FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Abraxane.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za korištenje lijeka Abraxane.
English: Around half of the patients in the study had already received treatments for their cancer after it had become metastatic.
Croatian: Oko polovice bolesnica u studiji već se liječilo od te vrste raka prije nego što je metastazirao.
English: Therefore, the company withdrew its application for the use of Abraxane as firstline treatment during the assessment of the medicine.
Croatian: Stoga je tvrtka povukla svoj zahtjev za primjenu lijeka Abraxane u primarnoj terapiji tijekom procjene lijeka.
English: What measures are being taken to ensure the safe and effective use of Abraxane?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Abraxane?
English: When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival.
Croatian: Kod analize samo onih bolesnika koji su primili prvu terapiju za metastatski rak dojke, nije bilo razlika između lijekova u smislu mjera djelotvornosti u pogledu vremena u kojem se bolest pogoršala, i preživljenja.
English: Other information about Abraxane
Croatian: Ostale informacije o lijeku Abraxane
English: Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Croatian: Paklitaksel blokira stadij podjele stanice, pri čemu se unutarnji "kostur" stanice onesposobi, što omogućava podjelu stanice.
English: Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Croatian: Abraxane također djeluje na stanice koje nisu stanice raka, poput stanica krvi i živaca, što može izazvati nuspojave.
English: By keeping this structure intact the cells cannot divide and they eventually die.
Croatian: Održavanjem takve strukture stanice nepromijenjenom, stanice se ne mogu dijeliti te s vremenom odumru.
English: Patients survived for around 8.5 months on treatment with the combination of Abraxane and gemcitabine, compared with 6.7 months on gemcitabine alone.
Croatian: Bolesnici su preživjeli oko 8,5 mjeseci na terapiji s kombinacijom lijeka Abraxane i gemcitabin u usporedbi s 6,7 mjeseci na terapiji samo gemcitabinom.
English: For more information about treatment with Abraxane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Abraxane pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The main measure of effectiveness was the percentage of patients who responded to treatment.
Croatian: Osnovna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na liječenje.
English: Why has Abraxane been approved?
Croatian: Zašto je Abraxane odobren?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abraxane, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Abraxane nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In non-small cell lung cancer, 33% of patients receiving Abraxane and carboplatin responded to treatment compared with 25% of those receiving conventional paclitaxel and carboplatin.
Croatian: Kod raka nemalih stanica pluća, 33% bolesnika koji su primili Abraxane i karboplatin odgovorilo je na liječenje u usporedbi s 25% bolesnika koji su primili konvencionalni paklitaksel i karboplatin.
English: Abraxane is a powder that is made up into a suspension for infusion (drip) into a vein.
Croatian: Abraxane je prašak od kojeg se radi otopina za infuziju (drip u venu).
English: What is Abraxane?
Croatian: Što je Abraxane?
English: • metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine.
Croatian: • metastatskog adenokarcinoma gušterače kao prva terapija u kombinaciji s drugim lijekom protiv raka, gemcitabinom;
English: The main measure of effectiveness was how long patients lived.
Croatian: Osnovna mjera djelotvornosti bio je životni vijek bolesnika.
English: For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around three-quarters of whom had received an anthracycline in the past.
Croatian: Kod metastatskog raka dojke, Abraxane je ispitivan u jednom glavnom ispitivanju koje je uključivalo 460 žena, od kojih je oko tri četvrtine prethodno primilo antraciklin.
English: In non-small cell lung cancer, treatment is carried out in 3-week cycles with Abraxane given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Abraxane.
Croatian: Kod raka nemalih stanica pluća, terapija se provodi u ciklusima od tri tjedna, tako što se Abraxane primjenjuje 1., 8. i 15. dana svakog ciklusa, a karboplatin se primjenjuje na dan neposredno nakon primjene lijeka Abraxane.
English: What is the risk associated with Abraxane?
Croatian: Koji su rizici povezani s lijekom Abraxane?
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Croatian: • raka nemalih stanica pluća, kao prva terapija u kombinaciji s lijekom protiv raka karboplatinom kad bolesnik ne može na operaciju niti na radioterapiju.
English: Immediately after giving Abraxane gemcitabine should be given at a dose of 1000 mg per square metre of body surface area.
Croatian: Odmah nakon primjene lijeka Abraxane, mora se primijeniti gemcitabin u dozi od 1000 mg po kvadratnom metru tjelesne površine.
English: The Committee decided that Abraxane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Abraxane nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: In metastatic breast cancer, Abraxane was more effective than conventional paclitaxel-containing medicines.
