natgillin/translations-raw huggingface dataset:
In clinical studies with tivozanib, elevations of ALT, AST, and bilirubin have been reported (see section 4.8). 
Pri kliničnem preskušanju tivozaniba so poročali o povišanjih ALT, AST in bilirubina (glejte poglavje 4.8).
Haemorrhage adverse reactions were reported in the core monotherapy studies during initial treatment (see section 4.4). 
O neželenih reakcijah v obliki krvavitve so poročali med začetnim zdravljenjem v osrednjih študijah monoterapije (glejte poglavje 4.4).
In clinical studies with tivozanib, hypertension (including persistent severe hypertension) has occurred (see section 4.8). 
Pri kliničnem preskušanju tivozaniba so poročali o hipertenziji (vključno z vztrajno hudo hipertenzijo) (glejte poglavje 4.8).
intolerance to heat, increased sweating, tremors, rapid heart rate); enlarged thyroid gland. 
neprenašanje vročine, povečano potenje, drgetanje, hiter srčni utrip); povečana ščitnica.
Wound healing complications 
Komplikacije pri celjenju ran
14 Dyspnoea including dyspnoea and exertional dyspnoea 15 Abdominal pain including abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and abdominal rigidity 
15 Abdominalna bolečina vključuje neprijetni občutek v trebuhu, abdominalno bolečino, abdominalno bolečino zgoraj in abdominalno bolečino spodaj in otrdelost trebuha
In vitro studies with tivozanib indicate that it is not a CYP enzyme inducer. 
Rezultati študij in vitro s tivozanibom so pokazali, da ni induktor CYP.
No dose adjustment is required when administering tivozanib to patients with mild hepatic impairment. 
Odmerka ni treba prilagoditi za bolnike z blago jetrno okvaro.
• Abnormal blood test results for liver, pancreas, kidney, and thyroid. 
• Nenormalni izvidi preiskav krvi za jetra, trebušno slinavko, ledvice in ščitnico.
Abdominal pain15 Nausea Diarrhoea Stomatitis16 
Abdominalna bolečina15
Tivozanib must be used with caution in patients who are at risk for, or who have a history of these events (such as myocardial infarction, stroke). 
Tivozanib je treba uporabljati previdno pri bolnikih s tveganjem za nastanek teh dogodkov (kot sta srčni infarkt, možganska kap) ali tistih, ki imajo te dogodke v anamnezi.
confusion, altered consciousness or sense of awareness, rapid, shallow breathing, a racing heart or excessive sweating. 
tesnoba, zmedenost, moteno stanje zavesti ali občutka zavedanja, hitro, plitko dihanje,
If you stop taking the capsules your condition may get worse. 
tvegate, da se vam stanje poslabša.
Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules 
Fotivda 890 mikrogramov trde kapsule Fotivda 1340 mikrogramov trde kapsule
- Printing ink, yellow: shellac, propylene glycol, strong ammonia solution, titanium dioxide 
- Tiskarska barva, modra: šelak, propilenglikol, koncentrirana raztopina amoniaka, indigotin
Monitoring for proteinuria before initiation of, and periodically throughout treatment is recommended. 
Priporočamo, da preverjate morebiten pojav proteinurije pred zdravljenjem in redno ves čas zdravljenja.
• Being sick; indigestion; constipation; dry mouth. 
• Bruhanje; prebavne težave; zaprtost; suha usta.
Tell your doctor right away as these may be symptoms of heart failure. 
• če ste zasopli ali vam zatekajo gležnji Zdravnika takoj obvestite o tem, saj sta to lahko simptoma srčnega popuščanja.
There were no deaths due to arterial thromboembolic adverse reactions in those receiving tivozanib as initial therapy but a myocardial infarction in a patient receiving second-line tivozanib had a fatal outcome. 
Pri bolnikih, ki so prejemali tivozanib kot začetno zdravljenje, ni bilo smrtnih primerov zaradi arterijskih trombemboličnih neželenih učinkov, miokardni infarkt bolnika, ki je prejemal tivozanib kot zdravljenje drugega reda, pa je imel smrtni izid.
Pulmonary embolism was reported in patients (0.7%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies, with the majority CTC Grade ≥ 3 (see section 4.4). 
O pljučnem embolizmu so poročali pri bolnikih (0,7 %), ki so prejemali tivozanib kot začetno zdravljenje, v petih osrednjih raziskavah monoterapije RCC, pri večini ≥3.
Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) (see section 4.5). 
Sočasna uporaba z zdravili rastlinskega izvora, v katerih je šentjanževka (Hypericum perforatum) (glejte poglavje 4.5).
No adverse reaction was experienced by the second patient who took 2 doses of 1340 microgram tivozanib in one day (total 2680 microgram). 
Drugi bolnik, ki je vzel 2 odmerka tivozaniba po 1340 miligramov v enem dnevu (skupaj 2680 mikrogramov), ni doživel neželenih učinkov.
Electrocardiogram QT prolonged 
Podaljšan interval QT na elektrokardiogramu
Back pain 
Bolečina v hrbtu
Epistaxis Rhinorrhoea Nasal congestion 
Rinoreja Kongestija nosu
• Muscle weakness. 
• Mišična šibkost.
Risk factors for ATE include malignant disease, age > 65 years, hypertension, diabetes mellitus, smoking, hypercholesterolaemia, and prior thromboembolic disease. 
hipertenzijo, sladkorno bolezen, kajenje, hiperholesterolemijo in predhodno trombembolijsko bolezen.
• Inflammation of the mouth; slight mouth pain or discomfort; feeling sick; pain, discomfort and tightness in the stomach. 
• Vnetje v ustih; blaga bolečina ali neugodje v ustih; slabost (siljenje na bruhanje); bolečina,
27 Pain including bone pain, cancer pain, flank pain, groin pain, oral pain, pain, pain in extremity and tumour pain 28 Chest pain including chest pain and non-cardiac chest pain 29 Chills including chills and hypothermia 
bolečino v ustih, bolečino, bolečino v udu in bolečino zaradi tumorja 28 Bolečina v prsnem košu vključuje bolečino v prsnem košu in nekardiogeno bolečino v prsnem košu
Patients receiving anti-hypertensive medication should still be monitored for hypotension when tivozanib is either interrupted or discontinued. 
Bolnike, ki prejemajo antihipertenzive, je po začasni prekinitvi ali ukinitvi zdravljenja s tivozanibom treba spremljati glede možnega pojava hipotenzije.
Depending on the results, your doctor may reduce your dose of Fotivda, or interrupt or stop this treatment. 
Odvisno od rezultatov se lahko zdravnik odloči zmanjšati odmerek zdravila Fotivda ali začasno prekiniti ali zaustaviti zdravljenje s tem zdravilom.
If necessary, your doctor may reduce your dose of Fotivda, or interrupt or stop this treatment. 
Po potrebi zdravnik lahko zmanjša odmerek zdravila Fotivda ali začasno prekine ali zaustavi zdravljenje s tem zdravilom.
PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. 
PRES je nevrološka bolezen z znaki, kot so glavobol, epileptični napad, letargija, zmedenost, slepota in druge motnje vida in nevrološke motnje.
• if you have had problems with blood clots. 
• če imate težave zaradi krvnih strdkov.
• Joint pain; muscle pain. 
• Bolečina v sklepih; bolečina v mišicah.
• if the skin on the palms of your hands and the soles of your feet become dry, cracked, 
• če koža na dlaneh ali podplatih postane suha, razpokana, se lušči, skeli ali ščemi
Fungal infection Pustular rash 
Glivična okužba Pustularni izpuščaj
Symptoms include shortness of breath or ankle swelling. 
Simptomi vključujejo zasoplost ali zatekanje gležnjev.
When dose reduction is necessary, the tivozanib dose can be reduced to 890 microgram once daily with the normal treatment schedule of 21 days of dosing, followed by a 7-day rest period. 
Če je potrebno zmanjšanje, lahko odmerek tivozaniba zmanjšate na 890 mikrogramov enkrat na dan,
Fotivda 1340 microgram hard capsules 
Fotivda 1340 mikrogramov trde kapsule
Blood pressure should be well controlled prior to initiating tivozanib. 
Pred začetkom zdravljenja s tivozanibom je treba skrbno meriti krvni tlak.
• Heart failure. 
• Srčno popuščanje.
Two patients received excessive doses of tivozanib during the monotherapy studies. 
