FrancophonIA/ELRC3.0 huggingface dataset:
English: In female rats, an increase in non-viable foetuses was noted at a dose 0.7-fold the recommended clinical dose, while dose levels ≥ 2 fold the recommended clinical dose produced infertility.
Estonian: Emasrottidel täheldati 0,7-kordse kliinilise annuse juures suurenenud eluvõimeta loodete arvu, samas kui ≥ 2-kordne annus (võrreldes kliinilise annusega) põhjustas viljatust.
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Estonian: Titaandioksiid (E171) Kollane raudoksiid (E172)
English: - Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminium lake (E132).
Estonian: - Sinine trükivärv: šellak, propüleenglükool, kontsentreeritud ammoniaagilahus, indigokarmiin alumiiniumlakk (E132).
English: • Bruising easily, bleeding into the skin.
Estonian: • Kergesti tekkivad verevalumid, naha veritsus.
English: Wound healing complications
Estonian: Haava paranemise komplikatsioonid
English: Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Estonian: Statistiliselt oli sõltumatu radioloogilise aruande kohaselt tivosaniibi ravi võrreldes sorafeniibiga efektiivsem uuringu PFS ja ORR osas (Tabel 2 ja joonis 1).
English: In clinical studies, one case of posterior reversible encephalopathy syndrome (PRES) was confirmed after treatment with tivozanib (see section 4.8).
Estonian: Tivosaniibi kliinilistes uuringutes kinnitati ühel korral pöörduva posterioorsse entsefalopaatia sündroomi (posterior reversible encephalopathy syndrome, PRES) esinemist (vt lõik 4.8).
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Estonian: - Kapsli kest: želatiin, titaandioksiid (E171), kollane raudoksiid (E172).
English: Tivozanib exposure was increased in patients with severe hepatic impairment (mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment (mean AUC0-∞ by 2.6-fold).
Estonian: Tivosaniibi plasmakontsentratsioon oli kõrgem raske (keskmine AUC0-∞ neljakordselt) ja mõõduka (keskmine AUC0-∞ 2,6-kordselt) maksakahjustusega patsientidel.
English: If you or your partner are taking hormonal contraceptives (the pill, an implant or patch) you must use an additional barrier method throughout treatment and for another month after completing treatment.
Estonian: Te peate kasutama lisa barjäärimeetodit terve Fotivda ravi ajal ja üks kuu pärast ravi lõppemist, kui teie või teie partner kasutab hormonaalseid rasestumisvastaseid vahendeid (tablet, implantaat või plaster)
English: Dizziness Dysgeusia3
Estonian: Pearinglus Düsgeuusia3
English: Hand foot skin reaction
Estonian: Käe-jala nahareaktsioon
English: Mild to severe hypertension may be present.
Estonian: Esineda võib ka mõõdukat kuni tõsist hüpertensiooni.
English: Fotivda 1340 microgram
Estonian: Fotivda 1340 μg
English: Increased testis weights were observed at a dose 7-fold higher than the recommended clinical dose.
Estonian: Suurenenud munandi kaalu täheldati kliinilisest annusest seitsmekordselt suurema annuse manustamisel.
English: Contents of the pack and other information
Estonian: Kuidas Fotivda kõvakapsleid säilitada Pakendi sisu ja muu teave
English: Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules
Estonian: Fotivda 890 mikrogrammi kõvakapslid Fotivda 1340 mikrogrammi kõvakapslid
English: Symptoms include severe headaches, blurred vision, shortness of breath, changes in your mental state, such as feeling anxious, confused or disorientated
Estonian: Sümptomite hulka kuuluvad tugevad peavalud, nägemise ähmastumine, hingeldamine, vaimse tervise muutus (näiteks ärevus, segasus või ruumis ja/või ajas orienteerumine).
English: 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.
Estonian: Korduva või metastaatilise neerurakulise kartsinoomiga viissada seitseteist (517) patsienti randomiseeriti (1:1), neile manustati kas 1340 mikrogrammi tivosaniibi üks kord ööpäevas kolmenädalase ravi käigus, millele järgnes 1 nädal pausi (ajakava 3/1) või 400 mg sorafeniibi kaks korda ööpäevas.
English: • Rashes with pus; fungal infections.
Estonian: • Mädane lööve, seeninfektsioonid.
English: The central tendency change for all measured days and across all time points was 2.2 ms. No subjects had a new > 500 ms change in QTcF; 2 patients (4%) had QTcF values > 480 ms. One subject (2%) had a > 60 ms change from baseline in QTcF and 6 subjects (12%) had a 30 ms to 60 ms change from baseline (see section 4.4 and section 4.8).
Estonian: Ühelgi patsiendil ei esinenud uut > 500 ms QTcF muutust, 2 patsiendil (4%) olid QTcF väärtused > 480 ms.
English: haemorrhagic stroke, mouth haemorrhage, pulmonary haemorrhage and respiratory tract haemorrhage 10 Arterial thromboembolism including acute myocardial infarction, arterial thrombosis, iliac artery thrombosis,
Estonian: 10 Arteriaalne trombemboolia sealhulgas akuutne südamelihase infart, arteriaalne tromboos, niudearteri tromboos,
English: 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.
Estonian: Kõrge vererõhu tekimisel võib teie arst teile välja kirjutada vastavat ravimit, alandada Fotivda annust või katkestada Fotivda ravi.
English: Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favour of tivozanib; e p-value for subgroup analyses based on unstratified log-rank test.
Estonian: Võrdeliste riskide eeldamisel tähendab ühest väiksem riskimäär riskimäära vähenemist tivosaniibi kasuks.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Estonian: Te saate teavitada kõigist võimalikest kõrvaltoimetest ka otse riikliku teavitamissüsteemi, mis on loetletud V lisas, kaudu.
English: 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).
Estonian: Mõõduka maksakahjustusega patsiente tohib ravida ülepäeviti ühe 1340-mikrogrammise tivosaniibi kapsliga seoses suurenenud kõrvaltoimete esinemise riskiga suurema plasmakontsentratsiooni tõttu annuse 1340 mikrogrammi üks kord ööpäevas kasutamisel (vt lõik 5.2).
English: Depending on the results, your doctor may reduce your dose of Fotivda, or interrupt or stop this treatment.
Estonian: Tulemustest sõltuvalt võib teie arst Fotivda annust vähendada, ravi ajutiselt peatada või lõpetada.
English: • Difficulty speaking
Estonian: • Rääkimisraskused.
English: • Abnormal electrocardiogram (ECG), rapid and/or irregular heart beat.
Estonian: • Normist erinev elektrokardiogramm (EKG).
English: If you get bleeding problems (with painful swollen stomach (abdomen), vomiting blood, coughing up blood, black stools, blood in your urine, headache or changes in your mental state), tell your doctor right away.
Estonian: Pöörduge kohe oma arsti poole, kui teil esineb probleeme veritsusega (valulik, turses alakõht, veriokse, veriköha, must väljaheide, veri uriinis, peavalu või muutused vaimses seisundis.
English: In clinical studies with tivozanib, elevations of ALT, AST, and bilirubin have been reported (see section 4.8).
Estonian: Tivosaniibi kliinilistes uuringutes on teavitatud ALAT, ASAT ja bilirubiini taseme tõusust (vt lõik 4.8).
English: By blocking VEGF-induced VEGFR activation, tivozanib inhibits angiogenesis and vascular permeability in tumour tissues, leading to inhibition of tumour growth in vivo.
Estonian: Tivosaniib inhibeerib vähikoes angiogeneesi ja veresoonte läbitavust blokeerides VEGF-indutseeritud VEGFR aktivatsiooni, mis toob kaasa vähkkasvaja kasvu pidurdumise in vivo.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PAKENDIMÄRGISTUS
English: Lipase increased
Estonian: Suurenenud lipaasi tase
English: Your doctor will treat the condition and, depending on the severity, the doctor may reduce your dose of Fotivda, or interrupt or stop this treatment.
Estonian: Teie arst ravib viidatud haigust ja sõltuvalt selle tõsidusest võib Fotivda annust vähendada, ravi ajutiselt katkestada või lõpetada.
English: Strong ammonia solution Indigo carmine aluminium lake (E132)
Estonian: Kontsentreeritud ammoniaagilahus Indigokarmiin-alumiiniumlakk (E132)
English: 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).
Estonian: Kopsuembooliat (CTC tase ≥ 3) esines patsientidel (0,7%), kes said tivosaniibi esmavaliku ravina viies neerurakulise kartsinoomi monoteraapia uuringus (vt lõik 4.4).
English: - Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide
Estonian: - Kapsli kest: želatiin, titaandioksiid (E171), indigokarmiin (E132), kollane raudoksiid (E172).
English: 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.
Estonian: Kahel (0,3%) tivosaniibi esmavaliku ravina saanud patsiendil avastati süvaveeni tromboos (CTC tase ≥ 3), millest ühel patsiendil (0,1%) oli CTC tase ≥ 3.
English: Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours.
Estonian: Tivosaniibi suukaudsel võtmisel on vereseerumi kõrgeimad tasemed ligikaudu 2...24 tundi peale ravimi manustamist.
English: • Diarrhoea
Estonian: • Mälukaotus
English: Sorafenib
Estonian: Sorafeniib
English: Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172)
Estonian: Titaandioksiid (E171) Indigokarmiin (E132) Kollane raudoksiid (E172)
English: • Joint pain; muscle pain.
Estonian: • Liigesevalu, lihasvalu.
English: Treatment with Fotivda may cause your thyroid gland to work less well than usual.
Estonian: Fotivda ravi võib põhjustada kilpnäärme talitluse vähenemist.
English: 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.
Estonian: Fotivda 890 mikrogrammi kõvakapslitel on tumesinine läbipaistmatu kapslikaas ja erkkollane läbipaistmatu kapslikeha, mille kaanele on trükitud kollase tindiga “TIVZ” ja kehale sinise tindiga “LD”.
English: The inducing effect of St John's wort may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Estonian: Liht-naistepuna toimeained võivad organismis püsida kuni kaks nädalat peale selle tarvitamise lõpetamist (vt lõik 4.3).
English: Caution should be exercised if tivozanib is co-administered with rosuvastatin.
Estonian: Tivosaniibi ja rosuvastatiini koosmanustamisel tuleb olla ettevaatlik.
English: Do not take a double dose to make up for a forgotten capsule.
Estonian: Ärge võtke kahekordset annust, kui kapsel jäi eelmisel korral võtmata.
English: Hypertension was reported as an adverse reaction in 47.6% of patients receiving tivozanib as initial therapy; in 23.0% the hypertension was CTC ≥Grade 3.
Estonian: 47,6% patsientidest, sealhulgas 23,0% patsientidest oli hüpertensiooni CTC tase ≥ 3.
English: There was no unchanged tivozanib recovered in the urine indicating that tivozanib does not undergo renal excretion.
Estonian: Tivosaniibi muutumata kujul molekule uriinist ei leitud, mis annab alust arvata, et tivosaniib ei eritu neerude kaudu.
English: 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,
Estonian: 9 Hemorraagia sealhulgas hemoptüüs, kopsuhemorraagia, hemorraagiline insult, hingamisteede hemorraagia, erosiivne hemorraagiline gastriit, hemorraagiline anaemia, kaksteistsõrmiksoole haavandi hemorraagia), neerupealiste hemorraagia, emakakaela hemorraagia, veriokse, suu hemorraagia, igmete veritsemine ja anaalne hemorraagia.
English: Haemorrhage
Estonian: Seljavalu
English: The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7-day rest period to comprise one complete treatment cycle of 4 weeks.
Estonian: Soovitatav annus on 1340 mikrogrammi tivosaniibi üks kord ööpäevas 21 järjestikusel päeval, millele järgneb 7-päevane ravimivaba period.
English: Arterial thromboembolic events
Estonian: Arteriaalse trombemboolia nähud
English: Propylene glycol Strong ammonia solution Titanium dioxide (E171) Tartrazine aluminium lake (E102)
Estonian: Propüleenglükool Kontsentreeritud ammoniaagilahus Titaandioksiid (E171) Tartrasiin-alumiiniumlakk (E102)
English: Common (may affect up to 1 in 10 people)
Estonian: Sage (võib mõjutada kuni ühte inimest kümnest)
English: Dose modification
Estonian: Annuste kohandamine
English: • Hand-foot-syndrome with skin reddening, swelling, numbness and skin peeling on palms and soles.
Estonian: • Käe-jala sündroom naha punetuse, turse, tuimuse ja ketendav nahaga peopesadel ja sisetaldadel.
English: Thyroid function should be monitored before initiation of, and periodically throughout treatment with tivozanib.
Estonian: Kilpnäärme talitlust peaks jälgima enne tivosaniibi ravi alustamist ja selle jooksul.
English: • Nose bleed; runny nose; blocked nose.
Estonian: • Ninaverejooks, ninavesisus, kinnine nina.
English: 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
Estonian: 27 Valu sealhulgas luuvalu, vähist tulenev valu, küljevalu, kubemevalu, suuvalu, valu, jäsemevalu ja kasvajast tingitud valu.
English: In cases of suspected overdose, tivozanib should be discontinued and the patient monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Estonian: Üledoosi kahtluse korral peaks lõpetama tivosaniibi tarbimise ja jälgima patsienti võimaliku hüpertensiooni osas (diagnoosi korral ka ravima standardsete hüpertensiooni vastaste ravimitega).
English: Each capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram of tivozanib.
Estonian: Üks kapsel sisaldab tivosaniibvesinikkloriidmonohüdraati koguses, mis vastab 890 mikrogrammile tivosaniibile.
English: 22 Erythema including erythema, generalised erythema and palmar erythema 23 Pruritus including generalised pruritus and pruritus
Estonian: 22 Erüteem sealhulgas erüteem, üldine erüteem ja palmaarerüteem.
English: In clinical studies with tivozanib as monotherapy for the treatment of patients with RCC, cardiac failure has been reported (see section 4.8).
Estonian: Neerurakulise kartsinoomiga patientidega läbiviidud tivosaniibi monoteraapia kliinilistes uuringutes on teavitatud südamepuudulikkusest (vt lõik 4.8).
English: Skin exfoliation Erythema22 Pruritus23
Estonian: Naha eksfoliatsioon Nahapunetus22 Sügelus23 Alopeetsia Lööve24 Akne25 Kuiv nahk
English: 6.6 Special precautions for disposal
Estonian: 6.6 Erihoiatused ravimi käsitlemiseks
English: Fotivda 1340 microgram hard capsules tivozanib
Estonian: Fotivda 1340 mikrogrammi kõvakapslid tivosaniib
English: Mucosal inflammation
Estonian: Limaskesta põletik
English: 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.
Estonian: Fotivda 1340 mikrogrammi kõvakapslitel on erkkollane läbipaistmatu kapslikaas ja erkkollane läbipaistmatu kapslikeha, mille kaanele on trükitud tumesinise tindiga “TIVZ” ja kehale tumesinise tindiga “SD”.
English: • if the skin on the palms of your hands and the soles of your feet become dry, cracked,
Estonian: • on nahk teie peopesadel ja jalataldadel muutub kuivaks, praguneb, ketendab, koorub või esineb torkivat või sügelevat tunnet
English: • if you get shortness of breath or ankle swelling
Estonian: • tekib hingeldus või pahkluude turse
English: • Do not take Fotivda if you are pregnant.
Estonian: Rasedus, imetamine ja viljakus • Ärge võtke Fotivda kõvakapsleid, kui te olete rase.
English: A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking 3 doses of 1340 microgram tivozanib in one day (total 4020 microgram).
Estonian: Varasema hüpertensiooniga patsiendil tekkis üledoosi tõttu (ühes ööpäevas tarbis patsient kolm 1340-mikrogrammist tivosaniibi annust ehk kokku 4020 mikrogrammi) ravile allumatu surmav hüpertensioon.
English: Fungal infection Pustular rash
Estonian: Seeninfektsioonid Mädavilliline lööve
English: Fotivda 890 microgram hard capsules tivozanib
Estonian: Fotivda 890 mikrogrammi kõvakapslid tivosaniib
English: Gammaglutamyltransferase increased
Estonian: Trombotsütopeenia Suurenenud hemoglobiin
English: Other side effects
Estonian: Täiendavad kõrvaltoimed
English: Swelling in the lungs caused by fluid build-up.
Estonian: Kopsuturse vedeliku kogunemise tõttu.
English: Your doctor will monitor this, and depending on the severity may reduce your dose of Fotivda, or interrupt or stop treatment with Fotivda.
Estonian: Teie arst jälgib edasist arengut ja võib sõltuvalt olukorra tõsidusest Fotivda annust vähendada, ravi katkestada või lõpetada.
English: Hyperhidrosis Xeroderma
Estonian: Liighigistamine Kuivnahksus
English: Rare (may affect up to 1 in 1,000 people)
Estonian: Harv (võib mõjutada kuni ühte inimest tuhandest)
English: Haemorrhage adverse reactions were reported in the core monotherapy studies during initial treatment (see section 4.4).
Estonian: Hemorraagia Esmavaliku monoteraapia uuringus teatati hemoraagiaga seotud kõrvaltoimest (vt lõik 4.4).
English: In the core RCC studies some adverse reaction occurred more commonly in the elderly (see section
Estonian: Põhilistes neerurakulise kartsinoomi uuringutes esinesid mõned kõrvaltoimed eakamatel patsientidel sagedamini (vt lõik 4,4).
English: • Being sick; indigestion; constipation; dry mouth.
Estonian: • Haiglane enesetunne, seedehäire, kõhukinnisus, suukuivus
English: 20 Gingivitis including gingival bleeding, gingival disorder, gingival pain and gingivitis 21 Alanine aminotransferase (ALT) increased / Aspartate aminotransferase (AST) increased including ALT increased and AST increased
Estonian: 21 Suurenenud alaniin aminotransferaas (ALAT) / aspartaat aminotransferaas (ASAT).
English: Each capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram of tivozanib.
Estonian: Üks kapsel sisaldab tivosaniibvesinikkloriidmonohüdraati koguses, mis vastab 1340 mikrogrammile tivosaniibile.
English: Fotivda 1340 microgram hard capsules
Estonian: Fotivda 1340 mikrogrammi kõvakapslid
English: 14 Dyspnoea including dyspnoea and exertional dyspnoea 15 Abdominal pain including abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and abdominal rigidity
Estonian: 15 Kõhuvalu sealhulgas ebamugavustunne kõhus, kõhuvalu, alakõhuvalu, ülakõhuvalu ja kõhujäikus.
English: Vision impairment6
Estonian: Nägemise kahjustus6
English: Anorexia
Estonian: Hemorraagia
English: Pain27 Asthenia Fatigue
Estonian: Valu27 Jõuetus Väsimus
English: Adverse reactions occurring in patients who continued to receive tivozanib as their initial on trial therapy in the five RCC monotherapy studies were pooled and are listed below by MedDRA body system organ class (SOC) and frequency.
Estonian: Koondandmeteks koguti kõrvaltoimed, mida esines patsientidel, kes said jätkuvalt tivosaniibi osaledes viies kliinilises neerurakulise kartsinoomi monoteraapia uuringus.
English: Fotivda 890 microgram hard capsules
Estonian: Fotivda 890 mikrogrammi kõvakapslid Kapsli sisu
English: Fertility
Estonian: Mannitool
English: • Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
Estonian: • Pearinglus, kumin kõrvus, pearinglus ja pöörlemistunne (peapööritus)
English: In clinical studies with tivozanib, haemorrhagic events have been reported (see section 4.8).
Estonian: Tivosaniibi kliinilistes uuringutes on teavitatud hemorraagilistest nähtudest (vt lõik 4.8).
English: lack of energy, confusion, blindness or other visual and neurologic disturbances.
Estonian: Sümptomid nagu peavalu, krambihood, energiapuudus, segasus, nägemise kadu või teised nägemise ja neuroloogilised häired.
English: In clinical studies with tivozanib, hypothyroidism has been reported (see section 4.8).
Estonian: Tivosaniibi kliinilistes uuringutes on teatatud hüpotüreoosi esinemisest (vt lõik 4.8).
English: It is recommended that symptoms of gastrointestinal perforation or fistula should be periodically monitored throughout treatment with tivozanib and that tivozanib should be used with caution in patients at risk for GI perforation or fistula.
Estonian: Ettevaatusega tuleb määrata tivosabiini patientidele, kellel on risk seedetrakti perforatsiooniks või fistuliks.
English: Tivozanib was shown to cause growth plate hypertrophy, absence of active corpora lutea and no maturing follicles in cynomolgus monkeys at dose levels that produced exposures equivalent to those seen at the recommended clinical dose.
Estonian: Soovituslike kliiniliste annuste juures põhjustas tivosaniib cynomolgus makaakidel kasvuplaadi hüpertroofiat, aktiivse kollaskeha puudumist ja folliikulite mitte küpsemist.
English: 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.
Estonian: Tumesinise läbipaistmatu kapslikaane ja erkkollase läbipaistmatu kapslikehaga kõvakapsel, mille kaaanele on trükitud kollase tindiga “TIVZ” ja kehale sinise tindiga “LD”.
English: Uncommon (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt (võib mõjutada kuni ühte inimest sajast)
English: Rare
Estonian: Hüpotüreoos
English: 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
Estonian: 18 Düsfaagia sealhulgas düsfaagia, odünofaagia ja orofarüngeaalne valu.
English: 24 Rash including rash, rash erythematous, rash generalised, rash maculo-papular, rash papular and rash pruritic 25 Acne including acne and dermatitis acneiform26 Dermatitis including dermatitis and dermatitis bullous
Estonian: 26 Dermatiit sealhulgas dermatiit ja bulloosne dermatiit.
English: Proteinuria has been reported in clinical studies with tivozanib (see section 4.8).
Estonian: Tivosaniibi kliinilistes uuringutes on teavitatud proteinuuriast (vt lõik 4.8).
English: Special populations
Estonian: Perifeerne turse
English: Chest pain28 Chills29 Pyrexia Peripheral oedema
Estonian: Rindkere valu28 Külmavärinad29
English: Hard capsule with 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.
Estonian: Erkkollase läbipaistmatu kapslikaane ja erkkollase läbipaistmatu kapslikehaga kõvakapsel, mille kaanele on trükitud tumesinise tindiga “TIVZ” ja kehale tumesinise tindiga “SD”.
English: Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram tivozanib.
Estonian: Üks kõvakapsel sisaldab tivosaniibvesinikkloriidmonohüdraati koguses, mis vastab 1340 mikrogrammile tivosaniibile