FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Teva is a blood thinning medicine that contains two active substances, clopidogrel and acetylsalicylic acid.
Croatian: Klopidogrel/acetilsalicilna kiselina Teva lijek je za razrjeđivanje krvi koji sadrži dvije djelatne tvari, klopidogrel i acetilsalicilnu kiselinu.
English: A risk management plan has been developed to ensure that Clopidogrel/Acetylsalicylic acid Teva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Klopidogrel/acetilsalicilna kiselina Teva.
English: What are the risks associated with Clopidogrel/Acetylsalicylic acid Teva?
Croatian: Koji su rizici povezani s lijekom Klopidogrel/acetilsalicilna kiselina Teva?
English: Other information about Clopidogrel/Acetylsalicylic acid Teva
Croatian: Ostale informacije o lijeku Klopidogrel/acetilsalicilna kiselina Teva
English: What is Clopidogrel/Acetylsalicylic acid Teva and what is it used for?
Croatian: Što je Klopidogrel/acetilsalicilna kiselina Teva i za što se koristi?
English: • patients who have unstable angina (a severe type of chest pain) or have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Croatian: ‚povišenja ST segmenta' (nenormalno očitavanje EKG-a ili elektrokardiograma), uključujući i one koji imaju stent (kratku cjevčicu) umetnut u arteriju radi sprječavanja njenog zatvaranja;
English: For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Teva, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Klopidogrel/acetilsalicilna kiselina Teva potražite u uputi o lijeku.
English: Why is Clopidogrel/Acetylsalicylic acid Teva approved?
Croatian: Zašto je lijek Klopidogrel/acetilsalicilna kiselina Teva odobren?
English: Clopidogrel/Acetylsalicylic acid Teva can only be obtained with a prescription.
Croatian: Klopidogrel/acetilsalicilna kiselina Teva izdaje se samo na liječnički recept.
English: For practical information about using Clopidogrel/Acetylsalicylic acid Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Klopidogrel/acetilsalicilna kiselina Teva Praktične informacije o korištenju lijeka Klopidogrel/acetilsalicilna kiselina Teva pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Clopidogrel/Acetylsalicylic acid Teva have been shown in studies?
Croatian: Koje su koristi lijeka Klopidogrel/acetilsalicilna kiselina Teva dokazane u ispitivanjima?
English: How is Clopidogrel/Acetylsalicylic acid Teva used?
Croatian: Kako se klopidogrel/acetilsalicilna kiselina Teva koristi?
English: How does Clopidogrel/Acetylsalicylic acid Teva work?
Croatian: Kako djeluje Klopidogrel/acetilsalicilna kiselina Teva?
English: Dublin 4, Ireland
Croatian: Dublin 4, Irska
English: if you are suffering from more than one infection.
Croatian: ako patite od više od jedne infekcije.
English: This is called overgrowth.
Croatian: To se naziva bujanje.
English: At least 10,000 Gram-positive isolates per year shall be included in the study from the surveillance networks in Europe, USA, Latin America and Asia-Pacific.
Croatian: Najmanje 10 000 gram-pozitivnih izolata godišnje mora biti uključeno u ispitivanje iz mreža za nadzor u Europi, SAD-u, Južnoj Americi i azijsko-pacifičkog područja.
English: Alternatively, your doctor may decide that this medicine is not suitable for you.
Croatian: Alternativno, liječnik može odlučiti da ovaj lijek nije prikladan za vas.
English: Read all of this leaflet carefully before you are given this medicine because it contains important
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta odobrena u {MM/GGGGG}.
English: VIBATIV will be given to you by a doctor or a nurse.
Croatian: VIBATIV će vam davati liječnik ili medicinska sestra.
English: Tell your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant.
Croatian: Recite svom liječniku ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Croatian: Prekidanje ili usporavanje infuzije može dovesti do povlačenja takvih reakcija.
English: Both effects were reversible following an 8 week recovery period.
Croatian: Oba su učinka bila reverzibilna nakon razdoblja oporavka od 8 tjedana.
English: A course of treatment usually lasts for 7 to 21 days.
Croatian: Uobičajeno trajanje liječenja je tijekom 7 do 21 dana.
