natgillin/translations-raw huggingface dataset:
Do not use in case of hypersensitivity to the active substance or to any of the excipients. 
Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively. 
Po enkratnem podkožnem odmerku meloksikama 0,5 mg/kg je Cmax znašala 2,1 μg/ml oziroma 2,7 μg/ml po 7,7 ure oziroma 4 ure pri mladem govedu oziroma kravah v obdobju laktacije.
METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC, IV 
POT(I) UPORABE ZDRAVILA Govedo: s.c., i.v.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard Box: 10 ml, 50 ml or 100 ml vials 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla: viale z 10 ml, 50 ml ali 100 ml
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs. 
Po dveh intramuskularnih odmerkih meloksikama po 0,4 mg/kg je Cmax pri prašičih po 1 uri znašala 1,9 μg/ml.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. 
Kot dodatna terapija pri zdravljenju akutnega mastitisa ob antibiotičnem zdravljenju.
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours. 
Končna razpolovna doba izločanja meloksikama po intravenski injekciji pri konjih znaša 8,5 ure.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity. 
Zaradi morebitne nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri zelo dehidriranih, hipovolemičnih ali hipotenzivnih živalih, ki potrebujejo parenteralno rehidracijo.
The active substance in Recocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v zdravilu Recocam je dovoljena snov, kot je navedena v tabeli 1 (dovoljene snovi) Priloge Uredbe Komisije (EU) št. 37/2010:
Horses: Do not use in pregnant or lactating mares. 
Konji: Ne uporabite pri kobilah v obdobju brejosti ali laktacije.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after “EXP”. 
Za shranjevanje zdravila niso potrebna posebna navodila Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
Disposal: read the package leaflet 
Odstranjevanje: preberite navodilo za uporabo.
Meloxicam20 mg 
Meloksikam 20 mg
Once broached, use by …. 
Načeto zdravilo uporabite do…
Not authorised to use in horses producing milk for human consumption. 
Ni dovoljena uporaba pri kobilah, katerih mleko je namenjeno prehrani ljudi.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml 
KOLIČINA UČINKOVIN(E) Meloksikam 20 mg/ml
Do not use in horses producing milk for human consumption. 
Ne uporabljajte pri kobilah, katerih mleko je namenjeno za prehrano ljudi.
A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies. 
V kliničnih raziskavah so zasledili blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goveda.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS Glass vial label for 50 ml and 100 ml 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Steklena viala - nalepka za 50 ml in 100 ml
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. 
Za umirjanje ohromelosti in vnetja pri neinfekcijskih lokomotornih motnjah.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 28 days 6.4. 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
Cattle: meat and offal: 15 days; milk: 5 days 
Govedo: Meso in organi: 15 dni, Mleko: 5 dni.
Active substance: Meloxicam20 mg 
Zdravilna učinkovina: Meloksikam 20 mg
STATEMENT OF ACTIVE SUBSTANCES Meloxicam 20 mg/ml 
NAVEDBA UČINKOVIN(E) Meloksikam 20 mg/ml
Bovine, caprine 
KARENCA Govedo:
Meat and offal: 15 days Milk: 5 days 
meso in organi: 15 dni, mleko: 5 dni.
Horses: meat and offal: 5 days. 
Konji: meso in organi: 5 dni.
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. 
Enkratna podkožna ali intravenska injekcija v odmerku po 0,5 mg meloksikama na kilogram telesne mase (to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Antiinflammatory agents/Nonsteroidal antiinflammatory agents 
Protivnetna zdravila/nesteroidna protivnetna zdravila govedo, koze
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight). 
Enkratna intravenska injekcija v odmerku po 0,6 mg meloksikama na kilogram telesne mase (to je 3,0 ml/100 kg telesne mase).
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
6.1 Seznam pomožnih snovi etanol 99,9 % citronska kislina, brezvodna poloksamer 188 meglumin glicin makrogol 300 natrijev hidroksid (za uravnavo pH) klorovodikova kislina (za uravnavo pH) voda za injekcije
LOT {number} 
ŠTEVILKA SERIJE LOT {številka}
For the relief of pain associated with equine colic. 
Za lajšanje s koliko povezane bolečine pri konjih.
NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
Shelf-life after first opening the container: 28 days Once broached, use by …. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. 
Enkratna intramuskularna injekcija v odmerku po 0,4 mg meloksikama na kilogram telesne mase (to je 2,0 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
Meglumine 
Presnavljanje
NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje meloksikam
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Meloxicam Meloxicam Bovine, caprine, porcine, rabbit, 
Terapevtske indikacije meloksikam meloksikam govedo, koze, prašiči, kunci, kopitarji µg/kg65 µg/kg 65 µg/kg mišice jetra ledvica
PACKAGE LEAFLET Recocam 20 mg/ml solution for injection for cattle, pigs and horses 
NAVODILO ZA UPORABO Recocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days 
Govedo: meso in organi: 15 dni, mleko: 5 dni.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial label for 10 ml 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Pigs: Meat and offal: 5 days 
Prašiči: meso in organi: 5 dni.
STATEMENT OF THE MRLS 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
Do not use in pregnant or lactating mares. 
Ne uporabljajte pri kobilah v obdobju brejosti in laktacije.
Excipient: Ethanol 
4.11 Karenca
The name of the medicine was changed to Bondenza on 18 August 2004. 
Ime zdravila je bilo 18. avgusta 2004 spremenjeno v Bondenza.
Other information about Bondenza 
Druge informacije o zdravilu Bondenza
The full EPAR for Bondenza 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 Bondenza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water. 
Tableto je treba vedno vzeti zjutraj na tešče, eno uro pred prvim obrokom ali pijačo (razen vode) s polnim kozarcem navadne vode.
Bondenza has been studied in three main studies involving women with osteoporosis. 
Zdravilo Bondenza so raziskovali v treh glavnih študijah, v katere so bile vključene ženske z osteoporozo.
Patients taking Bondenza should also take vitamin D and calcium supplements if they do not get enough from their diet. 
Bolnice, ki jemljejo zdravilo Bondenza, bi morale jemati tudi dodatke vitamina D in kalcija, če teh ne dobivajo v zadostni količini s prehrano.
For more information about treatment with Bondenza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Bondenza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Bondenza's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Bondenza večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Bondenza. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bondenza.
The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic Acid Roche on 23 February 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Roche, veljavno po vsej Evropski uniji, odobrila dne 23. februarja 2004.
What benefit has Bondenza shown during the studies? 
Kakšne koristi je zdravilo Bondenza izkazalo med študijami?
What is the risk associated with Bondenza? 
Kakšna tveganja so povezana z zdravilom Bondenza?
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 Bondenza. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bondenza, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Previously known as Ibandronic Acid Roche. 
Predhodno znano kot Ibandronic Acid Roche.
The 2.5-mg once-daily tablets used in the studies are no longer authorised. 
V študiji uporabljene 2,5-miligramske tablete, ki se jemljejo enkrat dnevno, niso več odobrene.
The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour. 
Tablet ne smejo jemati bolnice z nepravilnostmi v požiralniku ali bolnice, ki vsaj eno uro ne morejo stati ali sedeti vzravnano.
It must not be used in patients who have hypocalcaemia (low blood calcium levels). 
Zdravilo se ne sme uporabljati pri bolnicah, ki imajo hipokalciemijo (nizke ravni kalcija).
Bondenza must not be used in people who are hypersensitive (allergic) to ibandronic acid or any of the other ingredients. 
Zdravila Bondenza ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) ibandronsko kislino ali katero koli drugo sestavino zdravila.
Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established. 
V študijah so dokazali učinek zdravila pri zmanjševanju tveganja za zlome hrbtenice, medtem ko njegov vpliv na tveganje za zlom stegneničnega vratu (zgornjega dela stegnenice) ni bil dokazan.
The most common side effects with Bondenza (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms. 
Najpogostejši neželeni učinki zdravila Bondenza (opaženi pri 1 do 10 bolnic od 100) so artralgija (bolečine v sklepih) in gripi podobni simptomi.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. 
Zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Bondenza can be given either as a tablet or as an injection into a vein. 
Zdravilo Bondenza se daje bodisi s tabletami ali z injiciranjem v veno.
Why has Bondenza been approved? 
Zakaj je bilo zdravilo Bondenza odobreno?
Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks). 
Zdravilo Bondenza se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
Bondenza is a medicine that contains the active substance ibandronic acid. 
Bondenza je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
For the full list of all side effects reported with Bondenza, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondenza, glejte navodilo za uporabo.
The patient must not lie down for one hour after taking the tablet. 
Eno uro po zaužitju tablete bolnica ne sme ležati.
In the first study, daily treatment with Bondenza 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo. 
V prvi študiji je dnevno zdravljenje z 2,5-miligramskimi tabletami Bondenza v primerjavi s placebom za 62 % zmanjšalo tveganje za nove zlome hrbtenice.
ibandronic acid 
Bondenza ibandronska kislina
The active substance in Bondenza, ibandronic acid, is a bisphosphonate. 
Zdravilna učinkovina v zdravilu Bondenza, ibandronska kislina, je difosfonat.
How has Bondenza been studied? 
Kako je bilo zdravilo Bondenza raziskano?
The first study compared Bondenza 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years. 
V prvi študiji so zdravilo Bondenza v obliki 2,5-miligramskih tablet, ki so jih bolnice jemale enkrat dnevno, primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 3 000 bolnicah in ugotavljali število novih zlomov hrbtenice pri bolnicah v triletnem obdobju študije.
The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip. 
Drugi dve študiji sta pokazali, da so 150miligramske mesečne tablete in injekcije pri povečevanju kostne gostote v hrbtenici in kolkih učinkovitejše od 2,5-miligramskih tablet, ki se jemljejo enkrat na dan.
What is Bondenza used for? 
Za kaj se zdravilo Bondenza uporablja?
How is Bondenza used? 
Kako se zdravilo Bondenza uporablja?
What is Bondenza? 
Kaj je zdravilo Bondenza?
How does Bondenza work? 
Kako zdravilo Bondenza deluje?
Immediate Packaging Pack size pre-filled syringe (glass) 
Stična ovojnina Velikost pakiranja raztopina za injicoranje intravitrealna uporaba napolnjena injekcijska brizga (steklo)
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika Pot uporabe
vial (glass) 
raztopina za injiciranje intravitrealna uporaba viala (steklo)
90 sachets (with a dosing spoon) 
90 vrečic (z odmerno žličko)
Strength Pharmaceutical Form 
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
1 vial + 1 ampoule 
1 viala 1 ampula
3 vials + 3 ampoules 
3 viale 3 ampule prašek: 7,5 mg; vehikel: 5 ml (1,5 mg/ml)
• are over 75 years old 
• ste starejši od 75 let;
Drink the mixture. 
Mešanico spijte.
E-mail: medinfo_de@eisai.net 
E-pošta: medinfo_de@eisai.net
Date of first authorisation: 25 August 2016 
Datum prve odobritve: 25. avgust 2016
Medical Dictionary for Regulatory Activities (MedDRA) version 17.1. 
Medicinski slovar za regulativne dejavnosti (MedDRA) verzija 17.1.
The effects of Kisplyx in people younger than 18 years old are not known. 
Učinki zdravila Kisplyx pri ljudeh, mlajših od 18 let, niso znani.
The time to onset was 69.6 weeks. 
Čas do nastopa je bil 69,6 tedna.
Preferred terms have been reassigned to the SOC most relevant to the target organ. 
Prednostni izrazi so bili prerazporejeni v SOC, ki najbolj ustreza tarčnemu organu.
The study consisted of a Phase 1b dose finding and a Phase 2 portion. 
Študijo sta sestavljala del faze 1b za ugotavljanje odmerka in del faze 2.
Treatment should continue as long as there is clinical benefit or until unacceptable toxicity occurs. 
Zdravljenje naj se nadaljuje, dokler je klinično koristno ali dokler se ne pojavi nesprejemljiva toksičnost.
The Efron method was used for correction for tied events. 
Efronova metoda je bila uporabljena za popravek povezanih dogodkov.
Resolves to less than 2 gm / 24 hours. 
Izboljša se na manj kot 2 g/24 ur.
Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggests that it is in the order of 85%. 
Absolutne biološke uporabnosti pri ljudeh niso določili, vendar podatki iz študije masnega ravnovesja kažejo, da je približno 85 %.
If you forget to take Kisplyx Do not take a double dose (two doses at the same time) to make up for a forgotten dose. 
Če ste pozabili vzeti zdravilo Kisplyx Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), da bi nadomestili pozabljeni odmerek.
See detailed guidance in Table 3 in section 4.4. 
Glejte podrobne smernice v preglednici 3 v poglavju 4.4.
The combination should be used in patients with severe hepatic impairment only if the anticipated benefit exceeds the risk. 
Kombinacija naj se uporablja pri bolnikih s hudo okvaro jeter le, če je pričakovana korist večja od tveganja.
Grade 4 (despite medical management) 
stopnja 4 (kljub medicinski obravnavi)
Juvenile animal toxicity studies 
Študije toksičnosti na mladičih živali
The study was not powered for the OS analysis. 