4.9 Preveliko odmerjanje Dva bolnika sta prejela prevelike odmerke tivozaniba med kliničnim preskušanjem zdravila v monoterapiji.
Progression-Free Survival, No prior treatment for Metastatic RCC Subgroup [median, months (95% CI)] 
Preživetje brez napredovanja, brez predhodnega zdravljenja za podskupino metastatskega RCC
Fotivda 890 microgram hard capsules 
Fotivda 890 mikrogramov trde kapsule
Your doctor will monitor this, and depending on the severity may reduce your dose of Fotivda, or interrupt or stop treatment with Fotivda. 
Zdravnik bo stalno spremljaj to stanje in po potrebi glede na resnost zmanjšal odmerek zdravila Fotivda ali začasno prekinil ali zaustavil zdravljenje z zdravilom Fotivda.
After once daily dosing of 1340 microgram tivozanib for 21 or 28 days in RCC patients, Cmax was 67.5 to 94.3 ng/mL and AUC0-24 was 1,180 to 1,641 ng.hr/mL. 
Po enkratnem dnevnem odmerku 1340 mikrogramov tivozaniba 21 ali 28 dni pri bolnikih z RCC je bila Cmax 67,5 do
Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 5.2). 
Bolnike z zmerno jetrno oslabitvijo smejo jemati le po eno kapsulo tivozaniba 1340 mikrogramov vsak drugi dan, saj pri teh bolnikih obstaja tveganje za neželene učinke zaradi povečane izpostavljenosti pri odmerku 1340 miligramov vsak dan
Venous thromboembolism 
Venski tromboembolizem
Your doctor will regularly monitor you for these symptoms during your treatment with Fotivda. 
Med zdravljenjem z zdravilom Fotivda vas bo zdravnik redno pregledoval, če imate te simptome.
Propylene glycol Strong ammonia solution Titanium dioxide (E171) Tartrazine aluminium lake (E102) 
šelak propilenglikol koncentrirana raztopina amoniaka titanov dioksid (E171) tartrazin (E102)
Vision impairment6 
Motnje vida6
Eye disorders 
Kongestija ušesa
16 Stomatitis including oral discomfort, oral disorder and stomatitis 17 Pancreatitis including pancreatitis and pancreatitis acute 18 Dysphagia including dysphagia, odynophagia and oropharyngeal pain 19 Glossitis including glossitis and glossodynia 
16 Stomatitis vključuje neprijeten občutek v ustih, bolezni ust in stomatitis 17 Pankreatitis vključuje pankreatitis in akutni pankreatitis 18 Disfagija vkljčuje disfagijo, odinofagijo in orofaringealno bolečino
• Hand-foot-syndrome with skin reddening, swelling, numbness and skin peeling on palms and soles. 
• Sindrom roka-noga z rdečico na koži, zatekanjem, otrplostjo in luščenjem kože na dlaneh in podplatih.
- Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). 
- Ovojnina kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172).
This controlled clinical study was a Phase 3 multi-centre, open-label, international, randomised study comparing tivozanib with sorafenib in patients with advanced RCC. Five hundred and seventeen (517) patients with recurrent or metastatic RCC with a clear cell component were randomised (1:1) to receive either tivozanib 1340 microgram once daily on a schedule of 3 weeks on treatment followed by 1 week off (schedule 3/1) or sorafenib 400 mg twice a day. 
(517) bolnikov s ponavljajočim ali metastatskim RCC s svetlocelično komponento je bilo randomiziranih (1:1) na prejemanje tivozaniba po 1340 mikrogramov enkrat na dan po razporedu
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
ETIKETA NA STEKLENIČKI
By blocking VEGF-induced VEGFR activation, tivozanib inhibits angiogenesis and vascular permeability in tumour tissues, leading to inhibition of tumour growth in vivo. 
VEGF je učinkovit mitogen faktor, ki ima pomembno vlogo pri angiogenezi in vaskularni permeabilnosti tumorskih tkiv Z zaviranjem aktivacije VEGFR, ki jo inducira VEGF, tivozanib zavira angiogenezo in vaskularno permeabilnost tumorskih tkiv, kar vodi do zaviranja rasti tumorja in vivo.
• Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stomach; swollen and painful tongue; inflamed painful and/or bleeding gums. 
• Napenjanje; zgaga; oteženo požiranje in bolečina pri požiranju; vneto grlo; napihnjen trebuh;
Titanium dioxide (E171) Yellow iron oxide (E172) 
Ovojnica kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172)
Deep vein thrombosis was also reported in two patients (0.3%) and was CTC Grade ≥ 3 in one patient (0.1%) receiving initial tivozanib therapy. 
Poročali so o globoki venski trombozi pri dveh bolnikih (0,3 %), pri enem bolniku
• if you suffer or have suffered from any of these symptoms or are treated for heart failure: o Shortness of breath (dyspnoea) when you exert yourself or when you lie down o Feeling weak and tired o Swelling (oedema) in your legs, ankles and feet o Reduced ability to exercise o Persistent cough or wheezing with white or pink blood-tinged phlegm Signs and symptoms of heart failure will be monitored whilst you are taking your medicine. 
o Zasoplost (dispneja), ko se naprezate ali uležete o Občutek šibkosti in utrujenosti o Zatekanje (edem) v nogah, gležnjih in stopalih o Zmanjšana zmožnost telesne dejavnosti o Vztrajen kašelj ali piskajoče dihanje z belim ali roza izmečkom, obarvanim s krvjo
One Fotivda 890 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken. 
eno kapsula zdravila Fotivda po 890 mikrogramov na dan 21 dni (3 tedne) s 7-dnevnim premorom, ko
If you develop high blood pressure, your doctor may prescribe a medicine to treat your high blood pressure, lower your dose of Fotivda, or stop your treatment with Fotivda. 
vam lahko predpiše zdravilo proti visokem krvnem tlaku, zmanjša odmerek zdravila Fotivda ali prekine zdravljenje z zdravilom Fotivda.
Fotivda 890 microgram hard capsules have a dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body. 
Fotivda 890 mikrogramov trde kapsule imajo temnomodri neprozorni pokrovček in svetlorumeno neprozorno telo, rumeni napis “TIVZ” na pokrovčku in temnomodri napis “LD” na telesu kapsule.
Treatment with Fotivda may raise the risk of developing a blood clot (thrombus) in your blood vessels that could break loose and be carried by the blood stream to block another blood vessel. 
Pri zdravljenju z zdravilom Fotivda obstaja tveganje za nastanek krvnih strdkov (trombozo) v krvnih žilah.
- Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide 
- Ovojnina kapsule: želatina, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172).
Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favour of tivozanib; b p-value based on stratified log-rank test. Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2); 
Če predpostavljamo proporcionalna tveganja, razmerje tveganja manj kot 1 označuje zmanjšanje razmerja tveganja v korist tivozanibu; b p-vrednost, ki temelji na stratificiranem „logrank testu“.
It is recommended that tivozanib be used with caution in patients with a history of QT interval prolongation or other relevant pre-existing cardiac disease and those receiving other medications known to increase the QT interval. 
Svetujemo, da tivozanib uporabljate previdno pri bolnikih z anamnezo podaljšanja intervala QT ali drugih pomembnih obstoječih bolezni srca, in pri bolnikih, ki prejemajo druga zdravila, ki povzročajo podaljšanje intervala QT. Priporočamo, da na začetku zdravljenja in redno naprej nadzorujete elektrokardiograme in ohranjate elektrolite (npr. kalcij, magnezij, kalij) v normalnem območju.
6 Vision impairment including reduced visual acuity, vision blurred and visual impairment 7 Myocardial infarction (acute) / ischaemia including acute myocardial infarction, ischaemia and myocardial infarction 8 Tachycardia including sinus tachycardia, supraventricular tachycardia, tachycardia and tachycardia paroxysmal 9 Haemorrhage including adrenal haemorrhage, anal haemorrhage, cervix haemorrhage uterine, duodenal ulcer haemorrhage, gingival bleeding, haematemesis, haemoptysis, haemorrhagic anaemia, haemorrhagic erosive gastritis, 
8 Tahikardija vključuje sinusno tahikardijo, superventrikularno tahikardijo, tahikardijo in paroksizmalno tahikardijo 9 Krvavitve vključujejo krvavitev v nadledvični žlezi, krvavitev iz anusa, krvavitev iz materničnega vratu,krvavitev iz razjede dvanajstnika, krvavitvijo dlesni, s hematemezo, hemoptizo, hemoragično anemijo, hemoragični erozijski gastritis, hemoraično možgansko kap, pljučno krvavitev in krvavitev iz dihalnih poti 10 Arterijska trombembolija vključuje akutni miokardni infarkt, arterijsko trombozo, trombozo iliakalne arterije,
Talk to your doctor, pharmacist or nurse while taking Fotivda: 
Med jemanjem zdravila Fotivda se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro:
In nonclinical studies assessing mating and fertility parameters in male rats, doses > 2-fold higher than the recommended clinical dose, produced increased epididymis and testis weights associated with infertility. 
Razmnoževanje, mutagenost, zmanjšanje plodnosti Tivozanib lahko negativno vpliva na plodnost pri človeku Rezultati predkliničnega preskušanja zdravila, pri kateri so proučevali parametre parjenja in plodnosti pri samcih podgan, so >2-krat večji odmerki od priporočenega kliničnega odmerka povzročili povečanje epididimisa in mase mod, kar je bilo povezano z neplodnostjo.
• Nose bleed; runny nose; blocked nose. 
• Krvavitev iz nosu; izcedek iz nosu; zamašen nos.
Peripheral neuropathy2 
Periferna nevropatija2 Omotica Disgevzija3
Signs or symptoms of cardiac failure should be periodically monitored throughout treatment with tivozanib. 
Ves čas zdravljenja s tivozanibom je treba redno spremljati znake in simptome srčnega popuščanja.
Dose modification 
Prilagajanje odmerka
• Swelling or irritation of the mucous membranes. 
• Zatekanje ali draženje sluznic.
Gammaglutamyltransferase increased 
Trombocitopenija Povišan hemoglobin
Uncommon (may affect up to 1 in 100 people) 
Občasni (pojavijo se lahko pri največ 1 na 100 bolnikov)
No capsules are taken 
Ne vzeti nobene kapsule ne vzamete nobene kapsule.
In clinical studies with tivozanib, arterial thromboembolic events (ATEs) have occurred (see section 4.8). 
V kliničnem preskušanju tivozaniba so poročali o pojavu arterijskih trombemboličnih dogodkov (ATE) (glejte poglavje 4.8).
Fotivda 1340 microgram hard capsules have a bright yellow opaque cap and bright yellow opaque body, printed with dark blue ink “TIVZ” on the cap and with dark blue ink “SD” on the body. 
Fotivda 1340 mikrogramov trde kapsule imajo svetlorumeni neprozorni pokrovček in svetlorumeno neprozorno telo, temnomodri napis “TIVZ” na pokrovčku in temnomodri napis “SD” na telesu.
In clinical studies with tivozanib, hypothyroidism has been reported (see section 4.8). 
Pri kliničnem preskušanju tivozaniba so poročali o hipotiroidizmu (glejte poglavje 4.8).
Progression-Free Survival [median, months (95% CI)], ITT Population 
(95 % CI)], populacija
Most events in the five renal cell carcinoma monotherapy studies were CTC Grade 1 or 2 (≥ CTC Grade 3 was observed in < 2% of patients treated with tivozanib) and there were no serious events (see section 4.8). 
Večina dogodkov v petih študijah monoterapije pri raku ledvičnih celic je bila 1. ali 2. stopnje po skupnih kriterijih toksičnosti (≥3.
lack of energy, confusion, blindness or other visual and neurologic disturbances. 
Simptomi vključujejo glavobol, napad krčev, pomanjkanje energije, zmedenost, slepoto ali druge motnje vida in nevrološke motnje.
Palmar-plantar erythrodysaesthesia syndrome / Hand foot skin reaction (PPE/HFS) 
Sindrom palmarnoplantarne eritrodisestezije/ sindrom rokanoga
Each capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram of tivozanib. 
Ena trda kapsula vsebuje tivozanibijev klorid monohidrat v količini, ki ustreza 1340 mikrogramom tivozaniba.
Fotivda 1340 microgram hard capsules tivozanib 
IME ZDRAVILA Fotivda 1340 mikrogramov trde kapsule tivozanib
Blood thyroid stimulating hormone increased 
Povišana amilaza Povišana lipaza Povišana koncentracija tiroideo-stimulirajočega hormona v krvi
Tell your doctor right away if you have symptoms such as headache, seizure (fit), lack of energy, confusion, blindness or other visual and neurologic disturbances such as weakness in an arm or a leg. 
• če trpite možgansko bolezen, t. i. sindrom posteriorne reverzibilne encefalopatije (PRES) Če zaznate simptome, kot so glavobol, napad krčev, pomanjkanje energije, zmedenost, slepota ali druge motnje vida in nevrološke motnje, kot je šibkost v roki ali nogi, o tem takoj obvestite zdravnika.
Arterial thromboembolism10 
Krvavitev9 Arterijska tromboembolija10 Venska tromboembolija11
Contains tartrazine. 
žolčnika in žolčevodov
Fotivda 890 microgram hard capsules tivozanib 
IME ZDRAVILA Fotivda 890 mikrogramov trde kapsule tivozanib
Insomnia 
Nespečnost
Blood alkaline phosphatase increased 
Povišana gama-glutamiltransferaza Povišana alkalna fosfataza v krvi
Keep this medicine out of the sight and reach of children. 
Zdravilo hranite na mestu, ki ga otroci ne vidijo in ne dosežejo.
Vertigo Tinnitus 
Angina pektoris
After a single 1340 microgram dose, mean Cmax was 10.2 to 25.2 ng/mL across healthy subject and patient studies. 
V preskušanjih pri zdravih prostovoljcih in pri bolnikih je bila povprečna Cmax po enkratnem odmerku 1340 mikrogramov 10,2 do 25,2 ng/ml.
Each capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram of tivozanib. 
Ena trda kapsula vsebuje tivozanibijev klorid monohidrat v količini, ki ustreza 890 mikrogramom tivozaniba.
Talk to your doctor, pharmacist or nurse before taking Fotivda: 
Opozorila in previdnostni ukrepi Preden začnete jemati zdravilo Fotivda, se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro:
Alopecia Rash24 Acne25 
Pruritus23 Alopecija Izpuščaj24 Akne25 Suha koža
METHOD AND ROUTE(S) OF ADMINISTRATION 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Oralna uporaba.
Arthralgia Myalgia Musculoskeletal chest pain 
Mišično-skeletna bolečina v prsnem košu
Tabulated summary of adverse reactions 
Povzetek neželenih učinkov, prikazan v obliki preglednice
Coronary artery insufficiency 
Pljučni edem Koronarna insufienca
How to store Fotivda 
Shranjevanje zdravila Fotivda
Fotivda 890 microgram 
PODATKI V BRAILLOVI PISAVI Fotivda 890 mikrogramov
Hard capsule with dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body. 
Trda kapsula s temnomodrim neprozornim pokrovčkom in svetlorumenim neprozornim telesom, z rumenim napisom “TIVZ” na pokrovčku in svetlorumenim napisom “LD” na telesu kapsule.
Chest pain28 Chills29 Pyrexia Peripheral oedema 
Bolečina v prsnem košu28 Mrazenje29
Skin exfoliation Erythema22 Pruritus23 
Pankreatitis17 Disfagija18
- Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminium lake (E132). 
- Tiskarska barva, rumena: šelak, propilenglikol, koncentrirana raztopina amoniaka, titanov dioksid (E171), tartrazin (E102).
Fotivda 1340 microgram 
PODATKI V BRAILLOVI PISAVI Fotivda 1340 mikrogramov
Magnetic Resonance Imaging is necessary to confirm the diagnosis of PRES. Tivozanib must be discontinued in patients developing signs or symptoms of PRES. 
Pri bolnikih, ki razvijejo znake ali simptome PRES je treba zdravljenje s tivozanibom prekiniti.
Always take this medicine exactly as your doctor has told you. 
Kako jemati zdravilo Fotivda Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
Strong ammonia solution Indigo carmine aluminium lake (E132) 
šelak propilenglikol koncentrirana raztopina amoniaka indigotin (E132)
• Unable to sleep. 
• Nespečnost.
Ear and labyrinth disorders 
vključno z motnjami labirinta
EU/1/17/1215/002 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1215/002
Duodenal ulcer 
Pireksja Periferni edem
Proteinuria has been reported in clinical studies with tivozanib (see section 4.8). 
Pri kliničnem preskušanju tivozaniba so poročali o proteinuriji (glejte poglavje 4.8).
• Headache 
• Driska.