodynamic action of glimepiride.
Izsledke reproduktivnih toksičnih učinkov je mogoče povezati s farmakodinamičnim delovanjem
The maximum recommended daily dose is 8 mg rosiglitazone/4 mg glimepiride (given as one AVAGLIM tablet 8 mg/4 mg, once daily).
Največji priporočeni dnevni odmerek je 8 mg rosiglitazona/4 mg glimepirida (v obliki ene tablete AVAGLIM 8 mg/4 mg enkrat na dan).
There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Med obdobjem pomarketinške uporabe rosiglitazona so poročali o redkih primerih motenega delovanja jetrnih celic (glejte poglavje 4.8).
certain long acting sulphonamides, tetracyclines,
sulfinpirazon, nekateri dolgodelujoči sulfonamidi, tetraciklini, zaviralci MAO,
The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Pogostnost neželenih učinkov na osnovi podatkov po pridobitvi dovoljenja za promet z rosiglitazonom
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
− na zahtevo Evropske agencije za zdravila (EMEA).
GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk.com
GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk.com Norge
In a monotherapy study, the incidence in females for rosiglitazone was 9.3% (2.7 patients per 100 patient years) vs 5.1% (1.5 patients per 100 patient years) for metformin or 3.5% (1.3 patients per 100 patient years) for glibenclamide.
4 Dolgoročne študije kažejo večjo incidenco zlomov kosti pri osebah, zlasti ženskah, ki jemljejo rosiglitazon V študiji monoterapije je bila incidenca pri ženskah, ki so jemale rosiglitazon, 9,3 % (2,7 bolnice na 100 bolnikov-let) v primerjavi s 5,1 % (1,5 bolnice na 100 bolnikov-let) za metformin in s 3,5 % (1,3 bolnice na 100 bolnikov-let) za glibenklamid.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Med sočasno uporabo rosiglitazona in gemfibrozila (zaviralca CYP2C8) se je koncentracija rosiglitazona v plazmi dvakrat povečala.
As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance.
Pri bolnicah, ki nimajo ovulacije zaradi odpornosti proti insulinu, se zaradi izboljšane občutljivosti za insulin lahko ovulacija znova pojavi.
There are no data from the use of glimepiride in patients on renal dialysis (see section 4.3).
O uporabi glimepirida pri bolnikih na dializi ni zadostnih podatkov (glejte poglavje 4.3).
Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Podatki iz kliničnih preskušanj in podatki po pridobitvi dovoljenja za promet V preglednici 3 so navedeni neželeni učinki glede na organski sistem in kategorijo pogostnosti na osnovi izkušenj z glimepiridom in drugimi sulfonilsečninami.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Ker so nesteroidna protivnetna zdravila in rosiglitazon povezani z zastajanjem tekočine, lahko sočasna uporaba teh zdravil poveča tveganje za edeme.
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable
Pitje alkohola lahko nepredvidljivo poveča ali zmanjša učinek glimepirida na znižanje krvnega
Blood and the lymphatic system disorders
Bolezni krvi in limfatičnega sistema agranulocitoza
Glimepiride is completely metabolised by oxidative biotransformation after either an intravenous or oral dose.
Glimepirid se tako po intravenski kot po peroralni uporabi povsem presnovi z oksidativno biotransformacijo.
5 Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
5 V pomarketinškem obdobju so bili opisani redki primeri zvišanja jetrnih encimov in motenega delovanja jetrnih celic.
The majority of the fractures were reported in the upper limbs and distal lower limbs (see
Večina zlomov je bila zabeležena na zgornjih udih in distalnih delih spodnjih udov (glejte poglavje 4.4).
Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
Pogostnost je definirana kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10) in občasni (≥ 1/1.000,
• Don't breast-feed while you are taking Avaglim.
• Med jemanjem zdravila Avaglim ne smete dojiti.
Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h. There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Celotni plazemski očistek rosiglitazona je okrog 3 l/uro, njegov terminalni razpolovni čas izločanja pa približno 3 do 4 ure.
After about 8 weeks your doctor may need to increase your dose.
Po 8 tednih jenanja zdravila Avaglim, vam lahko zdravnik odmerek zviša.
Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e.g. rifampicin) or inhibitors (e.g.
