FrancophonIA/ELRC3.0 huggingface dataset:
English: The carmellose imparts a putty-like consistency to the medicinal product for ease of molding and placement on each side of the spine.
Croatian: Karmeloza daje ljepljivu konzistenciju lijeku za jednostavnije kalupljenje i postavljanje na svaku stranu kralježnice.
English: 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.
Croatian: MAH će dostaviti rezultate studije ili studija kako bi se istražila dugoročna sigurnost i djelotvornost u bolesnika liječenih lijekom Opgenra i također stvarno korištenje lijeka u stvarnom životu.
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisterima.
English: These descriptive texts are included in the product information.
Croatian: Ti opisi uključeni su u informacije o lijeku.
English: Carefully apply the product to the prepared site on each side of the spine, bridging the dorsal surfaces of the adjacent transverse processes.
Croatian: Pažljivo prenesite lijek na pripremljeno mjesto na svakoj strani kralježnice pritom premošćujući dorzalne površine susjednih transverznih procesa.
English: Animal studies that have been conducted cannot rule out possible effects of anti-OP-1 antibodies on embryofoetal development (see section 5.3).
Croatian: Provedene studije na životinjama ne mogu isključiti mogućnost učinaka protutijela anti-OP-1 na embriofetalni razvoj (vidjeti dio 5.3).
English: The frequency of adverse reactions listed in the table below is based on the following convention:
Croatian: Učestalost nuspojava navedenih u donjoj tablici temelji se na sljedećim konvencijama:
English: • the methods for soft tissue closure around the implant.
Croatian: • metode za zatvaranje mekog tkiva oko implantata.
English: Opgenra is contraindicated in children (<12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3).
Croatian: Opgenra je kontraindicirana u djece (u dobi <12 godina), adolescenata (u dobi 12-18 godina) i osoba s nerazvijenim kosturom (vidjeti dio 4.3).
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).
Croatian: Zbog nepoznatih rizika za fetus koje su povezane s potencijalnim razvojem neutralizirajućih antitijela na protein OP-1 lijek se ne bi smio primjenjivati u trudnoći, osim ako potencijalna korist opravdava potencijalne rizike za fetus (vidjeti dijelove 4.4 i
English: What Opgenra is and what it is used for.
Croatian: Što je Opgenra i zašto se koristi.
English: In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Croatian: U dvogodišnjoj studiji supkutanih implantacija kod štakora, prema očekivanjima, uočeno je formiranje heterotopične kosti.
English: Any material dislodged from the fusion site can cause ectopic ossification in the surrounding tissues with potential complications.
Croatian: U slučaju pomicanja bilo kojeg materijala s mjesta fuzije može doći do ektopičnog okoštavanja u okolnom tkivu s mogućim komplikacijama.
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.
Croatian: Za fuziju na jednoj razini lumbalne kralježnice koristi se jedna jedinica lijeka na svakoj strani kralježnice.
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.
Croatian: Tiskana uputa o lijeku mora navoditi naziv i adresu proizvođača odgovornog za stavljanje u promet serije u pitanju.
English: - if you require a spinal fusion because of a metabolic bone disease or tumours.
Croatian: - ako zahtijevate spinalnu fuziju zbog metaboličke bolesti kostiju ili tumora.
English: • redness of the skin (erythema) ,
Croatian: • (crvenilo kože (eritem),
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.
Croatian: Osim toga, potrebni su rezultati ispitivanja nakon puštanja na tržište radi istraživanja dugoročne sigurnosti i učinkovitosti Opengre te za istraživanje upotrebe lijeka u „stvarnom životu” radi daljnje karakterizacije profila sigurnosti i učinkovitosti.
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: Each vial is secured in a sterile blister.
Croatian: Svaka je bočica zaštićena sterilnim blisterom.
English: • product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
Croatian: • migracija lijeka (uočeno prilikom miješanja lijeka sa sintetičkim lijekovima koji se koriste za popunjavanje šupljina u kostima).
English: The surrounding muscle tissue is then closed around the implanted medicine as is the skin on top of the muscle.
Croatian: Okolno mišićno tkivo zatvara se oko implantiranog lijeka, kao i koža na površini mišića.
English: Opgenra is contraindicated in children aged 0 to 12 years old, adolescents aged 12 to 18 years and the skeletally immature.
Croatian: Opgenra je kontraindicirana u djece u dobi od 0 do 12 godina, adolescenata u dobi od 12 do 18 godina i osoba s nerazvijenim kosturom.
English: Provide adequate haemostasis to ensure that the material stays at the surgical site.
Croatian: Osigurajte odgovarajuću hemostazu kako bi materijal ostao na mjestu kirurškog zahvata.
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.
Croatian: Učinak protutijela anti-OP-1 na cijeljenje kosti istraživan je kod pasa nakon dva oštećenja dugih kostiju koje su liječene ponovljenim implantacijama.
English: The vials are maintained sterile within individual blisters and packaged together in an outer tray and box.
Croatian: Bočice se održavaju sterilnima unutar pojedinih blistera te se pakiraju zajedno u vanjski omot i kutiju.
English: The product should have a malleable, coherent putty-like consistency.
Croatian: Lijek mora imati savitljivu, koherentnu konzistenciju nalik ljepilu.
English: This should be considered in follow-up of patients with CT or X-ray.
Croatian: To treba uzeti u obzir kod kontrolnih CT ili rendgenskih pregleda bolesnika.
English: Do not breast-feed your baby during treatment with this medicine.
Croatian: Nemojte dojiti tijekom liječenja ovim lijekom.
English: Talk to your doctor before you are administered this medicine.
Croatian: Razgovarajte sa svojim liječnikom prije primanja ovog lijeka.
English: The cellular events induced by the active substance take place within the product matrix.
Croatian: Stanični događaji potaknuti aktivnom tvari odvijaju se unutar matriksa.
English: Prior to use of the product, surgeons should be provided with educational material containing: a copy of the SPC a detailed description of:
Croatian: Prije primjene lijeka kirurge treba opskrbiti edukacijskim materijalom koji sadrži: - kopiju Sažetka opisa svojstava lijeka - detaljni opis:
English: Opgenra is a type of medicine known as a bone morphogenetic protein (BMP).
Croatian: Opgenra je vrsta lijeka poznata kao koštani morfogenetski protein (BMP).
English: • Inform your doctor or surgeon if you have been administered this medicine in the past.
Croatian: • Obavijestite svog liječnika ili kirurga ako ste u prošlosti već primali ovaj lijek.
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.
Croatian: Opgenra se implantira odraslim bolesnicima s listezom kralježnice (spondilolisteza) u slučajevima gdje liječenje putem autolognog koštanog presatka (kost transplantirana iz kuka) nije uspjelo ili se ne smije koristiti.
English: Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Croatian: Opgenra je indicirana za posterolateralnu lumbalnu spinalnu fuziju u odraslih bolesnika sa spondilolistezom u slučaju kada fuzija autolognim presadakom nije uspjela ili je kontraindicirana.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji muskulature i vezivnog tkiva
English: The peak antibody response was seen 3 months following treatment.
Croatian: Vršni odgovor protutijela uočen je 3 mjeseca nakon liječenja.
English: Powder for implantation suspension.
Croatian: Prašak za suspenziju implantata.
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).
Croatian: Budući da se ljudski IgG izlučuje u majčino mlijeko u ljudi, a nije poznat štetni potencijal za dojenče, žene ne bi smjele dojiti tijekom terapije lijekom Opgenra (vidjeti dio 5.3).
English: *Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line.
Croatian: *Eptotermin alfa je ljudski rekombinantni osteogeni protein 1 (OP-1) proizveden na staničnoj liniji jajnika kineskog hrčka (CHO).
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.
Croatian: Nakon zatvaranja mekog tkiva oko implantata isperite područje kako biste uklonili sve zalutale čestice lijeka koje su možda izmještene tijekom zatvaranja mekog tkiva.
English: Remove the reconstituted product from the sterile bowl with a sterile instrument such as a spatula or curette.
Croatian: Izvadite rekonstituirani lijek iz sterilne posude sterilnim instrumentom poput špatule ili kirete.
English: • have a hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
Croatian: • su preosjetljivi na djelatnu tvar ili na bilo koju pomoćnu tvar navedenu u dijelu 6.1:
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.
Croatian: Obrazac nuspojava koje nisu povezane s postoperativnim nuspojavama variraju sa stupnjem kirurške traume, proceduralnim komplikacijama i predoperativnim zdravljem bolesnika.
English: • localised swelling, swelling over the implant site,
Croatian: • lokalizirano oticanje, oticanje iznad mjesta implantacije,
English: Therefore, Opgenra may only be administered to the fusion site under adequate vision and with utmost care.
Croatian: Stoga se Opgenra smije primijeniti samo na mjesto fuzije uz odgovarajuću preglednost i sa krajnjim mjerama opreza.
English: The matrix is also osteoconductive and it allows bone in-growth into the defect area from the adjacent healthy bone.
Croatian: Matriks također ima osteokonduktivne osobine i omogućuje urastanje kosti iz okolne zdrave kosti u područje koštanog defekta.
English: Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Opgenra.
Croatian: Žene s reproduktivnim potencijalom moraju obavijestiti svojeg kirurga o mogućnosti trudnoće prije liječenja lijekom Opgenra.
English: • have an active malignancy or are undergoing treatment for a malignancy;
Croatian: • imaju aktivnu zloćudnu bolest ili se liječe od zloćudne bolesti:
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.
Croatian: S obzirom da nije poznat štetni potencijal za dojenče, žene ne smiju dojiti neposredno nakon liječenja ovim lijekom.
English: 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.
Croatian: Pažljivo i polako dodajte 2,5 ml sterilne otopine natrijeva klorida za injekciju 9 mg/ml (0,9% w/v) u sterilnu zdjelu.
English: • problems at the implant site (for example abscess, hardening, pain, swelling, or fever)
Croatian: • Problemi na mjestu implantacije (primjerice, apsces, otvrdnuće, bol, oticanje ili vrućica)
English: Special care must be taken to prevent any leakage of Opgenra due to irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Croatian: Posebna briga mora se provesti da se spriječi curenje lijeka Opgenra uslijed ispiranja rane, lošeg zatvaranja okolnog tkiva ili neadekvatne hemostaze.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown.
Croatian: Studije na životinjama pokazale su da dolazi do izlučivanja protutijela IgG klase anti-OP-1 u mlijeko.
English: 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.
Croatian: Nuspojave zabilježene tijekom kliničkih ispitivanja nakon kirurškog zahvata koje nisu specifično povezane s ugrađenim materijalima uključivale su površinske infekcije rane, razdvajanje šavova na rani, osteomijelitis, komplikacije mehaničke potpore, nastanak hematoma, mučninu, povraćanje, vrućicu i bol.
English: Sjögren's syndrome and dermatomyositis/ polymyositis.
Croatian: sklerodermiju, Sjögrenov sindrom i dermatomiozitis/polimiozitis.
English: • Inform your doctor if you have a history of liver or kidney disease.
Croatian: • Obavijestite svog liječnika ako imate bolest jetre ili bubrega u povijesti bolesti.
English: Place the contents of the eptotermin alfa vial and carmellose vial in a sterile bowl.
Croatian: Stavite sadržaj bočice s eptoterminom alfa i karmelozom u sterilnu posudu.
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.
Croatian: Jednom vezana za staničnu površinu, djelatna tvar inducira slijed staničnih događaja čime dolazi do stvaranja hondroblasta i osteoblasta koji imaju ključnu ulogu u postupku formiranja koštanog tkiva.
English: The powders come in glass vials.
Croatian: Prašak se isporučuje u staklenim bočicama.
English: - If you get any side effects talk to your doctor.
Croatian: - Ako dobijete bilo koju nuspojavu obratite se svom liječniku.
English: The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Croatian: Rezultati su pokazali da tijekom razdoblja promatranja i nakon primjene nije bilo neočekivanih ili sustavnih toksičnih učinaka.
English: Possible side effects.
Croatian: Moguće nuspojave.
English: 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.
Croatian: Iskustvo o primjeni ovog lijeka u bolesnika s oštećenjem bubrega ili jetre je ograničeno, te stoga treba biti oprezan s uporabom lijeka u takvih bolesnika.
English: Patients with a known history of heart disease or frequent infections should be identified and observed more closely following surgery.
Croatian: Bolesnike s poznatom anamnezom srčane bolesti ili čestim infekcijama treba identificirati i pomnije pratiti nakon kirurškog zahvata.
English: “{Patient Name} was implanted with a medicinal product containing eptotermin alfa on {dd/mm/yyy}.
Croatian: “{Ime i prezime bolesnika} ugrađen je lijek koji sadrži eptotermin alfa dana {dd/mm/gggg}.
English: - if you are allergic to eptotermin alfa or to any of the ingredients of this medicine (see section
Croatian: Nemojte primati lijek Opgenra - ako ste alergični na eptotermin alfa ili na bilo koji drugi sastojak ovog lijeka (vidjeti dio 6).
English: Use of this medicine in the cervical spine cannot be recommended.
Croatian: Ne može se preporučiti primjena ovog lijeka na cervikalnoj kralježnici.
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).
Croatian: Podaci praćenja lijeka nakon stavljanja u promet ukazuju na to da primjena lijeka u kombinaciji sa sintetskim punilom za šupljine u kostima može dovesti do pojačanja lokalne upale, infekcije i povremene migracije implantiranog materijala (vidjeti dio 4.4).
English: Some patients that had a history of heart problems or were prone to frequent infections became worse after being administered this medicine.
Croatian: Neki bolesnici s anamnezom srčanih poremećaja ili oni koji su bili skloni čestim infekcijama doživjeli su pogoršanje nakon primjene ovog lijeka.
English: It has been observed following use (see section 4.8).
Croatian: Ta je pojava uočena nakon uporabe lijeka (vidjeti dio 4.8).
English: • have an autoimmune disease, including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis;
Croatian: • boluju od autoimune bolesti, uključujući Kronovu bolest, reumatoidni artritis, sistemski eritematozni lupus, sklerodermiju, Sjögrenov sindrom i dermatomiozitis/polimiozitis;
English: One unit of Opgenra is supplied in two Type I glass vials, sealed with a butyl rubber stopper and aluminium crimp cap.
Croatian: Jedna jedinica lijeka Opgenra dostupne su u dvije staklene bočice tipa I, zatvorene čepom od butilne gume i aluminijskom kapicom.
English: Once the vacuums are broken, remove the vial stoppers while holding the vials upright to prevent loss of contents.
Croatian: Nakon oslobađanja vakuuma uklonite čepove bočica, držeći ih uspravno, kako biste spriječili rasipanje sadržaja.
English: Keep the blisters in the outer carton.
Croatian: Čuvati blistere u vanjskom pakiranju.
English: • collection of fluid in the tissues (seroma),
Croatian: • nakupljanje tekućine u tkivima (serom)
English: Use in cervical spine
Croatian: Primjena lijeka na cervikalnoj kralježnici
English: • require arthrodesis as a result of metabolic bone disease or tumour.
Croatian: • trebaju artrodezu zbog metaboličke bolesti kostiju ili tumora.
English: The surrounding soft tissues are then closed around the implanted material.
Croatian: Okolno meko tkivo se nakon toga zatvara oko implantiranog materijala.
English: The active substance is eptotermin alfa (a recombinant human osteogenic protein 1 produced in a Chinese hamster ovary (CHO) cell line).
Croatian: Djelatna je tvar eptotermin alfa (rekombinantni ljudski osteogenski protein-1 proizveden na staničnoj liniji jajnika kineskog hrčka (CHO)).
English: It is unlikely that Opgenra will affect the ability to drive and use machines
Croatian: Nije vjerojatno da će lijek Opgenra utjecati na sposobnost upravljanja vozilima ili strojevima.
English: Opgenra is only used by an appropriately qualified surgeon during the course of spinal fusion surgery.
Croatian: Lijek Opgenra smije koristiti samo odgovarajuće obučeni kirurg tijekom kirurškog zahvata spinalne fuzije.
English: The other ingredients are bovine collagen and carmellose.
Croatian: Drugi sastojci su goveđi kolagen i karmeloza.
English: How to use Opgenra.
Croatian: Kako se koristi Opgenra.
English: The powder containing the excipient carmellose (carboxymethylcellulose) is yellowish white.
Croatian: Prašak koji sadrži pomoćnu tvar karmelozu (karboksimetilcelulozu) je žućkasto bijele boje.
English: Women of childbearing potential should be advised to use effective contraception for a period of at least 2 years after treatment.
Croatian: Žene s reproduktivnim potencijalom treba savjetovati da koriste učinkovitu kontracepciju najmanje 2 godine nakon liječenja.
English: Opgenra 3.3 mg powder for implantation suspension eptotermin alfa
Croatian: Opgenra 3,3 mg prašak za suspenziju implantata eptotermin alfa
English: Gently stir the contents of the bowl with a sterile spatula to aid mixing.
Croatian: Lagano promiješajte sadržaj zdjele sterilnom špatulom kako biste potpomogli miješanje.
English: Potential interaction with Calstrux, a bone void filler has been reported (see section 4.5).
Croatian: Zabilježene su moguće interakcije s lijekom Calstrux, punilom za šupljine u kostima (vidjeti dio 4.5).
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.
Croatian: Eptotermin alfa, djelatna tvar, potiče formiranje koštanog tkiva indukcijom stanične diferencijacije u mezenhimalnim stanicama, koje se sele na mjesto implantata iz koštane srži, pokosnice i mišića.
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.
Croatian: Prašak koji sadrži djelatnu tvar i pomoćnu tvar goveđi kolagen ima izgled bijelog do gotovo bijelog zrnatog praška, dok je prašak karmeloze žućkastobijele boje.
English: Handle the crimp caps with care.
Croatian: Pažljivo postupajte s kapicom.
English: After reconstitution, Opgenra contains 1 mg/ml eptotermin alfa.
Croatian: Nakon rekonstitucije, Opgenra sadrži 1 mg/ml eptotermina alfa.
English: Once Opgenra is prepared it should be used immediately.
Croatian: Nakon što se pripremi, Opgenra se treba odmah primijeniti.
English: What you need to know before you are administered Opgenra.
Croatian: Što morate znati prije nego primite lijek Opgenra.
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.
Croatian: Razine protutijela na eptotermin alfa također su pronađene u serumu iz prikupljene fetalne krvi i krvi iz pupkovine, a odgovarale su razini u majčinoj krvi.
English: For storage conditions after reconstitution, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3
English: This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Croatian: On omogućuje odgovarajuću biološki razgradivu konstrukciju potrebnu za učvršćivanje proliferativnih stanica i diferencijaciju koja je potaknuta aktivnom tvari.
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.
Croatian: U razdoblju promatranja uočeno je da je tjelesna težina potomaka u skupini koja je liječena manja od one u kontrolnoj skupini.
English: CT examination has suggested that significant medial displacement of Opgenra can occur post-operatively and this can result in bone forming medially.
Croatian: CT pregledima pokazalo se da može doći do značajanog medijalnog pomaka lijeka Opgenra nakon kirurškog zahvata što može rezultirati medijalnim formiranjem kosti.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava, dio 4.2).
English: The reconstituted product is administered by direct surgical placement into the lumber region of the spine following surgical preparation of the site.
Croatian: Pripremljeni lijek primjenjuje se izravnim kirurškim postavljanjem u lumbalnu regiju kralježnice nakon kirurške pripreme mjesta implantacije.
English: Skin and subcutaneous tissue disorders
Croatian: Kožni poremećaji i poremećaji potkožnog tkiva