FrancophonIA/ELRC3.0 huggingface dataset:
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Slovenian: Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: NAME OF THE MEDICINAL PRODUCT Hulio 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: • stroke;
Slovenian: • kap;
English: Mean steady-state trough levels of approximately 7 μg/ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Slovenian: Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najmanjšo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ml.
English: How to store Hulio
Slovenian: Shranjevanje zdravila Hulio
English: Clinical remission 12% 24%
Slovenian: Klinična remisija Klinični odziv (CR-100) 24 % 37 % 49 %**
English: Without MTX
Slovenian: Brez metotreksata
English: The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of
Slovenian: Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m² telesne površine adalimumaba do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
English: The long-term impact of these antibodies is not known.
Slovenian: Dolgoročni vpliv teh protiteles ni znan.
English: This is something that will be decided by your surgeon.
Slovenian: O tem odloča vaš zdravnik.
English: This medicine is only supplied to hospitals and specialist clinics.
Slovenian: To zdravilo se uporablja samo v bolnišnicam in specialističnih klinikah.
English: The frequency of possible side effects listed below is defined using the following convention:
Slovenian: Pogostnost možnih neželenih učinkov, ki so našteti spodaj, je opredeljena z uporabo naslednjih meril:
English: This is usually done under a full general anaesthetic so you will not be awake during the surgery.
Slovenian: To ponavadi poteka pod polno splošno anestezijo tako, da med operacijo niste budni.
English: • OTHER CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: • DRUGI POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO
English: Analysis of these antibodies showed that 9% had neutralizing capacity.
Slovenian: Analiza je pokazala, da 9 % teh protiteles ima zmožnost nevtralizacije.
English: However, external fixation may not provide sufficient immobilisation.
Slovenian: Zunanja učvrstitev morda ne bo ponujala zadostne imobilizacije.
English: These newly formed antibodies have not been found to cause any harm to patients.
Slovenian: Za ta novo nastala protitelesa ni bilo ugotovljeno, da bi škodovala bolnikom.
English: Repeated use of the product cannot be recommended.
Slovenian: Ponavna uporaba zdravila se ne priporoča.
English: If you have further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: Date of first authorisation: 18.05.2001 Date of latest renewal: 18.05.2011
Slovenian: Datum podaljšanja dovoljenja za promet: 18.05.2011
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Za razvrščanje neželenih učinkov po pogostnosti pojavljanja se uporabljajo naslednje kategorije: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1,000 do <1/100); redki (≥1/10,000 do <1/1,000); in zelo redki (<1/10,000), ter neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The Marketing Authorisation Holder will continue to submit PSURs every three years.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo tudi v prihodnje pošiljal poročila PSUR vsaka tri leta.
English: The results of radiological and histological examinations in this non-clinical study showed bone healing with the initial and repeat exposure in the same animal.
Slovenian: Rezultati radioloških in histoloških preiskav v tej neklinični študiji so pokazali celjenje kosti pri začetnem in ponavljajočem se izpostavljanju pri isti živali.
English: Antibodies are special proteins produced by the human body as part of the healing process in various diseases; one such illness is a virus infection.
Slovenian: Protitelesa so posebni proteini, ki jih proizvaja človeško telo kot del postopka zdravljenja pri različnih boleznih; ena takih je tudi virusna infekcija.
English: The maximum recommended dose for this medicine is 2 vials (2g) since its effectiveness at higher doses has not been established.
Slovenian: Največji priporočeni odmerek tega zdravila je 2 viali (2 g), ker njegova učinkovitost pri višjih odmerkih ni bila potrjena.
English: Do not insert a needle through the stopper.
Slovenian: Ne vstavljajte igle skozi zamašek.
English: The new bone formed is mechanically and radiographically comparable to normal bone.
Slovenian: Novonastala kost je mehansko in radiografsko primerljiva z normalno kostjo.
English: Some patients treated with this product were also reported to have experienced various undesirable effects associated with recent orthopaedic surgery.
Slovenian: Nekateri bolniki, ki so jih zdravili s tem zdravilom, so poročali tudi o različnih neželenih učinkih, povezanih z nedavno ortopedsko operacijo.
English: Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed.
Slovenian: Opravljene so bile raziskave enkratnih in večkratnih odmerkov na nizu živalskih modelov (podganah, psih in primatih).
English: The hospital pharmacist or surgeon is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
Slovenian: Bolnišnični farmacevt ali zdravnik (kirurg) je pristojen za pravilno shranjevanje tega zdravila tako pred uporabo kot med uporabo in tudi za pravilno odstranjevanje po uporabi.
English: If required, place it subcutaneously.