Croatian: Kod metastatskog rak dojke, Abraxane je bio djelotvorniji od konvencionalnih lijekova koji sadrže paklitaksel.
English: The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients with metastatic breast cancer whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, patients to be treated with Abraxane do not need pre-treatment with other medicines to prevent hypersensitivity reactions.
Croatian: CHMP je utvrdio da je Abraxane djelotvorniji od konvencionalnih lijekova koji sadrže paklitaksel kod bolesnika s metastatskim rakom dojke, kod kojih prva terapija više nije bila djelotvorna, te da za razliku od drugih lijekova koji sadrže paklitaksel, bolesnicima na terapiji lijekom Abraxane nije potrebna predterapija drugim lijekovima za sprječavanje reakcija preosjetljivosti.
English: It contains the active substance paclitaxel attached to a human protein called albumin.
Croatian: Sadrži aktivnu tvar paklitaksel vezanu za ljudsku bjelančevinu naziva albumin.
English: A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Abraxane.
English: Abraxane must not be used in patients who are breast-feeding or who have low levels of neutrophils in the blood before starting treatment.
Croatian: Abraxane se ne smije davati bolesnicama koje doje niti bolesnicima s niskim razinama neutrofila u krvi prije početka terapije.
English: For non-small cell lung cancer, the Abraxane-carboplatin combination was compared with a combination of a conventional paclitaxel-containing medicine and carboplatin in 1,052 patients.
Croatian: Kod raka nemalih stanica pluća, kombinacija Abraxane-karboplatin uspoređena je s kombinacijom konvencionalnog lijeka koji sadrži paklitaksel i karboplatin u 1 052 bolesnika.
English: Abraxane should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Croatian: Abraxane se može primijeniti samo uz nadzor liječnika specijaliste za rak, u specijaliziranim jedinicama za primjenu citotoksičnih lijekova (lijekova kojima se ubija stanice).
English: In Abraxane, unlike conventional paclitaxel-containing medicines, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Croatian: Za razliku od konvencionalnih lijekova koji sadrže paklitaksel, u Abraxaneu se paklitaksel veže na ljudsku bjelančevinu naziva albumin u sitnim česticama koje se zovu nanočestice.
English: The active substance in Abraxane, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Croatian: Djelatna tvar lijeka Abraxane, paklitaksel, spada u skupinu lijekova protiv raka pod nazivom "taksani".
English: • metastatic breast cancer, when the first treatment has stopped working and standard treatment including an ‘anthracycline' (another type of cancer medicine) is not suitable.
Croatian: • metastatskog raka dojke kad prva terapija više nije djelotvorna, a standardna terapija koja uključuje "antraciklin" (drugi lijek protiv raka) nije dostupna.
English: For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone.
Croatian: Kod metastatskog adenokarcinoma gušterače, Abraxane je ispitivan u jednom glavnom ispitivanju koje je uključivalo 861 bolesnika, koji su primili ili Abraxane u kombinaciji s gemcitabinom ili samo gemcitabin.
English: In metastatic breast cancer Abraxane is given on its own every three weeks.
Croatian: Kod metastatskog raka dojke, Abraxane se primjenjuje sam svaka tri tjedna.
English: In addition, Abraxane given in combination with gemcitabine was shown to improve survival in patients with metastatic adenocarcinoma of the pancreas compared with treatment with gemcitabine alone and was effective in combination with carboplatin in the treatment non-small cell lung cancer.
Croatian: Nadalje, Abraxane primijenjen u kombinaciji s gemcitabinom pokazao je djelotvornost u boljem preživljenju bolesnika s metastatskim adenokarcinomom gušterače u usporedbi s terapijom samo gemcitabinom, te je bio djelotvoran u kombinaciji s karboplatinom u liječenju raka nemalih stanica pluća.
English: Overall, in the main study, 31% of the women receiving Abraxane responded to treatment (72 out of 229), compared with 16% of the women receiving conventional paclitaxel-containing medicines (37 out of 225).
Croatian: (72 od 229), u usporedbi sa 16% žena koje su primile konvencionalne lijekove koji sadrže paklitaksel (37 od 225).
English: This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Croatian: To omogućava laganu pripremu otopine paklitaksela, koju se infuzijom unosi u venu.
English: For additional information, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: In metastatic adenocarcinoma of the pancreas, Abraxane was shown to improve overall survival.
Croatian: Kod metastatskog adenokarcinoma gušterače, Abraxane je pozitivno djelovao na opće poboljšanje preživljenja.
English: The recommended dose of Abraxane is 100 mg per square metre of body surface area.
Croatian: Preporučena doza lijeka Abraxane je 1000 mg po kvadratnom metru tjelesne površine.
English: In metastatic adenocarcinoma of the pancreas Abraxane is given in 4-week treatment cycles.
Croatian: Kod metastatskog adenokarcinoma gušterače Abraxane se primjenjuje u terapijskim ciklusima od četiri tjedna.
English: In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before.
Croatian: Međutim, Abraxane se pokazao djelotvornijim od konvencionalnih lijekova koji sadrže paklitaksel u bolesnika koji su prethodno primili terapiju za metastatski rak dojke.
English: What is Abraxane used for?
Croatian: Za što se Abraxane koristi?
English: Abraxane given on its own was compared with a conventional paclitaxel-containing medicine given together with other medicines to reduce side effects.
Croatian: Abraxane koji je bio primijenjen sam uspoređen je s konvencionalnim lijekom koji sadrži paklitaksel, primjenjivan zajedno s drugim lijekovima za ublažavanje nuspojava.
English: What benefit has Abraxane shown during the studies?
Croatian: Koje su koristi lijeka Abraxane utvrđene u ispitivanjima?
English: How is Abraxane used?
Croatian: Kako se Abraxane koristi?
English: Abraxane paclitaxel
Croatian: Abraxane paklitaksel
English: How does Abraxane work?
Croatian: Kako djeluje Abraxane?
English: For the full list of restrictions with Abraxane, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Abraxane potražite u uputi o lijeku.
English: How has Abraxane been studied?
Croatian: Kako je Abraxane ispitivan?
English: For the full list of all side effects reported with Abraxane, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Abraxane potražite u uputi o lijeku.
English: Treatment may be repeated for up to five consecutive days.
Croatian: Liječenje se može ponavljati do pet uzastopnih dana.
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Croatian: DATUM REVIZIJE TEKSTA <{MM/GGGG}>
English: No data have been presented on overdoses in adult cats.
Croatian: Nema podataka o predoziranju kod odraslih mačaka.
English: ATCvet code: QA04AD90
Croatian: ATCvet kod: QA04AD90
English: Maropitant is effective against vomiting.
Croatian: Maropitant je učinkovit protiv povraćanja.
English: For administration by subcutaneous injection, see also “special precautions for use in animals” (section 4.5).
Croatian: Za primjenu supkutanom injekcijom, vidjeti također „Posebne mjere opreza prilikom primjene na životinjama” (dio 4.5).
English: C. STATEMENT OF THE MRLs Not applicable.
Croatian: IZVJEŠĆE O MRL-u Nije primjenjivo.
English: Wash hands after use.
Croatian: Nakon primjene potrebno je oprati ruke.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi VMP-a ili smatrate da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: Excipients: Benzyl alcohol (E1519)
Croatian: Pomoćne tvari: benzilni alkohol (E1519)
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antiemetics.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: Antiemetici.
English: Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Croatian: Iako se maropitant pokazao učinkovitim za liječenje i sprječavanje povraćanja prouzročenog kemoterapijom, ustanovljeno je da je djelotvorniji ako se daje preventivno.
English: 11.1 mg For the full list of excipients, see section 6.1.
Croatian: 11,1 mg Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Croatian: Centar se sastoji od nekoliko jezgri moždanog stabla (area postrema, nucleus tractus solitarius, dorzalna motorička jezgra vagusa) koje primaju i integriraju osjetne podražaje iz centralnih i perifernih izvora te kemijske podražaje iz cirkulacije i cerebrospinalne tekućine.
English: Vomiting is a complex process coordinated centrally by the emetic centre.
Croatian: Povraćanje je složen proces, centralno koordiniran iz centra za povraćanje.
English: Signs of nausea in dogs including excessive salivation and lethargy might remain after treatment.
Croatian: Znakovi mučnine u pasa, uključujući pojačano slinjenje i letargiju, mogu se nastaviti i poslije liječenja.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Croatian: U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima u istoj štrcaljki.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label of the vial after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi bočice poslije EXP.
English: • For the treatment of vomiting, in combination with other supportive measures.
Croatian: • Za liječenje povraćanja u kombinaciji s drugim pomoćnim mjerama.
English: During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Croatian: Tijekom kliničkih ispitivanja razine maropitanta u plazmi postigle su djelotvornost 1 sat nakon primjene.
English: For subcutaneous or intravenous use in dogs and cats.
Croatian: Za supkutanu ili intravensku primjenu u pasa i mačaka.
