FrancophonIA/ELRC3.0 huggingface dataset:
English: Halaven was also studied in 143 patients with liposarcoma who had previously undergone at least two other treatments, which included an anthracycline.
Croatian: Halaven je također proučavan u 143 bolesnika s liposarkomom koji su prethodno podvrgnuti najmanje dvjema drugim terapijama koje su uključivale antraciklin.
English: Halaven is used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer.
Croatian: Halaven se koristi za liječenje lokalno uznapredovalog ili metastatskog karcinoma dojke koji se nastavio širiti nakon barem jedne prethodne terapije za uznapredovali karcinom.
English: The CHMP noted that, when Halaven was used as a third-line therapy for breast cancer (after at least two previous treatments with cancer medicines for advanced/metastatic disease), it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines.
Croatian: CHMP je zabilježio da kada se Halaven koristi kao terapija treće linije (nakon najmanje dvije prethodne terapije lijekovima protiv karcinoma za uznapredovalu/metastatsku bolest), produljila se duljina bolesnikova života, a sigurnosni mu je profil unutar onoga očekivanog za kemoterapeutike.
English: How has Halaven been studied?
Croatian: Kako je Halaven proučavan?
English: What is Halaven used for?
Croatian: Za što se Halaven koristi?
English: When Halaven was used as breast cancer second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile.
Croatian: Kada se Halaven koristi kao terapija druge linije (nakon najmanje jedne prethodne terapije karcinoma za uznapredovalu/metastatsku bolest), Halaven je vrijedna terapijska mogućnost slična kapecitabinu i s prihvatljivim sigurnosnim profilom.
English: The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) odlučio je da koristi od lijeka Halaven nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za stavljanje na tržište.
English: In the first study, Halaven was compared with other treatments in 762 women with advanced or metastatic breast cancer, who had previously undergone at least two other treatments, which included an anthracycline and a taxane.
Croatian: U prvom je ispitivanju Halaven uspoređen s drugim terapijama u 762 žene s uznapredovalim ili metastatskim karcinomom dojke koje su se prethodno podvrgnule najmanje dvjema terapijama koje su uključivale antraciklin i taksan.
English: What benefit has Halaven shown during the studies?
Croatian: Koje su koristi lijeka Halaven dokazane u ispitivanjima?
English: Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable.
Croatian: Prethodna terapija trebala je uključivati lijekove protiv karcinoma poznatih vrsta poput antraciklina i taksana, osim ako te terapije nisu prikladne. „Metastatski” znači da se karcinom proširio u druge dijelove tijela.
English: How is Halaven used?
Croatian: Kako se Halaven koristi?
English: For the full list of all side effects reported with Halaven, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Halaven potražite u uputi o lijeku.
English: How does Halaven work?
Croatian: Kako djeluje Halaven?
English: Treatment usually lasts for about 3 to 6 months.
Croatian: Liječenje obično traje otprilike 3 do 6 mjeseci.
English: • this is given once every 3 weeks
Croatian: • daje se svaka 3 tjedna
English: The following information is intended for healthcare professionals only: PREPARATION GUIDE
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: VODIČ ZA PRIPREMU
English: This can happen straight away or later on in your treatment.
Croatian: To se može dogoditi odmah ili kasnije tijekom liječenja.
English: The drip will be stopped straight away.
Croatian: Drip će odmah biti zaustavljen.
English: • yellow skin or eyes.
Croatian: • žuta koža ili oči.
English: 4 Less than 500
Croatian: 4 Manje od 500
English: Less than 25,000
Croatian: Manje od 25 000
English: Liquid waste may be flushed with large amounts of water.
Croatian: Tekući otpad može se isprati velikim količinama vode.
English: 4 Requires parenteral or enteral support
Croatian: 4 Zahtijeva parenteralnu ili enteralnu potporu
English: Your doctor will do tests during your treatment to check that the medicine is working properly.
