FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Gardasil 9 against cervical definitive therapy (including loop electrosurgical excision procedure [LEEP] or conisation) related to vaccine HPV types compared to qHPV vaccine was 90.7% (95% CI 76.3, 97.0) with 4/6,016 versus 43/6,018 cases.
Slovenian: Učinkovitost cepiva Gardasil 9 glede definitivnih posegov na materničnem vratu (vključno z elektrokirurško ekscizijo z zanko [LEEP] ali konizacijo), povezanih s tipi HPV v cepivu, je bila v primerjavi s qHPV cepivom 90,7 % (95 % IZ: 76,3; 97,0) s številom primerov 4/6.016 v primerjavi s 43/6.018.
English: Gardasil 9 suspension for injection in a pre-filled syringe:
Slovenian: Gardasil 9 suspenzija za injiciranje v napolnjeni injekcijski brizgi:
English: Gardasil 9 injection IM
Slovenian: Gardasil 9 injekcija i.m.
English: *The PPI population consisted of individuals who received all three vaccinations within predefined day ranges, did not have major deviations from the study protocol, met predefined criteria for the interval between the Month 6 and Month 7 visit, seronegative to the relevant HPV type(s) (types 6, 11, 16, and 18) prior to dose 1, and among 16 to 26 year old women, were PCR negative to the relevant HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Slovenian: *V populaciji PPI so bile osebe, ki so prejele vse 3 odmerke cepiva znotraj vnaprej določenega časovnega intervala, niso imele večjih odklonov od protokola študije, so izpolnjevale vnaprej določene kriterije glede razmika med obiskoma v 6. in 7. mesecu, so bile seronegativne za zadevni tip (zadevne tipe) HPV (tipi 6, 11, 16 in 18) pred 1. odmerkom, ter so bile ženske, stare 16 do 26 let, PCR negativne za zadevni tip (zadevne tipe) HPV pred 1. odmerkom do 1 meseca po 3. odmerku (7. mesec).
English: The efficacy of Gardasil 9 against cervical biopsy related to vaccine HPV types compared to qHPV vaccine was 95.9% (95% CI 92.7, 97.9) with 11/6,016 versus 262/6,018 cases.
Slovenian: Učinkovitost cepiva Gardasil 9 glede biopsij materničnega vratu, povezanih s tipi HPV v cepivu, je bila v primerjavi s qHPV cepivom 95,9 % (95 % IZ: 92,7; 97,9) s številom primerov 11/6.016 v primerjavi z 262/6.018.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Slovenian: • S sterilno iglo in injekcijsko brizgo iz enoodmerne viale izvlecite 0,5 ml odmerek cepiva.
English: In clinical studies 98.2% to 100% who received Gardasil 9 became seropositive for antibodies against all 9 vaccine types by Month 7 across all groups tested.
Slovenian: V kliničnih študijah je v vseh testiranih skupinah do 7. meseca od 98,2 % do 100 % oseb, ki so prejele cepivo Gardasil 9, postalo seropozitivnih za protitelesa proti vsem 9 tipom v cepivu.
English: Human Papillomavirus 9-valent Vaccine
Slovenian: 9-valentno cepivo proti humanim papilomavirusom
English: In clinical studies 99.2% to 100% who received Gardasil 9 became seropositive for antibodies against all 9 vaccine types by Month 7 across all groups tested.
Slovenian: V kliničnih študijah je v vseh testiranih skupinah do 7. meseca od 99,2 % do 100 % oseb, ki so prejele cepivo Gardasil 9, postalo seropozitivnih za protitelesa proti vsem 9 tipom v cepivu.
English: Antibodies against all 9 HPV types were transferred to the offspring during gestation and lactation.
Slovenian: Med brejostjo in dojenjem so se protitelesa proti vsem 9 tipom HPV prenesla na mladiče.
English: The PPE population consisted of individuals: - who received all 3 vaccinations within 1 year of enrolment, without major deviations from the study protocol, - who were seronegative to the relevant vaccine HPV type(s) prior to dose 1 and among women aged 16 to 26 years, PCR negative to the relevant vaccine HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Slovenian: Populacija PPE je vključevala posameznike, ki: - so prejeli vse 3 odmerke cepiva v 1 letu po vključitvi, niso imeli večjih odklonov od protokola študije, - so bili seronegativni za zadevni tip (zadevne tipe) HPV v cepivu pred 1. odmerkom in med ženskami starimi 16 do 26 let, PCR negativnimi za zadevni tip (zadevne tipe) HPV v cepivu pred 1. odmerkom in tekom enega meseca po 3. odmerku (7. mesec).
