FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not shake the pre-filled pen (neither before nor after injection) as it may destroy the effect of the medicine.
Croatian: • Ne protresajte napunjenu brizgalicu (ni prije ni nakon injiciranja) jer to može uništiti djelotvornost lijeka.
English: All women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
Croatian: Sve žene dobivale su dodatni kalcij (400-500 mg) i vitamin D (400 IU).
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste trebali uzeti neke druge lijekove.
English: What Preotact is and what it is used for
Croatian: Što je Preotact i za što se koristi
English: Manufacturer Nycomed Danmark ApS Langebjerg 1
Croatian: Nycomed Danmark ApS Langebjerg 1
English: The dose counter has now decreased by one.
Croatian: Broj doza se na brojaču smanjio za jedan.
English: The steps you have to go through with a new pre-filled pen:
Croatian: Koraci koje morate slijediti s novom napunjenom brizgalicom:
English: Osteoporosis is a disease that causes bones to become thin and fragile.
Croatian: Osteoporoza je bolest zbog koje kosti postaju slabe i krhke.
English: If you feel dizzy, do not drive or operate any machines until you feel better.
Croatian: Ako osjećate omaglicu, ne vozite i ne radite sa strojevima dok se stanje ne popravi.
English: Due to the relatively short duration of the pharmacological activity of Preotact further measures should not be necessary.
Croatian: Zbog relativno kratkog vremena farmakološke aktivnosti Preotacta, ostale mjere nisu potrebne.
English: This includes any possible side effects not listed in this leaflet..
Croatian: Ovo uključuje i sve ostale moguće nuspojave koje nisu navedene na ovoj uputi.
English: • fast or irregular heart beats,
Croatian: • ubrzani ili nepravilni rad srca,
English: • OTHER CONDITIONS
Croatian: C. OSTALI UVJETI
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
English: Furthermore, parathyroid hormone is not protein bound and has a low volume of distribution.
Croatian: Nadalje, paratireoidni hormon nije vezan na proteine i ima mali volumen distribucije.
English: Patients must be trained to use the proper injection techniques (see section 6.6).
Croatian: Bolesnike treba podučiti korištenju ispravne injekcijske tehnike (vidjeti dio 6.6).
English: The dose counter now shows 14 and the pre-filled pen is ready to use.
Croatian: Brojač doza sada pokazuje 14 i napunjena brizgalica je spremna za uporabu.
English: Similar increases occurred at the femoral neck, trochanter, and intertrochanter.
Croatian: Slično povećanje javilo se i u vratu femura, trohanteru i intertrohanteru.
English: The pre-filled pen contains medicine for 14 days.
Croatian: Napunjena brizgalica sadrži lijek za 14 dana.
English: The dose is administered as a subcutaneous injection into the abdomen.
Croatian: Doza se primjenjuje kao supkutana injekcija u abdomen.
English: Dosage adjustment based on age is not required.
Croatian: Prilagodba doze s obzirom na dob nije potrebna.
English: Reconstituted solution: chemical and physical in-use stability has been demonstrated for 28 days at 28°C.
Croatian: Rekonstituirana otopina: kemijska i fizikalna stabilnost u upotrebi dokazana je tijekom 28 dana na 28oC.
English: Gender The medicinal product has only been studied in postmenopausal women.
Croatian: Spol Lijek je ispitan samo na ženama u postmenopauzi.
English: Stopper (center and end): Bromobutyl rubber, grey.
Croatian: Čep (središnji i zadnji): Bromobutil guma, siva.
English: For patients with pre-existing fractures, number needed to treat (NNT) is 21 patients.
Croatian: U bolesnica koje su već imale prijelome, broj onih koje je potrebno liječiti (NNT) bio je 21.
English: • The medicine should not be used for more than 28 days after it has been mixed.
Croatian: • Lijek se ne smije koristiti ako je prošlo više od 28 dana nakon što je izmiješan.
English: • Do not store above 25°C.
Croatian: • Ne čuvajte iznad 25oC
English: • The pre-filled pen has an expiration date printed on it; do not use the medicine after this date.
Croatian: • Na napunjenoj brizgalici je naveden rok valjanosti; ne koristite lijek nakon tog datuma.