Croatian: Liječnik će provesti pretrage tijekom Vašeg liječenja kako bi se uvjerio da lijek ispravno djeluje.
English: These are signs of an allergic reaction and your drip (infusion) may have to be stopped:
Croatian: To su znakovi alergijske reakcije te će se drip (infuzija) možda morati prekinuti:
English: Not Known: frequency cannot be estimated from the available data:
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: The number of times you have the drip depends on:
Croatian: Broj davanja dripa ovisi o:
English: The use of gloves is required
Croatian: Zahtijeva se uporaba rukavica.
English: • a change in how you walk, speech problems
Croatian: • promjene u načinu hoda, problemi s govorom
English: The doctor may give you a lower dose if they think you need it.
Croatian: Liječnik Vam može sniziti dozu ako smatra da je potrebno.
English: 4.5 Interactions with other medicinal products and other forms of interactions
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: How much you will be given
Croatian: Koliko ćete lijeka dobiti
English: Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Croatian: Vrijeme pripreme: ________________
English: This medicine is normally given by a doctor or nurse.
Croatian: Ovaj lijek obično daje liječnik ili medicinska sestra.
English: It is important you read the entire contents of this guide prior to the preparation of this medicinal product.
Croatian: Važno je pročitati cijeli sadržaj ovog vodiča prije pripravljanja ovog lijeka.
English: This type of medicine is called “chemotherapy”.
Croatian: Ova vrsta lijeka naziva se „kemoterapija“.
English: • reduced levels of certain blood cells - your doctor will regularly check your blood for this and decide if any treatment is required.
Croatian: • smanjenu razinu određenih krvnih stanica - zbog toga će liječnik redovito provjeravati krvnu sliku te odlučiti je li Vam potrebno liječenje.
English: If you feel dizzy or are not sure how you feel, do not drive or use any tools or machines.
Croatian: Ako imate omaglicu ili niste sigurni kako se osjećate, nemojte voziti ili upravljati bilo kakvim alatima ili strojevima.
English: • high blood glucose level (your doctor will see this in a blood test)
Croatian: • visoka razina glukoze u krvi (liječnik će to vidjeti po krvnim testovima)
English: • cyclosporine - for changing your immune system.
Croatian: • ciklosporin - za promjenu imunološkog sustava.
English: They will also look out for any side effects such as blood problems or heart problems.
Croatian: Također će paziti na bilo koju nuspojavu poput problema s krvi ili srcem.
English: • the medicine “cyclophosphamide” is given on the same day.
Croatian: • lijek „ciklofosfamid“ daje se isti dan.
English: Median PFS (months)a
Croatian: Medijan PFS-a (mjeseci)a
English: Haematological as well as other toxicity may require dose reductions or delays.
Croatian: Hematološka kao i druga toksičnost također može zahtijevati smanjenje doze ili odgode.
English: You may get painful, red or dry skin.
Croatian: Koža Vam može postati bolna, crvena ili suha.
English: • Withdraw 1.9 ml of liposomes.
Croatian: • Izvucite 1,9 ml liposoma.
English: These side effects may stop if the drip is given more slowly over a longer period of time.
Croatian: Te nuspojave mogu prestati ako se drip daje sporije tijekom duljeg vremenskog razdoblja.
English: Date of first authorisation: 13 July 2000 Date of latest renewal: 02 July 2010
Croatian: Datum posljednje obnove: 02. srpnja 2010.
English: Patients who suffer from this should avoid driving and operating machinery.
Croatian: Bolesnici kod kojih se pojavi trebaju izbjegavati vožnju i upravljanje strojevima.
English: - Keep this medicine out of the sight and reach of children.
Croatian: - Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: If extravasation occurs, the infusion should be immediately terminated.
Croatian: U slučaju ekstravazacije infuziju treba odmah prekinuti.
English: Standard dose of 60 - 75mg/m2
Croatian: Standardna doza od 60 - 75mg/m2
English: If myelotoxicity delays treatment to greater than 35 days after the first dose of the previous cycle, then consideration should be given to stopping treatment.
Croatian: Ako se zbog mijelotoksičnosti odgodi liječenje za više od 35 dana nakon prve doze prethodnog ciklusa, treba razmotriti prekid liječenja.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Croatian: • Kod slučajnog kontakta s kožom ili očima potrebno je odmah ispirati obilnim količinama vode.
English: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spain
Croatian: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Španjolska
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika te ne bi smjeli biti dulji od 24 sata pri 2
English: • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
Croatian: • Protresite dobro u obrnutom položaju kako biste bili sigurni da je doksorubicin potpuno otopljen.
English: 4.7 Effect on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: palmarno-plantarni sindrom eritrodizestezije
English: Risk Ratio (95% C.I.)
Croatian: Omjer rizika (95% C.I.)
English: Your doctor will work out exactly how much you need.
Croatian: Liječnik će izračunati koliko lijeka trebate.
English: • Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.
Croatian: • Djelatnici koji rukuju ovim lijekom tijekom rekonstitucije trebaju nositi zaštitnu odjeću uključujući maske, zaštitne naočale i rukavice.
English: The medicine is contained inside very small droplets of fat called “liposomes”.
Croatian: Lijek se nalazi unutar vrlo malih kapljica masti zvanih „liposomi“.
English: It is given as a drip (infusion) into a vein.
Croatian: Daje se kao drip (infuzija) u venu.
English: None 2 1000 - Less than 1500 50,000 - Less than 75,000 None 25,000 - Less than 50,000 Wait until ANC 1500 or
Croatian: Nema 2 1000 - manje od 1500 50 000 - manje od 75 000 Nema 25 000 - manje od 50 000 Pričekajte dok ABN ne bude 1500 ili više i/ili trombociti 100 000 ili više, pa onda nastavite liječenje s
English: If possible, Myocet liposomal should be avoided in patients with bilirubin > 50 μmol/l as the recommendation is based mainly on extrapolations.
Croatian: Ako je moguće, Myocet liposomal treba izbjegavati u bolesnika s bilirubinom > 50 μmol/l jer se preporuka temelji uglavnom na ekstrapolaciji.
English: • While heating proceed to step 4.
Croatian: • Dok zagrijavate prijeđite na korak 4.
English: • All items for administration or cleaning, including gloves, should be placed in a high-risk, waste disposal bag for high-temperature incineration.
Croatian: • Sve predmete za primjenu ili čišćenje, uključujući rukavice treba staviti vrećicu za odlaganje visokorizičnog otpada za spaljivanje pri visokim temperaturama.
English: Congestive heart failure due to cardiomyopathy may occur suddenly, and may also be encountered after discontinuation of therapy.
Croatian: Kongestivno zatajenje srca zbog kardiomiopatije može se dogoditi iznenada te čak i nakon prekida terapije.
English: Ice will be put on the affected area for 30 minutes.
Croatian: Na zahvaćeno područje stavlja se led na 30 minuta.
English: • cholesterol
Croatian: • kolesterol
English: • low blood pressure, feeling unwell
Croatian: • niski krvni tlak, loše osjećanje
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: • water for injections
Croatian: • voda za injekciju
English: Then the drip will be started in another vein.
Croatian: Drip se će zatim nastaviti davati u drugu venu.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e.g. calcium antagonists) may increase the risk for cardiotoxicity.
Croatian: Istovremeno liječenje drugim tvarima za koje je prijavljena kardiotoksičnost ili s kardiološki aktivnim tvarima (primjerice, antagonistima kalcija) može povećati rizik od kardiotoksičnosti.
English: The recommended dose is between 60 and 75 mg of the medicine for each square meter of your body:
Croatian: Preporučena doza iznosi između 60 i 75 mg lijeka za svaki kvadratni metar tijela:
English: What Myocet liposomal is and what is it used for
Croatian: Što je Myocet liposomal i za što se koristi
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene u nastavku MedDRA preferiranim terminima prema klasi organskih sustava i učestalosti (učestalosti se definiraju kao: vrlo često ≥1/10, često ≥1/100 i <1/10, manje često ≥ 1/1000 i <1/100, nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • how well your body responds to the medicine.
