natgillin/translations-raw huggingface dataset:
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.
Fiziološko delovanje obščitničnega hormona vključuje spodbujanje tvorbe kostnine zaradi neposrednih učinkov na celice, ki tvorijo kosti (osteoblaste), pri čemer posredno povečuje absorpcijo kalcija v prebavilih, ter povečanje tubularne reabsorpcije kalcija in izločanje fosfata v ledvicah.
• smell disturbance, taste disturbance.
• motnje vonjanja, motnje okušanja.
The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10);
Neželeni učinki so razvrščeni v naslednje kategorije na podlagi pogostnosti: zelo pogosti (≥ 1/10); pogosti
It has not been shown that Preotact reduces the risk of breaking your hip.
Ni bilo dokazano, da zdravilo Preotact zmanjša tveganje za zlom kolka.
Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e.g. hyperparathyroidism).
Bolnice s trajno zvišanimi serumskimi ravnmi kalcija (nad zgornjo mejno vrednostjo normalnega območja) moramo preiskati za osnovne bolezni (npr. hiperparatiroidizem).
Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
Hiperkalciemija in/ali hiperkalciurija odražata znane farmakodinamične učinke obščitničnega hormona v prebavnih poteh, ledvicah in kosteh.
Preparing the new pre-filled pen for use - releasing air (priming)
Pripravljanje novega napolnjenega injekcijskega peresnika za uporabo - sproščanje zraka (priprava)
No potential for drug interactions was identified in the clinical program.
V kliničnem programu niso odkrili potenciala za interakcije z zdravili.
Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Zdravilo Preotact vsebuje rekombinantni človeški obščitnični hormon, ki je identičen celotnemu zaporedju nativnega polipeptida iz 84 aminokislin.
The container closure system is comprised of a dual-chamber cartridge, a center stopper, a crimp cap (containing a rubber seal) sealing the first chamber containing lyophilised powder and an end stopper sealing the second chamber containing the solvent for mixing.
Zaprti sistem vsebnika je sestavljen iz vložka z dvema komorama, osrednjega zamaška, objemne zaporke (ki vsebuje zamašek iz gume), ki zapira prvo komoro z liofiliziranim praškom, in končnega zamaška, ki zapira drugo komoro z vehiklom za pripravo.
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”).
Pred prvo uporabo je treba zdravilo v Preotact napolnjenem injekcijskem peresniku zmešati (glejte »Navodila za uporabo«).
Preotact contains less than 1 mmol sodium (23 mg) per dose.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria.
Pri teh bolnicah je bolj verjetno, da zdravljenje z zdravilom Preotact poslabša stanje hiperkalciurije.
You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Zdravilo Preotact je treba uporabljati previdno, če jemljete zdravila za srce (npr. digoksin, znan tudi kot digitalis).
This will release most of the air in the pre-filled pen and is called ‘priming'.
S tem boste sprostili večino zraka iz napolnjenega injekcijskega peresnika in to imenujemo priprava peresnika.
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).
Obščitnični hormon je naravni peptid, ki ga ne presnavljajo zdravila presnavljajoči mikrosomski encimi (npr. izoencimi citokroma P450).
Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Krožeče fragmente s karboksi-konci filtrirajo ledvice, vendar se kasneje med ponovnim privzemom v tubulih razcepijo v še manjše fragmente.
What Preotact is and what it is used for What you need to know before you use Preotact
Kaj je zdravilo Preotact in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Preotact Kako uporabljati zdravilo Preotact
• Add a needle
• Dodate iglo
The mean baseline lumbar T score was approximately -3.0 in each treatment group.
Povprečna izhodiščna lumbalna vrednost T je bila v vsaki skupini -3,0.
The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.
Osrednja raziskava je bila 18-mesečna dvojno slepa, s placebom nadzorovana študija faze III (TOP) o učinkih zdravila Preotact na pojavnost zlomov pri pomenopavznih ženskah z osteoporozo.
A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Skupno 238 žensk po menopavzi so naključno razporedili v skupine tako, da so prejemale bodisi zdravilo Preotact (100 µg obščitničnega hormona) bodisi alendronat (10 mg) bodisi kombinacijo navedenega, ter jih spremljali 12 mesecev.
Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Previdnost je potrebna pri bolnicah, ki prejemajo srčne glukozide zaradi nevarnosti za toksičnost digitalisa, če se pojavi hiperkalciemija (glejte poglavje 4.5).
White to off-white powder and clear, colourless solvent.
Bel do umazano bel prašek in bister, brezbarven vehikel.
• Protect the medicine and pre-filled pen against direct sunlight.
• Zaščitite zdravilo in napolnjen injekcijski peresnik pred neposredno sončno svetlobo.
• Always attach a new needle before use
• