FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicinal product should be used in breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Croatian: Opgenra se treba koristiti kod dojilja samo ako nadležni liječnik odluči da koristi nadmašuju potencijalne rizike.
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.
Croatian: Podaci dobiveni istraživanjem nakon puštanja lijeka u promet ukazuju da pri primjeni lijeka u kombinaciji sa sintetičkim punilom šupljina u kostima može doći do povećanja lokalnih upala, infekcija te ponekad i do migracije implantiranih materijala.
English: • hypersensitivity and antibody formation
Croatian: • preosjetljivosti i nastanku protutijela
English: The following adverse reactions were reported with Opgenra.
Croatian: Sljedeće nuspojave prijavljene su s lijekom Opgenra.
English: Debride and decorticate bone so that the reconstituted medicinal product will directly contact viable tissue.
Croatian: Odstranite tkivo i kortikalne fragmente kosti tako da pripremljeni lijek bude u izravnom kontaktu sa živim tkivom.
English: Talk to your doctor or surgeon about these precautions before you are administered this medicine.
Croatian: Razgovarajte sa svojim liječnikom o ovim mjerama opreza prije primjene ovog lijeka.
English: - if you are an adolescent (12-18 years old) or your skeleton is not yet be fully formed (you are still growing).
Croatian: - ako primate kemoterapiju, liječenje radioterapijom ili imunosupresijom. - ako ste dijete (u dobi manjoj od 12 godina starosti).. - ako ste adolescent (u dobi od 12 do 18 godina starosti) ili Vaš kostur još uvijek nije u potpunosti formiran (još uvijek rastete).
English: • post-surgery problems (for example discharge, swelling or other wound complications)
Croatian: • poslije operativni problemi (iscjedak, oticanje ili druge komplikacije rane)
English: Lift the plastic flip-tops and remove the crimp caps from the vials.
Croatian: Na bočicama podignite plastične poklopce i uklonite kapice.
English: Repeated use of this medicine cannot be recommended.
Croatian: Nije preporučljiva ponovna primjena lijeka.
English: • Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
Croatian: • Obavijestite svog liječnika ili kirurga ako ste nekada imali srčane poremećaje ili ste skloni čestim infekcijama tako da Vas može pomno nadzirati.
English: Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
Croatian: Obavijestite svog liječnika ili kirurga ako imate anamnezu srčanih poremećaja ili ste skloni čestim infekcijama tako da Vas može pomno nadzirati.
English: The powder containing the active substance is granular and white to off-white.
Croatian: Prašak koji sadrži djelatnu tvar je zrnate strukture i bijele do gotovo bijele boje.
English: Use the product promptly following reconstitution.
Croatian: Upotrijebite lijek odmah nakon rekonstitucije.
English: Each unit of Opgenra consists of two vials of powder, which are first combined and then reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Jedna jedinica lijeka Opgenra sastoji se od dvije bočice s praškom koje se najprije pomiješaju i potom prije primjene rekonstituiraju s 2,5 ml otopine natrijeva klorida za injekcije 9 mg/ml (0,9%).
English: What you need to know before you are administered Opgenra Do not use Opgenra
Croatian: Što morate znati prije nego primite lijek Opgenra
English: Excipients : Bovine collagen, carmellose.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: goveđi kolagen, karmeloza.
English: Care should be used when Opgenra is used in patients with renal or hepatic impairment (see section
Croatian: Treba biti oprezan s uporabom lijeka Opgenra u bolesnika s oštećenjem bubrega ili jetre (vidjeti dio 4.4).
English: • Use of this medicine with synthetic bone substitutes is not recommended.
Croatian: • Ne preporučuje se primjena ovog lijeka sa sintetičkim nadomjescima za kost.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 230 mg
English: The concomitant use of Opgenra with a synthetic bone void filler is not recommended (see section
Croatian: Istovremena primjena lijeka Opgenra sa sintetskim punilom šupljina u kostima nije preporučena (vidjeti dio 4.5).
English: Opgenra contains the active substance eptotermin alfa.
Croatian: Opgenra sadrži djelatnu tvar eptotermin alfa.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Croatian: Lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6. 6.3 Rok valjanosti
English: How to use Opgenra
Croatian: Kako se koristi Opgenra
English: Pre-existing co-morbidities
Croatian: Prethodni komorbiditeti
English: Irrigate the surgical site as necessary prior to the implantation of the medicinal product.
Croatian: Prema potrebi isperite mjesto kirurške ugradnje prije implantacije lijeka.
English: Common: bone formation increased (heterotopic bone formation)
Croatian: Često: povećanje stvaranja kosti (heterotopično stvaranje kosti) Nepoznato: osteoliza
English: • have prior history of exposure to any bone morphogenetic protein (BMP) product;
Croatian: • imaju prethodnu anamnezu izloženosti proizvodima koji sadrže koštani morfogenetski protein
English: Opgenra 3.3 mg powder for implantation suspension.
Croatian: NAZIV LIJEKA Opgenra 3,3 mg prašak za suspenziju implantata
English: - have had this medicine, eptotermin alfa or any similar medicine before.
Croatian: - ako ste ranije primali ovaj lijek, eptotermin alfa ili bilo koji sličan lijek. - ako imate tumore u području namijenjenom kirurškom zahvatu.
English: Sarcoma was associated with the long-term presence of the heterotopic bone.
Croatian: Uz dugoročnu prisutnost heterotopične kosti povezan je i nastanak sarkoma.
English: Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Croatian: Na kunićima su provedena kontrolirana ispitivanja učinka izloženosti eptoterminu alfa na prenatalni i postnatalni razvoj.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Upute o primjeni lijeka prije primjene potražite u dijelu 6.6.
English: Where practical, surgical manipulations to the site should be completed prior to product implantation.
Croatian: Ako je primjenjivo, kirurški postupak na kirurškom mjestu treba završiti prije implantacije lijeka.
English: Puncture of the stoppers with a needle may result in particles of stopper material contaminating the medicinal product.
Croatian: Ako čep probušite iglom, može doći do kontaminacije lijeka komadićima materijala od kojeg je izrađen čep.
English: No case of overdose has been reported.
Croatian: 4.9 Predoziranje Slučajevi predoziranja nisu zabilježeni.
English: 1 vial containing 230 mg carmellose.
Croatian: 1 bočica s 230 mg karmeloze.
English: 2 x 1 vial containing 230 mg carmellose.
Croatian: 2 × 1 bočica s 230 mg karmeloze.
English: One vial of this medicine contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen.
Croatian: Jedna bočica ovog lijeka sadrži 1 g praška s 3,3 mg eptotermina alfa i goveđi kolagen kao pomoćnu tvar.
English: Antibodies were detectable in adults and offspring during the gestation and lactation periods.
Croatian: Tijekom razdoblja gestacije i laktacije protutijela su bila detektibilna kod odraslih i mladunčadi.
English: • interaction with bone void fillers
Croatian: • interakcijama s punilima za šupljine u kostima
English: A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Croatian: Kod mladunčadi skupine koja je bila imunizirana protutijelima OP-1 uočena su statistički značajna povećanja fetalnih deformacija (otklon segmenata sternuma).
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test. Detectable levels of IgG and IgM antibodies to eptotermin alfa had developed and were found in the serum of all exposed adult animals.
Croatian: U redovitim intervalima prikupljani su uzorci krvi i majčina mlijeka te su analizirani enzimskim imunohistokemijskim testom (ELISA) na krutoj podlozi.
English: Opgenra should not be administered during pregnancy unless the benefits to the mother outweigh the risks to the unborn child. Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before they are administered this medicine.
Croatian: Opgenra se ne smije primjenjivati tijekom trudnoće, osim ako koristi lijeka za majku ne premašuju rizike za nerođeno dijete.
English: If you get any side effects, talk to your doctor or surgeon.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Use of this medicine with synthetic bone substitutes is not recommended.
Croatian: Primjena ovog lijeka sa sintetičkim punilima za šupljine u kostima se ne preporučuje.
English: Interaction with bone void fillers
Croatian: Interakcija s punilom šupljina u kostima
English: Excipients : Bovine collagen
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: goveđi kolagen
English: Bovine collagen Carmellose
Croatian: Goveđi kolagen
English: One unit of Opgenra powder for implantation suspension comes as two separate powders.
Croatian: Opgenra isporučuje se kao dva zasebna praška.
English: The other vial contains the excipient carmellose.
Croatian: Druga bočica sadrži pomoćnu tvar karmelozu.
English: Using your thumb pry up the edges of the stoppers.
Croatian: Palcem podignite rubove čepova.
English: One vial containing 1g of powder (3.3 mg eptotermin alfa); one vial containing 230 mg carmellose powder.
Croatian: Jedna bočica sadrži 1 g praška (3,3 mg eptotermina alfa); jedna bočica sadrži 230 mg karmeloze prašku.
English: Talk to your doctor if you have any of the following: - Common (may affect up to 1 in 10 people):
Croatian: - Često (može se javiti u do 1 na 10 osoba):
English: In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD containing animated images of an operation on a patient and including the following information: Product description
Croatian: Osim toga, prije uporabe kirurzi koji namjeravaju koristiti lijek Opgenra trebaju dobiti DVD za obuku koji sadrži animirane slike kirurškog zahvata na bolesniku i uključuju sljedeće informacije: - opis lijeka - postavljanje u sterilno polje - otvaranje rane (meka i tvrda tkiva) - rekonstituciju lijeka - pripremu polja implantacije (hemostaza) - primjenu (implantacija) - zadržavanje implantiranog materijala (meka tkiva) - instrumentaciju - zatvaranje rane (drenaža) - mjere praćenja
English: Carmellose powder for implantation suspension for Opgenra Intraosseous use
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Karmeloza u prašku za suspenziju implantata za lijek Opgenra
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER FOR THE CARMELLOSE POWDER VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BLISTER ZA BOČICU S PRAŠKOM KOJI SADRŽI KARMELOZU
English: How to store Opgenra
Croatian: Kako čuvati lijek Opgenra
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF ACTIVE SUBSTANCE POWDER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S PRAŠKOM DJELATNE TVARI
English: The antibody levels declined towards baseline during the follow-up period.
Croatian: Tijekom razdoblja praćenja došlo je do snižavanja razine protutijela na početne vrijednosti.
English: Not known: implant site complications (e.g. abscess, implant site induration, pain, oedema, pyrexia)
Croatian: Manje često: lokalizirano oticanje, Nepoznato: komplikacije na mjestu implantacije (npr. apsces, stvrdnjavanje mjesta implantacije, bol, edem, pireksija) Poremećaji imunološkog sustava Nepoznato: preosjetljivost, urtrikarija Ozljede, trovanje i komplikacije uslijed postupaka
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Heterotopic ossification commonly occurs in humans following accidental or surgical trauma to the skeleton.
Croatian: Kod ljudi se često nakon nezgode ili kirurške traume javlja heterotopično okoštavanje kostura.
English: - if you have an autoimmune disease (disease arising from or directed against your own tissues),
Croatian: - ako bolujete od autoimune bolesti (bolest koja se razvija iz vlastitog tkiva ili je usmjerena protiv vlastitog tkiva), uključujući Crohnovu bolest, reumatoidni artritis, sistemski eritematozni lupus,
English: - a pack of two units with 2 x 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 2 x 1 vial containing 230 mg carmellose powder.
Croatian: - dvojedinično pakiranje s 2 x 1 bočicom od kojih svaka sadrži 1 g praška (3,3 mg eptotermina alfa) i 2 × 1 bočicom od kojih svaka sadrži 230 mg karmeloze prašku.
English: See end of section 4 for how to report side effects.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: Intraosseous use Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARMELLOSE VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S KARMELOZOM
English: Immune system disorders
Croatian: Osiguravanje nepomicanja implantata
English: Each outer carton contains one 3.3 mg eptotermin alfa vial containing 1 g of powder and one carmellose powder vial containing 230 mg powder.
Croatian: Jedno vanjsko pakiranje sadrži jednu bočicu s 3,3 mg eptotermina alfa koja sadrži 1 g praška i jednu bočicu s 230 mg praška karmeloze.
English: To be attached to the patient's medical record.
Croatian: EDUKACIJSKA NALJEPNICA ZA ZDRAVSTVENE DJELATNIKE Nalijepiti u bolesnikov zdravstveni karton.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER FOIL ACTIVE SUBSTANCE POWDER VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BLISTER FOLIJA S BOČICOM S PRAŠKOM KOJA SADRŽI DJELATNU TVAR
English: Marketing Authorisation Holder Olympus Biotech International Limited Block 2, International Science Centre National Technology Park Castletroy
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka Olympus Biotech International Limited Block 2, International Science Centre National Technology Park
English: Contents of the pack and other information What Opgenra contains
Croatian: Sadržaj pakiranja i druge informacije
English: One vial containing 3.3 mg of eptotermin alfa
Croatian: TVARI Jedna bočica sadrži 3,3 mg eptotermina alfa
English: 2 x 1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
Croatian: 2 × 1 bočica s 1 g praška (3,3 mg eptotermina alfa).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Karmeloza (Opgenra)
English: 1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
Croatian: Jedna bočica sadrži 1 g praška (3,3 mg eptotermina alfa).
