FrancophonIA/ELRC3.0 huggingface dataset:
English: Equine allogeneic plasma (1 ml)
Croatian: Alogenična plazma konja (EAP) 1 ml
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment.
Croatian: U ključnom kliničkom terenskom ispitivanju sustavni NSAID primijenjen je istodobno s liječenjem.
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cell suspension: clear colourless suspension.
Croatian: Suspenzija hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja: prozirna, bezbojna suspenzija.
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i put primjene Put primjene:
English: Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
Croatian: Smanjenje blage do umjerene rekurentne hromosti povezane s aseptičnom upalom zglobova u konja.
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Croatian: U ključnom kliničkom terenskom ispitivanju sustavni NSAID primijenjen je jednom istodobno s proizvodom Arti-Cell Forte.
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNE MJERE ČUVANJA
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: Posebne mjere opreza prilikom odlaganja neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: PACKAGE LEAFLET: Arti-Cell Forte suspension for injection for horses
Croatian: UPUTA O VMP-u: Arti-Cell Forte suspenzija za injekciju za konje
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose - contains:
Croatian: Jedna doza od 2 ml sadrži:
English: Diluent (EAP) vial: Equine allogeneic plasma
Croatian: Bočica otapala (EAP): alogenična plazma konja
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intraarticular use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days.
Croatian: Karencija(e): Nula dana.
English: The product has been demonstrated to be efficacious in horses showing mild to moderate lameness in the fetlock joint.
Croatian: VMP se pokazao djelotvornim u konja s blagom ili umjerenom hromosti iz krunskog zgloba.
English: Dimethyl sulfoxide
Croatian: Bočica djelatne tvari (matičnih stanica): dimetil sulfoksid
English: The efficacy of the product was demonstrated in a pivotal field trial after single administration of the product and concurrent single systemic administration of an NSAID.
Croatian: Djelotvornost VMP-a utvrđena je u ključnom terenskom ispitivanju nakon jedne primjene VMP-a i istovremene jednokratne sustavne primjene nesteroidnog protuupalnog lijeka (engl. non-steroidal antiinflammatory drug, NSAID).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Polycarbonate container
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses
Croatian: Arti-Cell Forte suspenzija za injekciju za konje
English: Name and address of the manufacturer of the biological active substance Global Stem cell Technology (GST) NV Noorwegenstraat 4
Croatian: Naziv i adresa proizvođača biološki djelatne tvari Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: Equine allogeneic plasma suspension:
Croatian: Suspenzija alogenične plazme konja:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the stem cell suspension
Croatian: OSNOVNI PODATCI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKIRANJIMA
English: WITHDRAWAL PERIOD(S) Withdrawal period: zero days
Croatian: Karencija(e): nula dana
English: Store and transport frozen (-90 °C to -70 °C) or in liquid nitrogen.
Croatian: -70°C) ili u tekućem dušiku.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. NAPOMENA O NAJVEĆIM DOPUŠTENIM KOLIČINAMA REZIDUA
English: Chondrogenic induced mesenchymal stem cell suspension:
Croatian: Suspenzija hondrogeno induciranih mezenhimskih matičnih stanica:
English: Name and address of the manufacturer(s) responsible for batch release Global Stem cell Technology (GST) NV Noorwegenstraat 4
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: Marketing authorisation holder and manufacturer responsible for batch release: Global Stem cell Technology (GST) NV Noorwegenstraat 4
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Global Stem cell Technology (GST) NV
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Croatian: hondrogeno induciranih, alogeničnih mezenhimskih matičnih stanica izvedenih iz periferne krvi konja (1 ml)
English: Boehringer Ingelheim Animal Health UK Ltd. Bracknell,
Croatian: Boehringer Ingelheim Animal Health UK Ltd.
English: Route of administration: Intraarticular use.
Croatian: Za intraartikularnu primjenu.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Arti-Cell Forte
Croatian: Dodatak otapalu za Arti-Cell Forte
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), AKO JE(SU) POTREBNO(A)
English: 1.4-2.5×106 Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Croatian: Hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja (1 ml) 1,4 - 2,5 × 10
English: ΓΕΡΜΑΝΙΑ
Croatian: INDIKACIJE
English: Boehringer Ingelheim Animal Health Italia S.p.A.
