FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1 000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10 000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10 000 zdravljenih živali, vključno s posameznimi primeri).
English: The handling of liquid nitrogen should take place in a well-ventilated area.
Slovenian: Delo s tekočim dušikom mora potekati v dobro zračenem prostoru.
English: In order to avoid thrombosis in small vessels when administering intraarticular injections the correct placement of the needle is critical.
Slovenian: Za preprečitev tromboze v malih žilah med dajanjem intraartikularnih injekcij je pravilna namestitev igle bistvenega pomena.
English: Preparation of the suspension for injection:
Slovenian: Priprava suspenzije za injiciranje:
English: This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP).
Slovenian: To zdravilo vsebuje hondrogeno inducirane konjske mezenhimske matične celice in konjsko alogensko plazmo (EAP).
English: The product has been demonstrated to be efficacious in horses showing mild to moderate lameness in the fetlock joint.
Slovenian: Zdravilo je dokazano učinkovito pri konjih, pri katerih se pojavlja blago do zmerno šepanje v bicljevem sklepu.
English: Excipients (1 ml):
Slovenian: Učinkovina (1 ml):
English: PACKAGE SIZE One vial (1 ml) of stem cells and one vial (1 ml) of equine allogeneic plasma.
Slovenian: Ena viala (1 ml) matičnih celic in ena viala (1 ml) konjske alogenske plazme.
English: Single administration of 1 dose (equivalent to 2 ml) per animal
Slovenian: Odmerjanje: Enkratno dajanje enega odmerka (kar ustreza 2 ml) na žival
English: Diluent (EAP) vial: Equine allogeneic plasma
Slovenian: Viala z redčilom (EAP): konjska alogenska plazma
English: Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
Slovenian: Zmanjševanje blagega do zmernega ponavljajočega se šepanja, povezanega z aseptičnim vnetjem sklepov pri konjih.
English: Equine allogeneic plasma suspension (diluent): clear yellow suspension.
Slovenian: Suspenzija konjske alogenske plazme (redčilo): bistra rumena suspenzija.
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cell suspension: clear colourless suspension.
Slovenian: Suspenzija hondrogeno induciranih konjskih alogenskih mezenhimskih matičnih celic, pridobljenih iz periferne krvi: bistra, brezbarvna suspenzija.
English: Store and transport frozen (-90 ° to -70 °C) or in liquid nitrogen.
Slovenian: Shranjujte in prevažajte zamrznjeno (od -90 do -70 °C) ali v tekočem dušiku.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells
Slovenian: Arti-Cell Forte suspenzija za injiciranje za konje Hondrogeno inducirane konjske alogenske mezenhimske matične celice, pridobljene iz periferne krvi
English: Liquid nitrogen containers should be handled by properly trained personnel only.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Z vsebniki s tekočim dušikom sme ravnati samo ustrezno usposobljeno osebje.
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.
Slovenian: Učinkovitost zdravila so dokazali v ključnem terenskem preskušanju po enkratnem dajanju zdravila in sočasnem enkratnem sistemskem dajanju nesteroidnega protivnetnega zdravila.
English: Route of administration: Intraarticular use.
Slovenian: Pot uporabe zdravila: Intraartikularna uporaba.
English: SPECIAL STORAGE CONDITIONS Store and transport frozen (-90 °C to -70 °C or in liquid nitrogen).
Slovenian: Shranjujte in prevažajte zamrznjeno (od -90 do -70 °C ali v tekočem dušiku).
English: PACKAGE LEAFLET: Arti-Cell Forte suspension for injection for horses
Slovenian: NAVODILO ZA UPORABO: Arti-Cell Forte suspenzija za injiciranje za konje
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intraarticular use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: 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.
Slovenian: V prvem tednu po uporabi zdravila je zelo pogosto prišlo do blagega povečanja šepanja in reakcij na mestu injiciranja, kot sta blago do zmerno povečanje otekanja sklepa in blago zvišanje temperature na mestih injiciranja.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: BESEDILO „SAMO ZA ŽIVALI“
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Polycarbonate container
Slovenian: Polikarbonatni vsebnik
English: Chondrogenic induced mesenchymal stem cell suspension:
Slovenian: Suspenzija hondrogeno induciranih mezenhimskih matičnih celic:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Name and address of the manufacturer of the biological active substance Global Stem cell Technology (GST) NV Noorwegenstraat 4
Slovenian: Ime in naslov proizvajalca biološke učinkovine Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: ROUTE(S) OF ADMINISTRATION Intraarticular use
Slovenian: NAČIN IN POT(I) UPORABE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses
Slovenian: Arti-Cell Forte suspenzija za injiciranje za konje
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Slovenian: V ključnem kliničnem terenskem preskušanju so sočasno z zdravljenjem z zdravilom Arti-Cell Forte živalim dali tudi en odmerek nesteroidnega protivnetnega zdravila v sistemski obliki.
