natgillin/translations-raw huggingface dataset:
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.
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.
Black Injection button
Črni gumb za injiciranje
Pull off white cap
Odstranite bel pokrov
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).
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).
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
En odmerek 80 mikrolitrov vsebuje 20 mikrogramov teriparatida*.
Once the needle is removed from the skin, check to make sure the black injection button is all the way in.
Po zaključenem injiciranju: Ko iglo enkrat izvlečete iz kože, za zagotovitev preverite, da je črni gumb za injiciranje popolnoma noter.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o tem zdravilu so na voljo na internetni strani Evropske agencije za zdravila http://www.ema.europa.eu
One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
En napolnjeni injekcijski peresnik z 2,4 ml vsebuje 600 mikrogramov teriparatida (kar ustreza 250 mikrogramom na ml).
Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
V vsakem pakiranju zdravila FORSTEO je priložen Priročnik za uporabo, ki v celoti opisuje uporabo injekcijskega peresnika.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/247/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/247/001
If you do and have already injected, do not inject yourself a second time on the same day.
Če ga in ste si že injicirali, si ne injicirajte še drugič v istem dnevu.
3) Attach a new needle, pull off the large needle cover and save it.
3) Pritrdite novo iglo, odstranite večji pokrov igle in ga shranite.
Large Needle Cover
Večji pokrov igle
FORSTEO is used to treat osteoporosis in adults.
Zdravilo FORSTEO uporabljamo za zdravljenje osteoporoze pri odraslih.
• if you have ever been diagnosed with bone cancer or other cancers that have spread
• če so vam kdaj potrdili kostni rak ali druge oblike raka, ki so se razširile (metastazirale) v vaše kosti.
• if you suffer from kidney stones or have a history of kidney stones.
če imate težave zaradi ledvičnih kamnov ali če ste v preteklosti imeli ledvične kamne.
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.
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.
• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
če imate nenehno slabost s siljenjem na bruhanje, bruhanje, zaprtje, pomanjkanje energije ali mišično šibkost.
• Use a new needle for each injection.
• Za vsako injiciranje uporabite novo iglo.
Common: Depression
Pogosto: depresija
Lumbar spine BMD significantly increased by 3 months.
Mineralna gostota kosti (BMD) ledvenega dela hrbtenice se je značilno povišala po 3 mesecih.
The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Navodila o ravnanju z iglami ne morejo nadomestiti lokalnih smernic ali smernic zdravstvenega osebja oziroma ustanov.
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
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.
In some cases, no adverse events occurred as a result of the overdose.
V nekaterih primerih po prevelikem odmerjanju ni bilo nobenih neželenih učinkov.
Your pen contains 28 days of medicine.
Vaš injekcijski peresnik vsebuje zdravilo za 28 dni zdravljenja.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO
FORSTEO has not been studied in patients with active urolithiasis.
Zdravila FORSTEO pri bolnikih z aktivno urolitiazo niso preučevali.
• Never store the FORSTEO in the freezer.
• Injekcijskega peresnika FORSTEO nikoli ne shranjujte v zamrzovalniku.
FORSTEO (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Zdravilo FORSTEO (rhPTH(1-34)) je aktivni fragment (1-34)
• If the FORSTEO has been left out of the refrigerator, do not throw the pen away.
• Če ste injekcijski peresnik FORSTEO pozabili zunaj hladilnika, ga ne zavrzite.
• 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.
• Uporabljene igle odložite v vsebnik za ostre odpadke ali vsebnik iz trde plastike z varnim pokrovom.
The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.
Učinki prevelikega odmerjanja, ki jih lahko pričakujete vključujejo slabost, bruhanje, omotico in glavobol.
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.
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.
Also read the package leaflet provided.
Preberite tudi priloženo navodilo za uporabo.
Remove needle
Odstranit e iglo
Do not take more than one injection in the same day.
V istem dnevu si ne injicirajte več kot enkrat.
• Before disposing of the FORSTEO device, be sure to remove the pen needle.
• Pred odstranjevanjem medicinskega pripomočka FORSTEO zagotovite, da ste odstranili iglo peresnika.
• swelling, mainly in the hands, feet and legs.
• otekanje, zlasti rok, stopal in nog
In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.
Nadalje sta morda bili za uravnavanje pH dodani raztopina klorovodikove kisline in/ali raztopina natrijevega hidroksida.
Therefore, FORSTEO should be used with caution.
Pri uporabi zdravila FORSTEO je zato potrebna previdnost.
Results from up to 24 months (median: 19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 1).
(mediana: 19 mesecev) trajajočega zdravljenja z zdravilom FORSTEO kažejo statistično značilno znižanje števila zlomov (Preglednica 1).
What you need to know before you use FORSTEO
Kaj morate vedeti, preden boste uporabili zdravilo FORSTEO Ne uporabljajte zdravila FORSTEO
Becton, Dickinson and Company pen needles can be used.
Uporabljate lahko igle za peresnik družbe Becton, Dickinson and Company.
Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Po odprtju zdravila, lahko izdelek shranjujemo največ 28 dni pri temperaturi med
For the first doses, inject FORSTEO where you can sit or lie down right away if you get dizzy.
Prvih nekaj odmerkov injicirajte zdravilo FORSTEO na mestu, kjer se, če postanete omotični, lahko usedete ali takoj uležete.
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).
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).
FORSTEO has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo FORSTEO nima vpliva ali pa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• if you suffer from kidney problems (moderate renal impairment).
če imate težave z ledvicami (zmerno okvaro ledvic).
Method of administration FORSTEO should be administered once daily by subcutaneous injection in the thigh or abdomen.
Način uporabe Zdravilo FORSTEO se uporablja enkrat dnevno kot subkutana injekcija v stegno ali trebuh.
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.
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.
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).
občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000).
Push the white cap back on, and place FORSTEO in the refrigerator.
Ponovno namestite bel pokrov in položite FORSTEO v hladilnik.
• if you suffer from serious kidney problems.
• če imate resne težave z ledvicami.
FORSTEO increases serum uric acid concentrations.
Zdravilo FORSTEO zvišuje serumske koncentracije sečne kisline.
You should not receive more than one treatment course of 24 months over your lifetime.
V času vašega življenja ne smete prejeti več kot en postopek zdravljenja, ki traja 24 mesecev.
Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Po ukinitvi zdravljenja z zdravilom FORSTEO lahko bolniki naprej prejemajo druga zdravila za osteoporozo.
Gently hold a fold of skin from thigh or abdomen and insert needle straight into skin.
Nežno primite kožno gubo stegna ali trebuha in vbodite iglo naravnost v kožo.
Common: Palpitations
Pogosto: palpitacije
Pull off large needle cover and save it.
Odstranite večji pokrov igle in ga shranite.
MARKETING AUTHORISATION NUMBERS EU/1/03/247/001-002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/247/001-002
No bone tumours were observed in ovariectomised monkeys treated for 18 months or during a 3-year follow-up period after treatment cessation.
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.
Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, France
Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, Francija
What FORSTEO looks like and contents of the pack FORSTEO is a colourless and clear solution.
Izgled zdravila FORSTEO in vsebina pakiranja Zdravilo FORSTEO je brezbarvna in bistra raztopina.
• pain in the muscles and pain in the joints.
• ledvični kamni • bolečina v mišicah in bolečina v sklepih.
The device can be used with insulin pen injection needles.
Napravo lahko uporabljamo z injekcijskimi iglami za insulinske injekcijske peresnike.
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).
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).
How to use FORSTEO
Kako uporabljati zdravilo FORSTEO
*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.
*Teriparatid, rhPTH(1-34), izdelan v E. coli z uporabo tehnologije rekombinantne DNA, je istoveten
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).
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).
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women receiving FORSTEO.
V velikem kliničnem preskušanju so pri 2,8 % žensk, ki so prejemale zdravilo FORSTEO, zaznali protitelesa, ki so navzkrižno reagirala s teriparatidom.
If you forget or cannot take FORSTEO at your usual time, take it as soon as possible on that day.
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.
Each pen contains 28 doses of 20 micrograms (per 80 microliters).
En injekcijski peresnik vsebuje 28 odmerkov po 20 mikrogramov (na 80 mikrolitrov).
In patients with moderate renal impairment, FORSTEO should be used with caution.
Pri bolnikih z zmerno okvarjenim delovanjem ledvic moramo zdravilo FORSTEO uporabljati previdno.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Zdravljenje osteoporoze povezane s podaljšanim sistemskim glukokortikoidnim zdravljenjem pri ženskah in moških s povečanim tveganjem za zlom (glejte poglavje 5.1).
No data are available in patients with impaired hepatic function (see section 5.3).
Za bolnike z okvarjenim delovanjem jeter ni na voljo podatkov (glejte poglavje 5.3).
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.
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.
• The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
• Navodila za rokovanje z iglo niso namenjena nadomestitvi načina ravnanja v skladu z lokalnimi navodili ali navodili zdravstvenega delavca oziroma ustanove.
Rare: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri največ 1 od 1000 bolnikov:
Common: Dizziness, headache, sciatica, syncope
Pogosto: omotica, glavobol, išias, sinkopa
In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection.
Pri normokalcemičnih bolnikih so po injiciranju teriparatida opažali rahla in prehodna povišanja serumskih koncentracij kalcija.
• neuralgic pain in the leg
• nevralgične bolečine v nogah
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).
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).
Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Ne uporabljajte zdravila FORSTEO, če opazite trdne delce v raztopini ali je raztopina videti motna ali obarvana.
Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
Vsak mililiter raztopine za injiciranje vsebuje 250 mikrogramov teriparatida.
Transient events reported have included nausea, weakness/lethargy and hypotension.
Poročali so o naslednjih prehodnih učinkih: slabost, oslabelost/letargija in hipotenzija.
FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Izločanje Zdravilo FORSTEO se izloča z jetrnim in zunaj-jetrnim očistkom (približno 62 l/h pri ženskah in
Uncommon: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis Rare: Renal failure/impairment
Občasno: Inkontinenca urina, poliurija, pogosto siljenje na vodo, nefrolitiaza Redko:Odpoved/okvara ledvic
Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3).
Študije pri podganah so pokazale povečano incidenco osteosarkoma po dolgotrajnem dajanju teriparatida (glejte poglavje 5.3).
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.
Dajanje zdravila FORSTEO enkrat dnevno poveča apozicijo nove kostnine na trabekularne in kortikalne površine kosti s prednostno stimulacijo osteoblastnega delovanja proti osteoklastnimu delovanju.
FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
Zdravila FORSTEO ne smete uporabiti, če je raztopina motna, obarvana ali vsebuje trdne delce.
Women of childbearing potential / Contraception in females Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Ženske, ki bi lahko zanosile/Kontracepcija za ženske Ženske, ki bi lahko zanosile morajo med uporabo zdravila FORSTEO uporabljati učinkovito metodo kontracepcije.
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.
2 predhodna zloma vretenc; 57,9 % bolnic je že prejelo zdravljenje z bisfosfonati, 18,8 % pa jih je med študijo sočasno jemalo glukokortikoide.
After each injection, the FORSTEO pen should be returned to the refrigerator.
Po vsakem injiciranju morate injekcijski peresnik FORSTEO shraniti nazaj v hladilnik.
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.
Varnost in učinkovitost zdravila FORSTEO pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).
Zdravljenje osteoporoze pri ženskah po menopavzi in moških s povečanim tveganjem za zlom (glejte poglavje 5.1).
Change to a new FORSTEO to take your dose as directed by your doctor or pharmacist.
Zamenjajte za nov FORSTEO, da dobite vaš odmerek, kot vam je predpisal vaš zdravnik ali farmacevt.
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).
Zdravilo FORSTEO lahko uporabljate do 28 dni po prvem injiciranju, če je injekcijski peresnik shranjen pri temperaturi med
Ask your pharmacist how to throw away medicines you no longer use These measures will help to protect the environment.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
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.
bp ≤ 0,001 v primerjavi s placebom cPomembnega zmanjšanja incidence zlomov kolka niso dokazali.
Common: Anaemia
Pogosto: anemija
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.
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.
• increase in an enzyme called alkaline phosphatase.
• povišanje encima, imenovanega alkalna fosfataza
Male osteoporosis
Pomenopavzalna osteoporoza
Do not store the injection device with the needle attached.
Injekcijske naprave ne shranjujte s pritrjeno iglo.
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).
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).
It produced no teratogenic effects in rats, mice or rabbits.
Pri podganah, miših ali kuncih ni povzročil nobenih teratogenih učinkov.
Never store your pen with the needle attached.
Nikoli ne shranjujte vašega injekcijskega peresnika s pritrjeno iglo.
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.
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
If you are a woman of child-bearing potential, you should use effective methods of contraception during use of FORSTEO.
Če ste ženska, ki bi lahko zanosila, morate med uporabo zdravila FORSTEO uporabljati učinkovito metodo kontracepcije.
FORSTEO is available in pack sizes of 1 or 3 pens.
Zdravilo FORSTEO je na voljo v pakiranjih po 1 ali 3 injekcijske peresnike.
Manufacturer Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France.
Izdelovalec Lilly France S.A.S., Rue du Colonel Lilly, F-67640 Fegersheim, Francija
Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy.
12 mesecih zdravljenja, po ukinitvi zdravljenja pa se je koncentracija protiteles ponovno zmanjšala.
Common: Nausea, vomiting, hiatus hernia, gastroesophageal reflux disease Uncommon: Haemorrhoids
Pogosto: navzea, bruhanje, hiatalna hernija, gastroezofagealna refluksna bolezen Občasno: hemoroidi
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.
Sočasno dajanje zdravila FORSTEO in raloksifena ali hormonske nadomestne terapije z zdravilom FORSTEO ni spremenilo učinkov zdravila FORSTEO na serumske koncentracije kalcija,
Prepare the injection site as directed by your doctor or pharmacist.
Pripravite mesto injiciranja v skladu z navodili vašega zdravnika ali farmacevta.
• 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).
• če imate nepojasnjene visoke ravni alkalne fosfataze v krvi, kar pomeni, da imate morda
Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, water for injections.
Koncentrirana ocetna kislina, natrijev acetat (brezvodni), manitol, metakrezol, voda za injekcije.
Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)
Večji nevretenčni zlomi zaradi krhkostic (kolk, koželjnica, nadlahtnica, rebra in medenica)
Pregnancy FORSTEO is contraindicated for use during pregnancy (see section 4.3).
Zdravilo FORSTEO je med nosečnostjo kontraindicirano (glejte poglavje 4.3).