natgillin/translations-raw huggingface dataset:
How to store Zoledronic acid Teva Pharma 
Shranjevanje zdravila Zoledronska kislina Teva Pharma
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 
Bolezni sečil zvišana vrednost kreatinina v krvi, polakisurija, proteinurija okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia 
Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis neznana** vnetje beločnice in vnetje obočesnih tkiv
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles 
EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk
Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, 
Bolezni prebavil navzea, bruhanje, driska dispepsija, bolečine v zgornjem delu trebuha, bolečine v trebuhu, gastroezofagealna refluksna bolezen, obstipacija, suha usta,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMIČNEGA PAKIRANJA (z modrim okencem)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box) 
PODATKI NA ZUNANJI OVOJNINI PRIMARNA ŠKATLA (brez modrega okenca)
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis. 
Pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma v času trženja zdravila, so poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnic (odmiranje kosti v čeljustnic).
Placebo (N=3,861) event rate 
Izid placebo (N=3.861) delež dogodkov absolutno znižanje deleža zlomov % (IZ)
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low). 
Zoledronska kislina Teva Pharma (navedeni v poglavju 6), - če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka), - če imate hude težave z ledvicami, - če ste noseči, - če dojite.
Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures 
kateri koli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1) *vrednost p < 0,05, **vrednost p < 0,01
Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma. 
Preden bolniki dobijo zdravilo Zoledronska kislina Teva Pharma, morajo biti primerno hidrirani.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG 
PODATKI NA PRIMARNI OVOJNINI VREČA
Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential. 
Ženske v rodni dobi Zdravila Zoledronska kislina Teva Pharma ne uporabljajte pri ženskah v rodni dobi.
Nausea, vomiting, diarrhoea 
vnetje požiralnika, zobobol, gastritis#
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate. 
V združenih rezultatih so v teku 6 mesecev za zoledronsko kislino in risedronat ugotovili podobno zmanjšanje rezultatov ugotavljanja intenzivnosti bolečine in njenega oviranja vsakdanjih aktivnosti glede na izhodišče.
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration. 
Po uporabi zoledronske kisline so opazili okvaro ledvic, posebno pri bolnikih s predhodno ledvično disfunkcijo ali z dodatnimi dejavniki tveganja (npr. višja starost bolnika, onkološki bolniki s kemoterapijo, spremljajoča nefrotoksična zdravila, spremljajoče diuretično zdravljenje, huda dehidracija).
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags 
IME ZDRAVILA Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah
- Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma, This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over). 
To je zlasti pomembno pri bolnikih, ki jemljejo diuretike (zdravila za odvajanje vode), in pri starejših bolnikih (starih 65 let ali več).
proteinuria 
Dojenje
You must not be given Zoledronic acid Teva Pharma if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila Zoledronska kislina Teva Pharma.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis. 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Pri bolnicah, ki so prejemale zdravilo Zoledronska kislina Teva Pharma zaradi postmenopavzalne osteoporoze, so poročali o nepravilnem bitja srca (atrijski fibrilaciji).
One bag contains 5 mg zoledronic acid (as monohydrate). 
Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Each bag contains 5 mg zoledronic acid (as monohydrate). 
Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration. 
Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma se priporoča zadostno uživanje kalcija in vitamina D.
Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid 
Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah zoledronska kislina
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma. 
Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Teva Pharma s krvnimi preiskavami pregledati delovanje vaših ledvic.
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders 
Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis vnetje beločnice in vnetje obočesnih tkiv
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (z modrim okencem)
Very rare 
EDINSTVENA OZNAKA
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea 
Splošne težave in spremembe na mestu aplikacije zelo pogosti pireksija gripi podobna bolezen, mrzlica, utrujenost, astenija, bolečine, splošno slabo počutje, reakcija na mestu injiciranja periferni edemi, žeja, reakcija akutne faze vnetja, nekardiogena bolečina v prsnem košu neznana** dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma. 
Na dan, ko dobite zdravilo Zoledronska kislina Teva Pharma, lahko normalno jeste.