Croatian: Vaše tijelo reagira na lijek.
English: Doxorubicin and other anthracyclines can cause cardiotoxicity.
Croatian: Doksorubicin i drugi antraciklini mogu uzrokovati kardiotoksičnost.
English: It is used with another medicine called “cyclophosphamide”.
Croatian: Koristi se s drugim lijekom zvanim „ciklofosfamid“.
English: - Store in a refrigerator (2ºC to 8ºC).
Croatian: - Čuvati u hladnjaku (2ºC - 8ºC).
English: Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/free doxorubicin and its influence on the efficacy/safety of Myocet liposomal.
Croatian: Dostupni farmakokinetički podaci isključuju zaključke u vezi odnosa između plazmatskih razina ukupnog/slobodnog doksorubicina i njegovog utjecaja na djelotvornost/sigurnost lijeka Myocet liposomal.
English: If you have already had radiation therapy, this may react with Myocet liposomal.
Croatian: Ako ste već imali terapiju zračenjem, postoji mogućnost reakcije s lijekom Myocet liposomal.
English: If LVEF has decreased substantially from baseline e.g. by > 20 points to a final value > 50% or by > 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage.
Croatian: Ako se LVEF znatno smanji s početne vrijednosti, primjerice za > 20 točaka na konačnu vrijednost > 50% ili za > 10 točaka na konačnu vrijednost od < 50%, dobrobit od nastavka liječenja treba pažljivo vrednovati naspram rizika od nastanka neizlječivih oštećenja srca.
English: Verify the temperature set point by checking the thermometer.
Croatian: Postavljenu temperaturnu točku provjerite na termometru.
English: Content of the pack and other information What Myocet liposomal contains
Croatian: Sadržaj pakiranja i druge informacije Što Myocet liposomal sadrži
English: To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Croatian: Da biste se pobrinuli za ispravnu kontrolu temperature preporučuje se uporaba termometra od 35 mm za uranjanje.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu pogoditi više od jedne na 10 osoba)
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Croatian: PRIPREMA ZA INTRAVENSKU PRIMJENU
English: However, doxorubicin may potentiate the toxicity of other antineoplastic agents.
Croatian: No, doksorubicin može uvećati toksičnost drugih antineoplastičnih lijekova.
English: • Pregnant staff should be excluded from handling the medicinal product.
Croatian: • Trudne djelatnice treba isključiti iz rukovanja lijekom.
English: • Myocet liposomal should not be used during pregnancy unless clearly necessary.
Croatian: • Myocet liposomal ne smijete koristiti tijekom trudnoće osim ako je to prijeko potrebno.
English: • loss of appetite, diarrhoea, feeling or being sick (nausea or vomiting)
Croatian: • gubitak apetita, proljev, osjećaj mučnine (mučnina ili povraćanje)
English: • headache or back pain
Croatian: • glavobolja ili bol u leđima
English: Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Croatian: Liječenje akutnog predoziranja treba se usmjeriti na potpornu skrb za očekivanu toksičnost te može uključivati hospitalizaciju, antibiotike, transfuzije trombocita i granulocita i simptomatsko liječenje mukozitisa.
English: The risk of toxicity rises with increasing cumulative doses of those medicinal products and is higher in individuals with a history of cardiomyopathy, or mediastinal irradiation or pre-existing cardiac disease.
Croatian: Rizik od toksičnosti raste s porastom kumulativnih doza ovih lijekova te je viši u osoba s anamnezom kardiomiopatije ili ozračivanjem sredoprsja ili već postojećom srčanom bolesti.
English: Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet liposomal should not be used during pregnancy unless clearly necessary.
