FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Croatian: - oticanje lica, usana, usta, jezika i/ili grla - nedostatak zraka ili druge probleme s disanjem - bol ili stezanje u prsnom košu - svrbež - osip
English: OATP1B1 poor function haplotypes
Croatian: Haplotipovi povezani uz slabo funkcioniranje OATP1B1
English: EU/1/16/1126/001 56 film-coated tablets EU/1/16/1126/002 28 film-coated tablets
Croatian: EU/1/16/1126/001 56 filmom obloženih tableta EU/1/16/1126/002 28 filmom obloženih tableta
English: Tel: + 386 (0) 590 848 40
Croatian: Ewopharma d.o.o. Tel: + 386 (0) 590 848 40
English: - 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);
Croatian: - 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);
English: - 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
Croatian: - 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);
English: EU/1/16/1126/003 56 film-coated tablets EU/1/16/1126/004 28 film-coated tablets
Croatian: EU/1/16/1126/003 56 filmom obloženih tableta EU/1/16/1126/004 28 filmom obloženih tableta
English: Co-administration of eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by approximately 5-fold (see sections 4.3 and 4.5).
Croatian: Istodobna primjena eluksadolina s ciklosporinom (inhibitorom OATP1B1) povećala je izloženost eluksadolinu za približno 5 puta
English: Truberzi 100 mg film-coated tablets.
Croatian: Truberzi 100 mg filmom obložene tablete.
English: The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with ‘FX100' on one side.
Croatian: Filmom obložene tablete su modificiranog oblika kapsule, ružičasto-narančaste boje do boje breskve s utisnutom oznakom „FX100“ na jednoj strani.
English: Sphincter of Oddi spasm
Croatian: Spazam Oddijevog sfinktera
English: Truberzi 100 mg film-coated tablets
Croatian: Truberzi 100 mg filmom obložene tablete
English: The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75' on one side.
Croatian: Filmom obložene tablete su modificiranog oblika kapsule, blijedožute do svijetlosmeđe boje s utisnutom oznakom „FX75“ na jednoj strani.
English: EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)
Croatian: EU/1/16/1126/006 168 filmom obloženih tableta (3 pakiranja od 56)
English: EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)
Croatian: EU/1/16/1126/005 168 filmom obloženih tableta (3 pakiranja od 56)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE)75 mg
English: Truberzi 75 mg film-coated tablets.
Croatian: Truberzi 75 mg filmom obložene tablete.
English: 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.
Croatian: 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).
English: Therefore, in this population, the 75 mg dose twice daily can be used.
Croatian: Stoga se u toj populaciji može koristiti doza od 75 mg dvaput na dan (vidjeti dijelove 4.2 i 4.4).
English: - 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).
Croatian: - dihidroergotamin, ergotamin (koriste se za liječenje migrene); - pimozid (koristi se za liječenje psihičkih poremećaja); - kinidin (koristi se za liječenje bolesti srca);
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 100 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI (S PLAVIM OKVIROM - SAMO VIŠESTRUKO PAKIRANJE)100 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA KUTIJI (S PLAVIM OKVIROM - SAMO VIŠESTRUKO PAKIRANJE)75 mg
English: Truberzi 75 mg film-coated tablets
Croatian: Truberzi 75 mg filmom obložene tablete
English: - severe constipation.
Croatian: - teški oblik zatvora.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 100 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA-SAMO VIŠESTRUKO PAKIRANJE)100 mg
English: In rats, there was no effect on mating, fertility and fecundity indices (see section 5.3).
Croatian: plodnost i stope fekunditeta (vidjeti dio 5.3).
English: EXP
Croatian: AST-a
English: Responder rates P values
Croatian: ALT-a povišene vrijednosti
English: - 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
Croatian: - 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;
English: - 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);
Croatian: - ako ste alergični na eluksadolin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako imate, ili ste imali, pankreatitis (upalu gušterače);
English: Severe constipation that can lead to hospitalization has happened after taking Truberzi.
Croatian: Nakon uzimanja lijeka Truberzi bilo je pojava teškog oblika zatvora koji može dovesti do hospitalizacije.
English: 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.
Croatian: 100 mg dvaput na dan tijekom razdoblja od 6 mjeseci u Ispitivanju 2 i brojčano viši nego placebo u Ispitivanju
English: (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: 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).
Croatian: Učinci varijabilnosti funkcije prijenosnika OATP1B1 na razine u plazmi Razine u plazmi u bolesnika s genetskom predispozicijom za slabo funkcioniranje prijenosnika
English: • Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction.
Croatian: • Utvrđena ili suspektna opstrukcija žučnih kanala i/ili gušteračnog voda (npr. žučni kamenci, tumor,
English: Bile acid malabsorption
Croatian: Oštećenje funkcije jetre
English: 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).
Croatian: - vjetrovi; - nadutost; - žgaravica ili povrat kiseline; - osip;
English: Invented name Strength Pharmaceutical Form
Croatian: Zaštićeno ime Doza
English: 10 pre-filled syringes without needle
Croatian: 10 napunjenih štrcaljki bez igle
English: 1 pre-filled syringe with 2 separate needles
Croatian: 1 napunjena štrcaljka s 2 zasebne igle
English: 0.5 ml (10 µg/ml) 1 vial + 1 syringe + 1 needle
Croatian: 0,5 ml (10 µg/ml) 1 bočica + 1 štrcaljka + 1 igla
English: 10 pre-filled syringes with 1 separate needle
Croatian: 10 napunjenih štrcaljki s 1 zasebnom iglom
English: 1 pre-filled syringe with 1 separate needle
Croatian: 1 napunjena štrcaljka s 1 zasebnom iglom
English: 0.5 ml (10 µg/ml) 10 pre-filled syringes with 1
Croatian: 0,5 ml (10 µg/ml) 10 napunjenih štrcaljki s 1 zasebnom iglom
English: 0.5 ml (10 µg/ml) 1 pre-filled syringe without needle
Croatian: 0,5 ml (10 µg/ml) 1 napunjena štrcaljka bez igle
English: 0.5 ml (10 µg/ml) 1 pre-filled syringe with 1 separate needle
Croatian: 0,5 ml (10 µg/ml) 1 napunjena štrcaljka s 2 zasebne igle
English: 20 months.
Croatian: 20 mjeseci.
English: These effects have been seen frequently, and are sometimes severe.
Croatian: Ovi se učinci često vide, a ponekad su vrlo ozbiljni.
English: Paediatric population The experience in children is limited.
Croatian: Pedijatrijska populacija Iskustvo u djece je ograničeno.
English: Three cases were poorly documented and were excluded from the assessment.
Croatian: Tri slučaja su slabo dokumentirana i isključena su iz ocjene.
English: Wait an additional week
Croatian: Pričekati još jedan tjedan
English: * Measured at the end of a 30-minute infusion
Croatian: *Mjereno na kraju 30-minutne infuzije
English: The following information is intended for medical or healthcare professionals only (see section 3):
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima (vidjeti dio 3):
English: The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.
Croatian: Primjena leda na mjesto ekstravazacije tijekom približno 30 minuta može pomoći u ublažavanju lokalne reakcije.
English: Among the seven cases reviewed, the causality was stated as probable in 4 cases and possible in 1 case.
Croatian: Od sedam pregledanih slučajeva, uzročnost je navedena kao vjerojatna u 4 slučaja i moguća u jednom slučaju.
English: Reduce next dose by 25%.
Croatian: Smanjite sljedeću dozu za 25%.
English: The use of gloves is required.
Croatian: Potrebno je koristiti rukavice.
English: Patients and doctors must be aware of this higher incidence and take action as appropriate.
Croatian: Bolesnici i liječnici moraju biti svjesni ove povećane incidencije i prema potrebi poduzeti odgovarajuće korake.
English: not previously reported in clinical trials
Croatian: prethodno nezabilježeni u kliničkim ispitivanjima
English: If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
Croatian: Ako niste sigurni koje ste lijekove primali ili koje ste bolesti imali, razgovarajte o tome sa svojim liječnikom.
English: Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
Croatian: Preporučuje se liječiti bolesnike dva do tri mjeseca kako bi se postigao terapijski odgovor.
English: 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.
Croatian: Doza se ponavlja svaka 2 do 3 tjedna tijekom 2 - 3 mjeseca, a potom onoliko često koliko je potrebno da se održi poboljšano stanje.
English: Caelyx is not recommended in patients below 18 years of age.
Croatian: Caelyx se ne preporučuje u bolesnika mlađih od 18 godina.
English: This leaflet was last approved on
Croatian: Ova uputa je zadnji puta revidirana u
English: However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Croatian: Međutim, reakcija nije bila opasna po život i psi su se brzo oporavili nakon prekida liječenja.
English: Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Croatian: Stoga se Caelyx ne smije primjenjivati za vrijeme trudnoće osim ako ne postoji jasna potreba.
English: Continue treatment as needed to maintain a therapeutic response.
Croatian: Liječenje nastavite kako je potrebno za održavanje terapijskog odgovora.
English: PPE infrequently resulted in permanent treatment discontinuation (3.7%-7.0%).
Croatian: PPE je manje često prouzročio trajni prekid liječenja (3,7% - 7,0%).
English: Grade 4 (requires parenteral or enteral support)
Croatian: 4. stupanj (potrebna parenteralna ili enteralna potpora)
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Croatian: Međutim, skraćenje QRS kompleksa smatra se indikativnijim za srčanu toksičnost.
English: The overall incidence of PPE reported was 44.0%-46.1%.
Croatian: Zabilježena je ukupna incidencija PPE od 44,0% - 46,1%.
English: The frequencies are provided according to the following convention:
Croatian: Učestalosti su prikazane prema slijedećoj konvenciji:
English: < 1/10,000 including isolated reports
Croatian: Vrlo rijetko < 1/10 000 uključujući izolirane prijave
English: It is because of the potential changes in your blood cells that you will have regular blood tests.
Croatian: Zbog mogućih promjena u krvnim stanicama redovito ćete raditi krvne pretrage.
English: Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
Croatian: Ovisno o dozi i indikaciji, infuzija može trajati od 30 minuta do više od jednog sata (npr., 90 minuta).
English: Patients who suffer from these effects must avoid driving and operating machinery.
Croatian: Bolesnici koji pate od ovih simptoma moraju izbjegavati upravljanje vozilima i rad sa strojevima.
English: Other side effects Between infusions, the following may occur:
Croatian: Ostale nuspojave Između infuzija može nastati sljedeće:
English:  1/100 and < 1/10
Croatian:  1/100 i < 1/10
English: In very rare cases, seizures (convulsions) have occurred.
Croatian: U vrlo rijetkim slučajevima uočeni su napadaji (konvulzije).
English: PPE*, alopecia, rash PPE*
Croatian: PPE*, alopecija, osip PPE*
English: These results, though not mature, constituted the protocol defined final analysis.
Croatian: Ovi rezultati, premda nisu konačni, čine završnu analizu određenu planom ispitivanja.
English: The average duration of the most common severe (grade 3/4) events for both groups was 30 days or less.
Croatian: Prosječno trajanje najčešćih teških (stupanj 3/4) promjena u obje skupine bilo je 30 dana ili kraće.
English: The final analysis for overall survival (OS) performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Croatian: Konačna analiza za ukupno preživljenje (OS) napravljena nakon medijana praćenja u trajanju od 8,6 godina nije pokazala značajnu razliku u OS između dviju liječenih skupina.
English: In rare cases, having low white blood cells may lead to severe infection.
Croatian: U rijetkim slučajevima, niski broj bijelih krvnih stanica može dovesti do teške infekcije.
English: Date of first authorisation: 21 June 1996 Date of lastest renewal: 19 May 2006
Croatian: Datum posljednje obnove odobrenja: 19. svibnja 2006.
English: Manufacturer Janssen Pharmaceutica NV
Croatian: Proizvođač Janssen Pharmaceutica NV
English: In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely.
Croatian: U teškim slučajevima, ti učinci mogu ometati svakodnevne aktivnosti, a mogu trajati 4 tjedna ili dulje prije nego što se potpuno povuku.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Fever ≥ 38
Croatian: Vrućica ≥ 38
English: Doses of bortezomib should be at least 72 hours apart.
Croatian: Doze bortezomiba primjenjuju se u razmaku od najmanje 72 sata.
English: In patients experiencing this event, it is generally seen after two or three cycles of treatment.
Croatian: U bolesnica s ovom nuspojavom, ona općenito nastane nakon dva ili tri ciklusa liječenja.
English: The exact mechanism of the antitumour activity of doxorubicin is not known.
Croatian: Točan mehanizam antitumorskog djelovanja doksorubicina nije poznat.
English: Decreased appetite
Croatian: Manje često smanjen apetit
English: Grade 3 PPE was reported in 5% of patients.
Croatian: PPE 3. stupnja bio je uočen u 5% bolesnika.
English: Therefore, any patient treated with doxorubicin should be kept under haematological supervision.
Croatian: Stoga svaki bolesnik koji se liječi doksorubicinom treba biti pod hematološkim nadzorom.
English: If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50%.
Croatian: Ako je bilirubin > 3,0 mg/dl, prva se doza smanjuje za 50%.
English: Pegylated placebo liposomes are neither mutagenic nor genotoxic.
Croatian: Pegilirani placebo liposomi niti su mutageni niti genotoksični.
English: ○C and ANC < 1,000/mm
Croatian: ○C i ANC < 1000/mm
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Fertility The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).
Croatian: Plodnost Učinak doksorubicinklorida na plodnost u ljudi nije procijenjena (vidjeti dio 5.3).
English: Decrease dose by 25%; return to 4 week interval
Croatian: Smanjiti dozu za 25%; povratak na 4tjedni interval
English: However, this reaction can be severe and debilitating in some patients and may require discontinuation of treatment.
Croatian: Međutim, ova reakcija u nekih bolesnika može biti teška i onesposobljavajuća te može zahtijevati prekid liječenja.
English: These effects may occur early on in treatment.
Croatian: Ovi se učinci mogu javiti na početku liječenja.
English: Some of these abnormalities may have been related to the underlying HIV infection and not Caelyx.
Croatian: Neke od ovih abnormalnosti mogu biti povezane s osnovnom infekcijom HIV-om, a ne s Caelyxom.
English: In all patients, infusion-associated reactions occurred primarily during the first infusion.
Croatian: U svih bolesnika reakcije povezane s infuzijom prvenstveno su se pojavile tijekom prve infuzije.
English: Stinging or swelling of the skin at the site of injection may also occur.
Croatian: Mogu se pojaviti i bockanje ili oticanje kože na mjestu injekcije.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Croatian: Planom ispitivanja definirana privremena analiza (na temelju 249 TTP događaja) potaknula je prijevremeni prekid ispitivanja zbog djelotvornosti.
English: 3) and extensive mucocutaneous or visceral disease.
Croatian: 3) i proširenom mukokutanom ili visceralnom bolešću.
English: The risk of low blood counts and infections was similarly low in breast cancer studies.
Croatian: Rizik od niskog broja krvnih stanica i infekcije bio je sličan u ispitivanjima raka dojke.
English: Caelyx should not be used in children and adolescents, because it is not known how the medicine will affect them.
Croatian: Djeca i adolescenti Caelyx se ne smije primjenjivati u djece i adolescenata, jer nije poznato kako će lijek djelovati na njih.
English: The suspension is sterile, translucent and red.
Croatian: Suspenzija je sterilna, prozirna i crvena.
English: Pyridoxine (Vitamin B6): - vitamin B6 is available without prescription; - take 50-150 mg daily beginning at the first signs of redness or tingling.
Croatian: Piridoksin (Vitamin B6): - vitamin B6 izdaje se bez recepta; - uzimajte 50-150 mg na dan čim se pojave prvi znakovi crvenila ili trnci.
English: Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
Croatian: Anemija (smanjen broj crvenih krvnih stanica) može prouzročiti umor, a smanjeni broj krvnih pločica može povećati rizik od krvarenja.
English: Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary.
Croatian: Primjena tih dvaju lijekova može se 4. dan odgoditi do 48 sati, ako je to medicinski opravdano.
English: No dosage adjustments.
Croatian: Nije potrebna prilagodba doze.
English: No clinically significant increases in serum creatinine were reported.
Croatian: Nisu uočena klinički značajna povećanja kreatinina u serumu.
English: The incidence of anaemia was similar in both treatment groups (7% vs. 5%).
Croatian: Incidencija anemije bila je slična u obje skupine (7% naspram 5%).
English: If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Croatian: Ako infuzija peče ili boli dok primate dozu Caelyxa, odmah o tome obavijestite svog liječnika.
English: Although local necrosis following extravasation has been reported very rarely, Caelyx is considered to be an irritant.
Croatian: Premda je lokalna nekroza nakon ekstravazacije bila vrlo rijetka, Caelyx se smatra iritansom.
English: No grade 4 PPE was reported.
Croatian: Nije bilo 4. stupnja PPE.
English: Very common  1/10 Common
Croatian: Vrlo često  1/10 Često
English: Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution.
Croatian: Poboljšanje obično nastupi u roku od jednog do dva tjedna, a u nekim slučajevima može biti potrebno i do 4 tjedna ili dulje do potpunog povlačenja.
English: Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Croatian: Kongestivno zatajenje srca zbog kardiomiopatije može nastupiti iznenada, bez prethodnih promjena u EKG-u, a može se pojaviti i nekoliko tjedana nakon prekida liječenja.