FrancophonIA/ELRC3.0 huggingface dataset:
English: If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks.
Slovenian: Če občutite neugodje, kot so rdečica, bolečina, oteklina, srbenje, podplutbo ali manjše krvavitve okoli mesta injiciranja (pojavnost je pogosta), se to navadno izboljša v nekaj dneh ali tednih.
English: FORSTEO may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
Slovenian: Zdravilo FORSTEO lahko povzroči majhna povečanja izločanja kalcija s sečem, vendar se incidenca hiperkalciurije ni razlikovala od incidence pri bolnikih, ki so v kliničnih preskušanjih prejemali placebo.
English: A user manual is also available to instruct patients on the correct use of the pen.
Slovenian: Za navodila bolnikom o pravilni uporabi injekcijskega peresnika je na voljo tudi priročnik za uporabo.
English: In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.
Slovenian: Pri ženskah po menopavzi so dokazali pomembno znižanje pojavnosti vretenčnih in nevretenčnih zlomov, ne pa tudi zlomov kolka.
English: The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common).
Slovenian: Najpogostejši neželeni učinki so bolečine v okončinah (pojavnost je zelo pogosta, pojavijo se lahko pri več kot 1 od 10 bolnikov) in slabost, glavobol in omotica (pojavnost je pogosta).
English: Inject dose
Slovenian: Injicirajte odmerek
English: Common: Sweating increased
Slovenian: Pogosto: povečano znojenje
English: Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
Slovenian: Endogeni paratiroidni hormon (PTH) iz 84 aminokislin je primarni regulator presnove kalcija in fosfata v kosteh in ledvicah.
English: The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and postmarketing exposure are summarised in the table below.
Slovenian: Neželeni učinki, povezani z uporabo teriparatida pri bolnikih z osteoporozo v kliničnih preskušanjih in pri izpostavljenosti po prihodu zdravila na trg, so povzeti v spodnji preglednici.
English: Place the pen back in the refrigerator and contact your doctor or pharmacist.
Slovenian: Položite peresnik nazaj v hladilnik in se obrnite na vašega zdravnika ali farmacevta.
English: • Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the cartridge.
Slovenian: • Injekcijskega peresnika FORSTEO ne shranjujte s pritrjeno iglo, ker lahko to povzroči nastanek zračnih mehurčkov v vložku zdravila.
English: If you use more FORSTEO than you should If, by mistake, you have used more FORSTEO than you should, contact your doctor or pharmacist.
Slovenian: Če ste uporabili večji odmerek zdravila FORSTEO, kot bi smeli Če ste pomotoma uporabili višji odmerek zdravila FORSTEO, kot bi smeli, pokličite svojega zdravnika ali farmacevta.
English: Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C.
Slovenian: Pri temperaturi 2 do 8 °C so dokazali 28 dnevno kemijsko, fizikalno in mikrobiološko stabilnost med uporabo zdravila.
English: These patients should refrain from driving or the use of machines until symptoms have subsided.
Slovenian: Ti bolniki naj se, dokler simptomi ne izzvenijo, vzdržijo vožnje ali upravljanja strojev.
English: No metabolism or excretion studies have been performed with FORSTEO but the peripheral metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney.
Slovenian: Za zdravilo FORSTEO niso opravili nobenih študij presnove ali izločanja, vendar za periferno presnovo paratiroidnega hormona velja, da poteka predvsem v jetrih in ledvicah.
English: A 24-month, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 postmenopausal women with established osteoporosis.
Slovenian: 24-mesečna, randomizirana, dvojno slepa študija 4. faze, nadzorovana s primerjalnim zdravilom je vključevala 1.360 žensk po menopavzi z dokazano osteoporozo.
English: Pull off paper tab.
Slovenian: Odstranite papirni pokrov.
English: INFORMATION IN BRAILLE FORSTEO
Slovenian: PODATKI V BRAILLOVI PISAVI FORSTEO
English: Because FORSTEO transiently increases serum calcium, FORSTEO should be used with caution in patients taking digitalis.
Slovenian: Ker zdravilo FORSTEO prehodno zviša serumsko koncentracijo kalcija, ga moramo pri bolnikih, ki jemljejo digitalis, uporabljati previdno.
