FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 2,532 randomised intention-to-treat (ITT) patients, a total of 59 patients experienced at least one new vertebral fracture, placebo: 42 (3.37%) - Preotact: 17 (1.32%), p=0.001.
Slovenian: Od 2532 randomiziranih, vključenih bolnic (ITT - " intention-to-treat") je pri približno 59 bolnicah prišlo do najmanj enega novega vretenčnega zloma, in sicer pri 42 (3,37%) v skupini bolnic, ki so prejemale placebo, in pri 17 (1,32%) v skupini bolnic, ki so prejemale zdravilo Preotact; p=0,001.
English: • Point the needle end straight up
Slovenian: • Usmerite konec z iglo naravnost navzgor.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, mutagenosti, vpliva na plodnost in splošno sposobnost razmnoževanja in lokalne tolerance ne kažejo posebnega tveganja za človeka.
English: For all subjects who received parathyroid hormone 100 micrograms blood uric acid increase was reported for 8 subjects (0.6%) and hyperuricemia was reported for 5 subjects (0.4%).
Slovenian: Od vseh bolnic, ki so prejemale 100 µg obščitničnega hormona, so zvišanje ravni sečne kisline v krvi odkrili pri 8 bolnicah (0,6%), hiperurikemijo pa pri 5 bolnicah (0,4%).
English: It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3 and 4.4).
Slovenian: V kliničnem programu je bila obravnavana z laboratorijskim spremljanjem ravni in predhodno določenim algoritmom obravnave (glejte poglavja 4.3 in 4.4).
English: • Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
Slovenian: • Zdravilo Preotact si injicirajte kmalu potem, ko napolnjen injekcijski peresnik vzamete iz hladilnika.
English: • if you suffer from high calcium levels in your blood or other disturbances in the calcium
Slovenian: • če imate visoke ravni kalcija v krvi ali druge motnje fosfokalcijeve presnove;
English: • irritation of the skin at the injection site,
Slovenian: • draženje kože na mestu injiciranja,
English: • Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
Slovenian: • Po vsaki dnevni injekciji odstranite iglo in položite napolnjen injekcijski peresnik v hladilnik na temperaturo od 2 °C - 8 °C.
English: Patients with pre-existing hypercalciuria
Slovenian: Bolnice s predhodno obstoječo hiperkalciurijo
English: Put the cap back on the pre-filled pen and place it in the refrigerator.
Slovenian: Nataknite pokrov nazaj na napolnjen injekcijski peresnik in ga položite v hladilnik.
English: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Slovenian: Rezultati raziskav na podganah kažejo povečano pojavnost osteosarkoma pri dolgotrajnem zdravljenju z zdravilom Preotact (glejte poglavje 5.3).
English: For the mean change in hip BMD, there was a 4.5% increase from baseline with one year of alendronate compared to a 0.1% decrease after one year of placebo.
Slovenian: Povprečna sprememba BMD kolka je bila v primerjavi z izhodiščem 4,5% po enem letu prejemanja alendronata in 0,1% po enem letu prejemanja placeba.
English: • The priming should be done every time you mix a new pre-filled pen.
Slovenian: • To je treba napraviti ob vsakem mešanju novega napolnjenega injekcijskega peresnika.
English: Important information when using Preotact
Slovenian: Pomembni podatki o uporabi zdravila Preotact
English: Based on two placebo-controlled studies involving 2642 postmenopausal osteoporotic women, hypercalcemia was reported in 25.3% of patients treated with Preotact compared to 4.3% of placebotreated patients.
Slovenian: V dveh, s placebom nadzorovanih študijah, v katere je bilo vključenih 2642 pomenopavznih žensk z osteoporozo so hiperkalciemijo odkrili pri 25,3% bolnic, ki so prejemale zdravilo Preotact, in pri 4,3%
English: At the end of year 2 (12 months after Preotact was discontinued), there was a 12.1% mean increase in dual energy X-ray absorptiometry (DXA) spine BMD for patients who received alendronate for the second year.
