natgillin/translations-raw huggingface dataset:
Eluxadoline is a substrate of the hepatic efflux transporter MRP2.
Eluksadolin je supstrat prijenosnika jetrenog efluksa MRP2.
• these symptoms are uncommon and may indicate pancreas or bile duct system problems (i.e. inflammation of the pancreas or spasm of the sphincter of Oddi); o your risk of developing pancreas or bile duct system problems may be higher if you drink alcohol in excess, o the spasm of the sphincter of Oddi usually goes away when you stop Truberzi.
• ti su simptomi manje česti i mogu ukazivati na probleme s gušteračom ili žučovodom (tj. na upalu gušterače ili spazam Oddijevog sfinktera); o rizik od pojave problema s gušteračom ili žučovodom može biti veći ako prekomjerno konzumirate alkohol,
Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total [14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 192 hours.
ukupnog [14C] eluksadolina pronađeno je u fecesu u roku od 336 sati i manje od 1% pronađeno je u urinu u roku od 192 sata.
OATP1B1 inhibitors
Inhibitori OATP1B1
Truberzi should not be restarted in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking Truberzi (see section 4.3).
Liječenje lijekom Truberzi ne smije se ponovo započeti u bolesnika u kojih se javila opstrukcija žučnih kanala ili spazam Oddijevog sfinktera tijekom uzimanja lijeka Truberzi (vidjeti dio 4.3).
OATP1B1 substrates
Supstrati OATP1B1
The usual recommended dose is one 100 mg tablet twice a day.
Uobičajena preporučena doza je jedna tableta od 100 mg dvaput na dan.
The proportion of patients who were adequate relief responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in both studies.
Udio bolesnika koji je odgovorio na liječenje odgovarajućim ublažavanjem simptoma bio je statistički značajno viši uz lijek Truberzi 100 mg dvaput na dan nego kod placeba tijekom razdoblja od 6 mjeseci u oba ispitivanja.
(called ‘IBS with constipation' [IBS-C]); - if you have, or may have, a blockage in your intestine/bowels; - If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).
- ako ste imali zatvor neko vrijeme ili ako je zatvor glavni simptom vašeg IBS-a (zove se ‘IBS sa zatvorom' [engl. irritable bowel syndrome with constipation, IBS-C]); - ako imate, ili možda imate, začepljenje u crijevima; - ako uzimate lijekove koji mogu povećati razinu koncentracije eluksadolina u krvi (takozvani inhibitor OATP1B1, npr. ciklosporin).
However, patients 65 years of age and older, treated with the 75 mg dose twice daily experienced a reduced rate of serious adverse events as well as adverse events leading to discontinuation compared to patients treated with 100 mg dose twice daily (see section 4.8).
75 mg dvaput na dan imali su manju stopu ozbiljnih štetnih događaja kao i štetnih događaja koji su doveli do prekida liječenja u usporedbi s bolesnicima liječenima dozom od 100 mg dva puta na dan
The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
Preporučena doza je 200 mg dnevno (jedna tableta od 100 mg dva puta na dan).
Table 2: Efficacy Results in Randomized Clinical Studies Study 1 (IBS 3001)
Tablica 2: Rezultati djelotvornosti u randomiziranim kliničkim ispitivanjima
These medicines can include: - rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); - valsartan and olmesartan (used to treat high blood pressure);
Ti lijekovi mogu uključivati: - rosuvastatin (statin koji se koristi za liječenje visokog kolesterola i sprječavanje kardiovaskularne bolesti);
Package leaflet: Information for the patient Truberzi 100 mg film-coated tablets
Uputa o lijeku: Informacije za bolesnika Truberzi 100 mg filmom obložene tablete eluksadolin
The recommended dose is one 100 mg tablet twice a day.
Preporučena doza je jedna tableta od 100 mg dvaput na dan.
These patients are at increased risk for acute pancreatitis (see section 4.4).
U tih je bolesnika povećan rizik od akutnog pankreatitisa (vidjeti dio 4.4).
In vitro studies in human liver microsomes showed that eluxadoline is not a direct inhibitor of CYP3A4 at clinically relevant concentrations [IC50 =450 µM] but in human intestinal microsomes, eluxadoline was a metabolism dependent inhibitor of CYP3A4 with kinact of 0.1 min-1 and K-I of 450 µM (256 µg/mL).