English: • Pre-existing hypercalcaemia
Slovenian: • Že obstoječa hiperkalciemija
English: 2) Remove the needle.
Slovenian: 2) Odstranite iglo.
English: Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenetic mechanism.
Slovenian: Podgane, ki so skoraj ves čas življenja prejemale dnevne injekcije, so imele od odmerka odvisno povečano tvorbo kosti in povečano incidenco osteosarkomov, najverjetneje zaradi epigenetskega mehanizma.
English: • Check the FORSTEO label to make sure you have the correct medicine.
Slovenian: • Preverite nalepko injekcijskega peresnika FORSTEO za zagotovitev, da imate pravo zdravilo, ki ni pretečeno.
English: • If the medicine has been frozen, throw the device away and use a new FORSTEO.
Slovenian: • Če je zdravilo zamrznilo, ga zavrzite in uporabite nov injekcijski peresnik FORSTEO.
English: Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent FORSTEO injection.
Slovenian: Če se jemlje vzorec za določanje serumske koncentracije kalcija, mora biti le-ta vzet vsaj 16 ur po zadnji injekciji zdravila FORSTEO.
English: FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Slovenian: Zdravilo FORSTEO so dajali v enkratnih odmerkih do 100 mikrogramov in v večkratnih odmerkih do 60 mikrogramov dnevno 6 tednov.
English: • Do not transfer the medicine into a syringe.
Slovenian: • Zdravila ne prenašajte v injekcijsko brizgo.
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).
Slovenian: Ženske pred menopavzo, ki imajo osteoporozo povzročeno z glukokortikoidi, se morajo obravnavati z visokim tveganjem za zlom, če imajo pogosto zlom ali kombinacijo dejavnikov tveganja, kar jih postavlja na mesto z visokim tveganjem za zlom (npr. nizka kostna gostota [npr. T vrednost ≤ −2], podaljšani visoki odmerki glukokortikoidne terapije [npr. ≥ 7,5 mg/dan za najmanj 6 mesecev], visoko osnovno delovanje bolezni, nizki nivoji spolnega steroida).
English: Relative risk (95% CI) vs. placebo
Slovenian: Relativno tveganje (95 % IZ) v primerjavi s placebom
English: The 24-month course of FORSTEO should not be repeated over a patient's lifetime.
Slovenian: 24-mesečni postopek zdravljenja ne sme biti ponovljen v času bolnikovega življenja.
English: In short-term clinical studies with FORSTEO, isolated episodes of transient orthostatic hypotension were observed.
Slovenian: V kratkotrajnih kliničnih študijah zdravila FORSTEO so opažali osamljene epizode prehodne ortostatske hipotenzije.
English: Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.
Slovenian: Fiziološko delovanje paratiroidnega hormona vključuje stimulacijo tvorbe kosti z neposrednim učinkom na celice, ki izdelujejo kostnino (osteoblaste), posredno povečanje absorpcije kalcija iz črevesa, povišanje tubulne reabsorpcije kalcija in izločanje fosfata z ledvicami.
English: What FORSTEO is and what it is used for What you need to know before you use FORSTEO How to use FORSTEO
Slovenian: Kaj je zdravilo FORSTEO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo FORSTEO Kako uporabljati zdravilo FORSTEO
English: Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare).
Slovenian: Pri nekaterih bolnikih je prišlo do alergijske reakcije kmalu po injiciranju, ki je vključevala zadihanost, zatekanje obraza, izpuščaj in bolečine v prsnem košu (pojavnost je redka).
English: Do not try to make up for a missed dose.
Slovenian: Ne poskušajte nadomestiti izpuščenega odmerka.
English: • Unexplained elevations of alkaline phosphatase
Slovenian: • Nepojasnjene povišane vrednosti alkalne fosfataze
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje.
English: FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Slovenian: Zdravilo FORSTEO so vrednotili v študijah farmakodinamičnega medsebojnega delovanja s hidroklorotiazidom.
English: Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company.
Slovenian: Izdeluje Lilly France, F-67640 Fegersheim, Francija za Eli Lilly and Company.