Znano je, da na njegovo presnovo vpliva sočasna uporaba induktorjev CYP2C9 (npr. rifampicina) ali zaviralcev CYP2C9 (npr. flukonazola).
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
2 Če so rosiglitazon dodali k režimu zdravljenja s sulfonilsečnino (bodisi pri zdravljenju z dvema zdravilnima učinkovinama bodisi pri zdravljenju s tremi zdravilnimi učinkovinami), so opazili večjo pojavnost srčnega popuščanja, ki je bila pri 8 mg odmerku rosiglitazona večja kot pri 4 mg odmerku (skupni dnevni odmerek).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
Izkušnje pri bolnikih z zvišanimi jetrnimi encimi (ALT > 2,5-krat zgornja normalna meja) so omejene.
Take your tablets around the same time every day and follow any dietary advice that your doctor has
Upoštevajte vse zdravnikove nasvete o dietni
No intact active substance is excreted in urine or faeces.
V urinu ali blatu se ne izloči nič nespremenjene zdravilne učinkovine.
If you have kidney disease, or are over 65, your kidney function should be checked while you are
Med jemanjem zdravila Avaglim je treba preverjati delovanje ledvic, če ste starejši od 65 let ali če imate
CYP2C9 has been shown to be involved in the biotransformation of glimepiride to M1. M1 is further metabolised to M2 by one or several cytosolic enzymes.
Ugotovljeno je, da je v biotransformacijo glimepirida v M1 vpleten CYP2C9.
Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Rosiglitazon pri podganah in miših ni stimuliral pankreatičnega izločanja insulina in ni izzval hipoglikemije.
AVAGLIM tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
Tablete AVAGLIM vsebujejo laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The maximum dose is one combined tablet of 8 mg rosiglitazone and 4 mg glimepiride, taken once a day.
Maksimalni odmerek je ena kombinirana tableta 8 mg rosiglitazona in 4 mg glimepirida enkrat na dan.
Under the influence of sympatholytic drugs such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Znaki adrenergične protiregulacije na hipoglikemijo se lahko pod vplivom simpatikolitičnih zdravil, npr. zaviralcev beta, klonidina, gvanetidina in reserpina, zmanjšajo ali izginejo.
Premenopausal anovulatory women
Ženske pred menopavzo brez ovulacije
In a bioequivalence study under fasted conditions, the AUC and Cmax of rosiglitazone and the AUC of glimepiride following a single dose of a 4 mg/4 mg combination tablet were bioequivalent to concomitant administration of rosiglitazone 4 mg and glimepiride 4 mg.
V bioekvivalenčni študiji na tešče sta bila AUC in Cmax rosiglitazona in AUC glimepirida po posamičnem odmerku kombinirane tablete 4 mg/4 mg bioekvivalentna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
The active substances are rosiglitazone and glimepiride.
Zdravilni učinkovini sta rosiglitazon in glimepirid.
Glimepiride inhibits the hepatic glucose production by increasing the intracellular concentration of fructose-2,6 bisphosphate, which in turn inhibits gluconeogenesis.
Glimepirid poveča znotrajcelično koncentracijo fruktoza-2,6-bisfosfata, ki zavira glukoneogenezo, in zato zavira nastajanje glukoze v jetrih.
Your doctor should regularly test your
Redno spremljajte svojo telesno maso.
The frequency of glimepiride adverse reactions identified from clinical trial and post
Pogostnost neželenih učinkov glimepirida na osnovi podatkov iz kliničnih preskušanj in podatkov po pridobitvi dovoljenja za promet
NAME OF THE MEDICINAL PRODUCT AVAGLIM 8 mg/4 mg film-coated tablets.
IME ZDRAVILA AVAGLIM 8 mg/4 mg filmsko obložene tablete
The improved glycaemic control is associated with reductions in both fasting and post
Boljšo urejenost glikemije spremlja znižanje glukoze na tešče in postprandialne glukoze.
Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e.g. fluconazole) or inducers (see section 4.5).
Rosiglitazon je treba uporabljati previdno med sočasnim zdravljenjem z zaviralci CYP2C8 (npr. gemfibrozilom) ali njegovimi induktorji (npr. rifampicinom), glimepirid pa med sočasnim zdravljenjem z zaviralci CYP2C9 (npr. flukonazolom) ali njegovimi induktorji (glejte poglavje 4.5).