CYP3A4 pri klinički značajnim koncentracijama [IC50 =450 µM], dok je u ljudskim crijevnim mikrosomima eluksadolin bio o metabolizmu ovisan inhibitor CYP3A4, s vrijednošću kinact od 0,1 min
Assessment of drug interactions
Procjena interakcija s drugim lijekovima
These patients are at increased risk for sphincter of Oddi spasm (see section 4.4).
U tih je bolesnika povećan rizik od spazma Oddijevog sfinktera (vidjeti dio 4.4).
Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of symptoms.
Od 5 prijavljenih slučajeva, 3 su bila povezana s pretjeranim unosom alkohola, 1
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 100 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija - 100 mg
In a population pharmacokinetic analysis, the estimated apparent volume of distribution of eluxadoline was 27,100 L. In healthy subjects, eluxadoline was moderately (81%) bound to plasma proteins.
U zdravih ispitanika, eluksadolin se umjereno (81%) veže za proteine plazme.
Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
U kliničkim ispitivanjima prijavljeni su dodatni slučajevi pankreatitisa nepovezanog sa spazmom
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 75 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija - 75 mg
Truberzi 100 mg film-coated tablets Each film-coated tablet contains 100 mg of eluxadoline.
Truberzi 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg eluksadolina.
6”Hypersensitivity” term includes: anaphylaxis, angioedema, (e.g. swollen face and/or throat), dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing period.
6 Pojam „preosjetljivost” obuhvaća: anafilaksiju, angioedem (npr. otečeno lice i/ili grlo), dispneju,
Eluxadoline is an inhibitor of the hepatic uptake transporter OATP1B1.
Eluksadolin je inhibitor prijenosnika jetrenog unosa OATP1B1.
Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side.
Filmom obložena tableta ružičasto-narančaste boje do boje breskve, modificiranog oblika kapsule dimenzija približno 8 mm x 19 mm, s utisnutom oznakom „FX100“ na jednoj strani.
In ESRD participants not yet on dialysis relative to matched, healthy participants with normal renal function, eluxadoline plasma Cmax was 2.2-fold higher and AUC0-t was 4.2-fold higher.
Sudionici sa završim stadijem bolesti bubrega koji još nisu na dijalizi imali su Cmax plazme eluksadolina 2,2 puta veći, a AUC0-t 4,2 puta veći su u odnosu na njima odgovarajuće zdrave sudionike s normalnom funkcijom bubrega,.
Sphincter of Oddi spasm3
spazam Oddijevog sfinktera3 pankreatitis
Gastric lavage or charcoal administration should be considered.
Treba uzeti u obzir ispiranje želuca ili primjenu aktivnog ugljena.
Eluxadoline has a low potential for drug-drug interactions based on limited in vitro CYP inhibition/induction and given that eluxadoline is not a substrate for CYPs at clinically meaningful concentrations.
CYP inhibicije/indukcije i s obzirom da eluksadolin nije supstrat za CYP-ove pri klinički značajnim koncentracijama.
Truberzi 75 mg film-coated tablets Each film-coated tablet contains 75 mg of eluxadoline.
Truberzi 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg eluksadolina.
Adequate Relief Response
Odgovor u pogledu odgovarajućeg ublažavanja
Silicified microcrystalline cellulose (E460); Colloidal anhydrous silica (E551);
6.1 Popis pomoćnih tvari silicifirana mikrokristalična celuloza (E460);
The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 4.4).
OATP1B1 su povećane i u tih bolesnika se može očekivati viša stopa štetnih događaja, naročito što se tiče gastrointestinalnih događaja, kao i učinaka na središnji živčani sustav (vidjeti dio 5.2).
Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side.
Filmom obložena tableta blijedožute do svijetlosmeđe boje, modificiranog oblika kapsule dimenzija približno 7 mm x 17 mm, s utisnutom oznakom „FX75“ na jednoj strani.
Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation.
