FrancophonIA/ELRC3.0 huggingface dataset:
English: Before it is used for the first time, the medicine in the Preotact pre-filled pen has to be mixed (please refer to the “Instructions for use”).
Croatian: Prije prve primjene Preotacta, lijek u napunjenim brizgalicama treba izmiješati (molimo pogledajte u „Uputama za uporabu“).
English: • Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
Croatian: • Uklonite iglu nakon svakodnevne injekcije i vratite napunjenu brizgalicu u hladnjak na temperaturu od 2 - 8oC.
English: • Take your daily dose or store the pre-filled pen
Croatian: • Primijenite svoju dnevnu dozu ili spremite napunjenu brizgalicu
English: Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
Croatian: Hiperkalciemija i/ili hiperkalciurija odraz su farmakodinamičke aktivnost paratireoidnog hormona u gastrointestinalnom traktu, bubrezima i kostima.
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.
Croatian: Od 2532 randomizirane bolesnice s namjerom liječenja (ITT), njih ukupno 59 imalo je najmanje jedan novi prijelom kralješka, placebo: 42 (3,3%) - Preotact: 17 (1,32%), p=0,001.
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralization at exposure levels below clinical exposure levels.
Croatian: U majmuna koji su primali dnevnu supkutanu dozu tijekom 6 mjeseci, bila je povećana pojavnost bubrežne tubularne mineralizacije kod izloženosti razinama nižim od onih u kliničkim ispitivanjima.
English: Animal studies of reproductive toxicity are incomplete (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna za konačni zaključak o reproduktivnoj toksičnosti (vidjeti dio 5.3).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24.04.2006
Croatian: Datum prvog odobrenja: 24.04.2006.
English: Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Croatian: Preotact sadrži rekombinantni humani paratireoidni hormon koji je istovrstan prirodnom polipeptidu pune dužine od 84 aminokiseline.
English: • if you suffer from severe liver disease;
Croatian: • ako patite od teške bolesti jetre;
English: The pre-filled pen after mixing:
Croatian: Napunjena brizgalica nakon miješanja:
English: After you do this, the Preotact pre-filled pen is ready for use and the medicine is ready to be injected into the abdomen (under the skin).
Croatian: Nakon što ste to napravili, Preotact napunjena brizgalica je spremna za korištenje, a lijek za injiciranje u trbuh (pod kožu).
English: The pen can be used with standard injection pen needles.
Croatian: Brizgalica se koristi sa standardnim iglama za brizgalice.
English: • stomach upset, vomiting,
Croatian: • nelagoda u želucu, povraćanje,
English: Parathyroid hormone is a natural peptide that is not metabolised by, and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g. cytochrome P450 isoenzymes).
Croatian: Paratireoidni hormon je prirodni peptid koji se ne metabolizira mikrosomalnim enzimima preko kojih se metaboliziraju lijekova u jetri, niti ih inhibira (npr. citokrom P450 izoenzime).
English: Infections and infestations Uncommon
Croatian: Infekcije i infestacije
English: Metacresol Water for injections
Croatian: Otapalo metakrezol voda za injekcije
English: When you are not using it, put the pre-filled pen back into the refrigerator.
Croatian: Kada ga ne koristite, čuvajte napunjenu brizgalicu u hladnjaku.
English: • Do not use this medicine for more than 28 days after it has been mixed.
Croatian: • Ne koristite ovaj lijek ako je prošlo više od 28 dana nakon što je pripremljen.
English: The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
Croatian: Učinak paratireoidnog hormona na koštani sustav ovisi o obrascu sistemske izloženosti.
English: The occurrence of osteosarcoma only occurred at doses that produced systemic exposures > 27-times higher than that observed in humans at the 100 micrograms dose.
Croatian: Učestalost osteosarkoma primijećena je kod doza koje dovode do sistemske izloženosti 27 ili više puta veće od one zabilježene kod ljudi pri primjeni doze od 100 mikrograma.
English: What you need to know before you use Preotact
Croatian: Što morate znati prije nego počnete primjenjivati Preotact
English: The hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.
Croatian: Hiperkalciemija je bila prolazna i najčešće je zabilježena tijekom prva tri mjeseca liječenja.
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.
Croatian: Fragmeni nastali od amino-kraja se dalje razgrađuju unutar stanice dok se fragmenti nastali sa karboksilnog kraja oslobađaju natrag u krv i izlučuju bubrezima.
English: Systemic clearance of parathyroid hormone (45.3 l/hour) following an intravenous dose is close to normal liver plasma flow and is consistent with extensive hepatic metabolism of the active substance.
Croatian: Sistemski klirens paratireoidnog hormona (45,3 l/sat) nakon intravenske primjene blizu je normalnog jetrenog protoka i u skladu s ekstenzivnim jetrenim metabolizmom aktivne supstance.
