natgillin/translations-raw huggingface dataset:
The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Actrapid (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
Zdravilo Actrapid se lahko daje tudi intravensko (v žilo), vendar ga smeta tako uporabiti samo zdravnik ali medicinska sestra.
It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).
Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (NovoLet, InnoLet ali FlexPen).
Actrapid is used to treat diabetes.
Zdravilo Actrapid se uporablja za zdravljenje sladkorne bolezni.
The active substance in Actrapid, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Zdravilna učinkovina v zdravilu Actrapid, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri insulin izdelajo kvasovke, ki prejmejo ustrezni gen (DNK), s pomočjo katerega postanejo sposobne tvoriti insulin.
What benefit has Actrapid shown during the studies?
Kakšne koristi je zdravilo Actrapid izkazalo med študijami?
What is the risk associated with Actrapid?
Kakšna tveganja so povezana z zdravilom Actrapid?
Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins.
Actrapid je hitrodelujoči insulin in se lahko uporablja v kombinaciji s srednjedolgo- ali dolgodelujočimi insulini.
The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
V študijah so zdravilo Actrapid šest mesecev primerjali z drugim nadomestnim insulinom, imenovanim insulin aspart, na podlagi merjenja ravni glikoziliranega hemoglobina (HbA1c), ki predstavlja delež hemoglobina v krvi, na katerega se je vezala glukoza.
Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.
Zdravila Actrapid ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani insulin ali katero koli drugo sestavino zdravila.
For the full description of all side effects reported with Actrapid, see the package leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Actrapid, glejte navodilo za uporabo.
Actrapid is a solution for injection that contains the active substance human insulin.
Zdravilo Actrapid je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks).
Zdravilo Actrapid se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), deltoidnega predela (ramena) ali glutealnega predela (zadnjice).
Why has Actrapid been approved?
Zakaj je bilo zdravilo Actrapid odobreno?
Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.
Zdravilo Actrapid je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
How has Actrapid been studied?
Kako je bilo zdravilo Actrapid raziskano?
How is Actrapid used?
Kako se zdravilo Actrapid uporablja?
What is Actrapid used for?
Za kaj se zdravilo Actrapid uporablja?
What is Actrapid?
Kaj je zdravilo Actrapid?
How does Actrapid work?
Kako zdravilo Actrapid deluje?
Cattle: 46 days Dogs: not applicable injection
Govedo: 46 dni Psi: ni smiselna
Target species
Govedo
Bottle (HDPE) 1,000 ml Pack of 6 bottles
Pakiranju je 6 steklenic.
15 mg Coated tablets Dogs
Govedo in psi
This may take up to 20 minutes.
To lahko traja do 20 minut.
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Kitajska, Hong Kong, Indonezija, Japonska, Malezija, Filipini, Singapur, Tajvan in Tajska.
Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
Datum pridobitve dovoljenja: 24/06/2009 Datum zadnjega podaljšanja: 23/04/2014
An updated RMP shall be submitted:
Posodobljen RMP je treba predložiti:
b “m” is medians in months.
b “m” predstavlja mediane v mesecih.
*from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
*iz študij INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
if you have ever had problems with your liver.
• če ste kdaj imeli težave z jetri.
None of the patients had cancer, all had cirrhosis and some had hepatitis.
Noben bolnik ni imel raka, vsi so imeli cirozo in nekateri so imeli hepatitis.
These data are similar to those reported in the IPASS study.
Ti podatki so podobni tistim, ki so bili poročani v študiji IPASS.
Then take the next dose as usual.
Potem vzemite naslednji odmerek kot ponavadi.
These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Ti podatki se skladajo z vnaprej načrtovano eksplorativno analizo japonske podskupine v IPASS (Goto 2012).
The ORR according to investigator review was 70% and the median PFS was 9.7 months.
ORR je bil, glede na pregled preiskovalcev, 70 %, mediana PFS pa je bila 9,7 mesecev.
Other potential interactions
Druge možne interakcije
Barbiturates (a type of medicine used for sleeping problems).
• barbiturate (vrsto zdravil, ki se uporabljajo za težave s spanjem)
Allergic reactions (1.1%), including angioedema and urticaria
Alergijske reakcije (1,1 %), vključno z angioedemom in urtikarijo
The clinical relevance of these findings is unknown.
Klinični pomen teh izsledkov ni znan.
Overall survival a,b
Skupno preživetje a,b
In that study, sensitivity was 43.1%, specificity was
V tisti študiji je bila senzitivnost 43,1 % in specifičnost 100 %.
In one study a limited number of patients were treated weekly with doses from 1500 mg to 3500 mg.
V eni študiji so manjše število bolnikov vsak teden zdravili z odmerki od 1500 mg do 3500 mg.
This resulted in a 35% increase in exposure to metoprolol.
To je povzročilo 35 % povečanje izpostavljenosti metoprololu.
Plasma protein binding is approximately 90%.
Vezava na beljakovine v plazmi je približno 90 %.
Severe skin reactions (rare) affecting large areas of your body.
• Hude kožne reakcije (redke), ki prizadenejo obširne dele telesa.
Loss of appetite
• izguba apetita
IRESSA should not be used during pregnancy unless clearly necessary.
Zdravila IRESSA se ne sme uporabljati med nosečnostjo, če ni zares nujno.
Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so po pogostnosti opredeljeni kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Quality of life outcomes differed according to EGFR mutation status.
Izidi kakovosti življenja so se razlikovali glede na stanje mutacije EGFR.
Therefore, patients who experience this symptom should be cautious when driving or using machines.
Zato morajo biti bolniki, ki se jim pojavi ta simptom, previdni, če vozijo ali upravljajo s stroji.
Red or sore mouth
• rdeča ali vneta usta
Gefitinib showed no genotoxic potential.
Gefitinib ni pokazal genotoksičnega potenciala.
Survival outcomes differed by smoking status and ethnicity (see Table 6).
Izidi preživetja se razlikujejo glede na kadilski status in etnično pripadnost (glejte preglednico 6).
Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Pozitivna napovedna vrednost (9,5 % celotne populacije je z EGFR pozitivnimi mutacijami (M+))
These symptoms should be managed as clinically indicated (see section 4.8).
Te simptome je treba obvladati, kot je klinično indicirano (glejte poglavje 4.8).
This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
To lahko prizadene 1 od 100 bolnikov, ki jemljejo zdravilo IRESSA in je lahko smrtno nevarno.
FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
FACT-L Functional assessment of cancer therapy-lung LCS Lung cancer subscale
The tablet may be taken orally with or without food, at about the same time each day.
Tableto je mogoče vzeti peroralno s hrano ali brez nje, vsak dan ob približno istem času.
No other liquids should be used.
Uporabljena ne sme biti nobena druga tekočina.
Take the tablet at about the same time each day.
• Tableto vzemite vsak dan ob približno istem času.
Mechanism of action and pharmacodynamic effects
Mehanizem delovanja in farmakodinamski učinki
This protein is involved in the growth and spread of cancer cells.
Ta beljakovina je vpletena v rast in širjenje rakavih celic.
IRESSA did not prolong survival in the overall population.
Zdravilo IRESSA ni podaljšalo preživetja v skupni populaciji.
Swirl the water until the tablet has dissolved.
Vodo mešajte, dokler se tableta ne raztopi.
If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.
Če jemljete kakšno zdravilo, ki vsebuje to zdravilno učinkovino, vam bo zdravnik morda pogosteje kontroliral kri.
You can take the tablet with or without food.
• Tableto lahko vzamete s hrano ali brez nje.
The lips, nose, eyes and genitals may also be affected.
Prizadete so lahko tudi ustnice, nos, oči in spolovila.
The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes).
Vsebino občasno premešajte, dokler se tableta ne razpusti (to lahko traja do 20 minut).
40/235 (17%) of females are M+ 35/551 (6%) of males are M+
40/235 (17 %) žensk je M+ 35/551 (6 %) moških je M+
Then take the next tablet at the usual time.
Naslednjo tableto vzemite ob običajnem času.
Like all medicines this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Epidermalni rastni dejavnik (EGF) in njegov receptor (EGFR [HER1; ErbB1]) sta bila ugotovljena kot glavna dejavnika celične rasti in proliferacije normalnih in rakavih celic.
This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
To lahko pomeni, da imate vnetje pljuč, imenovano "intersticijska bolezen pljuč".
These patients should be closely monitored for adverse events.
Takšne bolnike je treba natančno kontrolirati glede neželenih učinkov.
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
Učinkovitost in varnost zdravila IRESSA pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
These medicines may affect the way IRESSA works.
Ta zdravila lahko vplivajo na delovanje zdravila IRESSA.
There are no data from the use of gefitinib in pregnant women.
Podatkov o uporabi gefitiniba pri nosečnicah ni.
This side effect is uncommon; however, some patients have died from this.
Ta neželeni učinek je občasen, vendar so nekateri bolniki zaradi njega umrli.
Never smoker
Nikdar kadilec
0.0397 1.7 times higher in females than males
0,0397 1,7-krat večji pri ženskah kot pri moških
Rifampicin (for tuberculosis).
• rifampicin (za tuberkulozo)
PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Perforirani pretisni omot iz PVC/aluminija, ki vsebuje 10 tablet ali neperforirani pretisni omot iz PVC/aluminija, ki vsebuje 10 tablet.
Figures 1 and 2 Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Sliki 1 in 2 Izidi učinkovitosti v podskupinah bolnikov Neazijcev v študiji INTEREST (N bolnikov = število randomiziranih bolnikov)
Tell your doctor as soon as possible if you notice any of the following side effects:
Zdravniku povejte, takoj ko je to mogoče, če opazite katerega od naslednjih neželenih učinkov:
Dose adjustment due to toxicity
Prilagoditev odmerka zaradi toksičnih učinkov
IFUM rate % (CI)
Delež v IFUM % (IZ)
Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Zdravljenje z zdravilom IRESSA mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Disperzijo popijte takoj, ko se tableta razpusti (tj. v 60 minutah).
63/396 (16%) of patients with adenocarcinoma histology are M+ 12/390 (3%) of patients with non-adenocarcinoma histology are M+
63/396 (16 %) bolnikov s histologijo adenokarcinoma je M+ 12/390 (3 %) bolnikov s histologijo neadenokarcinoma je M+
It is therefore considered unlikely that it contributes to the clinical activity of gefitinib.
Zato ni verjetno, da bi prispeval h kliničnemu delovanju gefitiniba.
Therefore, periodic liver function testing is recommended.
Zato so priporočljive redne kontrole delovanja jeter.
If you take more IRESSA than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Če ste vzeli večji odmerek zdravila IRESSA, kot bi smeli Če ste vzeli več tablet, kot bi smeli, se morate takoj posvetovati z zdravnikom ali farmacevtom.
Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Bolnik ne sme vzeti dvojnega odmerka (dveh odmerkov ob istem času), da bi nadomestil pozabljeni odmerek.
Histology <0.0001 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
< 0,0001 4,4-krat večji pri adenokarcinomu kot pri neadenokarcinomu
Warfarin (a so-called oral anticoagulant, to prevent blood clots).
• varfarin (t. i. peroralni antikoagulans, za preprečevanje krvnih strdkov).
What IRESSA is and what it is used for
Kaj je zdravilo IRESSA in za kaj ga uporabljamo
Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Po peroralni uporabi s C-14 označenega gefitiniba pri doječih podganah 14 dni po skotitvi je bila koncentracija radioaktivnosti v mleku od 11- do 19-krat večja kot v krvi.
The effects reached statistical significance for the female mice, but not for the males.
