natgillin/translations-raw huggingface dataset:
The pharmacodynamics of idarucizumab after administration of dabigatran etexilate were investigated in 141 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Farmakodinamiko idarucizumaba po dajanju dabigatran eteksilata so proučili pri 141 preizkušancih študij I. faze, pri čemer so predstavljeni podatki reprezentativne podskupine 6 zdravih preizkušancev, starih od 45 do 64 let, ki so prejeli odmerek 5 g v obliki intravenske infuzije.
The recommended dose is 5 g (2 vials of 50 mL).
Priporočeni odmerek je 5 g (2 viali po 50 ml).
There is no clinical experience with overdoses of Praxbind.
Kliničnih izkušenj s prevelikim odmerjanjem zdravila Praxbind ni.
Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see section 5.2).
Zdravilo Praxbind povzroča prehodno proteinurijo zaradi fiziološkega odziva na presežek beljakovin v ledvicah po bolusni/kratkotrajni intravenski uporabi idarucizumaba po 5 g (glejte poglavje 5.2).
A pre-existing intravenous line may be used for administration of Praxbind.
Za dajanje zdravila Praxbind lahko uporabimo obstoječa intravensko linijo.
- The other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection.
- Druge sestavine zdravila so natrijev acetat trihidrat, ocetna kislina, sorbitol, polisorbat 20 in voda za injekcije.
Compared to 272 patients without hepatic impairment, the median AUC of idarucizumab was changed by -6%, 37% and 10% in patients with AST/ALT elevations of 1 to <2x ULN (N=34), 2 to <3x ULN (N=3) and >3x ULN (N=21), respectively.
V primerjavi z 272 bolniki brez jetrne okvare se je mediana AUC idarucizumaba spremenila za -6 % pri bolnikih z vrednostmi AST/ALT, povišanimi za od 1- do < 2-kratnika zgornje meje normale (N = 34), za 37 % pri bolnikih z vrednostmi AST/ALT, povišanimi za od 2- do < 3-kratnik zgornje meje normale (N = 3), in za 10 % pri bolnikih z vrednostmi AST/ALT, povišanimi za > 3-kratnik zgornje meje normale (N = 21).
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja zdravila Praxbind z drugimi zdravili niso izvedli.
Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
Zdravljenje z zdravilom Pradaxa (dabigatran eteksilat) lahko ponovno uvedemo 24 ur po dajanju zdravila Praxbind, če je bolnik klinično stabilen in je bila dosežena ustrezna hemostaza.
Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.
Parenteralna zdravila, kot je zdravilo Praxbind, je treba pred dajanjem pregledati s prostim očesom glede prisotnosti trdnih delcev in obarvanosti.
Preclinical investigations with idarucizumab have shown no interactions with
Predklinične raziskave z idarucizumabom niso pokazale medsebojnega delovanja z:
The solution should not be exposed to light for more than 6 hours (in unopened vial and/or inuse).
Raztopina (v neodprti viali in/ali med uporabo) ne sme biti izpostavljen svetlobi več kot 6 ur.
In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind.
Zato obstaja pri bolnikih z dedno intoleranco na fruktozo tveganje za resne neželene učinke, ki jih je treba pretehtati glede na možne koristi nujnega zdravljenja z zdravilom Praxbind.
The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dilute thrombin time (dTT) or ecarin clotting time (ECT).
Primarni opazovani dogodek je bil največji odstotek izničenja antikoagulacijskega učinka dabigatrana v 4 urah po uporabi idarucizumaba, ki je temeljil na določitvi razredčitvenega trombinskega časa (dTT) ali ekarinskega časa koagulacije (EKT) v centralnem laboratoriju.
The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Farmakokinetiko idarucizumaba so proučili pri 224 preizkušancih v študijah I. faze, pri čemer so predstavljeni podatki reprezentativne podskupine 6 zdravih preizkušancev, starih od 45 do 64 let, ki so prejeli odmerek 5 g v obliki intravenske infuzije.
No anti-idarucizumab antibodies were detected in these subjects prior to the second administration.
Pred drugim dajanjem pri teh preizkušancih niso zaznali protiteles proti idarucizumabu.
A causal relationship to idarucizumab could not be established.
Vzročne povezave z idarucizumabom niso dokazali.
There are no data for the use of Praxbind in pregnant women.
Podatkov o uporabi zdravila Praxbind pri nosečnicah ni.
After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Po uporabi zdravila Praxbind lahko drugo antitrombotično terapijo (npr. nizkomolekularni heparin) uvedemo kadarkoli, če je bolnik klinično stabilen in je bila dosežena ustrezna hemostaza.
How to use Praxbind
Kako uporabljati zdravilo Praxbind
In a subgroup of 6 phase I subjects, idarucizumab was administered a second time, two months after the first administration.
Podskupini 6 oseb v preskušanju I. faze so idarucizumab dajali že drugič dva meseca po prvem dajanju.
Preclinical data reveal no special hazard for humans based on repeated dose toxicity studies of up to four weeks in rats and two weeks in monkeys.
Predklinični podatki na osnovi študij o toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do štiri tedne in pri opicah do dva tedna, ne kažejo posebnega tveganja za človeka.
Tell your doctor or nurse - if you are allergic to idarucizumab or to any other of the substances listed in section 6.
Povejte zdravniku ali medicinski sestri: - če ste alergični na idarucizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate gensko bolezen, imenovano dedna intoleranca za fruktozo.
After treatment with idarucizumab proteinuria has been observed.
Po zdravljenju z idarucizumabom so opazili proteinurijo.
Praxbind (2x2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Zdravilo Praxbind (2 x 2,5 g/50 ml) dajemo intravensko v obliki dveh zaporednih infuzij, ki trajata po 5 do 10 minut vsaka, ali kot bolusno injekcijo.
No adverse reactions have been identified.
Neželenih učinkov niso ugotovili.
LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: natrijev acetat trihidrat, ocetna kislina, sorbitol, polisorbat 20, voda za injekcije.
If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Če zdravilo Praxbind uporabimo pri teh bolnikih, jih moramo med dajanjem zdravila Praxbind in 24 ur po njem intenzivno spremljati.
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
Pomembni koagulacijski parametri so aktivirani delni tromboplastinski čas (aPTČ), razredčitveni trombinski čas (dTT-diluted Thrombin Time) ali ekarinski čas koagulacije (EKT) (glejte poglavje 5.1).
None of the patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies.
Pri nobenem od bolnikov, ki so prejeli ponoven odmerek idarucizumaba, test protiteles proti idarucizumabu ni bil pozitiven.
In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).
Pri podskupini bolnikov je v roku 24 ur po uporabi idarucizumaba prišlo do ponovnih plazemskih koncentracij nevezanega dabigatrana in sočasnega podaljšanja testov strjevanja krvi (glejte poglavje 5.1).
• The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL)
• Priporočeni odmerek zdravila Praxbind je 5 g (2 x 2,5 g/50 ml).
Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Izničenje terapije z dabigatranom bolnika izpostavi trombotičnemu tveganju, povezanemu z osnovno boleznijo.
Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2).
Ledvična okvara ni vplivala na idarucizumabov učinek izničenja antikoagulacijskega učinka (glejte poglavje 5.2).
The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Priporočeni odmerek zdravila Praxbind je 5 g (2 x 2,5 g/50 ml).
Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 12 % (33/283) of the phase I subjects and 3.8% (19/501) of the patients.
Pri približno 12 % (33/283) preizkušancev v preskušanju I. faze in 3,8 % (19/501) bolnikov so odkrili obstoječa protitelesa z navzkrižno reaktivnostjo na idarucizumab.
In one subject, treatment-emergent anti-idarucizumab antibodies were detected after the second administration.
Pri enem preizkušancu so po drugi uporabi opazili iz zdravljenja izvirajoča protitelesa proti idarucizumabu.
Idarucizumab is a specific reversal agent for dabigatran.
Idarucizumab je specifična protiučinkovina za dabigatran.
Figure 4 - Plasma-levels of unbound dabigatran in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slika 4 - Ravni nevezanega dabigatrana v plazmi v reprezentativni skupini zdravih preizkušancev (dajanje idarucizumaba ali placeba pri 0 h)
Figure 5 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slika 5 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določeno z dTT, v reprezentativni skupini zdravih preskušancev (dajanje idarucizumaba ali placeba pri 0 h)
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Pomembni koagulacijski parametri so aktivirani delni tromboplastinski čas (aPTČ), razredčitveni trombinski čas (dTT-diluted Thrombin Time) ali ekarinski čas koagulacije (EKT).
PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each
FARMACEVTSKA OBLIKA IN VSEBINA 2 viali po 50 ml raztopine za injiciranje/infundiranje
• volume expanders.
• volumskimi ekspanderji,
Preclinical pharmacodynamics
Predklinična farmakodinamika
Pradaxa can be given again 24 hours after Praxbind administration.
Ponovna uporaba zdravila Pradaxa je mogoča 24 ur po dajanju zdravila Praxbind.
Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Idarucizumab se močno in specifično veže na dabigatran in njegove presnovke ter nevtralizira njihov antikoagulacijski učinek.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial label
PODATKI NA PRIMARNI OVOJNINI Nalepka viale
• other anticoagulants (e.g. thrombin inhibitors other than dabigatran, Factor Xa inhibitors including low-molecular weight heparin, vitamin K-antagonists, heparin).
vključno z nizkomolekularnim heparinom, antagonisti vitamina K, heparinom).
Praxbind is used to rapidly trap dabigatran in order to inactivate its effect.
Zdravilo Praxbind uporabljamo za hitro vezavo dabigatrana in s tem izničenje njegovega učinka.
Subjects with a creatinine clearance below 44 mL/min have not been studied in Phase I. Depending on the degree of renal impairment the total clearance was reduced compared to healthy subjects, leading to an increased exposure of idarucizumab.
Glede na stopnjo ledvične okvare se je skupni očistek v primerjavi z zdravimi preizkušanci zmanjšal, kar je povzročilo večjo izpostavljenost idarucizumabu.
Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487)
Slika 1 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z dTT, pri bolnikih iz študije RE-VERSE AD (N = 487)
Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486)
Slika 3 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z aPTČ, pri bolnikih iz študije RE-VERSE AD (N = 486)
No dose adjustment is required in renally impaired patients.
Bolnikom z ledvično okvaro odmerka ni treba prilagajati.
Figure 6 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slika 6 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določeno z EKT, v reprezentativni skupini zdravih preizkušancev (dajanje idarucizumaba ali placeba pri 0 h)
What Praxbind contains - The active substance is idarucizumab.
Kaj vsebuje zdravilo Praxbind - Učinkovina je idarucizumab.
Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487)
Slika 2 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z EKT, pri bolnikih iz študije RE-VERSE AD (N = 487)
NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion
IME ZDRAVILA Praxbind 2,5 g/50 ml raztopina za injiciranje/infundiranje
Praxbind binds specifically to dabigatran and reverses its anticoagulant effect.
Zdravilo Praxbind se veže specifično na dabigatran in izniči njegov antikoagulacijski učinek.
What Praxbind is
Kaj je zdravilo Praxbind
Each vial contains 2.5 g idarucizumab in 50 mL.
Ena viala po 50 ml vsebuje 2,5 g idarucizumaba.
Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect.
Idarucizumab se specifično veže na dabigatran in izniči njegov antikoagulacijski učinek.
The transient proteinuria is a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously.
Prehodna proteinurija je fiziološki odziv na presežek beljakovin v ledvicah po bolusnem/kratkotrajnem intravenskem dajanju idarucizumaba po 5 g. Prehodna proteinurija je bila običajno najvišja 4 ure po uporabi idarucizumaba in se je normalizirala v 12-24 urah.
What Praxbind is used for
Za kaj uporabljamo zdravilo Praxbind
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 50 mL contains 2.5 g idarucizumab.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala po 50 ml vsebuje 2,5 g idarucizumaba.
Posology
percentilom
Nine patients were re-dosed with idarucizumab.
Devet bolnikov je ponovno prejelo odmerek idarucizumaba.
NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion Idarucizumab
Praxbind 2,5 g/50 ml raztopina za injiciranje/infundiranje idarucizumab
Package leaflet: Information for the patient and user Praxbind 2.5 g/50 mL solution for injection/infusion idarucizumab
Navodilo za uporabo Praxbind 2,5 g/50 ml raztopina za injiciranje/infundiranje idarucizumab
Clear to slightly opalescent, colourless to slightly yellow solution.
FARMACEVTSKA OBLIKA raztopina za injiciranje/infundiranje Bistra do rahlo opalescentna, brezbarvna do rumenkasta raztopina.
How to store Praxbind
Shranjevanje zdravila Praxbind
No local irritation of the blood vessel was observed after i.v.
Lokalnega draženja krvnih žil po intravenskem ali paravenskem dajanju idarucizumaba niso opazili.
-1 Porcine circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigenic units as determined in the in vitro potency test (antigenic mass assay).
--1 Cirkovirus prašičev tip 2, antigenska podenota ORF2 ≥ 2828 AU* * Enote antigena, določene z in vitro testom učinkovitosti (test antigenske mase)
EU (MA) Number Invented name
Dodatek A EU številka
The subgroups in these studies were too small to draw reliable conclusions.
Podskupine v teh študijah so bile premajhne za zanesljive zaključke.
You may require medical attention.
Lahko bi potrebovali zdravniško pomoč.
Then take the next capsule at the usual time.
Nato naslednjo kapsulo vzemite ob običajnem času.
• Take the capsule once in the morning and once in the evening.
• Vzemite eno kapsulo zjutraj in eno zvečer.
The educational pack should contain the following:
Paket z izobraževalnim gradivom mora vsebovati naslednje:
The indication does not cover children and adolescents.
Indikacija ne vključuje otrok in mladostnikov.
They may be taken with or without food.
Lahko se jih jemlje skupaj s hrano ali brez nje.
• Take the capsules at about the same time each day.
• Kapsule jemljite vsak dan ob približno enakem času.
This medicinal product should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Tega zdravila se med nosečnostjo ne sme uporabljati, razen če klinično stanje matere ne zahteva takega zdravljenja.
Treatment of children and adolescents with this medicine is not recommended.
Zdravljenje otrok in mladostnikov s tem zdravilom ni priporočljivo.
The final wording used on the educational material should be in line with the approved product information.
Končno besedilo, uporabljeno v izobraževalnem gradivu, se mora ujemati z odobrenimi informacijami o zdravilu.
• Reduction in the number of red blood cells (anaemia).
• zmanjšanje števila rdečih krvnih celic (anemija)
Fifty percent of objective tumour responses were achieved during the first 8 weeks of treatment.
Petdeset odstotkov objektivnih odzivov tumorjev na zdravljenje so dosegli v prvih 8 tednih zdravljenja.
It is important to take XALKORI every day, as long as your doctor prescribes it to you.
Pomembno je, da zdravilo XALKORI jemljete vsak dan, dokler vam ga zdravnik predpisuje.
Some side effects could be serious.
Nekateri neželeni učinki bi lahko bili resni.
No adverse drug reactions were reported with an absolute difference of ≥15%.
Poročali niso o nobenih neželenih učinkih z absolutno razliko  15 %.
These cases generally occurred within 3 months after the initiation of treatment.
Do teh primerov je navadno prišlo v treh mesecih po začetku zdravljenja.
Date of latest renewal: 29 July 2016
Datum prve odobritve: 23. oktober 2012 Datum zadnjega podaljšanja: 29. julij 2016
QT prolongation can result in arrhythmias and is a risk factor for sudden death.
Podaljšanje intervala QT lahko povzroči aritmije in je dejavnik tveganja za nenadno smrt.
If you are not able to take the medicine as your doctor prescribed, or you feel you do not need it anymore, contact your doctor right away.
Če niste zmožni zdravila jemati tako, kot je predpisal zdravnik, ali če imate občutek, da ga ne potrebujete več, se nemudoma posvetujte z zdravnikom.
• If you have ever had any other lung problems.
• če ste kdaj imeli kakršnekoli druge težave s pljuči.
Effect on other transport proteins
Učinek na druge prenašalne beljakovine
If you have any questions about how XALKORI works or why this medicine has been prescribed for you, ask your doctor.
Če imate kakršnakoli vprašanja o tem, kako zdravilo XALKORI deluje, ali zakaj vam je bilo to zdravilo predpisano, vprašajte zdravnika.
XALKORI with food and drink
Zdravilo XALKORI skupaj s hrano in pijačo
You should immediately contact your doctor if you experience any of the following serious side effects (see also section 2 “What you need to know before you take XALKORI ”):
Nemudoma se posvetujte z zdravnikom, če opazite kateregakoli od naslednjih resnih neželenih učinkov (glejte tudi poglavje 2 “Kaj morate vedeti, preden boste vzeli zdravilo XALKORI”):
Monitor heart rate and blood pressure regularly.
Redno je treba spremljati srčni utrip in krvni tlak.
The use of concomitant medicinal products associated with bradycardia should be carefully evaluated.
Uporabo sočasnih zdravil, povezanih z bradikardijo, je treba skrbno oceniti.
With twice daily dosing, steady state was achieved within 15 days.
Ob jemanju zdravila dvakrat na dan je bilo stanje dinamičnega ravnovesja doseženo v 15 dneh.
When assessing either ALK or ROS1 status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Pri določanju statusa ALK ali ROS1 pri bolniku je pomembno izbrati dobro validirano in robustno metodologijo, da se izognemo lažno negativnim ali lažno pozitivnim rezultatom.
Assessment should be performed by laboratories with demonstrated proficiency in the specific technology being utilised (see section 4.4).
Oceno morajo izvajati laboratoriji, ki izkazujejo strokovno usposobljenost glede uporabe specifične tehnologije (glejte poglavje 4.4).
The full effect of crizotinib on reduction of heart rate may not develop until several weeks after start of treatment.
Celokupen učinek krizotiniba na upočasnitev srčnega utripa se lahko razvije šele več tednov po začetku zdravljenja.
Treatment of overdose with the medicinal product consists of general supportive measures.
Zdravljenje prevelikega odmerjanja obsega splošne podporne ukrepe.
The median duration of treatment for these patients was 23 weeks.
Mediano trajanje zdravljenja pri teh bolnikih je bilo 23 tednov.
• Decreased levels of testosterone, a male sex hormone.
• zmanjšane koncentracije testosterona, moškega spolnega hormona
• You can take the capsules with or without food always avoiding grapefruit.
• Kapsule lahko jemljete skupaj s hrano ali brez nje, vedno pa se izogibajte uživanju grenivk.
There were 6 complete responses and 32 partial responses for an ORR of 72% (95% CI: 58%, 83%).
Bilo je 6 popolnih in 32 delnih odzivov za 72 % ORR (95 % IZ: 58 %, 83 %).
Dose reduction guidelines for haematological and non-haematological toxicities are provided in Tables 1 and 2.
Smernice za zmanjševanje odmerkov zaradi hematološke in nehematološke toksičnosti so navedene v preglednicah 1 in 2.
Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
Drugih škodljivih vplivov, ki bi lahko zadevali pediatrične bolnike, pri mladih živalih niso ovrednotili.
Median time to onset of increased Grade 3 or 4 transaminases was 43 days.
Mediani čas do pojava povečanja vrednosti transaminaz stopnje 3 ali 4 je bil 43 dni.
Do not take a double dose (two capsules at the same time) to make up for a forgotten capsule.
Ne vzemite dvojnega odmerka (dveh kapsul hkrati), če ste pozabili vzeti prejšnjo kapsulo.
The median duration of treatment was 42 weeks.
Mediano trajanje zdravljenja je znašalo 42 tednov.
Of the patients enrolled in these studies, the patients described below had received prior systemic therapy for locally advanced or metastatic disease.
Izmed bolnikov, vključenih v ti študiji, so spodaj opisani bolniki prejeli predhodno sistemsko zdravljenje za lokalno napredovalo ali metastatsko bolezen.
If there is any possibility that the person taking this medicine may become pregnant or father a child, they must use adequate contraception during treatment, and for at least 90 days after completing therapy as oral contraceptives may be ineffective while taking XALKORI.
Če obstaja kakršnakoli možnost, da bi oseba, ki to zdravilo jemlje, lahko zanosila ali spočela otroka, mora uporabljati ustrezne metode za preprečitev nosečnosti med zdravljenjem in še najmanj 90 dni po zaključku zdravljenja, ker so med jemanjem zdravila XALKORI peroralni kontraceptivi lahko neučinkoviti.
Patients should not take 2 doses at the same time to make up for a missed dose.
Bolniki ne smejo vzeti dveh odmerkov hkrati, da bi nadomestili pozabljeni odmerek.
Cases with fatal outcome, cases requiring hemodialysis and cases of grade 4 hyperkalemia were also observed.
Poročali so tudi o primerih s smrtnim izidom, primerih, ki so zahtevali hemodializo, in primerih hiperkaliemije stopnje 4.