FrancophonIA/ELRC3.0 huggingface dataset:
English: • comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions,
Slovenian: V preglednici 1 so po pogostnosti razvrščeni vsi neželeni učinki, za katere so ugotovili, da imajo vzročno povezavo z bevacizumabom: zaradi primerljive pojavnosti, ki so jo opazili med zdravljenimi skupinami v kliničnih preskušanjih (z najmanj 10 % razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 1-5 po NCI-CTCAE ali najmanj 2 % razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 3-5 po NCI-CTCAE); v študijah o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom; pri spontanem poročanju; v epidemioloških študijah/neintervencijskih ali opazovalnih študijah ali s presojo posameznih kliničnih primerov.
English: Laboratórios Pfizer, Lda.
Slovenian: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda
English: The administration of Zirabev should be permanently discontinued if you develop
Slovenian: Dajanje zdravila Zirabev je treba trajno prekiniti, če se vam pojavi karkoli od naslednjega:
English: Zirabev is also used for treatment of adult patients with advanced kidney cancer.
Slovenian: Zdravilo Zirabev uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim rakom ledvic.
English: Hazard ratio b
Slovenian: razmerje ogroženosti p-vrednost
English: Leucovorin on day 1 and 2
Slovenian: 22 ur oksaliplatin 1. dan levkovorin 1. in 2. dan 5-fluorouracil i.v.
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Zirabev fails to stop your tumour growing.
Slovenian: Z zdravljenjem morate nadaljevati, dokler zdravilo Zirabev ne bo več uspešno zaustavljalo rasti tumorja.
English: Pfizer Italia Srl Tel: +39 06 33 18 21
Slovenian: Tel: +39 06 33 18 21
English: You may be advised to have a dental check-up before you start treatment with Zirabev.
Slovenian: Pred začetkom zdravljenja z zdravilom Zirabev boste morda morali opraviti pregled zob.
English: An increased incidence of hypertension was observed in bevacizumab-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z bevacizumabom, so opazili povečano incidenco hipertenzije.
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Slovenian: Presnovne in prehranske motnje dehidracija, hiponatriemija
English: No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Slovenian: Med bolniki, ki so prejemali bevacizumab v monoterapiji, in bolniki, ki so se zdravili po shemi FOLFOX-4, niso opazili pomembne razlike v trajanju celokupnega preživetja.
English: The recommended dose of Zirabev is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Zirabev je 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne v obliki intravenske infuzije.
English: Pain, Lethargy, Mucosal inflammation
Slovenian: bolečina, letargija, vnetje sluznic
English: Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, pireksija, bolečina, vnetje sluznic letargija
English: The 131 patients in the bevacizumab + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving bevacizumab + IFN alfa-2a.
Slovenian: Pri 131 bolnikih iz skupine, ki je prejemala bevacizumab + IFN alfa2a, pri katerih so med preskušanjem zmanjšali in vzdrževali odmerek IFN alfa-2a pri 6 ali 3 mio i.e.,
English: Zirabev is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Slovenian: Zdravilo Zirabev uporabljamo za zdravljenje odraslih bolnikov z napredovalim rakom debelega črevesa in danke.
English: Overall survival - follow-up analysis2 Hazard ratio (95% CI)
Slovenian: Celokupno preživetje - nadaljnja analiza razmerje ogroženosti (95 % IZ)
English: Therapy should be permanently discontinued in patients who develop arterial thromboembolic reactions.
Slovenian: Pri bolnikih, pri katerih se pojavijo arterijski trombembolični dogodki, je treba zdravljenje trajno prekiniti.
English: Each vial contains 100 mg bevacizumab.
Slovenian: Ena viala vsebuje 100 mg bevacizumaba.
English: • diarrhoea,
Slovenian: • drisko,
English: 400 mg/m2 intravenous bolus,
Slovenian: bolus, 600 mg/m 2 i.v.
English: Intestinal perforation, Ileus , Intes tinal obstruction, Recto-vaginal fistulae c,d
Slovenian: Bolezni prebavil diareja, navzea, bruhanje, bolečina v trebuhu perforacija črevesa, ileus, obstrukcija črevesa, rektovaginalne fistule c,d bolezen prebavil, stomatitis, proktalgija perforacija prebavil a,b
English: Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab.