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.
Croatian: Kao odgovor na supkutanu dozu Preotacta (100 mikrograma paratireoidnog hormona), ukupna razina kalcija u serumu postepeno se povećava i dostiže vršnu koncentraciju (srednja vrijednost povećanja kod 129 bolesnika, 0,15 mmol/l ) približno 6 do 8 sati nakon doziranja.
English: Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Croatian: Nakon supkutanog doziranja Preotacta, fragmenti sa ugljikom na svojim krajevima čine 60-90% oblika molekule u cirkulaciji.
English: The pre-filled pen before mixing:
Croatian: Napunjena brizgalica prije miješanja:
English: No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Croatian: Preotacta s obzirom na dob pacijenata (raspon od 47-88 godina).
English: Abdominal pain
Croatian: Abdominalna bol
English: Overall, approximately 19% of the subjects in each treatment group had at least 1 prevalent vertebral fracture at baseline.
Croatian: Ukupno, otprilike 19% osoba iz svake ispitivane skupine imalo je pri uključivanju u ispitivanje barem jedan prijelom pretežno kralježaka.
English: Urine calcium/creatinine ratio increased Urine calcium increased
Croatian: Povećanje omjera kalcij/kreatinin u urinu Povećanje kalcija u urinu
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.
Croatian: Na kraju druge godine (12 mjeseci nakon prekida liječenja Preotactom), zabilježeno je srednje povećanje dvoenergetske apsorpciometrije X-zraka (DXA) kralježnice od 12,1% u bolesnica koje su u drugoj godini uzimale alendronat.
English: • If you drop your pre-filled pen you must replace it.
Croatian: • Ako vam brizgalica ispadne, morate je zamijeniti novom.
English: Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months.
Croatian: Volumetrijski trabekularni BMD u lumbalnoj kralježnici povećao se za 26%, 13% i 11% nakon 12 mjeseci (Preotact, Preotact sa alendronatom i alendronat,) u odnosu na početne vrijednosti.
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.
Croatian: Pod normalnim fiziološkim okolnostima , u cirkulaciji se nalazi samo 5-30% paratireoidnog hormona pune dužine (1-84), dok 70-95% čine dijelovi koji na krajevima imaju karboksilnu grupu.
English: The solvent contains
Croatian: Što Preotact sadrži
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.
Croatian: Ukupno 2532 bolesnice (1.286 na Preotactu i 1.246 na placebu), u dobi 45-94 godina (8,1% 45-54 godina i 11,4% ≥ 75 godina), randomizirane su u skupine gdje su primale 100 mikrograma/dan Preotacta ili placebo sa dnevnim dodatkom kalcija (700 mg) i vitamina D (400IJ).
English: • Mix the medicine
Croatian: • Izmiješajte lijek
English: Parathyroid hormone is the principal regulator of serum calcium homeostasis.
Croatian: Paratireoidni hormon je glavni regulator održavanja ravnoteže kalcija u serumu.
English: The other ingredients are: The powder contains:
Croatian: Prašak sadrži:
English: The Preotact pre-filled pen has been designed especially to make it easy for you to take your osteoporosis treatment.
Croatian: Preotact napunjena brizgalica je posebno oblikovana da olakša primjenu terapije za osteoporozu.
English: At baseline a total of 165 women (69%) had a T-score below -2.5, and 112 (47%) reported at least one fracture after menopause.
Croatian: Pri uključivanju u ispitivanje ukupno 165 žena (69%) imalo je T-vrijednost nižu od -2,5 a 112 žena (47%) prijavile su najmanje jedan prijelom nakon menopauze.
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.
Croatian: Liječnik će provesti testove krvi i/ili mokraće kako bi izmjerio razinu kalcija u Vašoj krvi i/ili mokraći u prvom, trećem i šestom mjesecu liječenja
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.
Croatian: U drugoj godini ispitivanja, žene iz početne Preotact grupe raspoređene su slučajnim odabirom u grupu koja je dobivala ili alendronat ili odgovarajući placebo, dok su žene iz druge dvije grupe dobivale alendronat.
English: Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Croatian: Paratireoidni hormon se metabolizira u jetri i u manjoj mjeri u bubrezima.
English: Peel off the protective paper from the needle cover.
Croatian: Odlijepite zaštitni papir sa pokrova igle.
English: Transient elevations in parathyroid hormone levels after subcutaneous injection of Preotact stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Croatian: Prolazno povećanje razine paratireoidnog hormona nakon supkutane injekcije Preotacta stimulira novu izgradnju kostiju na trabekularoj i kortikalnoj (periostealnoj i/ili endostealnoj) površini kosti preferiranom stimulacijom osteoblastičke nad osteoklastičkom aktivnosti.