Croatian: Boehringer Ingelheim Animal Health Italia S.p.A. Via Lorenzini 8
English: B. PACKAGE LEAFLET
Croatian: VELIČINA PAKIRANJA
English: C. STATEMENT OF THE MRLs
Croatian: NAPOMENA O NAJVEĆIM DOPUŠTENIM KOLIČINAMA REZIDUA (MRL)
English: SPECIAL STORAGE CONDITIONS Store and transport frozen (-90 °C to -70 °C or in liquid nitrogen).
Croatian: -70 °C ili u tekućem dušiku).
English: IL-ĠERMANJA
Croatian: UPUTA O VMP-u
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (2 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: Content (concentratio n)
Croatian: Sastav (koncentracija)
English: Strength Pharmaceutical form Route of administration
Croatian: Farmaceutski oblik
English: What you need to know before you take [product]
Croatian: Što morate znati prije nego počnete uzimati [lijek]
English: Interaction with other medicinal products and other forms of interaction
Croatian: Interakcije s drugim lijekovima i drugi oblici interakcija
English: There are medicines that may not mix with [product] because their effects could increase or decrease when taken together.
Croatian: Postoje lijekovi koji se ne smiju miješati s [lijek] jer bi se njihovi učinci mogli pojačati ili smanjiti kada se uzimaju zajedno.
English: In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly.
Croatian: U nekim će slučajevima vaš liječnik možda morati provesti određena testiranja, promijeniti dozu lijeka ili vas redovito pratiti.
English: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako vi ili vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT no 18940)
Croatian: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT br. 18940)
English: This is why you should tell your doctor if you are taking any medicines, including those you have bought yourself or herbal products, but it is especially important to mention these:
Croatian: Stoga morate obavijestiti svojeg liječnika ako uzimate bilo koje lijekove, uključujući lijekove koje ste kupili sami i biljne lijekove, a osobito je važno spomenuti sljedeće:
English: Adopted at the 5-8 February 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a 5. - 8. veljače 2018.
English: Aortitis [rare frequency]
Croatian: Aortitis [učestalost: rijetko]
English: Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Croatian: Upala kože koja uzrokuje crvene ljuskave mrlje i može se pojaviti zajedno s boli u zglobovima
English: See also section 4.8.
Croatian: Vidjeti dio 4.8. 4.8.
English: The following may affect the way that levothyroxine works: - Ritonavir - used to control HIV and chronic hepatitis C virus
Croatian: Na način djelovanja levotiroksina može utjecati sljedeće: - Ritonavir - koristi se za kontrolu infekcije virusom HIV-a i kronične infekcije virusom hepatitisa C
English: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism (EPITT no 18896)
Croatian: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levotiroksin - interakcija koja može dovesti do smanjene djelotvornosti levotiroksina i hipotireoze (EPITT br.
English: Systemic and cutaneous lupus erythematous (frequency very rare) Package leaflet
Croatian: Sistemski i kožni eritemski lupus (učestalost: vrlo rijetko)
English: Possible side effects [Rare frequency] Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Croatian: Moguće nuspojave [Učestalost: rijetko] Upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: • [Levothyroxine-containing products whose package leaflet does not mention a possible interaction with protease inhibitors:]
Croatian: • [Lijekovi koji sadrže levotiroksin za koje se u uputi o lijeku ne navodi moguća interakcija s inhibitorima proteaze:]
English: [Ritonavir containing products, including fixed drug combinations, and levothyroxine-containing products whose SPC section 4.5 does not mention a possible interaction with protease inhibitors:]
Croatian: Sažetak opisa svojstava lijeka (SPC) [Lijekovi koji sadrže ritonavir, uključujući fiksne kombinacije lijekova, te lijekovi koji sadrže levotiroksin za koje se u dijelu 4.5. SPC-a ne navodi moguća interakcija s inhibitorima proteaze:] 4.5.
