FrancophonIA/ELRC3.0 huggingface dataset:
English: Preparation of the suspension for injection:
Danish: Klargøring af injektionsvæsken, suspension:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte
Danish: VETERINÆRLÆGEMIDLETS NAVN
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Name and address of the manufacturer(s) responsible for batch release Global Stem cell Technology (GST) NV Noorwegenstraat 4
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse 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
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Global Stem cell Technology (GST) NV
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (2 ml) contains:
Danish: Hver dosis (2 ml) indeholder:
English: Dimethyl sulfoxide
Danish: Hætteglas med aktivt stof (stamceller): Dimethylsulfoxid
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN "TIL DYR"
English: ΓΕΡΜΑΝΙΑ
Danish: INDIKATIONER
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Danish: Kondrogent inducerede equine allogene perifert blod-deriverede mesenkymale stamceller
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the stem cell suspension
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial containing the equine allogeneic plasma suspension
Danish: Hætteglas indeholdende suspension af equint allogent plasma
English: 1.4-2.5×106 Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Danish: Aktivt stof (1 ml): Kondrogent inducerede equine allogene perifert blod-deriverede mesenkymale stamceller (1 ml)
English: ROUTE(S) OF ADMINISTRATION Intraarticular use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Strength Pharmaceutical form Route of administration
Danish: Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Content (concentratio n)
Danish: Synagis 100 mg/1 ml
English: In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly.
Danish: I nogle tilfælde kan lægen være nødt til at udføre bestemte test, ændre dosis eller undersøge dig regelmæssigt.
English: Adopted at the 5-8 February 2018 PRAC
Danish: Vedtaget på PRAC's møde 5.-8. februar 2018
English: There are medicines that may not mix with [product] because their effects could increase or decrease when taken together.
Danish: Der er lægemidler, som helst ikke skal blandes med [lægemiddel], fordi deres virkning kan øges eller nedsættes, når de tages sammen.
English: What you need to know before you take [product]
Danish: Det skal du vide, før du begynder at tage [lægemiddel]
English: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT no 18940)
Danish: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimaortitis (EPITT-nr. 18940)
English: Aortitis [rare frequency]
Danish: Aortitis [hyppighed "sjælden"]
English: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du eller dit barn bruger anden medicin eller har gjort det for nylig.
English: The following may affect the way that levothyroxine works: - Ritonavir - used to control HIV and chronic hepatitis C virus
Danish: Følgende lægemidler kan påvirke levothyroxins effekt: - Ritonavir - anvendes til at kontrollere hiv og kronisk hepatitis C
English: Systemic and cutaneous lupus erythematous (frequency very rare) Package leaflet
Danish: Systemisk og kutan lupus erythematosus (hyppighed "meget sjælden")
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Danish: Der er indberettet tilfælde efter markedsføring, der tyder på mulige interaktioner mellem ritonavirholdige lægemidler og levothyroxin.
English: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism (EPITT no 18896)
Danish: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxin - interaktioner, der kan medføre nedsat effekt af levothyroxin samt for lavt stofskifte (hypotyreose) (EPITT-nr. 18896)
English: • [Levothyroxine-containing products whose package leaflet does not mention a possible interaction with protease inhibitors:]
Danish: • [Levothyroxinholdige lægemidler, hvor indlægssedlen ikke nævner en mulig interaktion med proteasehæmmere:]
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:
Danish: Det er grunden til, at du skal informere din læge, hvis du tager nogen form for lægemidler, herunder dem, du selv har købt, eller naturlægemidler, men det er især vigtigt, at du nævner følgende: - levothyroxin (mod problemer med skjoldbruskkirtlen)
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.
Danish: Bivirkninger [Hyppighed "sjælden"] Betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen), se pkt.
English: Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Danish: Hudbetændelse, der giver røde afskallende pletter, evt. sammen med ledsmerter
English: Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939)
Danish: Hydroxycarbamid - kutan lupus erythematosus (EPITTnr.
English: abdominal pain, malaise, back pain and increased inflammatory markers.
Danish: Symptomerne kan omfatte feber, mavesmerter, utilpashed, rygsmerter og øgede betændelsesmarkører.
English: • [Ritonavir containing products:]
Danish: • [Ritonavirholdige lægemidler:]
English: • [Lopinavir/ritonavir containing products:]
Danish: • [Lopinavir/ritonavirholdige lægemidler:]
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:]
Danish: [Ritonavirholdige lægemidler, herunder faste lægemiddelkombinationer, og levothyroxinholdige lægemidler, hvor pkt.
English: Secondary mortality was observed 1-2 days later.
Danish: Sekundær dødelighed blev observeret 1-2 dage efter.
English: This is also supported by animal data.
Danish: Dette understøttes også af data fra dyrestudier.
English: This means that each pack contains:
Danish: Hver pakning indeholder:
English: Linearity/Non-Linearity
Danish: Linearitet/non-linearitet
English: Elderly ( 75 years)
Danish: Ældre (> 75 år)
English: Only clear solution without particles should be used.
Danish: Kun klare opløsninger uden partikler må anvendes.
English: This helps to prevent the damage caused by heart attacks and has been shown to save lives.
Danish: Dette er med til at forebygge skader skabt af hjerteanfald og har vist sig at redde liv.
English: In the few patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Danish: I de få patienter som ikke responderede på disse konservative mål kan velovervejet brug af transfusionsprodukter være indiceret.
English: Women exhibit in general lower clearance than men, but this can be explained by the generally lower body weight of women.
Danish: Kvinder udviser generelt lavere clearance end mænd, men dette kan forklares ved en generelt lavere legemsvægt hos kvinder.
English: These medicines help to dissolve blood clots.
Danish: Disse lægemidler hjælper med at opløse blodpropper.
English: Severe uncontrolled hypertension
Danish: Alvorlig ukontrolleret hypertension
English: The study population consisted of 1,892 patients randomised by means of an interactive voice response system.
Danish: Studiepopulationen bestod af 1.892 patienter, der blev randomiseret vha. et interaktivt voice response system.
English: This significant difference between the groups for the primary endpoint at 90 days was already present in-hospital and at 30 days.
Danish: Denne signifikante forskel mellem de to grupper på det primære endepunkt ved dag 90 var allerede tilstede ved hospitalisering og ved dag 30.
English: Polysorbate 20.
Danish: Polysorbat 20
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: Active peptic ulceration
Danish: Aktiv peptisk ulceration
English: In the event of overdose there may be an increased risk of bleeding.
Danish: I tilfælde af overdosering kan der være en øget risiko for blødning.
English: Antifibrinolytic agents are available as a last alternative.
Danish: Antifibrinolytisk behandling er mulig som sidste alternativ.
English: Investigations Rare
Danish: Undersøgelser Sjælden
English: Fat embolism, which may lead to corresponding consequences in the organs concerned
Danish: Fedtemboli, der kan have konsekvenser for de implicerede organer
English: Low body weight < 60 kg
Danish: Lav kropsvægt < 60 kg
English: Solvent for parenteral use
Danish: Solvens til parenteral brug
English: A target fibrinogen level of 1 g/l is desirable with cryoprecipitate infusion.
Danish: Et mål for fibrinogenniveau på 1 g/l er ønskeligt ved kryopræcipitatinfusion.
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.
Danish: Hvis den ikke straks anvendes, er i-brug-opbevaringstiden og forholdene før brug brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2-8 C.
English: Primary PCI (n=948)
Danish: Primær PCI (n=948)
English: However there is no systematic experience with re-administration of tenecteplase.
Danish: Dog er der ingen systematisk erfaring med gentagen administration af tenecteplase.
English: Any unused solution should be discarded.
Danish: Enhver ubrugt opløsning bør kasseres.
English: if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:
Danish: Hvis du har eller for nyligt har haft en sygdom, som øger din risiko for blødning (hæmoragi), f.eks.:
English: Coronary intervention
Danish: Koronar intervention
English: Ecchymoses are observed commonly but usually do not require any specific action.
Danish: Ekkymose ses ofte, men normalt kræver de ikke nogen speciel behandling.
English: GPIIb/IIIa antagonists
Danish: GPIIb/IIIa antagonister
English: Mutagenicity and carcinogenicity are not expected for this class of recombinant proteins and genotoxicity and carcinogenicity testing were not necessary.
Danish: Mutagenicitet og karcinogenicitet er ikke forventet i denne slags rekombinante proteiner og genotoksicitets- og karcinogenicitetstests var ikke nødvendige.
English: The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy.
Danish: Fordelen ved behandling skal opvejes i forhold til de potentielle risici i tilfælde af myokardieinfarkt under graviditet.
English: Hypersensitivity/Re-administration
Danish: Overfølsomhed/Gentagen administration
English: This observation is consistent with the intended effect of plasminogen activation.
Danish: Denne observation er i overensstemmelse med den forventede effekt af plasminogen aktivering.
English: L-arginine
Danish: L-arginin
English: This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002).
Danish: Dette medfører et signifikant lavere behov for transfusioner (4,3 % imod 5,5 %, p=0,0002).
English: Systolic blood pressure > 160 mm Hg
Danish: Systolisk blodtryk > 160 mm Hg
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP.
English: There is limited amount of data from the use of Metalyse in pregnant women.