English: Other medicines and Preotact
Croatian: Drugi lijekovi i Preotact
English: Risk Management Plan
Croatian: Plan upravljanja rizicima (RMP)
English: INFORMATION ON BRAILLE Preotact
Croatian: PODACI NA BRAILLEOVOM PISMU Preotact
English: • Use a new needle for each injection and throw the needle away after each use.
Croatian: • Za svaku injekciju upotrijebite novu iglu i bacite iglu nakon svake uporabe.
English: • if you have other bone disease (including hyperparathyroidism or Paget's disease);
Croatian: • ako imate neku drugu bolest kostiju (uključujući hiperparatireoidizam ili Pagetovu bolest);
English: DO NOT SHAKE; shaking may cause denaturation of the active substance.
Croatian: NE TRESTI; protresanje može denaturirati djelatnu tvar.
English: As some episodes of dizziness have been described in patients treated with Preotact, patients should refrain from driving or using machines until symptoms have subsided.
Croatian: Budući da su opisani slučajevi omaglice u bolesnika liječenih Preotactom, bolesnici se moraju suzdržati od upravljanja vozilima ili rada sa strojevima dok se simptomi ne povuku.
English: It is unknown whether recombinant human parathyroid hormone is excreted in the milk of lactating animals.
Croatian: Nepoznato je da li se rekombinantni humani paratireoidni hormon izlučuje u mlijeku životinja koje su u laktaciji.
English: • Always attach a new needle before use
Croatian: • Uvijek stavite novu iglu prije uporabe.
English: • mannitol,
Croatian: • manitol,
English: The steps you have to go through for each of the 14 injections:
Croatian: Koraci koje morate slijediti kod svake od 14 injekcija • Dodajte iglu
English: • The frequency of Preotact dosing should be changed to 100 micrograms every other day
Croatian: • Učestalost primjene Preotacta treba promijeniti na 100 mikrograma svaki drugi dan
English: Contents of the pack and other information.
Croatian: Sadržaj pakovanja i druge informacije
English: • A small air bubble may remain in the pre-filled pen - this is normal.
Croatian: • Mali mjehurić zraka može zaostati u napunjenoj brizgalici - ovo je normalno.
English: • flu,
Croatian: • gripa,
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Croatian: Pretklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, mutagenosti, toksičnosti na plodnost, reproduktivne toksičnosti i lokalne podnošljivosti.
English: • if you have high levels of alkaline phosphatase (an enzyme produced by the organism; may signal certain medical conditions, related to bones and liver);
Croatian: • ako imate visoku razinu alkalne fosfataze (enzim koji se stvara u organizmu; može biti znak različitih medicinskih stanja, povezanih s kostima i jetrom);
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal treba zbrinuti sukladno lokalnim propisima.
English: uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000), including isolated reports.
Croatian: ≥ 1/10); česte (≥1/100 i < 1/10); manje česte (≥1/1.000 i <1/100); rijetke (≥ 1/10.000 i <1.000) i vrlo rijetke (<1/10.000) uključujući pojedinačne slučajeve.
English: Interindividual variability in systemic clearance is about 15%.
Croatian: Varijabilnost sistemskog klirensa među pojedincima je oko 15%.
English: • Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4).
Croatian: • Na napunjenoj brizgalici mora biti postavljena igla (pogledajte slike 3 i 4).
English: The only other very commonly reported ADR was nausea.
Croatian: Jedina druga vrlo često prijavljena nuspojava bila je mučnina.
English: Pre-filled pen (before reconstitution): Do not store above 25°C.
Croatian: Napunjena brizgalica (prije rekonstitucije): Ne čuvati iznad 25oC.
English: When the dose counter is at 0, the pre-filled pen is empty and you must take a new pre-filled pen.
Croatian: Kada je brojač doza na 0, napunjena brizgalica je prazna i morate uzeti novu.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na stranicama Europske Medicinske Agencije http://www.ema.europa.eu
English: Preotact should not be used if the reconstituted solution is cloudy, coloured or contains particles.
Croatian: Preotact se ne smije koristiti ako je rekonstituirana otopina zamućena, obojena ili ako sadrži čestice.
English: It may harm them,
Croatian: Druge pomoćne tvari su:
English: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Croatian: Bolesnici moraju uzimati dodatni kalcij i vitamin D ako je dnevni unos prehranom nedovoljan.
English: • Protect the medicine and pre-filled pen against direct sunlight.