Slovenian: Pri bolnikih, ki se zdravijo z bevacizumabom, lahko obstaja povečano tveganje za nastanek perforacije prebavil in žolčnika.
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Slovenian: Pri bolnikih, pri katerih se pojavi perforacija prebavil, je treba zdravljenje trajno prekiniti.
English: Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi saharoza jantarna kislina dinatrijev edetat polisorbat 80 natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Slovenian: Tipična vrednost za volumen perifernega prostora (Vp), če so bevacizumab dajali sočasno z drugimi antineoplastičnimi zdravili, je pri bolnicah znašala 1,69 l, pri bolnikih pa 2,35 l. Po prilagoditvi glede na telesno maso so imeli bolniki večji volumen centralnega prostora Vc (+ 20 %) kot bolnice.
English: Number of patients Overall survival Median (months) 95% CI
Slovenian: Število bolnikov Celokupno preživetje mediana (meseci) 95 % IZ razmerje ogroženosti
English: 5 mg/kg intravenous 30-90 min
Slovenian: 30-90 min
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Zirabev:
Slovenian: Pred začetkom uporabe zdravila Zirabev se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Slovenian: O cerebrovaskularnih insultih (vključno s prehodnimi možganskimi ishemijami) so poročali pri največ 2,7 % bolnikov, ki so se zdravili z bevacizumabom v kombinaciji s kemoterapijo, v primerjavi z največ 0,5 % bolnikov, ki so se zdravili samo s kemoterapijo.
English: EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Slovenian: Kombinacija bevacizumaba in sunitinibijevega malata
English: Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Slovenian: Po neodobreni intravitrealni uporabi bevacizumaba iz vial, odobrenih za intravensko uporabo pri bolnikih z rakom, so poročali o posameznih primerih in skupini resnih neželenih učinkov na oči.
English: Do not use Zirabev
Slovenian: Ne uporabljajte zdravila Zirabev:
English: Congestive heart failure a,b
Slovenian: Srčne bolezni kongestivno srčno popuščanje a,b supraventrikularna tahikardija
English: Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus bevacizumab in comparison to chemotherapy alone.
Slovenian: Pri bolnikih, ki so se zdravili z nekaterimi mielotoksičnimi kemoterapevtskimi shemami in bevacizumabom, so v primerjavi s samo kemoterapijo opazili povečano pogostnost hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno z nekaj smrtnimi primeri).
English: Gallbladder perforation b,c
Slovenian: Bolezni jeter, žolčnika in žolčevodov perforacija žolčnika b,c
English: NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Slovenian: Zirabev 25 mg/ml koncentrat za raztopino za infundiranje
English: Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Naus ea, Vomiting, Abdominal pain
Slovenian: Bolezni prebavil rektalna krvavitev, stomatitis, zaprtje, diareja, navzea, bruhanje, bolečina v trebuhu perforacija prebavil b,d perforacija črevesa, ileus, obstrukcija črevesa, rektovaginalne fistule d,e
English: Overall survival - Primary analysis6 Median (months)
Slovenian: Celokupno preživetje - primarna analiza mediana (meseci) razmerje ogroženosti [95 % IZ]
English: Paclitaxel (n=273)
Slovenian: (n = 273)
English: b Relative to control arm.
Slovenian: Glede na kontrolno skupino.
English: Pulmonary haemorrhage/ Haemoptysis b,d
Slovenian: Bolezni kože in podkožja zapleti pri celjenju ran b,d
English: Congestive heart failure b,d
Slovenian: Srčne bolezni kongestivno srčno popuščanje b,d supraventrikularna tahikardija
English: Non-GI fistulae (see section 4.4)
Slovenian: Fistule izven prebavil (glejte poglavje 4.4)
English: PC in combination with bevacizumab at a dose of 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Slovenian: infuzije (PK) na 1. dan vsakega 3-tedenskega cikla, skupaj največ 6 ciklov, ali PK v kombinaciji z bevacizumabom v odmerku 15 mg/kg v obliki i.v.