Danish: Der findes begrænsede data fra anvendelse af Metalyse til gravide kvinder.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 23. februar 2001 Dato for seneste fornyelse: 23. februar 2006
English: In the following conditions, the risk of tenecteplase therapy may be increased and should be weighed against the anticipated benefits:
Danish: Under følgende omstændigheder kan risikoen ved brug af tenecteplase være forhøjet og derfor skal risikoen opvejes imod de forventede fordele:
English: No other medicinal product should be added to the injection solution.
Danish: Intet andet lægemiddel bør tilsættes injektionsvæsken.
English: It should not be administered in a line containing glucose.
Danish: Det bør ikke administreres i en indgang som indeholder glucose.
English: It is not known whether and to which extent tenecteplase binds to plasma proteins in humans.
Danish: Det er ikke kendt om og i hvilket omfang tenecteplase binder til plasmaproteiner i mennesker.
English: SPECIAL STORAGE CONDITIONS Keep the container in the outer carton.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar beholderen i den ydre karton.
English: The terminal half-life is 129 ± 87 min, and plasma clearance is 119 ± 49 ml/min.
Danish: Den afsluttende halveringstid er 129  87 min., og plasmaclearance er 119  49 ml/min.
English: Increasing body weight resulted in a moderate increase of tenecteplase clearance, and increasing age resulted in a slight decrease of clearance.
Danish: Stigende legemsvægt resulterede i en moderat stigning af tenecteplaseclearance, og stigende alder resulterede i et lille fald i clearance.
English: Single components of the primary composite endpoint for the pharmaco-invasive strategy versus primary PCI respectively were observed with the following frequencies:
Danish: Enkeltkomponenterne i det sammensatte primære endepunkt for den farmako-invasive strategi versus primær PCI blev observeret med følgende hyppigheder:
English: No clinically relevant antibody formation was detected at 30 days.
Danish: Der blev ikke fundet klinisk relevant antistofdannelse efter 30 dage.
English: The required dose should be administered as a single intravenous bolus over approximately 10 seconds.
Danish: Den anbefalede dosering bør administreres som en enkelt intravenøs bolus i løbet af ca. 10 sekunder.
English: ** the incidence in the pharmaco-invasive group is as expected for fibrinolysis with tenecteplase (as observed in previous studies).
Danish: ** forekomsten i den farmako-invasive gruppe er som forventet for fibrinolyse med tenecteplase (som observeret i tidligere studier).
English: Data on tissue distribution were obtained in studies with radioactively labelled tenecteplase in rats.
Danish: Data om vævsdistribution blev opnået i studier med radioaktivt mærket tenecteplase hos rotter.
English: Metalyse (U)
Danish: Metalyse (E)
English: Safety pharmacology data in cynomolgus monkeys revealed reduction of blood pressure followed by changes of ECG, but these occurred at exposures that were considerably higher than the clinical exposure.
Danish: Sikkerhedsfarmakologiske data i cynomolgus aber afslørede reduktion i blodtryk efterfulgt af forandringer af ECG, men disse fremkom ved eksponeringer der var langt højere end den kliniske eksponering.
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.
Danish: Fordelingsfasen udgør 31 % ± 22 % til 69 % ± 15 % (gennemsnit ± SD) af det totale AUC efter administration af doser i intervallet 5 til 50 mg.
English: METHOD OF ADMINISTRATION Reconstituted solution, for patients of body weight (kg):
Danish: ADMINISTRATIONSMETODE Rekonstitueret opløsning, til patienter med legemsvægt (kg):
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).
Danish: Bivirkningerne er opdelt efter systemorganklasse og hyppighed ud fra følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Breast-feeding should be discarded within the first 24 hours after thrombolytic therapy.
Danish: Brystmælk skal kasseres i de første 24 timer efter trombolytisk behandling.
English: Body temperature increased Injury, poisoning and procedural complications Not known
Danish: Forhøjet legemstemperatur Traumer, forgiftninger og behandlingskomplikationer Ikke kendt
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C.
Danish: Der er vist kemisk og fysisk i-brug-stabilitet i 24 timer ved 2-8C og i 8 timer ved 30 C.
English: The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
Danish: Øvrige indholdsstoffer: L-arginin, phosphorsyre og polysorbat 20.
English: Data on the foetal period are not available.
Danish: Data på den føtale periode var ikke tilgængelig.
English: However, the analysis of data from more than 12,000 patients treated during phase I, II and III did not reveal any clinically relevant interactions with medicinal products commonly used in patients with AMI and concomitantly used with tenecteplase.
Danish: Dog har analysedata fra mere end 12.000 patienter behandlet i fase I, II og III ikke vist nogen klinisk relevante interaktioner med andre lægemidler som sædvanligvis anvendes til patienter med AMI og sammen med tenecteplase.
