natgillin/translations-raw huggingface dataset:
Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Tivozanib je pokazal statistično značilno večje izboljšanje v PFS in ORR kot sorafenib, ocenjeno z neodvisnim radiološkim pregledom (preglednica 2 in slika 1).
In repeat-dose toxicity studies in rats, abnormalities were noted in growing incisors (thin brittle teeth, tooth loss, malocclusions) at doses approximately 2-fold greater than the calculated human equivalent dose and growth plate hypertrophy was observed at doses approximately 0.7- to 7-fold greater than the calculated human equivalent dose.
V raziskavah toksičnosti pri ponavljajočih odmerkih na podganah so poročali o nenormalnostih na rastočih sekalcih (tanki lomljivi zobje, izguba zob, malokluzija) pri odmerkih, približno 2-krat večjih kot izračunani ekvivalentni odmerek za človeka, in hipertrofijo rastnega hrustanca pri odmerkih, približno 0,7- do 7-krat večjih, kot je izračunani ekvivalentni odmerek za človeka.
If you are already taking a medicine to treat high blood pressure, and your doctor reduces the dose of Fotivda or interrupts or stops treatment, you will be regularly checked for low blood pressure.
Če že jemljete zdravilo za zdravljenje visokega krvnega tlaka in zdravnik zmanjša odmerek zdravila Fotivda ali prekine ali zaustavi zdravljenje, vas bodo redno pregledovali, če imate morda nizek krvni tlak.
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.
Priporočamo, da redno spremljate simptome gastrointestinalne perforacije ali fistule ves čas zdravljenja s tivozanibom in da pri bolnikih s tveganjem za gastrointestinalno perforacijo ali fistulo tivozanib uporabljate previdno.
1 Goitre including goitre and toxic nodular goitre
1 Golšavost vključuje golšo in toksično nodozno golšo
Figure 1: Kaplan-Meier plot of progression free survival, independent radiological review (ITT Population)
Slika 1: Kaplan-Meierjev postopek za preživetje brez napredovanja bolezni, neodvisni radiološki pregled (populacija ITT)
Fotivda should be supervised by a physician experienced in the use of anticancer therapies.
Zdravljenje z zdravilom Fotivda mora nadzorovati zdravnik, ki ima zadostne izkušnje z zdravili proti raku.
Medicinal products for which intestinal absorption is restricted by BCRP Tivozanib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown (see section 5.2).
Zdravila, pri katerih absorpcijo v črevesju preprečuje BCRP Tivozanib zavira prenašalno beljakovino BCRP in vitro, vendar klinična pomembnost te ugotovitve ni znana (glejte poglavje 5.2).
If you vomit after taking Fotivda, do not take a replacement capsule.
Če bruhate po zaužitju zdravila Fotivda, ne vzemite nadometne kapsule.
What Fotivda looks like and contents of the pack
Izgled zdravila Fotivda in vsebina pakiranja
Increased lacrimation
Povečano solzenje
Elderly patients No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).
Starejši bolniki Za bolnike, stare 65 let in več, ni treba prilagoditi odmerka (glejte poglavji 4.4 in 5.1).
Furthermore, tivozanib was not an in vitro inhibitor of OAT1, OAT3, OCT2, MATE1 and MATE2-K or substrate of MRP2 and BCRP.
Tivozanib nadalje ni bil in vitro zaviralec OAT1, OAT3, OCT2, MATE1 in MATE2-K niti substrat MRP2 in BCRP.
The study included patients who had all undergone prior nephrectomy, and who had received either no prior therapy or no more than one prior systemic therapy in the metastatic setting (immunotherapy/chemotherapy); prior treatment with VEGF or mechanistic Target of Rapamycin (mTOR) targeted therapy was not allowed.
V študijo so bili vključeni bolniki, ki so opravili nefrektomijo in predhodno niso prejeli zdravljenja ali so prejeli samo eno sistemsko zdravljenje metastatskega raka (imunoterapija ali kemoterapija); predhodno zdravljenje z VEGF ali zdravljenje z delovanjem na signalne potmi tarče rapamicina (mTOR) ni bilo dovoljeno.
• Lack of blood flow through the heart blood vessels.
• Pomanjkljiv pretok krvi skozi krvne žile.
QT prolongation was reported in two patients (CTC Grade 2 and Grade 3) in the tivozanib cardiac safety study, neither reaction was considered serious (see section 4.4 and section 5.1).
O podaljšanju QT so poročali pri dveh bolnikih (2. stopnje in 3. stopnje po CTC) v študiji varnosti tivozaniba za srce, nobena reakcija ni štela za resno (glejte poglavji 4.4 in 5.1).
Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (e.g. with blood tests), and if necessary may need to reduce how often you take Fotivda.
Zdravnik bo redno preverjal, kako dobro delujejo jetra, pred in med zdravljenjem z zdravilom Fotivda (npr. s krvnimi testi) ter po potrebi zmanjšal pogostost jemanja zdravila Fotivda.
Patients taking an oral BCRP substrate with a clinically-relevant efflux interaction in the gut should ensure that a suitable time window (e.g. 2 hours) is applied between administration of tivozanib and the BCRP substrate.
Bolniki, ki peroralno jemljejo substrat BCRP s klinično pomembnim medsebojnim delovanjem na efluks v črevesju, morajo zagotoviti ustrezen časovni interval (npr. 2 uri) med jemanjem tivozaniba in substrata BCRP.
Cross-over to the tivozanib arm was permitted upon Response Evaluation Criteria In Solid Tumours (RECIST)-defined progression on sorafenib according to the protocol of a separate extension study.
Prehod na krak s tivozanibom je bil dovoljen po napredovanju bolezni pri zdravljenju s sorafenibom, po kriterijih za ocenjevanje odziva pri solidnih tumorjih (RECIST - Response Evaluation Criteria In Solid Tumours); prehod je bil določen v protokolu ločene podaljšane študije.
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.
Tivozanib je povzročil hipertrofijo rastnega hrustanca, odsotnost aktivnih corpora lutea in odsotnost dozorevajočih foliklov pri opicah cynomolgus pri ravneh odmerkov, pri katerih je bila izpostavljenost ekvivalentna izpostavljenosti, zabeleženi pri priporočenem kliničnem odmerku.
• if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile
Get medical help straightaway if you experience confusion, changes in your mental state or headaches.
Takoj poiščite zdravniško pomoč, če ste zmedeni, če se spremeni vaše duševno stanje ali če imate glavobole.
Although the impact of further impairment of renal function on the overall disposition of tivozanib is unknown, a clinical study has shown that no unchanged tivozanib is excreted in the urine indicating that tivozanib does not undergo renal excretion..
Čeprav vpliv nadaljnjega slabenja ledvične funkcije na skupno dispozicijo tivozaniba ni znan, so rezultati klinične študije pokazali, da se nespremenjeni tivozanib ni izločal v urin, kar kaže, da se tivozanib ne izloča skozi ledvice.
OS was a key secondary endpoint in the pivotal study and the analysis included data from all randomized patients, including those who progressed on sorafenib and crossed over to receive tivozanib as part of the extension study.
OS je bil sekundarni cilj preskušanja v ključni študiji in analiza je vključevala podatke o vseh randomiziranih bolnikih, tudi o bolnikih, pri katerih je bolezen napredovala pri zdravljenju s sorafenibom in so začeli jemati tivozanib kot del razširjene študije.
Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2).
Dejavniki stratifikacije so število prejšnjih zdravljenj (0 ali 1) in število vključenih metastatskih mest ali organov (1 ali ≥2).
Pharmacotherapeutic group: antineoplastic agents, protein-kinase inhibitors, ATC code: L01XE34
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE34
Objective Response Rate (95% CI), ITT Population
(95 % CI), populacija ITT
Mild to severe hypertension may be present.
Prisotna je lahko blaga ali huda hipertenzija.
Fotivda 1340 microgram hard capsules EU/1/17/1215/002
Fotivda 1340 mikrogramov trde kapsule EU/1/17/1215/002
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.
Če se pojavijo težave zaradi krvavenja (zatečen boleč trebuh (abdomen), bljuvanje krvi, izkašljevanje krvi, črno blato, kri v urinu, glavobol ali sprememba duševnega stanja), o tem takoj obvestite zdravnika.
Single dose AUC0-inf for healthy volunteers dosed with 1340 microgram tivozanib was 1,950 to 2,491 ng.hr/mL.
AUC0-inf po enkratnem odmerku pri zdravih prostovoljcih, ki so prejeli odmerek 1340 mikrogramov tivozaniba, je bila 1.950 do 2.491 ng.hr/ml.
Studies in pregnant rabbits showed no effect on maternal health or embryo foetal development at doses approximately 0.6 times the human exposure at the recommended dose.
Študije pri brejih samicah kuncev niso pokazale vpliva na zdravje matere ali razvoj zarodka oz. ploda pri odmerkih, ki so ustrezali približno 0,6-kratniku izpostavljenosti človeka priporočenemu odmerku.
The clinical effects of strong CYP3A4 inducers on repeated daily dosing of tivozanib has not been studied but potentially the average time to reach steady-state and the average steady-state serum concentration of tivozanib may be reduced, due to the reduction in half-life.
