FrancophonIA/ELRC3.0 huggingface dataset:
English: • Set your pen down and wait until the powder is dissolved and the liquid is colourless, or until 5 minutes have passed.
Croatian: • Odložite brizgalicu i pričekajte da se prašak otopi a tekućina postane bezbojna, ili pričekajte da prođe 5 minuta.
English: Before the pen is used for the first time, the medicine has to be mixed.
Croatian: Prije prve uporabe brizgalice lijek se mora izmiješati.
English: Three of these patients had antibodies with neutralising activity; these patients maintained a clinical response with no evidence of immune-related adverse reactions.
Croatian: Trojica bolesnika imala su antitijela s neutralizirajućom aktivnošću; ti su bolesnici održavali klinički odgovor bez dokaza o nuspojavama povezanima s imunološkim sustavom.
English: A risk to the pregnant woman or developing foetus cannot be excluded.
Croatian: Ne može se isključiti rizik za trudnicu ili fetus u razvoju.
English: You may need to change your Natpar dose or stop the injections for a short time.
Croatian: Možda ćete trebati promijeniti svoju dozu lijeka Natpar ili nakratko prestati primati injekcije lijeka Natpar.
English: Date of latest renewal: 29 April 2019
Croatian: Datum posljednje obnove odobrenja: 29. travnja 2019.
English: Your doctor will check your calcium levels.
Croatian: Vaš liječnik će Vam provjeriti razine kalcija.
English: After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C - 8°C) and for up to 3 days when stored outside the refrigerator not above 25°C during the 14-day use period.
Croatian: Nakon rekonstitucije, kemijska i fizikalna stabilnost otopine tijekom primjene dokazana je do 14 dana kada se čuva u hladnjaku (2°C - 8°C) i do 3 dana kada se čuva izvan hladnjaka na temperaturi koja nije viša od 25°C, unutar razdoblja korištenja od 14 dana.
English: Patients should be monitored until signs and symptoms resolve (see sections 4.3 and 4.8).
Croatian: Bolesnike je potrebno pratiti dok se znakovi i simptomi ne povuku (vidjeti dijelove 4.3 i 4.8).
English: If you still cannot screw it down all the way, use a new needle.
Croatian: Ako se i dalje ne može pritegnuti do kraja, uzmite novu iglu.
English: Use in young adults
Croatian: Primjena u mladih odraslih osoba
English: The apparent transient nature of antibodies to PTH is likely due to the low titre.
Croatian: Očita prolazna priroda antitijela na PTH vjerojatno je uzrokovana niskim titrom.
English: The Instructions for Use of the Natpar Pre-filled Pen are included in 5 sections: A. Getting Started
Croatian: Upute za uporabu Natpar napunjene brizgalice opisane su u 5 dijelova: A.
English: • Keep the pen needle in your skin and slowly count to 10 while continuing to hold down the blue button.
Croatian: • Zadržite iglu brizgalice u koži i polako brojite do 10, i dalje držeći plavi gumb.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA03
Croatian: Farmakoterapijska skupina: Homeostaza kalcija, paratiroidni hormoni i analozi, ATK oznaka: H05AA03
English: Treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism.
Croatian: Liječenje treba nadzirati liječnik ili drugi kvalificirani zdravstveni djelatnik iskusan u liječenju bolesnika s hipoparatiroidizmom.
English: The recommended starting dose of Natpar is 50 micrograms per day.
Croatian: Preporučena početna doza lijeka Natpar je 50 mikrograma dnevno.
English: Discuss with your doctor if you want to stop treatment with Natpar.
Croatian: Razgovarajte sa svojim liječnikom ako želite prekinuti liječenje lijekom Natpar.
English: Interruption or discontinuation of treatment
Croatian: Privremen ili trajan prekid liječenja
English: Prior to initiating and during treatment with Natpar:
Croatian: Prije početka i tijekom liječenja lijekom Natpar:
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Croatian: Informacije u ovim uputama ne mogu zamijeniti razgovor s liječnikom ili medicinskom sestrom o Vašoj bolesti ili njezinu liječenju.
English: Why won't the blue button go all the way down?
Croatian: Zašto se plavi gumb ne da pritisnuti do kraja?
English: Active vitamin D
Croatian: Aktivni vitamin D
English: For the efficacy analysis, subjects that fulfilled three components of a three-part response criterion were considered responders.
Croatian: Za analizu djelotvornosti, ispitanici koji su ispunili tri komponente trodijelnog kriterija odgovora smatrani su ispitanicima koji su odgovorili na terapiju.
English: No osteosarcomas have been observed in clinical trials.
Croatian: Osteosarkomi nisu uočeni u kliničkim ispitivanjima.
English: Use in elderly patients
Croatian: Primjena u starijih bolesnika
English: Carton/pen label colours are used to indicate the different strengths:
Croatian: Boja naljepnice na kutiji/brizgalici koristi se za označavanje različitih jačina:
English: • water for injections
Croatian: • voda za injekcije
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including: - digoxin, also known as digitalis, a heart medicine - medicines used to treat osteoporosis, called bisphosphonates, such as alendronic acid - medicines that can affect calcium levels in your blood such as lithium or some medicines used to increase the amount of urine (diuretics).
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući: - digoksin, također poznat kao digitalis, lijek za srce - lijekove koji se koriste za liječenje osteoporoze, koji se nazivaju bisfosfonati, kao što je alendronatna kiselina - lijekove koji mogu utjecati na razine kalcija u krvi, kao što su litij ili neki lijekovi korišteni za povećanje količine urina (diuretici).
English: After reconstitution, the liquid must be colourless and practically free of foreign particles; parathyroid hormone (rDNA) must not be used if the reconstituted solution is cloudy, coloured, or contains visible particles.
Croatian: Nakon rekonstitucije, tekućina mora biti bistra i praktički bez ikakvih vidljivih čestica; paratiroidni hormon (rDNK) se ne smije primijeniti ako je rekonstituirana otopina mutna, obojena ili sadrži vidljive čestice.
English: • Very common: low levels of calcium in your blood; this can occur more often if you suddenly stop taking Natpar.
Croatian: • Vrlo često: niske razine kalcija u krvi; to se može pojavljivati češće ako iznenada prestanete primati Natpar.
English: Gender No clinically relevant gender differences were observed in the REPLACE study.
Croatian: Spol Nikakve klinički relevantne razlike vezane uz spol nisu uočene u ispitivanju REPLACE.
English: The optimisation of parameters of calcium-phosphate metabolism should be in line with current therapeutic guidelines for the treatment of hypoparathyroidism.
Croatian: Optimizacija parametara metabolizma kalcija i fosfata mora biti u skladu s trenutnim terapijskim smjernicama za liječenje hipoparatiroidizma.
English: 4 • Before attaching a new needle, check the medicine.
Croatian: 4. • Prije nego što pričvrstite novu iglu, provjerite izgled lijeka.
English: There is limited information on the safety of Natpar in pregnant women.
Croatian: Postoje ograničene informacije o sigurnosti lijeka Natpar u trudnica.
English: • Call your doctor or nurse.
Croatian: • obratite se liječniku ili medicinskoj sestri,
English: Do not throw away any medicines via household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u kućni otpad.
English: Hypercalcaemia of any cause may predispose to digitalis toxicity.
Croatian: Hiperkalcemija izazvana bilo kojim uzrokom može predisponirati za toksičnost digitalisa.
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Croatian: Ovaj lijek je odobren po shemi takozvanog „uvjetnog odobrenja”.
English: The risk for serious hypocalcaemia was greatest after the withdrawal of Natpar.
Croatian: Rizik od ozbiljne hipokalcemije bio je najveći nakon prekida primjene lijeka Natpar.
English: Natpar must not be administered intravenously or intramuscularly.
Croatian: Natpar se ne smije primjenjivati intravenski ili intramuskularno.
English: Since neurologic symptoms may be a sign of uncontrolled hypoparathyroidism, patients with disturbances in cognition or attention should be advised to refrain from driving or using machines until symptoms have subsided.
Croatian: Budući da neurološki simptomi mogu biti znak nekontroliranog hipoparatiroidizma, bolesnike s poremećajima kognicije ili pozornosti treba savjetovati da se suzdrže od upravljanja vozilima ili rada sa strojevima do prestanka simptoma.
English: Consider increase after at least 2-4 weeks at a stable dose
Croatian: Razmotrite povećanje nakon najmanje 2-4
English: It is common to see small bubbles.
Croatian: Uobičajeno je da se vide mali mjehurići.
English: Randomisation was followed by a 12-week Natpar titration phase and a 12-week Natpar dose maintenance phase.
Croatian: Nakon randomizacije uslijedila je 12-tjedna faza titracije lijeka Natpar i 12-tjedna faza održavanja doze lijeka Natpar.
English: Your doctor may tell you to take other medicines such as calcium supplements or vitamin D while you are taking Natpar.
Croatian: Vaš liječnik Vam može reći da uzimate druge lijekove kao što su nadomjesci kalcija ili vitamin D dok uzimate Natpar.
English: The powder is white and the solvent is a clear, colourless solution.
Croatian: Prašak je bijele boje, a otapalo je bistra, bezbojna otopina.
English: Do not touch the needle or the inside of the needle cap.
Croatian: Nemojte dodirivati iglu ili unutrašnjost kapice igle.
English: If you forget to use Natpar
Croatian: Ako ste zaboravili primijeniti Natpar
English: • Store your pen away from heat and light.
Croatian: • Brizgalicu čuvajte podalje od izvora topline i svjetlosti.
English: How do I clean my pen?
Croatian: Kako ću očistiti brizgalicu?
English: What if I see more than 1 or 2 drops of medicine leak from my skin or from the needle tip during or after an injection?
Croatian: Što ako vidim da mi iz kože ili s vrha igle iscuri više od 1 ili 2 kapi lijeka tijekom ili poslije injiciranja?
English: Above the upper limit of normal (ULN) (2.55 mmol/L)*
Croatian: Iznad gornje granice normale (GGN) (2,55 mmol/l)*
English: For a list of symptoms of low calcium, see section 4.
Croatian: Za popis simptoma niskog kalcija vidjeti dio 4.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će barem jednom godišnje procjenjivati nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Across all clinical studies in patients with hypoparathyroidism following treatment with Natpar for up to 4 years, the immunogenicity incidence rate was 17/87 (19.5%) and did not appear to increase over time.
Croatian: U svim kliničkim ispitivanjima u bolesnika s hipoparatiroidizmom nakon liječenja lijekom Natpar u trajanju do 4 godine, stopa incidencije imunogenih događaja bila je 17/87 (19,5%) i nije se činilo da ona s vremenom raste.
English: Missed dose
Croatian: Propuštena doza
English: Your doctor or nurse will train you on how to use the Natpar pre-filled pen.
Croatian: Vaš liječnik ili medicinska sestra će Vas obučiti kako koristiti Natpar napunjenu brizgalicu.
English: After you have mixed the medicine, the Natpar pen is ready for use and the medicine can be injected under the skin of your thigh.
Croatian: Nakon što izmiješate lijek, Natpar brizgalica je spremna za uporabu i lijek se može injicirati pod kožu u bedro.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: • Very common: high levels of calcium in your blood, which can occur more often when you start treatment with Natpar.
Croatian: • Vrlo često: visoke razine kalcija u krvi, koje se mogu pojavljivati češće kada započnete liječenje lijekom Natpar.
English: 25 micrograms - Purple 50 micrograms - Red 75 micrograms - Grey 100 micrograms - Blue
Croatian: 25 mikrograma - ljubičasta 50 mikrograma - crvena 75 mikrograma - siva 100 mikrograma - plava
English: Natpar has the same primary amino acid sequence as endogenous parathyroid hormone and may be anticipated to have the same physiological actions.
Croatian: Natpar ima isti primarni slijed aminokiselina kao endogeni paratiroidni hormon i može se očekivati da ima isto fiziološko djelovanje.
English: The final clinical study report should be submitted by:
Croatian: Završno izvješće o kliničkom ispitivanju treba dostaviti do:
English: Patients received doses of 25 micrograms, 50 micrograms, 75 micrograms or 100 micrograms/day for up to approximately 60 months (mean 1161 days, range 41 to 1820 days).
Croatian: Bolesnici su primali doze od 25 mikrograma, 50 mikrograma, 75 mikrograma ili 100 mikrograma dnevno tijekom razdoblja od otprilike 60 mjeseci (srednja vrijednost: 1161 dana, raspon: 41 do 1820 dana).
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Croatian: Budući da je ovo uvjetno odobrenje za stavljanje lijeka u promet, sukladno članku 14.-a stavku 4. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Very common (1/10) Common (1/100 to
Croatian: Vrlo često (1/10)
English: There were no apparent differences in the serum total calcium concentration-time profiles between the 2 hepatic function groups.
Croatian: Nije bilo vidljivih razlika u profilima ukupne koncentracije kalcija u serumu u ovisnosti o vremenu između te 2 skupine funkcije jetre.
English: • You may want to also write down the ”Date Mixed” and “Discard On” date in a place where you will remember, like a personal calendar or mobile device.
Croatian: • Datume koje ste upisali pored „Datum miješanja“ i „Baciti“ možete zabilježiti i na neko dodatno mjesto koje ćete upamtiti, primjerice u svoj kalendar ili mobitel.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Natpar in one or more subsets of the paediatric population in hypoparathyroidism (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Natpar u jednoj ili više podskupina pedijatrijske populacije koja boluje od hipoparatiroidizma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This will be done using tests to measure the level of calcium in your blood or urine.
Croatian: To će biti urađeno primjenom testova za mjerenje razine kalcija u krvi ili urinu.
English: Do not share your pen or pen needles with anyone else.
Croatian: Nemojte dijeliti s drugim osobama svoju brizgalicu ili igle za brizgalicu.
English: Before mixing
Croatian: Prije miješanja
English: Rats treated with daily injections of Natpar for 2 years had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to a non-genotoxic mechanism.
Croatian: Štakori koji su svakodnevno primali injekcije lijeka Natpar tijekom 2 godine imali su pretjerano stvaranje kostiju ovisno o dozi i povećanu incidenciju tumora kostiju, uključujući osteosarkom, najvjerojatnije zbog ne-genotoksičnog mehanizma.
English: People may need between 25 and100 micrograms of Natpar per day.
Croatian: Ljudima može biti potrebno između 25 i 100 mikrograma lijeka Natpar dnevno.
English: Natpar is available in a pack with 2 pre-filled pens.
Croatian: Natpar je dostupan u pakiranju s 2 napunjene brizgalice.
English: A decision must be made whether to initiate or discontinue treatment with Natpar during pregnancy taking into account the known risks of therapy versus the benefit for the woman.
Croatian: Mora se odlučiti treba li započeti ili prekinuti liječenje lijekom Natpar tijekom trudnoće uzimajući u obzir poznate rizike liječenja u odnosu na korist za ženu.
English: Continue following the instructions, being careful not to press the blue button until instructed to do so.
Croatian: Nastavite pratiti upute pazeći da ne pritisnete plavi gumb dok prema uputama za to ne bude vrijeme.
English: • Gather your pen and other supplies needed as shown in the figure below and set them on a clean, flat surface.
Croatian: • Brizgalicu i sav drugi potreban pribor, prikazan na slici ispod, stavite na čistu, ravnu površinu.
English: What Natpar contains
Croatian: Što Natpar sadrži
English: Absorption Natpar administered subcutaneously had an absolute bioavailability of 53%.
Croatian: Apsorpcija Natpar koji se primjenjuje supkutano ima apsolutnu bioraspoloživost od 53%.
English: Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves.
Croatian: Niski kalcij može izazvati simptome u raznim dijelovima tijela, uključujući kosti, srce, kožu, mišiće, bubrege, mozak i živce.
English: This hormone controls the amount of calcium and phosphate in the blood and urine.
Croatian: Taj hormon kontrolira količinu kalcija i fosfata u krvi i urinu.
English: In order to further confirm the efficacy and safety of NATPAR in the treatment of patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone, the MAH should conduct a randomised controlled trial comparing NATPAR to Standard of Care and to alternative dosing according to an agreed protocol.
Croatian: Radi dodatnog potvrđivanja djelotvornosti i sigurnosti lijeka NATPAR u liječenju bolesnika s kroničnim hipoparatireoidizmom koji ne mogu biti adekvatno liječeni samo standardnom terapijom, nositelj odobrenja mora provesti randomizirano, kontrolirano ispitivanje u kojem se NATPAR uspoređuje sa standardnim liječenjem i s alternativnom dozom u skladu s dogovorenim planom ispitivanja.
English: A greater increase in the levels of 1,25-(OH)2D in serum were observed with the 50 micrograms dose than with the 100 micrograms dose, likely due to direct inhibition of the renal 25-hydroxyvitamin D-1-hydroxylase enzyme by serum calcium.
Croatian: Veće povećanje razina 1,25-(OH)2D u serumu uočeno je pri dozi od 50 mikrograma nego pri dozi od 100 mikrograma, vjerojatno zbog izravne inhibicije renalnog 25-hidroksivitamin D-1-hidroksilaza enzima od strane kalcija u serumu.
English: In the kidney, parathyroid hormone and C-terminal fragments are cleared by glomerular filtration.
Croatian: U bubrezima, paratiroidni hormon i C-terminalni fragmenti izlučuju se glomerularnom filtracijom.
English: The results demonstrate durability of the physiological effects of Natpar over 60 months including maintenance of mean albumin-corrected serum calcium levels (n=49, 2.11 ±0.19 mmol/L), a decrease from baseline in urinary calcium excretion (n=47, -2.23 ±5.9 mmol/24 h), a decrease in serum phosphate (n=49, -0.29 ±0.28 mmol/L) and the maintenance of normal calcium phosphate product (n=49, <4.4mmol
Croatian: Rezultati pokazuju trajnost fizioloških učinaka lijeka Natpar tijekom 60 mjeseci, uključujući održavanje srednjih vrijednosti razina kalcija u serumu korigiranih za albumin (n=49, 2.11 ±0.19 mmol/l), smanjenje u urinarnom izlučivanju kalcija u odnosu na početne vrijednosti (n=47, -2.23 ±5.9 mmol/24h), smanjenje fosfata u serumu (n=49, -0.29 ±0.28 mmol/l) i održavanje normalnog produkta kalcija i fosfata (n=49, <4,4 mmol
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralisation at exposure levels 2.7 times the clinical exposure levels at the highest dose.
Croatian: U majmuna koji su svakodnevno primali supkutane doze tijekom 6 mjeseci bila je povećana pojavnost bubrežne tubularne mineralizacije pri razinama ekspozicije 2,7 puta većim od razina kliničke ekspozicije u ljudi pri najvišoj dozi.
English: Inject in the other thigh the following day and continue to alternate between the two.
Croatian: Injicirajte u drugo bedro sljedećeg dana i nastavite naizmjenično injicirati u jedno pa u drugo bedro.
English: Animal data do not indicate any impairment of fertility.
Croatian: Podaci u životinja ne ukazuju na nikakav poremećaj plodnosti.
English: • sodium hydroxide (for pH adjustment)
Croatian: • natrijev hidroksid (za podešavanje pH)
English: †, neck pain pain in extremity
Croatian: †, bol u vratu bol u ekstremitetu
English: Excipient(s) with known effect Each dose contains 0.32 mg of sodium.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna doza sadrži 0,32 mg natrija.
English: PTH has a variety of critical physiological functions that include its central role in modulating serum calcium and phosphate levels within tightly regulated levels, regulating renal calcium and phosphate excretion, activating vitamin D, and maintaining normal bone turnover.
Croatian: PTH ima brojne fiziološke funkcije od kritične važnosti koje uključuju njegovu središnju ulogu u moduliranju razina kalcija i fosfata u serumu unutar usko reguliranih razina, reguliranju izlučivanja kalcija i fosfata putem bubrega, aktiviranju vitamina D i održavanju normalnog obnavljanja kostiju.
English: For instructions on reconstitution of the medicinal product before administration and for using the pre-filled pen, see section 6.6 and the instructions included with the package leaflet.
Croatian: Za upute o rekonstituciji lijeka prije primjene i o uporabi napunjene brizgalice vidjeti dio 6.6 i upute sadržane u uputi o lijeku.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
English: Most of the hypocalcaemic events occurring in the clinical trials were mild to moderate in severity.
Croatian: Većina događaja hipokalcemije koji su nastupili u kliničkim ispitivanjima bili su blage do umjerene težine.
English: Natpar has been shown to pass into breast milk in rats, but it is not known if Natpar would pass into breast milk in humans.
Croatian: Uočeno je da se Natpar izlučuje u mlijeko u štakora, ali nije poznato prelazi li Natpar u majčino mlijeko u ljudi.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Ireland.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Irska.
English: Severe hypercalcaemia may be a life-threatening condition requiring urgent medical care and careful monitoring (see section 4.4).
Croatian: Teška hiperkalcemija može biti stanje opasno po život, koje zahtijeva hitnu medicinsku skrb i pozorno praćenje (vidjeti dio
English: A. Getting Started
Croatian: Kako početi
English: The dose of Natpar may be increased by 25 microgram increments approximately every 2 to 4 weeks, up to a maximum daily dose of 100 micrograms.
Croatian: Doza lijeka Natpar može se povećavati za 25 mikrograma otprilike svakih 2 do 4 tjedna, najviše do maksimalne dnevne doze od 100 mikrograma.
English: After mixing
Croatian: Nakon miješanja
English: These effects are more likely to occur: - when first starting Natpar, - if you change your Natpar dose, - if you miss one of your daily injections, - if you stop taking Natpar for a short time or altogether.
Croatian: Postoji veća vjerojatnost da će te nuspojave nastupiti: - kada prvi put počnete primati Natpar, - ako promijenite svoju dozu lijeka Natpar, - ako propustite jednu od svojih dnevnih injekcija, - ako prestanete primati