English: What you need to know before you use VIBATIV
Croatian: Što morate znati prije nego počnete primjenjivati VIBATIV
English: if you are allergic to antibiotics such as vancomycin.
Croatian: ako ste alergični na antibiotike kao što je vankomicin.
English: if you are suffering from heart disorders.
Croatian: ako patite od bolesti srca.
English: MIC (µg/ml)
Croatian: MIK (µg/ml)
English: VIBATIV can only be used when other antibiotics are not suitable.
Croatian: VIBATIV se može upotrebljavati samo kada drugi antibiotici nisu prikladni.
English: Tell your doctor that you are receiving VIBATIV.
Croatian: Recite svom liječniku da primate VIBATIV.
English: What VIBATIV is and what it is used for 2.
Croatian: Što je VIBATIV i za što se koristi 2.
English: In combination with the small Vss, this results in a t1/2 of about 8 h.
Croatian: U kombinaciji s malim Vss, to dovodi do t1/2 od približno 8 h.
English: Telavancin has a small volume of distribution.
Croatian: Telavancin ima mali volumen distribucije.
English: Human plasma protein binding is approximately 90%, primarily to serum albumin.
Croatian: Vezanje za ljudske proteine plazme je približno 90%, primarno na serumski albumin.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as
Croatian: Budući da se ove reakcije dobrovoljno prijavljuju iz populacije čija veličina nije sigurna, nije moguće pouzdano procijeniti njihovu učestalost koja se zbog toga kategorizira kao nepoznata.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje
English: The minimum inhibitory concentration (MIC) breakpoints are as follows:
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije (MIK) su kako slijedi:
English: If you use more VIBATIV than you should
Croatian: Ako primite više lijeka VIBATIV nego što ste trebali
English: Infusion related reactions can be limited if the daily dose is infused over a 1 hour period.
Croatian: Reakcije povezane s infuzijom mogu se ograničiti ako se dnevna doza daje infuzijom u trajanju od 1 sata.
English: Intermediate analysis results should be provided starting May 2015.
Croatian: Rezultati prijelazne analize predaju se od početka svibnja 2015.
English: The frequency of adverse reactions is defined as follows: 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 određena je na sljedeći način: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: The Healthcare Professional Guide should contain the following key messages:
Croatian: Vodič za zdravstvene radnike mora sadržavati sljedeće ključne poruke:
English: International normalised ratio
Croatian: Internacionalni normalizirani omjer
English: The potential risk for humans is unknown (see section 4.6).
Croatian: Potencijalni rizik za ljude nije poznat (vidjeti dio 4.6).
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često::može se javiti u više od 1 na 10 osoba
English: What VIBATIV looks like and contents of the pack
Croatian: Kako VIBATIV izgleda i sadržaj pakiranja
English: What VIBATIV is and what it is used for
Croatian: Što je VIBATIV i za što se koristi
English: Store in a refrigerator (2-8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Treba razmotriti službene smjernice o pravilnoj upotrebi antibakterijskih lijekova.
English: S. aureus (including methicillin-resistant strains)
Croatian: S. aureus (uključujući meticilin-rezistentne sojeve)
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Croatian: Upotreba antibiotika može potaknuti prekomjerni razvoj neosjetljivih mikroorganizama.
English: Your doctor will treat you as necessary.
Croatian: Liječnik će vas liječiti prema potrebi.
English: If your kidneys do not work well or if you are overweight, the dose may be reduced.
Croatian: Ako vaši bubrezi ne rade dobro ili imate prekomjernu tjelesnu težinu, doza se može smanjiti.
English: VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 and 5.1).
Croatian: VIBATIV se smije upotrebljavati samo u slučajevima kada je utvrđeno ili se pretpostavlja da niti jedna druga mogućnost nije prikladna (vidjeti dijelove 4.3, 4.4, 4.8 i 5.1).
English: You have to use effective contraception during
Croatian: Morate uzimati učinkovita kontracepcijska sredstva tijekom
English: • The Healthcare Professional Guide
Croatian: • Vodič za zdravstvene radnike
English: VIBATIV may cause the following side effects:
Croatian: VIBATIV može uzrokovati sljedeće nuspojave:
English: The first signs of a severe allergic reaction may include swelling of the skin, face and/or throat and/or difficulty breathing.