Klinični učinki močnih induktorjev CYP3A4 pri ponavljajočem dnevnem odmerjanju tivozaniba niso bili preskušani, vendar pa se lahko povprečen čas za doseganje stanja dinamičnega ravnovesja in povprečna serumska koncentracija tivozaniba v stanju dinamičnega ravnovesja zmanjšata zaradi skrajšanja razpolovnega časa.
Posterior Reversible Encephalopathy Syndrome (PRES) PRES (also known as reversible posterior leukoencephalopathy syndrome (RPLS)) was confirmed in one non-RCC patient after approximately 8 weeks on tivozanib.
Sindrom posteriorne reverzibilne encefalopatije (PRES) PRES (tudi t. i. sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)) so potrdili pri bolniku, ki ni imel RCC, po približno 8 tednih zdravljenja s tivozanibom.
Swelling in the lungs caused by fluid build-up.
Zatekanje v pljučih zaradi nabiranja tekočine.
[14C] Tivozanib was the predominant drug-related material in faeces.
[14C]-tivozanib je bil prevladujoča spojina, povezana z zdravilom, v blatu.
For precautionary reasons, temporary interruption of tivozanib therapy is recommended in patients undergoing major surgical procedures.
Zaradi previdnostnih razlogov priporočamo začasno prekinitev zdravljenja z zdravilom tivozanib pri bolnikih, ki jih čaka večji kirurški poseg.
Fotivda can have side effects that may affect your ability to drive or use machines.
Vpliv na sposobnost vožnje in upravljanje strojev Fotivda ima lahko neželene učinke, ki lahko vplivajo na vašo sposobnost vožnje in upravljanja strojev.
No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Pri bolnikih z blago ali zmerno ledvično okvaro ni treba prilagoditi odmerka (glejte poglavje 5.2).
Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least one month after completing therapy.
Tako bolnice kot bolniki in njihovi partnerji morajo uporabljati učinkovite metode kontracepcije ves čas zdravljenja in še najmanj en mesec po končanem zdravljenju s tem zdravilom.
Exposure is dose proportional between 890 and 1340 microgram and dose related over the wider range of 450 mg and 1790 microgram.
Izpostavljenost je sorazmerna z odmerkom v območju med 890 in 1340 mikrogramov, in odvisna od odmerka znotraj širšega območja med 450 mg in
In vitro studies have shown that tivozanib is neither a substrate nor inhibitor of the transporter proteins MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 and BSEP.
Študije in vitro so pokazale, da tivozanib ni ne substrat ne zaviralec prenašalnih beljakovin MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 in BSEP.
Fotivda can increase your blood pressure.
Zdravilo Fotivda lahko poviša krvni tlak.
All patients should have liver function tests evaluated, including aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase (AP), to determine hepatic function before starting and during treatment with tivozanib.
Pri vseh bolnikih je treba pred začetkom in med zdravljenjem s tivozanibom opraviti test jetrne funkcije, vključno z aminotransferazo (ALT), aspartat aminotransferazo (AST), bilirubinom in alkalno fosfatazo (AP), da se preveri delovanje jeter.
After chronic dosing of tivozanib in RCC patients for 21 days followed by 7 days without administration of tivozanib, tivozanib Cmin is approximately 16.0 to 30.9 ng/mL.
Po kroničnem odmerjanju tivozaniba pri bolnikih RCC 21 dni, ki jim sledi 7 dni brez uporabe tivozaniba, je Cmin tivozaniba približno 16,0 do 30,9 ng/ml.
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
• Razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
• Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals,
• Krvavenje, npr. v možganih, iz ust, dlesni, pljuč, želodca, črevesne razjede, ženskih spolovil,
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Naprošamo zdravstvene delavce, da poročajo o kakršnem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje s seznama v prilogi.
White HDPE bottle with a child resistant closure containing 21 hard capsules.
Bela plastenka iz HDPE s pokrovčkom, varnim za otroke, ki vsebuje 21 trdih kapsul.
If tivozanib is used during pregnancy, or if the patient becomes pregnant while receiving tivozanib, the potential hazard to the foetus must be explained to the patient.
Če tivozanib uporabite med nosečnostjo ali če bolnica zanosi med zdravljenjem s tivozanibom, je treba bolnici pojasniti morebitno tveganje za plod.
Tell your doctor if you have ever had one of the following: o a blood clot in your lungs (with cough, chest pain, sudden shortness of breath or coughing up blood), o blood clot in your legs or arms, eye, or brain (with pain or swelling in your hands or feet,
Zdravnika obvestite, če ste imeli kadar koli enega od naslednjih stanj: o krvni strdek v pljučih (s kašljem, bolečinami v prsih, nenadno zasoplostjo ali izkašljevanjem krvi), o krvni strdek v nogah ali rokah, očesu ali možganih (z bolečino ali zatekanjem rok in nog,
If any bleeding requires medical intervention, tivozanib should be temporarily interrupted.
Če je treba krvavitev zaustaviti z zdravniškim posegom, je treba začasno prekiniti zdravljenje s tivozanibom.
Tivozanib was shown to be teratogenic, embryotoxic and foetotoxic in pregnant rats at dose levels 5 times lower than the recommended clinical dose (based on a 60 kg human).
Tivozanib je teratogen, embriotoskičen in fetotoksičen pri brejih podganah, ki so prejemale 5-krat manjši odmerek, kot je priporočeni klinični odmerek (glede na človeka s 60 kg).
Within each SOC, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini organskega sistema so neželeni učinki navedeni po padajoči resnosti.
Studies conducted in vitro have shown that tivozanib is not a potent inhibitor of UGT (UDP-glucuronosyltransferase) metabolic activities and clinically relevant drug-drug interactions are unlikely with medicinal products metabolised by these pathways.
Rezultati študij in vitro so pokazali, da tivozanib ni močan zaviralec presnovnih aktivnosti UGT (UDP-glukuronil- transferaze), in da klinično pomembno medsebojno delovanje z zdravili, ki se presnavljajo po teh poteh, ni verjetno.
In clinical studies with tivozanib, hand foot skin reaction (palmar-plantar erythrodysaesthesia) has been reported.
Pri kliničnem preskušanju tivozaniba so poročali o kožni reakciji roka-noga (palmoplantarna eritrodisestezija).
Management of patients experiencing HFSR may include topical therapies for symptomatic relief with consideration of temporary interruption and/or reduction in treatment dose or, in severe or persistent cases, permanent discontinuation of treatment.
Ukrepanje pri bolnikih z reakcijo roka-noga lahko vključuje lokalno zdravljenje za lajšanje simptomov, in razmislek o začasni prekinitvi zdravljenja in/ali zmanjšanju odmerka, pri hudih in vztrajnih primerih pa tudi o trajni ukinitvi zdravljenja s s tivozanibom.
In a cardiac safety study of 50 patients with advanced solid tumours treated with tivozanib at 1340 microgram daily for 21 days, the mean change from baseline in QTcF was 6.8 ms on day 21 of dosing.
V študiji varnosti za srce na 50 bolnikih z napredovalimi čvrstimi tumorji, ki so se zdravili s tivozanibom po 1340 mikrogramov na dan 21 dni, je bila povprečna sprememba QTcF od začetka zdravljenja 6,8 ms na 21. dan odmerjanja.
Blood pressure should be well controlled prior to initiating tivozanib and patients should be monitored for hypertension during treatment (see section 4.4).
Krvni tlak bolnikov mora biti pred začetkom zdravljenja s tivozanibom pod nadzorom, med zdravljenjem pa je treba bolnike spremljati glede pojava hipertenzije (glejte poglavje 4.4).
• if you have had problems with bleeding
• če imate težave zaradi krvavenja
If the patient develops Grade 4 proteinuria (nephrotic syndrome) tivozanib has to be discontinued.
Če se pri bolniku pojavi proteinurijo 4. stopnje (nefrotski sindrom), je treba ukiniti zdravljenje s tivozanibom.
Results from a single dose study to evaluate the pharmacokinetics, safety and tolerability of tivozanib in subjects with hepatic impairment show that across the entire measurement period, tivozanib was eliminated more slowly in subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Jetrna okvara Rezultati preskušanja zdravila z enkratnim odmerkom, v kateri so proučevali farmakokinetiko, varnost in prenašanje tivozaniba pri preiskovancih z jetrno okvaro, so pokazali, da se je ves čas trajanja meritev tivozanib pri bolnikih z zmerno (Child-Pugh razred B) ali hudo (Child-Pugh razred C) jetrno okvaro izločal počasneje.
Herbal preparations containing St. John's wort (Hypericum perforatum) are contraindicated.
Zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so kontraindicirana.
One Fotivda capsule taken once daily
21 dni (tri tedne) Vzeti eno kapsulo Fotivda enkrat na dan
In the case of persistent hypertension despite use of anti-hypertensive therapy, the tivozanib dose should be reduced, or the treatment interrupted and re-initiated at a lower dose once the blood pressure is controlled, according to clinical judgment (see section 4.2).
