FrancophonIA/ELRC3.0 huggingface dataset:
English: FORSTEO increases serum uric acid concentrations.
Slovenian: Zdravilo FORSTEO zvišuje serumske koncentracije sečne kisline.
English: You should not receive more than one treatment course of 24 months over your lifetime.
Slovenian: V času vašega življenja ne smete prejeti več kot en postopek zdravljenja, ki traja 24 mesecev.
English: Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Slovenian: Po ukinitvi zdravljenja z zdravilom FORSTEO lahko bolniki naprej prejemajo druga zdravila za osteoporozo.
English: Gently hold a fold of skin from thigh or abdomen and insert needle straight into skin.
Slovenian: Nežno primite kožno gubo stegna ali trebuha in vbodite iglo naravnost v kožo.
English: Common: Palpitations
Slovenian: Pogosto: palpitacije
English: Pull off large needle cover and save it.
Slovenian: Odstranite večji pokrov igle in ga shranite.
English: MARKETING AUTHORISATION NUMBERS EU/1/03/247/001-002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/247/001-002
English: No bone tumours were observed in ovariectomised monkeys treated for 18 months or during a 3-year follow-up period after treatment cessation.
Slovenian: Pri opicah, ki so jim izrezali jajčnike in so 18 mesecev prejemale teriparatid, niso opazili nobenih kostnih tumorjev, niti v 3-letnem obdobju spremljanja po končanem zdravljenju.
English: Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, France
Slovenian: Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, Francija
English: What FORSTEO looks like and contents of the pack FORSTEO is a colourless and clear solution.
Slovenian: Izgled zdravila FORSTEO in vsebina pakiranja Zdravilo FORSTEO je brezbarvna in bistra raztopina.
English: • pain in the muscles and pain in the joints.
Slovenian: • ledvični kamni • bolečina v mišicah in bolečina v sklepih.
English: The device can be used with insulin pen injection needles.
Slovenian: Napravo lahko uporabljamo z injekcijskimi iglami za insulinske injekcijske peresnike.
English: The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day).
Slovenian: Povprečni (mediani) vnos vitamina D v skupini s teriparatidom je bil 1433 i.e./dan (1400 i.e./dan), v skupini z rizedronatom pa 1191 i.e./dan (900 i.e./dan).
English: How to use FORSTEO
Slovenian: Kako uporabljati zdravilo FORSTEO
English: *Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
Slovenian: *Teriparatid, rhPTH(1-34), izdelan v E. coli z uporabo tehnologije rekombinantne DNA, je istoveten
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).
Slovenian: V izhodiščnem stanju je imelo devetdeset odstotkov bolnikov enega ali več zlomov vretenc in v povprečju je bila mineralna gostota kosti (BMD) vretenc 0,82 g/cm2 (ustrezno T-vrednosti = - 2,6).
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women receiving FORSTEO.
Slovenian: V velikem kliničnem preskušanju so pri 2,8 % žensk, ki so prejemale zdravilo FORSTEO, zaznali protitelesa, ki so navzkrižno reagirala s teriparatidom.
English: If you forget or cannot take FORSTEO at your usual time, take it as soon as possible on that day.
Slovenian: Če ste pozabili ali ne morete uporabiti zdravila FORSTEO ob vaši običajni uri, si ga injicirajte, kakor hitro morete, še ta dan. Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
English: Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Slovenian: En injekcijski peresnik vsebuje 28 odmerkov po 20 mikrogramov (na 80 mikrolitrov).
English: In patients with moderate renal impairment, FORSTEO should be used with caution.
Slovenian: Pri bolnikih z zmerno okvarjenim delovanjem ledvic moramo zdravilo FORSTEO uporabljati previdno.
English: Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Slovenian: Zdravljenje osteoporoze povezane s podaljšanim sistemskim glukokortikoidnim zdravljenjem pri ženskah in moških s povečanim tveganjem za zlom (glejte poglavje 5.1).
English: No data are available in patients with impaired hepatic function (see section 5.3).
Slovenian: Za bolnike z okvarjenim delovanjem jeter ni na voljo podatkov (glejte poglavje 5.3).
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.