Slovenian: Če je potrebno, jo postavite pod
English: Heterotopic ossification may also occur following use (see section 4.8).
Slovenian: Do heterotopične okostenitve lahko pride tudi po uporabi (glejte poglavje 4.8).
English: The recommended dose is one single administration in adults.
Slovenian: Priporočeni odmerek je enkratna uporaba pri odraslih.
English: 6.5 Nature and contents of container and special equipment for use, administration or
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo
English: This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
Slovenian: Ta učinek, imenovan karcinogenost trdnih snovi, so pogosto opazili pri podganah, ki so jim podkožno vsadili trdne snovi (plastične ali kovinske).
English: The clinical implications of these observations for human use of the finished product remain uncertain (see section 4.6).
Slovenian: Klinični pomen teh ugotovitev za uporabo končnega izdelka pri človeku ni gotov (glejte poglavje 4.6).
English: If you have a known hypersensitivity to collagen you should not be treated with this medicine.
Slovenian: Če imate znano preobčutljivost za kolagen, se ne smete zdraviti s tem zdravilom.
English: EU/1/01/179/001
Slovenian: ŠTEVILKA(E) DOVOLJENJAZA PROMET EU/1/01/179/001
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, proteini za morfogenezo kosti, Oznaka ATC: M05BC02
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.
Slovenian: V drugi študiji so opazili razliko pri pridobivanju telesne mase pri imuniziranih odraslih samicah med 14. in 21. dnem laktacije, v primerjavi z živalmi iz kontrolne skupine.
English: In the absence of comparability studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Handle the crimp with care.
Slovenian: Z zaporko ravnajte previdno.
English: Interaction with other medicine
Slovenian: Interakcija z drugimi zdravili
English: WHAT OSIGRAFT IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO OSIGRAFT IN ZA KAJ GA UPORABLJAMO
English: Osigraft should not be used during pregnancy unless the expected benefits to the mother are thought to outweigh the possible risks to the unborn child.
Slovenian: Zdravilo Osigraft se ne sme uporabljati med nosečnostjo, razen kadar se predvideva, da bodo pričakovane koristi za mater odtehtale morebitno tveganje za nerojenega otroka.
English: However, there is evidence to suggest that heterotopic ossification is not linked to sarcoma in humans.
Slovenian: Vendar obstajajo dokazi, da heterotopična okostenitev ni povezana s pojavom sarkoma pri človeku.
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Slovenian: Ob rednih presledkih so odvzeli vzorce krvi in mleka ter jih analizirali z encimskim imunskim testom (ELISA) trdne faze.
English: The reconstituted product should be used immediately.
Slovenian: Rekonstituirano zdravilo je treba takoj uporabiti.
English: The surrounding muscle tissues are closed around the implanted medicine as is the skin on the top of the muscle.
Slovenian: Obkostna mišična tkiva se zaprejo okoli vsajenega zdravila, prav tako pa tudi koža na vrhu mišice.
English: Antibody test positive (Antibody formation)
Slovenian: Pozitivni test na protitelesa (Nastajanje protiteles)
English: The potential for harm to the breast-feed infant is unknown.
Slovenian: Morebitno tveganje za dojenega otroka je neznano.
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Slovenian: Študije s protitelesi proti OP-1 so pokazale določeno navzkrižno reaktivnost s sorodnimi beljakovinami BMP, BMP-5 in BMP-6.
English: Women should not breast-feed during the period immediately following treatment with Osigraft.
Slovenian: Ženske ne smejo dojiti v obdobju takoj po zdravljenju z zdravilom Osigraft.
English: Therefore, upon readministration of eptotermin alfa, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Slovenian: Zato ob ponovni uporabi eptotermina alfa obstaja tveganje za nastanek avtoimunosti proti endogenim beljakovinam BMP.
English: Depending on the size of the gap in the broken bone one or two vials of Osigraft may be administered.
Slovenian: Odvisno od velikosti razpoke v zlomljeni kosti, se lahko uporabita ena ali dve viali zdravila Osigraft.
English: The recommended maximum dose should not exceed 2 vials since efficacy in the treatment on non-unions requiring higher doses has not been established.
Slovenian: Priporočeni največji odmerek ne sme presegati 2 vial, ker učinkovitost zdravljenja nezraslih zlomov, za katere so potrebni višji odmerki, ni bila potrjena.
English: Osigraft is a type of medicine known as a bone morphogenetic protein (BMP).
Slovenian: Zdravilo Osigraft je vrsta zdravila, znanega kot protein za morfogenezo kosti (BMP).
English: A similar pattern of adverse reactions has been recorded from spontaneous reporting with an incidence significantly less than that seen in the clinical trials.
Slovenian: Podoben vzorec neželenih učinkov so zabeležili pri spontanem poročanju z občutno manjšo pogostnostjo kot je bila opažena v kliničnih preskušanjih.
English: The amount of Osigraft used should approximate the size of the bone
Slovenian: Količina zdravila Osigraft mora približno ustrezati velikosti poškodbe kosti.
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).
Slovenian: Pomembno visoke titre protiteles IgG proti OP-1 so odkrili v mleku skozi celoten čas študije postnatalne faze do 28. dne laktacije (glejte poglavje 4.6).
English: There are no data on the pharmacokinetics of the active substance in man.
Slovenian: Ni podatkov o farmakokinetiki učinkovine pri človeku.
English: Clinical outcomes of pain and weight-bearing were comparable to the autograft (81% success in the Osigraft group, 77% success in the autograft group).
Slovenian: Klinični izidi pri bolečinah in prenašanju teže so bili primerljivi z avtolognim presadkom (81-odstotni uspeh v skupini, ki so jo zdravili z Osigraftom, in 77-odstotni uspeh v skupini, ki so jo zdravili z avtolognim presadkom).
English: Take special care with Osigraft The following are precautions for use of Osigraft to be discussed with your doctor.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Osigraft V nadaljevanju so navedeni previdnostni ukrepi pri uporabi zdravila Osigraft, o katerih se posvetujte s svojim zdravnikom.
English: Fertility There is no evidence to suggest that eptotermin alfa alters fertility.
Slovenian: Plodnost Ni dokazov, da bi eptotermin alfa vplival na plodnost.
English: Do not place a drain directly in the implant site.
Slovenian: Drenažne cevke ne postavljajte neposredno v mesto implantacije.
English: Antibodies often form as part of the body's response to treatment with some medicines one of these is Osigraft.
Slovenian: Protitelesa pogosto nastajajo kot del odziva telesa na zdravljenje z nekaterimi zdravili, med katerimi je tudi zdravilo Osigraft.
English: After reconstitution, the single use suspension for implantation should be used immediately.
Slovenian: Suspenzijo za vstavljanje za enkratno uporabo je treba uporabiti takoj po rekonstituciji.
English: - if you are a child (below 18 years old) - if you have an autoimmune disease (disease arising from or directed against your own tissues),
Slovenian: - če ste mladostnik in vaš skelet še ni dokončno oblikovan (če še rastete); - če ste otrok (če ste stari manj kot 18 let); - če imate avtoimunsko bolezen (bolezen, ki izhaja iz vaših lastnih tkiv ali deluje proti njim),
English: Important information about some of the ingredients of Osigraft Osigraft contains bovine collagen.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Osigraft Zdravilo Osigraft vsebuje goveji kolagen.
English: Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Slovenian: Torej smete zdravilo Osigraft uporabljati le na mestu poškodbe pod ustreznim nadzorom in skrajno previdno.
English: Like all medicines, Osigraft can have side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Osigraft neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
English: The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.
Slovenian: Primarna ovojnina je ohranjena v sterilnem stanju v pretisnem omotu, ki ga sestavljata dva plastična podstavka in pokrova (notranji in zunanji).
English: The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs following two long bone defects treated with repeat implantations.
Slovenian: Učinek protiteles proti OP-1 na celjenje kosti so raziskovali pri psih, po dveh okvarah dolgih kosti, zdravljenih s ponavljajočimi se vsaditvami.
English: The cellular events induced by the active substance take place within the collagen matrix.
Slovenian: Celični dogodki, ki jih sproža učinkovina, potekajo znotraj kolagenskega matriksa.
English: However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Slovenian: Vendar rezultati implantacijskih študij zdravila Osigraft pri živalih kažejo, da se eptotermin alfa ne širi sistemsko.
English: Injury, poisoning and procedural complications Postoperative wound site erythema (Erythema)
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih Postoperativni eritem na mestu rane (Eritem)
English: If you are a nursing mother you should be treated with Osigraft only if your physician or surgeon considers the benefits to you outweigh the risks to your child.
Slovenian: Če ste doječamati, se lahko zdravite z zdravilom Osigraft samo, če vaš zdravnik ali kirurg oceni, da koristi zdravljenja za vas odtehtajo tveganje za vašega otroka.
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures; the antibody peak concentration was higher after the second implantation.
Slovenian: Po obeh izpostavitvah so odkrili protitelesa proti OP-1 in kostni kolagen vrste 1, najvišja koncentracija protiteles pa je bila večja po drugi vsaditvi.
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.
Slovenian: V obdobju opazovanja je bila telesna masa potomcev v skupini, ki je prejemala zdravljenje, manjša kot pri kontrolni skupini.
English: In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Slovenian: Pri raziskavi dveletnega podkožnega vsadka pri podganah so po pričakovanjih opazili nastanek heterotropičnih kosti.
English: Do not use Osigraft - if you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft (see section 6).
Slovenian: Ne uporabljajte zdravila Osigraft - če ste alergični na eptotermin alfa ali kolagen, pomožno snov v zdravilu Osigraft (glejte poglavje
English: have known autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis; have active infection at the site of non-union or active systemic infection; have inadequate skin coverage and vascularity of the non-union site; have vertebral fractures; have a non-union resulting from pathological fractures, metabolic bone disease or tumours; have any tumour in the vicinity of the non-union site; are receiving chemotherapy, radiation treatment or immunosuppression;
Slovenian: Osigraft ne smete uporabljati pri bolnikih, ki: imajo znano preobčutljivost za zdravilno učinkovino ali kolagen; so skeletno nezreli; imajo znano avtoimunsko bolezen, vključno z revmatoidnim artritisom, sistemskim lupusom eritematozusom, sklerodermo, Sjögrenovim sindromom in dermatomiositisom/polimiositisom; imajo aktivno okužbo na mestu nezaraslega zloma ali aktivno sistemsko okužbo; imajo neustrezno pokritost s kožo ali neustrezno prekrvavljenost na mestu nezaraslega zloma; imajo vretenčne zlome ; imajo nezarasel zlom, ki je posledica patoloških zlomov, presnovnih bolezni kosti ali tumorjev; imajo kakršenkoli tumor v bližini mesta nezraslega zloma; prejemajo kemo-, radio- ali imuno-supresivno terapijo.
English: Osigraft stimulates the growth of new bone as part of the treatment of a fracture non-union and needs the support of specialised surgical devices to stabilise the broken bone while it heals.
Slovenian: Zdravilo Osigraft spodbuja rast nove kosti kot dela zdravljenja nezaraslega zloma in potrebuje podporo posebnih kirurških pripomočkov za stabilizacijo zlomljene kosti med celjenjem.
English: Osigraft is an osteoinductive and osteoconductive medicinal product.
Slovenian: Zdravilo Osigraft je osteoinduktivno in osteokonduktivno zdravilo.
English: Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use.
Slovenian: Eno vialo zdravila Osigraft je treba pred uporabo rekonstituirati z 2 do 3 ml sterilne 9 mg/ml raztopine natrijevega klorida za injiciranje (0,9 % m/v).
English: FOIL FOR THE BLISTER PACK (OUTER) FOR THE VIAL
Slovenian: FOLIJA ZA (ZUNANJI) PRETISNI OMOT VIALE
English: very common (affects more than 1 user in 10)
Slovenian: • zelo pogosti (pojavijo se pri več kot 1 bolniku od 10 bolnikov)
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
Slovenian: V študijah na živalih so pokazali, da se protitelesa razreda IgG proti OP-1 izločajo v mleko.
English: Musculoskeletal and connective tissue disorders Bone formation increased (Heterotopic ossification / Myositis ossificans)
Slovenian: Povečana tvorba kosti (Heterotopic ossification / Myositis ossificans)
English: The edges of the crimp are sharp and may cut or damage gloves.
Slovenian: Robovi zaporke so ostri in lahko zarežejo ali poškodujejo rokavice.
English: Locking intramedullary rods were used in the majority of cases.
Slovenian: V večini primerov so uporabili intramedularne palice na zaklep.
English: Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, Osigraft should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see sections 4.4 and 5.3).
Slovenian: Zaradi neznanega tveganja za plod, povezanega z morebitnim nastankom nevtralizirajočih protiteles proti beljakovini OP-1, se sme zdravilo Osigraft med nosečnostjo uporabljati samo, kadar morebitne koristi prevladajo nad morebitnim tveganjem za plod (glejte poglavji 4.4 in 5.3).
English: Osigraft is only used by an appropriately qualified surgeon.
Slovenian: Zdravilo Osigraft lahko uporablja samo ustrezno usposobljen kirurg.
English: * Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Slovenian: * Pridobljen iz celic jajčnikov kitajskega hrčka (CHO - Chinese Hamster Ovary) s tehnologijo rekombinantne DNA.
English: Experience from controlled clinical trials is limited to stabilisation of the fracture by intramedullary nailing.
Slovenian: Izkušnje iz nadzorovanih kliničnih preskušanj so omejene na stabilizacijo zloma z intramedularno učvrstitvijo z vijaki.
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 veže na površino celic, učinkovina sproži niz celičnih dogodkov, ki pripeljejo do nastanka hondroblastov in osteoblastov, ki imajo ključno vlogo pri procesu tvorbe kosti.