natgillin/translations-raw huggingface dataset:
Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C - 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes). 
Prikladnim rukavicama uzmite dvije bočice (jednu bočicu stanica (1 ml) i jednu bočicu EAP-a (1ml)) iz zamrzivača / tekućeg dušika i odmah ih odmrznite na temperaturi od 25°C do 37°C, npr. u vodenoj kupelji, do otapanja sadržaja obiju bočica (približno pet minuta).
No data available. 
Podatci nisu dostupni.
Overdose: No data available 
Predoziranje: Nema dostupnih podataka.
In order to avoid thrombosis in small vessels when administering intraarticular injections the correct placement of the needle is critical. 
Kako bi se izbjegla tromboza u malim krvnim žilama pri primjeni intraartikularnih injekcija, ključno je pravilno postaviti iglu.
The veterinary product must be administered intraarticularly by a veterinary surgeon taking special precautions to ensure sterility of the injection process. 
Veterinar mora veterinarski proizvod primijeniti intraartikularno uz posebne mjere opreza kako bi osigurao sterilnost postupka primjene injekcije.
Each pack (polycarbonate container) contains a single dose of the product: one vial of stem cell suspension and one vial of EAP suspension. 
Jedno pakiranje (spremnik od polikarbonata) sadrži jednu dozu proizvoda: jednu bočicu suspenzije matičnih stanica i jednu bočicu suspenzije EAP-a.
Mild increases in lameness and injection site reactions, such as mild to moderate increases in joint swelling and mild increases in temperature at the injection sites, occurred very commonly in the first week after use of the product. 
Blaga povećanja hromosti i reakcije na mjestu primjene injekcije, kao što su blaga do umjerena povećanja oticanja zglobova i blaga povišenja temperature na mjestu primjene injekcije, pojavljivala su se vrlo često tijekom prvog tjedna nakon primjene VMP-a.
After injection of the product the stem cells do not migrate or distribute from the treated joint and synovia to tissues surrounding the synovial space. 
Nakon primjene proizvoda injekcijom, matične stanice ne migriraju niti se distribuiraju iz liječenog zgloba i sinovije u tkivo koje okružuje sinovijsku ovojnicu.
The chondrogenic induction of the mesenchymal stem cells aims to activate chondroprotective mechanisms, such as the production of extracellular matrix. 
Hondrogena indukcija mezenhimskih matičnih stanica ima za cilj aktivirati hrondroprotektivne mehanizme, kao što je proizvodnja izvanstanične matrice.
Do not use this veterinary medicinal product after the expiry date which is stated on the labels. 
Ovaj se veterinarsko-medicinski proizvod ne smije upotrijebiti nakon isteka roka valjanosti navedenog na etiketi.
Dosage: A single intraarticular injection of 1 dose (2 ml) per animal. 
Doziranje: Jedna intraartikularna injekcija jedne doze (2 ml) po životinji.
The product needs to be administered immediately after thawing to prevent significant cell death. 
Proizvod treba primijeniti odmah nakon odmrzavanja kako bi se spriječila značajnija smrt stanica.
According to the benefit-risk assessment of the responsible veterinarian of the individual case a single dose systemic NSAID may be administered on the day of intraarticular injection. 
Prema procjeni nadležnog veterinara omjera rizika i koristi za pojedinačni slučaj, jedna doza sustavnog NSAID-a može se primijeniti na dan intraartikularne injekcije.
If any cell clusters are visible in either of the vials after thawing, gently shake the vial concerned until the suspension is clear and colourless (stem cell suspension) or clear and yellow (equine allogeneic plasma suspension: the diluent). 
Ako su u bilo kojoj bočici nakon otapanja vidljive stanične nakupine, nježno protresite bočicu dok suspenzija ne postane prozirna i bezbojna (suspenzija matičnih stanica) ili prozirna i žuta (suspenzija alogenične plazme konja: otapalo).
Use only accordingly to the benefit-risk assessment by the responsible veterinarian. 
Primijeniti samo nakon procjene odnosa koristi i rizika nadležnog veterinara.
Efficacy data are not available regarding treatment of other joints. 
Podatci o djelotvornosti liječenja drugih zglobova nisu dostupni.
ul.Franciszka Klimczaka 1, 02-797 Warszawa 
Boehringer Ingelheim Sp.z o.o. ul.Franciszka Klimczaka 1, 02-797 Warszawa
Shelf life after preparation of the suspension for injection according to directions: use immediately 
Rok valjanosti nakon pripreme suspenzije za injekciju u skladu s uputama: odmah upotrijebiti.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 
Ne primjenjivati u slučajevima preosjetljivosti na djelatnu tvar ili neku od pomoćnih tvari.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 
U nedostatku ispitivanja kompatibilnosti ovaj veterinarski proizvod ne smije se miješati s drugim veterinarsko-medicinskim proizvodima.
Remove the cap of the vial that thawed first and aspirate the suspension in a syringe, then remove the cap of the other (thawed) vial and aspirate the suspension in the same syringe. 
Uklonite poklopac s bočice koja se prva odmrznula i aspirirajte suspenziju u štrcaljku, a zatim uklonite poklopac s druge (odmrznute) bočice i aspirirajte suspenziju u istu štrcaljku.
The addition of the EAP to the stem cells after thawing and just before injection of the product increases the viability of the stem cells. 
Dodatak EAP-a matičnim stanicama nakon odmrzavanja te neposredno prije primjene injekcijom povećava održivost matičnih stanica.
NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
The handling of liquid nitrogen should take place in a well-ventilated area. 
Rukovanje tekućim dušikom potrebno je provesti u dobro prozračenom prostoru.
Cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap. 
Bočica cikloolefinskog kopolimera (COC) s čepom od termoplastičnog elastomera (TPE) i poklopcem od polietilena visoke gustoće (HDPE).
This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP). 
Ovaj proizvod sadrži hondrogeno inducirane, mezenhimske matične stanice konja i alogeničnu plazmu konja (EAP).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Učestalost nuspojava određena je u skladu sa sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) 
Učestalost nuspojava određena je u skladu sa sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
The product must be manipulated and injected using sterile techniques and in a clean environment. 
Proizvodom treba rukovati te ga primijeniti s pomoću sterilnih tehnika u čistom okruženju.
Liquid nitrogen containers should be handled by properly trained personnel only. 
Sa spremnicima tekućeg dušika smije rukovati samo prikladno obučeno osoblje.
Active substance (1 ml): 
Pomoćne tvari (1 ml):
Shelf life after reconstitution according to directions: Use immediately. 
Rok valjanosti nakon rekonstitucije prema uputi: odmah upotrijebiti.
Excipients (1 ml): 
Djelatnu tvar (1 ml):
EXPIRY DATE EXP {month/year} Once reconstituted use immediately. 
EXP {mjesec/godina} Upotrijebiti odmah nakon rekonstitucije.
Single administration of 1 dose (equivalent to 2 ml) per animal 
Doziranje: Jedna primjena jedne doze (jednake 2 ml) po životinji
Preparation of the suspension for injection: 
Priprema suspenzije za injekciju:
In case of accidental self-injection this product can cause pain, local inflammatory reactions and swelling at the site of injection which may persist for several weeks and possibly cause fever, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju nehotičnog samoinjiciranja ovaj VMP može uzrokovati bol, lokalne upalne reakcije i oticanje na mjestu primjene injekcije koji mogu potrajati nekoliko tjedana te mogu uzrokovati vrućicu.
PACKAGE SIZE One vial (1 ml) of stem cells and one vial (1 ml) of equine allogeneic plasma. 
Jedna bočica (1 ml) matičnih stanica i jedna bočica (1 ml) alogenične plazme konja.
Equine allogeneic plasma suspension (diluent): clear yellow suspension. 
Suspenzija alogenične plazme konja (otapalo): prozirna, žuta suspenzija.
NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells 
Arti-Cell Forte suspenzija za injekciju za konje Hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja
4.1 Target species 
KLINIČKI PODATCI 4.1 Ciljne vrste životinja
Equine allogeneic plasma (1 ml) 
Alogenična plazma konja (EAP) 1 ml
In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment. 
U ključnom kliničkom terenskom ispitivanju sustavni NSAID primijenjen je istodobno s liječenjem.
Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cell suspension: clear colourless suspension. 
Suspenzija hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja: prozirna, bezbojna suspenzija.
4.9 Amounts to be administered and administration route 
4.9 Količine koje se primjenjuju i put primjene Put primjene:
Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses. 
Smanjenje blage do umjerene rekurentne hromosti povezane s aseptičnom upalom zglobova u konja.
In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte. 
U ključnom kliničkom terenskom ispitivanju sustavni NSAID primijenjen je jednom istodobno s proizvodom Arti-Cell Forte.
SPECIAL STORAGE PRECAUTIONS 
11. POSEBNE MJERE ČUVANJA
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
Posebne mjere opreza prilikom odlaganja neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
PACKAGE LEAFLET: Arti-Cell Forte suspension for injection for horses 
UPUTA O VMP-u: Arti-Cell Forte suspenzija za injekciju za konje
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose - contains: 
Jedna doza od 2 ml sadrži:
Diluent (EAP) vial: Equine allogeneic plasma 
Bočica otapala (EAP): alogenična plazma konja
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intraarticular use. 
