FrancophonIA/ELRC3.0 huggingface dataset:
English: The sensitivity was improved by between 6 and 42%, which means that between 6 and 42% more stenoses were detected when Ablavar was used than when it was not used.
Danish: Scanningernes følsomhed blev forbedret med mellem 6 % og 42 %, hvilket betyder, at der blev påvist mellem 6 % og 42 % flere stenoser, når der blev anvendt Ablavar, end når det ikke blev anvendt.
English: Other information about Ablavar:
Danish: Andre oplysninger om Ablavar:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ablavar.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Ablavar.
English: This means that the gadolinium stays in the blood long enough for a good scan to be obtained.
Danish: Dette betyder, at gadolinium bliver længe nok i blodet til, at der kan opnås en god scanning.
English: Imaging can start immediately after the injection, and can continue for up to one hour after Ablavar is injected.
Danish: Scanningen kan påbegyndes umiddelbart efter injektionen og kan fortsætte i op til én time efter indgivelsen af Ablavar.
English: For more information about treatment with Ablavar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ablavar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In Ablavar, the gadolinium is attached to another chemical so that the metal is not released in the body, and prepared so that it attaches to proteins in the blood.
Danish: I Ablavar bindes gadolinium til et andet kemisk stof, så metallet ikke udskilles i kroppen, og det er tillavet, så det bindes til proteiner i blodet.
English: The CHMP decided that Ablavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ablavar er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Ablavar.
English: Ablavar is for diagnostic use.
Danish: Ablavar er til diagnostisk brug.
English: The full EPAR for Ablavar can be found here.
Danish: Den fuldstændige EPAR for Ablavar findes her.
English: Ablavar is given as an injection into a vein lasting about 30 seconds.
Danish: Ablavar gives som en injektion i en vene, der varer cirka 30 sekunder.
English: The measure of effectiveness was based on the improvement in the detection of stenoses (narrowing of the blood vessels) that reduced the width of the vessel by 50% or more.
Danish: Virkningen blev bedømt på forbedringen i påvisningen af stenoser (forsnævring af blodkarrene), der reducerede bredden af blodkarrene med 50 % eller mere.
English: Using Ablavar as an enhancer improved the performance of the scans.
Danish: Brugen af Ablavar som kontraststof forbedrede effektiviteten af scanningerne.
English: The marketing authorisation holder is TMC Pharma Services Ltd.
Danish: Ejeren af markedsføringstilladelsen er TMC Pharma Services Ltd. Markedsføringstilladelsen er gyldig på ubegrænset tid.
English: Patients were having scans because of potential problems with the blood vessels that supply blood to the legs, the kidneys or the feet.
Danish: Patienterne fik udført scanninger på grund af mulige problemer med de blodkar, der fører blod til benene, nyrerne eller fødderne.
English: Ablavar should only be used by doctors who have experience in diagnostic imaging.
Danish: Ablavar må kun anvendes af læger med erfaring i diagnostisk scanning.
English: The most common side effects with Ablavar (seen in more than 1 patient in 100) are headache, paraesthesia (unusual sensations like pins and needles), dysgeusia (taste disturbances), a burning sensation, vasodilatation (widening of the blood vessels, including reddening of the skin), nausea (feeling sick), pruritus (itching) and feeling cold. For the full list of all side effects reported with Ablavar, see the package leaflet.
Danish: De hyppigste bivirkninger ved Ablavar (som optræder hos flere end 1 ud af 100 patienter) er hovedpine, paræstesi (prikkende og stikkende fornemmelse), dysgeusi (smagsforstyrrelser), en brændende fornemmelse, vasodilatation (udvidelse af blodkarrene, herunder rødmen), kvalme, pruritus (kløe) og kuldefornemmelse.
English: more than one dose during each MRI scan, and there should be a gap of at least a week between each Ablavar injection.
Danish: afgørende betydning, bør disse patienter højst få én dosis Ablavar under hver MRI-scanning, og der skal være et interval på mindst en uge mellem hver Ablavar-injektion.
English: All of the patients first had a scan using the standard X-ray method (angiography), followed by MRI scans without or with Ablavar used as a contrast enhancer.
Danish: Alle patienterne fik først en scanning, der anvendte den rutinemæssige røntgenmetode (angiografi) efterfulgt af MRIscanninger med eller uden Ablavar som kontraststof.
English: Doctors should avoid using Ablavar in patients who have severe kidney problems or who have recently had or are about to have a liver transplant.
Danish: Lægen bør undgå at give Ablavar til patienter, der lider af svære nyreproblemer, eller som lige har fået foretaget eller står for at skulle have foretage en levertransplantation.
English: Ablavar should not be used in people who may be hypersensitive (allergic) to gadofosveset trisodium or any of the other ingredients.
Danish: Ablavar bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for gadofosvesettrinatrium eller andre af indholdsstofferne.
English: What is the risk associated with Ablavar?
Danish: Hvilken risiko er der forbundet med Ablavar?
English: It is used in patients who are undergoing magnetic resonance angiography (MRA), a procedure where pictures of the flow of the blood in the body are taken using a scan called magnetic resonance imaging (MRI).
Danish: Det anvendes til patienter, der får udført magnetisk resonansangiografi (MRA), som er en diagnostisk metode, hvor der tages billeder af blodgennemstrømningen i kroppen ved brug af en speciel scanningsteknik, der kaldes magnetisk resonansscanning (MRI).
English: Gadolinium is used as a ‘contrast enhancer' to help obtain better pictures with MRI scanners.
Danish: Gadolinium anvendes som kontraststof for at få bedre billeder ved MRI-scanning.
English: The active substance in Ablavar, gadofosveset trisodium, contains gadolinium, a ‘rare-earth' metal element.
Danish: Det aktive stof i Ablavar, gadofosvesettrinatrium, indeholder gadolinium, der er et grundstof i gruppen af sjældne jordarter.
English: Why has Ablavar been approved?
Danish: Hvorfor blev Ablavar godkendt?
English: What is Ablavar?
Danish: Hvad er Ablavar?
English: Ablavar is a solution for injection that contains the active substance gadofosveset trisodium.
Danish: Ablavar er en injektionsvæske, opløsning, der indeholder det aktive stof gadofosvesettrinatrium.
English: What is Ablavar used for?
Danish: Hvad anvendes Ablavar til?
English: Ablavar is used to obtain a clearer scan in patients who have suspected or known problems with blood vessels in the abdomen (tummy) or limbs.
Danish: Ablavar anvendes til at give et tydeligere scanningsbillede hos patienter, hvor der er formodede eller allerede påviste problemer med blodkarrene i maven eller i arme og ben.
English: How has Ablavar been studied?
Danish: Hvordan blev Ablavar undersøgt?
English: What benefit has Ablavar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ablavar?
English: How is Ablavar used?
Danish: Hvordan anvendes Ablavar?
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen refererer den sidste dag i den pågældende måned.
English: Overdose: No data available
Danish: Overdosis: Ingen tilgængelige data
English: Do not use this veterinary medicinal product after the expiry date which is stated on the labels.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketterne.
English: Interaction with other medicinal products and other forms of interaction: No data available.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Der foreligger ingen data.
English: Pharmacotherapeutic group: {not yet assigned} ATCvet code: {not yet assigned}
Danish: Farmakoterapeutisk gruppe: {endnu ikke tildelt} ATCvet-kode: {endnu ikke tildelt}
English: The product needs to be administered immediately after thawing to prevent significant cell death.
Danish: Produktet skal administreres omgående efter optøning for at forhindre signifikant celledød.
English: OTHER INFORMATION
Danish: Andre oplysninger
English: In an experimental model of osteoarthritis in horses these effects were reflected through parameters related to cartilage turnover.
Danish: I en eksperimentel model af osteoartritis hos heste afspejlede disse virkninger sig gennem parametre relateret til bruskomsætning.
English: The product must be manipulated and injected using sterile techniques and in a clean environment.
Danish: Produktet skal håndteres og injiceres ved hjælp af sterile teknikker og i rene omgivelser.
English: No data available.
Danish: Der foreligger ingen data.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne, som er anført i punkt 6.1 i produktresuméet er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af forordning (EF) nr. 470/2009, når de anvendes som i dette veterinærlægemiddel.
English: Then mix both the suspensions in the same syringe to produce one dose of the product (2 ml).
Danish: Bland derefter de to suspensioner i samme sprøjte for at frembringe én dosis af produktet (2 ml).
English: 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.
Danish: Tilsætning af EAP til stamcellerne efter optøning og lige før injektion af produktet øger stamcellernes levedygtighed.
English: The handling of liquid nitrogen should take place in a well-ventilated area.
Danish: Håndtering af flydende kvælstof bør finde sted i et velventileret rum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/2019
Danish: Dato for første markedsføringstilladelse: 29/03/2019
English: Efficacy data are not available regarding treatment of other joints.
Danish: Der foreligger ikke data om virkning ved behandling af andre led.
English: Use a needle with a diameter greater than or equal to 22G in order to prevent cell damage.
Danish: Brug en kanyle med en diameter på mindst 22G for at undgå beskadigelse af cellerne.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/riskforholdet.
English: The chondrogenic induction of the mesenchymal stem cells aims to activate chondroprotective mechanisms, such as the production of extracellular matrix.
Danish: Hensigten med kondrogen induktion af de mesenkymale stamceller er at aktivere kondrobeskyttende mekanismer, såsom produktion af ekstracellulær matrix.
English: The veterinary product must be administered intraarticularly by a veterinary surgeon taking special precautions to ensure sterility of the injection process.
Danish: Dette veterinærlægemiddel skal indgives intraartikulært af en dyrlæge, der træffer særlige forholdsregler til at sikre sterilitet i injektionsprocessen.
English: 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).
Danish: Idet der anvendes egnede handsker, fjernes de to hætteglas (ét hætteglas med celler (1 ml) og ét hætteglas med EAP (1 ml)) fra fryseren/det flydende nitrogen og optøs straks ved 25 °C-37 °C, f.eks. i vandbad, indtil indholdet i begge er helt optøet (ca. 5 minutter).
English: The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktivt stof som principielt er af biologisk oprindelse, hvis formål er at producere passiv immunitet, falder ikke inden for anvendelsesområdet af forordning (EF) nr. 470/2009, når det anvendes som i dette veterinære lægemiddel.
English: 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.
Danish: Efter injektion af produktet migrerer stamcellerne ikke og bliver ikke fordelt fra det behandlede led og synovialvæsken til vævene omkring synovialkaviteten.
English: 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.
Danish: I tilfælde af selvinjektion (kan medføre smerter, lokale inflammatoriske reaktioner og hævelse på injektionsstedet, som kan vare i flere uger og muligvis medføre feber) ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Danish: Må ikke administreres samtidig med andre intraartikulære veterinærmedicinske produkter.
English: 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).
Danish: Hvis der efter optøning kan ses klumper af celler i nogen af hætteglassene, skal det pågældende hætteglas forsigtigt rystes, indtil suspensionen er klar og farveløs (stamcellesuspension) eller klar og gul (suspension af equint allogent plasma: fortyndingsvæsken).
English: Dosage: A single intraarticular injection of 1 dose (2 ml) per animal.
Danish: Dosering: En enkelt intraartikulær injektion af 1 dosis (2 ml) pr. dyr.
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler til brug til dyr
English: Each pack (polycarbonate container) contains a single dose of the product: one vial of stem cell suspension and one vial of EAP suspension.
Danish: Hver pakning (polycarbonatbeholder) indeholder en enkelt dosis af produktet: ét hætteglas med stamcellesuspension og ét hætteglas med EAP-suspension.
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.
Danish: Let øget halthed og reaktioner på injektionsstedet, såsom mild til moderat forøgelse af hævelse af led og let forhøjet temperatur på injektionsstedet, forekom meget almindeligt i den første uge efter anvendelsen af produktet.
English: This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP).
Danish: Dette produkt indeholder kondrogent inducerede equine mesenkymale stamceller og equint allogent plasma (EAP).
English: 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.
Danish: I overensstemmelse med den ansvarlige dyrlæges benefit/risk-vurdering med udgangspunkt i det enkelte tilfælde kan der administreres en systemisk enkeltdosis af et NSAID på samme dag som den intraartikulære injektion.
English: In order to avoid thrombosis in small vessels when administering intraarticular injections the correct placement of the needle is critical.
Danish: For at undgå trombose i små kar ved indgivelse af intraartikulære injektioner er korrekt placering af kanylen afgørende.
English: Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
Danish: Reduktion af mild til moderat tilbagevendende halthed i forbindelse med ikke-septisk ledinflammation hos heste.
English: EXP {month/year} Once reconstituted use immediately.
Danish: EXP {måned/år} Anvendes straks efter rekonstitution.
English: Cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap.
Danish: Hætteglas med cyclo-olefin copolymer (COC) med en prop af termoplastisk elastomer (TPE) og en kapsel af højdensitetspolyethylen (HDPE).
English: Single administration of 1 dose (equivalent to 2 ml) per animal
Danish: Dosering: Indgivelse af 1 enkelt dosis (svarende til 2 ml) pr. dyr
English: 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.
Danish: Tag kapslen af det hætteglas, der er tøet op først, træk suspensionen op i en sprøjte, fjern derefter kapslen fra det andet (optøede) hætteglas, og træk suspensionen op i samme sprøjte.
English: For any further information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette lægemiddel.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: Shelf life after preparation of the suspension for injection according to directions: use immediately
Danish: Opbevaringstid efter klargøring af injektionsvæske, suspension, ifølge anvisning: anvendes straks
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intraarticular use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cell suspension: clear colourless suspension.
Danish: Suspension af kondrogent inducerede perifert blod-deriverede equine allogene mesenkymale stamceller : klar, farveløs suspension.
English: Active substance (1 ml):
Danish: Hjælpestoffer (1 ml):
English: The product has been demonstrated to be efficacious in horses showing mild to moderate lameness in the fetlock joint.
Danish: Produktet effekt er påvist hos heste med mild til moderat halthed i kodeleddet.
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.
Danish: Produktets virkning er godtgjort i et pivotalt feltstudie efter enkeltadministration af produktet og samtidig systemisk enkeltadministration af et NSAID.
English: Colourless and clear suspension.
Danish: (1 ml) Farveløs, klar suspension.
English: Equine allogeneic plasma suspension:
Danish: Suspension af equint allogent plasma:
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Danish: I det pivotale kliniske feltstudie blev der administreret en enkelt systemisk dosis af et NSAID sideløbende med behandling med Arti-Cell Forte.
English: BATCH NUMBER Lot {number}
Danish: Batch {nummer}
English: Store and transport frozen (-90 ° to -70 °C) or in liquid nitrogen.
Danish: Opbevares og transporteres nedfrosset (-90 °C til -70 °C) eller i flydende nitrogen.
English: Excipients (1ml): Equine allogeneic plasma (EAP) 1 ml
Danish: Hjælpestoffer (1 ml): Equint allogent plasma (EAP) 1 ml
English: Shelf life after reconstitution according to directions: Use immediately.
Danish: Opbevaringstid efter rekonstitution ifølge anvisning: Anvendes straks.
English: Store and transport frozen (-90 °C to -70 °C) or in liquid nitrogen.
Danish: Opbevares og transporteres nedfrosset (-90 °C til -70 °C eller i flydende nitrogen).
English: PACKAGE SIZE One vial (1 ml) of stem cells and one vial (1 ml) of equine allogeneic plasma.
Danish: Ét hætteglas (1 ml) med stamceller og ét hætteglas (1 ml) med equint allogent plasma.
English: WITHDRAWAL PERIOD(S) Withdrawal period: zero days
Danish: Tilbageholdelsestid(er): 0 dage
English: Liquid nitrogen containers should be handled by properly trained personnel only.
Danish: Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr Beholdere med flydende kvælstof bør kun håndteres af behørigt uddannet personale.
English: WITHDRAWAL PERIOD(S) Zero days.
Danish: Tilbageholdelsestid(er): 0 dage.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose - contains:
Danish: Hver dosis på 2 ml indeholder:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/228/001
Danish: EU/2/18/228/001
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment.
Danish: I det pivotale kliniske feltstudie blev der givet en enkelt systemisk indgivelse af et NSAID sideløbende med behandlingen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Arti-Cell Forte
Danish: Fortyndingsvæske til Arti-Cell Forte
English: Equine allogeneic plasma suspension (diluent): clear yellow suspension.
Danish: Suspension af equint allogent plasma (fortyndingsvæske): klar, gul suspension.
English: In the absence of incompatibility studies, this veterinary product must not be mixed with other veterinary medicinal products
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler.
English: Name and address of the manufacturer of the biological active substance Global Stem cell Technology (GST) NV Noorwegenstraat 4
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Global Stem cell Technology (GST) NV Noorwegenstraat 4
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
Danish: Arti-Cell Forte, injektionsvæske, suspension, til heste Kondrogent inducerede equine allogene perifert blod-deriverede mesenkymale stamceller
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)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr)
English: PACKAGE LEAFLET: Arti-Cell Forte suspension for injection for horses
Danish: INDLÆGSSEDDEL: Arti-Cell Forte, injektionsvæske, suspension, til heste
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Polycarbonate container
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Diluent (EAP) vial: Equine allogeneic plasma
Danish: Hætteglas med fortyndingsvæske (EAP): Equint allogent plasma
English: Chondrogenic induced mesenchymal stem cell suspension:
Danish: Suspension af kondrogent inducerede mesenkymale stamceller: