FrancophonIA/ELRC3.0 huggingface dataset:
English: Hulio 40 mg solution for injection (injection) in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml clear or slightly opalescent, colourless to pale brownish-yellow solution.
Croatian: Hulio 40 mg otopina za injekciju (injekcija) u bočicama dolazi kao sterilna otopina s 40 mg adalimumaba otopljenog u 0,8 ml prozirne ili lagano opalescentne, bezbojne do blijedo smećkasto-žute otopine.
English: • You might get infections more easily while you are receiving Hulio treatment.
Croatian: • Dok primate terapiju lijekom Hulio, možete biti podložniji infekcijama.
English: Week 52 45.9% 41.2%
Croatian: 52. tjedan 45,9% 41,2% 61,6% < 0,001 < 0,001
English: The recommended dose of Hulio for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Croatian: U odraslih bolesnika preporučena početna doza lijeka Hulio je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: If a faster effect is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Croatian: Ako je potreban brži učinak liječenja, liječnik Vam može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan u dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna, a potom 40 mg svaki drugi tjedan.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your child's doctor will check your child for signs and symptoms of tuberculosis before starting Hulio.
Croatian: Vaše dijete počne s liječenjem lijekom Hulio, liječnik Vašeg djeteta će provjeriti ima li znakove i simptome tuberkuloze.
English: • DO NOT re-cap the needle.
Croatian: • NE vraćajte kapicu na iglu.
English: Children and adolescents from 6 to 17 years of age weighing less than 40 kg: The usual dose regimen is 40 mg initially, followed by 20 mg two weeks later.
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine 40 kg ili više: Uobičajena početna doza je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), a zatim 40 mg nakon dva tjedna.
English: Each Hulio pre-filled syringe contains 38.2 mg of sorbitol.
Croatian: Jedna napunjena brizgalica sadrži 38,2 mg sorbitola.
English: Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Croatian: A bili randomizirani za terapiju aktivnim lijekom, ponovno su randomizirani u razdoblju C tako da su tijekom dodatnih 19 tjedana primali adalimumab 40 mg svaki drugi tjedan ili placebo.
English: 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Croatian: Među njima je njih 64 (79,0%), 56 (69,1%) odnosno 43 (53,1%) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
English: Alcohol pads
Croatian: Jastučići natopljeni alkoholom
English: Medication Orange Indicator
Croatian: Narančasti pokazivač
English: Step 9 - Dispose syringe & cap Dispose of the used syringe and cap in an approved sharps disposal container.
Croatian: Korak 9 - Odložite štrcaljku i kapicu u otpad
English: If this dose does not work well enough, your doctor may increase the dosage frequency to 40 mg every week or 80 mg every other week.
Croatian: Ako ta doza nije djelotvorna, liječnik može povećati učestalost doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Hulio 40 mg solution for injection in pre-filled pen adalimumab
Croatian: Hulio 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica od 0,8 ml sadrži 40 mg adalimumaba.
English: Children and adolescents from 2 to 17 years of age weighing 30 kg or more: The recommended dose of Hulio is 40 mg every other week.
Croatian: Djeca i adolescenti u dobi od 2 do 17 godina, tjelesne težine 30 kg ili više: Preporučena doza lijeka Hulio je 40 mg svaki drugi tjedan.
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Croatian: Često hipertenzija, navale crvenila, hematomi manje često aneurizma aorte, okluzije arterijskih žila tromboflebitis
English: • excessive fluid around the lung;
Croatian: • nakupljanje tekućine oko pluća,
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine 30 kg ili više:
English: The recommended dose of Hulio is an initial dose of 40 mg, followed by 40 mg one week later, Thereafter the usual dose is 40 mg every other week.
Croatian: Preporučena doza lijeka Hulio je početna doza od 40 mg, a zatim 40 mg nakon tjedan dana.
English: Fill Marker
Croatian: Klip štrcaljke
English: Also this medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj brizgalici, tj. zanemarive količine natrija.
English: o DO NOT use the pen if the liquid is cloudy, discoloured, or has particles in it.