English: With regard to the indication and the single dose administration in humans, reproductive toxicity testing was limited to an embryotoxicity study in rabbits, as a sensitive species.
Danish: Med hensyn til indikationen og den enkelt dosis administration i mennesker var reproduktionstoksicitets-testning begrænset til et embryotoksicitets studie i kaniner som en følsom dyreart.
English: Clinical data as well as nonclinical studies on fertility are not available for tenecteplase (Metalyse).
Danish: Kliniske data samt prækliniske fertilitetsstudier er ikke tilgængelige for tenecteplase (Metalyse).
English: The mean residence time (MRT) in the body is approximately 1 h and the mean (± SD) volume of distribution at the steady-state (Vss) ranged from 6.3 ± 2 L to 15 ± 7 L.
Danish: Den gennemsnitlige residenstid (MRT, mean residence time) i kroppen er ca. 1 time og gennemsnitsfordelingsvolumenet (± SD) ved steady state (Vss) er fra 6,3 ± 2 l til 15 ± 7 l.
English: Once Metalysehas been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C.
Danish: Når Metalyse først er blevet rekonstitueret, kan det opbevares i 24 timer ved 2-8 C og i 8 timer ved 30 C.
English: Concomitant use of GPIIb/IIIa antagonists increases bleeding risk.
Danish: Samtidig brug af GPIIb/IIIa antagonister forøger blødningsrisikoen.
English: Metalyse is to be administered to the patient, intravenously in about 10 seconds.
Danish: Metalyse skal gives til patienten intravenøst i løbet af 10 sekunder.
English: Furthermore, Metalyse is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding:
Danish: Metalyse er kontraindiceret i følgende situationer, da trombolytisk behandling er forbundet med en større risiko for blødning:
English: Volume of reconstituted solution (ml)
Danish: Volumen af rekonstitueret opløsning (ml)
English: Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Danish: Død og permanent invaliditet er rapporteret hos patienter som har oplevet stroke (inklusiv intrakraniel blødning) og andre alvorlige blødningsepisoder.
English: Intracranial haemorrhage occurred at a rate of 0.93% vs. 0.94% for tenecteplase and alteplase, respectively.
Danish: Intrakranial hæmoragi forekom 0,93 % imod 0,94 % for henholdsvis tenecteplase og alteplase.
English: Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks Acute pericarditis and/or subacute bacterial endocarditis Acute pancreatitis
Danish: Forlænget kardiopulmonær genoplivning (> 2 minutter) indenfor de sidste 2 uger Akut pericarditis og/eller subakut bakteriel endocarditis Akut pankreatitis
English: Tenecteplase induced total litter deaths during the mid-embryonal period.
Danish: Tenecteplase inducerede total kulddød under midtembryonal perioden.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørgedin læge eller apotekspersonalettil råds, før du bruger dette lægemiddel.
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.
Danish: Metalyse gives som en enkelt injektion i en blodåre af en læge, som har erfaring med brug af denne type lægemiddel.
English: Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse.
Danish: Ufraktioneret heparin og enoxaparin er blevet anvendt som antitrombotisk behandling i kliniske studier med Metalyse.
English: It is not known if tenecteplase is excreted in human milk.
Danish: Det er ukendt, om tenecteplase udskilles i human mælk.
English: In any case, tenecteplase should not be readministered before assessment of haemostatic factors like fibrinogen, plasminogen and alpha2antiplasmin.
Danish: I alle tilfælde skal tenecteplase ikke gentages før vurdering af hæmostatiske faktorer som fibrinogen, plasminogen og alfa2-antiplasmin.
English: Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration.
Danish: Transfusion af kryopræcipitat, frisk frossen plasma og blodplader skal overvejes med klinisk og laboratorie vurdering efter hver administration.
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.
Danish: Styrken af tenecteplase udtrykkes i enheder (E) ved at bruge en standardreference, som er specifik for tenecteplase og ikke sammenlignelig med enheder brugt til andre trombolytiske stoffer.
English: No formal interaction studies with tenecteplase and medicinal products commonly administered in patients with AMI have been performed.
Danish: Der er ikke udført formelle interaktionsstudier med tenecteplase og lægemidler administreret på sædvanlig måde hos patienter med AMI.
English: The trial was prematurely terminated with 1667 randomised patients due to a numerically higher mortality in the facilitated PCI group receiving tenecteplase.
Danish: Studiet blev med 1.667 randomiserede patienter afsluttet før tid p.g.a. højere mortalitet i den PCI gruppe, der fik tenecteplase.
English: These cardiovascular events can be life-threatening and may lead to death.
Danish: Disse kardiovaskulære tilfælde kan blive livstruende og kan føre til død.