Croatian: Prvi znakovi teške alergijske reakcije mogu uključivati oticanje kože, lica i/ili grla i/ili otežano disanje
English: The AUC of the predominant metabolite accounted for approximately 2-3% of AUC of telavancin.
Croatian: AUC predominantog metabolita odgovoran je za približno 2-3% AUC-a telavancina.
English: Your doctor may decide to adjust the rate of the infusion.
Croatian: Vaš liječnik može odlučiti prilagoditi brzinu infuzije.
English: Like all medicines, VIBATIV can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, VIBATIV može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: The safety and efficacy of VIBATIV in children and adolescents aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka VIBATIV u djece i adolescenata u dobi manjoj od 18 godina još nije ustanovljena.
English: Fibrin degradation products
Croatian: Produkti razgradnje fibrina
English: Recommendations for dose adjustment can be found in section 4.2.
Croatian: Preporuke za prilagođavanje doze mogu se pronaći u dijelu 4.2.
English: Detailed information on this medicine is available on the European Medicines Agency website:
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove:
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 types of infections is questionable.
Croatian: Po potrebi mora se zatražiti stručni savjet kada je lokalna prevalencija rezistencije takva da je primjenjivost lijeka u barem nekim vrstama infekcija upitna.
English: Talk to your doctor or nurse before you are given VIBATIV if you have kidney problems.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego uzmete VIBATIV. ako imate problema s bubrezima.
English: This dose is given as an infusion (drip into a vein) over a period of about 60 minutes.
Croatian: Ta se doza daje kao infuzija (kapanjem u venu) tijekom razdoblja od oko 60 minuta.
English: From a microbiological point of view the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba odmah primijeniti.
English: if you notice a change in your hearing.
Croatian: ako primijetite promjene u sluhu.
English: • The existence and scope of the pregnancy register and details of how to enter patients into it.
Croatian: • postojanje i opseg registra trudnica i pojedinosti o načinu upisa bolesnica u njega.
English: Creatinine clearance* (ml/min)
Croatian: Klirens kreatinina* (ml/min)
English: Mean (SD) AUC0-24 amounts to 780 (125) µg.h/ml.
Croatian: Srednja vrijednost (SD) AUC0-24 iznosi 780 (125) µg.h/ml.
English: Final study results by 31 December
Croatian: Rezultati završnog ispitivanja do 31. prosinca
English: Vibativ should be used with caution with other nephrotoxic medicinal products.
Croatian: Vibativ se mora oprezno upotrebljavati s drugim nefrotoksičnim lijekovima.
English: The test results can suggest poor blood clotting when, in fact, there is no problem.
Croatian: Rezultati pretraga mogu upućivati na slabo zgrušavanje iako to u stvari nije problem.
English: It is only used when the bacteria that cause these infections can be killed with telavancin.
Croatian: Upotrebljava se samo kada se bakterija koja izaziva te infekcije može eliminirati telavancinom.
English: The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days.
Croatian: Preporučena doza je 10 mg/kg, jednom svaka 24 sata, tijekom 7 do 21 dana.
English: The final protocol for the PASS should be provided to the CHMP by 30 April 2014.
Croatian: Završni protokol za PASS mora se podnijeti CHMP-u do 30. travnja 2014.
English: In the absence of compatibility studies, this medicine must not be mixed with other medicines.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima.
English: Telavancin must not be given to pregnant women.
Croatian: Telavancin se ne smije propisivati trudnicama.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se superinfekcija pojavi tijekom liječenja moraju se poduzeti odgovarajuće mjere.
English: Higher concentrations were observed in alveolar macrophages with ratios varying between 0.360 (at 4 h) and 6.67 (at 24 h).
Croatian: Veće koncentracije su opažene u alveolarnim makrofagama s omjerima koji su varirali između 0,360 (nakon 4 h) i 6,67 (nakon 24 h).
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Croatian: • da postoji rizik od reakcija povezanih s infuzijom uključujući reakcije nalik na sindrom crvenog
English: Do not take any diarrhoea medicine without first checking with your doctor.
Croatian: Ne uzimajte lijekove za proljev, a da se niste najprije obratili liječniku.
English: The MAH shall continue to monitor the activity of telavancin and the microbiological resistance as compared to other agents, through the longitudinal resistance surveillance program.
Croatian: MAH će nastaviti s nadzorom aktivnosti telavancina i mikrobiološke rezistencije u usporedbi s drugim lijekovima kroz program nadzora longitudinalne rezistencije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with telavancin in one or more subsets of the paediatric population in nosocomial pneumonia.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja telavancina u jednoj ili više podskupina pedijatrijske populacije za bolničku pneumoniju.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija stečene rezistencije može varirati ovisno o zemljopisnom položaju i tijekom vremena za odabrane vrste, a poželjne su i lokalne informacije o rezistenciji, posebice za liječenje teških infekcija.
English: Telavancin is not to be used in children or adolescents under 18 years of age.
Croatian: Telavancin ne smiju primjenjivati djeca ili adolescenti mlađi od 18 godina.
English: Telavancin is mainly excreted unchanged accounting for approximately 82% of the total amount recovered over 48 hours in urine.
Croatian: Telavancin se uglavnom izlučuje nepromijenjen u količini od približno 82% od ukupne količine prikupljene tijekom 48 sati u urinu.
English: Your doctor will decide how long you should be treated.
Croatian: Vaš će liječnik odlučiti koliko treba trajati liječenje.
English: This data indicate that telavancin is not extensively distributed.
Croatian: Ovi podaci pokazuju da se telavancin ne distribuira opsežno.
English: Your doctor may monitor your hearing during treatment.
Croatian: Vaš liječnik može nadzirati vaš sluh tijekom liječenja.
English: If you also have other bacteria that cause your infection, your doctor may prescribe other antibiotics in
Croatian: Ako imate i druge bakterije koje izazivaju vašu infekciju, liječnik vam može osim lijeka VIBATIV propisati i druge antibiotike.
English: Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum).
Croatian: Telavancin je djelatan samo protiv gram-pozitivnih bakterija (vidjeti dio 5.1 za informacije o antimikrobnom spektru).
English: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Croatian: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT Ujedinjeno Kraljevstvo
English: Based on their pharmacokinetic properties, no interaction is expected with other beta-lactams, clindamycin, metronidazole, or
Croatian: Na temelju njihovih farmakokinetičkih svojstava ne očekuju se interakcije s drugim beta-laktamima, klindamicinom, metronidazolom ili
English: Your doctor may decide to reduce the dose of VIBATIV and monitor you more closely during treatment.
Croatian: Vaš liječnik može odlučiti smanjiti dozu lijeka VIBATIV i pažljivije vas nadzirati tijekom liječenja.
English: Your doctor will tell you if this is the case and may decide to monitor you more closely during treatment.
Croatian: Liječnik će vam reći ako je to slučaj i može odlučiti pažljivije vas nadzirati tijekom liječenja.
English: In healthy young adults, three hydroxylated metabolites were identified after infusion of telavancin.
Croatian: Kod zdravih mlađih odraslih osoba utvrđena su tri hidroksilirana metabolita nakon infuzije telavancina.
English: • That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
Croatian: • da postoji potencijalni rizik od teratogenosti i da je Vibativ kontraindiciran tijekom trudnoće.
English: Exposure to telavancin increases with increase in BMI; for each 10-unit increase in BMI, it is estimated that plasma exposure will increase by up to 25%.
Croatian: Izloženost telavancinu povećava se s povećanjem indeksa tjelesne mase; procjenjuje se da će za svako povećanje vrijednosti BMI od 10 jedinica, izloženost plazme narasti za do 25 %.
English: The liver, kidney, macrophages and testis were identified as target organs of toxicity in animals.
Croatian: Jetra, bubrezi, makrofagi i testisi utvrđeni su kao ciljni organi toksičnosti kod životinja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 September 2011
Croatian: Datum prvog odobrenja: 2. rujna 2011.
English: The use of VIBATIV is contraindicated during pregnancy (see section 4.3).
Croatian: Primjena lijeka VIBATIV kontraindicirana je tijekom trudnoće (vidjeti dio 4.3).
English: if you are at greater risk of developing kidney disorders or if you are receiving other medicines that can affect your kidney.