NAME OF THE MEDICINAL PRODUCT AVAGLIM 4 mg/4 mg film-coated tablets.
IME ZDRAVILA AVAGLIM 4 mg/4 mg filmsko obložene tablete
These include: y taking other medicines to treat diabetes y stress situations (such as trauma, surgery or infections) Early symptoms of low blood sugar are:
Nizek krvni sladkor (hipoglikemija): Če jemljete zdravilo Avaglim, lahko pomenijo določeni pogoji večjo verjetnost za prekomerno zmanjšanje krvnega sladkorja, kot so: y jemanje drugih zdravil za zdravljenje sladkorne bolezni y stresne okoliščine (npr. poškodba, operacija ali okužba) Zgodnji simptomi nizkega krvnega sladkorja so:
CONDITIONS OF THE MARKETING AUTHORISATION
Podatki po pridobitvi dovoljenja za promet
A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Študija je pokazala, da je bila pri vseh bolnikih, ki so imeli očistek kreatinina manj kot 22 ml/min, koncentracija glukoze ustrezno urejena z odmerjanjem zgolj 1 mg na dan (glejte poglavji 4.2 in 4.4).
In the fed state, the rate and extent of absorption of the rosiglitazone-glimepiride 4 mg/4 mg combination were equivalent to concomitant administration of 4 mg rosiglitazone and 4 mg glimepiride.
Na poln želodec sta bila hitrost in obseg absorpcije kombinacije 4 mg/4 mg rosiglitazona in glimepirida enakovredna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVAGLIM Pri zdravljenju sladkorne bolezni je pomembno, da natančno upoštevate vsa zdravnikova navodila, tako o dietni prehrani in življenjskem slogu kot jemanju zdravila Avaglim.
Pharmacotherapeutic group: Combinations of oral blood glucose lowering drugs, ATC code: A10BD04
Oznaka ATC: A10BD04
The ingredients may pass into breast milk and so may harm your baby.
Sestavine zdravila lahko prehajajo v materino
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Med sočasno uporabo katerega od naslednjih zdravil se lahko poveča učinek na znižanje glukoze v krvi, tako da se v nekaterih primerih pojavi hipoglikemija.
Always take Avaglim tablets exactly as your doctor has told you.
Pri jemanju Avaglim tablet natančno upoštevajte zdravnikova navodila.
Mean doses at the end of randomised treatment are shown in the following table:
Povprečne odmerke na koncu randomiziranega zdravljenja
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Po pridobitvi dovoljenja za promet so, pri uporabi tiazolidindionov, vključno z rosiglitazonom, poročali o primerih na novo nastalega diabetičnega edema makule z zmanjšano ostrino vida ali njegovega poslabšanja.
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 promet z rosiglitazonom so poleg neželenih učinkov, odkritih med kliničnimi preskušanji, poročali še o neželenih učinkih, ki so navedeni v preglednici 2.
4.2 Posology and method of administration
6.5 Vrsta ovojnine in vsebina
A more pronounced glucose-lowering effect was observed in obese patients.
Pri debelih bolnikih so opažali izrazitejši učinek na znižanje glukoze.
The absorption of rosiglitazone is not affected by increases in gastric pH.
Zvišanje pH v želodcu ne vpliva na absorpcijo
The AUC and Cmax of glimepiride increased in a dose-proportional manner following administration of rosiglitazone-glimepiride 4 mg/1 mg, 4 mg/2 mg, and 4 mg/4 mg.
AUC in Cmax glimepirida sta se po uporabi kombinacij 4 mg/1 mg, 4 mg/2 mg in 4 mg/4 mg rosiglitazona in glimepirida povečali sorazmerno odmerku.
Glaxo Wellcome, S.A.
Glaxo Wellcome, S.A. Avenida de Extremadura, 3
What Avaglim looks like and contents of the pack Avaglim 4 mg/4 mg tablets are pink, rounded triangular-shaped, and marked "gsk" on one side and
Izgled zdravila Avaglim in vsebina pakiranja Avaglim 4 mg/4 mg tablete so rožnate barve, zaokroženo trikotne oblike.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje rosiglitazonijev maleat v količini, ki ustreza 4 mg rosiglitazona, in 4 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje rosiglitazonijev maleat v količini, ki ustreza 8 mg rosiglitazona, in 4 mg
In their entirety, the available data on the risk of cardiac ischaemia are
V celoti pa razpoložljivi podatki ne omogočajo dokončnega sklepa o tveganju srčne za srčne ishemije.
New or worse cases of macular oedema have occurred on rare occasions in people taking Avaglim and similar medicines.
V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avaglim in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
No clinically significant reductions in glimepiride AUC and Cmax were observed after repeat doses of rosiglitazone for eight days in healthy adult
Po uporabi večkratnih odmerkov rosiglitazona pri zdravih odraslih preiskovancih v obdobju osmih dni niso ugotovili klinično pomembnega zmanjšanja AUC in Cmax glimepirida.
The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM
Začetni odmerek je 4 mg/dan rosiglitazona in 4 mg/dan glimepirida (uporabljenih v obliki ene tablete AVAGLIM 4 mg/4 mg).
- contains lactose (approximately 104 mg) For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The decision whether to continue the patient on therapy with AVAGLIM should be guided by clinical judgement pending laboratory evaluations.
Dokler nimate laboratorijskih izvidov, se morate o nadaljevanju terapije z AVAGLIMOM odločiti na osnovi klinične presoje.
No adequate pharmacokinetic studies of glimepiride have been conducted in subjects with functional hepatic impairment.
Pri preiskovancih s funkcijsko okvaro jeter ustrezne farmakokinetične študije glimepirida niso bile izvedene.
Adverse reactions are presented below for each of the component parts of AVAGLIM.
V nadaljevanju so navedeni neželeni učinki vsake od zdravilnih učinkovin zdravila AVAGLIM.
Therefore, AVAGLIM should not be used during pregnancy and the use of insulin is recommended.
Zato AVAGLIMA med nosečnostjo ne smete uporabljati.
In addition, glimepiride seems to have pronounced extrapancreatic effects, also postulated for other sulphonylureas.
Poleg tega kaže, da ima glimepirid izrazite ekstrapankreatične učinke, ki jih imajo
Just take your next dose at the usual time.
Vzemite le naslednji predvideni
Contains lactose, see leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
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 monoterapijo so neželeni učinki v preglednici, znotraj vsakega organskega sistema, navedeni po padajoči pogostnosti.
A switch to insulin should be considered in stress situations (e.g. trauma, surgery, infections).
V stresnih okoliščinah (npr. poškodba, operacija, okužbe) pride v poštev prehod na insulin.
What Avaglim is and what it is used for
Kaj je zdravilo Avaglim in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Avaglim
The frequency of adverse reactions identified from clinical trial data with rosiglitazone
Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj z
Avaglim 8 mg/4 mg tablets are red, rounded triangular-shaped, and marked "gsk" on one side and
Avaglim 8 mg/4mg tablete so rdeče barve, zaokroženo trikotne oblike.
Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
Med sočasno uporabo katerega od naslednjih zdravil se lahko zmanjša učinek na znižanje glukoze v krvi,
General disorders and administration site conditions oedema
Splošne težave in spremembe na mestu aplikacije
Medicinal product subject to medical prescription.
Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba AVAGLIMA pri otrocih mlajših od
What Avaglim contains
Vsebuje laktozo.
05 October 2012
5. oktober 2012
The main measure of effectiveness was overall survival (the length of time the patients lived).
Glavno merilo učinkovitosti je bilo celokupno preživetje (koliko časa so bolniki še živeli).
The full European Public Assessment Report for Erbitux can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Erbitux je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Erbitux is an anticancer medicine which has been authorised in the European Union (EU) since 29 June 2004.
Zdravilo Erbitux je zdravilo proti raku, ki je v Evropski uniji (EU) odobreno od 29. junija 2004.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo je bila umaknjena potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
When it attaches to EGFR, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Ko se cetuksimab veže na receptorje za epidermalni rastni faktor, tumorske celice ne morejo več prejemati sporočil, potrebnih za rast, napredovanje in širjenje.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far are not sufficient to address CHMP's concerns and that more data will be needed.
Družba je v uradnem pismu izjavila, da njena odločitev za umik vloge temelji na mnenju CHMP, da podatki, ki so bili zagotovljeni dotlej, niso zadostni za odpravo pomislekov Odbora in da bo potrebnih več podatkov.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
CHMP je ocenil odgovore družbe na vprašanja, a so nekatera vprašanja še vedno ostala nerešena.