English: Myalgia, Arthralgia, Muscular weaknes s, Back pain
Slovenian: disartrija, glavobol, disgevzija cerebrovaskularni zaplet, sinkopa, somnolenca sindrom posteriorne reverzibilne encefalopatije a,b,d hipertenzivna encefalopatija
English: Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Slovenian: 2 uri 1.000 mg/m2 peroralno dvakrat na dan oksaliplatin 1. dan kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1tedenski premor brez zdravljenja)
English: ● a hole in your gut wall,
Slovenian: • predrtje črevesne stene,
English: This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Slovenian: To je bilo randomizirano, z učinkovino nadzorovano, odprto preskušanje 3. faze, v katerem so proučevali bevacizumab v odmerku 10 mg/kg v kombinaciji z levkovorinom in bolusom 5fluorouracila, čemur je sledila infuzija 5-fluorouracila z i.v.
English: Gallbladder perforation a,b
Slovenian: Bolezni jeter, žolčnika in žolčevodov perforacija žolčnika a,b
English: Reactions consistent with CHF were reported in clinical trials.
Slovenian: Med kliničnimi preskušanji so poročali o neželenih učinkih, značilnih za KSP.
English: Cerebrovascular accident,
Slovenian: ● predrtje črevesne stene,
English: nose bleeds.
Slovenian: • krvavitve iz nosu.
English: Non-GI fistulae (see section 4.8)
Slovenian: Fistule izven prebavil (glejte poglavje 4.8)
English: Thromboemboli sm (venous)
Slovenian: Žilne bolezni hipertenzija b,d trombembolija (venska)
English: No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Slovenian: Rezultati populacijskih farmakokinetičnih analiz so pokazali, da ni klinično pomembnega delovanja sočasno dane kemoterapije na farmakokinetiko bevacizumaba.
English: Diarrhoea, Nausea, Vomiting, Abdominal pain
Slovenian: , bolezen prebavil, proktalgija razjeda v prebavilih
English: Febrile neutropenia, Leucopenia, Neutropenia b, Thrombo-cytopenia
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija, levkopenija, nevtropenija b, trombocitopenija anemija, limfopenija
English: Pulmonary hypertension c,
Slovenian: , razjeda v prebavilih c, rektalna krvavitev
English: Oxaliplatin on day 1
Slovenian: infuzije na 1. dan vsakega 3-tedenskega cikla.
English: Contents of the pack and other information What Zirabev contains
Slovenian: Kaj vsebuje zdravilo Zirabev
English: Wound healing complications a,b
Slovenian: Bolezni kože in podkožja zapleti pri celjenju ran a,b
English: The observed changes were only partially reversible.
Slovenian: Opazovane spremembe so le delno reverzibilne.
English: No improvement within 7 days or 2nd occurrence
Slovenian: brez izboljšanja v 7 dneh ali 2. pojav
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Slovenian: Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 22. maj 2018
English: • Median age: 63 years
Slovenian: • srednja starost: 63 let
English: Grade b All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Slovenian: stopnja a stopnja b stopnja b vse stopnje % stopnja 3/4 % vse stopnje % stopnja 3/4 % vse stopnje % stopnja 3/4 %
English: • Male: 88%
Slovenian: • moški: 88 %
English: Institute supportive measures immediately.
Slovenian: Takoj je treba uvesti podporne ukrepe.
English: This may be due to acceleration of an age-related physiological process.
Slovenian: To je lahko posledica pospešenega fiziološkega procesa, povezanega s starostjo.
English: Tell your doctor immediately if you have any of the following symptoms:
Slovenian: Takoj obvestite zdravnika, če imate katerega od naslednjih simptomov:
English: A pre-planned interim analysis for efficacy was performed when 432 deaths had occurred.
Slovenian: Vnaprej načrtovana vmesna analiza učinkovitosti je bila narejena, ko je umrlo 432 bolnikov.
English: An increase in AUC of irinotecan of approximately 28% was also observed.
Slovenian: Opazili so tudi povečanje AUC irinotekana za približno 28 %.
English: Your doctor may change your dose.
Slovenian: Zdravnik lahko spremeni vaš odmerek.
English: This is 1 cycle of treatment.
Slovenian: To je 1 cikel zdravljenja.
English: • Median duration of sorafenib treatment: 7.8 months
Slovenian: • srednje trajanje zdravljenja s sorafenibom: 7,8 mesecev
English: This medicine may also affect the results of some blood tests.
Slovenian: To zdravilo lahko vpliva tudi na izvide nekaterih krvnih preiskav.
English: Pharmacokinetic interactions of other antibiotics have not been studied.
Slovenian: Farmakokinetičnih interakcij z drugimi antibiotiki niso preučevali.
English: Thereafter, periodic monitoring should be continued at least monthly and as clinically indicated.
Slovenian: Nato je treba z rednim spremljanjem nadaljevati vsaj enkrat na mesec in ko je klinično indicirano.
English: Observed elevations of ALT and/or AST Occurrence
Slovenian: Opaženo povečanje vrednosti ALT in/ali
English: Most patients (52%) received 3 or fewer previous lines of treatment for metastatic disease.
Slovenian: Večina bolnikov (52 %) je prejela 3 ali manj predhodnih linij zdravljenja metastatske bolezni.
English: Your doctor will discuss with you the potential risks of taking Stivarga during pregnancy.
Slovenian: Zdravnik se bo z vami posvetoval o možnih tveganjih jemanja zdravila Stivarga med nosečnostjo.
English: - if you get chest pain or have any heart problems.
Slovenian: - če se vam pojavi bolečina v prsnem košu ali imate kakršne koli težave s srcem.
English: This 4-week period is considered a treatment cycle.
Slovenian: To 4-tedensko obdobje je en cikel zdravljenja.
English: Patients with performance status (PS) 2 or higher were excluded from clinical studies.
Slovenian: Bolniki s statusom zmogljivosti (PS - Performance Status) 2 ali več so bili izključeni iz kliničnih študij.
English: EU/1/13/858/001 EU/1/13/858/002
Slovenian: EU/1/13/858/002
English: • Radiotherapy prior to regorafenib treatment: 15%
Slovenian: • radioterapija pred zdravljenjem z regorafenibom: 15 %
English: • Absence of both macroscopic vascular invasion and extra-hepatic tumour spread: 19%
Slovenian: • odsotnost obeh makroskopskih vaskularnih invazij in razsoj tumorja zunaj jeter: 19 %
English: Randomisation was performed within 10 weeks after the last treatment with sorafenib.
Slovenian: Randomizacija je bila izvedena v 10 tednih po zadnjem zdravljenju s sorafenibom.
English: All Grades*
Slovenian: vse stopnje*
English: <0.000001 1.9 months
Slovenian: < 0,000001 1,9 mesecev
English: Studies on the carcinogenic potential of regorafenib have not been performed.
Slovenian: Študij kancerogenega potenciala regorafeniba niso izvedli.
English: This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 3 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Taking Stivarga with food and drink
Slovenian: Zdravilo Stivarga skupaj s hrano in pijačo
English: Elderly Age did not affect the regorafenib pharmacokinetics over the studied age range (29 - 85 years).
Slovenian: Starejši Starost ni vplivala na farmakokinetiko regorafeniba v preučevani starostni skupini (29 - 85 let).
English: Stivarga should be taken at the same time each day.
Slovenian: Zdravilo Stivarga je treba vzeti vsak dan ob istem času.
English: The exposure of regorafenib in various Asian populations (Chinese, Japanese, Korean) is within the same range as seen in Caucasians.
Slovenian: Izpostavljenost regorafenibu v različnih azijskih populacijah (Kitajci, Japonci, Korejci) je v enakem razponu, kot so ga opazili pri belcih.
English: These may be signs of bleeding.
Slovenian: To so lahko znaki krvavitve.
English: Laboratory Parameter (in % of samples investigated)
Slovenian: Laboratorijski kazalec (v % preučevanih vzorcev)
English: • Caucasian: 36%, Asian: 41%
Slovenian: • belci: 36 %, azijci: 41 %
English: Frequency groups are defined by the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10); pogosti ( ≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do <1/1.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates.
Slovenian: Zato je priporočljivo skrbno spremljanje bolnikov glede znakov in simptomov povečane izpostavljenosti substratom BCRP.
English: Specific studies on fertility have not been performed.
Slovenian: Specifičnih študij plodnosti niso izvedli.
English: The decision to re-start Stivarga therapy should be based on careful consideration of the potential benefits and risks of the individual patient.
Slovenian: Odločitev o ponovni uvedbi zdravljenja z zdravilom Stivarga mora temeljiti na skrbni oceni o možnih koristih in tveganjih za posameznega bolnika.
English: Metastatic colorectal cancer (CRC)
Slovenian: Metastatski kolorektalni rak (CRC)
English: Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
Slovenian: Na splošno se je pri približno 4,6 % bolnikih, zdravljenih z zdravilom Stivarga, razvil hipotiroidizem, zaradi katerega je bilo potrebno hormonsko nadomestno zdravljenje.
English: The highest dose of Stivarga studied clinically was 220 mg per day.
Slovenian: Največji odmerek zdravila Stivarga, ki so ga klinično preučevali, je bil 220 mg na dan.
English: Your doctor may temporarily stop your treatment.
Slovenian: Zdravnik lahko začasno prekine zdravljenje.
English: Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary.
Slovenian: Zdravnik vam bo morda moral zmanjšati odmerek ali se bo odločil za začasno prekinitev ali trajno prenehanje zdravljenja, če bo potrebno.
English: The study was un-blinded after this planned interim analysis of OS had crossed the pre-specified efficacy boundary.
Slovenian: Študija je bila razkrita potem, ko je ta načrtovana vmesna analiza učinkovitosti celokupnega preživetja presegla vnaprej določeno mejo učinkovitosti.
English: Only 59.5 % of patients enrolled in the CONCUR study were also previously treated with VEGF- or EGFR-targeted agents.
Slovenian: Le 59,5 % bolnikov, vključenih v študijo CONCUR, je bilo predhodno zdravljenih tudi z zaviralci VEGF ali EGFR.
English: You may require medical attention and your doctor may tell you to stop taking Stivarga.
Slovenian: Morda boste potrebovali medicinsko pomoč, zdravnik pa vam bo morda svetoval, da prenehate jemati zdravilo Stivarga.
English: You should not take Stivarga together with grapefruit juice (see also section ‘Taking Stivarga with food and drink').
Slovenian: Zdravila Stivarga ne smete zaužiti skupaj s sokom grenivke (glejte tudi poglavje »Zdravilo Stivarga skupaj s hrano in pijačo«).
English: There are no data on the use of regorafenib in pregnant women.
Slovenian: Podatkov o uporabi regorafeniba pri nosečnicah ni.
English: You may need treatment for them and extra tests may be done (see also section 4 ‘Possible side effects').
Slovenian: Morda bo potrebno zdravljenje ali pa bo treba opraviti dodatne preiskave (glejte tudi poglavje 4 »Možni neželeni učinki«).
English: • Loco-regional transarterial embolisation or chemoinfusion procedures: 61%
Slovenian: • regionalna transarterijska embolizacija ali postopek kemoinfuzije: 61 %
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli sestavino, navedeno v poglavju 6.1.
English: Arterial hypertension
Slovenian: Arterijska hipertenzija
English: Take Stivarga at the same time each day after a light (low-fat) meal.
Slovenian: Zdravilo Stivarga vzemite vsak dan ob istem času po lahkem obroku (z majhno vsebnostjo maščob).
English: The overall median time since most recent progression or relapse to randomisation was 6 weeks.
Slovenian: Mediana trajanja zdravljenja od zadnjega napredovanja ali ponovitve bolezni do randomizacije je bila 6 tednov.
English: Take the dose of Stivarga that your doctor prescribes for you.
Slovenian: Jemljite odmerek zdravila Stivarga, ki vam ga je predpisal zdravnik.
English: However, physiology-based pharmacokinetic modelling does not predict any relevant change in exposure in these patients.
Slovenian: Kljub temu pa farmakokinetično modeliranje na osnovi fiziologije pri teh bolnikih ne napoveduje pomembnih sprememb v izpostavljenosti.
English: To manage your symptoms, your doctor may recommend the use of creams and/or the use of shoe cushions and gloves.
Slovenian: Zdravnik vam lahko za lajšanje vaših simptomov priporoči uporabo krem in/ali uporabo vložkov za čevlje in rokavic.
English: Before initiating Stivarga, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Stivarga je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: Stivarga should not be used during pregnancy unless clearly necessary and after careful consideration of the benefits for the mother and the risk to the foetus.
Slovenian: Zdravila Stivarga se ne sme uporabljati med nosečnostjo, razen kadar je to nujno potrebno in po skrbni oceni koristi za mater in tveganja za plod.
English: Your doctor will usually ask you to take Stivarga for 3 weeks and then to stop for 1 week.
Slovenian: Običajno vam bo zdravnik svetoval, da jemljete zdravilo Stivarga 3 tedne in nato za 1 teden prekinete zdravljenje.
English: Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Slovenian: Kaiser-Wilhelm Allee 51368 Leverkusen Nemčija