natgillin/translations-raw huggingface dataset:
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC. 
Nakon otvaranja: Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
- if you have had some or all of the parathyroid glands in your neck surgically removed. 
- ako ne možete svaki dan uzimati nadomjestke kalcija. - ako su Vam iz vrata uklonjene neke ili sve paratireoidne žlijezde. - ako su Vam uklonjeni dijelovi crijeva.
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001). 
U subpopulaciji bolesnika koji su primali glukokortikoide 3 mjeseca ili kraće prije randomizacije zoledronatna kiselina povećala je BMD lumbalne kralježnice za 2,60% u odnosu na 0,64% pri primjeni risedronata (srednja razlika: 1,96%; p<0,001).
Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent). 
Djelotvornost i sigurnost primjene zoledronatne kiseline u liječenju i prevenciji osteoporoze povezane s dugotrajnim sistemskim liječenjem glukokortikoidima bila je procijenjena u randomiziranom, multicentričnom, dvostruko slijepom, stratificiranom ispitivanju s djelatnom kontrolom u 833 muškaraca i žena u dobi od 18 do 85 godina (srednja dob za muškarce 56,4 godine, za žene 53,5 godina) liječenih sa >7,5mg/dan oralno primijenjenog prednizona (ili ekvivalenta).
In patients with a recent low trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion. 
U bolesnika s nedavnim prijelomom kuka nakon manje traume, preporučuje se prije prve infuzije zoledronatne kiseline dati udarnu dozu od 50 000 do 125 000 IU vitamina
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Nakon otvaranja boce, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
- After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Nakon otvaranja vrećice, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
How to prepare and administer Zoledronic acid Teva Pharma 
Kako pripremiti i primijeniti Zoledronatnu kiselinu Teva Pharma
Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia 
Hiperemija oka Manje često Konjunktivitis, bol u oku Uveitis, episkleritis, iritis Nepoznato** Skleritis i upala očne šupljine
The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with zoledronic acid versus 8.7% for placebo. 
Incidencija kliničkih prijeloma bila je 7,5% u muškaraca liječenih zoledronatnom kiselinom u usporedbi sa 8,7% u onih koji su primali placebo.
Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card. 
Bolesnicima koji se liječe Zoledronatnom kiselinom Teva Pharma potrebno je dati uputu o lijeku i karticu s podsjetnikom za bolesnika.
Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml 
Višestruko pakiranje: 5 boca od 100 ml
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis. 
Nepravilni otkucaji srca (treperenje pretklijetki) zabilježeni su u bolesnica koje su primale Zoledronatnu kiselinu Teva Pharma zbog postmenopauzalne osteoporoze.
Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome 
Stope incidencije ključnih varijabli kliničkih prijeloma prikazane su u Tablici 4. Tablica 4 Usporedbe incidencije ključnih varijabli kliničkog prijeloma između liječenja Ishod
Solution for infusion Multipack: 5 bags of 100 ml Multipack: 10 bags of 100 ml 
Višestruko pakiranje: 5 vrećica od 100 ml
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle 
EU/1/12/772/001 višestruko pakiranje s 5 boca EU/1/12/772/002 višestruko pakiranje s 10 boca EU/1/12/772/005 1 boca
Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential. 
Žene reproduktivne dobi Primjena Zoledronatne kiseline Teva Pharma se ne preporučuje u žena reproduktivne dobi.
Each bottle contains 100 ml of solution. 
Svaka boca sadrži 100 ml otopine.
EU/1/12/772/004 
EU/1/12/772/003 EU/1/12/772/004
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors. 
Prije početka liječenja Zoledronatnom kiselinom Teva Pharma, u bolesnika s istodobnim rizičnim faktorima, preporučuje se stomatološki pregled uz obavljanje preventivnih stomatoloških zahvata i procjena individualne koristi i rizika.
Zoledronic acid Teva Pharma contains the active substance zoledronic acid. 
Zoledronatna kiselina Teva Pharma sadrži djelatnu tvar zoledronatnu kiselinu.
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles 
EU/1/12/772/001 višestruko pakiranje s 5 boca EU/1/12/772/002 višestruko pakiranje s 10 boca
How to store Zoledronic acid Teva Pharma 
Kako čuvati Zoledronatnu kiselinu Teva Pharma
ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8). 
U bolesnika koji su primali Zoledronatnu kiselinu Teva Pharma za osteoporozu prijavljena je ONJ nakon stavljanja lijeka u promet (vidjeti dio 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (s plavim okvirom)
How Zoledronic acid Teva Pharma is given 
Kako se primjenjuje Zoledronatna kiselina Teva Pharma
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. 
U bolesnika koji primaju Zoledronatnu kiselinu Teva Pharma za osteoporozu prijavljena je nuspojava koja se zove osteonekroza čeljusti (ONJ) (oštećenje koštanog tkiva čeljusti) nakon stavljanja lijeka u promet.
- you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone 
Prije nego počnete liječenje Zoledronatnom kiselinom Teva Pharma obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako - imate bilo kakav problem sa ustima ili zubima kao što je loše zdravlje zuba, bolesti desni ili planirano vađenje zuba; - ne dobivate rutinsku stomatološku skrb ili duže vrijeme niste obavili pregled kod zubara; - ste pušač (jer to može povećati rizik problema sa zubima); - ste se prije liječili bifosfonatima (u svrhu liječenja ili prevencije poremećaja kostiju); - uzimate lijekove koji se zovu kortikosteroidi (kao što su prednizolon ili deksametazon); - imate rak.
See section 4. 
Tablica 1.
Not known** Renal impairment. 
Nepoznato** Oštećenje funkcije bubrega.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture. 
Tijekom liječenja bisfosfonatima bolesnici se moraju uputiti da prijave svaku pojavu boli u bedrima, kukovima ili preponama.
Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma. 
Prijavljeni su slučajevi ONJ za Zoledronatnu kiselinu Teva Pharma nakon stavljanja lijeka u promet.
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate). 
Svaka boca sa 100 ml otopine sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease. 
U bolesnika s Pagetovom bolešću preporučuje se određivanje kalcija u serumu prije infuzije Zoledronatne kiseline Teva Pharma.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OVERPOUCH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA VREĆICA
One bottle contains 5 mg zoledronic acid (as monohydrate). 
Jedna boca sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Zoledronic acid 
Razine vitamina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA (s plavim okvirom )
Each bottle contains 5 mg zoledronic acid (as monohydrate). 
Svaka boca sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (bez plavog okvira)
proteinuria 
Doziranje
Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration. 
Uz primjenu Zoledronatne kiseline Teva Pharma, preporučuje se odgovarajući unos kalcija i vitamina D.
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma. 
Na dan kad ćete primiti Zoledronatnu kiselinu Teva Pharma možete normalno jesti.
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6). 
Ne smijete primati Zoledronatnu kiselinu Teva Pharma: - ako ste alergični na zoledronatnu kiselinu, druge bisfosfonate ili neki drugi sastojak ovog lijeka
Each bag contains 5 mg zoledronic acid (as monohydrate). 
Svaka vrećica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid 
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u bocama zoledronatna kiselina
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza „Rok valjanosti“.
1 bottle of 100 ml. 
Jedna boca sadrži 100 ml otopine.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags 
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u vrećicama
Zoledronic acid Teva Pharma 5 mg solution for infusion in bags zoledronic acid 
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u vrećicama zoledronatna kiselina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (s plavim okvirom)
EU/1/12/772/003 
EU/1/12/772/005 1 boca
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid 
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju zoledronatna kiselina
- Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza „Rok valjanosti“.
• Creatinine clearance should be calculated based on actual body weight using the 
• Prije svake doze Zoledronatne kiseline Teva Pharma treba izračunati klirens kreatinina na temelju stvarne tjelesne težine koristeći Cockcroft-Gaultovu formulu.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles 
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u bocama
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders 
Manje često Osip, hiperhidroza, svrbež, eritem
Absolute reduction in fracture event rate (CI) 
Apsolutno smanjenje stope događaja za prijelome % (CI)
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma. 