Ti učinki so dosegli statistično značilnost pri mišjih samicah, ne pa pri samcih.
Asymptomatic laboratory elevations in blood creatinine Proteinuria
Asimptomatično laboratorijsko zvišanje kreatinina v krvi
What you need to know before you take IRESSA
Kaj morate vedeti, preden boste vzeli zdravilo IRESSA
Some lung problems may get worse during treatment with IRESSA.
Nekatere težave s pljuči se lahko med zdravljenjem z zdravilom IRESSA poslabšajo.
The blister foil may be perforated or non-perforated.
Pretisni omot je lahko perforiran ali neperforiran.
Available data do not suggest any clinical consequences to this in vitro finding.
Razpoložljivi podatki ne kažejo kliničnih posledic tega izsledka in vitro.
Cases with fatal outcomes have been reported.
Opisani so bili primeri s smrtnim izidom.
ADRs usually occur within the first month of therapy and are generally reversible.
Neželeni učinki se ponavadi pojavijo prvi mesec zdravljenja in so praviloma reverzibilni.
If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Če je do naslednjega odmerka manj kot 12 ur, bolnik ne sme vzeti pozabljenega odmerka.
The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Med znaki so zelo hude bolečine v zgornjem delu trebuha in močno siljenje na bruhanje ali bruhanje.
Contains lactose and sodium, see package leaflet for further information.
Vsebuje laktozo in natrij, za dodatne informacije glejte navodilo za uporabo.
The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Varnostne značilnosti, prikazane v preglednici 1, temeljijo na programu kliničnega razvoja gefitiniba in pomarketinških izkušnjah.
Adverse reactions associated with overdose should be treated symptomatically; in particular severe diarrhoea should be managed as clinically indicated.
Neželene učinke, ki spremljajo preveliko odmerjanje, je treba zdraviti simptomatsko; zlasti hudo drisko je treba zdraviti, kot je klinično indicirano.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov navedeno v poglavju 6.1.
In this study IRESSA 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 IRESSA.
V tej študiji se izpostavljenost zdravilu IRESSA z naraščajočim odmerkom ni povečala, neželeni učinki so bili večinoma blagi do zmerni in skladni z znanimi varnostnimi značilnostmi zdravila IRESSA.
Women of childbearing potential must be advised not to get pregnant during therapy.
Ženske v rodni dobi Ženskam v rodni dobi je treba svetovati, da med zdravljenjem ne smejo zanositi.
Patients taking warfarin and gefitinib concomitantly should be monitored regularly for changes in prothrombin time (PT) or INR.
Bolnike, ki sočasno jemljejo varfarin in gefitinib, morate redno kontrolirati glede sprememb protrombinskega časa (PČ) ali INR.
To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
Da boste zaužili res vse zdravilo, kozarec nato zelo dobro splaknite s pol kozarca vode in to vodo popijte.
It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Priporočljivo je, da med zdravljenjem z zdravilom IRESSA ne zanosite in ne dojite, kajti zdravilo IRESSA lahko škoduje vašemu otroku.
This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.
Ta rak je bolezen, pri kateri v pljučnem tkivu nastajajo maligne (rakave) celice.
Asian patients also have a higher incidence of EGFR mutation-positive tumours.
Tudi azijski bolniki imajo večjo incidenco tumorjev s pozitivno mutacijo EGFR.
Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration.
Bolnikom naročite, da morajo takoj poiskati zdravniško pomoč, če se jim pojavijo huda ali dolgotrajna driska, navzea, bruhanje ali anoreksija, ker lahko vse te posredno povzročijo dehidracijo.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, zmanjšano celokupno aktivnostjo laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Smoking status <0.0001 6.5 times higher in never smokers than ever-smokers
< 0,0001 6,5-krat večji pri tistih, ki niso nikoli kadili, kot pri tistih, ki so kdaj kadili
Other medicines and IRESSA
Druga zdravila in zdravilo IRESSA
Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Erozija roženice, reverzibilna in včasih povezana z aberantno rastjo trepalnic Keratitis (0,12 %)
Gefitinib plus best supportive care was compared to placebo plus best supportive care.
