FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions listed in the table below is based on the following convention:
Danish: Hyppigheden af bivirkninger, som er anført i tabellen nedenfor, er baseret på den følgende konvention:
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10); Almindelig (≥1/100 to <1/10); Ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 to <1/1.000); meget sjælden (<1/10.000), kendes ikke (kan ikke vurderes ud fra de tilgængelige data).
English: - if you are an adolescent (12-18 years old) or your skeleton is not yet be fully formed (you are still growing).
Danish: - hvis De er ung (12-18 år), eller Deres skelet ikke er fuldt udviklet endnu (De vokser stadigvæk).
English: It has been observed following use (see section 4.8).
Danish: Dette er blevet observeret efter brug (se afsnit 4.8).
English: This should be considered in follow-up of patients with CT or X-ray.
Danish: Dette bør overvejes ved opfølgning på patienter med CT eller røntgen.
English: Not known: hypersensitivity, urticaria
Danish: Ikke kendt: overfølsomhed, urticaria
English: Not surprisingly, the antibody peak concentration was higher after the second exposure.
Danish: Det var ikke overraskende, at den maksimale koncentration af antistoffer var højere efter den anden eksponering.
English: The antibody levels declined towards baseline during the follow-up period.
Danish: Niveauet af antistof faldt ned mod baseline i løbet af opfølgningsperioden.
English: Do not place a drain directly in the implant or fusion site.
Danish: Anbring ikke noget dræn direkte på implantat- eller fusionsstedet.
English: Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group.
Danish: I testgruppen producerede 26% af patienterne antistoffer med neutraliserende kapacitet versus 1% i kontrolgruppen.
English: - if you have inadequate skin coverage and inadequate blood supply at the site of surgery (your doctor should have told you if this is the case).
Danish: - hvis De har utilstrækkelig huddækning og utilstrækkelig blodforsyning på indgrebsstedet (Deres læge skulle have underrettet Dem, hvis dette er tilfældet).
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisterne.
English: It is possible they may impair the effectiveness of this medicine or cause an immune system response.
Danish: Der er risiko for, at de reducerer effekten af dette lægemiddel eller forårsager en immunsystemreaktion..
English: The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Danish: Kollagenmatrix er uopløselig og består af partikler med en størrelse på mellem 75-425µm.
English: The hospital pharmacist or surgeon is responsible for the correct storage of this medicine both before and during its use, as well as for its correct disposal.
Danish: Hospitalets farmaceut eller kirurg er ansvarlig for korrekt opbevaring af produktet, både før og under dets brug, såvel som for korrekt bortskaffelse af dette.
English: Sarcoma was associated with the long-term presence of the heterotopic bone.
Danish: Sarkom var forbundet med langtids-tilstedeværelse af heterotop knogle.
English: This medicinal product should be used by an appropriately qualified surgeon.
Danish: Dette lægemiddel skal anvendes af en tilstrækkeligt kvalificeret kirurg.
English: • have an active malignancy or are undergoing treatment for a malignancy;
Danish: • har en aktiv malignitet eller får behandling for en malignitet
English: Opgenra must not be used in patients who:
Danish: Opgenra må ikke anvendes til patienter, som:
English: Common: post-operative infection
Danish: Almindelig: postoperativ infektion
English: Do not insert a needle through the stoppers.
Danish: Sæt ikke en nål gennem propperne.
English: The product should have a malleable, coherent putty-like consistency.
Danish: Produktet skal have en letbearbejdelig og sammenhængende kitagtig konsistens.
English: - if you are a child (less than 12 years old).
Danish: - hvis det er et barn, der skal behandles (under 12 år).
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 somværende lavere end vægten hos kontrolgruppen i observationsperioden.
English: There are no data on the pharmacokinetics of the active substance in man.
Danish: Der foreligger ingen data om farmakokinetikken for det aktive stof hos mennesker.
English: The CHMP recommend an additional five-year renewal based on the following pharmacovigilance grounds: the clinical experience with the product in the designated indication has been very limited in the EU during the first 5-year period of marketing authorisation.
Danish: CHMP anbefaler en fornyelse i yderligere fem år med følgende begrundelse, der tager udgangspunkt i bivirkningsovervågning: Den kliniske erfaring med dette produkt i forbindelse med den valgte indikation har været yderst begrænset inden for EU i løbet af den første 5-årige markedsføringstilladelsesperiode.
English: To be attached to the patient's medical record.
Danish: Skal påhæftes patientens medicinske journal.
English: The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6).
Danish: De kliniske implikationer af disse observationer ved humant brug af det færdige lægemiddel er fortsat usikre (se afsnit 4.6).
English: Closure is critical for containment and maintenance of the product in the area of intended fusion.
Danish: Lukningen er kritisk for, at produktet fastholdes og forbliver i området for den påtænkte fusion.
English: The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal.
Danish: Resultaterne af radiologiske og histologiske undersøgelser i denne undersøgelse viste knogleheling efter initial og gentagen eksponering i det samme dyr.
English: Place it subcutaneously if possible.
Danish: Anbring det om muligt subkutant.
English: The cellular events induced by the active substance take place within the product matrix.
Danish: De cellulære virkninger, der påføres af det aktive stof, finder sted inden for produktmatrix.
English: The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Danish: Resultaterne af disse undersøgelser viste ingen uforudsete eller systemiske virkninger af toksicitet i observationsperioden og efter indgift.
English: You can help by reporting any side effects you may get.
Danish: De Du kan hjælpe ved at indberette alle de bivirkninger, De du får.
English: This is normally done under a full general anaesthetic so you will not be awake during the surgery.
Danish: Dette udføres normalt under fuld narkose, så De vil ikke være vågen under indgrebet.
English: In a clinical study of the medicinal product, antibodies to the protein eptotermin alfa were detected in 194 out of 207 (94%) patients treated with it and 18 out of 86 (21%) treated with autograft bone (control group).
Danish: I en klinisk undersøgelse af lægemidlet blev der fundet antistoffer over for proteinet eptotermin alfa hos 194 ud af 207 (94%) patienter, der blev behandlet med det, og hos 18 ud af 86 (21%), der blev behandlet med knogle-autotransplantat (kontrolgruppe).
English: Remove the reconstituted product from the sterile bowl with a sterile instrument such as a spatula or curette.
Danish: Fjern det rekonstituerede produkt fra den sterile skål med et sterilt instrument som f.eks. en spatel eller curette.
English: However, results from implantation studies in animals demonstrate that the active substance eptotermin alfa is released from the implant site over several weeks and never reaches a level higher than 3% of the total amount implanted in the peripheral blood.
Danish: Resultaterne af implantationsforsøg på dyr viser imidlertid, at det aktive stof eptotermin alfa frigives fra implantatstedet over adskillige uger og aldrig når et højere niveau end 3% af den samlede mængde, der er implanteret, i det perifere blod.
English: Use of Opgenra does not guarantee fusion; additional surgeries may be required.
Danish: Brug af Opgenra er ikke garanti for fusion; yderligere indgreb kan være påkrævede.
English: However, an immune response to eptotermin alfa should be considered and appropriate validated 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 medicinal product is ineffective.
Danish: En immunreaktion over for eptotermin alfa skal imidlertid tages i betragtning, og passende validerede tests for tilstedeværelse af antistoffer i serum skal udføres i tilfælde, hvor der er mistanke om en immun-medieret bivirkning, inklusive tilfælde, hvor lægemidlet er ineffektivt.
English: Grounds for one additional renewal
Danish: Begrundelse for yderligere fornyelse
English: Treatment requires a single surgery.
Danish: Behandlingen kræver et enkelt indgreb.
English: The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established.
Danish: Den maksimale humane dosis bør ikke overstige 2 enheder, idet effektivitet og sikkerhed ved spinal fusion, som kræver større doser, ikke er undersøgt.
English: This effect, termed solid state carcinogenicity, has been frequently observed in rats in which 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 maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Danish: Den maksimale dosis af denne medicin bør ikke overstige 2 enheder (6,6 mg eptotermin alfa), da medicinens virkning og sikkerhed ved højere doser ikke er blevet undersøgt.
English: Opgenra has no known pharmacological effect on neuro-motor coordination or performance consequently it is unlikely to alter any pre-existing skills used for driving vehicles or operating machines.
Danish: Opgenra har ingen kendt farmakologisk virkning på neuromotorisk koordination eller præstation, og det er derfor usandsynligt, at det vil ændre allerede eksisterende evner til at føre motorkøretøj eller betjene maskiner.
English: Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De behandles med dette lægemiddel, da den indeholder vigtige oplysninger.
English: The frequency and severity of post-operative adverse events was similar in both test and control groups.
Danish: Hyppigheden og sværhedsgraden af postoperative bivirkninger var omtrent den samme i både test- og kontrolgrupperne.
English: The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra.
Danish: Det pivotale studie med 295 patienter involverede uinstrumenteret posterolateral lumbar spinalfusion hos 208 patienter behandlet med Opgenra.
English: However, there is no evidence to suggest that heterotopic ossification is linked to sarcoma development in humans.
Danish: Der er dog intet, der tyder på, at heterotop ossifikation er forbundet med udvikling af sarkom hos mennesker.
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 kontrollerne.
English: This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it.
Danish: Denne gruppe lægemidler får nyt knoglevæv til at vokse på det sted, hvor kirurgen har placeret (implanteret) lægemidlet.
English: However the rate of malformations was similar to those from historical controls.
Danish: Hyppigheden af misdannelser var imidlertid sammenlignelig med hyppigheden ved historiske kontroller.
English: Clinical studies to investigate the efficacy and safety of this medicinal product in cervical spine surgery have not been performed; consequently its use outside the region of the lumbar spine cannot be recommended.
Danish: Kliniske undersøgelser, der undersøger lægemidlets effektivitet og sikkerhed ved kirurgi af columna cervicalis, er ikke blevet udført; dets brug udenfor rygradens lumbale område kan derfor ikke anbefales.
English: • have inadequate skin coverage and vascularity at the site of spinal fusion;
Danish: • har utilstrækkelig huddækning og vaskularisering på spinal fusion-stedet;
English: There were no patients with neutralizing antibodies 2 years following treatment.
Danish: Der var ingen patienter med neutraliserende antistoffer 2 år efter behandlingen.
English: A small quantity (one unit) of this medicine is reconstituted and placed directly on each side of the spine at the site requiring fusion.
Danish: En lille mængde (en enhed) af dette lægemiddel rekonstitueres og placeres direkte på hver side af rygraden på det sted, som skal sammenføjes.
English: Opgenra is intended only for single use in each patient.
Danish: Opgenra er kun beregnet til engangsbrug hos hver enkelt patient.
English: Therefore, Opgenra may only be administered to the fusion site under adequate vision and with utmost care.
Danish: Opgenra må derfor kun anvendes på fusionsstedet under tilstrækkelig visuel kontrol og med yderste forsigtighed.
English: Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Danish: Anti-OP-1-antistoffer har evnen til som minimum at neutralisere in vitro-biologisk aktivitet på BMP-6.
English: Do not breast-feed your baby during treatment with this medicine.
Danish: De må ikke amme Deres barn under behandlingen med dette lægemiddel.
English: For intraosseous use.
Danish: Til intraossøs anvendelse.
English: Laboratory studies have demonstrated that there is a theoretical risk of developing autoimmunity towards the natural (endogenous) BMP proteins in your body following repeat exposure to this medicine.
Danish: Laboratorieundersøgelser har vist, at der er en teoretisk risiko for, at De kan udvikle en allergisk reaktion (autoimmunitet) over for de naturlige (endogene) BMP-proteiner i kroppen ved gentagen eksponering over for dette lægemiddel.
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 i kaninmodeller.
English: The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs with two long bone defects treated with repeat implantations.
Danish: Effekten af anti-OP-1-antistoffer på knoglehelingsprocessen blev undersøgt hos hunde med en defekt i to forskellige lange knogle, der blev behandlet med gentagne implantationer.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, knoglemorfogenetiske proteiner, ATC-kode: M05BC02
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: Talk to your doctor if you have any of the following: - Common (may affect up to 1 in 10 people):
Danish: Tal med lægen, hvis De får følgende bivirkninger: - Almindelige bivirkninger (påvirker 1 til 10 brugere ud af 100):
English: 4 vials:
Danish: 4 hætteglas:
English: The pattern of unrelated post-operative adverse events varied with the extent of surgical trauma, procedural complications and the pre-operative health of the patient.
Danish: Mønsteret af urelaterede postoperative bivirkninger varierede med omfanget af kirurgisk traume, behandlingskomplikationer og patientens præoperative helbred.
English: • have an active infection at the site of spinal fusion or history of recurring infections;
Danish: • har aktiv infektion på spinalfusionsstedet eller anamnese med tilbagevendende infektioner;
English: Therefore, upon re-administration of Opgenra, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Danish: Hvis Opgenra genadministreres, kan der derfor være en risiko for udvikling af autoimmunitet mod de endogene BMP-proteiner.
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 koncentrationer af IgG-klasse anti-OP-1-antistoffer blev konstateret i mælk under hele undersøgelsens postnatale fase til diedag 28 (se afsnit 4.6).
English: In the study populations, some patients with common pre-existing co-morbidities (e.g. cardiovascular, respiratory, genitourinary disorders, neoplasms) experienced exacerbations of their prior disease during the long term (three year) follow up period.
Danish: I forsøgspopulationerne oplevede nogle patienter med hyppigt forekommende præeksisterende komorbiditet (for eksempel kardiovaskulære, respiratoriske eller urogenitale sygdomme, neoplasmer) eksacerbationer af deres forudgående sygdom under den langvarige (tre år) opfølgningsperiode.
English: Opgenra is an osteoinductive and osteoconductive medicinal product.
Danish: Opgenra er et osteoinduktivt og osteokonduktivt medicinsk implantat.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Eventuelt ubrugt materiale eller affald skal bortskaffes i overensstemmelse med lokale krav.
English: Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Danish: Opgenra er indiceret til posterolateral lumbar spinalfusion hos voksne patienter med spondylolistese, hvor autograft er mislykket eller kontraindiceret.
English: • product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
Danish: • produktet flytter sig (migrerer) (dette er blevet observeret, når produktet blev blandet med nogle syntetiske fyldningsmaterialer til knogledefekter).
English: The matrix is also osteoconductive and it allows bone in-growth into the defect area from the adjacent healthy bone.
Danish: Matrix er også osteokonduktiv, og den giver mulighed for, at knoglevæv kan vokse ind i det defekte område fra den omgivende, sunde knogle.
English: To fuse a single level of the lumbar region of the spine, one unit of medicinal product is used on each side of the spine.
Danish: Til fusionering af et enkelt niveau af rygradens lumbale område anvendes der én enhed af lægemidlet på hver side af rygraden.
English: It is recommended that breast-feeding be discontinued following treatment.
Danish: Det anbefales at afbryde amningen efter behandling.
English: The MAH shall agree the details of an education programme for surgeons with the National Competent Authorities and must implement such programme nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med nationale ansvarlige myndigheder godkende detaljerne i et uddannelsesprogram for kirurger og implementere et sådant program nationalt for at sikre at:
English: The clinical study results suggest that there does not appear to be any association between neutralizing antibodies and the development of adverse events related to the immune system.
Danish: De kliniske undersøgelsesresultater antyder, at der ikke synes at være nogen forbindelse mellem neutraliserende antistoffer og udviklingen af bivirkninger i relation til immunsystemet.
English: • redness of the skin (erythema) ,
Danish: • rødmen af huden (erytem)
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6.
Danish: Undersøgelser med anti-OP-1-antistoffer viste nogen krydsreaktivitet med de nært beslægtede knoglemorfogenetiske proteiner BMP-5 og BMP-6.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown.
Danish: I dyreundersøgelser er udskillelse af IgG-klasse anti-OP-1-antistoffer i modermælk blevet påvist.
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 i føtale misdannelser (skæve brystben) blev observeret hos kuld i den OP-1-immuniserede gruppe.
English: - if you have an active infection in your spine or have been told that you have an active internal
Danish: - hvis De har en aktiv infektion i rygraden, eller har fået at vide, at De har en aktiv intern (systemisk) infektion.
English: Potential interaction with Calstrux, a bone void filler has been reported (see section 4.5).
Danish: Potentiel interaktion med Calstrux, et fyldningsmateriale til knogledefekter, er blevet rapporteret (se afsnit 4.5).
English: One unit of Opgenra powder for implantation suspension comes as two separate powders.
Danish: Én enhed Opgenra pulver til suspension til implantation leveres som to separate pulvere.
English: Single dose and repeat dose studies in a range of animal models (rats and primates) were performed.
Danish: Der er gennemført undersøgelser med enkeltdoser og gentagne doser på en række forsøgsdyr (rotter og pattedyr).
English: Opgenra is implanted during an invasive surgical procedure performed under general anaesthesia.
Danish: Opgenra implanteres under et invasivt kirurgisk indgreb, der udføres under generel anæstesi.
English: The same procedure should be used to prepare the medicinal product for the contralateral side of the spine.
Danish: Den samme procedure skal følges for at klargøre lægemidlet til den kontralaterale side af rygraden.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Trykte indlægsseddel for lægemidlet skal der anføres navn og adresse på fremstilleren ansvarlig for frigivelsen af det parti bekymring.
English: • collection of fluid in the tissues (seroma),
Danish: • væskeansamling i vævene (seroma)
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 den celleproliferation og de differentieringsprocesser, der er påført af det aktive stof.
English: Repeat use of this bone morphogenetic protein (BMP) is not recommended.”
Danish: Gentagen brug af dette knoglemorfogenetiske protein (BMP) frarådes.”
English: Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, the medicinal product should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see section 5.3).
Danish: På grund af de ukendte risici for fosteret i forbindelse med potentiel udvikling af neutraliserende antistoffer over for OP-1 protein, bør lægemidlet ikke bruges ved graviditet, medmindre de potentielle fordele retfærdiggør de potentielle risici for fosteret (se afsnit 5.3).
English: Opgenra is contraindicated in children aged 0 to 12 years old, adolescents aged 12 to 18 years and the skeletally immature.
Danish: Opgenra er kontraindiceret til børn mellem 0 og 12 år, unge mennesker mellem 12 og 18 år og ikkefuldvoksne mennesker.