natgillin/translations-raw huggingface dataset:
On 18 October 2012, the United Kingdom presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys.
Združeno kraljestvo je dne 18. oktobra 2012 agenciji predložilo obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje.
Therefore on 7 November 2013 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for all veterinary medicinal products containing enrofloxacin to be administered via drinking water to chickens and/or turkeys.
Odbor je zato 7. novembra 2013 soglasno sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje.
Content (concentration)
Vsebnost (koncentracija)
240 ml (10 mg/ml)
240 ml (10 mg/ml) 1 plastenka, (240 ml)+ 10 ml peroralna odmerna brizga in nastavek
10 mg/ml
10 mg/ml peroralna raztopina peroralna uporaba plastenka (HDPE)
Oral solution
Pakiranje
There were several measures of effectiveness in the studies.
V študijah je bilo uporabljenih več meril učinkovitosti.
It is used in patients with:
Uporablja se pri bolnikih:
The duration of treatment depends on the patient's condition and response to treatment.
Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje.
The recommended dose of Zeffix is 100 mg once a day.
Priporočeni odmerek zdravila Zeffix je 100 mg enkrat na dan.
• decompensated liver disease (when the liver does not work normally).
• z dekompenzirano jetrno boleznijo (jetra ne delujejo normalno).
The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix on 29 July 1999.
Evropska komisija je dovoljenje za promet z zdravilom Zeffix, veljavno po vsej Evropski uniji, izdala 29. julija 1999.
It is available as tablets (100 mg) and an oral solution (5 mg/ml).
Na voljo je v obliki tablet (100 mg) in peroralne raztopine (5 mg/ml).
The full EPAR for Zeffix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zeffix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Lamivudin ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
This document is a summary of the European public assessment report (EPAR) for Zeffix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zeffix.
Other information about Zeffix:
Druge informacije o zdravilu Zeffix:
These are patients infected with hepatitis B virus that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
To so bolniki, okuženi z virusom hepatitisa B, ki je mutiral (se spremenil), kar je povzročilo obliko kroničnega hepatitisa B, ki jo je težje zdraviti.
The CHMP decided that Zeffix's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zeffix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
• compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying and have signs of liver damage (raised levels of the liver enzyme alanine aminotransferase [ALT] and signs of damage when liver tissue is examined under a microscope).
• s kompenzirano jetrno boleznijo (jetra so poškodovana, a delujejo normalno), ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake poškodb jeter (povišane ravni jetrnega encima alanin-aminotransferaze [ALT] in znake poškodb, ki so vidni pod mikroskopom).
For more information about treatment with Zeffix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zeffix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Zeffix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In addition, information was presented on the use of Zeffix in patients with decompensated liver disease.
Predstavljeni so bili tudi podatki o uporabi zdravila Zeffix pri bolnikih z dekompenzirano jetrno boleznijo.
Zeffix was as effective as alfa-interferon.
Zdravilo Zeffix je bilo enako učinkovito kot alfa-interferon.
What benefit has Zeffix shown during the studies?
Kakšne koristi je zdravilo Zeffix izkazalo med študijami?
If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider switching treatment or adding another medicine for hepatitis B to reduce the risk of resistance.
Če je po šestih mesecih zdravljenja virus hepatitisa B v krvi še vedno prisoten, mora zdravnik razmisliti o spremembi zdravljenja ali dodajanju drugega zdravila za zdravljenje hepatitisa B, da se zmanjša tveganje za razvoj odpornosti.
Doses lower than 100 mg need to be given using the oral solution.
Odmerke, manjše od 100 mg, je treba dati v obliki peroralne raztopine.
Treatment with Zeffix should be started by a doctor who has experience in the management of chronic hepatitis B.
Zdravljenje z zdravilom Zeffix mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
These included looking at how the liver damage had evolved after a year of treatment using a liver biopsy (when a small sample of liver tissue is taken and examined under a microscope), as well as measuring other signs of the disease such as the levels of ALT or of hepatitis B virus DNA circulating in the blood.
Ta so vključevala proučevanje napredovanja jetrnega obolenja po enoletnem zdravljenju z uporabo biopsije jeter (odvzema majhnega vzorca jetrnega tkiva in njegove preiskave pod mikroskopom) kot tudi meritve drugih kazalnikov bolezni, kot so ravni ALT ali virusne DNK hepatitisa B, ki kroži v krvi.
Lamivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Lamivudin zavira delovanje virusnega encima DNK-polimeraze, ki je udeležen pri tvorbi virusne DNK.
