natgillin/translations-raw huggingface dataset:
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.
Mutagenicity and carcinogenicity are not expected for this class of recombinant proteins and genotoxicity and carcinogenicity testing were not necessary.
Mutagenost i kancerogenost nisu očekivane kod ove vrste rekombiniranih proteina te stoga ispitivanja genotoksičnosti i kancerogenosti nisu bila neophodna.
What Metalyse looks like and contents of the pack
Kako Metalyse izgleda i sadržaj pakiranja
The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy.
Koristi liječenja moraju se procijeniti s obzirom na moguće rizike u slučaju infarkta miokarda tijekom trudnoće.
Metalyse is not recommended for use in children (below 18 years) due to a lack of data on safety and efficacy.
Metalyse se ne preporučuje za primjenu kod djece (ispod 18 godina starosti) zbog manjka podataka o sigurnosti i djelotvornosti.
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.
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
Total stroke (all types)
Ukupni moždani udari (svi tipovi)
Linearity/Non-Linearity
Linearnost/nelinearnost
Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Farmakoterapijska skupina: Antitrombotici, enzimi; ATK oznaka: B01A D11
What do you need to know before you receive Metalyse
Što morate znati prije nego primite Metalyse
STREAM study
Ispitivanje STREAM
The main organ to which tenecteplase distributed was the liver.
Glavni organ u koji se tenekteplaza distribuira je jetra.
No clinically relevant antibody formation was detected at 30 days.
Nije pronađeno klinički značajno stvaranje antitijela tjekom 30 dana.
Body temperature increased Injury, poisoning and procedural complications Not known
Povišena tjelesna temperatura Ozljede, trovanja i proceduralne komplikacije
METHOD OF ADMINISTRATION Reconstituted solution, for patients of body weight (kg):
NAČIN PRIMJENE LIJEKA Rekonstituirana otopina, za bolesnike s tjelesnom težinom (kg):
Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Koronarna tromboliza može rezultirati aritmijama povezanim s reperfuzijom.
This observation is consistent with the intended effect of plasminogen activation.
Ovo opažanje je sukladno s očekivanim učinkom aktivacije plazminogena.
Tenecteplase is not considered to be teratogenic (please see section 5.3).
Tenekteplaza se ne smatra teratogenom (molimo, vidjeti dio 5.3).
Patients' body weight category (kg)
Tjelesna težina bolesnika prema kategorijama (kg)
However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.
Međutim, iz mikrobioloških razloga liječnik će, u pravilu, odmah primijeniti pripremljenu otopinu za injekciju.
Metalyse belongs to a group of medicines called thrombolytic agents.
Metalyse pripada skupini lijekova koji se nazivaju trombolitičkim lijekovima.
When tenecteplase was given during the mid- or late-embryonal period maternal animals showed vaginal bleeding on the day after the first dose.
Kada je tenekteplaza bila davana tijekom srednjeg ili kasnog embrionalnog razdoblja, životinje majke su imale vaginalno krvarenje na dan nakon primjene prve doze.
However there is no systematic experience with re-administration of tenecteplase.
Međutim, ne postoji sustavno iskustvo s ponovljenom primjenom tenekteplaze.