Študija ni imela ustrezne moči za analizo OS.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment: 
Nemudoma povejte zdravniku, če opazite katerega od naslednjih neželenih učinkov - mogoče boste potrebovali nujno zdravljenje:
Percentages are based on the total number of subjects in the Full Analysis Set within relevant treatment group. 
Odstotni deleži temeljijo na celotnem številu preiskovancev v celotnem naboru za analizo (Full Analysis Set) znotraj zadevne skupine zdravljenja.
• Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
Metastases were present in 95% of the patients and unresectable advanced disease was present in 5%. 
Metastaze so bile prisotne pri 95 % bolnikov, neresektabilna napredovala bolezen pa je bila prisotna pri 5 %.
How long to takeKisplyx You will usually carry on taking this medicine as long as you are getting benefit. 
Kako dolgo jemljite zdravilo Kisplyx Navadno boste jemali to zdravilo tako dolgo, kolikor vam bo koristilo.
Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd. 
Ime in naslov proizvajalca, odgovornega za sproščanje serij Eisai Manufacturing Ltd.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja.
Symptoms would depend on where the fistula is located. 
Simptomi so odvisni od lokacije fistule.
Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or the BSEP. 
Lenvatinib ni substrat za OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2 ali BSEP.
Diarrhoea was the most frequent cause of dose interruption/reduction and recurred despite dose reduction. 
Driska je bila najpogostejši vzrok prekinitve/zmanjšanja odmerjanja in se je ponovila kljub zmanjšanju odmerka.
Your doctor will discuss the results of these tests with you and decide whether you can be given Kisplyx. 
Zdravnik se bo pogovoril z vami o rezultatih teh preiskav in se odločil, ali vam lahko da zdravilo Kisplyx.
• headache and back pain 
• glavobol in bolečine v hrbtu,
Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances. 
Sočasna uporaba lenvatiniba, karboplatina in paklitaksela ni pomembno vplivala na farmakokinetiko katere koli od teh treh snovi.
Therefore mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs. 
Zato lahko smrtnost pripišemo zapletom, povezanim s primarnimi duodenalnimi lezijami, z možnim prispevkom dodatnih toksičnosti v nezrelih ciljnih organih.
Benefit-risk in these patients has not been evaluated. 
Razmerja med koristmi in tveganji pri teh bolnikih niso ovrednotili.
The treatment effect of the combination on PFS and ORR was also supported by a post-hoc retrospective independent blinded review of scans. 
Zdravilni učinek kombinacije zdravil na PFS in ORR je podprl tudi post-hoc retrospektivni neodvisen slep pregled radioloških slik.
The minimal washout period in clinical trials was of 4 weeks. 
Najkrajše obdobje spiranja v kliničnih preskušanjih je bilo obdobje 4 tednov.
No events of hypocalcaemia required dose reduction or interruption, and no patients discontinued treatment due to hypocalcaemia. 
Noben dogodek hipokalciemije ni zahteval zmanjšanja odmerka ali prekinitve odmerjanja in pri nobenem bolniku niso ukinili zdravljenja zaradi hipokalciemije.
GI perforation or fistula Grade 3 
GI perforacija ali fistula stopnja 3
The mean terminal exponential half-life of lenvatinib is approximately 28 hours. 
Povprečna končna eksponencialna razpolovna doba lenvatiniba je približno 28 ur.
What Kisplyx is and what it is used for 
Kaj je zdravilo Kisplyx in za kaj ga uporabljamo
Figure 2: Kaplan-Meier Plot of Overall Survival 
Slika 2: Kaplan-Meierjeva krivulja celotnega preživetja
Genotoxicity Lenvatinib was not genotoxic. 
Genotoksičnost Lenvatinib ni bil genotoksičen.
Patients with high ECOG performance status 
Bolniki z visokim stanjem zmogljivosti po ECOG
In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy. 
Pri večini primerov so gastrointestinalna perforacija in fistule nastale pri bolnikih z dejavniki tveganja, na primer predhodnim kirurškim posegom ali radioterapijo.
The capsules can be swallowed whole with water. 
Kapsule je mogoče pogoltniti cele z nekaj vode.
If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. 
Če bolnik pozabi vzeti odmerek in ga ne more vzeti v naslednjih 12 urah, naj tisti odmerek preskoči in ob običajnem času uporabe vzame naslednji odmerek.
Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness. 
Lenvatinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji, in to zaradi neželenih učinkov, kot sta utrujenost in omotica.
Similarly, no induction of P-gp mRNA expression was observed. 
Prav tako niso opazili nikakršne indukcije ekspresije P-gp mRNA.