natgillin/translations-raw huggingface dataset:
Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/FIV infections, the effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Mačke: Pošto je cijepljenje kontraindicirano u simptomatskoj fazi infekcije sa FeLV/FIV učinak VIRBAGEN OMEGA na cijepljenje mačaka nije istraživan.
Marketing authorisation holder and manufacturer responsible for batch release
Nositelj odobrenja i proizvođač odgovoran za puštanje proizvoda u prodaju
VIRBAGEN OMEGA Solvent for suspension for injection
Otapalo za suspenziju za injekciju
EXP: {month/year} Once reconstituted use immediately.
EXP {mjesec/godina} Poslije rekonstitucije primijeniti odmah.
Solvent: Type I glass vial of 1 ml of solvent closed with butyl elastomer rubber stopper.
Staklena bočica tipa I, od 1 ml zatvorena gumenim čepom od gumenog butilelastomera
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain, depending on the presentation, a limpid and colourless suspension containing 5 MU or 10 MU of recombinant interferon.
Liofilizirana frakcija mora biti rekonstituirana s 1 ml specifičnog otapala ovisno o tome da li prozirna i bezbojna suspenzija sadrži 5 MJ ili 10 MJ rekombiniranog interferona.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE
STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains:
SASTAV DJELATNIH TVARI Svaka doza od 1 ml sadrži: Djelatna tvar:
Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Liječenje mačaka inficiranih s FeLV i/ili FIV u neterminalnim kliničkim stadijima starijih od 9 tjedana.
Dogs: The dose is 2.5 MU/kg bodyweight.
Psi: doza je 2,5 MJ/kg tjelesne mase.
Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.
Djelotvornost proizvoda kod mačaka s tumoroznim oblikom infekcije FeLV ili mačaka zaraženih s
Isotonic sodium chloride solution
Izotonična otopina natrijevog klorida
Cats: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Mačke: Liječenje mačaka zaraženih s FeLV i/ili FIV, u neterminalnim kliničkim stadijima starijih od 9 tjedana.
The dose is 2.5 MU/kg bodyweight.
Doza je 2,5 MJ/kg tjelesne mase
Cats: The dose is 1 MU/kg bodyweight.
Mačke: doza je 1 MJ/kg tjelesne mase.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
Cats: The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Mačke: rekonstituirani proizvod treba aplicirati potkožno jedan puta na dan tijekom 5 uzastopnih dana.
Box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent.
Kutija s 2 bočice liofilizata i 2 bočice s 1 ml otapala.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
IZJAVA O DJELATNIM TVARIMA I DRUGIM SASTOJCIMA
Dogs: The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Psi: rekonstituirani proizvod treba aplicirati intravenozno jedan puta na dan tijekom tri uzastopna dana.
Once reconstituted use immediately.
Poslije rekonstitucije odmah primijeniti.
The dose is 1 MU/kg bodyweight.
Doza je 1 MJ/kg tjelesne mase.
Box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent.
Kutija s 5 bočica liofilizata i 5 bočica s 1 ml otapala.
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a suspension containing 5 MU of recombinant interferon.
NAČIN I PUT(EVI) PRIMJENE Liofilizirana frakcija mora biti rekonstituirana sa 1 ml specifičnog otapala da bi se dobila suspenzija koja sadrži 5 MJ rekombiniranog interferona.
The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Rekonstituirani proizvod treba aplicirati potkožno jednom dnevno, tijekom 5 uzastopnih dana.
For the 5MU presentation: Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Pakovanje od 5MJ: Kartonska kutija s 5 bočica liofilizata, i 5 bočica s 1 mL otapala.
The reconstituted product should be injected intravenously once daily for 3 consecutive days.
Rekonstituirani proizvod treba aplicirati intravenozno jednom dnevno tijekom 3 uzastopna dana.
Tel: +33-(0)4 92 08 73 00
France Tel: + 33-(0)4 92 08 73 00
Lyophilisate: white pellet Solvent: colourless liquid
Liofilizat: bijele pelete
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.
NAČIN I PUT(EVI) PRIMJENE Liofilizirana frakcija mora biti rekonstituirana sa 1 ml specifičnog otapala da bi se dobila suspenzija koja sadrži 10 MJ rekombiniranog interferona.
10 MU presentation: Recombinant Omega interferon of feline origin
Jačina 10 MJ: Rekombinirani omega interferon mačjeg podrijetla 10 MJ*
Recombinant Omega interferon of feline origin 10 MU* *MU : Million Units
Rekombinirani omega interferon mačjeg podrijetla 10 MJ*
Recombinant Omega interferon of feline origin 5 MU* 10 MU presentation:
Rekombinirani omega interferon mačjeg podrijetla 5 MJ*
Box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent.
Kartonska kutija s 1 bočicom liofilizata i 1 bočicom s 1 ml otapala.
Cats: as vaccination is contra-indicated in symptomatic phase of FeLV/FIV infections, effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Mačke: pošto je cijepljenje kontraindicirano u simptomatskoj fazi infekcije s FeLV/FIV učinak
This summary was last updated in 08-2016.
Sažetak je posljednji put ažuriran u 08.2016.
The full EPAR for IDflu can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek IDflu nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
IDflu contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
IDflu sadrži 15 mikrograma svakog od tri soja (vrste) virusa gripe (podvrsta H1N1, A/California/7/2009, NYMC X-179A, podvrsta H3N2, A/Hong Kong/4801/2014, NYMC X-263B i tip B, B/Brisbane/60/2008, divlji soj).
What measures are being taken to ensure the safe and effective use of IDflu?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka IDflu?
influenza vaccine (split virion, inactivated)
Cjepivo protiv influence (fragmentirani virion, inaktivirano)
Other information about IDflu
Ostale informacije o lijeku IDflu
For more information about treatment with IDflu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom IDflu pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
This is a summary of the European public assessment report (EPAR) for IDflu.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek IDflu.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Ubuduće će imunosni sustav biti u stanju brže stvarati protutijela nakon izloženosti bilo kojem od ovih sojeva virusa.
The antibodies will then help to protect against the disease caused by these strains of flu virus.
Protutijela zatim pomažu u zaštiti od bolesti uzrokovane tim sojevima virusa gripe.
The other two studies looked at use of a lower strength in people under the age of 60.
U druga su dva ispitivanja proučavane primjene manjih doza u ljudi mlađih od 60 godina.
Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Svake godine Svjetska zdravstvena organizacija (SZO) preporučuje koji se sojevi gripe moraju uključiti u cjepiva za nadolazeću sezonu gripe.
Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in IDflu before the
Fragmenti sojeva virusa za koje se očekuje da će prouzročiti gripu u nadolazećoj sezoni u skladu s preporukama SZO-a za sjevernu hemisferu kao i preporukama Europske unije (EU) moraju biti dodani cjepivu IDflu prije korištenja.
The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Najčešće nuspojave cjepiva IDflu (zabilježene u više od 1 na 10 osoba) su glavobolja, bol u mišićima i lokalne reakcije na mjestu cijepljenja (crvenilo, oteklina, otvrdnuće kože, bol i svrbež).
The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection).
Cjepivo sadrži fragmente virusa influence (gripe) koji su inaktivirani (obrađeni tako da sprečavaju nastanak infekcije).
When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign' and makes antibodies against them.
Nakon što osoba primi cjepivo, imunosni sustav prepoznaje fragmente virusa kao „strane” te protiv njih proizvodi protutijela.
The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in
Imunogenost i sigurnost naknadnih formulacija cjepiva također su proučavane u ispitivanjima.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka IDflu.
IDflu is a vaccine.
IDflu je cjepivo.
IDflu is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
IDflu se koristi za cijepljenje osoba od 60 godina i starijih protiv gripe, posebice onih koji su izloženi riziku od razvijanja komplikacija bolesti.
IDflu contains fragments from three different strains of flu virus.
IDflu sadrži fragmente iz tri različita soja virusa gripe.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of IDflu have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka IDflu nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
IDflu is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
IDflu se primjenjuje „intradermalnom” injekcijom u gornji sloj kože uz pomoć posebnog sustava mikro-injekcije.
The shoulder is the recommended site of injection.
Preporučeno mjesto primjene injekcije je područje ramena.
IDflu must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
IDflu se ne smije primjenjivati u osoba koje se preosjetljive (alergične) na djelatne tvari ili na bilo koji drugi sastojak, odnosno bilo koju komponentu koja može biti prisutna u vrlo malim količinama poput jaja (ovalbumin, pileći protein), neomicina, formaldehida ili octoksinola 9. Osobe koje imaju vrućicu ili akutnu (kratkoročnu) upalu ne smiju primiti cjepivo sve dok se ne oporave.
The vaccine can only be obtained with a prescription.
Cjepivo se izdaje samo na liječnički recept.
IDflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
IDflu je cjepivo koje je dostupno kao suspenzija za injekciju u prethodno napunjenoj štrcaljki.
What is the risk associated with IDflu?
Koji su rizici povezani s lijekom IDflu?
In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
U osoba u dobi od 60 godina i starijih, cjepivo jačine od 15 mikrograma potaklo je podjednako dobru razinu zaštite kao i usporedna cjepiva.
In one study in people aged 60 years and over, IDflu was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
U jednom ispitivanju u osoba u dobi od 60 godina i starijih IDflu je uspoređen s cjepivom protiv gripe koje sadrži adjuvans (spoj koji se dodaje za pojačanje imunosnog odgovora).
The CHMP decided that IDflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka IDflu nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Three studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Tri su ispitivanja obuhvatila osobe u dobi od 60 godina i starije koje su cijepljene cjepivom jačine 15 mikrograma.
The ability of IDflu to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Sposobnost lijeka IDflu da potakne stvaranje protutijela (imunogenost) ocijenjena je u pet glavnih ispitivanja koja su obuhvatila nešto manje od 9 000 bolesnika.
In the five original studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
U pet prvotnih ispitivanja IDflu i usporedno cjepivo doveli su do primjerene razine protutijela za zaštitu protiv sva tri soja gripe.
Later seasonal formulations of IDflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Kasnije sezonske formulacije lijeka IDflu potaknule su slične odgovore protutijela protiv sva tri soja gripe uključena u cjepivo kao u glavnim ispitivanjima.
Why has IDflu been approved?
Zašto je lijek IDflu odobren?
How does IDflu work?
Kako djeluje IDflu?
The use of the vaccine should be based on
Primjena cjepiva mora se temeljiti na službenim preporukama.
In all studies, IDflu was compared with another flu vaccine given by injection into a muscle.
U svim je ispitivanjima IDflu uspoređen s drugim cjepivom protiv gripe koje se primjenjuje injekcijom u mišić.
The European Commission granted a marketing authorisation valid throughout the EU for IDflu on 24
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek IDflu na snazi u Europskoj uniji od 24. veljače 2009.
The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before
Ispitivanjima je uspoređena sposobnost cjepiva da aktivira stvaranje protutijela (imunogenost), uspoređujući razine protutijela prije injekcije i tri tjedna nakon injekcije.
What benefit has IDflu shown during the studies?
Koje su koristi lijeka IDflu utvrđene u ispitivanjima?
For the full list of all side effects reported with IDflu, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni cjepiva IDflu potražite u uputi o lijeku.
• Take this medicine once daily about the same time each day.
• Uzmite ovaj lijek jedanput dnevno otprilike u isto vrijeme svaki dan.
The risk for humans is thus unknown.
Stoga, rizik u ljudi nije poznat.
The following other side effects have also been reported:
Također su prijavljene sljedeće druge nuspojave:
Do not give this medicine to children or adolescents under the age of 18 years.
Ne dajite ovaj lijek djeci ili adolescentima mlađim od 18 godina starosti.
No other liquids should be used.
Ne smiju se koristiti druge tekućine.
Data on Black racial groups was limited.
Podaci o crnačkoj rasnoj skupini bili su ograničeni.
See also section 4 “Possible side effects”.
Također pogledajte dio 4. „Moguće nuspojave“.
Do not open before use.
Ne otvarati prije uporabe.
% of patients improved a, c
% bolesnika s poboljšanjem a,c
Both individuals recovered from these adverse events.
Oba pojedinca su se oporavila od ovih nuspojava.
You may need urgent treatment.
To može zahtijevati hitno liječenje.
Drink the liquid straight away.
Odmah popijte tekućinu.
• Take this medicine at least 1 hour before eating, or
• Uzmite ovaj lijek najmanje 1 sat prije jela, ili
Overall Survival (OS)
Ukupno preživljenje (OS)
Then fill the glass again with water and drink it to make sure all medicine is taken.
Zatim ponovno napunite čašu s vodom i popijte ju kako biste bili sigurni da je lijek uzet u cijelosti.
Grade 2 (prolonged c or intolerable) or
Stupanj 2 (produljeno c ili nepodnošljivo) ili
Do not take a double dose (two tablets instead of one at the same time) to make up for a missed dose.
Nemojte uzeti dvostruku dozu (dvije tablete umjesto jedne u isto vrijeme) kako biste nadoknadili zaboravljenu dozu.
• if you are female, have a low body weight of less than 50 kg or have kidney problems.
• ako ste žena, imate tjelesnu težinu manju od 50 kg ili probleme s bubrezima.
Your doctor will decide with you whether treatment should be continued or not.
Vaš liječnik će odlučiti treba li nastaviti liječenje ili ne.
• If you have already eaten, wait at least 3 hours before taking this medicine.
• Ako ste već jeli, sačekajte najmanje 3 sata prije primjene ovog lijeka.
Your doctor may want to monitor you more closely.
Liječnik će Vas možda pažljivije pratiti.
The glass should be rinsed with approximately 100 ml of water which should also be consumed.
Čašu je potrebno isprati s oko 100 ml vode koja se također mora popiti.
Randomization was stratified by race (Eastern Asian vs non Eastern Asian).
Randomizacija je stratificirana prema rasi (istočni azijati naspram neistočnih azijata).
The following medicines may reduce the effectiveness of GIOTRIF:
Sljedeći lijekovi mogu smanjiti djelotvornost GIOTRIFA:
CR=complete response; PR=partial response
CR = potpuni odgovor; PR = djelomični odgovor
It is important to take this medicine every day, as long as your doctor prescribes it for you.
Važno je svakodnevno uzimati ovaj lijek, dok god ga je liječnik propisao.
No interruption
Bez prekida
This leaflet was last approved in {MM/YYYY} Other sources of information
Ova uputa je zadnji puta revidirana u {MM/GGGG} Ostali izvori informacija
Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.
Liječnik Vam može prilagoditi (povisiti ili sniziti) dozu ovisno o tome kako podnosite ovaj lijek.
NCI-CTC Grade
NCI-CTC stupanj
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući biljne lijekove i lijekove koje ste nabavili bez recepta.
PVC/PVDC perforated unit dose blister.
PVC/PVDC perforirani blister s jediničnim dozama.
These proteins are involved in the growth and spread of cancer cells, and can be affected by changes (mutations) in the genes that produce them.
Ovi proteini su uključeni u rast i širenje stanica raka, te na njih mogu utjecati promjene (mutacije) na genima koji ih proizvode.
Available non-clinical toxicology data have shown effects on reproductive organs at higher doses.
Dostupni neklinički podaci o toksičnosti pokazali su učinke na reproduktivne organe pri višim dozama.
Afatinib is eliminated with an effective half-life of approximately 37 hours.
Afatinib se eliminira uz efektivni poluvijek od približno 37 sati.
Tell your doctor before taking these medicines together with GIOTRIF.
Obavijestite liječnika prije uzimanja ovih lijekova zajedno s GIOTRIFOM.
Treatment in this population is not recommended (see section 4.4).
Liječenje se u ovoj populaciji ne preporučuje (vidjeti dio 4.4).
Do not take GIOTRIF - if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6).
Ne uzimajte GIOTRIF - ako ste alergični na afatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
• Decreased weight
• Smanjena težina
GIOTRIF has not been studied in children or adolescents.
GIOTRIF nije ispitivan na djeci i adolescentima.
Interactions with BCRP
Interakcije s BCRP-om
Therefore, treatment of children or adolescents with this medicinal product is not recommended.
Stoga se liječenje djece ili adolescenata ovim lijekom ne preporučuje.
There is no specific antidote for overdose with this medicinal product.
Ne postoji specifičan antidot za predoziranje ovim lijekom.
By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.
Blokiranjem aktivnosti ovih proteina ovaj lijek može zaustaviti rast i širenje stanica raka.
GIOTRIF is to be taken by mouth.
GIOTRIF se uzima kroz usta.
Body System
Tjelesni sustav
GIOTRIF may increase the blood levels of other medicines including but not limited to:
GIOTRIF može povisiti vrijednosti drugih lijekova u krvi uključujući, ali ne ograničeno na:
• It is important to take this medicine without food
• Važno je uzeti ovaj lijek bez hrane.
Interrupt until Grade 0/1
Prekid do stupnja 0/1
The tablets should be swallowed whole with water.
Tablete je potrebno progutati cijele s vodom.
Summary of the safety profile
Pregled profila sigurnosti
Left ventricular dysfunction has been associated with HER2 inhibition.
Disfunkcija lijevog ventrikula povezana je s HER2 inhibicijom.
This is because there may be a risk that an unborn baby is harmed.
Ovo je potrebno jer postoji mogućnost štetnosti za nerođeno dijete.
If you experience any of the symptoms above, contact your doctor as soon as possible.
Ako primijetite bilo koji od gore navedenih simptoma, javite se liječniku što je prije moguće.
If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 ml of non-carbonated drinking water.
Ako gutanje cijele tablete nije moguće, ona se može raspršiti u oko 100 ml negazirane vode za piće.
The median PFS was 12.0 months by independent review.
Medijan PFS-a je bio 12,0 mjeseci na temelju nezavisne procjene.
Efficacy in EGFR-negative tumours has not been established.
Djelotvornost u EGFR negativnih tumora nije ustanovljena.
If a dose is missed, it should be taken within the same day as soon as the patient remembers.
U slučaju propuštene doze, ona se mora uzeti u istom danu čim se bolesnik sjeti.
Then carry on taking your tablets at regular times as usual.
Zatim nastavite uzimati tablete u pravilnim intervalima na uobičajeni način.
> 48 hours of diarrhoea and/or > 7 days of rash
> 48 sati proljeva i/ili > 7 dana osipa
Assessment of EGFR mutation status
Procjena statusa mutacije EGFR
Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes.
Proljev može rezultirati dehidracijom sa ili bez oštećenja bubrega, što je u rijetkim slučajevima rezultiralo fatalnim ishodima.
Adverse changes were restricted to toxic dose levels.
Takve promjene bile su ograničene na vrijednosti do toksičnih doza.
Decreased appetite
Smanjeni apetit
If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
Ako bolesnik ne može podnijeti 20 mg/dan, potrebno je razmotriti trajni prekid primjene GIOTRIFA
If you take more GIOTRIF than you should
Ako uzmete više GIOTRIFA nego što ste trebali
The individual effect sizes of these covariates were considered not clinically relevant.
Važnost pojedinačnih učinaka ovih varijabli smatrani su klinički neznačajnima.