FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: Gele schacht
Croatian: Žuti valjak
Dutch: OVERIGE Bewaren in de koelkast.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
Dutch: Als u zwanger wordt, moet u het gebruik van FORSTEO staken.
Croatian: Dođe li do trudnoće, treba prekinuti primjenu lijeka FORSTEO.
Dutch: De volgende regel is gebruikt voor de classificatie van de bijwerkingen: Zeer vaak (≥1/10),
Croatian: Nuspojave su klasificirane prema učestalosti na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do
Dutch: Patiënten moeten aanvullend calcium- en vitamine-D-supplementen gebruiken als de inname met de voeding ontoereikend is.
Croatian: Bolesnici trebaju uzimati suplemente kalcija i vitamina
Dutch: Gebruik uw geneesmiddel iedere dag op ongeveer hetzelfde tijdstip, dit helpt u het niet te vergeten.
Croatian: Kako ne biste zaboravili primijeniti lijek, injicirajte ga svakoga dana u približno isto vrijeme.
Dutch: • als u last heeft van nierstenen of nierstenen heeft gehad
Croatian: • ako patite od bubrežnih kamenaca ili ste nekada imali bubrežne kamence
Dutch: Als u erover denkt te stoppen met de FORSTEO-behandeling, bespreek dat dan alstublieft met uw arts. Uw arts zal u adviseren en besluiten hoe lang u met FORSTEO behandeld moet worden.
Croatian: Liječnik će Vas savjetovati i odlučiti koliko dugo se trebate liječiti lijekom FORSTEO.
Dutch: Na 24 maanden was de gemiddelde toename vanaf uitgangsniveau in BMD (botmineraaldichtheid) van de lumbale wervelkolom, van de totale heup en van de femurhals respectievelijk 10,5%, 2,6% en 3,9%.
Croatian: Nakon 24 mjeseca je prosječan porast BMD-a u odnosu na početne vrijednosti iznosio 10,5% u lumbalnom dijelu kralježnice, 2,6% na cijelom kuku te 3,9% na vratu bedrene kosti.
Dutch: Premenopauzale vrouwen met glucocorticoïden-geïnduceerde osteoporose hebben een groot risico op fracturen indien zij een prevalente fractuur hebben gehad of een combinatie van meerdere risicofactoren hebben dat hen een groot risico op fracturen geeft (bijvoorbeeld lage botmineraaldichtheid [bijvoorbeeld T score ≤ -2], aanhoudend gebruik van hoge dosis glucocorticoïden [bijvoorbeeld ≥ 7,5mg/dag gedurende tenminste 6 maanden], zeer actieve onderliggende ziekte, lage geslachtshormoon spiegels).
Croatian: Treba smatrati da predmenopauzalne žene oboljele od osteoporoze izazvane glukokortikoidima imaju visok rizik za prijelome ako su već doživjele prijelom ili imaju kombinaciju faktora rizika koja ih izlaže visokom riziku od prijeloma (npr. mala gustoća kosti [npr.
Dutch: Bij patiënten met een matige nierinsufficiëntie moet FORSTEO met voorzichtigheid worden toegepast.
Croatian: U bolesnika s umjerenim oštećenjem bubrega FORSTEO treba primjenjivati uz oprez.
Dutch: Het wordt geleverd in een patroon in een voorgevulde wegwerp-pen.
Croatian: Dostupan je u ulošku koji se nalazi u napunjenoj brizgalici za jednokratnu uporabu.
Dutch: Niet-vertebrale fragiliteits fracturenc
Croatian: Nevertebralni prijelomi zbog krhkostic
Dutch: • nierstenen
Croatian: • nesvjestica
Dutch: Duw de zwarte injectieknop in totdat deze stopt.
Croatian: Pritisnite crni gumb za injiciranje dok se ne zaustavi.
Dutch: Trek de naaldbeschermer eraf en gooi weg zoals door uw arts of apotheker aangegeven.
Croatian: Skinite iglu zajedno sa štitnikom i uklonite prema uputama liječnika ili ljekarnika.
Dutch: • U heeft last van ernstige nierproblemen.
Croatian: • ako imate ozbiljnih tegoba s bubrezima.
Dutch: FORSTEO is gecontra-indiceerd voor gebruik tijdens borstvoeding.
Croatian: Primjena lijeka FORSTEO kontraindicirana je tijekom dojenja.
Dutch: Sommige patiënten worden duizelig of krijgen een hoge hartslag na de eerste paar doseringen.
Croatian: U nekih se bolesnika nakon prvih nekoliko doza lijeka može javiti omaglica ili ubrzano kucanje srca.
Dutch: Gebruik voor iedere injectie een nieuwe naald en gooi deze na ieder gebruik weg. Bewaar uw pen nooit met de naald er nog op.
Croatian: Za svaku injekciju upotrijebite novu iglu i zbrinite je nakon svake uporabe.
Dutch: • Lees en volg de instructies uit de Bijsluiter voor het gebruik van het product.
Croatian: • Za primjenu lijeka pročitajte i slijedite upute u uputi o lijeku.
Dutch: Soms: urinaire incontinentie, poly-urie, plotselinge mictiedrang, nefrolithiasis Zelden: nierfalen/nierfunctiestoornis
Croatian: Manje često: inkontinencija mokraće, poliurija, hitan nagon na mokrenje, nefrolitijaza Rijetko: zatajivanje/oštećenje bubrega
Dutch: Echter, er trad foetale resorptie en afgenomen worpgrootte op bij zwangere konijnen die een dagelijke dosis kregen toegediend van 3 tot 100 µg/kg.
Croatian: Međutim, u skotnih ženki kunića je pri dnevnim dozama od 3 do 100 µg/kg došlo do resorpcije fetusa i smanjene veličine legla.
Dutch: Gerelateerd aan het gebruik van teriparatide zijn gevallen van flauwvallen gemeld.
Croatian: Prijavljeni su slučajevi nesvjestice povezani s primjenom teriparatida.
Dutch: • pijn op de borst
Croatian: • bol u prsištu
Dutch: Niet bewaren met de naald bevestigd op het injectie apparaat.
Croatian: Naprava za injiciranje se ne smije čuvati s pričvršćenom iglom.
Dutch: GEBRUIKERSHANDLEIDING PEN
Croatian: PRIRUČNIK ZA UPORABU BRIZGALICE
Dutch: Houd ingedrukt en tel l-a-n-g-z-a-a-m tot 5.
Croatian: Držite ga pritisnutim i p-o-l-a-k-o brojite do 5. Zatim izvucite iglu iz kože.
Dutch: 3) Draai de naald helemaal los door de grote naaldbeschermer 3 tot 5 maal helemaal rond te draaien.
Croatian: 3) Okrećući veći pokrov igle za 3 do 5 punih okreta, odvijte iglu do kraja.
Dutch: De effectiviteit van FORSTEO bij mannen en vrouwen (N=428) die aanhoudende systemische glucocorticoïde behandeling ondergaan (gelijk aan 5 mg of meer prednison voor ten minste 3 maanden), werd aangetoond in de 18 maanden durende primaire fase van een 36 maanden durend, gerandomiseerd, dubbelblind, comparator-gecontroleerd onderzoek (alendronaat 10 mg/dag).
Croatian: Djelotvornost lijeka Forsteo u muškaraca i žena (N=428) dugotrajno liječenih sustavnim glukokortikoidima (ekvivalentno dozi prednizona od 5 mg ili više tijekom najmanje 3 mjeseca)
Dutch: Uw FORSTEO pen bewaren
Croatian: Kako čuvati FORSTEO
Dutch: Trek de kleine naaldbeschermer eraf en gooi deze weg.
Croatian: Skinite manji štitnik igle i uklonite ga.
Dutch: Injectienaalden worden niet bij de pen geleverd.
Croatian: Uz brizgalicu nisu priložene igle za injiciranje.
Dutch: • U bent allergisch voor een van de stoffen die in dit geneesmiddel zitten.
Croatian: • ako ste alergični na teriparatid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Dutch: GEGEVENS DIE OP DE BUITENVERPAKKING OF, INDIEN DEZE ONTBREEKT, OP DE PRIMAIRE VERPAKKING MOETEN WORDEN VERMELD:
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST NA KUTIJI
Dutch: Uw FORSTEO pen schoonmaken
Croatian: Čišćenje FORSTEO brizgalice
Dutch: Op baseline hadden de postmenopauzale vrouwen een gemiddelde leeftijd van 61 jaar, gemiddelde lumbale BMD T score van -2,7, mediaan prednison equivalente dosis van 7,5 mg/dag, en 34% had één of meer radiografische vertebrale fracturen; premenopauzale vrouwen hadden een gemiddelde leeftijd van 37 jaar, gemiddelde lumbale BMD T score van -2,5, mediaan prednison equivalente dosis van 10 mg/dag, en 9% had één of meer radiografische vertebrale fracturen; en mannen hadden een gemiddelde leeftijd van 57 jaar, gemiddelde lumbale BMD T score van -2,2, mediaan prednison equivalente dosis van 10 mg/dag, en 24% had één of meer radiografische vertebrale fracturen.
Croatian: Na početku ispitivanja je prosječna dob postmenopauzalnih žena bila 61 godinu, prosječna T-vrijednost BMD-a lumbalnog dijela kralježnice im je iznosila -2,7, primale su medijan doze glukokortikoida ekvivalentan dozi od 7,5 mg/dan prednizona, a 34% ih je imalo jedan ili više radiografski dokazanih prijeloma kralježaka.
Dutch: Plaats de grote naaldbeschermer op de naald.
Croatian: Vratite veći pokrov igle na iglu.
Dutch: FORSTEO is een kleurloze en heldere oplossing.
Croatian: FORSTEO je bezbojna i bistra otopina.
Dutch: Algemene aandoeningen en toedieningsplaatsstoornissen Vaak: vermoeidheid, pijn op de borst, asthenie, milde en voorbijgaande bijwerkingen op de injectieplaats, waaronder pijn, zwelling, erytheem, blauwe plekken, jeuk, en lichte bloeding op de injectieplaats.
Croatian: Opći poremećaji i reakcije na mjestu primjene Često: umor, bol u prsištu, astenija, blagi i prolazni događaji na mjestu injekcije, uključujući bol,
Dutch: De pen kan worden gebruikt met injectienaalden voor insulinepennen (Becton Dickinson).
Croatian: Možete koristiti igle za brizgalice proizvođača Becton,
Dutch: Negentig procent van de patiënten had in de uitgangssituatie één of meer vertebrale fracturen, en gemiddeld, vertebrale BMD was 0,82 g/cm2 (equivalent met een T-score = -2,6 ) Alle patiënten kregen per dag 1000 mg calcium en ten minste 400 IE vitamine D aangeboden.
Croatian: Na početku ispitivanja je 90% bolesnica imalo jedan ili više prijeloma kralježaka, a prosječna vertebralna mineralna gustoća kosti (BMD) je iznosila 0,82 g/cm2 (što odgovara T-vrijednosti od -2,6).
Dutch: a De incidentie van vertebrale fracturen werd bepaald uit 448 placebo- en 444 FORSTEO-patiënten die baseline en vervolg wervelkolom röntgenfoto hadden b p≤0,001 vergeleken met placebo c Een significante reductie in incidentie van heupfracturen werd niet aangetoond d p≤0,025 vergeleken met placebo
Croatian: b p ≤ 0,001 u usporedbi s placebom c Nije dokazano značajno smanjenje incidencije prijeloma kuka d p ≤ 0,025 u usporedbi s placebom.
Dutch: Draai de naald helemaal los door de naaldbeschermer 3 tot 5 keer helemaal rond te draaien.
Croatian: Okrećući pokrov igle za 3 do 5 punih okreta, odvijte iglu do kraja.
Dutch: Vaak: duizeligheid, hoofdpijn, ischias, flauwvallen Evenwichtsorgaan- en ooraandoeningen Vaak: vertigo
Croatian: Često: omaglica, glavobolja, išijas, sinkopa
Dutch: Patiënten met nierinsufficiëntie
Croatian: Populacija mlađih odraslih bolesnika
Dutch: Subcutaan gebruik EEN SPECIALE WAARSCHUWING DAT HET GENEESMIDDEL BUITEN HET ZICHT EN BEREIK VAN KINDEREN DIENT TE WORDEN GEHOUDEN Buiten het zicht en bereik van kinderen houden.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
Dutch: 1) Plaats de grote naaldbeschermer op de naald.
Croatian: 1) Vratite veći pokrov igle na iglu.
Dutch: De botmineraaldichtheid van wervelkolom en femurhals op uitgangsniveau waren respectievelijk de gemiddelde T-scores -2,2 en -2,1.
Croatian: Početna prosječna T-vrijednost mineralne gustoće kosti bila je -2,2 za kralježnicu, a -2,1 za vrat bedrene kosti.
Dutch: Er werden geen klinisch significante interacties waargenomen.
Croatian: Provedena su ispitivanja farmakodinamičkih interakcija lijeka FORSTEO s hidroklorotiazidom, u kojima nisu zabilježene klinički značajne interakcije.
Dutch: FORSTEO mag niet worden toegepast bij patiënten met een ernstige nierinsufficiëntie (zie rubriek 4.3).
Croatian: Bolesnici s teškim oštećenjem bubrega ne smiju uzimati FORSTEO (vidjeti dio 4.3).
Dutch: Lijst met bijwerkingen in tabelvorm
Croatian: Tablični prikaz nuspojava
Dutch: • ademnood
Croatian: • zaduha
Dutch: Na 36 maanden toonde analyse van spinale röntgenfoto's van 169 alendronaat patiënten en 173 FORSTEO patiënten aan dat 13 patiënten in de alendronaat groep (7,7%) een nieuwe vertebrale fractuur kregen vergeleken met 3 patiënten in de FORSTEO groep (1,7%) (p=0,01).
Croatian: 13 bolesnika iz skupine liječene alendronatom (7,7%) u usporedbi s 3 bolesnika iz skupine liječene lijekom FORSTEO (1,7%) (p = 0,01).
Dutch: Eli Lilly Norge A.S Tlf: + 47 22 88 18 00
Croatian: Tlf: + 47 22 88 18 00
Dutch: The patients were treated for up to 23 months.
Croatian: Bolesnici su liječeni do najviše 23 mjeseca.
Dutch: Forsteo teriparatide
Croatian: Forsteo teriparatid
Dutch: This summary was last updated in 05-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 05.2016.
Dutch: The full EPAR for Forsteo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Forsteo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dutch: EPAR summary for the public
Croatian: EPAR, sažetak za javnost
Dutch: Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding.
Croatian: Forsteo ne smiju uzimati djeca ili mlađe odrasle osobe čije kosti još nisu potpuno razvijene ili tijekom trudnoće ili dojenja.
Dutch: Forsteo has been studied in three main studies.
Croatian: Forsteo je ispitivan u trima glavnim ispitivanjima.
Dutch: It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Croatian: Također je smanjio rizik od nevertebralnih prijeloma za 62 %, ali nije smanjio rizik od prijeloma kuka.
Dutch: The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo on 10 June 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Forsteo na snazi u Europskoj uniji od 10. lipnja 2003.
Dutch: • men who are at an increased risk of fractures;
Croatian: • u muškaraca s povećanim rizikom od prijeloma;
Dutch: The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures.
Croatian: Glavna mjera učinkovitosti bio je broj novih vertebralnih prijeloma na kraju ispitivanja, iako su se ispitivanjem također proučavali nevertebralni prijelomi.
Dutch: A user manual is available for the pen.
Croatian: Dostupan je priručnik za korisnike brizgalice.
Dutch: The medicine can only be obtained with a prescription.
Croatian: Lijek se izdaje samo na liječnički recept.
Dutch: What measures are being taken to ensure the safe and effective use of Forsteo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Forsteo?
Dutch: What is the risk associated with Forsteo?
Croatian: Koji su rizici povezani s lijekom Forsteo?
Dutch: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forsteo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite uporabe proizvoda Forsteo nalaze se u sažetku opisa svojstava proizvoda i u uputi o proizvodu.
Dutch: The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Croatian: Preporučena doza je 20 mikrograma lijeka Forsteo jedanput na dan injekcijom ispod kože bedra ili abdomena (trbuha).
Dutch: It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Croatian: Također povećava apsorpciju kalcija iz hrane te sprječava preveliko izlučivanje kalcija urinom.
Dutch: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Forsteo.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Forsteo.
Dutch: For more information about treatment with Forsteo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Forsteo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Dutch: It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Croatian: Dostupan je u obliku otopine za injekciju unaprijed napunjenim brizgalicama (jedna unaprijed napunjena brizgalica od 2,4 ml sadrži 600 mikrograma teriparatida).
Dutch: Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Croatian: Forsteo ne smiju uzimati bolesnici koji boluju od drugih bolesti kostiju kao što su Pagetova bolest, rak kostiju ili metastaze u kostima (rak koji se proširio na kosti), u bolesnika koji su liječeni zračenjem koje obuhvaća kosti ili u bolesnika koji boluju od hiperkalcemije (visoka razina kalcija u krvi), u bolesnika s neobjašnjeno visokim razinama alkalne fosfataze (enzim) ili teške bolesti bubrega.
Dutch: This is a summary of the European public assessment report (EPAR) for Forsteo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Forsteo.
Dutch: The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Croatian: Najčešća nuspojava lijeka Forsteo (uočena u više od 1 na 10 osoba) je bol u rukama ili nogama.
Dutch: The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je zaključio da koristi od lijeka Forsteo nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Dutch: It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Croatian: Djeluje kao hormon kako bi se stimuliralo stvaranje kostiju djelujući na osteoblaste (stanice koje stvaraju kost).
Dutch: Other information about Forsteo
Croatian: Ostale informacije o lijeku Forsteo
Dutch: Gradually, the bones become thin and fragile, and more likely to break.
Croatian: Kosti postupno postaju tanke i krhke te podložnije lomovima.
Dutch: Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Croatian: Forsteo se koristi za liječenje osteoporoze (bolesti koja kosti čini krhkima) u sljedećih skupina:
Dutch: In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
Croatian: U ispitivanju koje je obuhvaćalo muškarce Forsteo je povećao gustoću kostiju kralježnice za otprilike 6 % nakon prosječno gotovo 12 mjeseci.
Dutch: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Croatian: Osteoporoza može također nastupiti u oba spola kao nuspojava terapije glukokortikoidima.
Dutch: The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Croatian: Ispitivanjima je također pokazano da su se koristi liječenja lijekom Forsteo nastavile povećavati do najviše dvije godine uz dodatna povećanja gustoće kostiju.
Dutch: Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Croatian: Forsteo je smanjio rizik od nastanka novog vertebralnog prijeloma tijekom 19 mjeseci za 65 % u usporedbi s placebom.
Dutch: What is Forsteo used for?
Croatian: Za što se Forsteo koristi?
Dutch: The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
Croatian: Prvim je ispitivanjem obuhvaćeno 1 637 žena s osteoporozom koje su bile u postmenopauzi (prosječna dob: 69,5 godina), u kojem je Forsteo uspoređivan s placebom (prividno liječenje) tijekom otprilike 19 mjeseci.
Dutch: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Croatian: U žena je osteoporoza učestalija nakon menopauze, nakon što se razine ženskog hormona estrogena smanje.
Dutch: Why has Forsteo been approved?
Croatian: Zašto je lijek Forsteo odobren?
Dutch: What is Forsteo?
Croatian: Što je Forsteo?
Dutch: • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Croatian: • u muškaraca i žena s povećanim rizikom od prijeloma zbog dugotrajne terapije glukokortikoidima
Dutch: Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Croatian: Forsteo je bio djelotvorniji od placeba u smanjenju vertebralnih prijeloma: 5 % žena koje su primale lijek Forsteo imalo je novi prijelom tijekom ispitivanja, u usporedbi s 14 % u grupi koja je primala placebo.
Dutch: The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Croatian: Djelatna tvar u lijeku Forsteo, teriparatid, identična je dijelu humanog paratiroidnog hormona.
Dutch: The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
Croatian: Ispitivanjem je obuhvaćeno 429 žena i muškaraca s osteoporozom i koji su uzimali glukokortikoide tijekom posljednja tri mjeseca.
Dutch: The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
Croatian: U trećem su ispitivanju uspoređeni učinci lijeka Forsteo i alendronata (drugog lijeka koji se koristi za liječenje osteoporoze) na gustoću kosti kralježnice tijekom razdoblja od tri godine.
Dutch: In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Croatian: U ispitivanju bolesnika koji su uzimali glukokortikoide, Forsteo je bio učinkovitiji od alendronata: bolesnici koji su primali Forsteo nakon 18 mjeseci imali su povećanje gustoće kostiju kralježnice od 7 % u usporedbi s 3 % u bolesnika koji su primali alendronat.
Dutch: Forsteo is a medicine that contains the active substance teriparatide.
Croatian: Forsteo je lijek koji sadrži djelatnu tvar teriparatid.
Dutch: The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Croatian: U drugom je ispitivanju proučavana primjena lijeka Forsteo u 437 muškaraca s osteoporozom, uspoređujući učinak lijeka na gustoću kostiju u kralježnici s učinkom placeba.
Dutch: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Croatian: Osteoporoza nastupa kada se kosti, koje se razgrađuju prirodnim putem, nedovoljno obnavljaju.
Dutch: What benefit has Forsteo shown during the studies?
Croatian: Koje su koristi lijeka Forsteo utvrđene u ispitivanjima?
Dutch: An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Croatian: U dodatnom su ispitivanju tijekom dvije godine proučavani učinci lijeka Forsteo na gustoću kostiju u 234 žene u postmenopauzi.
Dutch: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku.
Dutch: Patients may inject themselves once they have been trained.
Croatian: Ako prođu odgovarajuću obuku, bolesnici si mogu samostalno injicirati lijek Forsteo.
Dutch: • women who have been through the menopause.
Croatian: • u žena u postmenopauzi.
Dutch: In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Croatian: (spinalne) i nevertebralne prijelome (slomljene kosti), no ne i prijelom kuka;
Dutch: Only one two-year course of Forsteo should be given to a patient in their lifetime.
Croatian: Tijekom života bolesnik ne smije primiti više od jednog dvogodišnjeg ciklusa liječenja lijekom Forsteo.
Dutch: For the full list of all side effects reported with Forsteo, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene pri primjeni lijeka Forsteo potražite u uputi o lijeku.
Dutch: (EU-)handelsvergunningnummer
Croatian: Broj (EU) odobrenja