FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na denosumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Bone is a living tissue and is renewed all the time.
Croatian: Kost je živo tkivo i stalno se obnavlja.
English: To avoid bending the needle, gently pull the cover from the needle straight off without twisting, as shown in pictures 1 and 2.
Croatian: Kako biste izbjegli savijanje igle, nježno izvucite poklopac igle ravno s igle, bez izvijanja, kako je pokazano na slikama 1 i 2.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možete primijetiti mali mjehurić zraka u napunjenoj štrcaljki.
English: DO NOT use it if the date has passed the last day of the month shown.
Croatian: NE koristite ju ako je prošao posljednji dan naznačenog mjeseca.
English: Hypocalcaemia (see section 4.4).
Croatian: Hipokalcijemija (vidjeti dio 4.4).
English: The bones become weaker and break more easily.
Croatian: Kosti postanu slabije i lakše pucaju.
English: For instructions on how to inject Prolia, please read the section at the end of this leaflet.
Croatian: Za upute kako injicirati lijek Prolia, molimo pročitajte odjeljak na kraju ove upute.
English: Put the needle fully into the skin as shown by your doctor or healthcare provider.
Croatian: Uvedite iglu potpuno u kožu kako Vam je pokazao Vaš liječnik ili zdravstveni radnik.
English: Use the peel-off stickers to mark the next injection date on your personal calendar and/or the reminder card to keep a record of the next injection date.
Croatian: Koristite naljepnice za označavanje sljedećeg datuma injekcije u svom osobnom kalendaru i/ili kartici s podsjetnikom kako biste vodili računa o datumu sljedeće injekcije.
English: If a dose of Prolia is missed, the injection should be administered as soon as possible.
Croatian: Ako ste propustili dozu lijeka Prolia, injekciju treba primiti što je prije moguće.
English: Push the plunger with a slow constant pressure, always keeping the skin pinched.
Croatian: Pritisnite klip polaganim stalnim pritiskom, stalno držeći kožu uštipnutom.
English: However, due to its character it is unlikely that denosumab has any potential for genotoxicity.
Croatian: Međutim, zbog svojih svojstava nije vjerojatno da denosumab ima ikakav genotoksični potencijal.
English: B Carefully pull the grey needle cap straight out and away from your body.
Croatian: B Pažljivo ravno povucite sivi zatvarač s igle i dalje od Vašeg tijela.
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Croatian: Važno je da obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Other medicines and Prolia
Croatian: Drugi lijekovi i Prolia
English: Only use each pre-filled syringe for one injection.
Croatian: Koristite svaku napunjenu štrcaljku samo za jednu injekciju.
English: To get the most benefit from your treatment, it is important to use Prolia for as long as your doctor prescribes it for you.
Croatian: Kako biste dobili najviše koristi od svoje terapije, važno je da koristite lijek Prolia toliko dugo koliko Vam je liječnik propisao.
English: These effects were sustained with continued treatment.
Croatian: Ti su učinci bili zadržani s kontinuiranom terapijom.
English: Before receiving treatment, tell your doctor or nurse (health care professional) if you:
Croatian: Prije početka liječenja, obavijestite svog liječnika ili medicinsku sestru (zdravstvenog radnika) ako:
English: • painful urination, frequent urination, blood in the urine, inability to hold your urine,
Croatian: • bolno mokrenje, često mokrenje, krv u urinu, nemogućnost zadržavanja urina,
English: It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.
Croatian: Posebno je važno da obavijestite liječnika ako se liječite s drugim lijekom koji sadrži denosumab.
English: 0-3 years *p < 0.0001, **p < 0.0001 - exploratory analysis
Croatian: *p < 0,0001, **p < 0,0001 - eksplorativna analiza
English: Important Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Croatian: Važno Prije korištenja Prolia napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
English: Patients who did not complete the study for any reason had higher on-treatment fracture rates.
Croatian: Bolesnici koji nisu završili ispitivanje, iz bilo kojeg razloga, imali su više stope prijeloma na terapiji.
English: The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Croatian: Početak liječenja / novi ciklus liječenja treba odgoditi u bolesnika s nezacijeljenim otvorenim lezijama mekog tkiva u ustima.
English: These changes were partially reversible in this model when dosing with RANKL inhibitors was discontinued.
Croatian: U ovom modelu navedene promjene bile su djelomično reverzibilne nakon prekida doziranja s RANKL inhibitorima.
English: - The active substance is denosumab.
Croatian: - Djelatna tvar je denosumab.
English: What Prolia looks like and contents of the pack
Croatian: Kako Prolia izgleda i sadržaj pakiranja
English: • don't receive routine dental care or have not had a dental check-up for a long time.
Croatian: • nemate redovite stomatološke preglede ili niste dugo vremena obavili stomatološki pregled.
English: Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
Croatian: Osteoporoza se može javiti i kod muškaraca zbog niza uzroka koji uključuju starenje i/ili nisku razinu muškog hormona, testosterona.
English: 1 See section Description of selected adverse reactions 2 See section 4.4
Croatian: 1 Vidjeti dio Opis odabranih nuspojava 2 Vidjeti dio 4.4
English: If any of these apply to you, tell your doctor immediately.
Croatian: Ukoliko se bilo što od navedenog odnosi na Vas, recite odmah svom liječniku.
English: How do you give the injection?
Croatian: Kako davati injekciju?
English: Check the appearance of Prolia.
Croatian: Provjerite izgled lijeka Prolia.
English: Prolia is not recommended in paediatric patients (age < 18) as the safety and efficacy of Prolia in these patients have not been established.
Croatian: Prolia se ne preporučuje za primjenu u djece (dob < 18) jer u tih bolesnika nije utvrđena sigurnost i djelotvornost lijeka Prolia.
English: The study was not powered to show a difference in fractures.
Croatian: Cilj ispitivanja nije bio prikazati razlike u frakturama.
English: • have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
Croatian: • ste ranije liječeni bisfosfonatima (koriste se za liječenje ili sprječavanje bolesti kostiju).
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Croatian: Općenito, monoklonalna protutijela se ne eliminiraju putem jetrenih metaboličkih mehanizama.
English: • are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
Croatian: • uzimate lijekove zvane kortikosteroidi (poput prednizolona ili deksametazona).
English: Long-term antiresorptive treatment
Croatian: Dugoročna antiresorptivna terapija
English: Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG).
Croatian: Niska razina kalcija u krvi može također dovesti do promjene u srčanom ritmu koja se zove produženje QT intervala i može se uočiti na elektrokardiogramu (EKG).
English: Temporary interruption of treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Croatian: Treba razmotriti privremeni prekid terapije dok se stanje ne riješi i pridonoseći faktori rizika ne ublaže, ukoliko je moguće.
English: The pharmacokinetic profile in paediatric populations has not been assessed.
Croatian: Farmakokinetički profil u pedijatrijskoj populaciji nije procjenjivan.
English: The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established.
Croatian: Optimalno ukupno trajanje antiresorptivne terapije za osteoporozu (uključujući i denosumab i bisfosfonate) nije utvrđeno.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kosti - ostali lijekovi koji djeluju na koštanu strukturu i mineralizaciju, ATK oznaka: M05BX04
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Croatian: Očekuje se da njegov metabolizam i eliminacija slijede putove klirensa imunoglobulina rezultirajući razgradnjom na male peptide i pojedinačne aminokiseline.
English: Concomitant glucocorticoid treatment is an additional risk factor for hypocalcaemia.
Croatian: Istodobno liječenje glukokortikoidima dodatni je faktor rizika za hipokalcijemiju.
English: Effect on Bone Mineral Density (BMD)
Croatian: Učinak na mineralnu gustoću kostiju (BMD)
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Croatian: • Važno je da ne pokušavate dati sebi injekciju ukoliko niste prošli obuku kod svojeg liječnika ili zdravstvenog radnika.
English: Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Croatian: Tijekom 6 mjeseci nakon poroda promjene povezane uz kost pokazale su oporavak i nije bilo učinka na izbijanje zubi.
English: Prolia contains sorbitol
Croatian: Prolia sadrži sorbitol
English: Age (28-87 years), race and disease state (low bone mass or osteoporosis; prostate or breast cancer) do not appear to significantly affect the pharmacokinetics of denosumab.
Croatian: Čini se da dob (28-87 godina), rasa i stanje bolesti (niska koštana masa ili osteoporoza, rak prostate ili dojke) ne utječu značajno na farmakoinetiku denosumaba.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi i rizika, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: What Prolia is and how it works
Croatian: Što je Prolia i kako djeluje
English: Wash your hands thoroughly.
Croatian: Dobro operite ruke.
English: At 2 years, the corresponding numbers were 4.1% versus 5.8% for new radiological vertebral fractures and 5.3% versus 3.8% for non-vertebral fractures.
Croatian: Tijekom 2 godine odgovarajuće brojke bile su 4,1% u usporedbi s 5,8% za nove radiološke vertebralne frakture i 5,3% u usporedbi s 3,8% za nevertebralne frakture.
English: Please talk to your doctor before you consider stopping the treatment.
Croatian: Molimo da razgovarate s Vašim liječnikom prije nego što odlučite o prekidu terapije.
English: • if you have low calcium levels in the blood (hypocalcaemia).
Croatian: • ako imate niske razine kalcija u krvi (hipokalcijemija).
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Croatian: Nisu se procjenjivale standardne pretrage za ispitivanje genotoksičnog potencijala denosumaba jer te pretrage nisu relevantne za ovu molekulu.
English: A total of 2,626 subjects (58% of the women included in the extension study i.e. 34% of the women included in the pivotal study) completed the extension study.
Croatian: 2626 ispitanika (58% žena uključenih u produžetak ispitivanja, tj. 34% žena uključenih u pivotalno ispitivanje) je završilo produžetak ispitivanja.
English: Maternal mammary gland development was normal.
Croatian: Razvoj majčinih mliječnih žlijezda bio je normalan.
English: The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years).
Croatian: Rizik od ONČ povećava se u bolesnika koji se liječe dugoročno (može se pojaviti u do 1 na 200 osoba ako se liječe 10 godina).
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4).
Croatian: Potreba za kontinuiranom terapijom treba se periodički procjenjivati na temelju koristi i potencijalnih rizika primjene denosumaba za svakog pojeding bolesnika, posebno nakon 5 ili više godina primjene (vidjeti dio 4.4).
English: Injecting the solution with the air bubble is harmless.
Croatian: Injiciranje tekućine s mjehurićem zraka je bezopasno.
English: The carcinogenic potential of denosumab has not been evaluated in long-term animal studies.
Croatian: Kancerogeni potencijal denosumaba nije ispitivan u dugoročnim ispitivanjima u životinja.
English: Please tell your doctor immediately if you develop any of these symptoms.
Croatian: Odmah se javite Vašem liječniku ako se pojavi bilo koji od ovih simptoma.
English: If needed, you may cover the injection site with a plaster.
Croatian: Ako je potrebno, možete mjesto uboda pokriti flasterom.
English: Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.
Croatian: Bolesnike s takvim simptomima treba pregledati radi nepotpune femoralne frakture.
English: In clinical studies examining the effects of discontinuation of Prolia, BMD returned to approximately pre-treatment levels and remained above placebo within 18 months of the last dose.
Croatian: U kliničkim ispitivanjima u kojima se ispitivao učinak prestanka uzimanja lijeka Prolia BMD se vratio na približne razine prije terapije i ostao iznad placeba tijekom 18 mjeseci od zadnje doze.
English: A no observed adverse effect level for reproductive effects was not established.
Croatian: Nije ustanovljena razina pri kojoj nema štetnih učinaka za reprodukciju.
English: • Talk to your doctor if you have ear pain, discharge from the ear and/or an ear infection.
Croatian: • Obratite se Vašem liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: • concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Croatian: • istodobne terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze, radioterapija glave i vrata.
English: INFORMATION IN BRAILLE Prolia
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prolia
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Croatian: Korak 1: Priprema A Izvadite podlogu napunjene štrcaljke iz pakiranja i prikupite pribor potreban za davanje injekcije: blazinice natopljene alkoholom, pamučnu vatu ili jastučić gaze, flaster i spremnik za odlaganje oštrih predmeta (nije uključeno u pakiranje).
English: Any effects of Prolia are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Croatian: Bilo koji učinak lijeka Prolia će vjerojatno biti veći tijekom drugog i trećeg tromjesečja trudnoće budući da monoklonska protutijela prolaze kroz placentu linearno kako trudnoća napreduje, s najvećim prijenosom tijekom trećeg tromjesečja.
English: A trend was observed between higher body weight and lower exposure based on AUC and Cmax.
Croatian: Zabilježen je trend između više tjelesne mase i niže izloženosti temeljem područja ispod krivulje (AUC) i Cmax.
English: Prolia has not been tested in pregnant women.
Croatian: Prolia nije ispitivana na trudnicama.
English: Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.
Croatian: Recite liječniku ako imate ili ste ikada imali ozbiljnih problema s bubrezima, zatajenje bubrega ili ste trebali dijalizu ili da uzimate lijekove zvane glukokortikoidi (poput prednizolona ili deksametazona), što može povećati Vaš rizik od niske razine kalcija u krvi ako ne uzimate dodatke kalcija.
English: After the menopause, oestrogen level drops which may cause bones to become thin and fragile.
Croatian: Nakon menopauze razina estrogena pada što može uzrokovati da kosti postanu tanke i krhke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2010
Croatian: Datum prvog odobrenja: 26. svibnja 2010.
English: It is important to identify patients at risk for hypocalcaemia.
Croatian: Važno je prepoznati bolesnike s rizikom za hipokalcijemiju.
English: • The used syringe should be disposed of in accordance with local requirements.
Croatian: • Iskorištena štrcaljka treba se zbrinuti u skladu s lokalnim propisima.
English: However, the trend is not considered clinically important, since pharmacodynamic effects based on bone turnover markers and BMD increases were consistent across a wide range of body weight.
Croatian: Međutim, taj trend se ne smatra klinički važnim s obzirom da su učinci temeljeni na markerima koštane pregradnje i povećanja BMD-a bili konzistentni unutar širokog raspona tjelesnih težina.
English: Disinfect the skin by using an alcohol wipe.
Croatian: Očistite kožu koristeći alkoholnu blazinicu.
English: Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur.
Croatian: Atipične femoralne frakture mogu se pojaviti uz slabu ozljedu ili bez ozljede u subtrohanternoj i dijafizalnoj regiji femura.
English: Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones, especially in the spine, hips and wrists.
Croatian: Mnogi bolesnici s osteoporozom nemaju simptoma, ali su također pod rizikom od prijeloma kostiju, posebice kralježnice, kukova i ručnog zgloba.
English: In a study of 55 patients with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab.
Croatian: U ispitivanju u 55 bolesnika koji su imali različite stupnjeve bubrežne funkcije, uključujući bolesnike na dijalizi, stupanj oštećenja bubrega nije utjecao na farmakokinetiku denosumaba.
English: Your doctor may ask you to undergo a dental examination before you start treatment with Prolia.
Croatian: Vaš liječnik može zatražiti da obavite stomatološki pregled prije nego započnete liječenje s lijekom Prolia.
English: • potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Croatian: • potentnost lijeka koji inhibira resorpciju kostiju (viši rizik za visoko potentne spojeve), put primjene (viši rizik za parenteralnu primjenu) i kumulativnu dozu terapije za resorpciju kostiju.
English: Problems with your mouth, teeth or jaw
Croatian: Problemi s usnom šupljinom, zubima ili čeljusti
English: Every 6 months Amgen Europe B.V.
Croatian: Svakih 6 mjeseci Amgen Europe B.V.
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: Provjerite rok valjanosti na oznaci napunjene štrcaljke (EXP).
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Prolia.
Croatian: Ako ste u tijeku stomatološkog liječenja ili ćete biti podvrgnuti stomatološkom kirurškom zahvatu (npr. vađenje zuba), obavijestite Vašeg liječnika o stomatološkom liječenju i recite Vašem stomatologu da se liječite lijekom Prolia.
English: The following convention has been used for the classification of the adverse reactions (see table 1): 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Sljedeća je razdioba korištena za klasifikaciju nuspojava (vidjeti tablicu 1): vrlo česte (≥ 1/10), česte (≥ 1/100 do < 1/10), manje česte (≥ 1/1000 do < 1/100), rijetke (≥ 1/10 000 do < 1/1000), vrlo rijetke (< 1/10 000) i nepoznate (ne mogu se procijeniti iz dostupnih podataka).
English: Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose.
Croatian: Preporučuje se kliničko praćenje razina kalcija prije svake doze i, kod bolesnika koji su predisponirani za hipokalcijemiju unutar dva tjedna nakon početne doze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001 1 pre-filled syringe (blistered) EU/1/10/618/002 1 pre-filled syringe (unblistered) EU/1/10/618/003 1 pre-filled syringe with automatic needle guard (blistered)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/618/001 1 napunjena štrcaljka (u blisteru) EU/1/10/618/002 1 napunjena štrcaljka (bez blistera) EU/1/10/618/003 1 napunjena štrcaljka s automatskim štitnikom za iglu (u blisteru)
English: Bone biopsy results showed bone of normal architecture and quality with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Croatian: Rezultati biopsije kostiju pokazali su normalnu arhitekturu i kvalitetu kosti bez znakova defekata mineralizacije, vlaknaste kosti ili fibroze koštane srži.
English: 0-2 years
Croatian: 0-2 godina
English: The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity.
Croatian: Najčešće nuspojave kod primjene lijeka Prolia (zabilježene u više od jednog bolesnika od deset) su mišićno-koštana bol i bol u ekstremitetima.
English: Very common Very common Rare
Croatian: Vrlo često Vrlo često Rijetko Rijetko Nepoznato
English: 0-1 year
Croatian: 0-1 godina
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 5 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Croatian: Korištenjem osjetljive metode „imunoassay” < 1% bolesnika koji su primali denosumab u razdoblju do 5 godina bilo je pozitivno na ne-neutralizirajuća vezna protutijela, bez dokaza o izmijenjenoj farmakokinetici, toksičnosti ili kliničkom odgovoru.
English: Prolia has no or negligible influence on the ability to drive and use machines.
Croatian: Prolia nema, ili ima zanemarive učinke na sposobnost upravljanja vozilima i strojevima.
English: After Cmax, serum levels declined with a half-life of 26 days (range 6-52 days) over a period of 3 months (range 1.5-4.5 months).
Croatian: Nakon vrijednosti Cmax, razine u serumu su se smanjivale s poluvijekom od 26 dana (raspon 6-52 dana) tijekom razdoblja od 3 mjeseca (raspon 1,5-4,5 mjeseci).
English: Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Prolia.
Croatian: Pogledajte dio 4. Vaš liječnik će Vam dati karticu s podsjetnikom za bolesnika, koja sadrži važne sigurnosne informacije koje trebate znati prije i tijekom liječenja lijekom Prolia.
English: The best places to inject are the top of your thighs and the abdomen.
Croatian: Najbolje mjesto za injekcije je gornji dio bedara i trbuh.