English: • [Lopinavir/ritonavir containing products:]
Croatian: • [Lijekovi koji sadrže lopinavir/ritonavir:]
English: • [Ritonavir containing products:]
Croatian: • [Lijekovi koji sadrže ritonavir:]
English: Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939)
Croatian: Hidroksikarbamid - kožni eritemski lupus (EPITT br.
English: Secondary mortality was observed 1-2 days later.
Croatian: Sekundarni mortalitet primijećen je 1-2 dana kasnije.
English: Elderly ( 75 years)
Croatian: Starije osobe ( 75 godina)
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta odobrena u {MM/GGGG}.
English: Ecchymoses are observed commonly but usually do not require any specific action.
Croatian: Često su primijećene ekhimoze, ali one obično ne zahtijevaju posebnu intervenciju.
English: GPIIb/IIIa antagonists
Croatian: GPIIb/IIIa antagonisti
English: This helps to prevent the damage caused by heart attacks and has been shown to save lives.
Croatian: Ovo pomaže u sprječavanju pojave oštećenja nastalih srčanim udarima, i dokazano se spašavaju ljudski životi.
English: These medicines help to dissolve blood clots.
Croatian: Ovi lijekovi pomažu u razgradnji krvnih ugrušaka.
English: Date of last renewal: 23 February 2006
Croatian: Datum posljednje obnove odobrenja: 23. veljače 2006.
English: This significant difference between the groups for the primary endpoint at 90 days was already present in-hospital and at 30 days.
Croatian: Ova značajna razlika između tih dviju grupa u primarnim ishodima ispitivanja tijekom 90 dana već je bila prisutna u bolnici i u prvih 30 dana.
English: Primary PCI (n=948)
Croatian: Primarni PCI (n=948)
English: This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002).
Croatian: Ovo upućuje na značajno manju potrebu za transfuzijama (4,3% prema 5,5%, p=0,0002).
English: if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:
Croatian: - ako imate ili ste nedavno imali bolest koja povećava rizik od krvarenja (hemoragije), uključujući:
English: In the event of overdose there may be an increased risk of bleeding.
Croatian: U slučaju predoziranja, može doći do povećanog rizika od krvarenja.
English: For coronary intervention see section 4.4.
Croatian: Za koronarnu intervenciju, vidjeti dio 4.4.
English: Women exhibit in general lower clearance than men, but this can be explained by the generally lower body weight of women.
Croatian: Žene su pokazale općenito niži klirens nego muškarci, što može biti objašnjeno općenito manjom tjelesnom težinom žena.
English: This is also supported by animal data.
Croatian: Ovome u prilog idu i podaci iz ispitivanja na životinjama.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Please follow accurately the instructions for use.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Točno slijedite upute za uporabu.
English: The volume required to administer the correct dose can be calculated from the following scheme:
Croatian: Volumen potreban za primjenu ispravne doze može se izračunati prema sljedećoj shemi:
English: The study population consisted of 1,892 patients randomised by means of an interactive voice response system.
Croatian: Ispitivana populacija sastojala se od 1892 bolesnika randomiziranih putem sustava interaktivnog glasovnog odgovora.
English: Other medicinesand Metalyse
Croatian: Drugi lijekovi i Metalyse
English: Coronary intervention
Croatian: Koronarna intervencija
English: Data on the foetal period are not available.
Croatian: Podaci o fetalnom razdoblju nisu dostupni.
English: For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: What Metalyse is and what it is used for
Croatian: Što je Metalyse i za što se koristi
English: The powder is white to off-white.
Croatian: Prašak je bijele do gotovo bijele boje.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: It should not be administered in a line containing glucose.
Croatian: Ne smije se primijeniti u liniji koja sadrži glukozu.
English: Mutagenicity and carcinogenicity are not expected for this class of recombinant proteins and genotoxicity and carcinogenicity testing were not necessary.
Croatian: Mutagenost i kancerogenost nisu očekivane kod ove vrste rekombiniranih proteina te stoga ispitivanja genotoksičnosti i kancerogenosti nisu bila neophodna.
