FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are nursing, you should receive this medicine only if your treating physician or surgeon considers the benefits to you outweigh the risks to your child.
Slovenian: Če dojite, lahko prejmete to zdravilo samo, če lečeči zdravnik ali kirurg oceni, da koristi odtehtajo tveganje za otroka.
English: The medicinal product should be used in breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Slovenian: To zdravilo se pri nosečih ženskah lahko uporablja le, če se zdravnik odloči, da koristi prevladajo nad tveganjem.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown.
Slovenian: V študijah na živalih so pokazali, da se protitelesa razreda IgG proti OP-1 izločajo v mleko.
English: • Inform your doctor or surgeon if you have been administered this medicine in the past.
Slovenian: • Zdravnika ali kirurga obvestite, če ste že kdaj v preteklosti prejeli to zdravilo.
English: Debride and decorticate bone so that the reconstituted medicinal product will directly contact viable tissue.
Slovenian: S kosti odstranite tkivo in jo oluščite, tako da bo rekonstituirano zdravilo v neposrednem stiku z viabilnim tkivom.
English: • have inadequate skin coverage and vascularity at the site of spinal fusion;
Slovenian: • z neustrezno pokritostjo s kožo ali vaskularizacijo mesta spinalne fuzije;
English: Place the contents of the eptotermin alfa vial and carmellose vial in a sterile bowl.
Slovenian: Vsebino vial z eptoterminom alfa in karmelozo prenesite v sterilno posodo.
English: There are no data on the pharmacokinetics of the active substance in man.
Slovenian: Podatkov o farmakokinetiki zdravilne učinkovine pri človeku ni.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Navodila za rekonstitucijo zdravila pred uporabo so v poglavju 6.6.
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.
Slovenian: da obstaja teoretično tveganje za nastanek avtoimunosti proti naravnim (endogenim) proteinom za morfogenezo kosti v telesu po ponavljajoči se izpostavitvi temu zdravilu.
English: Handle the crimp caps with care.
Slovenian: Z zaporkami ravnajte previdno.
English: After closure of the soft tissues around the implant, irrigate the field if necessary to remove any stray particles of the medicinal product which may have been dislodged during soft tissue closure.
Slovenian: Ko so mehka tkiva v okolici vsadka zaprta, jih po potrebi izperite, da odstranite delce zdravila, ki so se morda nabrali med zapiranjem mehkega tkiva.
English: Opgenra should be used immediately after reconstitution.
Slovenian: Zdravilo Opgenra je treba uporabiti takoj po rekonstituciji.
English: Use of this medicine with synthetic bone substitutes is not recommended.
Slovenian: Uporaba tega zdravila s sintetičnimi kostnimi nadomestki se ne priporoča.
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.
Slovenian: Ko se zdravilna učinkovina veže na površino celic, sproži niz celičnih dogodkov, ki pripeljejo do nastanka hondroblastov in osteoblastov, ki imajo ključno vlogo pri procesu tvorbe kosti.
English: Potential interaction with Calstrux, a bone void filler has been reported (see section 4.5).
Slovenian: Poročali so o mogočih interakcijah z zdravilom Calstrux, kostnim polnilom (glejte poglavje 4.5).
English: There were no patients with neutralizing antibodies 2 years following treatment.
Slovenian: Dve leti po zdravljenju bolnikov z nevtralizirajočimi protitelesi ni bilo.
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).
Slovenian: Zaradi neznanega tveganja za plod, povezanega z morebitnim nastankom nevtralizirajočih protiteles proti beljakovini OP-1, se to zdravilo med nosečnostjo sme uporabljati samo, kadar morebitne koristi prevladajo nad morebitnim tveganjem za plod (glej poglavji 5.3).
English: Post-marketing surveillance data includes reports that the use of the medicinal product in combination with a synthetic bone void filler, may lead to an increase in local inflammation, infection and occasionally migration of the implanted materials (see section 4.4).
Slovenian: Podatki iz postmarketinškega nadzora kažejo, da uporaba tega zdravila v kombinaciji s sintetičnim kostnim polnilom lahko poveča pogostnost lokalnih vnetij, okužb in občasno premikanja vsajenega materiala (glejte poglavje 4.4).
English: Common: wound dehiscence, secretion, pseudarthrosis Uncommon: product migration when mixed with synthetic bone
Slovenian: Pogosti: odprtje rane, sekrecija, psevdoartroza Občasni: premikanje zdravila, kadar se meša s sintetičnim kostnim
English: The antibody levels declined towards baseline during the follow-up period.
Slovenian: V obdobju sledenja so se ravni protiteles zmanjšale na izhodiščno vrednost.
English: Opgenra is implanted during an invasive surgical procedure performed under general anaesthesia.
Slovenian: Zdravilo Opgenra se vsadi med invazivnim kirurškim posegom, ki se opravlja pod splošno anestezijo.
English: The cellular events induced by the active substance take place within the product matrix.
Slovenian: Celični dogodki, ki jih sproža zdravilna učinkovina, potekajo znotraj matriksa zdravila.
English: The surrounding muscle tissue is then closed around the implanted medicine as is the skin on top of the muscle.
Slovenian: Okoliško mišično tkivo se nato zapre okoli vsajenega zdravila, čez mišice pa se nazaj zašije koža.
English: See end of section 4 for how to report side effects.
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
English: Opgenra is only used by an appropriately qualified surgeon during the course of spinal fusion surgery.
Slovenian: Zdravilo Opgenra lahko uporablja samo ustrezno usposobljen kirurg med kirurškim posegom za spinalno fuzijo.
English: As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Opgenra therapy (see section 5.3).
Slovenian: Pri človeku se protitelesa IgG izločajo v mleko, morebitno tveganje za dojenčka pa je neznano, zato ženske med zdravljenjem z zdravilom Opgenra ne smejo dojiti (glejte poglavje 5.3).
English: including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma,
Slovenian: vključno s Crohnovo boleznijo, revmatoidnim artritisom, sistemskim eritematoznim lupusom,
English: Post-marketing surveillance data includes reports that the use of the medicinal product in combination with a synthetic bone void filler, may lead to an increase in local inflammation, infection and occasionally migration of the implanted materials.
Slovenian: Podatki iz nadzora v obdobju trženja vključujejo poročila, da lahko uporaba zdravila v kombinaciji s sintetičnim kostnim polnilom privede do povečanja lokalnega vnetja, okužbe in občasno premika vsajenega materiala.
English: As the potential for harm to the breast fed infant is unknown, women should not breast-feed during the period immediately following treatment with this medicine.
Slovenian: Morebitno tveganje za novorojenca, ki se doji, ni znano, zato ženske ne smejo dojiti v obdobju takoj po zdravljenju s tem zdravilom.
English: • collection of fluid in the tissues (seroma),
Slovenian: • nabiranje tekočine v tkivih(serom),
English: Repeated use of this medicine cannot be recommended.
Slovenian: Ponavljajoča se uporaba tega zdravila ni priporočljiva.
English: • Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
Slovenian: • Zdravnika ali kirurga obvestite, če ste v preteklosti imeli težave s srcem ali če ste nagnjeni k pogostim okužbam, da vas bo lahko skrbno spremljal.
English: The surrounding soft tissues are then closed around the implanted material.
Slovenian: Nato se okrog implantiranega materiala zaprejo obkostna mehka tkiva.
English: The matrix is also osteoconductive and it allows bone in-growth into the defect area from the adjacent healthy bone.
Slovenian: Matriks ima tudi osteokonduktivne lastnosti in omogoča vraščanje kosti iz zdrave kosti v okolici v območje poškodbe.
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.
Slovenian: Za ustrezno shranjevanje tega zdravila pred uporabo in med njo ter za njegovo pravilno odstranjevanje sta odgovorna bolnišnični farmacevt in kirurg.
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.
Slovenian: Zdravilna učinkovina, eptotermin alfa, spodbuja nastanek kosti z indukcijo celične diferenciacije mezenhimskih celic, ki se na mesto vsadka preselijo iz kostnega mozga, periosta in mišic.
English: The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Slovenian: Rezultati so pokazali, da po uporabi in v obdobju opazovanja ni nepričakovanih sistemskih toksičnih učinkov.
English: • hypersensitivity and antibody formation
Slovenian: • preobčutljivosti in tvorbi protiteles,
English: Opgenra is a type of medicine known as a bone morphogenetic protein (BMP).
Slovenian: Opgenra je vrsta zdravila, znana kot kostni morfogenezni protein.
English: The carmellose imparts a putty-like consistency to the medicinal product for ease of molding and placement on each side of the spine.
Slovenian: Zaradi karmeloze postane zdravilo podobno kitu, kar omogoči lažje oblikovanje in nanos na obe strani hrbtenice.
English: Special care must be taken to prevent any leakage of Opgenra due to irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Slovenian: Zlasti morate preprečiti iztekanje zdravila Opgenra zaradi izpiranja, nepravilnega zaprtja obkostnih tkiv ali neustrezne preprečitve krvavitve.
English: • require arthrodesis as a result of metabolic bone disease or tumour.
Slovenian: • ki potrebujejo artrodezo zaradi presnovne bolezni kosti ali tumorja.
English: To be attached to the patient's medical record.
Slovenian: NALEPKA S PODATKI ZA ZDRAVSTVENE DELAVCE Priložiti zdravstveni kartoteki bolnika.
English: • Inform your doctor if you have a history of liver or kidney disease.
Slovenian: • Obvestite svojega zdravnika, če ste v preteklosti imeli jetrno ali ledvično bolezen
English: • have a hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
Slovenian: • s preobčutljivostjo na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju
English: One unit of Opgenra is supplied in two Type I glass vials, sealed with a butyl rubber stopper and aluminium crimp cap.
Slovenian: Ena enota zdravila Opgenra je pakirana v dve viali iz stekla vrste I, zaprti z zamaškom iz butilne gume in aluminijasto zaporko.
English: • failure of the spine to fuse (pseudarthrosis),
Slovenian: • neuspela fuzija hrbtenice(psevdartroza),
English: Closure is critical for containment and maintenance of the product in the area of intended fusion.
Slovenian: Zaprtje teh tkiv je pomembno za zadrževanje vsadka v območju fuzije in njegovo vzdrževanje.
English: Not known: implant site complications (e.g. abscess, implant site induration, pain, oedema, pyrexia)
Slovenian: Neznana: zapleti na mestu implantacije (npr. absces, induracija na mestu implantacije, bolečina, edem, pireksija)
English: Powder for implantation suspension.
Slovenian: Prašek za suspenzijo za implantacijo.
English: The powder containing the active substance and the excipient bovine collagen has the appearance of a white to offwhite granular powder; the carmellose powder is a yellowish white powder.
Slovenian: Prašek, ki vsebuje zdravilno učinkovino in pomožno snov goveji kolagen je bel do umazano bel granularni prašek; karmeloza je rumenkasto bel prašek.
English: Opgenra contains the active substance eptotermin alfa.
Slovenian: Opgenra vsebuje zdravilno učinkovino eptotermin alfa.
English: What Opgenra looks like and contents of the pack
Slovenian: Izgled zdravila Opgenra in vsebina pakiranja
English: CT examination has suggested that significant medial displacement of Opgenra can occur post-operatively and this can result in bone forming medially.
Slovenian: Preiskava CT je pokazala, da se lahko po kirurškem posegu pojavi pomemben medialen premik zdravila Opgenra, kar lahko povzroči medialno formacijo kosti.
English: • problems at the implant site (for example abscess, hardening, pain, swelling, or fever)
Slovenian: • težave na mestu implantacije (npr. absces, otrdelost, bolečina, otekanje ali vročina),
English: Talk to your doctor before you are administered this medicine.
Slovenian: Pred uporabo tega zdravila se posvetujte s svojim zdravnikom.
English: This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Slovenian: To je ustrezen, biološko razgradljiv nosilec za proliferacijo celic, odvisno od sidranja, in proces diferenciacije, ki ga sproža zdravilna učinkovina.
English: How to use Opgenra
Slovenian: Kako uporabljati zdravilo Opgenra
English: Animal studies that have been conducted cannot rule out possible effects of anti-OP-1 antibodies on embryofoetal development (see section 5.3).
Slovenian: Opravili so študije na živalih, ki so pokazale, da učinkov protiteles proti OP-1 na razvoj zarodka in ploda ni mogoče izključiti (glejte poglavje 5.3).
English: • allergic reactions (for example rash or hives)
Slovenian: • alergijske reakcije (npr. kožni izpuščaj ali koprivnica),
English: The reconstituted product is administered by direct surgical placement into the lumber region of the spine following surgical preparation of the site.
Slovenian: Rekonstituirano zdravilo se kirurško nanese neposredno v lumbalni predel hrbtenice po kirurški pripravi mesta.
English: - If you get any side effects talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: Antibodies to eptotermin alfa were also found in sera from pooled foetal and umbilical cord blood, at levels that correlated to that of the maternal blood.
Slovenian: Ravni protiteles proti eptoterminu alfa, ki so jih našli tudi v serumu iz zbrane fetalne krvi in krvi popkovnice, so ustrezale ravnem v krvi matere.
English: The active substance is eptotermin alfa (a recombinant human osteogenic protein 1 produced in a Chinese hamster ovary (CHO) cell line).
Slovenian: Zdravilna učinkovina je eptotermin alfa (rekombinantni humani osteogeni protein 1, pridobljen iz rekombinantne celične linije jajčnikov kitajskega hrčka (Chinese Hamster Ovary - CHO).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: The product should have a malleable, coherent putty-like consistency.
Slovenian: Izdelek mora biti gnetljiv, enakomeren in podoben kitu.
English: Lift the plastic flip-tops and remove the crimp caps from the vials.
Slovenian: Odprite plastična pokrova in z vial odstranite zaporki.
English: Opgenra is implanted in adult patients with slippage of the spine (spondylolisthesis) in cases where treatment with autograft (transplanted bone from your hip) has failed or must not be used.
Slovenian: Zdravilo Opgenra se vsaja odraslim bolnikom s premaknjenimi hrbteničnimi vretenci (spondilolisteza), kadar zdravljenje z avtolognim presadkom (presajenim iz kolčne kosti) ni bilo uspešno ali pa se ne sme uporabiti.
English: Heterotopic ossification commonly occurs in humans following accidental or surgical trauma to the skeleton.
Slovenian: Pri človeku se po nezgodni ali kirurški travmi skeleta pogosto pojavlja heterotopična okostenitev.
English: Women of childbearing potential should be advised to use effective contraception for a period of at least 2 years after treatment.
Slovenian: Ženskam v rodni dobi je treba svetovati, da vsaj še 2 leti po zdravljenju uporabljajo učinkovito kontracepcijo.
English: 1 vial containing 230 mg carmellose.
Slovenian: 1 viala vsebuje 230 mg karmeloze.
English: Gently stir the contents of the bowl with a sterile spatula to aid mixing.
Slovenian: Nežno premešajte vsebino posode s sterilno spatulo, da pospešite mešanje.
English: • Opgenra has not been studied for use in cervical spine surgery.
Slovenian: • Zdravila Opgenra niso preskušali pri kirurških posegih na vratnem delu hrbtenice.
English: Each unit of Opgenra consists of two vials of powder, which are first combined and then reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsaka enota zdravila Opgenra je sestavljena iz dveh vial s praškom, ki se najprej zmeša in se pred uporabo rekonstituira z 2,5 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje.
English: Women of childbearing potential are advised to use effective contraception for a period of 2 years after their treatment.
Slovenian: Ženskam v rodni dobi se svetuje, da še 2 leti po zdravljenju uporabljajo učinkovito kontracepcijo.
English: 2 x 1 vial containing 230 mg carmellose.
Slovenian: 2 x 1 viala, ki vsebuje 230 mg karmeloze.
English: It is recommended that breast-feeding be discontinued following treatment.
Slovenian: Po zdravljenju je priporočeno dojenje prekiniti.
English: After reconstitution, Opgenra contains 1 mg/ml eptotermin alfa.
Slovenian: Po rekonstituciji zdravilo Opgenra vsebuje 1 mg/ml eptotermina alfa.
English: Close soft tissues around the site containing the product using suture material of choice.
Slovenian: Mehka tkiva v okolici mesta, kjer je vsajeno zdravilo, zašijte z materialom po izbiri.
English: Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Slovenian: Na kunčjih modelih so opravili nadzorovane študije učinkov izpostavljenosti eptoterminu alfa na prein postnatalni razvoj.
English: • redness of the skin (erythema) ,
Slovenian: • rdečica kože (eritem)
English: Using your thumb pry up the edges of the stoppers.
Slovenian: S palcem dvignite robova zamaškov.
English: Excipients : Bovine collagen
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: goveji kolagen
English: Using sterile technique, remove the vials from the packaging.
Slovenian: Viali s sterilno tehniko vzemite iz ovojnine.
English: One vial of this medicine contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen.
Slovenian: Ena viala tega zdravila vsebuje 1 g praška, ki vključuje 3,3 mg eptotermina alfa in pomožno snov goveji kolagen.