English: • metacresol ,
Croatian: • metakrezol,
English: Effect on fracture incidence
Croatian: Utjecaj na incidenciju prijeloma
English: • Store in a refrigerator (2-8°C).
Croatian: • Čuvatjte u hladnjaku (2-8°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).
Croatian: Preotact je u kombinaciji s hormonskim nadomjestnim liječenjem (HRT) kod 180 žena u postmenopauzi pokazao značajno povećanje BMD u lumbalnoj kralježnici u 12-om mjesecu liječenja u usporedbi sa samostalnim hormonskim nadomjestnim liječenjem (7,1% vs. 1,1%, p<0,001).
English: The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact.
Croatian: Povećanje BMD u lumbalnoj kralježnici i femoralnom vratu femura u odnosu na početne vrijednosti bilo je 6,8%, odnosno 2,2% u bolesnica liječenih Preotactom.
English: If you forget to use Preotact
Croatian: Ako zaboravite primijeniti Preotact
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo česte (mogu se javiti kod više od 1 od 10 korisnika):
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
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.
Croatian: Supkutana primjena 100 mikrograma paratireoidnog hormona u abdomen izaziva brzo povećanje razine paratireoidnog hormona u plazmi koji postiže vršnu koncentraciju 1 do 2 sata nakon doziranja.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Croatian: Nositelj odobrenja će provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom , kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2 odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane Povjerenstva za humane lijekove (CHMP).
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.
Croatian: Temeljem dva placebom kontrolirana ispitivanja koja su uključivala 2642 žene u postmenopauzi sa osteoporozom, hiperkaciemija je prijavljena kod 25,3% bolesnica liječenih Preotactom u usporedbi sa 4,3% bolesnica koje su uzimale placebo.
English: The most relevant fracture reduction was observed among patients at high risk of fractures such as patients with previous fractures and in patients with a lumbar spine T-score of < - 3.
Croatian: Najvažnije smanjenje rizika prijeloma primijećeno je u bolesnica sa visokim rizikom prijeloma, kao što su bolesnice s prethodnim prijelomima i bolesnice s T-vrijednošću lumbalne kralježnice ≤ -3.
English: No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem jetre (ukupna vrijednost 7-9 na Child-Pugh ljestvici).
English: Wash your hands with soap and water before you handle the pre-filled pen.
Croatian: Prije rukovanja napunjenom brizgalicom operite ruke vodom i sapunom.
English: Pull both needle covers off. Save the outer needle cover as you will need it to remove the needle after the injection.
Croatian: Sačuvajte vanjski poklopac, jer će Vam trebati kad budete uklanjali iglu nakon korištenja.
English: Patients with urolithiasis
Croatian: Bolesnika s urolitijazom
English: In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria.
Croatian: Kod ovih bolesnika je veća vjerojatnost da će liječenje Preotactom pogoršati podležeću hiperkalciuriju.
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.
Croatian: U velikom kliničkom ispitivanju faze III, antitijela na paratiroidni hormon otkrivena su kod 3% žena koje su primale Preotact u usporedbi sa 0,2% žena koje su primale placebo.
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.
Croatian: Ukupna izloženost i Cmax paratireoidnog hormona bila je blago povećana (22%, odnosno 56%) u grupi od 8 žena i 8 muškaraca sa blagim do umjerenim oštećenjem bubrega (klirens kreatinina od 30-80 ml/min) u odnosu na odgovarajuću grupu od 16 osoba sa normalnom bubrežnom funkcijom.
English: • If you have just mixed a new pre-filled pen you can use the needle already on.
Croatian: • Ako ste upravo pomiješali novu napunjenu brizgalicu,
English: 5.3 Preclinical safety data
Croatian: 5.3 Pretklinički podaci o sigurnosti primjene
English: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Croatian: Ispitivanja na miševima ukazuju na povećanu incidenciju osteosarkoma kod dugotrajne primjene Preotacta (vidjeti dio 5.3).
English: • if you shall have or previously have had radiation therapy to the skeleton;
Croatian: • ako ste bili ili trebate ići na terapiju zračenjem koštanog sustava;
English: Effects on serum calcium concentrations
Croatian: Učinak na koncentraciju kalcija u serumu
English: Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
Croatian: U kliničkom ispitivanju faze III uključeno je relativno malo bolesnica koje su u postmenopauzi manje od 5 godina i imaju 45-54 godina (2-3%).
English: Preotact increases serum uric acid concentrations.
Croatian: Preotact povećava koncentraciju urične kiseline u serumu.
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.
Croatian: Terapija Preotactom smanjila je volumetrijski BMD kortikalne kosti (mjereno na distalnom promjeru i srednjem dršku tibie), dok je periostealna cirkumferencija i indeks snage kortikalne kosti bio održan.
English: No osteosarcomas have been observed in clinical trials.
Croatian: U kliničkim ispitivanjima nije primjećen razvoj osteosarkoma.
English: These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Croatian: Za dijelove koji na krajevima imaju karboksilnu skupinu smatra se da igraju ulogu u regulaciji djelovanja paratireoidnog hormona.
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).
Croatian: Iz saznanja o mehanizmu djelovanja, istodobno uzimanje Preotacta i srčanih glikozida može izložiti bolesnika toksičnosti digitalisa ako se pojavi hiperkalciemija (vidjeti dio 4.4).
English: A user manual is included in the box to instruct patients on the correct use of the pen.
Croatian: Priručnik za korisnika s uputama o pravilnoj uporabi brizgalice uključen je u sadržaj kutije.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU • UVJETI ILI OGRANIČENJA VEZANI UZ DOSTUPNOST I UPORABU PREMA
English: Put the cap back on the pre-filled pen and place it in the refrigerator.
Croatian: Vratite poklopac natrag napunjenu brizgalicu i spremite je u hladnjak.
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, 4.4, and 5.1).
Croatian: Tijekom kliničkog programa kontrolirana je praćenjem laboratorijskih vrijednosti i korištenjem prethodno detaljiziranog algoritma praćenja (vidjeti dio 4.3, 4.4, i 5.1).
English: • Put the outer needle cover on.
Croatian: • Nataknite vanjski poklopac na iglu.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Croatian: Međutim, ako patite od osteoporoze, veća je vjerojatnost da ćete slomiti kost, bilo u kralježnici,
English: • You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
Croatian: • Nakon pripreme za primjenu, napunjenu brizgalicu čuvajte najviše 28 dana u hladnjaku.
English: • suffer from kidney stones;
Croatian: • patite od bubrežnih kamenaca;
English: Parathyroid hormone should not be used in women of childbearing potential, during pregnancy or breast-feeding.
Croatian: Paratireoidni hormon se ne smije koristiti u žena rerproduktivne dobi, tijekom trudnoće ili dojenja.
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.
Croatian: Za srednju promjenu u BMD kuka zabilježeno je povećanje od 4,5% u odnosu na početnu vrijednost nakon jednogodišnjeg liječenja alendronatom u usporedbi sa 0,1%-tnim smanjenjem nakon jedne godine na placebu.
English: Preotact has not been studied in patients with active urolithiasis.
Croatian: Preotact nije ispitan u bolesnika s aktivnom urolitijazom.
English: Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Croatian: Nastavno na liječenje Preotactom bolesnici se mogu liječiti bifosfonatom kako bi se dodatno povećala mineralna gustoća kostiju (vidjeti dio 5.1).
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.
Croatian: PaTH ispitivanje bilo je randomizirano, placebom kontrolirano, dvogodišnje, multicentrično, dvostruko-slijepo ispitivanje sponzorirano od Nacionalnog Instituta za zdravlje (NIH) sa Preotactom i alendronatom kao monoterapijom, te njihovom kombinacijom u liječenju postmenopauzalne osteoporoze.
English: Patients with pre-existing hypercalciuria
Croatian: Bolesnika s postojećom hiperkalciurijom
English: Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Croatian: Dijelovi koji na krajevima imaju karboksilnu skupinu filtriraju se bubrezima i kasnije kidaju na još manje dijelove tijekom tubularne reapsorpcije.
English: Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Croatian: Preotact je indiciran za liječenje osteoporoze kod žena u postmenopauzi koje imaju visoki rizik prijeloma kosti (vidjeti dio 5.1)
English: The recommended dose of Preotact is 100 micrograms per day.
Croatian: Preotacta je 100 mikrograma na dan.
English: For the patients who received placebo during the second year, the mean percent increase was 4.1% compared to baseline, but had decreased slightly compared to the end of 12 months of Preotact treatment.
Croatian: U bolesnica koje su tijekom druge godine primale placebo, srednje postotno povećanje bilo je 4,1% u odnosu na početne vrijednosti, ali se lagano smanjilo u odnosu na vrijednosti s kraja 12-mjesečnog liječenja Preotactom.
English: Physiological actions of parathyroid hormone include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular reabsorption of calcium and excretion of phosphate by the kidney.
Croatian: Fiziološka funkcija paratireoidnog hormona uključuje stimulaciju izgradnje kostiju direktnim utjecajem na stanice koje grade kost (osteoblaste) posrednim povećavanjem apsorpcije kalcija u crijevima, te povećavanjem tubularne reapsorpcije kalcija i izlučivanja fosfata bubrezima.