natgillin/translations-raw huggingface dataset:
Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
• krvavitev (npr. krvavitev iz nosu ali kri v urinu)
Further precautions for use
Dodatni previdnostni ukrepi
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Gefitinib se pretežno presnovi prek izoencima CYP3A4 citokroma P450, pa tudi prek izoencima CYP2D6.
Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Številke v oglatih oklepajih so 95 % intervali zaupanja za ROG.
No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events (see section 5.2).
Bolniki, ki imajo genotip slabih metabolizatorjev s CYP2D6, ne potrebujejo specifične prilagoditve odmerka, vendar jih je treba natančno kontrolirati glede neželenih učinkov (glejte poglavje 5.2).
Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Zdravilne učinkovine, katerih koncentracijo v plazmi lahko spremeni gefitinib Študije in vitro so pokazale omejen potencial gefitiniba za zaviranje CYP2D6.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free'.
Zdravilo IRESSA vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODATKI NAVEDENI NA ZUNANJI OVOJNINI
1692 8.0% vs 1.3%
1692 8,0 % v prim.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
1 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).
Randomizirana študija III. faze IPASS v zdravljenju prve izbire je bila opravljena pri bolnikih v Aziji bolniki so imeli napredovalega (stadij IIIB ali IV) nedrobnoceličnega pljučnega raka s histološko sliko adenokarcinoma ter so bili nekdanji blagi kadilci (kajenje so opustili pred > 15 let in so kadili < 10 škatlic-let) ali niso nikoli kadili (glejte preglednico 3).
Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Preglednica 5 Izidi učinkovitosti gefitiniba v primerjavi z docetakselom v študiji INTEREST
High doses of short-acting antacids may have a similar effect if taken regularly close in time to administration of gefitinib.
Veliki odmerki kratkodelujočih antacidov, uporabljenih blizu časa jemanja gefitiniba, imajo lahko podoben učinek.
If you have any further questions, ask your doctor, pharmacist or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
342 12.4% vs 2.1%
342 12,4 % v prim.
Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Zdravilne učinkovine, ki lahko zmanjšajo koncentracijo gefitiniba v plazmi Snovi, ki inducirajo CYP3A4, lahko povečajo presnovo in zmanjšajo koncentracijo gefitiniba v plazmi ter tako zmanjšajo učinkovitost gefitiniba.
CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Induktorji CYP3A4 lahko povečajo presnovo gefitiniba in zmanjšajo njegovo koncentracijo v plazmi.
375 18.1% vs 0%
375 18,1 % v prim.
Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Snovi, ki občutno in dolgotrajno zvišajo pH v želodcu, lahko zmanjšajo koncentracijo gefitiniba v plazmi in tako zmanjšajo učinkovitost gefitiniba.
Haemorrhage, such as epistaxis and haematuria
Krvavitev, npr. epistaksa in hematurija
(48.0% vs 40.8%) p=0.0148
s 40,8 %) p = 0,0148
Haemorrhagic cystitis
Hemoragični cistitis
N FACT-L QoL improvement rate
N Delež izboljšanja kakovosti življenja po FACT-L
The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Če uporaba celih tablet ni mogoča, se jih lahko uporabi v obliki disperzije v (negazirani) vodi.
1350 6.8% vs 1.0%
1350 6,8 % v prim.
OTHER
Mera
In the IFUM trial, mutation status was assessed in tumour and ctDNA samples derived from plasma, using the Therascreen EGFR RGQ PCR kit (Qiagen).
Tumorska DNK v obtoku (ctDNK - cirkulirajoča tumorska DNK) V preskušanju IFUM so mutacijsko stanje v vzorcih tumorja in iz plazme dobljenih vzorcih ctDNK testirali s kompletom Therascreen EGFR RGQ PCR (Qiagen).
Proportion of tumour M- that are Mby ctDNA)
Delež tumorskih M-, ki so M- po ctDNK
IRESSA contains lactose
Zdravilo IRESSA vsebuje laktozo
In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA 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 IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Odprto klinično preskušanje III. faze (IPASS) je primerjalo zdravljenje z zdravilom IRESSA in dvotirno kemoterapijo s karboplatinom/paklitakselom kot zdravljenje prve linije pri 1217 izbranih bolnikih z napredovalim nedrobnoceličnim pljučnim rakom v Aziji.
IRESSA contains lactose.
Zdravilo IRESSA vsebuje laktozo.
323 19.7% vs 8.7%
323 19,7 % v prim.
<2D barcode carrying the unique identifier included.>
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
V preskušanju gefitiniba samega so poročali o še enem primeru krvavitve v osrednje živčevje pri otroku z ependimomom.
189 2.6% vs 0%
189 2,6 % v prim.
Dry, red or itchy eyes
• suhe, pordele in srbeče oči
(14.6% vs 36.3%) p=0.0021
s 36,3 %) p = 0,0021
26 37.5% vs 0%
26 37,5 % v prim.
Ever smoker
Kajenje kdaj v življenju
Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Preglednica 6 Izidi učinkovitosti gefitiniba v primerjavi s placebom v študiji ISEL
1466 9.1% vs 7.6%
1466 9,1 % v prim.
Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Preglednica 3 Izidi učinkovitosti gefitiniba v primerjavi s karboplatinom/paklitakselom v študiji IPASS
780 43.3% vs 29.2%
780 43,3 % v prim.
3.7 m vs 5.9 m p=0.4449
s 5,9 m p = 0,4449
Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
Pri 652 od 1060 presejanih bolnikov so bili za ocenjevanje primerni tako vzorci ctDNK kot vzorci tumorja.
1217 43.0% vs 32.2%
1217 43,0 % v prim.
There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Uporaba gefitiniba za indikacijo nedrobnocelični pljučni rak v pediatrični populaciji ni primerna.
261 71.2% vs 47.3%
261 71,2 % v prim.
An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed.
Pri bolnikih z zmerno in hudo okvaro jeter so ugotovili v povprečju 3,1-krat večjo izpostavljenost gefitinibu.
9.5 m vs 5.5 m p=0.0100
s 5,5 m p = 0,0100
1317 5.3% vs 1.6%
1317 5,3 % v prim.
IRESSA 250 mg film-coated tablets gefitinib
IRESSA 250 mg filmsko obložene tablete gefitinib
No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours.
Pri bolnikih s tumorji brez mutacije EGFR (negativna mutacija EGFR) niso ugotovili klinično pomembnega delovanja.
The hepatocellular adenomas were also seen in a 2-year carcinogenicity study in mice, which demonstrated a small increased incidence of this finding in male mice at the mid dose, and in both male and female mice at the highest dose.
Hepatocelularne adenome so ugotovili tudi v 2-letni študiji kancerogenosti pri miših.
Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.
Gefitinib je selektiven malomolekulski zaviralec receptorja za epidermalni rastni dejavnik tirozin-kinaze.
6.4 m vs 6.0 m p=0.9131
s 6,0 m p = 0,9131
IRESSA 250 mg film-coated tablets
IRESSA 250 mg filmsko obložene tablete
1143 6.2% vs 7.3%
1143 6,2 % v prim.
5.0 m vs 4.9 m p=0.2420
s 4,9 m p = 0,2420
44 42.1% vs 21.1%
44 42,1 % v prim.
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
• zvišanje bilirubina in drugega jetrnega encima, imenovanega aspartat-aminotransferaza, na preiskavi krvi; če je njuna raven previsoka, vam bo zdravnik morda naročil, da nehajte jemati zdravilo IRESSA
(70.2% vs 44.5%) p<0.0001
s 44,5 %) p < 0,0001
INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Pri nekaterih bolnikih, ki so sočasno jemali varfarin, so se pojavili zvišanje INR in/ali krvavitve (glejte poglavje 4.4).
Inflammation of the liver.
• vnetje trebušne slinavke.
Table 1 Adverse reactions
Preglednica 1: Neželeni učinki
2.0 m vs 2.6 m p=0.5771
z 2,6 m p = 0,5771
5.6 m vs 5.1 m p=0.0871
s 5,1 m p = 0,0871
In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Med sočasnim zdravljenjem z močnimi zaviralci CYP3A4 je bolnike treba natančno kontrolirati glede neželenih učinkov gefitiniba.
(75.6% vs 53.9%) p=0.0003
s 53,9 %) p = 0,0003
7.6 m vs 8.0 m p=0.7332
z 8,0 m p = 0,7332
International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Pri nekaterih bolnikih, ki so jemali varfarin skupaj z gefitinibom, so se pojavili zvišanje internacionalnega normaliziranega razmerja (INR) in/ali krvavitve (glejte poglavje 4.5).
2.2 m vs 2.7 m p=0.4658
z 2,7 m p = 0,4658
6.9 m vs 6.9 m p=0.9259
s 6,9 m p = 0,9259
5.2 m vs 5.1 m p=0.2942
s 5,1 m p = 0,2942
The glass should be rinsed with half a glass of water, which should also be drunk.
Tableto dajte v pol kozarca vode za pitje, ne da bi jo zdrobili.
This medicine has been prescribed for you only.
• Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
(51.5% vs 48.5%) p=0.3037
z 48,5 %) p = 0,3037
Elevations in aspartate aminotransferase, mainly mild to moderate
Zvišanje aspartat-aminotransferaze, v glavnem blago do zmerno Zvišanje celotnega bilirubina, v glavnem blago do zmerno
Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
Če ste noseči, če bi lahko zanosili ali če dojite, se posvetujte z zdravnikom, preden vzamete to zdravilo.
10.4 m vs 12.2 m p=0.7711
z 12,2 m p = 0,7711
How to store IRESSA
Shranjevanje zdravila IRESSA
4.4 m vs 2.2 m p=0.0084
z 2,2 m p = 0,0084
253 6.6% vs 9.8%
253 6,6 % v prim.
If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The proportion of ILD-type events with a fatal outcome was
Delež dogodkov tipa IBP s smrtnim izidom je bil 38,6 %.
An increased risk of cerebral haemorrhage in adult patients with NSCLC receiving gefitinib has not been established.
Pri odraslih bolnikih z nedrobnoceličnim rakom pljuč, ki dobivajo gefitinib, niso ugotovili večjega tveganja za možgansko krvavitev.
1.7 m vs 2.6 m p=0.1353
z 2,6 m p = 0,1353
4m p=0.1087
s 17,4 m p=0,1087
Nail problems
• težave z nohti
14.2 m vs 16.6 m p=0.6043
s 16,6 m p = 0,6043
18.8 m vs 17.
18,8 m v prim.
Non-Asians
Neazijci
(20.2% vs 47.5%) p=0.0002
s 47,5 %) p = 0,0002
Odds of EGFR mutation
Obeti za mutacijo EGFR
7.0 m vs 4.1 m p=0.0012
s 4,1 m p = 0,0012
There have been isolated reports of hepatic failure which in some cases led to fatal outcomes.
Opisani so bili posamezni primeri odpovedi jeter; nekateri so se končali s smrtjo.
The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
In vitro je ugotovljeno, da O-dezmetilgefitinib nastaja z delovanjem CYP2D6.
10.8 m vs 3.8m p=0.7382
s 3,8 m p = 0,7382
EGFR mutation-positive
Pozitivna mutacija EGFR
Stomatitis, predominantly mild in nature (CTC grade 1)
Stomatitis, pretežno blag (1. stopnja po CTC)
2.9 m vs 2.7 m p=0.0197
z 2,7 m p = 0,0197
In a phase I/II trial studying the use of gefitinib and radiation in paediatric patients, with newly diagnosed brain stem glioma or incompletely resected supratentorial malignant glioma, 4 cases (1 fatal) of Central Nervous System (CNS) haemorrhages were reported from 45 patients enrolled.
faze so raziskovali uporabo gefitiniba in obsevanja pri pediatričnih bolnikih z novoodkritim gliomom možganskega debla ali nepopolno reseciranim supratentorijskim malignim gliomom.
Discontinuation should be considered if changes are severe.
Če so spremembe hude, pride v poštev prekinitev zdravljenja.
8.9 m vs 6.1 m p=0.0124
s 6,1 m p = 0,0124
1.5 m vs 5.5 m p<0.0001
s 5,5 m p < 0,0001
21.6 m vs 21.9 m
z 21,9 m
6.1List of excipients
6.1 Seznam pomožnih snovi
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 IRESSA 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.
Kot dejavnike tveganja za nastanek IBP (ne glede na to, ali je bolnik dobival zdravilo IRESSA ali kemoterapijo) so ugotovili: kajenje, slab zmogljivostni status (zmogljivostni status ≥ 2), računalniško-tomografske (CT) znake zmanjšanja normalnih pljuč (≤ 50 %), nedavno postavljeno
2.7 m vs 2.6 m p=0.0707
z 2,6 m p = 0,0707
2.0 m vs 2.7 m p=0.1041
z 2,7 m p = 0,1041
HR 1.01
z 1,0 %
EGFR mutation-negative
Negativna mutacija EGFR
EGFR mutationunknown
Neznana mutacija EGFR
Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Morda boste potrebovali nujno zdravniško pomoč:
2.9 m vs 2.8 m p=0.1746
z 2,8 m p = 0,1746
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:
Neželeni učinki, ki jih niso opazili v kliničnih študijah, opaženi pa so bili pri kliničnih stopnjah izpostavljenosti v študijah na živalih in bi lahko bili pomembni za klinično uporabo, so: - atrofija roženičnega epitelija in translucence roženice - renalna papilarna nekroza - hepatocelularna nekroza in eozinofilna sinusoidalna infiltracija z makrofagi
3.0 m vs 2.6 m p=0.0006
z 2,6 m p = 0,0006
176 1.1% vs 23.5%
176 1,1 % v prim.
HR 1.16
z 1,6 %
Gefitinib is extensively metabolised in humans.
• Zdravilna učinkovina je gefitinib.
Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Dehidracija zaradi driske, navzee, bruhanja ali anoreksije Suha usta*, pretežno blaga (1. stopnja po CTC)
5.7 m vs 5.8 m p<0.0001
s 5,8 m p < 0,0001
Numbers in square brackets are 96% confidence interval for overall survival
Številke v oglatih oklepajih so 96 % intervali zaupanja za razmerje ogroženosti za skupno preživetje ROG v celotni populaciji, sicer pa 95 % intervali zaupanja za ROG.
Weakness
• šibkost
Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
Red and sore eyelids
• pordele in pekoče veke
Trial outcome index results were supportive of FACT-L and LCS results
Trial outcome index rezultati so potrdili rezultate FACT-L in LCS a Prikazane so vrednosti za zdravilo IRESSA v primerjavi s karboplatinom/paklitakselom N Število bolnikov, primernih za analize kakovosti življenja KŽ kakovost življenja
5.6 m vs 2.8 m p<0.0001
z 2,8 m p < 0,0001
9.5 m vs 6.3 m p<0.0001
s 6,3 m p < 0,0001
HR NC
PC:
Values presented are for IRESSA versus carboplatin/paclitaxel.
• fenitoin ali karbamazepin (za epilepsijo)
Measure
Odmerjanje
Hair loss
Bolezni nohtov
42.9 v. 20.0 EGFR Mutation+
Pozitivna mutacija EGFR 259 (70,2 % v prim.
Adenocarcinoma
Proteinurija
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).
Ta se lahko pojavi akutno in je bila v nekaterih primerih smrtna (glejte poglavje 4.8).
11.2 m vs 12.7 m
z 12,7 m
Bottle (glass)
Steklenička (steklo)
1 bottle +1 adaptor + 3 oral syringes
1 steklenica + 1 nastavek + 3 brizge za peroralno dajanje
MA (EU) number Invented name
(Izmišljeno) ime
Oral suspension
Peroralna suspenzija Peroralna uporaba
Immediate Packaging Content
Velikost pakiranja
Strength Pharmaceutical form Route of administration
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
London, 23 July 2009 Doc.
London, 23. julija 2009 Sklic dok.
Ref. EMEA/448660/2009 EMEA/H/C/1041
EMA/123941/2010 EMEA/H/C/1041
In 2008, the CHMP had formulated a list of questions to be answered by the company.
Leta 2008 je CHMP pripravil seznam vprašanj, na katera naj bi družba odgovorila.