Croatian: ◦ NEMOJTE upotrebljavati brizgalicu ako je otopina zamućena, promjenjene boje ili sadrži čestice.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: • 1 vial adapter (2)
Croatian: • 1 nastavak za bočicu (2)
English: • 2 pre-filled pens (with 2 alcohol pads)
Croatian: • 2 napunjene štrcaljke (s 2 jastučića natopljena alkoholom)
English: Throwing away supplies
Croatian: Odlaganje pribora u otpad
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Croatian: 24 tjedna i nakon 52 tjedna b 40 mg adalimumaba primijenjenog svaki drugi tjedan c MTX = metotreksat ** p<0.01, adalimumab u usporedbi s placebom
English: Table 13: Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Croatian: Tablica 13: Djelotvornost u placebom kontroliranom ispitivanju kod AS a - ispitivanje
English: STATEMENT OF ACTIVE SUBSTANCE(S) 0.8 ml vial contains 40 mg adalimumab
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 0,8 ml sadrži 40 mg adalimumaba
English: • 2 pre-filled syringes (with 2 alcohol pads)
Croatian: • 2 napunjene brizgalice (s 2 jastučića natopljena alkoholom)
English: Beyond 16 weeks, patients with inadequate response to Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na Hulio u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: If your child takes Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako Vaše dijete primijenjuje lijek Hulio.
English: • 1 pre-filled syringe (with 2 alcohol pads)
Croatian: • 1 napunjena brizgalica (s 2 jastučića natopljena alkoholom)
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially, followed by 40 mg every other week starting two weeks later.
Croatian: Uobičajena početna doza za Crohnovu bolest je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg.
English: The Hulio pre-filled pen is made of plastic with a stopper and a needle with a needle cap. Each pack contains 1, 2 or 6 pre-filled pens with 2, 2 or 6 alcohol pads.
Croatian: Jedno pakiranje sadrži 1, 2 ili 6 napunjenih brizgalica s 2, 2, odnosno 6 jastučića natopljenih alkoholom.
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Odrasli s nezaraznim uveitisom kod kojeg upala zahvaća stražnji dio oka Uobičajena doza za odrasle s nezaraznim uveitisom je početna doza od 80 mg (u obliku dvije injekcije u jednom danu), nakon čega slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: Week 104 42.8% 36.9%
Croatian: 104. tjedan 42,8% 36,9% 59,0% < 0,001 < 0,001
English: Hulio 40 mg solution for injection in pre-filled pen
Croatian: Hulio 40 mg otopina za injekciju u napunjenoj brizgalici
English: Psychiatric disorders
Croatian: Demijelinizacijska bolest
English: Deafness, tinnitus
Croatian: Često vertigo manje često gluhoća, tinitus
English: • 1 pre-filled pen (with 2 alcohol pads)
Croatian: • 1 napunjena štrcaljka (s 2 jastučića natopljena alkoholom)
English: The Hulio pre-filled syringe is made of plastic syringe with a stopper and a needle with a needle cap. Each pack contains 1, 2 or 6 pre-filled syringes with 2, 2 or 6 alcohol pads.
Croatian: Jedno pakiranje sadrži 1, 2 ili 6 napunjenih štrcaljki s 2, 2, odnosno 6 jastučića natopljenih alkoholom.
English: Table 24: Maintenance of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 23: Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Table 20: Paediatric CD Study PCDAI Clinical Remission and Response Standard Dose 40/20 mg eow N = 93
Croatian: Tablica 20: Ispitivanje kod Crohnove bolesti u djecePCDAI klinička remisija i odgovor
English: Slovenija Mylan Healthcare d.o.o.
Croatian: Norge Mylan Healthcare Norge AS
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Croatian: Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Croatian: Kroz 10 godina terapiju adalimumabom 40 mg svaka dva tjedna nastavio je 81 od 207 bolesnika.
English: Pancreatitis, dysphagia, face oedema
Croatian: • težak osip, koprivnjača,
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Croatian: 24. tjedan ***,** Statistički značajno uz p<0,001, p<0,01 za sve usporedbe adalimumaba s placebom u 2., 12. i
English: Cardiac arrest
Croatian: Prekid terapije
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Croatian: često rak kože, isključujući melanom (uključujući bazocelularni karcinom i karcinom skvamoznih stanica), benigne neoplazme manje često limfom**, novotvorine na solidnim organima (uključujući rak dojke, novotvorine na plućima i štitnjači), melanom**
English: If you have further questions, ask your doctor.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku.
English: This is something that will be decided by your surgeon.
Croatian: O tome će odlučiti kirurg.
English: Date of first authorisation: 18.05.2001 Date of latest renewal: 18.05.2011
Croatian: Datum prvog odobrenja: 18.05.2001. Datum posljednje obnove odobrenja: 18.05.2011.
English: This medicine is only supplied to hospitals and specialist clinics.