English: What Metalyse looks like and contents of the pack
Croatian: Kako Metalyse izgleda i sadržaj pakiranja
English: The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy.
Croatian: Koristi liječenja moraju se procijeniti s obzirom na moguće rizike u slučaju infarkta miokarda tijekom trudnoće.
English: Metalyse is not recommended for use in children (below 18 years) due to a lack of data on safety and efficacy.
Croatian: Metalyse se ne preporučuje za primjenu kod djece (ispod 18 godina starosti) zbog manjka podataka o sigurnosti i djelotvornosti.
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 2-8°C.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika, te ne bi, u redovnim uvjetima, trebali biti dulji od 24 sata na 2-8
English: Total stroke (all types)
Croatian: Ukupni moždani udari (svi tipovi)
English: Linearity/Non-Linearity
Croatian: Linearnost/nelinearnost
English: Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Croatian: Farmakoterapijska skupina: Antitrombotici, enzimi; ATK oznaka: B01A D11
English: What do you need to know before you receive Metalyse
Croatian: Što morate znati prije nego primite Metalyse
English: STREAM study
Croatian: Ispitivanje STREAM
English: The main organ to which tenecteplase distributed was the liver.
Croatian: Glavni organ u koji se tenekteplaza distribuira je jetra.
English: No clinically relevant antibody formation was detected at 30 days.
Croatian: Nije pronađeno klinički značajno stvaranje antitijela tjekom 30 dana.
English: Body temperature increased Injury, poisoning and procedural complications Not known
Croatian: Povišena tjelesna temperatura Ozljede, trovanja i proceduralne komplikacije
English: METHOD OF ADMINISTRATION Reconstituted solution, for patients of body weight (kg):
Croatian: NAČIN PRIMJENE LIJEKA Rekonstituirana otopina, za bolesnike s tjelesnom težinom (kg):
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Croatian: Koronarna tromboliza može rezultirati aritmijama povezanim s reperfuzijom.
English: This observation is consistent with the intended effect of plasminogen activation.
Croatian: Ovo opažanje je sukladno s očekivanim učinkom aktivacije plazminogena.
English: Tenecteplase is not considered to be teratogenic (please see section 5.3).
Croatian: Tenekteplaza se ne smatra teratogenom (molimo, vidjeti dio 5.3).
English: Patients' body weight category (kg)
Croatian: Tjelesna težina bolesnika prema kategorijama (kg)
English: However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.
Croatian: Međutim, iz mikrobioloških razloga liječnik će, u pravilu, odmah primijeniti pripremljenu otopinu za injekciju.
English: Metalyse belongs to a group of medicines called thrombolytic agents.
Croatian: Metalyse pripada skupini lijekova koji se nazivaju trombolitičkim lijekovima.
English: When tenecteplase was given during the mid- or late-embryonal period maternal animals showed vaginal bleeding on the day after the first dose.
Croatian: Kada je tenekteplaza bila davana tijekom srednjeg ili kasnog embrionalnog razdoblja, životinje majke su imale vaginalno krvarenje na dan nakon primjene prve doze.
English: However there is no systematic experience with re-administration of tenecteplase.
Croatian: Međutim, ne postoji sustavno iskustvo s ponovljenom primjenom tenekteplaze.
English: The terminal half-life is 129 ± 87 min, and plasma clearance is 119 ± 49 ml/min.
Croatian: Terminalni poluvijek je 129 ± 87min, a klirens plazme je 119 ± 49 ml/min.
English: In any case, tenecteplase should not be readministered before assessment of haemostatic factors like fibrinogen, plasminogen and alpha2antiplasmin.
Croatian: U svakom slučaju, tenekteplaza se ne smije ponovo primijeniti prije procjene faktora hemostaze kao što su fibrinogen, plazminogen i alfa2-antiplazmin.
English: Tenecteplase (mg)
Croatian: Tenekteplaza (mg)
English: Intracranial haemorrhage occurred at a rate of 0.93% vs. 0.94% for tenecteplase and alteplase, respectively.