Izbjegavajte čestu primjenu loperamida (lijek koji se koristi za liječenje proljeva) ako uzimate
Stop taking Truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: - swelling of your face, lips, mouth, tongue, and/or throat - shortness of breath or other breathing problems - chest pain or tightness - itching - rash - hives
- oticanje lica, usana, usta, jezika i/ili grla - nedostatak zraka ili druge probleme s disanjem - bol ili stezanje u prsnom košu - svrbež - osip
OATP1B1 poor function haplotypes
Haplotipovi povezani uz slabo funkcioniranje OATP1B1
EU/1/16/1126/001 56 film-coated tablets EU/1/16/1126/002 28 film-coated tablets
EU/1/16/1126/001 56 filmom obloženih tableta EU/1/16/1126/002 28 filmom obloženih tableta
Tel: + 386 (0) 590 848 40
Ewopharma d.o.o. Tel: + 386 (0) 590 848 40
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum); - if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);
- ako imate, ili ste imali, bilo kakvo začepljenje žučnog mjehura, žučovoda ili gušterače (poput žučnih kamenaca, tumora, divertikula na dvanaesniku); - ako imate, ili ste imali, bolest ili disfunkciju Oddijevog sfinktera (malog okruglog mišića u gornjem dijelu trbuha koji kontrolira protok žuči i gušteračinih sokova u gornji dio crijeva);
- if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine); - if you have liver disease with decreased liver function; - if you have had constipation for a while or if constipation is the main symptom of your IBS
- ako imate, ili ste imali, bolest ili disfunkciju Oddijevog sfinktera (malog okruglog mišića u gornjem dijelu trbuha koji kontrolira protok žuči i gušteračinih sokova u gornji dio crijeva);
EU/1/16/1126/003 56 film-coated tablets EU/1/16/1126/004 28 film-coated tablets
EU/1/16/1126/003 56 filmom obloženih tableta EU/1/16/1126/004 28 filmom obloženih tableta
Co-administration of eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by approximately 5-fold (see sections 4.3 and 4.5).
Istodobna primjena eluksadolina s ciklosporinom (inhibitorom OATP1B1) povećala je izloženost eluksadolinu za približno 5 puta
Truberzi 100 mg film-coated tablets.
Truberzi 100 mg filmom obložene tablete.
The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with ‘FX100' on one side.
Filmom obložene tablete su modificiranog oblika kapsule, ružičasto-narančaste boje do boje breskve s utisnutom oznakom „FX100“ na jednoj strani.
Sphincter of Oddi spasm
Spazam Oddijevog sfinktera
Truberzi 100 mg film-coated tablets
Truberzi 100 mg filmom obložene tablete
The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75' on one side.
Filmom obložene tablete su modificiranog oblika kapsule, blijedožute do svijetlosmeđe boje s utisnutom oznakom „FX75“ na jednoj strani.
EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)
EU/1/16/1126/006 168 filmom obloženih tableta (3 pakiranja od 56)
EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)
EU/1/16/1126/005 168 filmom obloženih tableta (3 pakiranja od 56)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 75 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE)75 mg
Truberzi 75 mg film-coated tablets.
Truberzi 75 mg filmom obložene tablete.
Cmax and AUC for the metabolite 1hydroxy-midazolam increased by ~14% and 7% respectively, suggesting that eluxadoline may be a mild inducer of CYP3A4 and may decrease the exposure of concomitantly administered CYP3A4 substrates.
7%, što upućuje da bi eluksadolin mogao biti blagi induktor enzima CYP3A4 te da bi mogao smanjiti izloženost istodobno primijenjenih supstrata CYP3A4 (vidjeti dio 4.5).
Therefore, in this population, the 75 mg dose twice daily can be used.
Stoga se u toj populaciji može koristiti doza od 75 mg dvaput na dan (vidjeti dijelove 4.2 i 4.4).
- midazolam (a medicine to sedate you when you e.g.undergo endoscopic procedures); - nifedipine (used to treat high blood pressure); - alfentanil, fentanyl (opioid analgesic used to treat pain); - dihydroergotamine, ergotamine (used to treat migraine); - pimozide (used to treat mental disorders); - quinidine (used to treat heart diseases); - sirolimus, tacrolimus (immunosuppressant used for the control of body's immune response).
