FrancophonIA/ELRC3.0 huggingface dataset:
English: An overview of Afinitor and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Afinitor i zašto je odobren u EU-u
English: How does Afinitor work?
Croatian: Kako djeluje Afinitor?
English: Afinitor is used together with a medicine called exemestane after other treatments called ‘nonsteroidal aromatase inhibitors' have not worked;
Croatian: Lijek Afinitor primjenjuje se zajedno s lijekom eksemestanom nakon što se pokaže da druge terapije koje se nazivaju „nesteroidni inhibitori aromataze” nisu bile uspješne;
English: For more information about using Afinitor, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Afinitor pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Afinitor contains the active substance everolimus.
Croatian: Lijek Afinitor sadrži djelatnu tvar everolimus.
English: • neuroendocrine tumours originating in the lungs or gut, when the cancer cells are welldifferentiated and the cancer is metastatic or cannot be removed by surgery.
Croatian: • neuroendokrinih tumora koji su nastali u plućima ili crijevima, ako su stanice raka dobro diferencirane i ako je rak metastazirao ili se ne može kirurški ukloniti.
English: Pancreatic neuroendocrine tumours
Croatian: Neuroendokrini tumori gušterače
English: The Agency also concluded that the 7-month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was valuable, despite the known side effects of Afinitor.
Croatian: Agencija je isto tako zaključila da se odgađanje progresije bolesti za sedam mjeseci u bolesnika s neuroendokrinim tumorima koji su nastali u plućima ili crijevima može smatrati vrijednim, unatoč poznatim nuspojavama lijeka Afinitor.
English: What benefits of Afinitor have been shown in studies?
Croatian: Koje su koristi od lijeka Afinitor utvrđene u ispitivanjima?
English: Afinitor is used in breast cancer that is ‘hormone receptor-positive' (when the cancer cells have oestrogen receptors on their surface) and ‘HER2/neu negative' (when the cancer cells do not contain high levels of the HER2/neu [human epidermal growth factor receptor-2] protein).
Croatian: Lijek Afinitor primjenjuje se u liječenju raka dojke koji je „pozitivan na hormonski receptor” (kada stanice raka na površini imaju receptore estrogena) i „negativan na protein HER2/neu” (kada stanice raka ne sadrže visoku razinu proteina HER2/neu (receptora 2 ljudskog epidermalnog čimbenika rasta)).
English: • advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a ‘VEGF-targeted' medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).
Croatian: • uznapredovalog karcinoma bubrežnih stanica (raka bubrega) ako se rak pogoršao unatoč terapiji „VEGF-ciljanim” lijekom (vrsta lijeka koja blokira učinke protein ȃ vaskularnog endote čimbenika rasta).
English: Afinitor was studied in 416 patients with advanced renal cell carcinoma that had got worse despite treatment with VEGF-targeted medicines (sunitinib, sorafenib or both).
Croatian: Lijek Afinitor ispitivan je na 416 bolesnika s uznapredovalim karcinomom bubrežnih stanica koji se pogoršao unatoč terapiji VEGF-ciljanim lijekovima (sunitinib, sorafenib ili oboje).
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells).
Croatian: • neuroendokrinih tumora gušterače (tumora stanica koje proizvode hormone u gušterači) ako su stanice raka dobro ili umjereno diferencirane (što znači da ih se može razlikovati od uobičajenih stanica gušterače).
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply.
Croatian: Taj kompleks zatim onemogućuje djelovanje enzima mTOR. Budući da mTOR sudjeluje u kontroli diobe stanica i rastu krvnih žila, lijek Afinitor sprječava diobu stanica raka i smanjuje njihovu opskrbljenost krvlju.
English: Afinitor slowed down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma and hormone-receptorpositive advanced breast cancer.
Croatian: Lijek Afinitor usporio je progresiju bolesti u bolesnika s uznapredovalim endokrinim tumorima nastalima u gušterači, uznapredovalim karcinomom bubrežnih stanica i uznapredovalim rakom dojke pozitivnim na hormonski receptor.
English: A study in 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin compared Afinitor with placebo.
Croatian: U ispitivanju provedenom na 410 bolesnika s dobro ili umjereno diferenciranim neuroendokrinim tumorima koji su nastali u gušterači uspoređeni su lijek Afinitor i placebo.
English: Neuroendocrine tumours originating in the lung or gut
Croatian: Neuroendokrini tumori nastali u plućima ili crijevima
English: Patients who received Afinitor and best supportive treatments lived for an average of 11 months without the disease getting worse compared with around 4 months for patients who received placebo and best supportive treatments to relieve disease symptoms.
Croatian: Bolesnici koji su primili lijek Afinitor i najbolje potporne terapije živjeli su u prosjeku 11 mjeseci bez pogoršanja bolesti u usporedbi s otprilike 4 mjeseca za bolesnike koji su primali placebo i najbolje potporne terapije u svrhu ublažavanja simptoma bolesti.
English: Afinitor in combination with exemestane has been studied in 724 patients with hormone receptorpositive and HER2/neu-negative advanced breast cancer which had got worse after treatment with letrozole and anastrazole (non-steroidal aromatase inhibitors).
Croatian: Provedeno je ispitivanje lijeka Afinitor u kombinaciji s eksemestanom na 724 bolesnica s uznapredovalim rakom dojke pozitivnim na hormonski receptor i negativnim na protein HER2/neu, rakom dojke koji se pogoršao nakon liječenja letrozolom i anastrazolom (nesteroidnim inhibitorima aromataze).
English: Afinitor was studied in 302 patients with advanced neuroendocrine tumours of lung or gut origin.
Croatian: Lijek Afinitor ispitivan je na 302 bolesnika s uznapredovalim neuroendokrinim tumorima nastalima u plućima ili crijevima.
English: The active substance in Afinitor, everolimus, blocks an enzyme called ‘mammalian target of rapamycin' (mTOR).
Croatian: Djelatna tvar lijeka Afinitor, everolimus, lijek je protiv raka koji inhibira djelovanje enzima koji se naziva „ciljna molekula rapamicina u sisavaca” (mTOR).
English: Patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo (a dummy treatment).
Croatian: Bolesnice koji su uzimali lijek Afinitor živjele su u prosjeku 7,8 mjeseci bez pogoršanja bolesti, u usporedbi s 3,2 mjeseca za bolesnice koje su uzimale placebo (prividno liječenje).
English: Patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.
Croatian: Bolesnici koji su uzimali lijek Afinitor živjeli su u prosjeku 4,9 mjeseci bez pogoršanja bolesti, u usporedbi s 1,9 mjeseci za bolesnike koji su uzimali placebo.
English: For the full list of side effects of Afinitor, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Afinitor potražite u uputi o lijeku.
English: Patients who took Afinitor lived for an average of 11.0 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
Croatian: Bolesnici koji su uzimali lijek Afinitor živjeli su u prosjeku 11,0 mjeseci bez pogoršanja bolesti, u usporedbi s 4,6 mjeseci za bolesnike koji su uzimali placebo.
English: 400 mg / 100 mg Film-coated tablet
Croatian: 400 mg/100 mg Filmom obložena tableta
English: Oral use bottle (HDPE)
Croatian: Kroz usta bočica (HDPE)
English: MA (EU) Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: Treatment should not exceed 4 months.
Croatian: Liječenje ne smije biti dulje od 4 mjeseca.
English: Italy, Portugal : Targosid
Croatian: Italija, Portugal: Targosid
English: After the fourth day of treatment:
Croatian: Nakon četvrtog dana liječenja:
English: Targocid is an antibiotic.
