FrancophonIA/ELRC3.0 huggingface dataset:
English: Once-daily administration of FORSTEO increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Croatian: Primjena lijeka FORSTEO jedanput na dan povećava apoziciju novog koštanog tkiva na površini trabekularne i kortikalne kosti tako što jače stimulira aktivnost osteoblasta u odnosu na aktivnost osteoklasta.
English: Screw on needle until firmly attached.
Croatian: Navijte iglu dok ne bude čvrsto pričvršćena.
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in Forsteo- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001.
Croatian: Među ispitanicama u kojih je učinjena radiografska snimka kralježnice na početku i tijekom ispitivanja, incidencija novih prijeloma kralježaka iznosila je 28/516 (5,4%) u skupini liječenoj lijekom Forsteo te 64/533 (12,0%) u onoj koja je primala risedronat, relativan rizik (95% CI) = 0,44 (0,29-0,68), P < 0,0001.
English: Solution
Croatian: Rješenje
English: Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Croatian: Nakon otvaranja, lijek se može čuvati najdulje 28 dana na temperaturi od
English: Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
Croatian: Jedan mililitar otopine za injekciju sadrži 250 mikrograma teriparatida.
English: Independent risk factors, for example, low BMD, age, the existence of previous fracture, family history of hip fractures, high bone turnover and low body mass index should be considered in order to identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.
Croatian: Treba uzeti u obzir neovisne faktore rizika, primjerice nizak BMD, dob, prethodne prijelome, prijelome kuka u obiteljskoj anamnezi, ubrzanu koštanu pregradnju te nizak indeks tjelesne mase,
English: FORSTEO is supplied in a pre-filled pen.
Croatian: FORSTEO se isporučuje u napunjenoj brizgalici.
English: • irregular heart beats
Croatian: • nepravilno kucanje srca
English: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection.
Croatian: U bolesnika s normalnom razinom kalcija u krvi primijećen je blag i prolazan porast koncentracije serumskog kalcija nakon injekcije teriparatida.
English: At the 18 month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2 %) compared with alendronate (3.4 %) (p<0.001).
Croatian: U ishodu nakon 18 mjeseci FORSTEO je značajno povećao BMD lumbalnog dijela kralježnice (7,2%) u usporedbi s alendronatom (3,4%) (p < 0,001).
English: Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
Croatian: Pročitajte i slijedite upute za čuvanje brizgalice u uputi o lijeku.
English: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3).
Croatian: Istraživanja na štakorima pokazala su povećanu incidenciju osteosarkoma pri dugotrajnoj primjeni teriparatida (vidjeti dio 5.3).
English: Common: Anaemia
Croatian: Rijetko: anafilaksija
English: The recommended treatment time of 24 months should not be exceeded.
Croatian: Ne smije se prekoračiti preporučeno trajanje liječenja od 24 mjeseca.
English: At baseline, ninety percent of the patients had one or more vertebral fractures, and on average, vertebral BMD was 0.82 g/cm2 (equivalent to a T-score = - 2.6).
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).
English: Musculoskeletal and connective tissue disorders Very common: Pain in limb
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često: bol u udovima
English: No data are available in patients with impaired hepatic function (see section 5.3).
Croatian: Nema podataka o primjeni u bolesnika s oštećenjem jetre (vidjeti dio 5.3).
English: - The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections.
Croatian: Drugi sastojci su: ledena acetatna kiselina, natrijev acetat (bezvodni), manitol, metakrezol i voda za injekcije.
English: • abnormal heart sound
Croatian: • neuobičajen zvuk srca
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5 % and 1 %, respectively, compared with placebo.
Croatian: Nakon 12 mjeseci se BMD lumbalnog dijela kralježnice povećao za 5%, a BMD cijelog kuka za 1% u odnosu na primjenu placeba.
English: FORSTEO contains a clear and colourless solution.
Croatian: FORSTEO sadrži bistru i bezbojnu otopinu.
English: Remove needle
Croatian: Odstranite iglu
English: Twenty-eight percent of patients had one or more radiographic vertebral fractures at baseline.
Croatian: Na početku ispitivanja je 28% bolesnika imalo jedan ili više radiografski dokazanih prijeloma kralježaka.
English: Change to a new FORSTEO to take your dose as directed by your doctor or pharmacist.
Croatian: Uzmite novi FORSTEO kako biste si dali dozu prema preporukama liječnika ili ljekarnika.
English: What FORSTEO contains - The active substance is teriparatide.
Croatian: Sadržaj pakiranja i druge informacije Što FORSTEO sadrži - Djelatna tvar je teriparatid.
English: In clinical trials, 2.8 % of FORSTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7 % of placebo patients.
Croatian: U kliničkim je ispitivanjima koncentracija mokraćne kiseline u serumu iznad gornje granice normale zabilježena u 2,8% bolesnika liječenih lijekom FORSTEO u usporedbi s 0,7% bolesnika koji su primali placebo.
English: Common: Nausea, vomiting, hiatus hernia, gastroesophageal reflux disease Uncommon: Haemorrhoids
Croatian: Često: mučnina, povraćanje, hijatalna hernija, gastroezofagealna refluksna bolest
English: After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9 % and 4 % compared with placebo (p<0.001).
Croatian: Nakon 19 mjeseci (medijan) liječenja mineralna gustoća kosti (BMD) u lumbalnom dijelu kralježnice povećala se za 9%, a na cijelom kuku za 4% (p < 0,001) u odnosu na placebo.
English: • if you suffer from kidney stones or have a history of kidney stones.
Croatian: • ako patite od bubrežnih kamenaca ili ste nekada imali bubrežne kamence
English: 4) If you still cannot get the needle off, ask someone to help you.
Croatian: 4) Ako još uvijek ne možete skinuti iglu,
English: • Before disposing of the FORSTEO device, be sure to remove the pen needle.
Croatian: • Prije odlaganja FORSTEO injektora, provjerite jeste li skinuli iglu s brizgalice.
English: Some patients get dizzy or get a fast heartbeat after the first few doses.
Croatian: U nekih se bolesnika nakon prvih nekoliko doza lijeka može javiti omaglica ili ubrzano kucanje srca.
English: 3 pens of 2.4 mL solution each.
Croatian: 3 brizgalice, svaka s 2,4 ml otopine.
English: The pen should be returned to the refrigerator immediately after use.
Croatian: Vratite brizgalicu u hladnjak odmah nakon uporabe.
English: In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2 % versus −1.9 %; p<0.001) and total hip (3.8 % versus 0.9 %; p=0.005).
Croatian: U predmenopauzalnih je žena porast BMD-a od početka ispitivanja do 18. mjeseca bio značajno veći u skupini liječenoj lijekom FORSTEO u odnosu na skupinu liječenu alendronatom, i to u lumbalnom dijelu kralježnice (4,2% u odnosu na -1,9%; p<0,001) te na cijelom kuku (3,8% u odnosu na 0,9%; p = 0,005).
English: Τηλ: + 30 210 629 4600
Croatian: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: + 30 210 629 4600
English: Do not use FORSTEO if it is, or has been, frozen.
Croatian: FORSTEO se ne smije upotrijebiti ako je zamrznut ili je bio zamrznut.
English: • Keep the FORSTEO out of the sight and reach of children.
Croatian: • Čuvajte FORSTEO izvan pogleda i dohvata djece.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 250 micrograms of teriparatide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml sadrži 250 mikrograma teriparatida.
English: Also read the package leaflet provided.
Croatian: Također pročitajte priloženu uputu o lijeku.
English: The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in Forsteo and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), P=0.0009.
Croatian: Ukupna incidencija kliničkih prijeloma (klinički prijelomi kralježaka i nevertebralni prijelomi) iznosila je 4,8% u skupini koja je primala Forsteo te 9,8% u bolesnica liječenih risedronatom, omjer hazarda (95% CI) = 0,48 (0,32-0,74), P=0,0009.
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje često: može se javiti u do 1 na 100 osoba
English: In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.
Croatian: Osim toga, za podešavanje pH može biti dodana otopina kloridne kiseline i/ili natrijevog hidroksida.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Common: Dizziness, headache, sciatica, syncope
Croatian: Često: omaglica, glavobolja, išijas, sinkopa
English: A user manual is also available to instruct patients on the correct use of the pen.
Croatian: Postoji i Priručnik za korisnike s uputama za pravilno korištenje brizgalice.
English: Dosage adjustment based on age is not required.
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob bolesnika.
English: Uncommon: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis Rare: Renal failure/impairment
Croatian: Manje često: inkontinencija mokraće, poliurija, hitan nagon na mokrenje, nefrolitijaza Rijetko: zatajivanje/oštećenje bubrega
English: OTHER SPECIAL WARNING(S), IF NECESSARY To open, lift here and pull.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: 1 pen of 2.4 mL solution.
Croatian: 1 brizgalica s 2,4 ml otopine.
English: Eli Lilly ČR, s.r.o.
Croatian: Česká republika ELI LILLY ČR, s.r.o.
English: FORSTEO increased BMD at the total hip (3.6 %) compared with alendronate (2.2 %) (p<0.01), as well as at the femoral neck (3.7 %) compared with alendronate (2.1 %) (p<0.05).
Croatian: FORSTEO je povećao BMD cijelog kuka (3,6%) u odnosu na alendronat (2,2%) (p < 0,01) kao i BMD vrata bedrene kosti (3,7%) u usporedbi s alendronatom
English: • Pre-existing hypercalcaemia
Croatian: • Postojeća hiperkalcijemija.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FORSTEO 20 micrograms/80 microliters, injection Teriparatide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA FORSTEO 20 mikrograma/80 mikrolitara, injekcija teriparatid
English: • increase in blood uric acid level
Croatian: • povišene razine mokraćne kiseline u krvi
English: 2) Use the large needle cover to unscrew the needle.
Croatian: 2) Koristite veći pokrov igle kako biste iglu odvili.
English: The mean increase in BMD from 18 to 24 months was 1.4 %, 1.2 %, and 1.6 % at the lumbar spine, total hip and femoral neck, respectively.
Croatian: Prosječan porast BMD-a od 18. do 24. mjeseca liječenja iznosio je 1,4% u lumbalnom dijelu kralježnice, 1,2% na cijelom kuku i 1,6% na vratu bedrene kosti.
English: • Store the FORSTEO with the white cap on.
Croatian: • Čuvajte FORSTEO poklopljen bijelim zatvaračem.
English: FORSTEO has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima FORSTEO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The device can be used with insulin pen injection needles.
Croatian: Uz ovo se pomagalo mogu koristiti injekcijske igle za inzulinske brizgalice.
English: Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Croatian: Žene generativne dobi moraju koristiti djelotvorne metode kontracepcije tijekom primjene lijeka
English: How to store FORSTEO
Croatian: Kako čuvati FORSTEO
English: Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria
Croatian: Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Beč, Austrija Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, Francuska
English: • if you suffer from kidney problems (moderate renal impairment).
Croatian: • ako imate tegoba s bubrezima (umjereno oštećenje bubrega)
English: FORSTEO must not be used in patients with severe renal impairment (see section 4.3.).
Croatian: Bolesnici s teškim oštećenjem bubrega ne smiju uzimati FORSTEO (vidjeti dio 4.3).
English: It is supplied in a cartridge contained in a pre-filled disposable pen.
Croatian: Dostupan je u ulošku koji se nalazi u napunjenoj brizgalici za jednokratnu uporabu.
English: Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Croatian: Liječnik će Vam možda savjetovati da uz FORSTEO uzimate kalcij i vitamin D.
English: Forsteo parts*
Croatian: Dijelovi Forsteo brizgalice*
English: • if you suffer from serious kidney problems.
Croatian: • ako imate ozbiljnih tegoba s bubrezima.
English: Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e.g., low bone density [e.g., T score ≤−2], sustained high dose glucocorticoid therapy [e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).
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.
English: The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.
Croatian: Zabilježena embriotoksičnost u kunića možda je povezana s njihovom značajno većom osjetljivošću na djelovanje
English: 5) Pull off the small needle protector and throw away.
Croatian: 5) Skinite manji štitnik igle i uklonite ga.
English: m.b.H.
Croatian: Icepharma hf.
English: Small needle protector
Croatian: Manji štitnik igle
English: Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
Croatian: Bolesnici trebaju uzimati suplemente kalcija i vitamina
English: 4) Pull out the black injection button until it stops.
Croatian: 4) Izvucite crni gumb za injiciranje dok se ne zaustavi.
English: Pull off small needle protector and throw away.
Croatian: Skinite manji štitnik igle i uklonite ga.
English: The total duration of treatment with FORSTEO should not exceed 24 months.
Croatian: Liječenje lijekom FORSTEO ne smije trajati dulje od 24 mjeseca.
English: Do not store the injection device with the needle attached.
Croatian: Naprava za injiciranje se ne smije čuvati s pričvršćenom iglom.
English: Transient, orthostatic hypotension or dizziness was observed in some patients.
Croatian: U nekih su bolesnika primijećene prolazna ortostatska hipotenzija ili omaglica.
English: During a median of 18 months following discontinuation of FORSTEO, there was a 41 % reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
Croatian: Tijekom medijana od 18 mjeseci nakon prekida liječenja lijekom FORSTEO broj bolesnica s najmanje jednim novim prijelomom kralješka smanjio se za 41% u odnosu na skupinu koja je primala placebo (p=0,004).
English: • increase in blood calcium level
Croatian: • povišene razine kalcija u krvi
English: 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Croatian: 3) Okrećući veći pokrov igle za 3 do 5 punih okreta, odvijte iglu do kraja.
English: 1) Put the large needle cover on the needle.
Croatian: 1) Vratite veći pokrov igle na iglu.
English: Rare: Anaphylaxis
Croatian: Često: vrtoglavica
English: Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use.
Croatian: Za svaku injekciju upotrijebite novu iglu i zbrinite je nakon svake uporabe.
English: Nausea, vomiting, dizziness, and headache can also occur.
Croatian: Mogu se javiti i mučnina, povraćanje, omaglica te glavobolja.
English: The efficacy of FORSTEO in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
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)
English: Serum and urine calcium
Croatian: Kalcij u serumu i mokraći
English: Yellow Shaft
Croatian: Žuti valjak
English: Pull off needle cover and throw away as directed by your doctor or pharmacist.
Croatian: Skinite iglu zajedno sa štitnikom i uklonite prema uputama liječnika ili ljekarnika.
English: However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 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.
English: Injection needles are not included with the pen.
Croatian: Igle nisu priložene u pakiranju lijeka.
English: The black injection button will be all the way in to show that the full dose has been injected from the FORSTEO.
Croatian: FORSTEO brizgalice injicirala cijela doza.
English: • Read and follow the instructions in the Information for the Patient leaflet for using the product.
Croatian: • Za primjenu lijeka pročitajte i slijedite upute u uputi o lijeku.
English: Renal impairment Caution should be exercised in patients with moderate renal impairment.
Croatian: Potreban je oprez u bolesnika s umjerenim oštećenjem bubrega.
English: Disposal of Pen Needles and Device Disposal of Pen Needles and FORSTEO Device
Croatian: Odlaganje igala za brizgalicu i injektora Odlaganje igala za brizgalicu i FORSTEO injektora
English: If you cannot pull out the black injection button see
Croatian: Ako ne možete izvući crni gumb za injiciranje pogledajte Rješavanje problema, Problem E.
English: FORSTEO is contraindicated for use during breast-feeding.
Croatian: Primjena lijeka FORSTEO kontraindicirana je tijekom dojenja.
English: Pull out black injection button until it stops.
Croatian: Izvucite crni gumb za injiciranje dok se ne zaustavi.
English: Some patients may feel dizzy after injecting FORSTEO.
Croatian: Nakon injekcije lijeka FORSTEO neki bolesnici mogu osjetiti omaglicu.
English: Push in black injection button until it stops.
Croatian: Pritisnite crni gumb za injiciranje dok se ne zaustavi.
English: • Refrigerate the FORSTEO immediately after every use.
Croatian: • Svaki puta stavite FORSTEO u hladnjak odmah nakon uporabe.
English: Male osteoporosis
Croatian: Osteoporoza u muškaraca
English: Non-vertebral fragility fractures c
Croatian: Nevertebralni prijelomi zbog krhkostic
English: Overdose management
Croatian: Liječenje predoziranja
English: General disorders and administration site conditions Common: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritis and minor bleeding at injection site.
Croatian: Opći poremećaji i reakcije na mjestu primjene Često: umor, bol u prsištu, astenija, blagi i prolazni događaji na mjestu injekcije, uključujući bol,
English: At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5 %, 2.6 % and 3.9 % respectively.
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.
English: Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.
Croatian: Za upute o uporabi FORSTEO brizgalice, pročitajte priručnik za korisnike koji je priložen u kutiji.
English: Set dose
Croatian: Namjestite dozu
English: 437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.
Croatian: (definirano kao niska jutarnja razina slobodnog testosterona ili povišene razine FSH-a ili LH-a) ili idiopatskom osteoporozom.
English: Package leaflet: Information for the user FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen Teriparatide
Croatian: Uputa o lijeku: Informacije za korisnika FORSTEO 20 mikrograma/80 mikrolitara otopina za injekciju u napunjenoj brizgalici teriparatid
English: Eli Lilly Norge A.S Tlf: + 47 22 88 18 00
Croatian: Tlf: + 47 22 88 18 00
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Često: pojačano znojenje
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari acetatna kiselina, ledena natrijev acetat (bezvodni) manitol metakrezol kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Croatian: Provedena su ispitivanja farmakodinamičkih interakcija lijeka FORSTEO s hidroklorotiazidom, u kojima nisu zabilježene klinički značajne interakcije.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Često: anemija
English: ask your doctor.
Croatian: zamolite nekoga za pomoć.
English: Put large needle cover on needle.
Croatian: Vratite veći pokrov igle na iglu.
English: At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 FORSTEO patients showed that 13 patients in the alendronate group (7.7 %) had experienced a new vertebral fracture compared with 3 patients in the FORSTEO group (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).
English: Do not use FORSTEO
Croatian: Nemojte primjenjivati FORSTEO
English: FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
Croatian: FORSTEO, 20 mikrograma (µg)/ 80 mikrolitara otopina za injekciju u napunjenoj brizgalici
English: Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Croatian: Okrećući veći pokrov igle za 3 do 5 punih okreta, odvijte iglu do kraja.
English: Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns.
Croatian: Okrećući pokrov igle za 3 do 5 punih okreta, odvijte iglu do kraja.
English: PEN USER MANUAL
Croatian: PRIRUČNIK ZA UPORABU BRIZGALICE
English: BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34 % had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9 % had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD
Croatian: 37 godina, prosječna T-vrijednost BMD-a lumbalnog dijela kralježnice bila je -2,5, primale su medijan doze glukokortikoida ekvivalentan dozi od 10 mg/dan prednizona, a 9% ih je imalo jedan ili više radiografski dokazanih prijeloma kralježaka.