English: Common: wound dehiscence, secretion, pseudarthrosis Uncommon: product migration when mixed with synthetic bone
Croatian: Često: razdvajanje šavova na rani, curenje iz rane, pseudoartroza Manje često: migracija lijeka prilikom miješanja sa sintetskim punilom šupljina u kostima, serom Nepoznato: poslijeoperativne komplikacije (iscjedak nakon postupka, oticanje, druge komplikacije rane)
English: One vial containing 3.3 mg of eptotermin alfa.
Croatian: TVARI Jedna bočica sadrži 3,3 mg eptotermina alfa.
English: Use with bone void fillers
Croatian: Primjena s punilom šupljina u kostima
English: Pack sizes: - a single unit pack with 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 1 vial containing 230 mg carmellose powder
Croatian: Veličine pakiranja: - jedinično pakiranje s 1 bočicom koja sadrži 1 g praška (3,3 mg eptotermina alfa) i 1 bočica koja sadrži 230 mg karmeloze prašku - dvojedinično pakiranje s 2 x 1 bočicom od kojih svaka sadrži 1 g praška (3,3 mg eptotermina alfa) i 2 x 1 bočicom koja sadrži 230 mg karmeloze prašku.
English: One vial contains 1g powder with 3.3 mg of eptotermin alfa*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 1 g praška s 3,3 mg eptotermina alfa*.
English: Instrumentation
Croatian: OBLIK
English: Opgenra 3.3 mg
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Opgenra 3,3 mg
English: • wound problems including infection, discharge and rupture.
Croatian: • zatajenje fuzije kralježak a(pseudoartroza), problemi s ranom koji obuhvaćaju infekciju, iscjedak i puknuće.
English: Close soft tissues around the site containing the product using suture material of choice.
Croatian: 12. Materijalom po izboru zašijte meko tkivo oko kirurškog mjesta na koje ste nanijeli lijek.
English: Renal/hepatic impairment
Croatian: Oštećenje bubrega/jetre
English: What you will need:
Croatian: Što ćete trebati:
English: ● if you notice a change in your vision.
Croatian: • ako primijetite promjenu u vidu.
English: ALT Normalisation
Croatian: ALT normalizacija
English: 3) Clean your hands
Croatian: 3) Operite ruke
English: ● you may not have received an entire dose.
Croatian: ● možda niste primili cijelu dozu lijeka.
English: However, due to high variability, the confidence intervals were quite wide.
Croatian: Međutim, zbog veće varijabilnosti, intervali pouzdanosti bili su prilično široki.
English: Wash your hands well using soap and water.
Croatian: Dobro operite ruke sapunom i vodom.
English: 27% 19% N/A
Croatian: 27% 19% N/P
English: Some patients have actually committed suicide.
Croatian: Neki su bolesnici počinili samoubojstvo.
English: ● if the patient is a child less than 3 years old.
Croatian: • ako je bolesnik dijete mlađe od 3 godine.
English: Let the skin dry for 10 seconds.
Croatian: Pustite da se koža osuši kojih 10 sekundi.
English: This can be discussed with your doctor.
Croatian: O tome porazgovarajte sa svojim liječnikom.
English: CAUTION: If the viewing window is not completely filled by the red indicator,
Croatian: OPREZ: Ako se prozorčić za provjeru nije potpuno ispunio crvenim pokazateljem,
English:  A "click" sound will indicate the start of the injection.
Croatian: → Zvuk „klik“ će označiti početak injekcije.
English: This will lessen the chance for ribavirin to be left in the woman's body.
Croatian: Na taj će se način smanjiti mogućnost da ribavirin ostane u tijelu žene.
English: ● if you have ever had anaemia.
Croatian: • ako ste ikada bolovali od anemije.
English: Response at End of Treatment
Croatian: Odgovor na kraju liječenja
English: Efficacy results were similar to those reported in adults.
Croatian: Rezultati djelotvornosti bili su slični onima prijavljenima u odraslih.
English: The risk of developing anaemia is higher in the female population.
Croatian: Rizik od razvoja anemije veći je u ženskoj populaciji.
English: ● the needle-shield may not have locked.
Croatian: ● štitnik za iglu se možda nije zaključao.
English: The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
Croatian: Prosječna molekularna masa iznosi otprilike 60 000, od čega proteinski dio čini otprilike 20 000.
English:  The viewing window will now be completely red.
Croatian: → Prozorčić za provjeru sada će biti potpuno crven.
English: Unless otherwise noted, the management of all other toxicities should follow the adult recommendations.
Croatian: Ako nije drugačije navedeno, u zbrinjavanju svih ostalih toksičnosti treba slijediti preporuke za odrasle.
English: However in neither disease was this correlated with lack of therapeutic response.
Croatian: Ni u jednoj bolesti, međutim, to nije bilo u vezi s nedostatkom terapijskog odgovora.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: ● use through clothing covering the skin.
Croatian: ● ne primjenjujte kroz odjeću koja prekriva kožu.
English: *Grading according to Trey, Burns and Saunders (1966)
Croatian: * stupnjevanje prema Treyu, Burnsu i Saundersu (1966)
English: Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.
Croatian: Recite liječniku ako uzimate lijekove protiv astme jer će možda dozu Vašeg lijeka za liječenje astme trebati promijeniti.
English: Grade 3-4*
Croatian: stupanj 3-4*
English: Date of latest renewal: 20 June 2007
Croatian: Datum posljednje obnove odobrenja: 20. lipnja 2007.
English: Patients and caregivers must not attempt to break the 200 mg tablets.
Croatian: Bolesnici i njegovatelji ne smiju pokušavati lomiti tablete od 200 mg.
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Croatian: Ako dođe do takve reakcije, treba ih savjetovati da nakon toga temeljito isperu usta.
English: With your other hand hold the syringe as you would a pencil.
Croatian: Drugom rukom uhvatite štrcaljku kao što biste primili olovku.
English: Choose a place on your stomach or thigh (see the picture).
Croatian: Izaberite mjesto na trbuhu ili bedru (pogledajte sliku).
English: Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases.
Croatian: Interferon je protein koji mijenja odgovor tjelesnog imunološkog sustava kako bi mu pomogao u obrani od infekcija i teških bolesti.
English: The study was not powered for efficacy considerations.
Croatian: Ispitivanje nije bilo zasnovano radi razmatranja djelotvornosti.
English: These instructions do not replace training from your healthcare provider.
Croatian: Ove upute ne mogu nadomjestiti poduku koju ćete dobiti od svojega zdravstvenog radnika.
English: You may see a small drop(s) or loss of some liquid coming out of the pen.
Croatian: Možda ćete ugledati malu kapljicu (kapljice) ili nešto tekućine kako izlazi iz brizgalice.
English: It is important to note that ribavirin should never be given as monotherapy.
Croatian: Važno je napomenuti da se ribavirin nikada ne smije davati kao monoterapija.
English: ● if you have ever had a heart attack or have been hospitalised for serious chest pains in the last six months.
Croatian: • ako ste ikad doživjeli srčani udar ili ste u posljednjih šest mjeseci boravili u bolnici zbog ozbiljnih bolova u prsnom košu.
English: You are now ready to inject the dose.
Croatian: Sada možete ubrizgati dozu.
English: < 12 g/dl despite 4 weeks at reduced dose
Croatian: <12 g/dl usprkos 4 tjedna liječenja smanjenom dozom
English: Do not warm up pre-filled pen in any other way.
Croatian: Ne zagrijavajte napunjenu brizgalicu na bilo koji drugi način.
English: There are no data on long-term effects on sexual maturation.
Croatian: Nema podataka o dugoročnim učincima na spolno sazrijevanje.
English: Predictability of response
Croatian: Predvidljivost odgovora
English: • A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4)
Croatian: • prethodna teška bolest srca uključujući nestabilnu ili nekontroliranu bolest srca u prethodnih šest mjeseci (vidjeti dio 4.4)
English: Collect the necessary items before beginning: Included in the pack:
Croatian: Prije početka pripremite potreban pribor: U pakiranju se nalazi:
English: If necessary, the dose may be changed during treatment.
Croatian: U slučaju potrebe, doza se tijekom liječenja može promijeniti.