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days. 
Karencija(e): Nula dana.
The product has been demonstrated to be efficacious in horses showing mild to moderate lameness in the fetlock joint. 
VMP se pokazao djelotvornim u konja s blagom ili umjerenom hromosti iz krunskog zgloba.
Dimethyl sulfoxide 
Bočica djelatne tvari (matičnih stanica): dimetil sulfoksid
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. 
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).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Polycarbonate container 
PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses 
Arti-Cell Forte suspenzija za injekciju za konje
Name and address of the manufacturer of the biological active substance Global Stem cell Technology (GST) NV Noorwegenstraat 4 
Naziv i adresa proizvođača biološki djelatne tvari Global Stem cell Technology (GST) NV Noorwegenstraat 4
Equine allogeneic plasma suspension: 
Suspenzija alogenične plazme konja:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the stem cell suspension 
OSNOVNI PODATCI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKIRANJIMA
WITHDRAWAL PERIOD(S) Withdrawal period: zero days 
Karencija(e): nula dana
Store and transport frozen (-90 °C to -70 °C) or in liquid nitrogen. 
-70°C) ili u tekućem dušiku.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. NAPOMENA O NAJVEĆIM DOPUŠTENIM KOLIČINAMA REZIDUA
Chondrogenic induced mesenchymal stem cell suspension: 
Suspenzija hondrogeno induciranih mezenhimskih matičnih stanica:
Name and address of the manufacturer(s) responsible for batch release Global Stem cell Technology (GST) NV Noorwegenstraat 4 
Naziv i adresa proizvođača odgovornog za puštanje serije u promet Global Stem cell Technology (GST) NV Noorwegenstraat 4
Marketing authorisation holder and manufacturer responsible for batch release: Global Stem cell Technology (GST) NV Noorwegenstraat 4 
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Global Stem cell Technology (GST) NV
Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml) 
hondrogeno induciranih, alogeničnih mezenhimskih matičnih stanica izvedenih iz periferne krvi konja (1 ml)
Boehringer Ingelheim Animal Health UK Ltd. Bracknell, 
Boehringer Ingelheim Animal Health UK Ltd.
Route of administration: Intraarticular use. 
Za intraartikularnu primjenu.
NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Arti-Cell Forte 
Dodatak otapalu za Arti-Cell Forte
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 
POSEBNO(A) UPOZORENJE(A), AKO JE(SU) POTREBNO(A)
1.4-2.5×106 Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml) 
Hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja (1 ml) 1,4 - 2,5 × 10
ΓΕΡΜΑΝΙΑ 
INDIKACIJE
Boehringer Ingelheim Animal Health Italia S.p.A. 
Boehringer Ingelheim Animal Health Italia S.p.A. Via Lorenzini 8
B. PACKAGE LEAFLET 
VELIČINA PAKIRANJA
C. STATEMENT OF THE MRLs 
NAPOMENA O NAJVEĆIM DOPUŠTENIM KOLIČINAMA REZIDUA (MRL)
SPECIAL STORAGE CONDITIONS Store and transport frozen (-90 °C to -70 °C or in liquid nitrogen). 
-70 °C ili u tekućem dušiku).
IL-ĠERMANJA 
UPUTA O VMP-u
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (2 ml) contains: 
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
Content (concentratio n) 
Sastav (koncentracija)
Strength Pharmaceutical form Route of administration 
Farmaceutski oblik
What you need to know before you take [product] 
Što morate znati prije nego počnete uzimati [lijek]
Interaction with other medicinal products and other forms of interaction 
Interakcije s drugim lijekovima i drugi oblici interakcija
There are medicines that may not mix with [product] because their effects could increase or decrease when taken together. 
Postoje lijekovi koji se ne smiju miješati s [lijek] jer bi se njihovi učinci mogli pojačati ili smanjiti kada se uzimaju zajedno.
In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly. 
U nekim će slučajevima vaš liječnik možda morati provesti određena testiranja, promijeniti dozu lijeka ili vas redovito pratiti.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines. 
Obavijestite svojeg liječnika ili ljekarnika ako vi ili vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT no 18940) 
Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT br. 18940)
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: 
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:
Adopted at the 5-8 February 2018 PRAC 
Usvojeno na sjednici PRAC-a 5. - 8. veljače 2018.
Aortitis [rare frequency] 
Aortitis [učestalost: rijetko]
Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints 
Upala kože koja uzrokuje crvene ljuskave mrlje i može se pojaviti zajedno s boli u zglobovima
See also section 4.8. 
Vidjeti dio 4.8. 4.8.
The following may affect the way that levothyroxine works: - Ritonavir - used to control HIV and chronic hepatitis C virus 
Na način djelovanja levotiroksina može utjecati sljedeće: - Ritonavir - koristi se za kontrolu infekcije virusom HIV-a i kronične infekcije virusom hepatitisa C
Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism (EPITT no 18896) 
Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levotiroksin - interakcija koja može dovesti do smanjene djelotvornosti levotiroksina i hipotireoze (EPITT br.
Systemic and cutaneous lupus erythematous (frequency very rare) Package leaflet 
Sistemski i kožni eritemski lupus (učestalost: vrlo rijetko)
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. 
Moguće nuspojave [Učestalost: rijetko] Upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
• [Levothyroxine-containing products whose package leaflet does not mention a possible interaction with protease inhibitors:] 
• [Lijekovi koji sadrže levotiroksin za koje se u uputi o lijeku ne navodi moguća interakcija s inhibitorima proteaze:]
[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:] 
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.
• [Lopinavir/ritonavir containing products:] 
• [Lijekovi koji sadrže lopinavir/ritonavir:]
• [Ritonavir containing products:] 
• [Lijekovi koji sadrže ritonavir:]
Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939) 
Hidroksikarbamid - kožni eritemski lupus (EPITT br.
Secondary mortality was observed 1-2 days later. 
Sekundarni mortalitet primijećen je 1-2 dana kasnije.
Elderly ( 75 years) 
Starije osobe ( 75 godina)
This leaflet was last approved in {MM/YYYY}. 
Ova uputa je zadnji puta odobrena u {MM/GGGG}.
Ecchymoses are observed commonly but usually do not require any specific action. 
Često su primijećene ekhimoze, ali one obično ne zahtijevaju posebnu intervenciju.
GPIIb/IIIa antagonists 
GPIIb/IIIa antagonisti
This helps to prevent the damage caused by heart attacks and has been shown to save lives. 
Ovo pomaže u sprječavanju pojave oštećenja nastalih srčanim udarima, i dokazano se spašavaju ljudski životi.
These medicines help to dissolve blood clots. 
Ovi lijekovi pomažu u razgradnji krvnih ugrušaka.
Date of last renewal: 23 February 2006 
Datum posljednje obnove odobrenja: 23. veljače 2006.
This significant difference between the groups for the primary endpoint at 90 days was already present in-hospital and at 30 days. 
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.
Primary PCI (n=948) 
Primarni PCI (n=948)
This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002). 
Ovo upućuje na značajno manju potrebu za transfuzijama (4,3% prema 5,5%, p=0,0002).
if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including: 
- ako imate ili ste nedavno imali bolest koja povećava rizik od krvarenja (hemoragije), uključujući:
In the event of overdose there may be an increased risk of bleeding. 
U slučaju predoziranja, može doći do povećanog rizika od krvarenja.
For coronary intervention see section 4.4. 
Za koronarnu intervenciju, vidjeti dio 4.4.
Women exhibit in general lower clearance than men, but this can be explained by the generally lower body weight of women. 
Žene su pokazale općenito niži klirens nego muškarci, što može biti objašnjeno općenito manjom tjelesnom težinom žena.
This is also supported by animal data. 
Ovome u prilog idu i podaci iz ispitivanja na životinjama.
OTHER SPECIAL WARNING(S), IF NECESSARY Please follow accurately the instructions for use. 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Točno slijedite upute za uporabu.
The volume required to administer the correct dose can be calculated from the following scheme: 
Volumen potreban za primjenu ispravne doze može se izračunati prema sljedećoj shemi:
The study population consisted of 1,892 patients randomised by means of an interactive voice response system. 
Ispitivana populacija sastojala se od 1892 bolesnika randomiziranih putem sustava interaktivnog glasovnog odgovora.
Other medicinesand Metalyse 
Drugi lijekovi i Metalyse
Coronary intervention 
Koronarna intervencija
Data on the foetal period are not available. 
Podaci o fetalnom razdoblju nisu dostupni.
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder: 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
What Metalyse is and what it is used for 
Što je Metalyse i za što se koristi
The powder is white to off-white. 
Prašak je bijele do gotovo bijele boje.
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. 
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.
It should not be administered in a line containing glucose. 
Ne smije se primijeniti u liniji koja sadrži glukozu.