STATEMENT OF ACTIVE SUBSTANCE(S) Each bag contains 5 mg zoledronic acid (as monohydrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid 
Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje zoledronic acid
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Teva Pharma or after stopping treatment. 
Če pride do navedenih simptomov v času zdravljenja ali po zaključku zdravljenja z zdravilom Zoledronska kislina Teva Pharma, takoj obvestite svojega zdravnika in zobozdravnika.
EU/1/12/772/004 multipack with 10 bags 
EU/1/12/772/003 skupno pakiranje po 5 vreč EU/1/12/772/004 skupno pakiranje po 10 vreč
Medicinal product subject to medical prescription. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks. 
Priporočeni odmerek je 210 mg enkrat na teden prve tri tedne, nato pa vsaka dva tedna.
The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks. 
Zdravnik se lahko odloči za prenehanje zdravljenja, če se stanje po 12 do 16 tednih ne izboljša.
What measures are being taken to ensure the safe and effective use of Kyntheum? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kyntheum?
The full EPAR for Kyntheum 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 Kyntheum je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Kyntheum 
Druge informacije o zdravilu Kyntheum
This is a summary of the European public assessment report (EPAR) for Kyntheum. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kyntheum.
Although there have been recent advances in the treatment of plaque psoriasis, there remains a need for new treatment options. 
Čeprav je v zadnjem času prišlo do napredka pri zdravljenju psoriaze v plakih, še vedno ostaja potreba po novih možnostih zdravljenja.
Studies have shown that Kyntheum was highly effective at clearing the skin and the positive effects were maintained with continued use. 
Študije so pokazale, da je zdravilo Kyntheum zelo učinkovito pri čiščenju kože, pozitivni učinki pa so se z nadaljnjo uporabo ohranili.
The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, tiredness, diarrhoea and oropharyngeal pain (pain in the mouth and throat). 
Najpogostejši neželeni učinki zdravila Kyntheum (ki se lahko pojavijo pri več kot 1 bolniku od 100) so bolečine v sklepih, glavobol, utrujenost, driska in orofaringealna bolečina (bolečina v ustih in grlu).
After training, patients may inject Kyntheum if their doctor considers it appropriate. 
Bolniki si lahko po opravljenem usposabljanju sami injicirajo zdravilo Kyntheum, če zdravnik meni, da je to primerno.
The European Medicines Agency therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Kyntheum večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment. 
Zdravilo Kyntheum se je pokazalo kot učinkovito pri zdravljenju psoriaze v plakih v treh glavnih študijah, ki so vključevale več kot 4 300 bolnikov, ki so potrebovali sistemsko zdravljenje.
The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to block the activity of certain substances called interleukins 17 (A, F and A/F), which are messengers in the body's immune system (the body's natural defences). 
Zdravilna učinkovina zdravila Kyntheum, brodalumab, je monoklonsko protitelo, beljakovina, zasnovana tako, da zavira delovanje določenih snovi, imenovanih interlevkini 17 (A, F in A/F), ki so prenašalci sporočil v imunskem sistemu telesa (naravni obrambi telesa).
Data from one study also showed that the benefits of treatment with Kyntheum were maintained when treatment was continued for one year. 
Podatki ene študije so pokazali tudi, da so se koristi zdravljenja z zdravilom Kyntheum ohranile, če so bolniki nadaljevali z zdravljenjem eno leto.
What are the risks associated with Kyntheum? 
Kakšna tveganja so povezana z zdravilom Kyntheum?
What benefits of Kyntheum have been shown in studies? 
Kakšne koristi je zdravilo Kyntheum izkazalo v študijah?
What is Kyntheum and what is it used for? 
Kaj je zdravilo Kyntheum in za kaj se uporablja?
By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease. 
Z zaviranjem delovanja interlevkinov 17 brodalumab zmanjša vnetje in simptome, povezane z boleznijo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kyntheum have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kyntheum upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Also, 79% of patients given Kyntheum had clear or nearly clear skin after 12 weeks, compared with 3% of patients given placebo and 70% of patients given ustekinumab. 
Poleg tega je imelo 79 % bolnikov, ki so prejemali zdravilo Kyntheum, po 12 tednih čisto oziroma skoraj čisto kožo v primerjavi s 3 % bolnikov, ki so prejemali placebo, in 70 % bolnikov, ki so prejemali ustekinumab.
Kyntheum must not be given to patients who have potentially serious infections such as tuberculosis and to patients with active Crohn's disease (an inflammatory disease affecting the gut). 
Zdravilo Kyntheum se ne sme dajati bolnikom s potencialno resnimi okužbami, kot je tuberkuloza, in bolnikom z aktivno Crohnovo boleznijo (vnetno črevesno boleznijo).
Side effects are similar to those of other medicines that target interleukin molecules. 
Neželeni učinki so podobni kot pri drugih zdravilih, ki delujejo proti interlevkinskim molekulam.
It is not intended to provide practical advice on how to use Kyntheum. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Kyntheum should be stopped in patients who show new symptoms of depression or anxiety or in case they worsen. 
Zdravljenje z zdravilom Kyntheum je treba prekiniti pri bolnikih, pri katerih se pojavijo novi simptomi depresije ali anksioznosti oziroma se obstoječi poslabšajo.
Why is Kyntheum approved? 
Zakaj je bilo zdravilo Kyntheum odobreno?
It is used in adults whose disease is moderate to severe and who require systemic treatment (treatment with medicines given by mouth or by injection). 
Uporablja se pri odraslih z zmerno do hudo boleznijo, ki potrebujejo sistemsko zdravljenje (zdravljenje z zdravili, ki se dajejo peroralno ali z injiciranjem).
For the full list of all side effects and restrictions with Kyntheum, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Kyntheum glejte navodilo za uporabo.
Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis. 
Predpisovanje in izdaja zdravila Kyntheum je le na recept, zdravilo pa se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
Although there is no evidence of a link to the medicine, the decision to start Kyntheum in patients who have had suicidal behaviour in the past or suffered from depression or anxiety should be made after carefully looking at all the risks and benefits for that patient. 
Čeprav ni dokazov za povezavo z zdravilom, je treba pri odločanju za začetek zdravljenja z zdravilom Kyntheum pri bolnikih, ki v preteklosti izkazovali samomorilno vedenje ali imeli depresijo ali anksioznost, skrbno pretehtati tveganja in koristi za bolnika.
For more information about treatment with Kyntheum, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Kyntheum preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This compares with 6% of those given placebo and with 70% of patients given ustekinumab. 
Ta delež je pri bolnikih, ki so prejemali placebo, znašal 6 %, pri bolnikih, ki so prejemali ustekinumab, pa 70 %.
Plaque psoriasis improved to a greater extent in patients treated with Kyntheum than with placebo (a dummy treatment) or with ustekinumab (another medicine for psoriasis that targets interleukin molecules). 
Psoriaza v plakih se je pri bolnikih, ki so bili zdravljeni z zdravilom Kyntheum, izboljšala v primerjavi z bolniki, zdravljenimi s placebom (zdravilom brez zdravilne učinkovine) ali ustekinumabom (drugim zdravilom za psoriazo, ki deluje na molekule interlevkina).
Kyntheum is available as a solution for injection in pre-filled syringes. 
Zdravilo Kyntheum je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
Interleukins 17 are involved in the process of inflammation that causes plaque psoriasis. 
Interlevkini 17 so vključeni v vnetni proces, ki povzroča psoriazo v plakih.
For practical information about using Kyntheum, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Kyntheum naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Looking at the results of the 3 studies together, 85% of patients treated with Kyntheum obtained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks. 
Skupna analiza rezultatov treh študij je pokazala, da je po 12 tednih prišlo do 75-odstotnega znižanja ocene PASI (merilo za resnost bolezni in površino prizadete kože) pri 85 % bolnikov, zdravljenih z zdravilom Kyntheum.
Kyntheum is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. 
Zdravilo Kyntheum se uporablja za zdravljenje psoriaze v plakih, tj. bolezni, ki povzroča rdeče, luskaste spremembe na koži.
There have been some reports of suicidal behaviour in patients taking the medicine. 
Pri bolnikih, ki so jemali to zdravilo, so poročali o nekaj primerih samomorilnega vedenja.
How is Kyntheum used? 
Kako se zdravilo Kyntheum uporablja?
How does Kyntheum work? 
Kako zdravilo Kyntheum deluje?
Kyntheum contains the active substance brodalumab. 
Zdravilo Kyntheum vsebuje zdravilno učinkovino brodalumab.
The full EPAR for Kisplyx 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 Kisplyx je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Kisplyx? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kisplyx?
The recommended dose is 18 mg (made up of one 10 mg capsule and two 4 mg capsules) once a day at the same time each day in combination with 5 mg of everolimus once a day. 
Priporočen odmerek je 18 mg (ki ga sestavlja ena 10 mg kapsula in dve 4 mg kapsuli) enkrat dnevno ob istem času v kombinaciji s 5 mg everolimusa enkrat na dan.
Kisplyx is available as capsules (4 mg and 10 mg). 
Na voljo je v obliki kapsul (4 mg in 10 mg).
This is a summary of the European public assessment report (EPAR) for Kisplyx. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kisplyx.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Kisplyx's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Kisplyx večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Patients who took the combination of Kisplyx and everolimus lived for an average of 14.6 months without their disease getting worse, compared with 7.4 months for the patients who took Kisplyx alone and 5.5 months for the patients who took everolimus alone. 
Bolniki, ki so prejemali kombinacijo zdravila Kisplyx in everolimusa, so živeli povprečno 14,6 meseca, ne da bi se jim bolezen poslabšala, v primerjavi s 7,4 meseca pri bolnikih, ki so prejemali samo zdravilo Kisplyx, in 5,5 meseca pri bolnikih, ki so prejemali samo everolimus.
Other information about Kisplyx 
Druge informacije o zdravilu Kisplyx
What is Kisplyx and what is it used for? 
Kaj je zdravilo Kisplyx in za kaj se uporablja?
Treatment is given for as long as the patient benefits from it or until side effects become unacceptable. 
Zdravilo se daje, dokler je za bolnika koristno oziroma do pojava nesprejemljivih neželenih učinkov.
It is not intended to provide practical advice on how to use Kisplyx. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Kisplyx? 
Kakšna tveganja so povezana z zdravilom Kisplyx?
Kisplyx can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in using cancer medicines. 
Predpisovanje in izdaja zdravila Kisplyx je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
By blocking these enzymes, lenvatinib can block the formation of new blood vessels, cutting off the blood supply that keeps cancer cells growing, and reduce the growth of the cancer. 
Z zaviranjem teh encimov lahko lenvatinib zavira nastajanje novih krvnih žil in prekine dotok krvi, ki omogoča rast rakastih celic, ter zmanjša rast raka.
What benefits of Kisplyx have been shown in studies? 
Kakšne koristi je zdravilo Kisplyx izkazalo v študijah?
Kisplyx must not be taken by breastfeeding women. 
Zdravilo Kisplyx se ne sme dajati ženskam, ki dojijo.
This means that it blocks the activity of enzymes known as tyrosine kinases. 
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
The dose of Kisplyx should be decreased in patients with severely reduced kidney or liver function. 
Odmerek zdravila Kisplyx je treba zmanjšati pri bolnikih z močno zmanjšanim delovanjem ledvic ali jeter.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisplyx have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kisplyx upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Kisplyx, used in combination with everolimus, was shown to significantly improve the time these patients lived without their disease getting worse. 
Za zdravilo Kisplyx, uporabljeno v kombinaciji z everolimusom, je bilo ugotovljeno, da znatno izboljša čas, ki so ga živeli ti bolniki, ne da bi se jim bolezen poslabšala.
Why is Kisplyx approved? 
Zakaj je bilo zdravilo Kisplyx odobreno?