natgillin/translations-raw huggingface dataset:
- The other ingredients are lactose monohydrate, microcrystalline cellulose (101), crospovidone (type A), povidone (K30), sodium laurilsulfate, magnesium stearate in the tablet core.
- Drugi sastojci su laktoza hidrat, mikrokristalična celuloza (101), krospovidon (vrsta A), povidon (K30), natrijev laurilsulfat, magnezijev stearat u jezgri tablete.
Tablet coating Polyvinyl alcohol (E1203) Macrogol 4000 (E1521) Talc (E553b) Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Ovojnica tablete poli(vinilni alkohol) (E1203) makrogol 4000 (E1521) talk (E553b) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
• Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
• dehidracija (često) uzrokovana dugotrajnim ili teškim proljevom, povraćanje, mučnina ili gubitak apetita.
If you take more Gefitinib Mylan than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Ako ste uzeli više tableta nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
In a phase III open-label clinical trial (IPASS) in 1217 patients comparing gefitinib to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the gefitinib treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
U otvorenom kliničkom ispitivanju faze III (IPASS) s 1217 bolesnika, u kojem se uspoređivao gefitinib s dvostrukom kemoterapijom karboplatinom/paklitakselom u prvoj liniji liječenja u odabranih bolesnika s uznapredovalim NSCLC-om u Aziji, incidencija nuspojava tipa ILD-a iznosila je 2,6% u skupini liječenoj gefitinibom u usporedbi s 1,4% u skupini koja je primala karboplatin/paklitaksel.
The randomised phase III first line IPASS study was conducted in patients in Asia1 with advanced (stage IIIB or IV) NSCLC of adenocarcinoma histology who were ex-light smokers (ceased smoking ≥ 15 years ago and smoked ≤ 10 pack years) or never smokers (see Table 3).
Randomizirano kliničko ispitivanje faze III prve linije liječenja (IPASS) provedeno je u bolesnika u Aziji1 koji su imali uznapredovali NSCLC (stadij IIIB ili IV) s histološkom slikom adenokarcinoma, a koji su bili bivši laki pušači (prestali su pušiti prije 15 ili više godina, a pušili su ≤ 10 kutija godišnje) ili nikada nisu pušili (vidjeti Tablicu 3).
The tablet coating contains polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Ovojnica tablete sadrži poli(vinilni alkohol) (E1203), makrogol 4000 (E1521), talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172).
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: - Corneal epithelia atrophy and corneal translucencies - Renal papillary necrosis - Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration.
Nuspojave koje nisu uočene u kliničkim ispitivanjima, no koje su zapažene u životinja pri razinama izloženosti sličnim kliničkim, i s mogućim značajem za kliničku primjenu, bile su sljedeće: - Atrofija epitela rožnice i prozirnost rožnice - Bubrežna papilarna nekroza - Hepatocelularna nekroza i eozinofilna sinusoidalna infiltracija makrofagima.
63/396 (16%) of patients with adenocarcinoma histology are M+.
63/396 (16%) osoba s histologijom adenokarcinoma su M+ 12/390 (3%) osoba s histologijom neadenokarcinoma su M+
Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse reactions reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients).
Kategorije učestalosti nuspojava u Tablici 1 određene su, kad je to bilo moguće, na temelju incidencije usporedivih prijava nuspojava u zbirnim podacima iz kliničkih ispitivanja faze III ISEL, INTEREST i IPASS (2462 bolesnika liječena gefitinibom).
Lactose monohydrate Microcrystalline cellulose (101) Crospovidone (Type A) Povidone (K30) Sodium laurilsulfate Magnesium stearate
Jezgra tablete laktoza hidrat celuloza, mikrokristalična (101) krospovidon (vrsta A) povidon (K30) natrijev laurilsulfat magnezijev stearat
It comes in PVC/PVDC/Aluminium blisters in packs of 30 film-coated tablets or in PVC/PVDC/Aluminium perforated unit dose blisters in packs of 30x1 film-coated tablets.