But, the company withdrew its application before responding to the questions.
Vendar je družba umaknila svojo vlogo, še preden je odgovorila na vprašanja.
The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Družba je morala predložiti svoje odgovore Odboru za napredne terapije v skladu z novo zakonodajo Evropske unije o naprednih terapijah.
Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Poleg tega družba ni predložila dovolj dokazov o tem, da je zdravilo varno, da ga je mogoče izdelati zanesljivo ali da ni škodljivo za okolje ali ljudi, ki so v tesnem stiku z bolnikom.
Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Končno je CHMP menil, da ni dovolj informacij o toksičnosti zdravila, njegovi porazdelitvi v telesu in vlogi nekaterih genov in nečistoč v zdravilu.
It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Uporabljalo naj bi se pri neodzivnem (ki se ne odziva na zdravljenje) ali ponavljajočem se (ki se ponavlja) raku.
This is a type of medicine that works by delivering genes into the body.
To je vrsta zdravila, ki dovaja gene v telo.
The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Novi geni povzročijo, da telo začne ali preneha proizvajati beljakovino, ki lahko pomaga pri zdravljenju bolezni.
The application was at day 120 of the procedure when the company withdrew.
Družba je vlogo umaknila na 120. dan postopka.
Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Zdravilo Contusugene Ladenovec Gendux naj bi se uporabljalo za zdravljenje karcinoma skvamoznih celic glave in vratu (vrste raka, ki se začne v celicah sluznice ustne votline, nosu, žrela ali ušes).
Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Contusugene Ladenovec Gendux contusugene ladenovec
The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Učinki zdravila Contusugene Ladenovec Gendux so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Ker rakave celice vsebujejo poškodovano DNK, beljakovina p53 bodisi pomaga popraviti DNK bodisi povzroči odmrtje celic.
The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
Beljakovina p53 tudi zmanjša tvorbo krvnih žil, ki oskrbujejo rakave celice.
The p53 protein normally contributes to the repair of damaged DNA, causes cell death when the DNA cannot be repaired and helps control the formation of blood vessels.
Beljakovina p53 običajno prispeva k popravilu poškodovane DNK, povzroča odmiranje celic, kjer DNK ni mogoče popraviti, in pomaga nadzorovati tvorbo krvnih žil.
The Committee was of the opinion that the company had not shown that Contusugene Ladenovec Gendux was beneficial to patients.
Odbor je menil, da družba ni dokazala, da je zdravilo Contusugene Ladenovec Gendux koristno za bolnike.
In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
V eni glavni študiji s 123 bolniki z neodzivnim ali ponavljajočim se karcinomom skvamoznih celic glave in vratu so zdravilo Contusugene Ladenovec Gendux primerjali z metotreksatom (drugo zdravilno učinkovino za zdravljenje raka).
On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Družba Gendux Molecular Limited je dne 12. junija 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Contusugene Ladenovec Gendux, namenjenim zdravljenju ponavljajočega se ali neodzivnega karcinoma skvamoznih celic glave in vratu.
The virus in Contusugene Ladenovec Gendux is an ‘adenovirus' that has been modified so that it does not cause disease in humans.
Virus v zdravilu Contusugene Ladenovec Gendux je „adenovirus“, ki je bil spremenjen tako, da ne povzroča bolezni pri ljudeh.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Contusugene Ladenovec Gendux?
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Contusugene Ladenovec Gendux could not have been approved for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Na podlagi pregleda podatkov je CHMP v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Contusugene Ladenovec Gendux ni mogoče odobriti za zdravljenje ponavljajočega se ali neodzivnega raka skvamoznih celic glave in vratu.
Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Zdravilo Contusugene Ladenovec Gendux je bilo razvito kot vrsta zdravila za napredno terapijo, imenovano „zdravilo za genetsko terapijo“.
By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
S povečanjem tvorbe beljakovine p53 naj bi zdravilo Contusugene Ladenovec Gendux ozdravilo raka ali upočasnilo njegovo napredovanje.
What is Contusugene Ladenovec Gendux?
Kaj je zdravilo Contusugene Ladenovec Gendux?