Croatian: • Zaštitite lijek i napunjenu brizgalicu od izravnog sunčevog svjetla.
English: • if you have cancer of the bones;
Croatian: • ako imate karcinom kostiju;
English: • receive heart medicine (e.g. digoxin also known as digitalis).
Croatian: • uzimate lijekove za srce (npr. digoksin, također poznat kao digitalis)
English: If no underlying condition is found, the following management procedures should be followed:
Croatian: Ako takve bolesti nisu pronađene, mora se postupiti na slijedeći način:
English: Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.
Croatian: Preotact smanjuje rizik od prijeloma kostiju kralježnice, jer povećava kvalitetu i snagu Vaših kostiju.
English: Similarly, volumetric trabecular BMD at the total hip increased by 4.7%.
Croatian: Slično, volumetrijski trabekularni BMD u cijelom kuku narastao je za 4,7%.
English: Preotact has been administered in single doses up to 5 micrograms/kg and in repeated doses of up to 3 micrograms/kg/day for 3 days and up to 2.5 micrograms/kg/day for 7 days.
Croatian: Preotact se primjenjivao u jednokratnim dozama do 5 mikrograma/kg i u uzastopnim dozama do 3 mikrograma/kg/dan tijekom 3 dana i do 2,5 mikrograma/kg/dan tijekom 7 dana.
English: Every day you have to check that the medicine is clear, add a new needle, take the injection in your abdomen and then throw away the needle before storing your pre-filled pen in the refrigerator (2-8°C).
Croatian: Svaki dan morate provjeriti da je lijek bistar, dodati novu iglu, primijeniti injekciju u trbuh i baciti iglu prije nego što napunjenu brizgalicu spremite u hladnjak (2-8oC).
English: Preparing the new pre-filled pen for use - releasing air (priming)
Croatian: Pripremanje nove napunjene brizgalice za uporabu - oslobađanje zaostalog zraka
English: Important information when using Preotact
Croatian: Važna informacija kada koristite Preotact
English: White to off-white powder and clear, colourless solvent.
Croatian: Bijeli do bjeličasti prašak i prozirno, bezbojno otapalo.
English: Please see how to use the pen in the Instructions for use manual.
Croatian: Molimo pogledajte kako koristiti brizgalicu u Uputama za korištenje.
English: A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Croatian: Dokazano je značajno smanjenje incidencije prijeloma kralježaka, ali ne i prijeloma kuka.
English: • If elevated levels continue, Preotact therapy should be stopped and the patient monitored until the abnormal values have reverted to normal
Croatian: • Ako je razina kalcija i dalje povišena, liječenje Preotactom se mora prekinuti, a bolesnika treba nadzirati sve dok se odstupajuće vrijednosti ne vrate u normalu
English: • Do not use this medicine if it has not been stored correctly, even if it is not used up.
Croatian: • Ne koristite ovaj lijek ako je bio nepropisno čuvan, čak i ako nije upotrebljavan.
English: In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Croatian: U 24-mjesečnom ispitivanju kombinirane terapije s alendronatom (PaTH), učinak Preotacta na izgradnju kostiju također je bio procijenjen korištenjem QCT.
English: Do not use Preotact • if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed
Croatian: Nemojte primjenjivati Preotact • ako ste alergični na paratireoidni hormon ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: The safety and efficacy of Preotact in patients under 18 years have not been studied.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost Preotacta u djece u dobi do 18 godina nije ispitana.
English: Sodium chloride, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Croatian: Natrijev klorid, manitol, citratna kiselina hidrat, kloridna kiselina, metakrezol, natrijev hidroksid, voda za injekcije.
English: If you stop taking Preotact
Croatian: Ako prestanete uzimati Preotact
English: Before taking your first injection with a new pre-filled pen you have to add a needle and mix the medicine by following the instructions in this leaflet.
Croatian: Prije nego što s novom napunjenom brizgalicom primijenite prvu injekciju, morate dodati iglu i izmiješati lijek slijedeći naputke u ovoj uputi.
English: • Keep Preotact protected from light
Croatian: • Preotact čuvajte zaštićen od svjetla
English: Inclusion criteria were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Croatian: Kriteriji za uključivanje u ispitivanje bili su: žene između 55 i 85 godina sa T-vrijednošću mineralne gustoće kostiju manjom od -2,5 ili manjom od -2 i najmanje jednim dodatnim rizičnim faktorom za prijelome.
English: There are no studies of foetal, developmental, perinatal or postnatal toxicity.
Croatian: Nema ispitivanja o fetalnoj, razvojnoj, perinatalnoj i postnatalnoj toksičnosti.
English: The mean baseline lumbar T score was approximately -3.0 in each treatment group.
Croatian: Srednja početna lumbalna T-vrijednost bila je približno -3,0 u svakoj skupini.
English: Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
Croatian: Posavjetujte se s Vašim liječnikom ako namjeravate prekinuti liječenje Preotactom prije isteka propisanog trajanja terapije.
English: • The priming should be done every time you mix a new pre-filled pen.
Croatian: • “Priming” se mora napraviti svaki put kad miješate novu napunjenu brizgalicu.
English: Preotact is contraindicated in patients
Croatian: Preotact je kontraindiciran u bolesnika
English: The effects of overdose that might be expected include delayed hypercalcemia, nausea, vomiting, dizziness and headache.
Croatian: Učinci koji se mogu očekivati pri predoziranju uključuju odgođenu hiperkalciemiju, mučninu, povraćanje, omaglicu i glavobolju.
English: • Throw away the needle as you have been instructed by your doctor or nurse
Croatian: • Uklonite iglu na način kako su Vam savjetovali Vaš liječnik ili medicinska sestra.
English: Elderly Dose adjustment based upon age is not required (see section 5.2).
Croatian: Prilagodba doze s obzirom na dob nije potrebna (vidjeti dio 5.2)
English: • Put the pre-filled pen back into the refrigerator immediately after you have used it.
Croatian: • Vratite napunjenu brizgalicu u hladnjak odmah nakon što ste je upotrijebili.
English: • Gently rotate the pre-filled pen back and forth a few times to mix the medicine.
Croatian: • Nježno naginjite napunjenu brizgalicu nekoliko puta naprijed-natrag kako bi izmiješali lijek.
English: Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
Croatian: Podaci govore u prilog neprekidnom liječenju Preotactom do 24 mjeseca (vidjeti dio 4.4).
English: • with hypersensitivity to parathyroid hormone or to any of the excipients (see section 6.1)
Croatian: • s preosjetljivošću na paratireoidni hormon ili neku od pomoćnih tvari (vidjeti dio 6.1)
English: • Do not freeze.
Croatian: • Ne zamrzavajte.
English: It is especially common in women after the menopause.
Croatian: Posebno je česta kod žena u postmenopauzi.
English: Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse.
Croatian: Obuhvatite prstima kožu na trbuhu i dajte injekciju pod kutem od 90o kao što su Vam pokazali Vaš liječnik ili medicinska sestra.
English: It may also cause back pain, loss of height, and a curved back.
Croatian: Bolest također može izazvati bolove u leđima, smanjenje visine i iskrivljena leđa.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1 odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: When you receive your pre-filled pen the dose counter is at , to show that it is full.
Croatian: Kada dobijete svoju napunjenu brizgalicu, brojač doza je na ●, i to pokazuje da je pun.
English: Talk to your doctor or pharmacist before using Preotact if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Preotact ako:
English: The effects of Preotact on bone architecture were evaluated using quantitative computed tomography (QCT) and peripheral QCT.
Croatian: Preotacta na izgradnju kosti procijenjen je upotrebom kvantitativne kompjuterske tomografije (QCT) i periferne QCT.
English: There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture: 5.52% for Preotact vs. 5.86% for placebo.
Croatian: Nije bilo značajne razlike između liječenih skupina u incidenciji prijeloma nevezanih uz kralješke: 5,52% kod Preotacta vs 5,86% za placebo.
English: It has not been shown that Preotact reduces the risk of breaking your hip.
Croatian: Nije dokazano da Preotact smanjuje rizik od prijeloma kuka.
English: Preotact contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Peotact sadrži manje od 1mmol natrija (23 mg) po dozi.
English: If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.
Croatian: Ako slučajno primijenite više od jedne doze na dan, odmah obavijestite svog liječnika ili ljekarnika.
English: After reconstitution the liquid should be clear and colourless.
Croatian: tekućina mora biti bistra i bezbojna.
English: Continued treatment for up to 24 months in an open-label extension of this study resulted in a continued increase in BMD.
Croatian: Nastavakom terapije do 24 mjeseca, u produžetku ispitivanja otvorenog tipa, pokazalo se stalno povećanje BMD.
English: You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Croatian: Preotact je potrebno koristiti s oprezom ako uzimate lijekove za srce (npr. digoksin, također poznat kao digitalis).
English: For instructions on how to use the pre-filled pen, please read the ”Instructions for use”..
Croatian: Za informacije kako koristiti napunjenu brizgalicu, molimo pročitajte „Upute za uporabu“.
English: Preotact should be used with caution in patients with active or previous urolithiasis.
Croatian: Preotact se mora koristiti s oprezom u bolesnika s aktivnom ili prethodnom urolitijazom.
English: Pharmacotherapeutic group: Calcium homeostatis, parathyroid hormones and analogues, ATC code: H05AA03.
Croatian: Farmakoterapijska skupina: Pripravci s utjecajem na mijenu kalcija, Partireoidni hormoni i analozi, ATK oznaka: H05AA03
English: In these women with a positive titre, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.
Croatian: U žena sa pozitivnim titrom nisu bile zabilježene reakcije preosjetljivosti, alergijske reakcije, utjecaj na mineralnu gustoću kostiju ili na koncentraciju kalcija u serumu.
English: Press the blue injection button until it is fully depressed -then count slowly to 10 and remove the needle from your skin.
Croatian: Pritisnite plavo dugme za injektiranje do krajazatim polako brojite do 10, pa izvucite iglu iz kože.
English: Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Croatian: Približno 71,4% bolesnica na paratireoidnom hormonu prijavilo je bar jednu nuspojavu.
English: Parathyroid hormone is not excreted from the body in its intact form.
Croatian: Paratireoidni hormon se ne izlučuje iz tijela u nepromijenjenom obliku.
English: Antibodies to parathyroid hormone
Croatian: Antitijela na paratireoidni hormon
English: Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
Croatian: Hiperkalciemija je prijavljena u 25,3% bolesnica, a hiperkalciurija u 39,3% bolesnica liječenih Preotactom.
English: Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e.g. hyperparathyroidism).
Croatian: Bolesnici s trajno povećanim vrijednostima serumskog kalcija (iznad gornje normalne razine) moraju se ispitati podležeće bolesti (npr. hiperparatiroidizam).
English: • Never share your pre-filled pen with anyone.
Croatian: • Nikad ne dijelite ni sa kim svoju napunjenu brizgalicu.
English: In general, serum calcium levels return to baseline levels 24 hours after dosing.
Croatian: Općenito, razina kalcija u serumu vraća se na početnu vrijednost 24 sata nakon doziranja.
English: A new sterile needle must be used for every injection.
Croatian: Za svako injiciranje mora se koristiti nova sterilna igla.
English: The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Croatian: Farmakokinetika paratireoidnog hormon u bolesnika sa ozbiljnim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) nije ispitana.
English: No potential for drug interactions was identified in the clinical program.
Croatian: U kliničkom programu nije utvrđen potencijal za interakcije s lijekovima.
English: Be careful not to push the yellow release button while you handle the pre-filled pen - if you accidentally do so, the blue injection button will pop out.
Croatian: Pazite da tijekom rukovanja s napunjenom brizgalicom, ne pritisnete žuto dugme za otpuštanje lijeka - ako to slučajno učinite, izvirit će plavo dugme za injektiranje.
English: What Preotact looks like and contents of the pack
Croatian: Kako Preotact izgleda i sadržaj pakovanja
English: The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Croatian: Apsolutna bioraspoložljivost 100 mikrograma paratireoidnog hormona nakon supkutane primjene u abdomen je 55%.
English: • Do not use this medicine if you notice that it became cloudy or coloured.
Croatian: • Ne koristite ovaj lijek ako primjetite da je zamućen ili obojen.
English: • Do not use the medicine if it is cloudy or coloured (if it is unclear).
Croatian: • Ne upotrebljavajte lijek ako je zamućen ili obojen (ako nije proziran).
English: • water for injections
Croatian: • vodu za injekcije.
English: What Preotact is and what it is used for What you need to know before you use Preotact
Croatian: Što je Preotact i za što se koristi Što morate znati prije nego počnete primjenjivati Preotact Kako primjenjivati Preotact
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Vanjska kutija (2 napunjene brizgalice)