English: Persistent infection detected in samples from two or more consecutive visits 6 months (±1 month visit windows) apart.
Slovenian: N = število oseb, randomiziranih v skupino s posameznim cepivom, ki so prejele vsaj eno injekcijo n = število oseb, vključenih v analizo persistentna okužba, odkrita v vzorcih z dveh ali več zaporednih obiskov v razmiku 6 mesecev (okno ± 1 mesec) persistentna okužba, odkrita v vzorcih s treh ali več zaporednih obiskov v razmiku 6 mesecev (okno ± 1 mesec) Papanicolaouov test
English: Gardasil 9 suspension for injection Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Slovenian: Gardasil 9 suspenzija za injiciranje 9-valentno cepivo proti humanim papilomavirusom (rekombinantno, adsorbirano)
English: • Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Slovenian: Najbolje je, da se ga aplicira v deltoidni predel nadlakti ali v zgornji anterolateralni predel stegna.
English: Individuals 9 to and including 14 years of age at time of first injection Gardasil 9 can be administered according to a 2-dose (0, 6 - 12 months) schedule (see section 5.1).
Slovenian: Posamezniki od 9. do vključno 14. leta starosti ob prejemu prve injekcije Cepivo Gardasil 9 se lahko aplicira v skladu z 2-odmerno shemo cepljenja (0., 6.
English: • developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV types 6, 11, 16, and 18) or Gardasil 9.
Slovenian: • če se je pri vas ali vašem otroku po cepljenju s predhodnim odmerkom cepiva Gardasil oz. Silgard (HPV tipi 6, 11, 16 in 18) ali cepiva Gardasil 9 pojavila alergijska reakcija.
English: Gardasil 9 suspension for injection in a pre-filled syringe Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Slovenian: Gardasil 9 suspenzija za injiciranje v napolnjeni injekcijski brizgi 9-valentno cepivo proti humanim papilomavirusom (rekombinantno, adsorbirano)
English: Anti-HPV responses at Month 7 among girls/boys aged 9 to 15 years were comparable to anti-HPV responses in women aged 16 to 26 years in the combined database of immunogenicity studies for Gardasil 9.
Slovenian: V kombinirani podatkovni bazi študij imunogenosti cepiva Gardasil 9 so bili anti-HPV odzivi v 7. mesecu pri deklicah/dečkih, starih 9 do 15 let, podobni kot anti-HPV odzivi pri ženskah, starih 16 do 26 let.
English: Asthenia, chills, malaise
Slovenian: Neznana astenija, mrzlica, splošno slabo počutje
English: Shake well before use.
Slovenian: intramuskularna uporaba Pred uporabo dobro pretresite!
English: What other important information should you or your child know about Gardasil 9
Slovenian: Drugi pomembni podatki o cepivu Gardasil 9, ki jih morate vi ali vaš otrok poznati
English: Gardasil 9 suspension for injection.
Slovenian: Gardasil 9 suspenzija za injiciranje
English: When Gardasil 9 was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more injection-site swelling.
Slovenian: Pri sočasnem cepljenju (ob istem obisku) s cepivom Gardasil 9 in obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju [acelularno, komponentno cepivo] in otroški ohromelosti [inaktivirano cepivo] je bilo več primerov otekanja na mestu injiciranja.
English: The GMTs to HPV types 6, 11, 16, 18 were higher than in the population who had not previously received qHPV vaccine in other studies whereas the
Slovenian: GMT za tipe HPV 6, 11, 16 in 18 so bili višji kot v populaciji, ki predhodno ni prejela qHPV cepiva v drugih študijah, GMT za tipe HPV 31, 33, 45, 52 in 58 pa so bili nižji.
English: • Choose an appropriate needle to ensure an intramuscular (IM) administration depending on your patient's size and weight.
Slovenian: • Glede na bolnikovo velikost in telesno maso izberite ustrezno iglo za intramuskularno (i.m.)
English: Efficacy evaluation of Gardasil 9 against cervical high grade diseases caused by vaccine HPV types in the PPE
Slovenian: Dodatno ovrednotenje učinkovitosti cepiva Gardasil 9 proti tipom HPV v cepivu
English: No clinical study of Gardasil 9 was conducted in HIV-infected individuals.
Slovenian: Pri osebah, okuženih s HIV, niso izvedli nobene klinične študije s cepivom Gardasil 9.
English: What Gardasil 9 contains
Slovenian: Kaj vsebuje cepivo Gardasil 9
English: The efficacy of Gardasil 9 against CIN 2 and worse related to vaccine HPV types compared to qHPV vaccine was 94.4% (95% CI 78.8, 99.0) with 2/5,952 versus 36/5,947 cases.
Slovenian: Ovrednotenje učinkovitosti cepiva Gardasil 9 proti boleznim materničnega vratu visoke stopnje, ki jih povzročajo tipi HPV v cepivu, v populaciji PPE Učinkovitost cepiva Gardasil 9 proti CIN 2 in hujšim, povezanim s tipi HPV v cepivu, je bila v primerjavi s qHPV cepivom 94,4 % (95 % IZ: 78,8; 99,0) s številom primerov 2/5.952 v primerjavi s 36/5.947.
English: Gardasil 9 induced robust anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 responses measured at Month 7, in
Slovenian: Merjenje v 7. mesecu, v Protokolih 001, 002, 004, 005, 007 in GDS01C/Protokolu 009, je pokazalo, da je cepivo Gardasil 9 sprožilo močan anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, antiHPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52 in anti-HPV 58 odziv.
English: Pyrexia, fatigue, At the injection site: pruritus, bruising
Slovenian: Pogosti zvišana telesna temperatura, utrujenost; na mestu injiciranja: srbenje, hematom
English: How to store Gardasil 9
Slovenian: Kako uporabljati cepivo Gardasil 9
English: HPV 31-, 33-, 45-, 52-, 58-related CIN 2/3, AIS, Cervical Cancer, VIN 2/3, VaIN 2/3, Vulvar Cancer, and Vaginal Cancer
Slovenian: CIN 2/3, AIS, rak materničnega vratu, VIN 2/3, VaIN 2/3, rak vulve in rak nožnice, povezani s HPV 31, 33, 45, 52 in
English: The efficacy of Gardasil 9 against CIN 3 related to vaccine HPV types compared to qHPV vaccine was 100% (95% CI 46.3, 100.0) with 0/5,952 versus 8/5,947 cases.
Slovenian: Učinkovitost cepiva Gardasil 9 proti CIN 3, povezanim s tipi HPV v cepivu, je bila v primerjavi s qHPV cepivom 100 % (95 % IZ: 46,3; 100,0) s številom primerov 0/5.952 v primerjavi z
English: The qHPV vaccine was used as an active control during the clinical development program for Gardasil 9.
Slovenian: V programu kliničnega razvoja cepiva Gardasil 9 so kot primerjalno učinkovino uporabljali qHPV cepivo.
English: N=Number of individuals randomised to the respective vaccination group who received at least one injection.
Slovenian: GMT = geometrična sredina titrov cLIA = kompetitivni imunski preizkus Luminex (Competitive Luminex Immunoassay) N = število oseb, randomiziranih v skupino s posameznim cepivom, ki so prejele vsaj eno injekcijo n = število oseb, vključenih v analizo
English: Prior to agitation, Gardasil 9 may appear as a clear liquid with a white precipitate.
Slovenian: • Pred pretresanjem ima lahko cepivo Gardasil 9 videz bistre tekočine z belo oborino.
English: For subjects receiving Gardasil 9 after receiving 3 doses of qHPV vaccine, there was an interval of at least 12 months between completion of vaccination with qHPV vaccine and the start of vaccination with Gardasil 9 with a 3-dose regimen (the time interval ranged from approximately 12 to 36 months).
Slovenian: Pri preiskovankah, ki so cepivo Gardasil 9 prejele potem, ko so že prejele 3 odmerke qHPV cepiva, je bil razmik med zadnjim cepljenjem s qHPV
English: Not known (cannot be estimated from the available data)
Slovenian: Pogostnosti so navedene kot: zelo pogosti (≥ 1/10) pogosti (≥ 1/100 do < 1/10) neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: The following side effects can be seen after the use of Gardasil 9:
Slovenian: Po uporabi cepiva Gardasil 9 se lahko pojavijo naslednji neželeni učinki:
English: Pre-filled syringe, pack of 10
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI napolnjena injekcijska brizga, pakiranje po 10
English: Injection-site cellulitis
Slovenian: Infekcijske in parazitske bolezni Neznana celulitis na mestu injiciranja
English: A total of 92 women were breast-feeding during the vaccination period of the clinical studies of Gardasil 9 in women aged 16 to 26 years.
Slovenian: V kliničnih študijah s cepivom Gardasil 9 pri ženskah, starih 16 do 26 let, je v obdobju cepljenja dojilo skupno 92 žensk.
English: 1 Type 58 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 58
English: Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
Slovenian: Pri osebah, ki imajo akutno hudo bolezen z zvišano telesno temperaturo, je treba cepljenje odložiti.