Zeffix has been studied in five main studies involving a total of 1,083 adults with compensated liver disease due to chronic hepatitis B. Three studies compared Zeffix with placebo (a dummy treatment), one of which looked particularly at ‘HBeAg-negative' patients.
Zdravilo Zeffix so raziskali v petih glavnih študijah, v katere je bilo vključenih skupaj 1 083 odraslih s kompenzirano boleznijo jeter zaradi kroničnega hepatitisa B. V treh študijah so zdravilo Zeffix primerjali s placebom (zdravilom brez zdravilne učinkovine) zlasti pri „HBeAg-negativnih“ bolnikih.
Zeffix is a medicine that contains the active substance lamivudine.
Zeffix je zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
Because the hepatitis B virus can become resistant to Zeffix, the doctor should only consider prescribing Zeffix if other treatments that are less likely to lead to resistance cannot be used;
Ker lahko virus hepatitisa B postane odporen proti zdravilu Zeffix, naj ga zdravnik predpiše le, če drugih zdravil, pri katerih je razvoj odpornosti manj verjeten, ni mogoče uporabiti;
Zeffix is used to treat adults (aged 18 years or over) who have chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Zdravilo Zeffix se uporablja za zdravljenje odraslih bolnikov (starejših od 18 let) s kroničnim (dolgotrajnim) hepatitisom B (obolenjem jeter zaradi okužbe z virusom hepatitisa B).
The dose needs to be lower in patients who have reduced kidney function.
Pri bolnikih z zmanjšanim delovanjem ledvic morajo biti odmerki nižji.
To reduce the risk of resistance, Zeffix must be used in combination with another anti-hepatitis B medicine that does not cause resistance in the same way as Zeffix.
Za zmanjšanje tveganja za razvoj odpornosti se mora zdravilo Zeffix uporabiti skupaj z drugim zdravilom za zdravljenje okužbe z virusom hepatitisa B, ki ne povzroča razvoja odpornosti enako kot zdravilo Zeffix.
What is the risk associated with Zeffix?
Kakšna tveganja so povezana z zdravilom Zeffix?
The other two studies compared Zeffix taken on its own with alfa-interferon (another treatment used in chronic hepatitis B) on its own and with the combination of Zeffix and alfa-interferon.
V drugih dveh študijah so zdravilo Zeffix, ki se jemlje samostojno, primerjali z alfa-interferonom (drugim zdravilom za zdravljenje kroničnega hepatitisa B), ki se jemlje samostojno, kot tudi s kombinacijo zdravila Zeffix in alfa-interferona.
Why has Zeffix been approved?
Zakaj je bilo zdravilo Zeffix odobreno?
About half of the patients taking Zeffix had an improvement in liver damage assessed in a biopsy, compared with about a quarter of the patients who took placebo.
Po ocenah biopsije je pri več kot polovici bolnikov, ki so jemali zdravilo Zeffix, prišlo do izboljšanja jetrnega obolenja v primerjavi s četrtino bolnikov, ki so jemali placebo.
In patients with compensated liver disease, Zeffix was more effective than placebo in slowing down the progression of liver disease.
Pri bolnikih s kompenzirano jetrno boleznijo je bilo zdravilo Zeffix pri zaviranju napredovanja jetrnega obolenja učinkoviteje od placeba.
The active substance in Zeffix, lamivudine, is an antiviral agent that belongs to the class ‘nucleoside analogues'.
Zdravilna učinkovina zdravila Zeffix, lamivudin, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
In patients with decompensated liver disease, Zeffix also reduced levels of hepatitis B virus DNA and ALT.
Pri bolnikih z dekompenzirano jetrno boleznijo je zdravilo Zeffix zmanjšalo tudi ravni virusne DNK hepatitisa B in serumske alanin-aminotransferaze (ALT).
How has Zeffix been studied?
Kako je bilo zdravilo Zeffix raziskano?
What is Zeffix used for?
Za kaj se zdravilo Zeffix uporablja?
How does Zeffix work?
Kako zdravilo Zeffix deluje?
What is Zeffix?
Kaj je zdravilo Zeffix?
How is Zeffix used?
Kako se zdravilo Zeffix uporablja?
The most common side effect with Zeffix (seen in more than 1 patient in 10) is raised ALT levels.
Najpogostejši neželeni učinek zdravila Zeffix (opažen pri več kot 1 bolniku od 10) so povišane ravni ALT. Za celoten seznam neželenih učinkov ali omejitev pri uporabi zdravila Zeffix glejte navodilo za uporabo.