English: In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
Croatian: U vrlo rijetkim slučajevima mogu se javiti reakcije anafilaktičkog tipa (alergijski edem, urtikarija, eritem, kolaps, dispneja, blijede mukozne sluznice).
English: Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver.
Croatian: Maropitant podliježe metabolizmu citokroma P450 (CYP) u jetri.
English: Amber glass type I vial closed with a coated bromobutyl rubber stopper and aluminium cap in a cardboard box.
Croatian: Bočica od smeđeg stakla tip I, zatvorena prevučenim čepom od brombutilne gume i aluminijskom kapicom u kartonskoj kutiji.
English: Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Croatian: Primijeniti samo nakon što nadležni veterinar provede procjenu koristi i rizika, s obzirom da ispitivanja reproduktivne toksičnosti nisu provedena kod nijedne životinjske vrste.
English: Pack sizes of 1 vial of 10 ml, 20 ml, 25 ml or 50 ml.
Croatian: Veličine pakiranja od 1 bočice, od: 10 ml, 20 ml, 25 ml ili 50 ml.
English: Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Croatian: Dobra veterinarska praksa pokazuje da antiemetike treba koristiti zajedno s drugim veterinarskim i pomoćnim mjerama, kao što su dijetna prehrana i nadoknada izgubljene tekućine dok se djeluje na osnovni uzrok povraćanja.
English: Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
Croatian: Prevomax se ne smije miješati s drugim veterinarsko-medicinskim proizvodima u istoj štrcaljki jer kompatibilnost s drugim proizvodima nije ispitana.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: Comment: Given the small vial size(s), would it not be preferable to replace these by “SC, IV"
Croatian: Napomena: S obzirom na veličine bočica, bolje je zamijeniti oznakama “s.c., i.v."
English: Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent.
Croatian: Stoga se preporučuje davanje veterinarsko-medicinskog proizvoda prije davanja kemoterapeutika.
English: Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Croatian: Maropitant je antagonist receptora neurokinina 1 (NK1) koji djeluje inhibicijom vezivanja tvari P, neuropeptida iz obitelji tahikinina.
English: • For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.
Croatian: • Za sprječavanje mučnine i povraćanja u perioperativnom razdoblju te poboljšanje u oporavku od opće anestezije nakon primjene, agonista μ-opijatnih receptora morfina.
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja, odmah potražite savjet liječnika i pokažite mu uputu o VMP-u ili etiketu.
English: The anti-emetic efficacy of maropitant against central and peripheral emetics was demonstrated in experimental studies including apomorphine, cisplatin and syrup of ipecac (dogs) and xylazine (cats).
Croatian: Antiemetička djelotvornost maropitanta protiv centralnih i perifernih emetika dokazana je u eksperimentalnim ispitivanjima koja su uključivala apomorfin, cisplatin i sirup ipekakuane (psi) te ksilazin (mačke).
English: Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting.
Croatian: Tvar P se u značajnim koncentracijama nalazi u jezgrama koje obuhvaćaju centar za povraćanje i smatra se ključnim neurotransmiterom uključenim u čin povraćanja.
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Croatian: Proizvođač odgovoran za puštanje serije u promet: Produlab Pharma B.V.
English: Betadex sulfobutyl ether sodium Benzyl alcohol (E1519) Citric acid, anhydrous Sodium hydroxide Water for injections
Croatian: Popis pomoćnih tvari natrijev sulfobutileter betadeks benzilni alkohol (E1519) limunska kiselina, bezvodna natrijev hidroksid voda za injekcije
English: The duration of effect is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.
Croatian: Trajanje učinka iznosi približno 24 sata pa se stoga može primijeniti noć prije primjene tvari koja može prouzročiti povraćanje, npr. kemoterapija.
English: 11.1 mg A clear, colourless to light yellow solution.
Croatian: 11,1 mg Bistra, bezbojna do svijetložuta otopina.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
English: 4.7 Use during pregnancy, lactation or lay
Croatian: Primjena tijekom graviditeta, laktacije ili nesenja
English: EXP Once broached use within 56 days.
Croatian: EXP Jednom otvorenu treba upotrijebiti unutar 56 dana.
English: Injecting the product at refrigerated temperature may reduce pain at injection.
Croatian: Injektiranje rashlađenog proizvoda može smanjiti bol prilikom aplikacije.
English: Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Croatian: Povraćanje može biti povezano s ozbiljnim, teškim iscrpljujućim stanjima, uključujući gastrointestinalne zastoje (smetnje) i stoga je potrebno provesti ciljane dijagnostičke pretrage.