Slovenian: V času po ukinitvi zdravila FORSTEO (mediana 18 mesecev) je za 41 % (p = 0,004) manj bolnikov imelo najmanj en novi zlom vretenca v primerjavi z bolniki, ki so prejemali placebo.
English: • The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Slovenian: • Navodila za rokovanje z iglo niso namenjena nadomestitvi načina ravnanja v skladu z lokalnimi navodili ali navodili zdravstvenega delavca oziroma ustanove.
English: Rare: may affect up to 1 in 1,000 people
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1000 bolnikov:
English: Common: Dizziness, headache, sciatica, syncope
Slovenian: Pogosto: omotica, glavobol, išias, sinkopa
English: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection.
Slovenian: Pri normokalcemičnih bolnikih so po injiciranju teriparatida opažali rahla in prehodna povišanja serumskih koncentracij kalcija.
English: • neuralgic pain in the leg
Slovenian: • nevralgične bolečine v nogah
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).
Slovenian: Analiza rentgenskih posnetkov 169 bolnikov, ki so dobivali alendronat, in 173 bolnikov, ki so dobivali zdravilo FORSTEO, je po 36 mesecih pokazala nov zlom vretenc pri 13 bolnikih v skupini z alendronatom (7,7 %) in pri 3 bolnikih v skupini zdravila FORSTEO (1,7 %) (p = 0,01).
English: Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Slovenian: Ne uporabljajte zdravila FORSTEO, če opazite trdne delce v raztopini ali je raztopina videti motna ali obarvana.
English: Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
Slovenian: Vsak mililiter raztopine za injiciranje vsebuje 250 mikrogramov teriparatida.
English: Transient events reported have included nausea, weakness/lethargy and hypotension.
Slovenian: Poročali so o naslednjih prehodnih učinkih: slabost, oslabelost/letargija in hipotenzija.
English: FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Slovenian: Izločanje Zdravilo FORSTEO se izloča z jetrnim in zunaj-jetrnim očistkom (približno 62 l/h pri ženskah in
English: Uncommon: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis Rare: Renal failure/impairment
Slovenian: Občasno: Inkontinenca urina, poliurija, pogosto siljenje na vodo, nefrolitiaza Redko:Odpoved/okvara ledvic
English: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3).
Slovenian: Študije pri podganah so pokazale povečano incidenco osteosarkoma po dolgotrajnem dajanju teriparatida (glejte poglavje 5.3).
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.
Slovenian: Dajanje zdravila FORSTEO enkrat dnevno poveča apozicijo nove kostnine na trabekularne in kortikalne površine kosti s prednostno stimulacijo osteoblastnega delovanja proti osteoklastnimu delovanju.
English: FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
Slovenian: Zdravila FORSTEO ne smete uporabiti, če je raztopina motna, obarvana ali vsebuje trdne delce.
English: Women of childbearing potential / Contraception in females Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Slovenian: Ženske, ki bi lahko zanosile/Kontracepcija za ženske Ženske, ki bi lahko zanosile morajo med uporabo zdravila FORSTEO uporabljati učinkovito metodo kontracepcije.
English: At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
Slovenian: 2 predhodna zloma vretenc; 57,9 % bolnic je že prejelo zdravljenje z bisfosfonati, 18,8 % pa jih je med študijo sočasno jemalo glukokortikoide.
English: After each injection, the FORSTEO pen should be returned to the refrigerator.
Slovenian: Po vsakem injiciranju morate injekcijski peresnik FORSTEO shraniti nazaj v hladilnik.
English: Paediatric population and young adults with open epiphyses The safety and efficacy of FORSTEO in children and adolescents less than 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila FORSTEO pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).
Slovenian: Zdravljenje osteoporoze pri ženskah po menopavzi in moških s povečanim tveganjem za zlom (glejte poglavje 5.1).
English: Change to a new FORSTEO to take your dose as directed by your doctor or pharmacist.
Slovenian: Zamenjajte za nov FORSTEO, da dobite vaš odmerek, kot vam je predpisal vaš zdravnik ali farmacevt.
English: You can use FORSTEO for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).
Slovenian: Zdravilo FORSTEO lahko uporabljate do 28 dni po prvem injiciranju, če je injekcijski peresnik shranjen pri temperaturi med
English: Ask your pharmacist how to throw away medicines you no longer use These measures will help to protect the environment.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: b p≤0.001 compared with placebo c A significant reduction in the incidence of hip fractures has not been demonstrated d p≤0.025 compared with placebo.
Slovenian: bp ≤ 0,001 v primerjavi s placebom cPomembnega zmanjšanja incidence zlomov kolka niso dokazali.
English: Common: Anaemia
Slovenian: Pogosto: anemija
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.
Slovenian: Kumulativna incidenca kliničnih zlomov (klinični vretenčni in nevretenčni zlomi) je bila 4,8 % v skupini z zdravilom Forsteo in 9,8 % pri bolnicah, zdravljenih z rizedronatom, razmerje tveganja (95-odstotni IZ) = 0,48 (0,32-0,74), P = 0,0009.
English: • increase in an enzyme called alkaline phosphatase.
Slovenian: • povišanje encima, imenovanega alkalna fosfataza
English: Male osteoporosis
Slovenian: Pomenopavzalna osteoporoza
English: Do not store the injection device with the needle attached.
Slovenian: Injekcijske naprave ne shranjujte s pritrjeno iglo.
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).
Slovenian: Zdravilo FORSTEO je zvišalo mineralno gostoto kosti (BMD) v celem kolku (7,2 %) v primerjavi z alendronatom (2,2 %) (p < 0,01), kot tudi v vratu stegnenice (3,7 %) v primerjavi z alendronatom (2,1 %) (p < 0,05).
English: It produced no teratogenic effects in rats, mice or rabbits.
Slovenian: Pri podganah, miših ali kuncih ni povzročil nobenih teratogenih učinkov.
English: Never store your pen with the needle attached.
Slovenian: Nikoli ne shranjujte vašega injekcijskega peresnika s pritrjeno iglo.
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.
Slovenian: Pogosto: utrujenost, bolečina v prsnem košu, astenija, blagi in prehodni učinki na mestu injiciranja, vključno z bolečino, oteklino, rdečino, omejeno podplutbo, srbenjem in manjšo krvavitvijo na mestu injiciranja
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of FORSTEO.
Slovenian: Če ste ženska, ki bi lahko zanosila, morate med uporabo zdravila FORSTEO uporabljati učinkovito metodo kontracepcije.
English: FORSTEO is available in pack sizes of 1 or 3 pens.
Slovenian: Zdravilo FORSTEO je na voljo v pakiranjih po 1 ali 3 injekcijske peresnike.
English: Manufacturer Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France.
Slovenian: Izdelovalec Lilly France S.A.S., Rue du Colonel Lilly, F-67640 Fegersheim, Francija
English: Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy.
Slovenian: 12 mesecih zdravljenja, po ukinitvi zdravljenja pa se je koncentracija protiteles ponovno zmanjšala.
English: Common: Nausea, vomiting, hiatus hernia, gastroesophageal reflux disease Uncommon: Haemorrhoids
Slovenian: Pogosto: navzea, bruhanje, hiatalna hernija, gastroezofagealna refluksna bolezen Občasno: hemoroidi
English: Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events.
Slovenian: Sočasno dajanje zdravila FORSTEO in raloksifena ali hormonske nadomestne terapije z zdravilom FORSTEO ni spremenilo učinkov zdravila FORSTEO na serumske koncentracije kalcija,
English: Prepare the injection site as directed by your doctor or pharmacist.
Slovenian: Pripravite mesto injiciranja v skladu z navodili vašega zdravnika ali farmacevta.
English: • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget's disease of bone (disease with abnormal bone changes).
Slovenian: • če imate nepojasnjene visoke ravni alkalne fosfataze v krvi, kar pomeni, da imate morda
English: Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, water for injections.
Slovenian: Koncentrirana ocetna kislina, natrijev acetat (brezvodni), manitol, metakrezol, voda za injekcije.
English: Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)
Slovenian: Večji nevretenčni zlomi zaradi krhkostic (kolk, koželjnica, nadlahtnica, rebra in medenica)
English: Pregnancy FORSTEO is contraindicated for use during pregnancy (see section 4.3).
Slovenian: Zdravilo FORSTEO je med nosečnostjo kontraindicirano (glejte poglavje 4.3).
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).
Slovenian: Po 19 mesecih (mediana) zdravljenja se je mineralna gostota kosti (BMD) povišala v ledvenem delu hrbtenice oziroma celem kolku, za 9 % oziroma 4 % v primerjavi s placebom (p < 0,001).
English: A new, sterile needle must be used for every injection.
Slovenian: Za vsako injiciranje morate uporabiti novo, sterilno iglo.
English: Do not use this medicine after the expiry date which is stated on the carton and pen after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in injekcijskem peresniku po oznaki EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
Slovenian: Če vnos s hrano ne zadošča, naj bolniki prejemajo dodatek kalcija in vitamina D.
English: The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Slovenian: Učinki zdravila FORSTEO na okostje so odvisni od načina izpostavljanja sistema.
English: If pregnancy occurs, FORSTEO should be discontinued.
Slovenian: Če zanosijo, mora biti zdravilo FORSTEO ukinjeno.
English: 5) Pull off the small needle protector and throw away.
Slovenian: 5) Odstranite manjšo zaščito igle in jo zavrzite.
English: Multiple vertebral fractures (≥2) a
Slovenian: Več zlomov vretenc (≥ 2)a
English: Cases of fainting have been reported in association with teriparatide use.
Slovenian: Pri uporabi teriparatida so poročali o primerih omedlevice.
English: • Prior external beam or implant radiation therapy to the skeleton
Slovenian: • Teleradioterapija ali brahiradioterapija za zdravljenje okostja v preteklosti
English: To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Slovenian: 11 žensk zdraviti mediano 19 mesecev.
English: FORSTEO should be stored in a refrigerator (2°C to 8°C) at all times.
Slovenian: Zdravilo FORSTEO vedno shranjujte v hladilniku (2 °C - 8 °C).
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).
Slovenian: Pri ženskah pred menopavzo je bilo povišanje mineralne gostote kosti (BMD) z osnove na končno točko po 18 mesecih značilno višje v skupini zdravila FORSTEO v primerjavi s skupino alendronata za ledveni del hrbtenice (4,2 % proti -1,9 %; p < 0,001) in celi kolk (3,8 % proti 0,9 %; p < 0,005).
English: • increase in blood cholesterol levels
Slovenian: • povišanje koncentracij holesterola v krvi
English: However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/kg.
Slovenian: Vendar se je pojavila resorpcija ploda in zmanjšanje zaroda pri brejih kuncih, ki so prejemali dnevne odmerke od 3
English: Pull out black injection button until it stops.
Slovenian: Potegnite ven črni gumb za injiciranje, dokler se ne ustavi.
English: Pull off small needle protector and throw away.
Slovenian: Odstranite manjšo zaščito igle in jo zavrzite.
English: All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Slovenian: Vsem bolnikom so ponudili 1000 mg kalcija na dan in
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: and that it has not expired.
Slovenian: dokler se ne ustavi.
English: • Severe renal impairment
Slovenian: • Hudo okvarjeno delovanje ledvic
English: - The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections.
Slovenian: - Pomožne snovi so koncentrirana ocetna kislina, natrijev acetat (brezvodni), manitol, metakrezol in voda za injekcije.
English: Posology The recommended dose of FORSTEO is 20 micrograms administered once daily.
Slovenian: Odmerjanje Priporočeni odmerek zdravila FORSTEO je 20 mikrogramov enkrat dnevno.
English: The pen should be discarded 28 days after the first use.
Slovenian: Injekcijski peresnik zavrzite 28 dni po prvi uporabi.
English: Talk to your doctor or pharmacist before or while using FORSTEO:
Slovenian: Pred ali med uporabo zdravila FORSTEO se posvetujte s svojim zdravnikom ali farmacevtom:
English: Never share your FORSTEO pen with others.
Slovenian: Svojega peresnika za zdravilo FORSTEO nikoli ne delite z drugimi.