The full EPAR for Exforge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exforge je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Exforge amlodipine / valsartan
Exforge amlodipin/valsartan
The European Commission granted a marketing authorisation valid throughout the EU for Exforge on 17 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Exforge, veljavno po vsej Evropski uniji, izdala 16. januarja 2007.
Other information about Exforge
Druge informacije o zdravilu Exforge
The CHMP decided that Exforge's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Exforge večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Exforge.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Exforge.
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 Exforge.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo , na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Exforge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Exforge preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Exforge shown during the studies?
Kakšne koristi je zdravilo Exforge izkazalo med študijami?
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Z znižanjem krvnega tlaka se zmanjša možnost tveganj, povezanih z visokim krvnim tlakom, kot je na primer kap.
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.
Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Exforge, in ljudeh, ki so obe zdravilni učinkovini jemali ločeno.
The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Najpogostejši neželeni učinki zdravila Exforge (opaženi pri 1 do 10 bolnikih od 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), hipokaliemija (nizke ravni kalija v krvi), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
Exforge is taken by mouth as one tablet once a day with some water.
Zdravilo Exforge se jemlje peroralno, in sicer se zaužije ena tableta na dan z malo vode.
The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Odmerek zdravila Exforge, ki ga je treba vzeti, je odvisen od odmerkov amlodipina ali valsartana, ki ju je bolnik jemal prej.
Exforge must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Zdravila Exforge prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri ali izločanjem žolča, bolniki z nekaterimi obolenji srca ter bolniki s hudo hipotenzijo (nizkim krvnim tlakom).
What is the risk associated with Exforge?
Kakšna tveganja so povezana z zdravilom Exforge?
Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Zdravilo Exforge se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnati samo z amlodipinom ali valsartanom.
Exforge must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Zdravila Exforge ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda derivatov dihidropiridina, valsartan ali katero koli drugo sestavino zdravila.
Exforge must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Zdravilo Exforge se prav tako ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
For the full list of all side effects reported with Exforge, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exforge, glejte navodilo za uporabo.
Exforge is a medicine that contains two active substances, amlodipine and valsartan.
Exforge je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
How has Exforge been studied?
Kako je bilo zdravilo Exforge raziskano?
Why has Exforge been approved?
Zakaj je bilo zdravilo Exforge odobreno?
How is Exforge used?
Kako se zdravilo Exforge uporablja?
Exforge contains two active substances, amlodipine and valsartan.
Zdravilo Exforge vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
What is Exforge used for?
Za kaj se zdravilo Exforge uporablja?
What is Exforge?
Kaj je zdravilo Exforge?
Date of first authorisation: 6 May 2019
Datum prve odobritve: 6. maj 2019
Then take the next tablet at the usual time.
Nato vzemite naslednjo tableto ob običajnem času.
- if you are taking any of these medicines:
- če jemljete katerokoli izmed naslednjih zdravil:
Children and adolescents This medicine is only indicated in adults and it is not to be given to children and adolescents.
Otroci in mladostniki To zdravilo je indicirano le pri odraslih in ga ne smemo dajati otrokom in mladostnikom.
The clinical study report will be submitted by:
Poročilo klinične študije je treba predložiti do:
Elderly (≥ 65 years)
Starejši bolniki (≥ 65 let)
The effects on male reproductive organs were partially to fully reversible.
Učinki na moške reproduktivne organe so bili delno do popolnoma reverzibilni.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali kaže znake odpiranja.
This is because it may harm your baby.
To zdravilo lahko namreč škoduje vašemu otroku.
What to do if you forget to take a tablet depends on how long it is until your next dose.
Kaj storiti, če ste pozabili vzeti tableto, je odvisno od tega, kdaj morate vzeti naslednji odmerek.
The main efficacy results for Study A are included in Tables 3 and 4.
Glavni rezultati učinkovitosti za študijo A so vključeni v preglednicah 3 in 4.
• Do not take Lorviqua if you are pregnant.
• Ne jemljite zdravila Lorviqua, če ste noseči.
Treatment of overdose with the medicinal product consists of general supportive measures.
Zdravljenje prevelikega odmerjanja zdravila obsega splošne podporne ukrepe.
The safety and efficacy of lorlatinib in paediatric patients below 18 years have not been established.
Varnost in učinkovitost lorlatiniba pri pediatričnih bolnikih, mlajših od 18 let, nista bili dokazani.
Atrioventricular block occurred in 1.0% of patients.
Atrioventrikularni blok se je pojavil pri 1,0 % bolnikov.
If you are not able to take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with your doctor right away.
Če zdravila ne morete jemati tako, kot vam je predpisal zdravnik, ali če se vam zdi, da ga ne potrebujete več, se nemudoma posvetujte z zdravnikom.
These symptoms could be signs of heart problems.
Ti simptomi so lahko znak težav s srcem.
Your doctor may investigate further and treat you with other medicines such as antibiotics and steroids.
Zdravnik bo morda stanje nadalje preučil in vas zdravil z drugimi zdravili, kot so antibiotiki in steroidi.
Given the dose-dependent effect on PR interval, ECG monitoring is recommended.
Glede na od odmerka odvisen učinek na interval PR je priporočljivo spremljanje z EKG.
- speech problems, difficulty speaking, including slurred or slow speech.
- težave z govorom, otežen govor, vključno z nerazločnim ali upočasnjenim govorom.
Tell your doctor immediately if you develop: - heart problems.
Nemudoma obvestite zdravnika, če se vam pojavi naslednje: - težave s srcem.
a Grade categories are based on NCI CTCAE classifications.
Kategorije stopenj temeljijo na razvrstitvi po NCI CTCAE.
Talk to your doctor about the right methods of contraception for you and your partner.
Posvetujte se z zdravnikom, katere metode kontracepcije so prave za vas in vašega partnerja.
Within each frequency grouping, undesirable effects are presented in order of decreasing medical seriousness.
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči medicinski resnosti.
It is important to take Lorviqua every day, for as long as your doctor asks you to.
Pomembno je, da zdravilo Lorviqua jemljete vsak dan in tako dolgo, kot vam je naročil zdravnik.
Terms actually reported in the studies and contributing to the relevant adverse reaction are indicated in parentheses, as listed below.
Izrazi, o katerih so dejansko poročali v študijah in ki so prispevali k ustreznim neželenim učinkom, so navedeni v oklepajih, kot je navedeno spodaj.
Tell your doctor straight away if you notice any of the following side effects (also section 2 What you need to know before you take Lorviqua).
Nemudoma obvestite zdravnika, če opazite kateregakoli od naslednjih neželenih učinkov (glejte tudi poglavje 2 Kaj morate vedeti, preden boste vzeli zdravilo Lorviqua).
Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day with or without food (see section 5.2).
Bolnike je treba spodbujati, da vzamejo svoj odmerek lorlatiniba vsak dan ob približno istem času, s hrano ali brez nje (glejte poglavje 5.2).
Also troleandomycin, a medicine used to treat certain types of bacterial infections.
To velja tudi za troleandomicin, zdravilo, ki ga uporabljamo za zdravljenje določenih vrst bakterijskih okužb.
Lorviqua with food and drink
Zdravilo Lorviqua skupaj s hrano in pijačo
Patients should not take 2 doses at the same time to make up for a missed dose.
Bolniki ne smejo vzeti 2 odmerkov hkrati, da bi nadomestili izpuščeni odmerek.
Lorlatinib has moderate influence on the ability to drive and use machines.
Lorlatinib ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Lorlatinib may be administered with or without food.
Lorlatinib se lahko daje s hrano ali brez nje.
- You can take the tablets with food or between meals always avoiding grapefruit and grapefruit juice.
- Tablete lahko vzamete s hrano ali med dvema obrokoma, vedno pa se izogibajte grenivki in soku grenivke.
Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity.
Zdravljenje z lorlatinibom je priporočeno, dokler bolniku prinaša klinično korist brez nesprejemljive toksičnosti.
Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na foliji pretisnega omota in škatli poleg oznake ''EXP''.
Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval.
Razmislite o učinkih sočasnih zdravil ter ocenite in korigirajte neravnovesje elektrolitov, ki lahko podaljša interval PR.
Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Študije na živalih so pokazale embriofetalno toksičnost (glejte poglavje 5.3).
Delayed or missed doses
Zakasneli odmerek ali izpuščeni odmerek
Based on the available clinical study data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and lorlatinib.
Na podlagi razpoložljivih podatkov iz kliničnih študij ni mogoče ugotoviti vzročne povezave med učinki na spremembe krčljivosti srca in lorlatinibom.
Do not take Lorviqua - if you are allergic to lorlatinib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Lorviqua: - če ste alergični na lorlatinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Grade 4: Life-threatening/Urgent intervention indicated
4. stopnja: življenjsko ogrožajoči/indicirana nujna intervencija