Croatian: Targocid je antibiotik.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Luxemburg, Malta, Netherlands, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Targocid
Croatian: Austrija, Belgija, Bugarska, Češka Republika, Danska, Francuska, Njemačka, Grčka, Mađarska, Irska, Luksemburg, Malta, Nizozemska, Poljska, Rumunjska, Slovačka Republika, Slovenija, Španjolska, Švedska, Velika Britanija: Targocid
English: This is more likely if:
Croatian: Vjerojatnost za to je veća:
English: No specific interaction studies have been performed.
Croatian: Nisu provedena posebna ispitivanja interakcija.
English: • Elderly patients:
Croatian: • Stariji bolesnici:
English: The following information is intended for medical or healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima:
English: The duration of treatment should be decided based on the clinical response.
Croatian: Odluku o trajanju liječenja treba donijeti na temelju kliničkog odgovora.
English: a No current data were available when the tables were published.
Croatian: Trenutni podaci nisu bili dostupni u vrijeme objavljivanja ovih tablica.
English: Other medicines and Targocid
Croatian: Drugi lijekovi i Targocid
English: • hearing loss, ringing in the ears or a feeling that you, or things around you are moving
Croatian: • gubitak sluha, zvonjava u ušima ili osjećaj da se pomičete Vi ili predmeti oko Vas
English: • your treatment will last for a long time
Croatian: • ako Vaše liječenje bude dugotrajno
English: Your doctor or nurse will have instructions about when to give you Targocid.
Croatian: Vaš liječnik ili medicinska sestra će imati upute o tome kada Vam trebaju dati Targocid.
English: Paediatric population The dose recommendations are the same in adults and children above 12 years of age.
Croatian: Pedijatrijska populacija Preporučene doze jednake su za odrasle i djecu stariju od 12 godina.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Croatian: Smanjenje brzine ili prekid primjene infuzije može dovesti do povlačenja tih reakcija.
English: If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment:
Croatian: Ako imate problema s bubrezima, obično će trebati smanjiti dozu nakon četvrtog dana liječenja:
English: The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 3.1, February 11, 2013 are displayed in the following table:
Croatian: European Committee on Antimicrobial Susceptibility Testing, EUCAST), verzija 3.1 od 11. veljače 2013., prikazane su u sljedećoj tablici:
English: For infective endocarditis a minimum of 21 days is usually considered appropriate.
Croatian: Za infektivni endokarditis prikladnim se obično smatra liječenje u trajanju od najmanje 21 dana.
English: Spectrum of antibacterial activity
Croatian: Spektar antibakterijskog djelovanja
English: • you are allergic to an antibiotic called ‘vancomycin'
Croatian: • ako ste alergični na antibiotik koji se zove „vankomicin“
English: Targeted trough concentrations at day 3 to 5
Croatian: Ciljne najniže koncentracije od 3. do 5. dana
English: If the solution does become foamy, then it should be left to stand for about 15 minutes.
Croatian: Ako se otopina zapjeni, treba je ostaviti da odstoji približno 15 minuta.
English: Practical information for healthcare professionals on preparation and handling of Targocid.
Croatian: Praktične informacije za zdravstvene djelatnike o pripremi i rukovanju lijekom Targocid.
English: <Detailed information on this medicinal product is available on the website of {name of MS/Agency}>
Croatian: <Detaljnije informacije o ovom lijeku dostupne su na internet stranicama {naziv države članice/ nadležnog tijela}>
English: What Targocid is and what it is used for
Croatian: Što je Targocid i za što se koristi
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Croatian: Testovi identifikacije i antimikrobne osjetljivosti svakog takvog izolata moraju se ponoviti i, ako se rezultat potvrdi, izolat poslati u referentni laboratorij.
English: Mechanism of resistance Resistance to teicoplanin can be based on the following mechanisms:
Croatian: Mehanizam rezistencije Rezistencija na teikoplanin može se temeljiti na sljedećim mehanizmima:
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality.
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost pri visokim dozama (vidjeti dio 5.3): u štakora je primijećena povećana incidencija mrtvorođenja i neonatalnog mortaliteta.
English: Therefore, teicoplanin should not be used during pregnancy unless clearly necessary.
Croatian: Stoga se teikoplanin ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno.
English: Do not use Targocid if: • you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Targocid: • ako ste alergični na teikoplanin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće razviti kod svakoga.
English: Two metabolites are formed probably by hydroxylation and represents 2 to 3% of the administered dose.
Croatian: Dva metabolita vjerojatno nastaju hidroksilacijom, a predstavljaju 2-3% primijenjene doze.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some of types of infections is questionable.
Croatian: Po potrebi treba zatražiti savjet stručnjaka kada je lokalna prevalencija rezistencije takva da dovodi u pitanje korisnost lijeka kod barem nekih vrsta infekcija.
English: It contains a medicine called ‘teicoplanin'.
Croatian: Sadrži lijek koji se zove „teikoplanin“.
English: Solvent: water for injections.
Croatian: Otapalo: voda za injekcije.
English: The highest values of Vss are observed in the recent studies where the sampling period was superior to 8 days.
Croatian: Vss primijećene su u nedavnim ispitivanjima gdje je razdoblje prikupljanja uzoraka bilo dulje od 8 dana.
English: • peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD), • bacteraemia that occurs in association with any of the indications listed above.
Croatian: • peritonitis povezan s kontinuiranom ambulantnom peritonejskom dijalizom (CAPD), • bakterijemija koja se javi udružena s bilo kojom od navedenih indikacija.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Treba uzeti u obzir službene smjernice za pravilnu uporabu antibakterijskih lijekova.
English: The powder is packaged:
Croatian: Prašak je pakiran:
English: The medicine will normally be given to you by a doctor or nurse.
Croatian: Ovaj će Vam lijek obično davati liječnik ili medicinska sestra.
English: If you have more Targocid than you should
Croatian: Ako primite više lijeka Targocid nego što ste trebali
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti rukovati alatima ili strojevima.
English: • getting more infections than usual - these could be signs of a decrease in your blood cell count
Croatian: • veći broj infekcija nego inače - to mogu biti znakovi smanjenog broja krvnih stanica
English: They will decide whether or not you are given this medicine while you are pregnant.
Croatian: Oni će odlučiti možete li primiti ovaj lijek tijekom trudnoće.
English: It works by killing the bacteria that cause infections in your body.
Croatian: Djeluje tako da uništava bakterije koje uzrokuju infekcije u organizmu.
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija rezistencije odabranih vrsta može se razlikovati s obzirom na geografsko područje i tijekom vremena pa su poželjne lokalne informacije o rezistenciji, osobito pri liječenju teških infekcija.
English: The final solution is isotonic with plasma and has a pH of 7.2-7.8.
Croatian: Konačna otopina je izotonična s plazmom i ima pH od 7,2-7,8.
English: Resistance rate can vary depending on the actual streptococcus species
Croatian: Stopa rezistencije može varirati ovisno o pojedinoj vrsti streptokoka
English: Information about storage and the time to use Targocid, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Targocid'.
Croatian: Informacije o čuvanju lijeka Targocid i vremenskom razdoblju za njegovu primjenu nakon što je rekonstituiran i spreman za primjenu opisane su u dijelu „Praktične informacije za zdravstvene djelatnike o pripremi i rukovanju lijekom Targocid“.
English: Cases of accidental administration of excessive doses to paediatric patients have been reported.
Croatian: Prijavljeni su slučajevi slučajne primjene prekomjernih doza u pedijatrijskih bolesnika.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Croatian: Nakon odluke Europske komisije, nadležna tijela država članica će, u suradnji s referentnom državom članicom, prema potrebi ažurirati informacije o lijeku.
English: The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the teicoplanin concentrations.
Croatian: Vezanje za proteine u serumu ljudi kreće se u rasponu od 87,6 do 90,8%, bez varijacija funkcije koncentracija teikoplanina.
English: The primary literature, standard volumes and treatment recommendations assume sensitivity b Collective term for a heterogeneous group of streptococcus species.
Croatian: U osnovnoj literaturi, standardnim svescima i preporukama za liječenje pretpostavlja se osjetljivost b Kolektivni izraz za heterogenu skupinu streptokoknih vrsta.
English: b Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported.
Croatian: b Izolati s MIK vrijednostima iznad granice osjetljivosti vrlo su rijetki ili još nisu prijavljeni.
English: Targocid and associated names (see Annex I) is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1):
Croatian: Targocid i pridružena imena (vidjeti Dodatak I) je indiciran u odraslih osoba i djece od rođenja za parenteralno liječenje sljedećih infekcija (vidjeti dijelove 4.2, 4.4 i 5.1):
English: As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of nonsusceptible organisms.
Croatian: Kao i kod drugih antibiotika, primjena teikoplanina, osobito dugotrajna, može za posljedicu imati prekomjeran rast neosjetljivih organizama.
English: • Aminoglycosides as they must not be mixed together with Targocid in the same injection.
Croatian: • aminoglikozide, jer se oni ne smiju miješati s lijekom Targocid u istoj injekciji.
English: • Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium.
Croatian: • Modificiranoj ciljnoj strukturi: ovaj oblik rezistencije osobito je primijećen kod bakterije Enterococcus faecium.
English: Elimination half-life of teicoplanin varies from 100 to 170 hours in the most recent studies where blood sampling duration is about 8 to 35 days.
Croatian: Poluvijek eliminacije teikoplanina varira od 100 do 170 sati u najnovijim ispitivanjima u kojima su uzorci krvi prikupljani tijekom približno 8 do 35 dana.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava je definirana na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Periodic haematological examinations are recommended during treatment, including complete cell blood count.
Croatian: Preporučuju se periodične hematološke pretrage tijekom liječenja, uključujući kompletnu krvnu sliku.
English: Not known (cannot be estimated from available data)
Croatian: Nepoznate (učestalost se ne može procijeniti iz dostupnih podataka)
English: To treat certain infections, the solution may be taken by mouth (oral use).
Croatian: Za liječenje određenih infekcija otopina se može uzeti kroz usta (peroralna primjena).
English: Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.
Croatian: Kemijska i fizikalna stabilnost rekonstituirane otopine pripremljene prema preporuci dokazana je tijekom 24 sata na temperaturi od 2°C do 8°C.
English: Inherently resistant bacteria All Gram-negative bacteria Other bacteria
Croatian: Inherentno rezistentne bakterije sve Gram-negativne bakterije Ostale bakterije
English: However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.
Croatian: Međutim, anamneza “sindroma crvenog čovjeka” kod liječenja vankomicinom nije kontraindikacija za primjenu teikoplanina.
English: If you forget to have Targocid
Croatian: Ako ste zaboravili primiti Targocid
English: Paediatric population Interaction studies have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija provedena su samo u odraslih osoba.
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Croatian: Dok ne bude dokaza o kliničkom odgovoru potvrđenih izolata s MIK vrijednošću iznad trenutne granične vrijednosti rezistencije, treba ih prijavljivati kao rezistentne.
English: If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.
Croatian: Ako se pojavi alergijska reakcija na teikoplanin, liječenje se mora odmah prekinuti i moraju se uvesti odgovarajuće hitne mjere.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se za vrijeme liječenja razvije superinfekcija, treba poduzeti odgovarajuće mjere.
English: >15 mg/L once a week
Croatian: >15 mg/l jedanput tjedno
English: Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.
Croatian: Antimikrobno djelovanje teikoplanina u načelu ovisi o vremenu tijekom kojega je koncentracija lijeka viša od minimalne inhibitorne koncentracije (MIK) za patogen.
English: After intramuscular administration, the bioavailability of teicoplanin (as compared to intravenous administration) is almost complete (90%).
Croatian: Nakon intramuskularne primjene, bioraspoloživost teikoplanina (u usporedbi s intravenskom primjenom) gotovo je potpuna (90%).