natgillin/translations-raw huggingface dataset:
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: 
Imetnik dovoljenja za promet se bo z nacionalnimi pristojnimi organi dogovoril o podrobnih informacijah o izobraževalnem programu za kirurge in bo uvedel ta program na nacionalni ravni, da bi zagotovil:
Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02 
Farmakoterapevtska skupina: zdravila za bolezni kosti, proteini za morfogenezo kosti, oznaka ATC: M05BC02
Talk to your doctor if you have any of the following: - Common (may affect up to 1 in 10 people): 
Če opazite katerega koli od naslednji neželenih učinkov, se pogovorite s svojim zdravnikom: - Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov ):
Opgenra is intended only for single use in each patient. 
Zdravilo Opgenra je namenjeno enkratni uporabi pri enem bolniku.
- Uncommon (may affect up to 1 in 100 people): 
- Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
Therefore, Opgenra may only be administered to the fusion site under adequate vision and with utmost care. 
Zato se sme zdravilo Opgenra uporabljati le na mestu fuzije pod ustreznim nadzorom in skrajno previdno.
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. 
Vendar rezultati iz študij implantacije pri živalih kažejo, da se zdravilna učinkovina eptotermin alfa sprošča iz mesta vsaditve več tednov in da koncentracija v periferni krvi nikoli ne preseže 3 % skupne vsajene količine.
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). 
Pomembno visoke titre protiteles IgG proti OP-1 so odkrivali v mleku skozi ves čas študije postnatalne faze do 28. dne laktacije (glejte poglavje 4.6).
For storage conditions after reconstitution, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji glejte poglavje 6.3.
Do not place a drain directly in the implant or fusion site. 
Drenažne cevke ne postavljajte neposredno v mesto vsaditve ali fuzije.
Use of Opgenra does not guarantee fusion; additional surgeries may be required. 
Uporaba zdravila Opgenra ne zagotavlja fuzije, zato bodo morda potrebne dodatne operacije.
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. 
Rezultati te klinične študije kažejo, da ni povezave med nevtralizirajočimi protitelesi in pojavom neželenih učinkov, povezanih z imunskim sistemom.
• that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients 
• enkratni uporabi zdravila; - podrobne informacije o študijah nadzora v obdobju trženja, vključno z informacijami o tem, kako so se vključevali bolniki.
• product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void) 
• premik zdravila (to so opazili, kadar se je zdravilo zmešalo s sintetičnim zdravilom, ki se uporablja za polnjenje praznine v kosti).
The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established. 
Največji odmerek pri človeku ne sme presegati 2 enot, saj učinkovitost in varnost spinalne fuzije pri večjih odmerkih nista bili ugotovljeni.
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. 
V populaciji bolnikov, ki so sodelovali v študiji, so se pri nekaterih bolnikih s pogostimi obstoječimi sočasnimi boleznimi (npr. kardiovaskularnimi, respiratornimi ali genitourinarnimi boleznimi in neoplazmami) pojavile eksacerbacije obstoječe bolezni v dolgotrajnem (triletnem) obdobju sledenja.
There have been reports of swelling and infection following the use of this medicine with synthetic bone substitutes. 
Poročali so o otekanju in okužbah po uporabi tega zdravila s sintetičnimi kostnimi polnili.
The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6). 
Klinični pomen teh ugotovitev za uporabo končnega zdravila pri človeku ni gotov (glejte poglavje 4.6).
Contents of the pack and other information. 
Vsebina pakiranja in dodatne informacije
The MAH shall submit the results of a study or studies to investigate the long term safety and efficacy of patients treated with Opgenra and also actual drug utilisation in real life. 
Imetnik dovoljenja za promet predloži rezultate študije ali študije, da se razišče dolgoročna varnost in učinkovitost pri bolnikih, zdravljenih z zdravilom Opgenra in tudi dejanska uporaba zdravil v vsakodnevnem življenju.
This specialised medicine is used instead of autograft bone (some of a patient's own bone taken from the hip) to fuse the spine. 
To specializirano zdravilo se uporablja namesto avtolognega kostnega presadka (kadar se košček bolnikove kosti vzame iz kolka), da se hrbtenica zraste.
The vials are maintained sterile within individual blisters and packaged together in an outer tray and box. 
Viali sta sterilno pakirani v posamezna pretisna omota in pakirani skupaj v zunanji pladenj ter škatlo.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6. 
Študije s protitelesi proti OP-1 so pokazale neko navzkrižno reaktivnost s sorodnimi proteini za morfogenezo kosti, BMP-5 in BMP-6.
Each vial is secured in a sterile blister. 
Vsaka viala je zavarovana s sterilnim pretisnim omotom.
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. 
Zdravilo Opgenra nima znanih farmakoloških učinkov na nevromotorično koordinacijo ali zmogljivost, zato ni verjetno, da bo spremenilo obstoječo sposobnost za vožnjo ali upravljanje s stroji.
Opgenra is contraindicated in children aged 0 to 12 years old, adolescents aged 12 to 18 years and the skeletally immature. 
Zdravilo Opgenra je kontraindicirano pri otrocih starih od 0 do 12 let, mladostnikih starih od 12 do 18 let in osebah z nezrelim skeletom.
The peak antibody response was seen 3 months following treatment. 
Največji odziv protiteles so opazili 3 mesece po zdravljenju.
• increased bone formation or bone formation outside of the fusion area (heterotopic bone formation), 
• povečana tvorba kosti ali tvorba kosti zunaj območja fuzije (heterotopična tvorba kosti),
• have an active infection at the site of spinal fusion or history of recurring infections; 
• z znano aktivno okužbo mesta spinalne fuzije ali ponavljajočimi se okužbami v anamnezi;
Do not use this medicine after the expiry date which is stated on the carton and blisters. 
Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
Provide adequate haemostasis to ensure that the material stays at the surgical site. 
Poskrbite za ustrezno hemostazo in tako zagotovite, da material ostane na mestu kirurškega posega.
There is limited experience on the use of the medicinal product in patients with renal or hepatic impairment therefore caution with its use in such patients is advised. 
Izkušnje pri uporabi tega zdravila pri bolnikih z ledvično ali jetrno okvaro so omejene, zato se pri uporabi pri teh bolnikih svetuje previdnost.
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. 
Vzorec nepovezanih pooperacijskih neželenih učinkov se je razlikoval glede na stopnjo kirurške travme, zaplete pri postopku in zdravje bolnika pred kirurškim posegom.
• There is a possibility that new antibodies can form in your body when this medicine is used. 
• Obstaja verjetnost, da bodo po uporabi tega zdravila v telesu nastala nova protitelesa.
The powders come in glass vials. 
Prašek je pakiran v steklenih vialah.
• the recommended methods for reconstitution of the product prior to implantation 
• priporočenih metod za rekonstitucijo zdravila pred vsaditvijo,
The frequency of adverse reactions listed in the table below is based on the following convention: 
Pogostnost neželenih učinkov, navedenih v preglednici spodaj, je razvrščena na naslednji način:
Some patients that had a history of heart problems or were prone to frequent infections became worse after being administered this medicine. 
Nekaterim bolnikom s težavami s srcem ali nagnjenostjo k pogostim okužbam se je po tem, ko so prejeli to zdravilo, stanje poslabšalo.
• the risks of ectopic bone formation 
• tveganju ektopične tvorbe kosti,
Any material dislodged from the fusion site can cause ectopic ossification in the surrounding tissues with potential complications. 
Snovi, ki se odstranijo z mesta fuzije, lahko povzročijo ektopično okostenitev v obkostnih tkivih z morebitnimi zapleti.
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. 
Za fuzijo ene ravni lumbalnega predela hrbtenice se uporabi ena enota zdravila na vsaki strani hrbtenice.
Remove the reconstituted product from the sterile bowl with a sterile instrument such as a spatula or curette. 
Rekonstituirano zdravilo odstranite iz sterilne posode s sterilnim instrumentom, na primer spatulo ali kireto.
This leaflet was last revised in <Month YYYY>. 
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
• have an active malignancy or are undergoing treatment for a malignancy; 
• ki imajo aktivno maligno tvorbo ali ki se zdravijo zaradi malignih tvorb;
Common: bone formation increased (heterotopic bone formation) 
Pogosti: povečana tvorba kosti (heterotopična tvorba kosti)
Opgenra is an osteoinductive and osteoconductive medicinal product. 
Zdravilo Opgenra je osteoinduktivno in osteokonduktivno zdravilo.
In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected. 
Pri dveletni raziskavi podkožnega vsadka pri podganah so po pričakovanjih opazili nastanek heterotopičnih kosti.
Prior to use of the product, surgeons should be provided with educational material containing: a copy of the SPC a detailed description of: 
Pred uporabo tega zdravila je treba kirurgom ponuditi izobraževalni material, ki vključuje: kopijo Povzetka glavnih značilnosti zdravila; podroben opis:
• embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant 
• embrio-fetotoksičnosti in potrebi po uporabi učinkovite kontracepcije pri ženskah v rodni dobi dve leti po vsaditvi,
Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group. 
V preskusni skupini so nevtralizirajoča protitelesa nastala pri 26 % bolnikov, v kontrolni skupini pa pri 1 % bolnikov.
The edges of the crimp caps are sharp and may cut or damage gloves. 
Robovi zapork so ostri in lahko zarežejo ali poškodujejo rokavice.
• wound problems including infection, discharge and rupture. 
• težave z rano, vključno z okužbo, izcedkom in raztrganjem.
Patients with a known history of heart disease or frequent infections should be identified and observed more closely following surgery. 
Bolnike z znano boleznijo srca v anamnezi ali pogostimi okužbami je treba identificirati in jih po kirurškem posegu pozorneje opazovati.
Adverse events recorded during the clinical studies following such surgery and not specifically causally related to the implanted materials included superficial wound infection, wound dehiscence, osteomyelitis, complications of mechanical support, haematoma formation, nausea, vomiting, fever and pain. 
Neželeni učinki, ki so jih opazili med kliničnimi študijami po takšnih kirurških posegih, ki niso bile vzročno-posledično povezane z vsajenimi materiali, so vključevale površinske okužbe rane, odprtje rane, osteomielitis, zaplete pri mehanski opori, nastanek hematoma, navzejo, bruhanje, zvišano telesno temperaturo in bolečino.
The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period. 
V obdobju opazovanja je bila telesna masa potomcev v skupini, ki je prejela zdravljenje, manjša kot pri kontrolni skupini.
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated. 
Zdravilo Opgenra je indicirano za posterolateralno lumbalno fuzijo vretenc pri odraslih bolnikih s spondilolistezo, pri katerih avtologni presadek ni bil uspešen ali pa je kontraindiciran.
Use in cervical spine 
Uporaba na cervikalni hrbtenici
Carefully apply the product to the prepared site on each side of the spine, bridging the dorsal surfaces of the adjacent transverse processes. 
Zdravilo previdno nanesite na pripravljeni mesti na obeh straneh hrbtenice, pri čemer premostite dorzalni površini sosednjih transverzalnih izrastkih.
This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. 
Ta skupina zdravil povzroči rast nove kosti na mestu, kjer ga je zdravnik nanesel (vsadil).
• localised swelling, swelling over the implant site, 
• lokalizirano otekanje, otekanje nad mestom implantacije,
Opgenra is contraindicated in children (<12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3). 
Zdravilo Opgenra je kontraindicirano pri otrocih (starih manj kot 12 let), mladostnikih (12-18 let) in osebah z nezrelim skeletom (glejte poglavje 4.3).
Tell your doctor if you are taking or have recently taken any other medicines. 
Druga zdravila in zdravilo Opgenra Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo.
This medicinal product should be used by an appropriately qualified surgeon. 
To zdravilo lahko uporabljajo le ustrezno usposobljeni kirurgi.
Do not breast-feed your baby during treatment with this medicine. 
Med zdravljenjem s tem zdravilom ne dojite.
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. 
Učinek protiteles proti OP-1 na celjenje kosti so raziskovali pri psih, po dveh okvarah dolgih kosti, zdravljenih z večkratnimi vsaditvami.
What you need to know before you are administered Opgenra. 
Kaj morate vedeti, preden boste prejeli zdravilo Opgenra
*Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line. 
*Eptotermin alfa je humani rekombinantni osteogeni protein 1 (OP-1), pridobljen iz celične linije jajčnikov kitajskega hrčka (Chinese Hamster Ovary - CHO).
One unit of Opgenra powder for implantation suspension comes as two separate powders. 
Ena enota praška zdravila Opgenra za suspenzijo za implantacijo je pakirana v dve ločeni viali.
Using a sterile syringe, add 2.5 ml of sterile 9 mg/ml sodium chloride solution for injection (0.9% w/v) to the sterile bowl slowly and carefully. 
S sterilno brizgo počasi in previdno dodajte 2,5 ml sterilne 0,9-odstotne (v/v) raztopine natrijevega klorida (9 mg/ml) v sterilno posodo.
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. 
Če dojite, lahko prejmete to zdravilo samo, če lečeči zdravnik ali kirurg oceni, da koristi odtehtajo tveganje za otroka.
The medicinal product should be used in breast-feeding women only when the attending physician decides that the benefits outweigh the risks. 
To zdravilo se pri nosečih ženskah lahko uporablja le, če se zdravnik odloči, da koristi prevladajo nad tveganjem.
In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown. 