Croatian: Ovaj se lijek isporučuje samo bolnicama i specijalnim klinikama.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta.
English: The long-term impact of these antibodies is not known.
Croatian: Nije poznat dugoročni učinak tih protutijela.
English: Analysis of these antibodies showed that 9% had neutralizing capacity.
Croatian: Analiza tih antitijela pokazala je da ih je 9% imalo sposobnost neutralizacije.
English: However, external fixation may not provide sufficient immobilisation.
Croatian: No, vanjska fiksacija možda neće pružati dostatnu imobilizaciju.
English: WHAT OSIGRAFT IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE OSIGRAFT I ZA ŠTO SE KORISTI
English: If required, place it subcutaneously.
Croatian: Ako je potrebno, postavite ga supkutano.
English: This is usually done under a full general anaesthetic so you will not be awake during the surgery.
Croatian: To se uobičajeno provodi pod općom anestezijom pa tijekom operacije nećete biti budni.
English: What Osigraft contains
Croatian: Što Osigraft sadrži
English: The frequency of possible side effects listed below is defined using the following convention:
Croatian: Učestalost niže navedenih mogućih nuspojava definirana je prema sljedećim pravilima:
English: The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Croatian: Kolagenski matriks netopiv je i sastoji se od čestica veličine 75-425 µm.
English: 6.5 Nature and contents of container and special equipment for use, administration or
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za uporabu, primjenu ili ugradnju
English: Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required.
Croatian: Osigraft ne pruža nikakvu biomehaničku potporu, stoga se mora koristiti s internom ili eksternom fiksacijom kada je potrebna inicijalna mehanička stabilizacija.
English: • OTHER CONDITIONS
Croatian: DRUGI UVJETI
English: The recommended dose is one single administration in adults.
Croatian: Preporučena doza je jedna primjena za odrasle.
English: Antibody test positive (Antibody formation)
Croatian: Pozitivni test na antitijela (stvaranje antitijela)
English: It is recommended that breast-feeding be discontinued following treatment.
Croatian: Preporučuje se da se dojenje prekine nakon liječenja.
English: Like all medicines, Osigraft can have side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, i Osigraft može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
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.
Croatian: Rezultati radioloških i histoloških pretraga u ovoj nekliničkoj studiji pokazali su zacjeljivanje kosti u početnoj i ponovljenoj izloženosti za iste životinje.
English: Do not insert a needle through the stopper.
Croatian: Nemojte umetati iglu kroz čep.
English: In the absence of comparability studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
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).
Croatian: Sljedeće su kategorije nuspojava grupiranih prema učestalosti nastupa nuspojava: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1.000 do <1/100); rijetko (1/10.000 do <1/1.000); i vrlo rijetko (<1/10.000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Some patients treated with this product were also reported to have experienced various undesirable effects associated with recent orthopaedic surgery.
Croatian: Prijavljeno je i da su neki pacijenti liječeni ovim lijekom imali razne nuspojave povezane s nedavnim ortopedskim kirurškim operacijama.
English: The new bone formed is mechanically and radiographically comparable to normal bone.
Croatian: Novonastala kost je mehanički i radiografski usporediva s normalnom kosti.
English: Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed.
Croatian: Provedene su studije jednokratnih i ponavljanih doza na više životinjskih modela (štakori, psi i primati).
English: The maximum recommended dose for this medicine is 2 vials (2g) since its effectiveness at higher doses has not been established.
Croatian: Najveća preporučena doza za ovaj lijek je dvije bočice (2 g), jer učinkovitost u većim dozama nije utvrđena.
English: White to off-white granular powder.
Croatian: Bijeli do bjelkasti granulirani prašak.
English: Osigraft is an osteoinductive and osteoconductive medicinal product.
Croatian: Osigraft je osteoinduktivan i osteokonduktivan lijek.
English: - if you are receiving chemotherapy, radiation treatment or immunosuppression
Croatian: ako primate kemoterapiju, liječenje radioterapijom ili imunosupresijom.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju, koštani morfogenetski proteini, ATK oznaka: M05BC02
English: Interaction with other medicine
Croatian: Interakcije s drugim lijekovima
English: Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za ne navođenje Braillea
English: After reconstitution, the single use suspension for implantation should be used immediately.
Croatian: Nakon pripreme, jednokratnu suspenziju za implantaciju treba odmah primijeniti.
English: Therefore, upon readministration of eptotermin alfa, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Croatian: Stoga u slučaju ponovne primjene eptotermina alfa postoji rizik od razvoja autoimuniteta prema endogenim proteinima BMP.
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).
Croatian: Značajno visoki titri antitijela IgG klase anti-OP-1 otkriveni su u mlijeku u cijelom razdoblju postnatalne faze studije do 28. dana laktacije (vidjeti dio 4.6).
English: This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
Croatian: Taj učinak, nazvan karcinogenošću krutih tvari, često je uočen u štakora kad su kruti materijali (plastika ili metal) implantirani supkutano.
English: The clinical implications of these observations for human use of the finished product remain uncertain (see section 4.6).
Croatian: Kliničke implikacije tih promatranja za primjenu gotovog lijeka kod ljudi i dalje su nepouzdane (vidjeti dio 4.6).
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.
Croatian: Bolnički farmaceut ili kirurg odgovoran je za ispravno čuvanje lijeka prije, kao i za vrijeme njegove primjene te također i za ispravno zbrinjavanje.
English: Locking intramedullary rods were used in the majority of cases.
Croatian: U većini slučajeva korištene su intramedularne šipke.
English: The edges of the crimp are sharp and may cut or damage gloves.
Croatian: Rubovi zatvarača su oštri i mogu razrezati ili oštetiti rukavice.
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).
Croatian: Klinički rezultati boli i nosivosti tereta bili su usporedivi s autograftom (81% uspjeha u skupini liječenoj Osigraftom i 77% uspjeha u skupini liječenoj autograftom).
English: There is a possibility that new antibodies can form in your body after treatment with Osigraft.
Croatian: Postoji mogućnost stvaranja novih protutijela u tijelu nakon liječenja Osigraftom.
English: Bovine collagen (vacuum dried).
Croatian: Goveđi kolagen (sušen u vakuumu).
English: Heterotopic ossification may also occur following use (see section 4.8).
Croatian: Do heterotopičnog okoštavanja također može doći nakon primjene (vidjeti dio 4.8).
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.
Croatian: Sličan uzorak nuspojava zabilježen je u spontanom izvještavanju sa značajno nižom incidencijom od onih uočenih u kliničkim ispitivanjima.
English: If you have a known hypersensitivity to collagen you should not be treated with this medicine.
Croatian: Ako je poznato da ste preosjetljivi na kolagen, ne biste se trebali liječiti ovim lijekom.
English: Laboratory studies have shown that antibodies to the eptotermin alfa component of this medicine could react with similar antibodies that the body makes naturally.
Croatian: Laboratorijska ispitivanja pokazala su da protutijela na eptotermin alfa, koji je sastojak ovog lijeka, mogu reagirati sa sličnim protutijelima koje tijelo prirodno stvara.
English: Osigraft is a type of medicine known as a bone morphogenetic protein (BMP).
Croatian: Osigraft je vrsta lijeka poznata kao koštani morfogenetski protein (BMP).
English: Important information about some of the ingredients of Osigraft Osigraft contains bovine collagen.
Croatian: Važne informacije o nekim sastojcima Osigrafta Osigraft sadrži goveđi kolagen.
English: An immune response to Osigraft should be considered and appropriate tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the product is ineffective.
Croatian: Treba uzeti u obzir imuni odgovor na Osigraft, a odgovarajući testovi na prisutnost antitijela u serumu moraju se provesti u slučajevima kada se sumnja na imunološki posredovanu nuspojavu, uključujući slučajeve u kojima je lijek nedjelotvoran.
English: The Marketing Authorisation Holder will continue to submit PSURs every three years.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet nastavit će predavati PSUR-eve svake tri godine.
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.
Croatian: Nositelj odobrenja se obvezuje provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom kako je dogovoreno u verziji 1.0 RMP-a prikazanog u Modulu 1.8.2 odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane CHMP.
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).
Croatian: Zbog nepoznatih rizika za fetus koje su povezane s potencijalnim razvojem neutralizirajućih antitijela na protein OP-1, Osigraft se ne bi smio primjenjivati u trudnoći osim ako potencijalna korist opravdava potencijalne rizike za fetus (vidjeti dio 4.4 i 5.3).
English: Do not place a drain directly in the implant site.
Croatian: Nemojte postavljati dren direktno na mjesto implantata.
English: However, there is evidence to suggest that heterotopic ossification is not linked to sarcoma in humans.
Croatian: No, postoje dokazi koji ukazuju na to da heterotopično okoštavanje nije povezano s pojavom sarkoma u čovjeka.
English: Using other medicines
Croatian: Uzimanje drugih lijekova