Če hipertenzija ne popusti tudi po zdravljenju z antihipertenzivi, je treba zmanjšati odmerek tivozaniba ali začasno prekiniti zdravljenje in ga znova začeti z manjšim odmerkom, potem ko obvladate krvni tlak in po klinični presoji (glejte poglavje 4.2).
• Underactive thyroid gland which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, weight gain.
• Premalo aktivna ščitnica, ki lahko povzroči simptome, kot so utrujenost, otopelost, mišična šibkost, počasen srčni utrip, pridobivanje telesne teže.
Based on these data, tivozanib can be dosed with or without food (see section 4.2).
Na podlagi podatkov lahko ugotovimo, da se tivozanib lahko jemlje skupaj s hrano ali brez hrane (glejte poglavje 4.2).
Tivozanib must be used with caution in patients who are at risk for, or who have a history of bleeding.
Tivozanib je treba uporabljati previdno pri bolnikih s tveganjem za krvavitve ali ki imajo anamnezo krvavitev.
Direct N-glucoronidation of tivozanib was a minor pathway of metabolism in vitro.
Neposredna N-glukuronidacija tivozaniba je bila manj pomembna presnovna pot in vitro.
If you have missed taking a capsule do not take a replacement capsule.
Če ste pozabili vzeti kapsulo, ne vzemite nadomestne kapsule.
Progression-Free Survival, One Prior Therapy for Metastatic Disease Subgroup [median, months (95% CI)]
Preživetje brez napredovanja, eno predhodno zdravljenje za podskupino metastatske bolezni [mediana, meseci
Treatment with Fotivda may need to be temporarily stopped.
Morda boste morali začasno prekiniti zdravljenje z zdravilom Fotivda.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
For the 30% of patients receiving prior treatment, the predominant therapy was interferon alpha as monotherapy which was received by 75 patients in the tivozanib arm and 62 patients in the sorafenib arm.
Za več kot 30 % bolnikov, ki so prejeli predhodno zdravljenje, je bilo prevladujoče zdravljenje z interferonom alfa kot monoterapijo, ki ga je prejelo 75 bolnikov v kraku s tivozanibom in
Hypothyroidism was reported as an adverse reaction for 5.6% of patients during initial therapy and was CTC Grade 2 or lower in all cases.
O hipotiroidizmu so poročali kot o neželenem učinku pri 5,6 % bolnikov med začetnim zdravljenjem in je vila v vseh primerih 2. stopnje ali manj po CTC.
Do not take a double dose to make up for a forgotten capsule.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo kapsulo.
Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Zdravilo Fotivda je indicirano kot zdravilo prvega izbora za zdravljenje odraslih bolnikov z napredovalim rakom ledvičnih celic (RCC- renal cell carcinoma) in za odrasle paciente, ki še niso prejeli zaviralcev VEGFR in zaviralcev poti mTOR, potem ko je po enem predhodnem zdravljenju napredovalega RCC s citokini bolezen napredovala.
Pooled data of 674 patients with advanced RCC who continued to receive tivozanib as their initial on trial therapy in the five core RCC monotherapy studies have been evaluated in the overall assessment of safety and tolerability of tivozanib.
Zbrane podatke o 674 bolnikih z napredovalim RCC, ki so nadaljevali s prejemanjem tivozaniba kot začetnega zdravila v petih osrednjih preskušanjih zdravila v monoterapiji RCC, so ocenili v skupni oceni varnosti in prenašanja tivozaniba.
In the five core RCC monotherapy studies tivozanib was discontinued in a total of 20 patients (3%) owing to adverse reactions, most commonly due to hypertension (0.4%), persistent severe hypertension (0.3%), or acute myocardial infarction (0.3%).
V petih osrednjih preskušanjih zdravila v monoterapiji RCC so zaradi neželenih učinkov ukinili jemanje zdravila tivozanib pri skupaj 20 bolnikih (3 %), najpogosteje zaradi hipertenzije (0,4 %), vztrajne hude hipertenzije (0,3 %) ali akutnega srčnega infarkta (0,3 %).
• if you have symptoms of gastrointestinal perforation or fistula formation (developing a hole in the stomach or intestine or abnormal passages forming between parts of the intestine) such as severe stomach pain, chills, fever, nausea, vomiting or painful bowel obstruction, diarrhoea or rectal bleeding.
• če imate simptome gastrointestinalne perforacija ali nastajanja fistule (nastajanje luknje v želodcu ali črevesju ali nastajanje nenormalnega prehoda med deli črevesja), kot so hude bolečine v želodcu, mrzlica, vročina, slabost, bruhanje ali boleča zapora črevesja, driska ali krvavitev iz zadnjika.