V študijah na živalih so pokazali, da se protitelesa razreda IgG proti OP-1 izločajo v mleko.
• Inform your doctor or surgeon if you have been administered this medicine in the past. 
• Zdravnika ali kirurga obvestite, če ste že kdaj v preteklosti prejeli to zdravilo.
Debride and decorticate bone so that the reconstituted medicinal product will directly contact viable tissue. 
S kosti odstranite tkivo in jo oluščite, tako da bo rekonstituirano zdravilo v neposrednem stiku z viabilnim tkivom.
• have inadequate skin coverage and vascularity at the site of spinal fusion; 
• z neustrezno pokritostjo s kožo ali vaskularizacijo mesta spinalne fuzije;
Place the contents of the eptotermin alfa vial and carmellose vial in a sterile bowl. 
Vsebino vial z eptoterminom alfa in karmelozo prenesite v sterilno posodo.
There are no data on the pharmacokinetics of the active substance in man. 
Podatkov o farmakokinetiki zdravilne učinkovine pri človeku ni.
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
Navodila za rekonstitucijo zdravila pred uporabo so v poglavju 6.6.
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. 
da obstaja teoretično tveganje za nastanek avtoimunosti proti naravnim (endogenim) proteinom za morfogenezo kosti v telesu po ponavljajoči se izpostavitvi temu zdravilu.
Handle the crimp caps with care. 
Z zaporkami ravnajte previdno.
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. 
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.
Opgenra should be used immediately after reconstitution. 
Zdravilo Opgenra je treba uporabiti takoj po rekonstituciji.
Use of this medicine with synthetic bone substitutes is not recommended. 
Uporaba tega zdravila s sintetičnimi kostnimi nadomestki se ne priporoča.
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. 
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.
Potential interaction with Calstrux, a bone void filler has been reported (see section 4.5). 
Poročali so o mogočih interakcijah z zdravilom Calstrux, kostnim polnilom (glejte poglavje 4.5).
There were no patients with neutralizing antibodies 2 years following treatment. 
Dve leti po zdravljenju bolnikov z nevtralizirajočimi protitelesi ni bilo.
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). 
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).
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). 
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).
Common: wound dehiscence, secretion, pseudarthrosis Uncommon: product migration when mixed with synthetic bone 
Pogosti: odprtje rane, sekrecija, psevdoartroza Občasni: premikanje zdravila, kadar se meša s sintetičnim kostnim
The antibody levels declined towards baseline during the follow-up period. 
V obdobju sledenja so se ravni protiteles zmanjšale na izhodiščno vrednost.
Opgenra is implanted during an invasive surgical procedure performed under general anaesthesia. 
Zdravilo Opgenra se vsadi med invazivnim kirurškim posegom, ki se opravlja pod splošno anestezijo.
The cellular events induced by the active substance take place within the product matrix. 
Celični dogodki, ki jih sproža zdravilna učinkovina, potekajo znotraj matriksa zdravila.
The surrounding muscle tissue is then closed around the implanted medicine as is the skin on top of the muscle. 
Okoliško mišično tkivo se nato zapre okoli vsajenega zdravila, čez mišice pa se nazaj zašije koža.
See end of section 4 for how to report side effects. 
Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
Opgenra is only used by an appropriately qualified surgeon during the course of spinal fusion surgery. 
Zdravilo Opgenra lahko uporablja samo ustrezno usposobljen kirurg med kirurškim posegom za spinalno fuzijo.
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). 
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).
including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, 
vključno s Crohnovo boleznijo, revmatoidnim artritisom, sistemskim eritematoznim lupusom,
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. 
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.
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. 
Morebitno tveganje za novorojenca, ki se doji, ni znano, zato ženske ne smejo dojiti v obdobju takoj po zdravljenju s tem zdravilom.
• collection of fluid in the tissues (seroma), 
• nabiranje tekočine v tkivih(serom),
Repeated use of this medicine cannot be recommended. 
Ponavljajoča se uporaba tega zdravila ni priporočljiva.
• 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. 
• 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.
The surrounding soft tissues are then closed around the implanted material. 
Nato se okrog implantiranega materiala zaprejo obkostna mehka tkiva.
The matrix is also osteoconductive and it allows bone in-growth into the defect area from the adjacent healthy bone. 
Matriks ima tudi osteokonduktivne lastnosti in omogoča vraščanje kosti iz zdrave kosti v okolici v območje poškodbe.
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. 
Za ustrezno shranjevanje tega zdravila pred uporabo in med njo ter za njegovo pravilno odstranjevanje sta odgovorna bolnišnični farmacevt in kirurg.