Prije svake doze Zoledronatne kiseline Teva Pharma liječnik Vam mora napraviti krvnu pretragu kako bi provjerio Vašu bubrežnu funkciju (razine kreatinina).
The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks. 
Preporučena doza je 210 mg jednom tjedno prva 3 tjedna, a zatim svaka 2 tjedna.
The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks. 
Liječnik može odlučiti prekinuti liječenje ako se stanje ne popravi nakon 12 do 16 tjedana.
The full EPAR for Kyntheum can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Kyntheum nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Kyntheum 
Ostale informacije o lijeku Kyntheum
There have been some reports of suicidal behaviour in patients taking the medicine. 
Postoje slučajevi suicidalnog ponašanja u bolesnika koji uzimaju lijek.
What measures are being taken to ensure the safe and effective use of Kyntheum? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kyntheum?
Although there have been recent advances in the treatment of plaque psoriasis, there remains a need for new treatment options. 
Iako ne postoji nedavni napredak u liječenju plak-psorijaze, i dalje postoji potreba za novim mogućnostima liječenja.
What is Kyntheum and what is it used for? 
Što je Kyntheum i za što se koristi?
This is a summary of the European public assessment report (EPAR) for Kyntheum. 
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Kyntheum.
After training, patients may inject Kyntheum if their doctor considers it appropriate. 
Nakon obuke bolesnici mogu sami injektirati Kyntheum ako to liječnik smatra primjerenim.
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). 
Najčešće nuspojave povezane s lijekom Kyntheum (koje se mogu pojaviti u više od 1 od 100 osoba) su bolovi u zglobovima, glavobolja, umor, proljev i bol u ustima i grlu.
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. 
Iako nema dokaza o povezanosti takvog ponašanja s lijekom, odluka o primjeni lijeka Kyntheum u bolesnika koji su u prošlosti pokazali suicidalno ponašanje ili su bolovali od depresije ili anksioznosti treba biti pažljivo donesena nakon temeljite procjene rizika i koristi za tog bolesnika.
Side effects are similar to those of other medicines that target interleukin molecules. 
Nuspojave su slične nuspojavama drugih lijekova koji ciljaju molekule interleukina.
What are the risks associated with Kyntheum? 
Koji su rizici povezani s lijekom Kyntheum?
It is not intended to provide practical advice on how to use Kyntheum. 
Svrha sažetka nije davati praktične savjete o primjeni lijeka Kyntheum.
Why is Kyntheum approved? 
Zašto je lijek Kyntheum odobren?
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). 
Djelatna tvar u lijek Kyntheum je brodalumab, monoklonalno protutijelo, bjelančevina koja blokira aktivnost određenih tvari koje se nazivaju interleukini 17 (A, F i A/F) i djeluju kao glasnici u imunosnom sustavu (prirodni obrambeni sustav tijela).
Studies have shown that Kyntheum was highly effective at clearing the skin and the positive effects were maintained with continued use. 
Ispitivanja su pokazala da je lijek Kyntheum vrlo djelotvoran u čišćenju kože te da se pozitivni učinci mogu održavati redovitom uporabom.
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. 
Nadalje, 79 % bolesnika koji su uzimali Kyntheum imalo je čistu ili gotovo čistu kožu nakon 12 tjedana, dok je ta brojka za bolesnike koji su uzimali placebo iznosila 3 %, a za bolesnike koji su uzimali ustekinumab 70 %.
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. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Kyntheum nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Data from one study also showed that the benefits of treatment with Kyntheum were maintained when treatment was continued for one year. 
Podatci iz jednog ispitivanja pokazuju da su se koristi liječenja lijekom Kyntheum održale jednu godinu nakon prekida terapije.
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. 
Ukupna procjena u sva tri ispitivanja dokazuje da je u 85 % bolesnika koji su uzimali lijek Kyntheum došlo do smanjenja PASI ocjena (izračun ozbiljnosti bolesti i područja kože zahvaćene bolešću) za 75 % nakon 12 tjedana.
Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis. 
Kyntheum se izdaje samo na liječnički recept i namijenjen je za primjenu pod nadzorom liječnika iskusnog u dijagnosticiranju i liječenju psorijaze.
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). 
Lijek Kyntheum ne smije se davati bolesnicima koji imaju moguće ozbiljne infekcije kao što su tuberkuloza i bolesnicima koji imaju aktivnu Crohnovu bolest (ili upalnu bolest koja zahvaća crijeva).
Kyntheum contains the active substance brodalumab. 
Kyntheum sadrži djelatnu tvar brodalumab.
Kyntheum should be stopped in patients who show new symptoms of depression or anxiety or in case they worsen. 
Primjena lijeka Kyntheum treba se prekinuti u bolesnika u kojih se jave novi simptomi depresije ili anksioznosti ili se ti simptomi pogoršavaju.
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). 
Primijećeno je veće poboljšanje plakpsorijaze u bolesnika koji su primali lijek Kyntheum nego u bolesnika koji su primali placebo (prividno liječenje) ili ustekinumab (drugi lijek za liječenje psorijaze koji cilja molekule interleukina).
Interleukins 17 are involved in the process of inflammation that causes plaque psoriasis. 
Interleukini 17 sudjeluju u postupku upale koja uzrokuje plak-psorijazu.
Kyntheum is available as a solution for injection in pre-filled syringes. 
Kyntheum je dostupan kao suspenzija za injekciju u napunjenim štrcaljkama.
By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease. 
Brodalumab blokira djelovanje interleukina 17 i tako smanjuje upalu i simptome povezane s tom bolešću.
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. 
Stoga je stav CHMP-a da koristi lijeka Kyntheum nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za njegovu primjenu u EU-u.
For more information about treatment with Kyntheum, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom Kyntheum pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
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). 
Primjenjuje se u odraslih osoba s umjerenom do teškom plak-psorijazom kojima je potrebno sustavno liječenje (liječenje lijekovima koji se uzimaju oralno ili putem injekcije).
This compares with 6% of those given placebo and with 70% of patients given ustekinumab. 
Smanjenje u bolesnika koji su uzimali placebo iznosilo je 6 %, a u bolesnika koji su uzimali ustekinumab 70 %.
For practical information about using Kyntheum, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o primjeni lijeka Kyntheum bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
What benefits of Kyntheum have been shown in studies? 
Koje su koristi lijeka Kyntheum utvrđene u ispitivanjima?
Kyntheum is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. 
Kyntheum je lijek za liječenje osoba s plak-psorijazom, bolešću koja na koži uzrokuje crvenkasta žarišta koja se ljušte.
For the full list of all side effects and restrictions with Kyntheum, see the package leaflet. 
Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Kyntheum potražite u uputi o lijeku.
How is Kyntheum used? 
Kako se Kyntheum koristi?
How does Kyntheum work? 
Kako djeluje lijek Kyntheum?
Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment. 
U tri glavna ispitivanja u kojima je sudjelovalo više od 4300 bolesnika kojima treba sustavno liječenje utvrđeno je da lijek Kyntheum djelotvorno liječi plak-psorijazu.
The full EPAR for Kisplyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Kisplyx nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Kisplyx is available as capsules (4 mg and 10 mg). 
Kisplyx je dostupan u obliku kapsula (4 i 10 mg).
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. 
Preporučena doza je 18 mg (jedna kapsula od 10 mg i dvije kapsule od 4 mg) jedanput na dan u isto vrijeme svakoga dana u kombinaciji s 5 mg everolimusa jedanput na dan.
The main measure of effectiveness was how long the patients lived without their disease getting worse (progression-free survival). 
Glavna mjera djelotvornosti bilo je vrijeme koje su bolesnici preživjeli bez pogoršanja bolesti (preživljenje bez progresije bolesti).
What measures are being taken to ensure the safe and effective use of Kisplyx? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kisplyx?