English: • heartburn (painful or burning sensation just below the breast bone)
Slovenian: • zgaga (boleč ali pekoč občutek tik pod prsnico)
English: The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Slovenian: Priporočeni odmerek je 20 mikrogramov, danih enkrat dnevno z injiciranjem pod kožo (subkutano injiciranje) v stegno ali trebuh.
English: C. I see an air bubble in my FORSTEO.
Slovenian: FORSTEO vidim zračni mehurček.
English: In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83 % had received previous osteoporosis therapy) were treated with FORSTEO for up to 24 months.
Slovenian: V odprti študiji so 503 ženske po menopavzi, ki so imele hudo osteoporozo in zlom zaradi krhkosti v zadnjih 3 letih (83 % jih je bilo predhodno zdravljenih za osteoporozo), do 24 mesecev dobivale zdravilo FORSTEO.
English: Red Stripe Blue Body Medicine Cartridge White Cap Paper Tab Needle
Slovenian: Rdeča črta Modro ohišje Vložek zdravila Bel pokrov Papirni pokrov Igla
English: You should take your FORSTEO injection shortly after you take the pen out of the refrigerator as described in the user manual.
Slovenian: Zdravilo FORSTEO si vbrizgajte kmalu po tem, ko vzamete injekcijski peresnik iz hladilnika, kot je opisano v Priročniku za uporabo.
English: Post-treatment management: Following treatment with FORSTEO, 1262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study.
Slovenian: Obravnava po zdravljenju: Po zdravljenju z zdravilom FORSTEO je 1262 žensk po menopavzi iz ključnega preskušanja sodelovalo v kontrolni študiji bolnikov po zdravljenju.
English: Each pen contains 2.4 mL of solution enough for 28 doses.
Slovenian: Vsak injekcijski peresnik vsebuje 2,4 ml raztopine, kar zadošča za 28 odmerkov.
English: In addition, no osteosarcomas have been observed in clinical trials or during the post treatment follow-up study.
Slovenian: Nadalje v kliničnih preskušanjih ali v času študije kontrole bolnikov po zdravljenju niso opazili nobenih osteosarkomov.
English: Screw on needle until firmly attached.
Slovenian: Privijte iglo, dokler ni čvrsto pritrjena.
English: The total duration of treatment with FORSTEO should not exceed 24 months.
Slovenian: Celotno trajanje zdravljenja z zdravilom FORSTEO ne sme biti daljše od 24 mesecev.
English: No needles are supplied with the product.
Slovenian: Izdelku niso priložene igle.
English: FORSTEO should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
Slovenian: Zdravila FORSTEO pri pediatrični populaciji (mlajših od 18 let) ali mladih odraslih z odprtimi epifizami ne smemo uporabljati.
English: • Read and follow the instructions in the Information for the Patient leaflet for using the product.
Slovenian: • Preberite in sledite navodilom v Navodilu za uporabo glede uporabe izdelka.
English: What FORSTEO contains - The active substance is teriparatide.
Slovenian: Kaj vsebuje zdravilo FORSTEO - Učinkovina je teriparatid.
English: New vertebral fracture (≥1) a
Slovenian: Nov zlom vretenc (≥ 1)a
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.
Slovenian: 2,8 % bolnikov, ki so prejemali zdravilo FORSTEO, serumske koncentracije sečne kisline nad zgornjo mejo normalnih vrednosti v primerjavi z 0,7 % bolnikov, ki so prejemali placebo.
English: Black Injection button
Slovenian: Črni gumb za injiciranje
English: Pull off white cap
Slovenian: Odstranite bel pokrov
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).
Slovenian: Učinkovitost zdravila FORSTEO pri moških in ženskah (N=428), ki so prejemali podaljšano sistemsko glukokortikoidno terapijo (kar ustreza 5 mg ali več prednizona v najmanj 3 mesecih) so dokazali v 18-mesečni začetni fazi 36-mesečne, randomizirane, dvojno slepe, s primerjavo kontrolirane študije (alendronat 10 mg/dan).
English: Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Slovenian: En odmerek 80 mikrolitrov vsebuje 20 mikrogramov teriparatida*.
