FrancophonIA/ELRC3.0 huggingface dataset:
English: During surgery Osigraft is placed directly at the injury site in contact with the damaged bone surfaces.
Danish: Under operationen placeres Osigraft direkte på brudstedet i kontakt med de beskadigede knogleoverflader.
English: Motion in the non-union site may disrupt the fracture healing process.
Danish: Bevægelse i det ikke ophelede område kan afbryde frakturophelingsprocessen.
English: Experience from controlled clinical trials is limited to stabilisation of the fracture by intramedullary nailing.
Danish: Erfaring fra kontrollerede kliniske forsøg er begrænset til stabilisering af frakturen ved marvsømning.
English: Implanted material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications.
Danish: Implanteret materiale, som er løsnet fra frakturstedet, kan forårsage ektopisk knogledannelse i det omgivende væv med mulige komplikationer.
English: Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
Danish: Fjern om nødvendigt overskydende væske ved at suge uden om implantatstedet eller forsigtigt duppe området med en steril svamp.
English: Depending on the size of the gap in the broken bone one or two vials of Osigraft may be administered.
Danish: Afhængigt af størrelsen af spalten i den brækkede knogle vil der blive brugt et eller to hætteglas Osigraft.
English: Osigraft stimulates the growth of new bone as part of the treatment of a fracture non-union and needs the support of specialised surgical devices to stabilise the broken bone while it heals.
Danish: Osigraft stimulerer væksten af nyt knoglevæv som del af behandlingen af uophelet knoglebrud, og det er nødvendigt at stabilisere den brækkede knogle med specielle kirurgiske anordninger, mens den heler.
English: Eptotermin alfa, the active substance, initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle.
Danish: Eptotermin alfa, det aktive stof, starter knogledannelsen ved at påføre celle-differentiering i mesenchymale celler, der hentes til implantatstedet fra knoglemarv, periost og muskler.
English: Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of powder.
Danish: Når vakuummet er brudt, fjernes proppen, mens hætteglasset holdet lodret for at hindre spild af pulver.
English: Sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette.
Danish: Steril natriumchloridinjektionsvæske og indholdet af Osigraft hætteglasset overføres til en steril skål og blandes med en steril spatel eller curette.
English: The recommended maximum dose should not exceed 2 vials since efficacy in the treatment on non-unions requiring higher doses has not been established.
Danish: Den maksimale dosis bør ikke overstige 2 hætteglas, idet effektivitet ved behandling af manglende opheling med åbninger, der kræver større doser, ikke er undersøgt.
English: Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process.
Danish: Når det aktive stof først er bundet på celleoverfladen, påføres en kaskade af cellulære virkninger, der fører til dannelse af chondroblaster og osteoblaster, der spiller en vigtig rolle i knogledannelsesprocessen.
English: In the absence of comparability studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke forligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater.
English: To avoid breakage, do not tap the bottom of the vial when transferring contents.
Danish: For at hindre, at hætteglasset går i stykker, må man ikke slå på bunden af hætteglasset, når indholdet overføres.
English: The pivotal clinical trial supporting the approval of Osigraft did not include the use of synthetic bone void fillers.
Danish: Pivotalforsøget, der understøttede godkendelsen af produktet, omfattede ikke brugen af syntetiske fyldningsmaterialer til knogledefekter.
English: Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium).
Danish: Pulver i hætteglas af glas (type 1, borsilikat) lukket med en prop (butylgummi) og hætte (aluminium).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (se bilag I: Produktresume; afsnit 4.2).
English: Puncture of the stopper with a needle may result in particles of stopper material contaminating the powder.
Danish: Hvis proppen punkteres med en nål, kan det medføre, at partikler af propmaterialet kontaminerer pulveret.
English: Close soft tissues around the defect containing the product using suture material of choice.
Danish: Luk bløddele omkring defekten, som indeholder produktet, med egnet suturmateriale.
English: What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber coloured glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.
Danish: Osigraft leveres som et hvidt til off-white pulver pakket i et ravfarvet hætteglas (pakkestørrelse på 1) inden i en blisterpakning bestående af en plastbakke og låg i en æske.
English: Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Danish: Behandling af uophelet tibia af mindst 9 måneders varighed som følge af traume hos fuldvoksne patienter i tilfælde, hvor tidligere behandling med autograft er mislykket, eller hvor anvendelse af autograft ikke er mulig.
English: Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with the medicine.
Danish: Fertile kvinder skal informere deres kirurg om muligheden for graviditet inden behandling med lægemidlet.
English: Special care must be taken to prevent any leakage of Osigraft due to wound irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Danish: Der skal udvises ekstra forsigtighed for at hindre eventuel lækage af Osigraft som følge af sårskylning, utilstrækkelig lukning af omgivende væv eller utilstrækkelig hæmostase.
English: Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.
Danish: Fertile kvinder skal anbefales at anvende effektiv kontraception i mindst 12 måneder efter behandlingen.
English: Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before undergoing treatment with Osigraft.
Danish: Fødedygtige kvinder skal informere kirurgen om mulighed for graviditet før behandling med Osigraft.
English: The active substance is eptotermin alfa (a recombinant human Osteogenic protein 1 produced in a recombinant Chinese hamster ovary (CHO) cell line).
Danish: Aktivt stof: eptotermin alfa (et rekombinant humant osteogent protein, som produceres i en cellelinje fra kinesiske hamstres ovarier (CHO)).
English: Experience from controlled clinical trials is limited to stabilisation of tibial non-union site using concomitant intramedullary nailing.
Danish: Erfaringer fra kontrollerede kliniske forsøg er begrænset til stabilisering af det tibiale fraktursted ved hjælp af samtidig anvendelse af intramedullære søm.
English: Marketing Authorisation Holder Olympus Biotech International Limited 40 Upper Mount Street Dublin 2
Danish: Indehaver af markedsføringstilladelsen Olympus Biotech International Limited 40 Upper Mount Street Dublin 2
English: After closure of the soft tissues around the bone defect, irrigate field if necessary to remove any of the product which may have become dislodged during soft tissue closure.
Danish: Efter lukning af bløddele omkring knogledefekten, skylles området om nødvendigt for at fjerne eventuelt implantat, der kan have flyttet sig under lukningen af bløddelene.
English: The following table of adverse reactions was compiled from those observed and recorded during clinical trials.
Danish: Nedenstående tabel over bivirkninger er kompileret ud fra de bivirkninger, der er observeret og registreret i kliniske forsøg.
English: Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of eptotermin alfa.
Danish: I studiet med tibiafrakturer blev der påvist antistoffer over for OP-1-protein hos 66% af patienterne efter indgivelse af epotermin alfa.
English: Women of childbearing potential are advised to use effective contraception up to at least 12 months after treatment.
Danish: Fødedygtige kvinder anbefales at bruge et effektivt præventionsmiddel i mindst 12 måneder efter behandlingen.
English: Osigraft should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Danish: Osigraft bør kun anvendes til ammende kvinder, hvis den ansvarlige læge skønner, at fordelene herved opvejer risiciene.
English: Antibodies to eptotermin alfa were found in sera from pooled foetal and umbilical cord blood at levels that correlated to that of the maternal blood.
Danish: Antistoffer over for eptotermin alfa blev fundet i sera fra samlet foster- og navlestrengeblod ved nivauer, som korrelerede med moderblodet.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen, hvis De bruger anden medicin eller har brugt det for nylig.
English: Bovine collagen.
Danish: Bovint kollagen.
English: The reconstituted product is administered by direct surgical placement at the non-union site in contact with the prepared bone surface.
Danish: Det rekonstituerede produkt indgives ved direkte kirurgisk placering på det uophelede sted i kontakt med den klargjorte knogleoverflade.
English: Post market surveillance data has signalled that the use of the product in combination with a synthetic bone void filler may lead to an increase in local inflammation, infection and occasional migration of the implanted materials and it is therefore not recommended.
Danish: Overvågningsdata indsamlet efter markedsføringen har signaleret, at brugen af produktet i kombination med et syntetisk fyldningsmateriale til knogledefekter kan medføre en forøgelse af lokal inflammation, infektion og lejlighedsvis migration af de implanterede materialer, og det anbefales derfor ikke.
English: The amount of Osigraft used should approximate the size of the bone
Danish: Mængden af anvendt Osigraft skal svare til
English: One vial of Osigraft contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen.
Danish: Et hætteglas med Osigraft indeholder 1 g pulver, som indeholder 3,3 mg epotermin alfa og hjælpestoffet bovint kollagen.
English: Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.2).
Danish: Osigraft er kontraindikeret hos børn og unge (under 18 år) og ved ikke fuldt udvokset skelet (se afsnit
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren/fremstillerne ansvarlig(e) for batchfrigivelse
English: including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome
Danish: Deres eget væv), herunder rheumatoid arthritis, systemisk lupus eythematosus, scleroderma,
English: Bovine Collagen
Danish: Bovint kollagen
English: This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. Osigraft is implanted in adult patients with fractures of the tibia which have failed to heal for at least 9 month duration in cases where treatment with autograft (transplanted bone from your hip) has failed or should not be used.
Danish: Osigraft implanteres hos voksne patienter med frakturer i skinnebenet (tibia), som ikke er vokset sammen efter mindst 9 måneder, i tilfælde, hvor behandling med autotransplantat (transplanteret knogle fra patientens hofte) er mislykkedes eller ikke kan anvendes.
English: Osigraft 3.3 mg powder for suspension for implantation eptotermin alfa
Danish: Osigraft 3,3 mg pulver til suspension til implantation eptotermin alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3,3 mg
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER/FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Keep out of the reach and sight of children.
Danish: Opbevares utilgængeligt for børn og uden for børns synsvidde.
English: Post procedural tenderness (Tenderness)
Danish: Ømhed efter behandling (ømhed)
English: - for treating non-union resulting from pathological (disease-related) fractures, metabolic bone
Danish: - til behandling af manglende heling som følge af patologiske (sygdomsrelaterede) frakturer,
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: If you have further questions, ask your doctor.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended (see section 4.5).
Danish: Brugen af Osigraft med et syntetisk fyldningsmateriale til knogledefekter, kan medføre en risiko for forøgelse af lokal inflammation, infektion og lejlighedsvis migration af de implanterede materialer, og anbefales derfor ikke (se pkt.
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Danish: Blod- og mælkeprøver blev indsamlet med regelmæssige mellemrum og analyseret ved hjælp af en fast fase enzym-bundet immunoassay (ELISA) test. Påviselige niveauer af IgG og IgM antistoffer over for eptotermin alfa havde udviklet sig og blev fundet i serum fra alle eksponerede voksne dyr.
English: The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended.
Danish: Brug af Osigraft sammen med et syntetisk fyldningsmateriale til knogledefekter kan medføre en risiko for forøgelse af lokal vævsirritation, infektion og lejlighedsvis migration af de implanterede materialer og anbefales derfor ikke.
English: Precaution for use
Danish: Forholdsregler vedrørende anvendelse
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Ikke anvendt lægemiddel og affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Using sterile technique, remove the vial from its packaging.
Danish: Tag hætteglasset ud af emballagen under anvendelse af steril teknik.
English: Use of Osigraft does not guarantee repair; additional surgery may be required.
Danish: Brug af Osigraft garanterer ikke heling; ekstra indgreb kan være påkrævede.
English: Osigraft must not be used in patients who: have a known hypersensitivity to the active substance or to collagen;
Danish: • har en kendt overfølsomhed over for det aktive stof eller kollagen;
English: Osigraft 3.3 mg powder for suspension for implantation
Danish: LÆGEMIDLETS NAVN Osigraft 3,3 mg pulver til suspension til implantation
English: This medicine should not be used after the expiry date which is printed on the carton and the blister.The expiry date refers to the last day of that month.
Danish: Brug ikke Osigraft efter den udløbsdato, der står på æsken og blisterpakningen.
English: have known autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis; have active infection at the site of non-union or active systemic infection; have inadequate skin coverage and vascularity of the non-union site; have vertebral fractures; have a non-union resulting from pathological fractures, metabolic bone disease or tumours; have any tumour in the vicinity of the non-union site; are receiving chemotherapy, radiation treatment or immunosuppression;
Danish: Sjögrens syndrom og dermatomyositis/polymyositis, - hvis De har en aktiv infektion på det sted, der ikke vil hele (inflammation og dræn på skadestedet) eller en aktiv systemisk infektion, - hvis Deres læge har konstateret, at De har utilstrækkelig huddækning (på frakturstedet) og utilstrækkelig blodforsyning til operationsstedet, - til frakturer i rygsøjlen.
English: Osigraft 3.3 mg powder for suspension for implantation.
Danish: LÆGEMIDLETS NAVN Osigraft 3,3 mg pulver til suspension til implantation.
English: Do not use Osigraft - if you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft (see section 6).
Danish: Brug ikke Osigraft - hvis De er overfølsom (allergisk) over for eptotermin alfa, kollagen eller et af de øvrige indholdsstoffer i Osigraft (se afsnit 6), - hvis De er ung, og Deres skelet ikke er fuldt udvokset (De vokser stadig), - hvis De er et barn (under 18 år), - hvis De har en kendt autoimmunsygdom (sygdom, der stammer direkte fra eller er rettet mod
English: - when there are any tumours in the area of the non-union site.
Danish: • har eventuel svulst i nærheden af frakturstedet;
English: Injury, poisoning and procedural complications Postoperative wound site erythema (Erythema)
Danish: Erytem på det postoperative sted (erytem)
English: 3.3 mg of eptotermin alfa
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 3,3 mg eptotermin alfa
English: However, use of Osigraft does not guarantee repair; additional surgery may be required.
Danish: Anvendelse af Osigraft er dog ikke nogen sikkerhed for heling, yderligere indgreb kan være påkrævede.
English: Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed.
Danish: Der er gennemført undersøgelser af enkeltdoser og gentagne doser på en række forsøgsdyr.
English: Special care is taken during surgery to prevent Osigraft leaking into the surrounding tissue in order to avoid the possibility of new bone growing outside the treated non-union location.
Danish: For at undgå risiko for ny knoglevækst uden for det behandlede uophelede sted skal der udvises særlig omhu under operationen for at forhindre, at Osigraft kommer ind i det omgivende væv.
English: Use of Osigraft does not guarantee repair, additional surgery may be required.
Danish: Anvendelse af Osigraft er ikke nogen sikkerhed for heling, yderligere indgreb kan være påkrævede.
English: - for vertebral (spine) fractures.
Danish: • har vertebralfrakturer;
English: Each vial contains 3.3 mg eptotermin alfa*.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 3,3 mg eptotermin alfa*.
English: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om blindeskrift
English: POSSIBLE SIDE EFFECTS
Danish: Bivirkninger Almindelige
English: Paediatric population
Danish: Fertile kvinder
English: common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data
Danish: • ikke almindelig (forekommer hos mellem 1 og 10 brugere ud af 1.000)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intraossøs anvendelse.
English: Breast-feeding
Danish: Limerick
English: If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: VIAL
Danish: UDLØBER
English: In clinical studies, the following undesirable effects have been reported: Common reported side effects included: discoloration of the wound site, erythema (redness of the skin), tenderness, and swelling over the implant site, heterotopic ossification / myositis ossificans (bone formation outside of the fracture area).
Danish: • har kendt autoimmun sygdom, herunder arthritis rheumatoides, systemtisk lupus erythematosus,scleroderma, Sjögrens syndrom og dermatomyositis/polymyositis;
English: - if your doctor determines that you have inadequate skin coverage (at the fracture site) and inadequate blood supply at your site of surgery.
Danish: • har utilstrækkelig huddækning og vaskularisering af frakturstedet;
English: Not statistically significant
Danish: Ikke statistisk signifikant
English: This may increase the risk of cancer.
Danish: Dette kan øge risikoen for kræft.
English: Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013
Danish: Dato for første markedsføringstilladelse: 16. januar 2009 Dato for seneste fornyelse: 19. september 2013
English: These are both normal and do not need to be removed
Danish: Begge dele er normalt, og de behøver ikke fjernes.
English: • Improve your physical function.
Danish: • for at forbedre din fysiske funktion
English: Your body weight
Danish: Din kropsvægt
English: • If you have an active infection which your doctor thinks is important.
Danish: • hvis du har en aktiv infektion, som din læge anser for at være betydningsfuld.
English: No reduced efficacy was observed.
Danish: Der blev ikke observeret reduceret virkning.
English: UNIFI-I included 961 patients.
Danish: UNIFI-I omfattede 961 patienter.
English: These include:
Danish: De kan omfatte:
English: This appearance is not unusual for proteinaceous solutions.
Danish: Dette udseende er ikke usædvanligt for proteinholdige opløsninger.
English: • it is the right medicine
Danish: • at det er den rigtige medicin
English: In these patients, 45 mg was also shown to be efficacious.
Danish: Hos disse patienter har 45 mg også vist sig at være effektivt.
English: • Wash your hands very well with soap and warm water
Danish: • Vask dine hænder grundigt med sæbe og varmt vand.
English: The following doses are usually the same as the starting dose.
Danish: De efterfølgende doser er sædvanligvis de samme som startdosen.
English: • After the expiry date which is stated on the label and the carton after ‘EXP'.
Danish: • efter den udløbsdato, der står på etiketten og pakningen efter "EXP".
English: It should be administered over at least one hour.
Danish: Det skal administreres i løbet af mindst en time.
English: Get everything together that you need and lay out on a clean surface.
Danish: Find alt det frem, som du har brug for, og læg det ud på en ren overflade.
English: Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Danish: Monoklonale antistoffer er proteiner, som genkender og bindes specifikt til visse proteiner i kroppen.
English: Do not use the medicine if it has been shaken strongly.
Danish: Brug ikke medicinen, hvis den er blevet rystet voldsomt.
English: Regulation of CYP450 enzymes
Danish: Regulering af CYP450-enzymer
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Danish: Hvis lægemidlet ikke anvendes straks, er opbevaringstid og -forhold under brug brugerens ansvar.
English: • If the product has been shaken vigorously.
Danish: • hvis produktet er blevet rystet voldsomt.