English: 4.1 Target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste Konji
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Slovenian: hondrogeno induciranih konjskih alogenskih mezenhimskih matičnih celic, pridobljenih iz periferne krvi (1 ml)
English: Name and address of the manufacturer(s) responsible for batch release Global Stem cell Technology (GST) NV Noorwegenstraat 4
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: Equine allogeneic plasma suspension:
Slovenian: Suspenzija konjske alogenske plazme:
English: ΓΕΡΜΑΝΙΑ
Slovenian: celic
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Arti-Cell Forte
Slovenian: Redčilo za zdravilo Arti-Cell Forte
English: 1.4-2.5×106 Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Slovenian: Učinkovina (1 ml): hondrogeno inducirane konjske alogenske mezenhimske matične celice, pridobljene iz periferne krvi (1 ml) 1,4-2,5×10
English: Active substance (stem cells) vial:
Slovenian: Viala z učinkovino (matičnimi celicami): dimetilsulfoksid
English: Marketing authorisation holder and manufacturer responsible for batch release: Global Stem cell Technology (GST) NV Noorwegenstraat 4
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: Global Stem cell Technology (GST) NV
English: IL-ĠERMANJA
Slovenian: Rp-Vet.
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment.
Slovenian: V ključnem kliničnem terenskem preskušanju so sočasno z zdravljenjem živalim dali tudi en odmerek nesteroidnega protivnetnega zdravila.
English: Excipients (1ml): Equine allogeneic plasma (EAP) 1 ml
Slovenian: Pomožne snovi (1 ml): konjska alogenska plazma (EAP - equine allogeneic plasma) 1 ml Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the equine allogeneic plasma suspension
Slovenian: Viala, ki vsebuje suspenzijo konjske alogenske plazme
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the stem cell suspension
Slovenian: Viala, ki vsebuje suspenzijo matičnih celic
English: Content (concentratio n)
Slovenian: Vsebina (koncentracija
English: Invented name
Slovenian: (Izmišljen o) ime
English: Immediate Packaging
Slovenian: Velikost pakiranj
English: Strength Pharmaceutical form Route of administration
Slovenian: Farmacevtska oblika
English: Adopted at the 5-8 February 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 5. in 8. februarjem 2018
English: What you need to know before you take [product]
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [zdravilo]
English: In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly.
Slovenian: V nekaterih primerih bo zdravnik morda moral narediti določene preiskave, spremeniti odmerek ali vas redno spremljati.
English: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT no 18940)
Slovenian: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimaortitis (št. EPITT 18940)
English: Aortitis [rare frequency]
Slovenian: Žilne bolezni aortitis [redka pogostnost]
English: There are medicines that may not mix with [product] because their effects could increase or decrease when taken together.
Slovenian: Nekaterih zdravil ne smete jemati obenem z zdravilom [zdravilo], ker se lahko njihovi učinki med sočasno uporabo z zdravilom [zdravilo] povečajo ali zmanjšajo.
English: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism (EPITT no 18896)
Slovenian: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levotiroksin - interakcije, ki lahko privedejo do zmanjšane učinkovitosti levotiroksina in hipotiroidizma (št. EPITT 18896)
English: The following may affect the way that levothyroxine works: - Ritonavir - used to control HIV and chronic hepatitis C virus
Slovenian: Na način delovanja levotiroksina lahko vpliva naslednje: - ritonavir - uporablja se za nadzor okužbe z virusom HIV in kronične okužbe z virusom hepatitisa C
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.
Slovenian: Možni neželeni učinki [Redka pogostnost] Vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
English: Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Slovenian: Možni neželeni učinki vnetje kože, ki povzroča nastajanje rdečih, luskastih zaplat in se lahko pojavlja skupaj z bolečinami v sklepih
English: • [Levothyroxine-containing products whose package leaflet does not mention a possible interaction with protease inhibitors:]
Slovenian: • [Zdravila, ki vsebujejo levotiroksin, pri katerih v navodilu za uporabo niso omenjene morebitne interakcije z zaviralci proteaze:]
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:
Slovenian: Zato morate zdravniku povedati, če jemljete kakršnakoli zdravila, vključno s tistimi, ki ste jih dobili brez recepta, in zdravili rastlinskega izvora.
English: Systemic and cutaneous lupus erythematous (frequency very rare) Package leaflet
Slovenian: Neželeni učinki sistemski in kožni eritematozni lupus (zelo redka pogostnost)
English: • [Lopinavir/ritonavir containing products:]
Slovenian: • [Zdravila, ki vsebujejo lopinavir/ritonavir:]
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij V obdobju trženja so poročali o primerih, ki kažejo na morebitno interakcijo med zdravili, ki vsebujejo ritonavir, in levotiroksinom.
English: • [Ritonavir containing products:]
Slovenian: • [Zdravila, ki vsebujejo ritonavir:]
English: EMA/PRAC/59227/2018
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/99217/2018
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:]
Slovenian: Povzetek glavnih značilnosti zdravila [Zdravila, ki vsebujejo ritonavir, vključno s fiksnimi kombinacijami zdravil, in zdravila, ki vsebujejo levotiroksin, pri katerih v poglavju 4.5 povzetka glavnih značilnosti zdravila niso omenjene morebitne interakcije z zaviralci proteaze:]
English: abdominal pain, malaise, back pain and increased inflammatory markers.
Slovenian: Simptomi lahko vključujejo povišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev.
English: Summary of product characteristics (SPC)
Slovenian: Povzetek glavnih značilnosti zdravila
English: Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939)
Slovenian: Hidroksikarbamid - kožni eritematozni lupus (št. EPITT
English: This means that each pack contains:
Slovenian: To pomeni, da vsako pakiranje vsebuje:
English: Secondary mortality was observed 1-2 days later.
Slovenian: Sekundarno umrljivost so zasledili 1 do 2 dni pozneje.
English: This is also supported by animal data.
Slovenian: Tako kažejo tudi podatki iz raziskav na živalih.
English: Elderly ( 75 years)
Slovenian: Starejši (> 75 let)
English: STREAM study
Slovenian: Študija STREAM
English: This significant difference between the groups for the primary endpoint at 90 days was already present in-hospital and at 30 days.
Slovenian: Ta pomembna razlika med skupinama glede na primarni opazovani dogodek po 90 dneh je bila prisotna že v bolnišnici in po 30 dneh.
English: Ecchymoses are observed commonly but usually do not require any specific action.
Slovenian: Ekhimoze so pogoste, vendar zaradi njih običajno niso potrebni posebni ukrepi.
English: In the few patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Slovenian: Pri redkih bolnikih, ki se na te konservativne ukrepe ne odzovejo, je indicirana razumna uporaba transfuzijskih pripravkov.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Please follow accurately the instructions for use.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Natančno upoštevajte navodila za uporabo.
English: The study population consisted of 1,892 patients randomised by means of an interactive voice response system.
Slovenian: Obravnavano populacijo je sestavljalo 1892 bolnikov, ki so bili naključno razvrščeni po sistemu interaktivnega glasovnega odziva.
English: These medicines help to dissolve blood clots.
Slovenian: Ta zdravila raztapljajo krvne strdke.
English: Adverse reactions listed below are classified according to frequency and system organ class.
Slovenian: Spodaj navedeni neželeni učinki so razvrščeni po pogostnosti in organskih sistemih.
English: Coronary intervention
Slovenian: Koronarna intervencija
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Slovenian: Iz mikrobiološkega vidika je treba rekonstituirano raztopino takoj uporabiti.
English: Table 1 displays the frequency of adverse reactions.
Slovenian: Preglednica 1 navaja podatke o pogostnosti neželenih učinkov.
English: Primary PCI (n=948)
Slovenian: Primarna PKI (n = 948)
English: This observation is consistent with the intended effect of plasminogen activation.
Slovenian: To opažanje je v skladu s predvidenim učinkom aktivacije plazminogena.
English: This helps to prevent the damage caused by heart attacks and has been shown to save lives.
Slovenian: Prepreči poškodbe, ki nastanejo pri srčnem napadu in pokazalo se je, da rešuje življenja.
English: The terminal half-life is 129 ± 87 min, and plasma clearance is 119 ± 49 ml/min.
Slovenian: Končna razpolovna doba je 129 ± 87 minut, očistek iz plazme pa 119 ± 49 ml/min.
English: if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:
Slovenian: če imate ali ste nedavno imeli eno od naslednjih bolezni, ki povečajo nevarnost krvavitve (hemoragije):
English: Tenecteplase is not considered to be teratogenic (please see section 5.3).
Slovenian: Tenekteplaza ne velja za teratogeno učinkovino (glejte poglavje 5.3).
English: Antifibrinolytic agents are available as a last alternative.
Slovenian: Kot zadnja možnost so na voljo antifibrinolitiki.
English: It is not known whether and to which extent tenecteplase binds to plasma proteins in humans.
Slovenian: Ni znano, če in v kakšnem obsegu se tenekteplaza pri človeku veže na beljakovine v plazmi.
English: The volume required to administer the correct dose can be calculated from the following scheme:
Slovenian: Volumen, ki je potreben za pravilen odmerek, lahko izračunamo po naslednji shemi:
English: The main organ to which tenecteplase distributed was the liver.
Slovenian: Poglavitni organ, v katerega se je razporejala tenekteplaza, so bila jetra.
English: Metalyse (U)
Slovenian: Metalyse (E)
English: Mutagenicity and carcinogenicity are not expected for this class of recombinant proteins and genotoxicity and carcinogenicity testing were not necessary.
Slovenian: Mutagenosti in kancerogenosti pri tej skupini rekombinantnih proteinov ne pričakujemo, zato raziskave o genotoksičnosti in kancerogenosti niso bile potrebne.
English: Frequency groupings are defined according to the following convention: 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).
Slovenian: Skupine bolezni so po pogostnosti opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Linearity/Non-Linearity
Slovenian: Linearnost/nelinearnost
English: What Metalyse is and what it is used for
Slovenian: Kaj je zdravilo Metalyse in za kaj ga uporabljamo
English: Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Slovenian: Farmakoterapevtska skupina: antitrombotiki, encimi; oznaka ATC: B01A D11
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli po znaku EXP.
English: Should serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately.
Slovenian: Če se pojavi resna krvavitev, zlasti možganska, moramo nemudoma ukiniti sočasno zdravljenje s heparinom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23. februar 2001 Datum zadnjega podaljšanja: 23. februar 2006
English: Systolic blood pressure > 160 mm Hg
Slovenian: • sistolični krvni tlak > 160 mm Hg,
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: Oneželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Sterile needle for single use.
Slovenian: Sterilna igla za enkratno uporabo.
English: Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.
Slovenian: Acetilsalicilno kislino je treba začeti dajati čim prej po pojavu simptomov in z dajanjem nadaljevati doživljenjsko, razen če je kontraindicirano.
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.
Slovenian: Faza porazdelitve je 31 % ± 22 % do 69 % ± 15 % (srednja vrednost ± SD) skupne AUC po dajanju odmerkov v razponu 5 do 50 mg.
English: Women exhibit in general lower clearance than men, but this can be explained by the generally lower body weight of women.
Slovenian: Pri ženskah je očistek na splošno manjši kot pri moških, kar lahko pojasnimo z njihovo manjšo telesno maso.
English: This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002).
Slovenian: To pomeni, da je pri zdravljenju s tenekteplazo potreba po transfuzijah pomembno manjša (4,3 % proti 5,5 %; p = 0,0002).
English: The powder is white to off-white.
Slovenian: Prašek je bele do skoraj bele barve.
English: The trial was prematurely terminated with 1667 randomised patients due to a numerically higher mortality in the facilitated PCI group receiving tenecteplase.
Slovenian: Preskušanje so predčasno končali pri 1667 naključno izbranih bolnikih, ker je bila umrljivost številčno večja v skupini s PKI, ki je prejemala tenekteplazo.
English: GPIIb/IIIa antagonists
Slovenian: Antagonisti GPIIb/IIIa
English: For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: No other medicinal product should be added to the injection solution.
Slovenian: V raztopino za injiciranje ne smemo dodajati drugih zdravil.
English: Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents.
Slovenian: Jakost tenekteplaze je izražena v enotah (E), ki so določene s specifičnim referenčnim standardom za tenekteplazo in niso primerljive z enotami, ki jih uporabljamo za druge trombolitike.
English: Furthermore, Metalyse is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding:
Slovenian: Zdravilo Metalyse je kontraindicirano še pri naslednjih stanjih, saj je trombolitično zdravljenje povezano s tveganjem krvavitve;
English: Tenecteplase (mg)
Slovenian: Tenekteplaza (mg)
English: Gentamicin is contained as trace residue from the manufacturing process
Slovenian: Gentamicin je ostanek v sledeh iz proizvodnega postopka.
English: What do you need to know before you receive Metalyse
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Metalyse
English: Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional antiarrhythmic therapies.
Slovenian: Reperfuzijske aritmije lahko povzročijo srčni zastoj, ogrozijo življenje in zahtevajo uvedbo konvencionalnih antiaritmikov.