FrancophonIA/ELRC3.0 huggingface dataset:
English: While there was a treatment-related reduction in time to radiographic fracture union, there was no difference over time between the TruScient treated group and the control group for the individual clinical parameters, lameness and pain, or for an overall score based on clinical signs of fracture healing.
Danish: Mens der var en behandlingsrelateret reduktion i tid til radiografisk frakturopheling, så var der ingen forskel over tid mellem den TruScient-behandlede gruppe og kontrolgruppen for de individuelle kliniske parametre halthed og smerter eller samlede score for kliniske tegn på frakturopheling.
English: Read the instructions below each time the veterinary medicinal product is used.
Danish: Læs anvisningerne nedenfor hver gang det veterinære lægemiddel skal anvendes.
English: The safety of the veterinary medicinal product has not been established during breeding, pregnancy and lactation.
Danish: Dette veterinære lægemiddels sikkerhed er ikke fastlagt under avl, drægtighed og diegivning.
English: The safety, including potential immune responses, and effectiveness of repeated administration have not been evaluated in dogs.
Danish: Sikkerhed, herunder potentielt immunrespons og virkning efter gentagen administration er ikke vurderet hos hunde.
English: Read the instructions for preparation and use below each time the veterinary medicinal product is used.
Danish: Læs anvisningerne for tilberedning og anvendelse nedenfor hver gang det veterinære lægemiddel skal anvendes.
English: The following adverse reactions have been observed in a field study in dogs:
Danish: Følgende bivirkninger er observeret i et feltstudie med hunde:
English: The incidence of antibody titres in treated dogs under field conditions is low and the puppies will have no or very limited exposure to anti-BMP-2 antibodies due to the potential for limited transfer across the placenta in dogs.
Danish: Forekomsten af antistof-titere hos behandlede hunde i deres naturlige omgivelser er lav og hvalpe vil være udsat for ingen eller meget begrænset eksponering for anti-BMP-2 antistoffer på grund af mulighed for begrænset overførsel gennem placenta hos hunde.
English: Clinical pharmacology studies demonstrate that the absorbable collagen sponge alone is not osteoinductive and is completely resorbed over time.
Danish: Kliniske farmakologiske undersøgelser viser, at den absorberbare kollagene matrix alene ikke er osteoinduktiv og resorberes fuldstændig over tid.
English: BMP-2 antibody response to TruScient was evaluated in 133 dogs receiving surgery for diaphyseal fractures stabilised with internal fixation.
Danish: BMP-2-antistof respons over for TruScient blev vurderet hos 133 hunde, der blev opereret for diafysefrakturer stabiliseret med intern fiksering.
English: Radiographic, biomechanical, and histological evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Danish: Radiografisk, biomekanisk og histologisk vurdering af det inducerede knoglevæv indikerer, at det biologisk og biomekanisk fungerer som naturligt knoglevæv.
English: The efficacy and safety of the veterinary medicinal product for the treatment of diaphyseal fractures was evaluated in a randomised, controlled, multicenter clinical field study involving dogs randomised to treatment with the veterinary medicinal product plus Standard Of Care (SOC) [n=84] or SOC [n=42] alone.
Danish: Det veterinære lægemiddels virkning og sikkerhed for behandling af diafyse-frakturer blev undersøgt i en randomiseret, kontrolleret, klinisk, multicenter feltundersøgelse med hunde, der var randomiseret til behandling med det veterinære lægemiddel plus standardbehandling (Standard Of Care (SOC)) [n=84] eller standardbehandling alene [n=42].
English: The following adverse reactions have been observed in laboratory studies in dogs:
Danish: Følgende bivirkninger er observeret i laboratorieundersøgelser med hunde:
English: Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy.
Danish: Må ikke anvendes hos hunde med umodent skelet, hos hunde der har en aktiv infektion på operationsstedet, patologisk fraktur eller enhver aktiv malignitet.
English: Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Danish: Dibotermin alfa binder til receptorer på overfladen af mesenchymale celler og får cellerne til at differentiere sig i brusk- og knogledannende celler.
English: Remodeling of the surrounding trabecular bone occurs in a manner that is consistent with the biomechanical forces placed on it.
Danish: Gendannelse af den omgivende trabekulære knogle sker på en måde, der er i overensstemmelse med de biomekaniske kræfter, den udsættes for.
English: Do not store above 25 C. Do not refrigerate.
Danish: Må ikke opbevares over 25° C. Må ikke opbevares i køleskab.
English: EXP {month/year} Discard the remaining solvent after reconstitution.
Danish: EXP {måneder/år} Bortskaf overskydende solvens efter rekonstitution.
English: TruScient should only be administered to the fracture site with utmost care.
Danish: TruScient må kun anbringes på frakturstedet med største omhu.
English: TruScient can cause initial resorption of surrounding trabecular bone.
Danish: TruScient kan medføre initial resorption af omgivende trabekulær knogle.
English: The maximum recommended dosage is the entire contents of a single TruScient kit for each dog (i.e., up to two 2.5 x 5 cm prepared TruScient sponges per dog).
Danish: Den højeste anbefalede dosis er hele indholdet af ét enkelt TruScient sæt for hver hund (dvs. op til to 2,5 x 5 cm tilberedte TruScient matrixer pr. hund).
English: Preclinical studies have suggested that bone formation initiated by TruScient is a self-limiting process, forming a well-defined volume of bone.
Danish: Prækliniske undersøgelser antyder, at knogledannelse, der fremkaldes af TruScient, er en selvbegrænsende proces, der danner en veldefineret mængde knogle.
English: White lyophilisate and a clear colourless solvent.
Danish: Hvidt lyofilisat og en klar, farveløs solvens.
English: Solvent for TruScient Water for injections
Danish: Solvens til TruScient Vand til injektionsvæsker
English: One vial of lyophilisate contains:
Danish: Et hætteglas med lyofilisat indeholder:
English: Each kit contains:
Danish: Hvert sæt består af:
English: TruScient should not be mixed with other agents.
Danish: TruScient bør ikke blandes med andre midler.
English: These swellings are the result of local proliferation of mesenchymal tissue maturing to new bone and are consistent with the pharmacologic activity of rhBMP-2
Danish: Disse hævelser er resultatet af lokal proliferation af mesenkymalt væv, der modnes til ny knogle og er i overensstemmelse med rhBMP-2s farmakologiske aktivitet.
English: No studies have been performed in dogs with metabolic bone diseases.
Danish: Der er ikke udført studier med hunde med metaboliske knoglesygdomme.
English: B. Prepare TruScient sponges in the sterile field:
Danish: B. Klargør TruScient matrix i et sterilt område:
English: It must not be re-sterilised.
Danish: Det må ikke gensteriliseres.
English: It is concluded therefore that at the site of implantation dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Danish: Det konkluderes derfor, at dibotermin alfa på implantationsstedet langsomt frigøres fra matrix og hurtigt udskilles efter optagelse i kredsløbet.
English: Figure 2: Preparation of TruScient sponges
Danish: Figur 2: Klargøring af TruScient matrix
English: Observed clinical signs were listed as adverse reactions for TruScient when they exceeded in intensity and/or duration of what would be considered normal for fracture healing after Standard of Care (SOC).
Danish: De kliniske tegn, der blev observeret, blev anført som bivirkninger af TruScient, når de i intensitet og/eller varighed oversteg det der kunne anses for at være normalt for heling af fraktur efter standardbehandling (Standard Of Care (SOC)).
English: The antibody titers did not correlate with any adverse clinical sign including any immune mediated adverse events such as allergic reactions.
Danish: Antistof-titerne korrelerede ikke med nogen uønskede kliniske tegn, herunder immunmedierede bivirkninger så som allergiske reaktioner.
English: Type I bovine collagen
Danish: Type I bovint kollagen
English: Place the prepared sponge so that it bridges the fracture and makes good contact with the major proximal and distal fracture fragments.
Danish: Anbring den klargjorte matrix så den dækker frakturen og opnår god kontakt med de større proksimale og distale frakturfragmenter.
English: Although no clear association with clinical outcome or undesirable effects could be observed in clinical and safety studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded.
Danish: Selvom der ikke blev observeret nogen klar sammenhæng mellem det kliniske udbytte og bivirkninger i kliniske og sikkerhedsstudier, så kan risikoen for at udvikle neutraliserende antistoffer eller overfølsomhedsreaktioner ikke udelukkes.
English: The bone formation process develops from the outside of the prepared sponge towards the center until the entire prepared sponge is replaced by trabecular bone.
Danish: Den knogledannende proces udvikler sig fra implantatets yderside og ind mod centrum, indtil hele implantatet er erstattet af trabekulær knogle.
English: The ability of TruScient to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by TruScient with that of the surrounding bone.
Danish: TruScients evne til at understøtte gendannelse af knoglen kan være årsagen til den biologiske og biomekaniske integration af den nye knogle som TruScient medfører med den omgivende knogle.
English: TruScient used in concentrations or amounts greater than those recommended is associated with excessive bone formation and increased generation of fluid-filled void spaces within the induced bone.
Danish: Anvendelse af TruScient i større koncentrationer eller mængder end anbefalet er forbundet med ekstra knogledannelse og øget dannelse af væskefyldte hulrum i den pågældende knogle.
English: Both rhBMP-2 and bovine Type I collagen can elicit an immune response in dogs.
Danish: Både rhBMP-2 og bovint type 1-kollagen kan fremkalde immunreaktion hos hunde.
English: The recommended dose is up to two sponges (2.5 x 5 cm) per dog.
Danish: Den anbefalede dosis er op til 2 matrixer (2,5 x 5 cm) pr. hund.
English: This self-limitation is likely due to the loss of dibotermin alfa from the application site, as well as the presence of BMP inhibitors in the surrounding tissues.
Danish: Denne selvbegrænsning skyldes sandsynligvis tabet af dibotermin alfa fra implantationsstedet samt tilstedeværelsen af BMP-hæmmere i det omgivende væv.
English: Sponge for TruScient
Danish: Matrix til TruScient
English: Biomechanical data suggest these voids had little influence on the biomechanical properties of the induced bone or its integration with the abutting cortices.
Danish: Biomekaniske data tyder på, at disse hulrum har ringe indflydelse på de biomekaniske egenskaber af den pågældende knogle eller dens integration med tilstødende cortex.
English: In animal studies (rats) using radiolabelled dibotermin alfa on absorbable collagen sponge, the mean residence time at the site of implantation was 4-8 days.
Danish: I dyrestudier (rotter) blev der anvendt radioaktivt mærket dibotermin alfa på absorberbar kollagenmatrix, var middel-residualtiden på implantationsstedet 4-8 dage.
English: As dibotermin alfa (rhBMP-2) is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Danish: Da dibotermin alfa (rhBMP-2) er et protein og ikke er blevet identificeret i den almindelige cirkulation, er det usandsynligt, at der opstår en farmakokinetisk interaktion med andre lægemidler.
English: This veterinary medicinal product should be used by an appropriately qualified veterinarian.
Danish: Dette veterinære lægemiddel bør kun anvendes af en dyrlæge med passende kvalifikationer.
English: The differentiated cells form trabecular bone as the sponge is degraded, with vascular invasion evident at the same time.
Danish: De differentierede celler danner trabekulær knogle efterhånden som matrix nedbrydes, samtidig med at vaskulær invasion er tydelig.
English: The results demonstrated that TruScient was effective in reducing the time to radiographic fracture union when added to SOC compared to treatment with SOC alone regardless of fracture type (open or closed).
Danish: Resultaterne viste at TruScient var effektiv til reduktion af tid til radiografisk frakturopheling, når det blev tilføjet til standardbehandling sammenlignet med behandling med standardbehandling alene, uanset frakturtype (åben eller lukket).
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life in the vial after reconstitution according to directions: 3 hours Discard any unused veterinary medicinal product.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning: 3 timer Ikke anvendt lægemiddel destrueres.
English: The prepared sponge may be wrapped around the bone or placed up to the edges of a bone plate as the geometry of the fracture and fixation requires.
Danish: Den tilberedte matrix kan svøbes omkring knoglen eller lægges op til hjørnerne af en knogleskinne afhængig af frakturens geometri og fiksering.
English: Very common (more than 1 in 10 animals) Mild to moderate Lameness Firm swelling within the first 3 weeks postoperatively which recedes gradually over several months Soft swelling which recedes within 3 weeks
Danish: Meget almindelig (hos flere end 1 ud af 10 dyr) Let til moderat halthed hård hævelse inden for de første 3 uger efter operationen, som gradvist svinder over adskillige måneder blød hævelse, som svinder inden for 3 uger
English: *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Danish: *Dibotermin alfa (rekombinant humant knogle-morfogenetisk protein-2; rhBMP-2) er et humant protein, der er fremstillet ved rekombinant teknologi i en cellelinje fra kinesiske hamsteres æggestokke.
English: Two sponges made of Bovine Type I collagen.
Danish: To matrixer fremstillet af bovint Type 1-kollagen.
English: TruScient does not provide mechanical stability and should not be used to fill space in the presence of compressive forces.
Danish: TruScient skaber ikke mekanisk stabilitet og bør ikke bruges til udfyldning ved tilstedeværelse af kompressionskræfter.
English: In the absence of compatibility studies, this veterinary medicinal product must be reconstituted only with the solvent provided and should not be mixed with other solvents or other veterinary medicinal products.
Danish: Da der ikke foreligger kompatibilitetsundersøgelser, må dette veterinære lægemiddel kun fortyndes med den medleverede solvens og bør ikke blandes med andre solvenser eller andre veterinære lægemidler.
English: TruScient is intended for single use only.
Danish: TruScient er kun til éngangsbrug.
English: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Danish: Zoetis Deutschland GmbH Tel: +49 30 330063 0
English: If a surgical drain is required, place the drain at least one layer superficial to or remote from the prepared sponge.
Danish: Hvis der er behov for kirurgisk dræn, skal drænet anbringes mindst et lag over eller fjernt fra den klargjorte matrix.
English: The amount of prepared sponge placed is determined by the fracture anatomy and the ability to close the wound with minimal compression of the sponge.
Danish: Mængden af klargjort matrix, der skal anvendes, afgøres af frakturens anatomi og muligheder for at lukke såret med minimal sammenpresning af matrix.
English: Dibotermin alfa (rhBMP-2) is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Danish: Dibotermin alfa (rhBMP-2) er et osteoinduktivt protein, der medfører induktion af nyt knoglevæv på implantationsstedet.
English: In case of accidental spillage onto skin and eyes rinse off immediately.
Danish: Ved kontakt med hud og øjne ved hændeligt uheld skylles omgående.
English: Achieve definitive fracture reduction, fixation, and hemostasis prior to placement of the prepared sponge.
Danish: Opnå fuldstændig frakturreduktion, fiksering og hæmostase før den klargjorte matrix anbringes.
English: Use within 2 hours of wetting the sponges.
Danish: Anvendes inden for 2 timer efter fugtning af matrixerne.
English: Two sterile sponges 2.5 x 5 cm in a polyvinyl chloride (PVC) blister package sealed with a Tyvek lid.
Danish: To sterile matrixer 2,5 x 5 cm i en polyvinylchlorid (PVC) blisterpakning, der er forseglet med et Tyvek-låg.
English: Discard any unused veterinary medicinal product.
Danish: Al ubrugt veterinærlægemiddel bortskaffes.
English: Investigators were aware of treatment assignment; reviewers assessing time to radiographic fracture union for each dog were masked to treatment.
Danish: Behandling var maskeret for analysemedarbejdere, der vurderede tid til radiografisk frakturopheling for hver hund.
English: In order to avoid excessive postoperative swelling, use only the amount of prepared TruScient sponge needed to achieve coverage of accessible fracture lines and defects (less than one to up to two prepared sponges).
Danish: For at undgå kraftig postoperativ hævelse, må der kun anvendes den nødvendige mængde tilberedt TruScient-matrix til dækning af tilgængelige frakturlinjer og -defekter (mindre end 1 matrix og op til 2 tilberedte matrixer).
English: Excessive bone and fluid filled cysts remodel into normal bone over time.
Danish: Ekstra knogledannelse og væskefyldte cyster omdannes til normalt knoglevæv over tid.
English: Use only the amount of prepared sponge needed to achieve coverage of accessible fracture lines and defects (less than one up to two prepared sponges).
Danish: Anvend kun den mængde af matrix der er nødvendig til at opnå dækning af tilgængelige frakturlinjer og defekter (mindre end 1 og op til 2 klargjorte matrixer).
English: ABSORBABLE COLLAGEN SPONGE LABEL
Danish: ETIKET - ABSORBERBAR KOLLAGEN MATRIX
English: Disinfect with alcohol the stoppers of the lyophilisate and the solvent vials.
Danish: Desinficér med alkohol propperne på hætteglassene med lyofilisat og solvens.
English: Sodium hydroxide (pH adjustment agent) Hydrochloric acid (pH adjustment agent)
Danish: Natirumhydroxid (pH-justering) Saltsyre (pH-justering)
English: 2 absorbable collagen sponges 2 sterile 3 ml disposable syringes with needles 1 sterile 6 ml disposable syringe with needle
Danish: 2 absorberbare kollagene matrixer 2 sterile 3 ml engangssprøjter med kanyler 1 steril 6 ml engangssprøjte med kanyle
English: Sponge: Bovine Type I collagen
Danish: Matrix: Bovint type I kollagen
English: Use the prepared sponge(s) within 15 minutes to 2 hours of wetting the sponges.
Danish: Anvend klargjort(e) matrix(er) inden for 15 minutter til 2 timer efter fugtning af matrixerne.
English: Cut or fold the prepared sponge as needed prior to placement.
Danish: Klip eller fold den klargjorte matrix efter behov før anbringelse.
English: Using the 6 ml syringe and needle, withdraw 3.2 ml of solvent (more solvent is supplied than is needed).
Danish: Med 6 ml sprøjten og kanylen udtages 3,2 ml solvens (der er mere solvens i hætteglasset, end der skal anvendes).
English: Failure to follow the instructions may compromise the safety and effectiveness of the medicinal product.
Danish: Manglende overholdelse af anvisningerne kan være kompromitterende for lægemidlets sikkerhed og virkning.
English: Peel open the inner package of sponges and leave them in the tray.
Danish: Åbn den indre emballage med matrixer og lad dem ligge i bakken.
English: Wait a MINIMUM of 15 minutes before using the prepared sponges.
Danish: Vent MINDST 15 minutter før de klargjorte matrixer anvendes.
English: Prepare sponges at least 15 minutes prior to use and use within 2 hours of wetting the sponges.
Danish: Tilbered matrixerne mindst 15 minutter før anvendelse og anvend inden for 2 timer efter fugtning af matrixerne.
English: Slowly inject the 3.2 ml of solvent into the lyophilisate vial (see Figure 1) to achieve a 0.2 mg/ml solution of rhBMP-2.
Danish: Injicer langsomt de 3,2 ml solvens i hætteglasset med lyofilisat (se figur 1) for at få en opløsning på 0,2 mg/ml rhBMP-2.
English: A. Reconstitute dibotermin alfa (rhBMP-2) in a non-sterile field: 1.
Danish: A. Tilbered dibotermin alfa (rhBMP-2) i et ikke-sterilt område:
English: TruScient 0.66 mg kit for implant for dogs
Danish: TruScient 0,66 mg, sæt til implantation til hunde
English: Shelf life in the vial after reconstitution: 3 hours Discard any unused veterinary medicinal product.
Danish: I hætteglas efter rekonstitution: 3 timer Ikke anvendt lægemiddel destrueres.
English: Bone plates should not be covered with the prepared sponge in order to facilitate plate removal if needed following fracture healing.
Danish: Knogleskinner bør ikke dækkes af matrix for at lette fjernelse af skinnen, om nødvendigt, efter opheling af fraktur.
English: Pharmacotherapeutic group: Bone Morphogenetic Proteins ATCvet code: QM05BC01
Danish: ATCvet-kode: QM05BC01
English: The dibotermin alfa (rhBMP-2) is reconstituted to 0.2 mg/ml solution and then distributed uniformly across both sponges.
Danish: Dibotermin alfa (rhBMP-2) rekonstitueres til en 0,2 mg/ml opløsning og fordeles jævnt over begge matrixer.
English: For accurate dosing ensure there are no suspended air bubbles in the transfer volumes.
Danish: Kontrollér at der ikke er iblandet luftbobler i opløsningen, der skal overføres.
English: EXP {month/year} Shelf life in the vial after reconstitution: 3 hours
Danish: EXP {måneder/år} Efter rekonstitution i hætteglasanvendes inden 3 timer
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinære lægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Using sterile technique, transfer the two 3 ml syringes with needles and the sponges inner package into the sterile field.
Danish: Under anvendelse af steril teknik overføres de to 3 ml sprøjter og kanyler samt indre emballage med matrixer til det sterile område.
English: Prepare sponges at least 15 minutes prior to use from components contained in the kit.
Danish: Tilbered matrixerne mindst 15 minutter før anvendelse med indholdet i sættet.
English: 1 vial (solvent)
Danish: 1 hætteglas (lyofilisat) 1 hætteglas (solvens)
English: Discard syringe and needle after use.
Danish: Bortskaf sprøjte og kanyle efter brug.
English: The following adverse reactions have been observed in laboratory studies in dogs: o Heterotopic ossification of the surrounding tissues o Exuberant bone formation at the site of placement and ectopic bone formation o Excessive bone and fluid filled cysts that remodel into normal bone over time o Increased swelling at the site of placement has been observed by 2-3 weeks post surgery.
Danish: ○ heterotopisk ossifikation af det omgivende væv ○ hypertrofisk knogledannelse på implantationsstedet og ektopisk knogledannelse ○ ekstra knogledannelse og væskefyldte cyster, der over tid omdannes til normalt knoglevæv ○ øget hævelse på implantationsstedet er observeret 2-3 uger efter operation.
English: Figure 1: Reconstitution of dibotermin alfa (rhBMP-2)
Danish: Figur 1: Rekonstitution af dibotermin alfa (rhBMP-2)
English: TruScient 0.66 mg kit for implant for dogs dibotermin alfa (rhBMP-2)
Danish: TruScient 0,66 mg, sæt til implantation til hunde dibotermin alfa (rhBMP-2)
English: Treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs.
Danish: Behandling af diafysefrakturer hos hunde som supplement til kirurgisk standardbehandling i form af åben reposition.