English: 1 pen of 2.4 mL solution.
Slovenian: 1 injekcijski peresnik z 2,4 ml raztopine.
English: Uncommon: Emphysema
Slovenian: Občasno: Emfizem
English: Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
Slovenian: Preberite in sledite navodilom v Navodilu za uporabo glede shranjevanja zdravila.
English: Hydrochloric acid solution and/or sodium hydroxide solution (for pH adjustment).
Slovenian: Po potrebi raztopina klorovodikove kisline in/ali raztopina natrijevega hidroksida (za uravnavanje pH).
English: 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Slovenian: 3) Odvijte iglo do konca s 3 do 5 popolnimi obrati večjega pokrova igle.
English: Store in a refrigerator (2°C - 8°C) at all times.
Slovenian: Vedno shranjujte v hladilniku (2 °C - 8 °C).
English: FORSTEO must not be used in patients with severe renal impairment (see section 4.3.).
Slovenian: Zdravila FORSTEO pri bolnikih s hudo okvarjenim delovanjem ledvic ne smemo uporabljati (glejte poglavje 4.3).
English: 2) Use the large needle cover to unscrew the needle.
Slovenian: 2) Uporabite večji pokrov igle za odvijanje igle.
English: OTHER SPECIAL WARNING(S), IF NECESSARY To open, lift here and pull.
Slovenian: Če hočete odpreti, dvignite tukaj in potegnite.
English: Nausea, vomiting, dizziness, and headache can also occur.
Slovenian: Pojavijo se lahko tudi slabost, bruhanje, omotica in glavobol.
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.
Slovenian: Povprečno povečanje BMD od 18. do 24. meseca je bilo v ledvenem delu hrbtenice 1,4 %, celem kolku 1,2 % in vratu stegnenice 1,6 %.
English: 5 How to store FORSTEO Content of the pack and other information
Slovenian: Shranjevanje zdravila FORSTEO Vsebina pakiranja in dodatne informacije
English: Uncommon: Tachycardia
Slovenian: Občasno: tahikardija
English: FORSTEO contains a clear and colourless solution.
Slovenian: Zdravilo FORSTEO vsebuje bistro in brezbarvno raztopino.
English: FORSTEO can be injected at meal times.
Slovenian: Zdravilo FORSTEO si lahko injicirate v času obrokov.
English: Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle from skin.
Slovenian: Držite ga pritisnjenega in p-o-č-a-s-i štejte do 5.
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7 %, 0.9 %, and 0.4 %, respectively.
Slovenian: Pri bolnikih zdravljenih s teriparatidom, se je BMD ledvenega dela hrbtenice od 18. do 24. meseca dodatno povečala za 1,7 %, celega kolka za 0,9 % in vratu stegnenice za 0,4 %.
English: Small needle protector
Slovenian: Manjša zaščita igle
English: 4) If you still cannot get the needle off, ask someone to help you.
Slovenian: 4) Če še vedno ne morete odstraniti igle,
English: • irregular heart beats
Slovenian: • nepravilni srčni utripi
English: Common: Hypotension
Slovenian: Pogosto: hipotenzija
English: Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Slovenian: Povprečni T-vrednosti osnovne mineralne gostote kosti hrbtenice in vratu stegnenice sta bili-2,2 in -2,1.
English: The recommended treatment time of 24 months should not be exceeded.
Slovenian: Ne smete preseči priporočenega časa zdravljenja 24 mesecev.
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.
Slovenian: Pri bolnicah, pri katerih so opravili radiografijo osnovnega stanja in radiografijo za spremljanje stanja, je bila incidenca novih zlomov vretenc 28/516 (5,4 %) v skupini z zdravilom Forsteo in 64/533 (12,0 %) pri bolnicah, zdravljenih z rizedronatom, relativno tveganje (95
English: Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Slovenian: Odvijte iglo do konca s 3 do 5 popolnimi obrati večjega pokrova igle.
English: No special caution is required for patients with mild renal impairment.
Slovenian: Pri bolnikih z blago okvarjenim delovanjem ledvic posebna previdnost ni potrebna.