Croatian: Intrakranijalna krvarenja pojavila su se u omjeru 0,93% prema 0,94% u odnosu tenekteplaze i alteplaze.
English: For details see section 6.6: Special precautions for disposal and other handling
Croatian: Za detaljne informacije, vidjeti dio 6.6: Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Tenecteplase (U)
Croatian: Tenekteplaza (U)
English: The distribution phase represents 31% ± 22% to 69% ± 15% (mean ± SD) of the total AUC following the administration of doses ranges from 5 to 50 mg.
Croatian: Faza distribucije predstavlja 31% ± 22% do 69% ± 15% (srednja vrijednost ± SD) ukupnog AUC nakon primjene doza u rasponu od 5 do 50 mg.
English: Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional antiarrhythmic therapies.
Croatian: Reperfuzijske aritmije mogu dovesti do zastoja srca, mogu biti opasne po život te mogu zahtijevati primjenu konvencionalnog liječenja antiaritmicima
English: Concomitant use of GPIIb/IIIa antagonists increases bleeding risk.
Croatian: Istovremena primjena GPIIb/IIIa antagonista povećava rizik od krvarenja.
English: It is not known whether and to which extent tenecteplase binds to plasma proteins in humans.
Croatian: Nije poznato veže li se, i u kojoj mjeri, tenekteplaza na proteine plazme kod ljudi.
English: Fat embolism, which may lead to corresponding consequences in the organs concerned
Croatian: Masna embolija koja može dovesti do odgovarajućih posljedica u zahvaćenim organima
English: The side effects described below have been experienced by people given Metalyse:
Croatian: Nuspojave opisane u nastavku imale su osobe koje su primile Metalyse:
English: Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA.
Croatian: Tenekteplaza ima veću fibrinsku specifičnost i veći otpor na inaktivaciju pomoću svog endogenog inhibitora (PAI-1) u usporedbi s fiziološkim t-PA.
English: Administration of protamine should be considered if heparin has been administered within 4 hours before the onset of bleeding.
Croatian: Potrebno je razmotriti primjenu protamina, ukoliko je heparin primijenjen unutar 4 sata od pojave krvarenja.
English: In the following conditions, the risk of tenecteplase therapy may be increased and should be weighed against the anticipated benefits:
Croatian: Rizik liječenja tenekteplazom može biti povećan u sljedećim stanjima te ga treba usporediti s očekivanom koristi:
English: Your doctor will take special care with Metalyse:
Croatian: Liječnik će obratiti posebnu pažnju u primjeni Metalysea:
English: Blood pressure decreased
Croatian: Sniženi krvni tlak
English: The safety and efficacy of Metalyse in children (below 18 years) have not been established.
Croatian: Sigurnost i djelotvornost Metalysea u djece (ispod 18 godina starosti) nisu ustanovljene.
English: Metalyse is given by a single injection into a vein by a doctor who is experienced in the use of this type of medicinal product.
Croatian: Metalyse se daje putem jednokratne injekcije u venu od strane liječnika koji ima iskustva u primjeni ove vrste lijekova.
English: What Metalyse contains
Croatian: Što Metalyse sadrži
English: Should serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately.
Croatian: Ukoliko dođe do pojave teškog krvarenja, osobito cerebralne hemoragije, nužno je odmah prekinuti istovremenu primjenu heparina.
English: Sterile needle for single use.
Croatian: Sterilna igla za jednokratnu primjenu.
English: ** the incidence in the pharmaco-invasive group is as expected for fibrinolysis with tenecteplase (as observed in previous studies).
Croatian: ** incidencije u skupini s farmakoinvazivnom metodom su očekivane za fibrinolizu uz tenekteplazu (prema zapažanjima u prethodnim ispitivanjima).
English: Data on tissue distribution were obtained in studies with radioactively labelled tenecteplase in rats.
Croatian: Podaci o distribuciji u tkiva dobiveni su pomoću ispitivanja na štakorima s radioaktivno obilježenom tenekteplazom.