Croatian: ako ste u izloženi povećanom riziku od razvoja bubrežnih poremećaja ili ako primate druge lijekove koji mogu utjecati na vaše bubrege.
English: All-cause mortality was 32/73 (44%) in the telavancin group and 16/64 (25%) in the vancomycin group, whereas in patients without acute renal failure at baseline it was 118/678 (17%) and 124/688 (18%), respectively.
Croatian: Smrtnost od svih uzroka bila je 32/73 (44%) u skupini koja je primala telavancin i 16/64 (25%) u skupini koja je primala vankomicin, dok je kod bolesnika bez početnog akutnog zatajenja bubrega ona iznosila 118/678 (17%), odnosno 124/688 (18%).
English: In vitro studies have shown that CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 and 4F12 are able to metabolise telavancin, resulting in hydroxylation at the 7, 8 and 9 position of the 2-(decylamino) ethyl side chain of telavancin.
Croatian: In vitro ispitivanja su pokazala da CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 i 4F12 mogu metabolizirati telavancin, što dovodi do hidroksilacije na 7, 8 i 9 položaju 2-(decilamino)etil postraničnog lanca telavancina.
English: The macrophages were shown to contain telavancin and
Croatian: Za makrofage je pokazano da sadrže telavancin i
English: The results shall be reported to the CHMP on an annual basis and the final report shall be submitted no later than 31 May 2017.
Croatian: Rezultati se trebaju podnositi CHMP-u jednom godišnje, a završni izvještaj mora se podnijeti najkasnije 31. svibnja 2017.
English: For doses of 150 to 800 mg, the appropriate volume of reconstituted concentrate must be further diluted in 100 to 250 ml prior to infusion.
Croatian: Za doze od 150 do 800 mg, odgovarajući volumen rekonstituiranog koncentrata mora se dodatno razrijediti u 100 do 250 ml prije infuzije.
English: VIBATIV must be reconstituted and then further diluted prior to administration by intravenous infusion through a dedicated line or through a Y-site over a 60 minute period.
Croatian: VIBATIV se mora rekonstituirati i zatim dodatno razrijediti prije primjene intravenskom infuzijom kroz za to namijenjenu liniju ili putem Y-linije tijekom razdoblja od 60 minuta.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment.
Croatian: Stoga se ova dijagnoza mora razmotriti kod bolesnika kod kojih je došlo do pojave dijareje tijekom ili netom nakon liječenja.
English: The dose for adults (18 years and older) is 10 milligrams (mg) for every kilogram (kg) of body weight, given once a day.
Croatian: Doza za odrasle osobe (18 godina i starije) je 10 miligrama (mg) po svakom kilogramu (kg) tjelesne težine, jednom dnevno.
English: Final results of the study and the re-evaluation of the benefit/risk ratio for Vibativ should be provided to CHMP no later than 31 December 2017.
Croatian: Završni rezultati ispitivanja i ponovne procjene omjera rizika i koristi za Vibativ trebaju se predati CHMP-u najkasnije 31. prosinca 2017.
English: Both studies consistently showed that the area under the curve (AUC) of telavancin, but not the maximum plasma concentration (Cmax) increases with decreasing renal function.
Croatian: Oba ispitivanja dosljedno su pokazala da se površina ispod krivulje (AUC) telavancina, ali ne i maksimalna koncentracija plazme (Cmax) povećavaju kako se smanjuje bubrežna funkcija.
English: Telavancin has been shown to affect sperm quantity and quality of male rats (see section 5.3) although no effect on fertility, mating, or early embryogenesis has been reported.
Croatian: Pokazalo se da telavancin utječe na količinu i kvalitetu spermija muških štakora (vidjeti dio 5.3) iako nije prijavljen utjecaj na plodnost, parenje i ranu embriogenezu.
English: Vacuolisation is considered to be a cytoprotective event, which is not associated with functional impairment.
Croatian: Vakuolizacija se smatrala citoprotektivnim događajem što nije povezano s oštećenjem funkcije.
English: Discard the vial if the vacuum does not pull the diluent into the vial.
Croatian: Bacite bočicu ako vakuum ne uvuče otapalo u bočicu.