English: If you get any side effects, talk to your doctor or surgeon.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Antibodies were detectable in adults and offspring during the gestation and lactation periods.
Slovenian: Med nosečnostjo in dojenjem so protitelesa odkrili pri odraslih živalih in potomcih.
English: Opgenra 3.3 mg powder for implantation suspension eptotermin alfa
Slovenian: Opgenra 3,3 mg prašek za suspenzijo za implantacijo eptotermin alfa
English: Puncture of the stoppers with a needle may result in particles of stopper material contaminating the medicinal product.
Slovenian: Če zamaška prebodete z iglo, lahko delci njegovega materiala kontaminirajo zdravilo.
English: To avoid breakage, do not tap the bottom of the vial when transferring contents.
Slovenian: Pri prenosu vsebine ne udarjajte (niti šibko) po dnu viale, da ne poči.
English: The other vial contains the excipient carmellose.
Slovenian: Druga viala vsebuje pomožno snov karmelozo.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 230 mg
English: Sarcoma was associated with the long-term presence of the heterotopic bone.
Slovenian: S prisotnostjo heterotopične kosti je bil povezan nastanek sarkoma.
English: Use the product promptly following reconstitution.
Slovenian: Zdravilo uporabite takoj po rekonstituciji.
English: • have prior history of exposure to any bone morphogenetic protein (BMP) product;
Slovenian: • ki so v preteklosti bili izpostavljeni kakršnemukoli zdravilu, ki vsebuje proteine za morfogenezo kosti;
English: The other ingredients are bovine collagen and carmellose.
Slovenian: Pomožni snovi sta goveji kolagen in karmeloza.
English: “{Patient Name} was implanted with a medicinal product containing eptotermin alfa on {dd/mm/yyy}.
Slovenian: “Bolniku {ime bolnika} so dne {dd. mm. llll} vstavili zdravilo, ki vsebuje eptotermin alfa.
English: It is unlikely that Opgenra will affect the ability to drive and use machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Opgenra vplivalo na sposobnost upravljanja vozil in strojev.
English: Intraosseous use Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo.
English: Excipients : Bovine collagen, carmellose.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: goveji kolagen, karmeloza.
English: In addition, results of the post-authorisation studies to investigate the long term safety and efficacy of Opgenra and also investigate the actual drug utilisation in ‘real life' are needed to further characterise the safety and efficacy profile.
Slovenian: Poleg tega je treba dopolniti profil varnosti in učinkovitosti z rezultati študij, opravljenih po pridobitvi dovoljenja, namenjenih raziskavi dolgoročne varnosti in učinkovitosti ter dejanske uporabe zdravila Opgenra v praksi.
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test. Detectable levels of IgG and IgM antibodies to eptotermin alfa had developed and were found in the serum of all exposed adult animals.
Slovenian: Ob rednih presledkih so odvzeli vzorce krvi in mleka in jih analizirali z encimskim imunskim testom (ELISA) trdne faze.
English: The concomitant use of Opgenra with a synthetic bone void filler is not recommended (see section
Slovenian: Sočasna uporaba zdravila Opgenra in sintetičnih kostnih polnil ni priporočena (glejte poglavje 4.5).
English: Fax +353-61-585151 medicalinfo@olympusbiotech.com
Slovenian: Irska tel.: +353-61-585100 faks: +353-61-585151 medicalinfo@olympusbiotech.com
English: • Use of this medicine with synthetic bone substitutes is not recommended.
Slovenian: • Sočasna uporaba tega zdravila in sintetičnih kostnih polnil ni priporočljiva.
English: Talk to your doctor or surgeon about these precautions before you are administered this medicine.
Slovenian: Pred uporabo tega zdravila se o teh previdnostnih ukrepih pogovorite s svojim zdravnikom ali kirurgom.
English: Use of this medicine in the cervical spine cannot be recommended.
Slovenian: Uporaba tega zdravila na vratnem delu hrbtenice ni priporočljiva.
English: Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Opgenra.
Slovenian: Ženske v rodni dobi morajo pred zdravljenjem z zdravilom Opgenra obvestiti zdravnika o možni zanositvi.
English: Fax +353 61 585151 medicalinfo@olympusbiotech.com
Slovenian: Irska tel.: +353 61 585100 faks: +353 61 585151 medicalinfo@olympusbiotech.com