English: 1 Type 31 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 31
English: 1 Type 33 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 33
English: HPV 31-, 33-, 45-, 52-, 58-related VIN 2/3, VaIN 2/3
Slovenian: VIN 2/3 in VaIN 2/3, povezani s HPV 31, 33, 45, 52 in 58
English: 1 Type 45 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 45
English: 1 Type 52 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 52
English: 1 Type 6 L1 protein
Slovenian: L1 protein humanega papilomavirusa 1 tipa 6
English: Clear liquid with white precipitate.
Slovenian: suspenzija za injiciranje bistra tekočina z belo usedlino
English: HPV 31-, 33-, 45-, 52-, 58-related CIN2
Slovenian: CIN2, povezane s HPV 31, 33, 45, 52 in
English: HPV 31-, 33-, 45-, 52-, 58-related CIN3
Slovenian: CIN3, povezane s HPV 31, 33, 45, 52 in
English: HPV types.
Slovenian: 1 tipa 45
English: • Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.
Slovenian: • Preden ga pretresemo, je cepivo Gardasil 9 bistra tekočina z belo oborino.
English: The PPE population consisted of individuals who received all 3 vaccinations with qHPV vaccine in the base study within 1 year of enrolment without major deviations from the study protocol, were seronegative to the relevant HPV type(s) (types 6, 11, 16, and 18) prior to dose 1, and among subjects 16 years and older at enrolment in the base study, PCR negative to the relevant HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Slovenian: Osebe so bile seronegativne za zadevni tip (zadevne tipe) HPV (tipi 6, 11, 16 in 18) pred 1. odmerkom ter med osebami starimi 16 let ali več ob vključitvi v izhodiščno študijo, PCR negativne za zadevni tip (zadevne tipe) HPV pred 1. odmerkom in tekom enega meseca po 3. odmerku (7. mesec).
English: Intramuscular use.
Slovenian: Navodilo za uporabo
English: HPV 31-, 33-, 45-, 52-, 58-related CIN 2/3 or AIS
Slovenian: CIN 2/3 ali AIS, povezane s HPV 31, 33, 45, 52 in 58
English: - If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če pri sebi oz. otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom,
English: First injection: at chosen date
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: If you forget one dose of Gardasil 9
Slovenian: Če enega odmerka cepiva Gardasil 9 niste prejeli
English: The usual dose is one 1,340-microgram capsule once a day for three weeks, followed by a week when the patient does not take any capsules.
Slovenian: Običajni odmerek je ena 1 340mikrogramska kapsula enkrat dnevno v obdobju treh tednov, ki mu sledi obdobje enega tedna, v katerem bolnik ne jemlje kapsul.
English: The full EPAR for Fotivda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fotivda je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects are high blood pressure (which occurs in almost half of patients) and voice changes, tiredness and diarrhoea (which occur in about a quarter of patients).
Slovenian: Najpogostejši neželeni učinki so visok krvni tlak (ki se pojavi pri skoraj polovici bolnikov) in spremembe glasu, utrujenost in driska (ki se pojavijo pri približno četrtini bolnikov).
English: What measures are being taken to ensure the safe and effective use of Fotivda?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fotivda?
English: It is not intended to provide practical advice on how to use Fotivda.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Fotivda is available as capsules (890 and 1,340 micrograms).
Slovenian: Zdravilo Fotivda je na voljo v obliki kapsul (890 μg in 1 340 μg).
English: What is Fotivda and what is it used for?
Slovenian: Kaj je zdravilo Fotivda in za kaj se uporablja?
English: A main study of 517 patients with advanced renal cell carcinoma that had either come back or spread to other parts of the body has shown that Fotivda can help stop the disease from getting worse.
Slovenian: Glavna študija s 517 bolniki z napredovalim karcinomom ledvičnih celic, ki se je ponovil ali razširil v druge dele telesa, je dokazala, da lahko zdravilo Fotivda zaustavi poslabšanje bolezni.
English: If the patient has troublesome side effects, the doctor may decide to switch to the lower-strength 890-microgram capsules or interrupt treatment.
Slovenian: Če se pri bolniku pojavijo problematični neželeni učinki, se lahko zdravnik odloči za prehod na 890-mikrogramske kapsule nižje jakosti ali prekinitev zdravljenja.
English: This is a summary of the European public assessment report (EPAR) for Fotivda.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fotivda.
English: Other information about Fotivda
Slovenian: Druge informacije o zdravilu Fotivda
English: The most common side effects with Fotivda are considered manageable, although they may affect the patient's quality of life.
Slovenian: Najpogostejši neželeni učinki zdravila Fotivda veljajo za obvladljive, čeprav lahko vplivajo na kakovost bolnikovega življenja.
English: The patients should continue repeating this 4-week course for as long as the disease does not get worse or until side effects become unacceptable.
Slovenian: Bolniki morajo ta štiritedenski cikel zdravljenja ponavljati, dokler se bolezen ne poslabša ali dokler neželeni učinki ne postanejo nesprejemljivi.
English: What benefits of Fotivda have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Fotivda izkazalo v študijah?
English: Why is Fotivda approved?
Slovenian: Zakaj je bilo zdravilo Fotivda odobreno?
English: The most important serious side effect with Fotivda is high blood pressure.
Slovenian: Najpomembnejši neželeni učinek zdravila Fotivda je visok krvni tlak.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fotivda have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fotivda upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Fotivda?
Slovenian: Kakšna tveganja so povezana z zdravilom Fotivda?
English: In this study, patients taking Fotivda lived for longer without their disease worsening (12 months) than those given another approved medicine sorafenib (9 months).
Slovenian: V tej študiji so bolniki, ki so jemali zdravilo Fotivda, brez poslabšanja bolezni živeli dlje (12 mesecev) od tistih, ki so jemali drugo odobreno zdravilo, sorafenib (9 mesecev).
English: Fotivda can only be obtained with a prescription, and treatment should be supervised by a doctor with experience of treating cancers.
Slovenian: Predpisovanje in izdaja zdravila Fotivda je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: By blocking this protein, tivozanib stops the formation of new blood vessels that the tumour needs, thereby cutting off its blood supply and reducing the growth of the cancer.
Slovenian: Z zaviranjem te beljakovine tivozanib zaustavi nastanek novih krvnih žil, ki jih potrebuje tumor, s tem pa prekine dovod krvi do tumorja in zmanjša rast raka.
English: For more information about treatment with Fotivda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fotivda preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Fotivda may be used in previously untreated patients or in those whose disease has got worse despite treatment with another medicine working in a different way.
Slovenian: Zdravilo Fotivda se lahko uporablja pri bolnikih, ki še niso bili zdravljeni, ali pri bolnikih, pri katerih se je bolezen kljub zdravljenju z drugim, drugače delujočim zdravilom, poslabšala.
English: The European Medicines Agency therefore concluded that the benefits of Fotivda outweighed its risk and recommended that it be granted authorisation in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da koristi zdravila Fotivda odtehtajo z njim povezano tveganje, in priporočila, da se zanj izda dovoljenje za promet.
English: Fotivda is a medicine for treating adults with advanced renal cell carcinoma (a kidney cancer).
Slovenian: Zdravilo Fotivda se uporablja za zdravljenje odraslih z napredovalim karcinomom ledvičnih celic (rakom ledvic).
English: On the whole, its side effects are in line with what is expected of a medicine of its class (VEGF inhibitors).
Slovenian: V splošnem so neželeni učinki zdravila v skladu s pričakovanimi za zdravilo tega razreda (zaviralce VEGF).
English: It contains the active substance tivozanib.
Slovenian: Vsebuje zdravilno učinkovino tivozanib.
English: The active substance in Fotivda, tivozanib, works by blocking the activity of proteins known as VEGF, which stimulate the formation of new blood vessels.
Slovenian: Zdravilna učinkovina v zdravilu Fotivda, tivozanib, deluje tako, da zavira delovanje beljakovin, imenovanih VEGF, ki spodbujajo nastanek novih krvnih žil.
English: For practical information about using Fotivda, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Fotivda naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How is Fotivda used?
Slovenian: Kako se zdravilo Fotivda uporablja?
English: A main study showed that Fotivda increased the time it took for the disease to get worse by almost 3 months when compared with another approved medicine sorafenib.
Slovenian: V glavni študiji so dokazali, da zdravilo Fotivda v primerjavi z drugim odobrenim zdravilom, sorafenibom, podaljša čas do poslabšanja bolezni za skoraj 3 mesece.
English: Patients must not take St John's wort (a herbal remedy for depression) during treatment with Fotivda.
Slovenian: Bolniki med zdravljenjem z zdravilom Fotivda ne smejo jemati šentjanževke (zdravila rastlinskega izvora za zdravljenje depresije).
English: How does Fotivda work?
Slovenian: Kako zdravilo Fotivda deluje?
English: More information on Uptravi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Uptravi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This also applies to any changes in the dose.
Slovenian: To se nanaša tudi na vsako spremembo odmerka.
English: This could lead to patients receiving either too much (overdose) or too little (underdose) of the medicine.
Slovenian: To lahko privede do tega, da bolniki prejemajo preveč (prevelik odmerek) ali premalo (premajhen odmerek) zdravila.