Dostupne su u PVC/PVDC/aluminijskim blisterima u pakiranjima od 30 filmom obloženih tableta ili u PVC/PVDC/aluminijskim perforiranim blisterima s jediničnim dozama u pakiranjima od 30x1 filmom obložena tableta.
Uncommon Pancreatitis Gastrointestinal perforation
Pankreatitis Gastrointestinalna perforacija
Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Djelatne tvari čija se koncentracija u plazmi može promijeniti djelovanjem gefitiniba In vitro studije pokazale su da gefitinib ima ograničen potencijal za inhibiciju CYP2D6.
In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
U ispitivanju praćenja lijeka u razdoblju nakon stavljanja u promet u Japanu (3350 bolesnika) zabilježena je stopa nuspojava tipa ILD-a od 5,8% u bolesnika koji su primali gefitinib.
Time to treatment failurea,b
Vrijeme do prestanka odgovora na liječenjea,b
• Vomiting.
• povraćanje
In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
U tom se ispitivanju za analizu mutacije EGFR-a koristila ctDNK iz seruma, a ne iz plazme, a provedena je uz pomoć kompleta testnih reagensa EGFR Mutation Test Kit (DxS) (N=86).
In this study gefitinib exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of gefitinib.
U tom se ispitivanju izloženost gefitinibu nije povećala s povećanjem doze, a nuspojave su uglavnom bile blage do umjereno teške i sukladne poznatom sigurnosnom profilu gefitiniba.
Table 2 - Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Tablica 2 - Sažetak početnog statusa mutacije u uzorcima tumora i ctDNK kod svih bolesnika koji su pristupili probiru i kod kojih su se mogla ocijeniti oba uzorka
• If it is less than 12 hours until your next dose: skip the missed tablet.
• Ako je do sljedeće doze ostalo manje od 12 sati: preskočite propuštenu tabletu.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar iste kategorije učestalosti, nuspojave su navedene u padajućem nizu prema ozbiljnosti.
• Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
• hemoragijski cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem uz prisutnost krvi u mokraći).
V.J.
Pg-p.
Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort, Hypericum perforatum) should be avoided.
Treba izbjegavati istodobnu primjenu lijekova koji induciraju CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, barbiturati ili gospina trava, Hypericum perforatum).
PVC/PVDC/Aluminium blister in cartons containing 30 film-coated tablets.
PVC/PVDC/aluminijski blister u kutiji s 30 filmom obloženih tableta.
The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitizing EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Multicentrično ispitivanje s jednom skupinom, IFUM, provedeno je na ispitanicima bijele rase (n=106) s rakom pluća nemalih stanica (NSCLC) s aktivirajućom senzibilizirajućom mutacijom EGFR s ciljem potvrde da je aktivnost gefitiniba jednaka u populaciji bijelaca i azijata.
INFORMATION IN BRAILLE gefitinib mylan 250 mg
16. PODACI NA BRAILLEOVOM PISMU gefitinib mylan 250 mg
The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Povećanje može biti klinički značajno, jer su nuspojave povezane s dozom i izloženošću.
Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1).
Konjunktivitis, blefaritis i suhoća oka*, uglavnom blagi (CTC stupanj 1)
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Interval pouzdanosti je u cijelosti ispod granice neinferiornosti od 1,154.
Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Intersticijska bolest pluća (1,3%), često teška (CTC stupanj 3 ili 4).
Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Intersticijska bolest pluća (engl. interstitial lung disease, ILD), koja može nastupiti u akutnom obliku, zabilježena je u 1,3% bolesnika liječenih gefitinibom, a u nekim je slučajevima imala smrtni ishod (vidjeti dio 4.8).
Uncommon Corneal erosion, reversible and sometimes in association with aberrant eyelash growth.
Erozija rožnice, reverzibilna i ponekad udružena s aberantnim rastom trepavica Keratitis (0,12%)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VREĆICA
Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Istodobna primjena gefitiniba s ranitidinom u dozi koja uzrokuje trajno povišenje želučanog pH ≥ 5, u zdravih je dobrovoljaca uzrokovala smanjenje prosječnog AUC-a gefitiniba za 47% (vidjeti dijelove 4.4 i 5.2).
The recommended posology of Gefitinib Mylan is one 250 mg tablet once a day.
Preporučena doza lijeka Gefitinib Mylan je jedna tableta od 250 mg jednom na dan.
1.7 times higher in females than males
0,0397 1,7 puta veći u žena nego u muškaraca
Haemorrhage, such as epistaxis and haematuria.
Krvarenje, kao što su epistaksa i hematurija
In EGFR mutation-positive patients, significantly more gefitinib-treated patients experienced an improvement in quality of life and lung cancer symptoms vs carboplatin/paclitaxel (see Table 4).
Među bolesnicima pozitivnima na mutaciju EGFR-a, poboljšanje kvalitete života i simptoma raka pluća zabilježeno je u značajno većem broju onih liječenih gefitinibom u odnosu na one liječene karboplatinom/paklitakselom (vidjeti Tablicu 4).
In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received gefitinib or chemotherapy) were identified: smoking, poor performance status (PS≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
U farmakoepidemiološkom ispitivanju parova (engl. case-control) provedenom u Japanu na 3159 bolesnika s NSCLC-om liječenih gefitinibom ili kemoterapijom koji su praćeni tijekom 12 tjedana, utvrđeni su sljedeći čimbenici rizika za razvoj ILD-a (bez obzira jesu li bolesnici primali gefitinib ili kemoterapiju): pušenje, loše opće stanje (PS (engl. performance status) ≥ 2), CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), nedavno dijagnosticiran NSCLC
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of gefitinib.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
Gefitinib Mylan indiciran je kao monoterapija za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica (engl. non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama tirozin kinaze receptora epidermalnog faktora rasta (engl. epidermal growth factor receptor tyrosine kinase, EGFR-TK) (vidjeti dio 4.4).
Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Prethodno liječenje itrakonazolom (snažan inhibitor CYP3A4) u zdravih je dobrovoljaca izazvalo porast prosječnog AUCa gefitiniba za 80%.
The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy.
Randomizirano kliničko ispitivanje faze III (INTEREST) provedeno je u bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica koji su prethodno liječeni kemoterapijom temeljenom na platini.
• Nail problems.
• problemi s noktima
• Cystitis (burning sensations during urination and frequent, urgent need to urinate).
• cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘ sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
a Values presented are for gefitinib versus placebo.
Prikazane su vrijednosti za gefitinib u usporedbi s placebom.
Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Intersticijska bolest pluća (ILD) se javila u 1,3% bolesnika i često je bila teška (CTC stupanj 3 ili 4).
In the IPASS trial, gefitinib demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
U ispitivanju IPASS, gefitinib se pokazao boljim što se tiče preživljenja bez progresije bolesti, stope objektivnog odgovora, kvalitete života i olakšanja simptoma, dok nije bilo značajne razlike u ukupnom preživljenju u usporedbi s liječenjem karboplatinom/paklitakselom u prethodno neliječenih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica, koji imaju tumor s aktivirajućom mutacijom tirozin kinaze EGFR-a.
Idifarma Desarrollo Farmacéutico, S.L.
Idifarma Desarrollo Farmacéutico, S.L. Polígono Mocholí
Table 4 - Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study
Tablica 4 - Ishodi kvalitete života za gefitinib u usporedbi s karboplatinom/paklitakselom u ispitivanju IPASS
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Natrij Ovaj lijek sadržava manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
Primary endpoint overall survivala,b,c
Primarna mjera ishoda: ukupno preživljenjea,b,c
Very common Elevations in alanine aminotransferase, mainly mild to moderate.
Povišenje vrijednosti alanin aminotransferaze, većinom blago do umjereno
• Protein in your urine (shown in a urine test).
• proteini u mokraći (u nalazima pretraga mokraće)
HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m a b
HR 0,82 [0,70 do 0,96] 18,9 m vs 17,2 m a
HR Hazard ratio (hazard ratios <1 favour gefitinib).
HR Omjer hazarda (omjer hazarda < 1 ide u korist gefitiniba).
• Inflammation of the liver.
• upala jetre.
PVC/PVDC/Aluminium perforated unit dose blister in cartons containing 30x1 film-coated tablets.
PVC/PVDC/aluminijski perforirani blister s jediničnim dozama u kutiji s 30x1 filmom obloženom tabletom.
How to take Gefitinib Mylan
Kako uzimati Gefitinib Mylan
Some lung problems may get worse during treatment with Gefitinib Mylan.
Neke tegobe s plućima mogu se pogoršati tijekom liječenja lijekom Gefitinib Mylan. - ako ste nekad imali tegoba s jetrom.
Each film-coated tablet contains 250 mg of gefitinib.
Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
117 Allée des Parcs 69800 Saint-Priest
69800 Saint Priest
Table 5 - Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study Population
Tablica 5 - Ishodi djelotvornosti za gefitinib u usporedbi s docetakselom u INTEREST ispitivanju
a Values presented are for gefitinib versus docetaxel.
Prikazane su vrijednosti za gefitinib u usporedbi s docetakselom.
Numbers in square brackets are 95% confidence intervals for HR Number of patients randomised.
Brojevi u uglatim zagradama predstavljaju 95%-tni interval pouzdanosti za omjer hazarda.
Very common Anorexia mild or moderate (CTC grade 1 or 2).
Anoreksija blaga ili umjerena (CTC stupanj 1 ili 2)
• Fever.
• vrućica
Odds of EGFR mutation
Izgledi za mutaciju EGFR
Each tablet contains 161.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tableta sadržava 161,0 mg laktoze (u obliku hidrata) Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
How to store Gefitinib Mylan
Kako čuvati Gefitinib Mylan
Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Tablica 6 - Ishodi djelotvornosti za gefitinib u usporedbi s placebom u ispitivanju ISEL Populacija
Values presented are for gefitinib versus carboplatin/paclitaxel.
Prikazane su vrijednosti za gefitinib u usporedbi s karboplatinom/paklitakselom.
*from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
40/235 (17%) žena su M+ 35/551 (6%) muškaraca su M+ *iz sljedećih studija: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Numbers in square brackets are 95%confidence intervals for HR. c Stratified log-rank test for overall; otherwise cox proportional hazards model.
Stratificirani log-rank test za ukupno; u protivnom Coxov model proporcionalnih hazarda.
Primary endpoint overall survivala,b
Primarna mjera ishoda ukupno preživljenjea,b
Table 3 - Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Tablica 3 - Ishodi djelotvornosti za gefitinib u usporedbi s karboplatinom/paklitakselom u IPASS ispitivanju
Gefitinib Mylan 250 mg film-coated tablets gefitinib
Gefitinib Mylan 250 mg filmom obložene tablete gefitinib
30x1 film-coated tablets
OBLIK I SADRŽAJ Filmom obložena tableta 30 filmom obloženih tableta 30x1 filmom obložena tableta
Gefitinib Mylan contains lactose.
Gefitinib Mylan sadrži laktozu.
INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
U nekih bolesnika koji su istodobno uzimali varfarin prijavljene su povišene vrijednosti INR-a i/ili krvarenja (vidjeti dio 4.4).
International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
U nekih bolesnika koji su zajedno s gefitinibom uzimali varfarin zabilježen je porast međunarodnog normaliziranog omjera (engl. international normalised ratio, INR) i/ili epizode krvarenja (vidjeti dio 4.5).
• Red and sore eyelids.
• crveni i bolni kapci
Progression free survivala,b
Preživljenje bez progresije bolestia,b
Vomiting, mainly mild or moderate (CTC grade 1 or 2).
Povraćanje, većinom blago ili umjereno (CTC stupanj 1 ili 2)
Gefitinib Mylan contains sodium
Gefitinib Mylan sadrži natrij
EGFR mutation-positive
Pozitivni na mutaciju EGFR
Elevations in aspartate aminotransferase, mainly mild to moderate.
Povišenje vrijednosti aspartat aminotransferaze, većinom blago do umjereno Povišenje vrijednosti ukupnog bilirubina, većinom blago do umjereno
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of gefitinib.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
Proportion of tumour M- that are M- by ctDNA)
Udio M- tumora kod kojih je ctDNK bio M
Asiansc
Azijatic
Cutaneous vasculitis
Kožni vaskulitis
NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg tablets gefitinib
NAZIV LIJEKA Gefitinib Mylan 250 mg tablete gefitinib
• Dry mouth.
Kroz usta.
Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
In vitro ispitivanja pokazala su da je gefitinib supstrat P-glikoproteina (Pgp).
smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Rizik smrtnosti bolesnika u kojih se razvio ILD tijekom liječenja gefitinibom ili kemoterapijom bio je veći u bolesnika sa sljedećim čimbenicima rizika: pušenje, CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), otprije postojeći ILD, starija dob (≥ 65 godina) te opsežne pleuralne priraslice (≥ 50%).
Numbers in square brackets are 96% confidence interval for overall survival
Brojevi u uglatim zagradama predstavljaju 96%-tni interval pouzdanosti za omjer hazarda za ukupno preživljenje u ukupnoj populaciji, odnosno 95%-tni interval pouzdanosti za omjer hazarda.
Gefitinib Mylan contains lactose
Gefitinib Mylan sadrži laktozu
Nausea, mainly mild (CTC grade 1).
Astenija, pretežno blaga (CTC stupanj 1)
Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Lijekovi koji uzrokuju značajno trajno povišenje želučanog pH, kao što su inhibitori protonske pumpe i antagonisti
NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg film-coated tablets gefitinib
NAZIV LIJEKA Gefitinib Mylan 250 mg filmom obložene tablete
B. PACKAGE LEAFLET
Tablica 1 - Nuspojave
Very common Diarrhoea, mainly mild or moderate (CTC grade 1 or 2).
Proljev, većinom blag ili umjeren (CTC stupanj 1 ili
FACT-L QoL improvement ratea
Stopa poboljšanja kvalitete života prema FACT-La
Asiansd
Doziranje
Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia.
Dehidracija kao posljedica proljeva, mučnina, povraćanje ili anoreksija Suha usta*, pretežno blaga (CTC stupanj 1)
HR 1.020 [0.905, 1.150]c 7.6 m vs 8.0 m p=0.7332
HR 1,020 7,6 m vs 8,0 m p=0,7332
The withdrawal letter is available here.
Dopis o povlačenju dostupan je ovdje
It was to be available as 300 mg tablets.
Dostupan je u obliku tableta od 300 mg.
EMA/261739/2015 EMEA/H/C/002830
21. svibnja 2015. EMA/386107/2015 EMEA/H/C/002830
What is Corluxin?
Što je Corluxin?
Corluxin was not compared with any other medicine.
Corluxin nije uspoređen niti s jednim drugim lijekom.
In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog strateških poslovnih razloga.
The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment.
Tijekom ispitivanja promatrana su poboljšanja razine šećera u krvi i krvnog tlaka nakon 24 tjedana terapije lijekom Corluxin.
On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Dana 23. ožujka 2015., tvrtka FGK Representative Service GmbH službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoju zahtjev za odobrenje za stavljanje u promet lijeka Corluxin, za liječenje Cushingovog sindroma.
Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Corluxin (mifepriston)
The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
CHMP je također izrazio zabrinutost u vezi s glavnim ispitivanjem, navodeći, između ostalog, nedostatak usporednog lijeka.