Croatian: Zbog poznatih citotoksičnih, mutagenih i embriotoksičnih svojstava doksorubicina, Myocet liposomal se ne smije koristiti tijekom trudnoće osim ako je to prijeko potrebno.
English: All patients receiving Myocet liposomal should also routinely undergo ECG monitoring.
Croatian: Svi bolesnici koji primaju Myocet liposomal trebaju se rutinski podvrgnuti EKG nadzoru.
English: οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Croatian: οC, osim ako se rekonstitucija i razrjeđivanje provode u kontroliranim i validiranim aseptičkim uvjetima.
English: Thus, caution should be exercised in patients with impaired cardiac function.
Croatian: Stoga je potreban oprez u bolesnika s oštećenjem srčane funkcije.
English: • itchy, dry skin or swollen areas around hair roots
Croatian: • svrbljiva, suha koža ili natečena područja oko korijena kose
English: This is because Myocet liposomal can damage your skin.
Croatian: To je zato jer Myocet liposomal može oštetiti kožu.
English: Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
Croatian: Dokazano je da tvari koje inhibiraju P-glikoprotein (P-Gp) mijenjaju raspodjelu doksorubicina i doksorubicinola (vidjeti također dio 4.5).
English: Three inserts, each with two 43.7mm openings per insert must be used.
Croatian: Potrebno je koristiti tri uloška, svaki s dva otvora od 43,7 mm po umetku.
English: • phenobarbital or phenytoin - for epilepsy
Croatian: • fenobarbital ili fenitoin - za liječenje epilepsije
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Tell your doctor or nurse straight away if any medicine leaks from the drip (infusion) onto your skin.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako lijek curi iz dripa (infuzije) na Vašu kožu.
English: Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet liposomal is reduced in accordance with the following table
Croatian: Na temelju ograničenih podataka u bolesnika s metastazama na jetri preporučuje se smanjenje početne doze lijeka Myocet liposomal u skladu sa sljedećom tablicom
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before having Myocet liposomal.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, pitajte svog liječnika ili medicinsku sestru za savjet prije nego uzmete ovaj lijek.
English: Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet liposomal in this population was comparable to that observed in patients less than 65 years old.
Croatian: Podaci iz randomiziranih kontroliranih kliničkih ispitivanja pokazuju da je djelotvornost lijeka Myocet liposomal i njegova sigurnost za srce u ovoj populaciji usporediva s onom primijećenom u bolesnika mlađih od 65 godina.
English: In the clinical program, there were nine cases of accidental extravasation of Myocet liposomal, none of which were associated with severe skin damage, ulceration or necrosis.
Croatian: U kliničkom programu bilo je devet slučajeva slučajne ekstravazacije od kojih nijedan nije bio povezan s teškim oštećenjem kože,
English: Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C - 8
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni nakon rekonstitucije je do 8 sati pri temperaturi od 25°C te do 5 dana na temperaturi od 2°C - 8
English: (Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55°C-60°C)).
Croatian: (Molimo imajte na umu da dok su kontrolne postavke vodene kupelji i bloka za grijanje podešene na različite razine, temperature sadržaja bočice u istom su rasponu (55°C-60°C)).
English: What Myocet liposomal looks like and contents of the pack
Croatian: Kako Myocet liposomal izgleda i sadržaj pakiranja
English: This is because Myocet liposomal can affect the way some other medicines work.
Croatian: To je zato jer Myocet liposomal može utjecati na djelovanje drugih lijekova.
English: The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet liposomal shows a high degree of inter-patient variability.
Croatian: Plazmatska farmakokinetika za ukupni doksorubicin u bolesnika koji primaju Myocet liposomal pokazuje visoki stupanj varijabilnosti između bolesnika.
English: • the stage of your breast cancer
Croatian: • stadiju Vašeg karcinoma dojke
English: In particular tell your doctor or nurse if you are taking any of the following medicines:
Croatian: Posebice recite svom liječniku ili medicinskoj sestri ako uzimate bilo koji od sljedećih lijekova: