FrancophonIA/ELRC3.0 huggingface dataset:
English: For instructions on reconstitution of the medicinal product before administration, see section
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: You will be monitored by your doctor if there is any medical suspicion that new antibodies have formed.
Danish: De vil blive overvåget af Deres læge, hvis der er mistanke om, at De kan have dannet nye antistoffer.
English: Like all medicines, Osigraft can have side effects, although not everybody gets them.
Danish: Osigraft kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Heterotopic ossification may also occur following use (see section 4.8).
Danish: Heterotop ossifikation kan også forekomme efter anvendelse (se afsnit 4.8).
English: The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period.
Danish: Ungernes vægt i den behandlede gruppe blev noteret at være lavere end vægten hos kontrolgruppen i observationsperioden.
English: The frequency of possible side effects listed below is defined using the following convention:
Danish: Hyppigheden af bivirkningerne på listen nedenfor er defineret ud fra den følgende konvention:
English: Handle the crimp with care.
Danish: Behandl krympehætten forsigtigt.
English: The results of radiological and histological examinations in this non-clinical study showed bone healing with the initial and repeat exposure in the same animal.
Danish: Resultaterne af radiologiske og histologiske undersøgelser i denne ikke-kliniske undersøgelse viste knogleheling med initiel og gentagen eksponering i det samme dyr.
English: Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed.
Danish: Anvend ikke sug eller irrigation direkte på implantatstedet, da partiklerne af Osigraft kan blive fjernet.
English: Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required.
Danish: Osigraft giver ingen biomekanisk styrke og bør anvendes sammen med intern eller ekstern fiksering, hvis der kræves initiel mekanisk stabilisering.
English: The reconstituted product should be used immediately.
Danish: Det rekonstituerede produkt skal straks anvendes.
English: The maximum recommended dose for this medicine is 2 vials (2g) since its effectiveness at higher doses has not been established.
Danish: Den maksimale anbefalede dosis af dette lægemiddel er 2 hætteglas (2 g), da dets effektivitet ved større doser ikke er fastlagt.
English: In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals.
Danish: I en anden undersøgelse blev en forskel i kropsvægtsøgning observeret hos de immuniserede voksne hundyr mellem diedag 14 til 21 i sammenligning med kontroldyrene.
English: Important information about some of the ingredients of Osigraft Osigraft contains bovine collagen.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Osigraft Osigraft indeholder bovint kollagen.
English: Do not insert a needle through the stopper.
Danish: Sæt ikke en nål gennem proppen.
English: However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Danish: Imidlertid viser resultater af Osigraft implantationsforsøg på dyr, at det aktive stof eptotermin alfa stort set er systemisk utilgængeligt.
English: Take special care with Osigraft The following are precautions for use of Osigraft to be discussed with your doctor.
Danish: Vær ekstra forsigtig med at tage Osigraft Følgende forholdsregler for anvendelse af Osigraft skal drøftes med Deres læge:
English: These newly formed antibodies have not been found to cause any harm to patients.
Danish: Det er ikke observeret, at disse nydannede antistoffer forårsager nogen skade på patienter.
English: Some patients treated with this product were also reported to have experienced various undesirable effects associated with recent orthopaedic surgery.
Danish: Nogle patienter, som blev behandlet med dette produkt, rapporteredes også at have oplevet forskellige bivirkninger i forbindelse med nylig ortopædkirurgi.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: 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); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende kategorier blev anvendt til at klassificere bivirkningerne efter, hvor hyppigt de forekom: 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 de tilgængelige data).
English: Therefore, upon readministration of eptotermin alfa, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Danish: Efter gentagen administration af epotermin alfa kan der derfor være en risiko for udvikling af autoimmunitet mod de endogene BMP-proteiner.
English: This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
Danish: Denne virkning, betinget fast karcinogenitet, er ofte set på rotter, hvor faste materialer (plast eller metal) blev implanteret subkutant.
English: The antibody levels declined towards baseline during the follow-up period.
Danish: Antistofniveauet faldt ned mod basislinien løbet af opfølgningsperioden.
English: Fertility There is no evidence to suggest that eptotermin alfa alters fertility.
Danish: Fertilitet Der er ingen beviser, som antyder, at epotermin alfa ændrer fertiliteten.
English: 6.5 Nature and contents of container and special equipment for use, administration or
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse, administration eller
English: An immune response to Osigraft should be considered and appropriate tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the product is ineffective.
Danish: En immunreaktion over for Osigraft skal tages i betragtning, og passende test for tilstedeværelse af antistoffer i serum skal udføres i tilfælde, hvor der er mistanke om en immunmedieret bivirkning, inklusive tilfælde, hvor produktet er ineffektivt.
English: Repeated use of Osigraft is not recommended because clinical trials of multiple surgical treatments at different times have not been undertaken in patients.
Danish: Gentagen anvendelse af Osigraft anbefales ikke, da kliniske forsøg med flere kirurgiske behandlinger på forskellige tidspunkter ikke er udført på patienter.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt inden De begynder at bruge medicine.
English: The cellular events induced by the active substance take place within the collagen matrix.
Danish: De cellulære virkninger, der påføres af det aktive stof, finder sted inden for kollagenmatrixen.
English: Laboratory studies have shown that antibodies to the eptotermin alfa component of this medicine could react with similar antibodies that the body makes naturally.
Danish: Laboratorieundersøgelser har vist, at antistoffer mod epotermin alfa-komponenten i dette lægemiddel kunne reagere med lignende antistoffer, som kroppen danner naturligt.
English: There is a possibility that new antibodies can form in your body after treatment with Osigraft.
Danish: Der er en mulighed for, at nye antistoffer kan dannes i kroppen efter behandling med Osigraft.
English: Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use.
Danish: Hvert hætteglas med Osigraft rekonstitueres med 2-3 ml steril 9 mg/ml natriumchloridinjektionsvæske (0,9 % w/v) inden brug.
English: If you have a known hypersensitivity to collagen you should not be treated with this medicine.
Danish: Hvis De ved, De er overfølsom over for kollagen, må De ikke behandles med dette lægemiddel.
English: What Osigraft contains
Danish: Osigraft indeholder
English: Intraosseous use.
Danish: Intraossøs anvendelse.
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures; the antibody peak concentration was higher after the second implantation.
Danish: Antistoffer over for OP-1 og bovint kollagen type 1 blev fundet efter begge eksponeringer; peakkoncentrationen af antistoffer var højere efter den anden implantation.
English: This is usually done under a full general anaesthetic so you will not be awake during the surgery.
Danish: Operationen udføres normalt i helbedøvelse, så De vil ikke være vågen under operationen.
English: Repeat Use
Danish: Gentagen anvendelse
English: However, there is evidence to suggest that heterotopic ossification is not linked to sarcoma in humans.
Danish: Der er dog noget, der tyder på, at heterotop ossifikation ikke er forbundet med sarkom hos mennesker.
English: Clinical outcomes of pain and weight-bearing were comparable to the autograft (81% success in the Osigraft group, 77% success in the autograft group).
Danish: De kliniske resultater af smerter og vægtbæring kunne sammenlignes med autograft-kontrollen (81% succes i Osigraftbehandlingsgruppen, 77% succes i autograft-gruppen).
English: Women should not breast-feed during the period immediately following treatment with Osigraft.
Danish: Kvinder må ikke amme i perioden umiddelbart efter behandling med Osigraft.
English: Antibodies are special proteins produced by the human body as part of the healing process in various diseases; one such illness is a virus infection.
Danish: Antistoffer er specielle proteiner, som kroppen producerer som del af helbredelsesprocessen ved forskellige sygdomme som f.eks. en virusinfektion.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 °C - 8 °C)
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 1.0, Modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Danish: I en 2 års subkutan implantationsundersøgelse på rotter blev der som forventet set heterotop knogledannelse.
English: The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs following two long bone defects treated with repeat implantations.
Danish: Effekten af anti-OP-1 antistoffer på knoglehelingsprocessen blev undersøgt hos hunde efter to lang knogle-defekter, der blev behandlet med gentagne implantationer.
English: Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Danish: Kontrollerede undersøgelser af effekten af eksponering over for eptotermin alfa på præ- og postnatal udvikling blev udført hos kaninmodeller.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, knoglemorfogenetiske proteiner, ATC-kode: M05BC02
English: Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Danish: Anti-OP-1antistoffer har evnen til at neutralisere biologisk aktivitet in vitro, i hvert fald af BMP-6.
English: Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Danish: Signifikant højere titre af IgG klasse anti-OP-1 antistoffer blev konstateret i mælk under hele undersøgelsens postnatale fase til diedag 28 (se afsnit 4.6).
English: The new bone formed is mechanically and radiographically comparable to normal bone.
Danish: Det nye knoglevæv dannes mekanisk og radiografisk sammenligneligt med normalt knoglevæv.
English: The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively).
Danish: Røntgenresultaterne af Osigraftbehandlingsgruppen var lidt mindre end autograft-kontrolgruppen (68% henholdsvis 79%).
English: After reconstitution, the single use suspension for implantation should be used immediately.
Danish: Efter rekonstitution skal suspensionen til implantation anvendes straks.
English: The potential for harm to the breast-feed infant is unknown.
Danish: Risikoen for skade på ammede børn er ukendt.
English: Depending on the size of the bone defect, more than one 1 g vial of Osigraft may be required.
Danish: Afhængigt af knogledefektens omfang kan det være nødvendigt at anvende mere end et enkelt hætteglas Osigraft på 1g.
English: Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Danish: Osigraft må derfor kun anvendes på det defekte område under tilstrækkelig visuel kontrol og med yderste forsigtighed.
English: Antibodies often form as part of the body's response to treatment with some medicines one of these is Osigraft.
Danish: Antistoffer dannes ofte som en del af kroppens reaktion på behandling med visse lægemidler, og et af disse er Osigraft.
English: Tel +353 87 9278653 medicalinfo@olympusbiotech.com
Danish: Tlf +353 87 9278653 medicalinfo@olympusbiotech.com
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Danish: Undersøgelser med anti-OP-1-antistoffer viste nogen krydsreaktivitet med de nært beslægtede BMP-proteiner BMP-5 og BMP-6.
English: A similar pattern of adverse reactions has been recorded from spontaneous reporting with an incidence significantly less than that seen in the clinical trials.
Danish: Et tilsvarende bivirkningsmønster er registreret ud fra spontane indberetninger med en signifikant lavere hyppighed end den, der er set i de kliniske forsøg.
English: The matrix is also osteoconductive and it allows bone in-growth into the defect area from the surrounding healthy bone.
Danish: Matrixen er også osteokonduktiv, og den giver mulighed for, at knoglevæv kan vokse ind i det defekte område fra den omgivende sunde knogle.
English: Heterotopic ossification commonly occurs in humans following accidental or surgical trauma.
Danish: Heterotop ossifikation sker almindeligvis hos mennesker som følge af ulykke eller kirurgisk trauma.
English: Animal studies were conducted that cannot rule out effects of anti-OP-1 antibodies on embryo-foetal development (see section 5.3).
Danish: Der er udført dyreforsøg, som ikke kan udelukke indvirkninger af anti-OP-1-antistoffer på embryoføtal udvikling (se afsnit 5.3).
English: FOIL FOR THE BLISTER PACK (OUTER) FOR THE VIAL
Danish: FOLIE TIL BLISTERPAKKEN (YDRE) FOR HÆTTEGLASSET
English: The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.
Danish: Primærpakken holdes steril i en blisterpakning, som består af to (indre og ydre) plastbakker og låg.
English: As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-fed during Osigraft therapy (see section 5.3).
Danish: Da human IgG udskilles i human mælk, og potentialet for skade på spædbarnet er ukendt, bør kvinder ikke amme, mens de bliver behandlet med Osigraft (se afsnit 5.3).
English: A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Danish: En statistisk signifikant stigning af føtale misdannelser (skæve brystben) blev observeret hos kuld i den OP-1-immuniserede gruppe.
English: Where practical, surgical manipulations to the site should be completed prior to implantation of the product.
Danish: Hvis det er praktisk, gennemføres kirurgiske manipulationer på området inden implantation af produktet.
English: This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Danish: Dette giver et egnet bioresorberbart stativ til forankring, afhængigt af celleproliferation og differentieringsprocesser påført af det aktive stof.
English: Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, Osigraft should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see sections 4.4 and 5.3).
Danish: På grund af de ukendte risici for fosteret i forbindelse med potentiel udvikling af neutraliserende antistoffer over for OP-1-protein, skal Osigraft ikke bruges ved graviditet medmindre de potentielle fordele retfærdiggør de potentielle risici for fosteret (se afsnit 4.4 og afsnit
English: If you are a nursing mother you should be treated with Osigraft only if your physician or surgeon considers the benefits to you outweigh the risks to your child.
Danish: Hvis De er mor og ammer, må De kun behandles med Osigraft, hvis Deres læge eller kirurg mener, at fordelene for Dem opvejer risikoerne for Deres barn.
English: Using your thumb, pry up the edge of the stopper.
Danish: Brug tommelfingeren til at vippe kanten af proppen op.
English: Osigraft is an osteoinductive and osteoconductive medicinal product.
Danish: Osigraft er et osteoinduktivt og osteokonduktivt medicinsk implantat.
English: Osigraft should not be used during pregnancy unless the expected benefits to the mother are thought to outweigh the possible risks to the unborn child.
Danish: Osigraft må ikke bruges under graviditet, medmindre de forventede fordele for moren menes at opveje de mulige risikoer for fosteret.
English: Method of administration: Intraosseous use.
Danish: Indgivelsesmåde: Intraossøs anvendelse.
English: Osigraft is only used by an appropriately qualified surgeon.
Danish: Osigraft anvendes kun af en kvalificeret kirurg.
English: Do not place a drain directly in the implant site.
Danish: Anbring ikke dræn direkte på implantationsstedet.
English: Powder for suspension for implantation.
Danish: Pulver til suspension til implantation.
English: The surrounding muscle tissues are closed around the implanted medicine as is the skin on the top of the muscle.
Danish: Det omgivende muskelvæv lukkes omkring det implanterede lægemiddel, og huden lukkes oven på musklen.
English: If required, place it subcutaneously.
Danish: Anbring det om nødvendigt subkutant.
English: Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone fragments so that the reconstituted Osigraft is in direct contact with bleeding bone and viable osseous tissue.
Danish: Debridér fibrøst, nekrotisk eller sklerotisk væv og fortag passende dekapsulering af knoglefragmenter, således at det rekonstituerede Osigraft er i direkte kontakt med blødende knogle og egnet knoglevæv.
English: The surrounding soft tissues are then closed around the implant.
Danish: De omgivende bløddele lukkes derefter omkring implantatet.
English: Apply the reconstituted product to the prepared osseous site using a sterile instrument such as a spatula or curette.
Danish: Anbring det rekonstituerede produkt på det præparerede knoglevævsområde med et sterilt instrument, som f.eks. en spatel eller en curette.
English: Antibody test positive (Antibody formation)
Danish: Antistoftest positiv (antistofdannelse)
English: Bovine collagen (vacuum dried).
Danish: Bovint kollagen (vakuumtørret).
English: No association with clinical outcome or adverse event could be observed in clinical studies.
Danish: Der kunne ikke observeres nogen forbindelse med kliniske resultater eller bivirkninger i kliniske undersøgelser.
English: Irrigate as necessary prior to the implantation of Osigraft.
Danish: Skyl om nødvendigt inden implantering af Osigraft.
English: - if you are receiving chemotherapy, radiation treatment or immunosuppression
Danish: • får kemoterapi, strålebehandling eller behandling med immunsuppressiva.
English: Interaction with other medicine
Danish: Interaktion med andre lægemidler
English: Osigraft is a type of medicine known as a bone morphogenetic protein (BMP).
Danish: Osigraft indeholder en type medicin, som kaldes et knoglemorfogenisk protein (BMP).
English: The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
Danish: Det afgørende forsøg med manglende opheling af tibia sammenlignede Osigraft med autograft med et primært effektivitets-slutpunkt på 9 måneder efter behandlingen.
English: Musculoskeletal and connective tissue disorders Bone formation increased (Heterotopic ossification / Myositis ossificans)
Danish: Knogleopbygning forøget (heterotopisk ossifikation/myositis ossificans )
English: The edges of the crimp are sharp and may cut or damage gloves.
Danish: Kanterne af den kan være skarpe og kan rive eller beskadige handsker.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING
English: The new bone remodels naturally, cortices are formed and marrow elements are generated.
Danish: Det nye knoglevæv genskabes naturligt, der dannes cortex og marvelementer genereres.
English: No case of overdose has been reported.
Danish: 4.9 Overdosering Der er ikke rapporteret tilfælde af overdosering.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når der modtages ny information, der kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilance-plan eller på risikominimeringsaktiviteter
English: Posology Osigraft should be used by an appropriately qualified surgeon.
Danish: Dosering Osigraft skal anvendes af en tilstrækkeligt kvalificeret kirurg.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
Danish: I dyreundersøgelser er udskillelse OP-1-antistoffer i IgG-klassen i modermælk blevet påvist.
English: Lift the plastic flip-top and remove the crimp from the vial.
Danish: Løft plast-vippelåget og tag krympehætten af hætteglasset.
English: Closure is critical for containment of the implant in the area of the bone defect.
Danish: Lukningen er kritisk for, at implantatet forbliver lukket inde i området med knogledefekten.
English: When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Danish: Når Osigraft er rekonstitueret, har det konsistens som vådt sand, hvilket letter implantation og placering i knogledefekt-områder.
English: * Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Danish: * Fremstillet i celler fra kinesiske hamstres ovarier (CHO) ved rekombinant DNA teknologi.
English: Provide adequate haemostasis to ensure that the implanted material is not dislodged from the surgical site.
Danish: Sørg for tilstrækkelig hæmostase til at sikre, at det implanterede materiale ikke flytter sig fra operationsstedet.
English: Name and address of the manufacturer(s) of the biological active substance
Danish: Navn og adresse på fremstilleren/fremstillerne af det (de) biologisk aktive stof
English: very common (affects more than 1 user in 10)
Danish: • meget almindelig (forekommer hos flere end 1 bruger ud af 10)