- dihidroergotamin, ergotamin (koriste se za liječenje migrene); - pimozid (koristi se za liječenje psihičkih poremećaja); - kinidin (koristi se za liječenje bolesti srca);
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 100 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI (S PLAVIM OKVIROM - SAMO VIŠESTRUKO PAKIRANJE)100 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 75 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI (S PLAVIM OKVIROM - SAMO VIŠESTRUKO PAKIRANJE)75 mg
Truberzi 75 mg film-coated tablets
Truberzi 75 mg filmom obložene tablete
- severe constipation.
- teški oblik zatvora.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 100 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA-SAMO VIŠESTRUKO PAKIRANJE)100 mg
In rats, there was no effect on mating, fertility and fecundity indices (see section 5.3).
plodnost i stope fekunditeta (vidjeti dio 5.3).
EXP
AST-a
Responder rates P values
ALT-a povišene vrijednosti
- if you have liver disease with decreased liver function; - if you have had constipation for a while or if constipation is the main symptom of your IBS
- ako ste imali zatvor neko vrijeme ili ako je zatvor glavni simptom Vašeg IBS-a (zove se ‘IBS sa zatvorom' [engl. irritable bowel syndrome with constipation, IBS-C]); - ako imate, ili možda imate, začepljenje u crijevima;
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum);
- ako ste alergični na eluksadolin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako imate, ili ste imali, pankreatitis (upalu gušterače);
Severe constipation that can lead to hospitalization has happened after taking Truberzi.
Nakon uzimanja lijeka Truberzi bilo je pojava teškog oblika zatvora koji može dovesti do hospitalizacije.
The proportion of patients who were global symptom responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in Study 2 and numerically higher than placebo in Study 1.
100 mg dvaput na dan tijekom razdoblja od 6 mjeseci u Ispitivanju 2 i brojčano viši nego placebo u Ispitivanju
(See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
Effect of OATP1B1 transporter function variability on plasma levels The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased, and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 5.2).
Učinci varijabilnosti funkcije prijenosnika OATP1B1 na razine u plazmi Razine u plazmi u bolesnika s genetskom predispozicijom za slabo funkcioniranje prijenosnika
• Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction.
• Utvrđena ili suspektna opstrukcija žučnih kanala i/ili gušteračnog voda (npr. žučni kamenci, tumor,
Bile acid malabsorption
Oštećenje funkcije jetre
Common: may affect up to 1 in 10 people - dizziness; - sleepiness; - constipation; - feeling sick (nausea); - stomach ache; - being sick (vomiting); - gas (flatulence); - feeling bloated; - heartburn or acid reflux; - rash; - abnormal blood test results (increased levels of certain liver enzymes).
- vjetrovi; - nadutost; - žgaravica ili povrat kiseline; - osip;
Invented name Strength Pharmaceutical Form
Zaštićeno ime Doza
10 pre-filled syringes without needle
10 napunjenih štrcaljki bez igle
1 pre-filled syringe with 2 separate needles
1 napunjena štrcaljka s 2 zasebne igle
0.5 ml (10 µg/ml) 1 vial + 1 syringe + 1 needle
0,5 ml (10 µg/ml) 1 bočica + 1 štrcaljka + 1 igla
10 pre-filled syringes with 1 separate needle
10 napunjenih štrcaljki s 1 zasebnom iglom
1 pre-filled syringe with 1 separate needle
1 napunjena štrcaljka s 1 zasebnom iglom
0.5 ml (10 µg/ml) 10 pre-filled syringes with 1
0,5 ml (10 µg/ml) 10 napunjenih štrcaljki s 1 zasebnom iglom
0.5 ml (10 µg/ml) 1 pre-filled syringe without needle
0,5 ml (10 µg/ml) 1 napunjena štrcaljka bez igle
0.5 ml (10 µg/ml) 1 pre-filled syringe with 1 separate needle
0,5 ml (10 µg/ml) 1 napunjena štrcaljka s 2 zasebne igle
20 months.
20 mjeseci.
These effects have been seen frequently, and are sometimes severe.
Ovi se učinci često vide, a ponekad su vrlo ozbiljni.
Paediatric population The experience in children is limited.
Pedijatrijska populacija Iskustvo u djece je ograničeno.
Three cases were poorly documented and were excluded from the assessment.
Tri slučaja su slabo dokumentirana i isključena su iz ocjene.
Wait an additional week
Pričekati još jedan tjedan
* Measured at the end of a 30-minute infusion
*Mjereno na kraju 30-minutne infuzije
The following information is intended for medical or healthcare professionals only (see section 3):
Sljedeće informacije namijenjene su samo zdravstvenim radnicima (vidjeti dio 3):
The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.
Primjena leda na mjesto ekstravazacije tijekom približno 30 minuta može pomoći u ublažavanju lokalne reakcije.
Among the seven cases reviewed, the causality was stated as probable in 4 cases and possible in 1 case.
Od sedam pregledanih slučajeva, uzročnost je navedena kao vjerojatna u 4 slučaja i moguća u jednom slučaju.
Reduce next dose by 25%.
Smanjite sljedeću dozu za 25%.
The use of gloves is required.
Potrebno je koristiti rukavice.
Patients and doctors must be aware of this higher incidence and take action as appropriate.
Bolesnici i liječnici moraju biti svjesni ove povećane incidencije i prema potrebi poduzeti odgovarajuće korake.
not previously reported in clinical trials
prethodno nezabilježeni u kliničkim ispitivanjima
If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
Ako niste sigurni koje ste lijekove primali ili koje ste bolesti imali, razgovarajte o tome sa svojim liječnikom.
Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
Preporučuje se liječiti bolesnike dva do tri mjeseca kako bi se postigao terapijski odgovor.
The dose is repeated every 2 to 3 weeks for 2-3 months, then as often as necessary to maintain an improvement in your condition.
Doza se ponavlja svaka 2 do 3 tjedna tijekom 2 - 3 mjeseca, a potom onoliko često koliko je potrebno da se održi poboljšano stanje.
Caelyx is not recommended in patients below 18 years of age.
Caelyx se ne preporučuje u bolesnika mlađih od 18 godina.
This leaflet was last approved on
Ova uputa je zadnji puta revidirana u
However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Međutim, reakcija nije bila opasna po život i psi su se brzo oporavili nakon prekida liječenja.
Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Stoga se Caelyx ne smije primjenjivati za vrijeme trudnoće osim ako ne postoji jasna potreba.
Continue treatment as needed to maintain a therapeutic response.
Liječenje nastavite kako je potrebno za održavanje terapijskog odgovora.
PPE infrequently resulted in permanent treatment discontinuation (3.7%-7.0%).
PPE je manje često prouzročio trajni prekid liječenja (3,7% - 7,0%).
Grade 4 (requires parenteral or enteral support)
4. stupanj (potrebna parenteralna ili enteralna potpora)
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Međutim, skraćenje QRS kompleksa smatra se indikativnijim za srčanu toksičnost.
The overall incidence of PPE reported was 44.0%-46.1%.
Zabilježena je ukupna incidencija PPE od 44,0% - 46,1%.
The frequencies are provided according to the following convention:
Učestalosti su prikazane prema slijedećoj konvenciji:
< 1/10,000 including isolated reports
Vrlo rijetko < 1/10 000 uključujući izolirane prijave
It is because of the potential changes in your blood cells that you will have regular blood tests.
Zbog mogućih promjena u krvnim stanicama redovito ćete raditi krvne pretrage.
Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
Ovisno o dozi i indikaciji, infuzija može trajati od 30 minuta do više od jednog sata (npr., 90 minuta).
Patients who suffer from these effects must avoid driving and operating machinery.
Bolesnici koji pate od ovih simptoma moraju izbjegavati upravljanje vozilima i rad sa strojevima.
Other side effects Between infusions, the following may occur:
Ostale nuspojave Između infuzija može nastati sljedeće:
 1/100 and < 1/10
 1/100 i < 1/10
In very rare cases, seizures (convulsions) have occurred.
U vrlo rijetkim slučajevima uočeni su napadaji (konvulzije).
PPE*, alopecia, rash PPE*
PPE*, alopecija, osip PPE*
These results, though not mature, constituted the protocol defined final analysis.
Ovi rezultati, premda nisu konačni, čine završnu analizu određenu planom ispitivanja.
The average duration of the most common severe (grade 3/4) events for both groups was 30 days or less.
Prosječno trajanje najčešćih teških (stupanj 3/4) promjena u obje skupine bilo je 30 dana ili kraće.