Gefitinib in najboljšo podporno oskrbo so primerjali s placebom in najboljšo podporno oskrbo.
Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme Cutaneous vasculitis
Bulozne spremembe, vključno s toksično epidermalno nekrolizo, StevensJohnsonovim sindromom in multiformnim eritemom Kutani vaskulitis
EGFR activating mutation within a cancer cell is an important factor in promotion of tumour cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Mutacija, ki aktivira EGRF v rakavi celici je pomemben dejavnik, ki prispeva k rasti tumorskih celic, blokiranju apoptoze, povečanemu nastajanju angiogenetskih faktorjev in olajševanju metastaziranja.
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA Velika Britanija
Each tablet contains 163.5 mg of lactose (as monohydrate).
Ena tableta vsebuje 163,5 mg laktoze (v obliki monohidrata).
Exposure to gefitinib is not significantly altered by food.
Hrana izpostavljenosti gefitinibu ne spremeni bistveno.
It is not known whether gefitinib is secreted in human milk.
Ni znano, ali se gefitinib pri človeku izloča v materino mleko.
If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
• Če je do naslednjega odmerka 12 ur ali več: Vzemite pozabljeno tableto, čim se spomnite.
LCS symptom improvement rate
Delež izboljšanja simptomov po LCS
The higher average exposures that could be achieved by individuals with no active CYP2D6 may be clinically relevant since adverse effects are related to dose and exposure.
Večja povprečna izpostavljenost, ki jo lahko dosežejo posamezniki brez aktivnega CYP2D6, bi lahko bila klinično pomembna, ker so neželeni učinki povezani z odmerkom in izpostavljenostjo.
Do not crush the tablet.
Tablete ne smete zdrobiti.
*This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.
* Ta neželeni učinek lahko spremlja druga suha stanja (predvsem kožne reakcije), opažene med uporabo gefitiniba.
No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Odmerka ni treba prilagoditi bolnikom z okvarjenim delovanjem ledvic, ki imajo očistek kreatinina > 20 ml/min.
Do not use any other liquids.
Za raztapljanje ne smete uporabiti nobene druge tekočine.
N Number of patients randomised.
N število randomiziranih bolnikov.
Data from 4 patients with severe hepatic impairment due to liver metastases suggested that steady-state exposures in these patients are also similar to those in patients with normal hepatic function.
Podatki 4 bolnikov s hudo okvaro jeter zaradi metastaz na jetrih kažejo, da je izpostavljenost v stanju dinamičnega ravnovesja tudi pri teh bolnikih podobna kot pri bolnikih z normalnim delovanjem jeter.
Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Poleg tega je bila v 5 do 10 % primerov opisana fenotipska sprememba v drobnocelični rak pljuč.
Itraconazole (for fungal infections).
• itrakonazol (za glivične okužbe)
Elderly No dose adjustment is required on the basis of patient age (see section 5.2).
Starejši Odmerka ni treba prilagoditi glede na starost (glejte poglavje 5.2).
Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Podatki o odzivu na gefitinib so bolj skromni pri bolnikih, ki imajo tumorje z manj pogostimi mutacijami; podatki, ki so na voljo, kažejo, da mutacije G719X, L861Q in S7681 povečujejo občutljivost, sama mutacija T790M ali same insercije v eksonu 20 pa so mehanizmi odpornosti.
Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Redno jemanje antacidov, uporabljenih blizu časa jemanja gefitiniba, imajo lahko podoben učinek (glejte poglavji 4.5 in 5.2).
Approximately 8% of patients had a severe ADR (common toxicity criteria (CTC) grade 3 or 4).
Približno 8 % bolnikov je imelo hude neželene učinke (3. ali 4. stopnjo po Skupnih merilih toksičnosti [common toxicity criteria], CTC).