Slovenian: Ob koncu drugega leta (12 mesecev po prekinitvi dajanja zdravila Preotact) je bilo pri bolnicah, ki so drugo leto prejemale alendronat, povprečno povečanje BMD hrbtenice 12%, izmerjeno z dvoenergijsko rentgensko absorpciometrijo (DXA - "dual energy X-ray absorptiometry").
English: Before mixing
Slovenian: Pred mešanjem:
English: Treatment with Preotact reduced volumetric cortical bone BMD (measured at the distal radius and mid-shaft tibia), while periosteal circumference or indices of cortical bone strength were maintained.
Slovenian: Zdravljenje z zdravilom Preotact je zmanjšalo volumetrični kortikalni BMD (izmerjen na distalnem delu koželjnice in na sredini diafize golenice), obseg periosta in indeksi kostne moči pa so se ohranili.
English: • if you suffer from severe kidney problems;
Slovenian: • če imate hude težave z ledvicami;
English: The overall exposure and Cmax of parathyroid hormone were slightly increased (22% and 56%, respectively) in a group of 8 male and 8 female subjects with mild-to-moderate renal impairment (creatinine clearances of 30 to 80 ml/min) compared with a matched group of 16 subjects with normal renal function.
Slovenian: Celokupna izpostavitev obščitničnemu hormonu in Cmax obščitničnega hormona sta bila v skupini 8 moških in 8 žensk z blago do zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/min) rahlo zvišana (celokupna izpostavitev za 22% in Cmax za 56%) v primerjavi z ujemajočo se skupino 16 preiskovancev z normalno ledvično funkcijo.
English: Subcutaneous administration of 100 micrograms of parathyroid hormone into the abdomen produces a rapid increase in plasma parathyroid hormone levels and achieves a peak at 1 to 2 hours after dosing.
Slovenian: Podkožno dajanje 100 µg obščitničnega hormona v trebuh povzroči hitro zvišanje plazemskih ravni obščitničnega hormona tako, da dosežejo najvišjo koncentracijo 1 do 2 uri po odmerjanju.
English: Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
Slovenian: 5 let in ki so bile stare 45-54 let (2-3%).
English: Citric acid monohydrate Sodium chloride
Slovenian: Citronska kislina monohidrat Natrijev klorid
English: Hypercalcemia
Slovenian: Hiperkalciemija
English: Management of elevated serum calcium
Slovenian: Obravnavanje zvišanih serumskih ravni kalcija
English: The only other very commonly reported ADR was nausea.
Slovenian: Drugi zelo pogosto navajan neželeni učinek je bil slabost.
English: During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Slovenian: V 28dnevnem časovnem obdobju se lahko pripravljena raztopina shranjuje do 7 dni pri temperaturi do 25 °C.
English: Preotact in combination with hormone replacement therapy (HRT) in 180 postmenopausal women has been shown to significantly increase lumbar spine BMD at 12 months compared with HRT alone (7.1 % vs. 1.1%, p<0.001).
Slovenian: Pri 180 ženskah po menopavzi so dokazali, da zdravilo Preotact v kombinaciji s hormonskim nadomestnim zdravljenjem v 12 mesecih statistično značilno poveča BMD ledvenega predela hrbtenice v primerjavi s samim hormonskim nadomestnim zdravljenjem (7,1% proti 1,1%, p<0,001).
English: In a large phase III clinical study, antibodies to parathyroid hormone were detected in 3% of women receiving Preotact compared to 0.2% of women receiving placebo.
Slovenian: Protitelesa proti obščitničnemu hormonu V veliki klinični študiji faze III so zaznali protitelesa proti obščitničnemu hormonu pri 3% žensk, ki so prejemale zdravilo Preotact, in pri 0,2% žensk, ki so prejemale placebo.
English: • Store in a refrigerator (2-8°C).
Slovenian: • Shranjujte v hladilniku (2 °C -8 °C).
English: Preotact increases serum uric acid concentrations.
Slovenian: Zdravilo Preotact zviša serumske koncentracije sečne kisline.
English: Gender The medicinal product has only been studied in postmenopausal women.
Slovenian: Zdravilo je bilo preučeno le pri ženskah po menopavzi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (2 napolnjena injekcijska peresnika)
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje.
English: You can choose to continue and take your daily injection now or store the pre-filled pen in the refrigerator, as described under ‘Practical information', at the end of the Instructions for use.
Slovenian: Lahko nadaljujete in si takoj vbrizgate dnevno injekcijo ali pa shranite napolnjen injekcijski peresnik v hladilniku, kot je opisano v poglavju
English: • sodium hydroxide.
Slovenian: • natrijev hidroksid.
English: Preotact is contraindicated in patients
Slovenian: 4.3 Kontraindikacije Zdravilo Preotact je kontraindicirano pri bolnicah
English: Preotact has not been studied in patients with active urolithiasis.
Slovenian: Uporaba zdravila Preotact ni bila raziskana pri bolnicah z aktivno urolitiazo.
English: Although gout, arthralgia and nephrolithiasis were reported as ADRs, the relationship to elevations in uric acid due to Preotact administration has not been fully established.
Slovenian: Kot neželeni učinki so bili navedeni tudi protin, artralgija in nefrolitiaza, vendar povezava z zvišanjem ravni sečne kisline zaradi uporabe zdravila Preotact ni popolnoma dokazana.
English: Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Slovenian: Zdravilo Preotact se uporablja za zdravljenje osteoporoze pri ženskah po menopavzi s povečanim tveganjem za zlome.
English: Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
Slovenian: Bolnice, ki so prejemale zdravilo Preotact, so imele po 18 mesecih za 61% manjše relativno tveganje novega vretenčnega zloma v primerjavi z bolnicami, ki so prejemale placebo.
English: • You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
Slovenian: • Pripravljeno zdravilo v napolnjenem injekcijskem peresniku je uporabno največ 28 dni, če ga shranjujete v hladilniku.
English: • mannitol,
Slovenian: • manitol
English: • Screw the needle off.
Slovenian: • Odvijte iglo.
English: In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
Slovenian: V drugem letu študije so ženske, ki so prvotno prejemale zdravilo Preotact, naključno razporedili v skupini, ki sta prejemali bodisi alendronat bodisi placebo,
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Slovenian: Po pripravi en odmerek z 71,4 mikrolitri vsebuje 100 mikrogramov obščitničnega hormona.
English: The pre-filled pen before mixing:
Slovenian: Napolnjen injekcijski peresnik pred mešanjem:
English: Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Slovenian: Pri bolnicah, katerih serumske ravni kalcija so po 6 mesecih v normalnem območju, spremljanje po 6. mesecu ni priporočljivo.
English: Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium.
Slovenian: Pri bolnicah, pri katerih uvedemo zdravljenje z zdravilom Preotact, moramo spremljati morebitne zvišane ravni kalcija v serumu in/ali urinu v 1., 3. in 6. mesecu.
English: • if you shall have or previously have had radiation therapy to the skeleton;
Slovenian: • če se boste ali ste se kdaj zdravili z obsevanjem okostja;
English: What Preotact looks like and contents of the pack
Slovenian: Izgled zdravila Preotact in vsebina pakiranja
English: Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Slovenian: Po zdravljenju z zdravilom Preotact lahko bolnice zdravimo z difosfonatom, da še povečamo mineralno gostoto kosti (glejte poglavje 5.1).
English: This includes any possible side effects not listed in this leaflet..
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
English: Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
Slovenian: Klorovodikova kislina, razredčena (za uravnavanje pH)
English: • nausea.
Slovenian: • slabost.
English: • decreased muscle strength, muscle cramps, dizziness,
Slovenian: • zmanjšana mišična moč, mišični krči, omotica,
English: When you are not using it, put the pre-filled pen back into the refrigerator.
Slovenian: Ko napolnjenega injekcijskega persnika ne uporabljate, ga shranite v hladilniku.
English: • have a high level of calcium in your urine;
Slovenian: • imate visoko raven kalcija v urinu,
English: After mixing
Slovenian: Po mešanju:
English: Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Slovenian: Zato zdravila Preotact ne smemo uporabljati pri bolnicah s hudo okvaro ledvic (glejte poglavje 4.3).
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Slovenian: ZDRAVILA Navedba smiselno ni potrebna.
English: In the Preotact clinical program, accidental overdose has been reported.
Slovenian: V kliničnem programu zdravila Preotact so poročali o nenamernem prevelikem odmerjanju.
English: From the knowledge of the mechanism of action, combined use of Preotact and cardiac glucosides may predispose patients to digitalis toxicity if hypercalcemia develops (see section 4.4).
Slovenian: Na podlagi poznavanja mehanizma delovanja lahko sklepamo, da kombinacija zdravila Preotact in srčnih glukozidov lahko vpliva na predispozicijo za toksičnost digitalisa, če se pojavi hiperkalciemija
English: - If you have any further questions, ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Slovenian: Podobno se je volumetrični trabekularni BMD celotnega kolka povečal za 9% v prvi omenjeni skupini, za 6% v drugi omenjeni skupini in za 2% v zadnji omenjeni skupini.
English: The content of the cartridge is reconstituted in the pen.
Slovenian: Vsebina vložka se pripravi v peresniku.
English: Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
Slovenian: predstavlja le 5-30% krožečih oblik molekule, 70-95% ostalih oblik pa so fragmenti s karboksi-koncem.
English: • Put the outer needle cover on.
Slovenian: • Nataknite zunanji pokrovček igle.
English: Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Slovenian: Obščitnični hormon se presnovi v jetrih, v manjšem obsegu tudi v ledvicah.
English: Do not shake the pre-filled pen
Slovenian: Ne pretresajte napolnjenega injekcijskega peresnika
English: Press the blue injection button until it is fully depressed -then count slowly to 10 and remove the needle from your skin.
Slovenian: Pritisnite na modri injekcijski gumb do konca, da se zaskoči - potem počasi štejte do
English: No studies have been conducted in patients with severe hepatic impairment.
Slovenian: Študij pri bolnikih s hudo okvaro jeter niso opravili.
English: Common (may affect up to 1 in 10 people):
Slovenian: Občasni (lahko se pojavijo pri 1 od 10 bolnikov):
English: • You can store the unmixed pre-filled pen at temperatures between 2-25°C.
Slovenian: • Napolnjen injekcijski peresnik z nezmešanim zdravilom lahko shranjujete pri temperaturah od 2 °C25 °C.
English: • Press the yellow release button to release the blue injection button.
Slovenian: • Pritisnite na rumeni sprožilni gumb, da s tem sprostite modri injekcijski gumb.
English: The other ingredients are: The powder contains:
Slovenian: -Druge sestavine zdravila (pomožne snovi) so:
English: Your doctor will perform blood and/or urine tests to measure the level of calcium in your blood and/or urine at month 1, 3 and 6 after starting your treatment with Preotact.
Slovenian: Vaš zdravnik bo po enem mesecu, treh in šestih mesecih od začetka zdravljenja z zdravilom Preotact opravili preiskave krvi in/ali urina za merjenje ravni kalcija v krvi in/ali urinu.
English: Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Preotact je indicirano za zdravljenje osteoporoze pri ženskah po menopavzi, ki imajo povečano tveganje za zlome (glejte poglavje 5.1).
English: A total of 2532 patients (1286 Preotact and 1246 placebo), aged 45-94 years (8.1% 45-54 years and 11.4% > 75 years), were randomised to receive 100 micrograms/day or placebo with daily calcium (700 mg) and vitamin D (400 IU) supplementation.
Slovenian: 45 do 94 let (8,1% starih od 45 do 54 let in 11,4% starejših od 75 let), je bilo naključno razporejenih v skupino, ki je prejemala 100 µg/dan, ali v skupino, ki je prejemala placebo.
English: Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Slovenian: Objemna zaporka (ki vsebuje zamašek iz gume): aluminij.
English: • metacresol ,
Slovenian: • metakrezol
English: Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House 1 Grand Canal Street Upper Dublin 4
Slovenian: Imetnik dovoljenja za promet z zdravilom NPS Pharma Holdings Limited Grand Canal House
English: • if you suffer from severe liver disease;
Slovenian: • če imate hude težave z jetri.
English: Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Slovenian: 60-90 % krožečih oblik molekule.
English: • Never store your pre-filled pen with the needle attached.
Slovenian: • Napolnjenega injekcijskega peresnika nikoli ne shranjujte z nameščeno iglo.
English: • Screw the pre-filled pen together until the clear front part and the pen body meet.
Slovenian: • Privijte napolnjen injekcijski peresnik do konca, dokler se prozorni sprednji del ne spoji s telesom peresnika.
English: • Put the pre-filled pen back into the refrigerator immediately after you have used it.
Slovenian: • Napolnjen injekcijski peresnik po uporabi nemudoma znova shranite v hladilniku.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Slovenian: Pri bolnicah z blago do zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/min) ni treba prilagajati odmerka.
English: • Keep Preotact protected from light
Slovenian: • Zdravilo Preotact shranjujte zaščiteno pred svetlobo.
English: Keep this medicine out of sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: • citric acid monohydrate,
Slovenian: • citronsko kislino monohidrat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje obščitnični hormon subkutana uporaba
English: The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Slovenian: Fragmenti, ki izhajajo iz karboksi-konca, pa se sproščajo nazaj v kri in se očistijo v ledvicah.
English: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Slovenian: Če bolnice s prehrano ne zaužijejo zadosti kalcija in vitamina D, morajo prejemati dodatke teh snovi.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: In response to subcutaneous doses of Preotact (100 micrograms parathyroid hormone), serum total calcium levels increase gradually and reach peak concentration (mean increase in 129 patients, 0.15 mmol/l) at approximately 6 to 8 hours after dosing.
Slovenian: Kot odziv na podkožno injicirane odmerke zdravila Preotact (100 µg obščitničnega hormona), se postopno višajo serumske koncentracije celokupnega kalcija in dosežejo najvišjo koncentracijo (povprečno zvišanje pri 129
English: Infections and infestations Uncommon
Slovenian: Infekcijske in parazitske bolezni
English: Pre-filled pen (before reconstitution): Do not store above 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Napolnjen injekcijski peresnik (pred pripravo): Shranjujte pri temperaturi do 25 °C.
English: Press the yellow release button to release the blue injection button.
Slovenian: Pritisnite rumeni sprožilni gumb, s čimer sprostite modri injekcijski gumb.
English: The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent.
Slovenian: Prva komora vsebuje 1,61 mg obščitničničnega hormona v obliki praška in druga komora vsebuje1,13 ml vehikla.
English: • with unexplained elevations of bone-specific alkaline phosphatase
Slovenian: • z zvišanimi ravnmi za kosti značilne alkalne fosfataze brez ugotovljenega vzroka
English: The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
Slovenian: V spodnji preglednici je pregled neželenih učinkov, kjer je bila pojavnost v skupini bolnic, ki so prejemale obščitnični hormon za 0,5% višja kot v skupini bolnic, ki so prejemale placebo.
English: • increased level of alkaline phosphatase in the blood ,
Slovenian: • zvišana raven alkalne fosfataze v krvi,
English: Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na napolnjenem injekcijskem peresniku in na škatlici poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: • hydrochloric acid,
Slovenian: • klorovodikovo kislino
English: Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
Slovenian: Šlo je za dveletno, randomizirano, s placebom nadzorovano, multicentrično, dvojno slepo preskušanje zdravila Preotact in alendronata za zdravljenje pomenopavzne osteoporoze v monoterapiji ali v kombinaciji.
English: Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Slovenian: Držite prozorni sprednji del napolnjenega injekcijskega peresnika in do konca privijte iglo na prozorni sprednji del napolnjenega injkecijskega peresnika.
English: • Release residual air (prime the pen)
Slovenian: • Sprostite odvečen zrak (pripravite peresnik)
English: There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Slovenian: V študiji pri 6 moških in 6 ženskah z zmerno okvaro jeter so odkrili manjše (približno 20%) zvišanje za povprečno osnovnico popravljene izpostavitve (AUC) obščitničnemu hormonu v primerjavi z ujemajočo se skupino 12 preiskovancev z normalno jetrno funkcijo.