English: Once the needle is removed from the skin, check to make sure the black injection button is all the way in.
Slovenian: Po zaključenem injiciranju: Ko iglo enkrat izvlečete iz kože, za zagotovitev preverite, da je črni gumb za injiciranje popolnoma noter.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o tem zdravilu so na voljo na internetni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Slovenian: En napolnjeni injekcijski peresnik z 2,4 ml vsebuje 600 mikrogramov teriparatida (kar ustreza 250 mikrogramom na ml).
English: Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
Slovenian: V vsakem pakiranju zdravila FORSTEO je priložen Priročnik za uporabo, ki v celoti opisuje uporabo injekcijskega peresnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/247/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/247/001
English: If you do and have already injected, do not inject yourself a second time on the same day.
Slovenian: Če ga in ste si že injicirali, si ne injicirajte še drugič v istem dnevu.
English: 3) Attach a new needle, pull off the large needle cover and save it.
Slovenian: 3) Pritrdite novo iglo, odstranite večji pokrov igle in ga shranite.
English: Large Needle Cover
Slovenian: Večji pokrov igle
English: FORSTEO is used to treat osteoporosis in adults.
Slovenian: Zdravilo FORSTEO uporabljamo za zdravljenje osteoporoze pri odraslih.
English: • if you have ever been diagnosed with bone cancer or other cancers that have spread
Slovenian: • če so vam kdaj potrdili kostni rak ali druge oblike raka, ki so se razširile (metastazirale) v vaše kosti.
English: • if you suffer from kidney stones or have a history of kidney stones.
Slovenian: če imate težave zaradi ledvičnih kamnov ali če ste v preteklosti imeli ledvične kamne.
English: The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm.
Slovenian: Povprečni (mediani) kumulativni odmerek glukokortikoida je bil 474,3 (66,2) mg v skupini s teriparatidom in 898,0 (100,0) mg v skupini z rizedronatom.
English: • if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Slovenian: če imate nenehno slabost s siljenjem na bruhanje, bruhanje, zaprtje, pomanjkanje energije ali mišično šibkost.
English: • Use a new needle for each injection.
Slovenian: • Za vsako injiciranje uporabite novo iglo.
English: Common: Depression
Slovenian: Pogosto: depresija
English: Lumbar spine BMD significantly increased by 3 months.
Slovenian: Mineralna gostota kosti (BMD) ledvenega dela hrbtenice se je značilno povišala po 3 mesecih.
English: The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Slovenian: Navodila o ravnanju z iglami ne morejo nadomestiti lokalnih smernic ali smernic zdravstvenega osebja oziroma ustanov.
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
Slovenian: 7,5 mg/dan in 34 % jih je imelo enega ali več radiografskih zlomov; ženske pred menopavzo so imele povprečno starost 37 let, srednjo T-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice -2,5, srednji ustrezni odmerek prednizona 10 mg/dan in 9 % jih je imelo enega ali več radiografskih zlomov; moški so imeli povprečno starost 57 let, srednjo T-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice -2,2, srednji ustrezni odmerek prednizona 10 mg/dan in 24 % jih je imelo enega ali več radiografskih zlomov.
English: In some cases, no adverse events occurred as a result of the overdose.
Slovenian: V nekaterih primerih po prevelikem odmerjanju ni bilo nobenih neželenih učinkov.
English: Your pen contains 28 days of medicine.
Slovenian: Vaš injekcijski peresnik vsebuje zdravilo za 28 dni zdravljenja.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO
English: FORSTEO has not been studied in patients with active urolithiasis.
Slovenian: Zdravila FORSTEO pri bolnikih z aktivno urolitiazo niso preučevali.
English: • Never store the FORSTEO in the freezer.
Slovenian: • Injekcijskega peresnika FORSTEO nikoli ne shranjujte v zamrzovalniku.
English: FORSTEO (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Slovenian: Zdravilo FORSTEO (rhPTH(1-34)) je aktivni fragment (1-34)
English: • If the FORSTEO has been left out of the refrigerator, do not throw the pen away.
Slovenian: • Če ste injekcijski peresnik FORSTEO pozabili zunaj hladilnika, ga ne zavrzite.
English: • Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
Slovenian: • Uporabljene igle odložite v vsebnik za ostre odpadke ali vsebnik iz trde plastike z varnim pokrovom.
English: The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.
Slovenian: Učinki prevelikega odmerjanja, ki jih lahko pričakujete vključujejo slabost, bruhanje, omotico in glavobol.
English: 2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen.
Slovenian: 2,4 ml raztopine v vložku (silikonizirano steklo tipa I) z batom (halobutilna guma), zaporno ploščico (poliizopren/bromobutil gumijasti laminat)/aluminij, sestavljenih v injekcijski peresnik za enkratno uporabo.
English: Also read the package leaflet provided.
Slovenian: Preberite tudi priloženo navodilo za uporabo.
English: Remove needle
Slovenian: Odstranit e iglo
English: Do not take more than one injection in the same day.
Slovenian: V istem dnevu si ne injicirajte več kot enkrat.
English: • Before disposing of the FORSTEO device, be sure to remove the pen needle.
Slovenian: • Pred odstranjevanjem medicinskega pripomočka FORSTEO zagotovite, da ste odstranili iglo peresnika.
English: • swelling, mainly in the hands, feet and legs.
Slovenian: • otekanje, zlasti rok, stopal in nog
English: In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.
Slovenian: Nadalje sta morda bili za uravnavanje pH dodani raztopina klorovodikove kisline in/ali raztopina natrijevega hidroksida.
English: Therefore, FORSTEO should be used with caution.
Slovenian: Pri uporabi zdravila FORSTEO je zato potrebna previdnost.
English: Results from up to 24 months (median: 19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 1).
Slovenian: (mediana: 19 mesecev) trajajočega zdravljenja z zdravilom FORSTEO kažejo statistično značilno znižanje števila zlomov (Preglednica 1).
English: What you need to know before you use FORSTEO
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo FORSTEO Ne uporabljajte zdravila FORSTEO
English: Becton, Dickinson and Company pen needles can be used.
Slovenian: Uporabljate lahko igle za peresnik družbe Becton, Dickinson and Company.
English: Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Slovenian: Po odprtju zdravila, lahko izdelek shranjujemo največ 28 dni pri temperaturi med
English: For the first doses, inject FORSTEO where you can sit or lie down right away if you get dizzy.
Slovenian: Prvih nekaj odmerkov injicirajte zdravilo FORSTEO na mestu, kjer se, če postanete omotični, lahko usedete ali takoj uležete.
English: In addition, 15 of 214 patients in the alendronate group (7.0 %) had experienced a non-vertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5 %) (p=0.84).
Slovenian: Poleg tega se je nevretenčen zlom pojavil pri 15 od 214 bolnikov v skupini z alendronatom (7,0 %) in pri 16 od 214 bolnikov v skupini zdravila FORSTEO (7,5 %) (p = 0,84).
English: FORSTEO has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo FORSTEO nima vpliva ali pa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • if you suffer from kidney problems (moderate renal impairment).
Slovenian: če imate težave z ledvicami (zmerno okvaro ledvic).
English: Method of administration FORSTEO should be administered once daily by subcutaneous injection in the thigh or abdomen.
Slovenian: Način uporabe Zdravilo FORSTEO se uporablja enkrat dnevno kot subkutana injekcija v stegno ali trebuh.
English: Of patients in the teriparatide trials, 82.8 % of the FORSTEO patients and 84.5 % of the placebo patients reported at least 1 adverse event.
Slovenian: Od bolnikov v preskušanjih teriparatida je o vsaj 1 neželenem dogodku poročalo 82,8 % bolnikov, ki so prejemali zdravilo FORSTEO, in 84,5 % bolnikov, ki so prejemali placebo.
English: The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000).
Slovenian: občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000).
English: Push the white cap back on, and place FORSTEO in the refrigerator.
Slovenian: Ponovno namestite bel pokrov in položite FORSTEO v hladilnik.
English: • if you suffer from serious kidney problems.
Slovenian: • če imate resne težave z ledvicami.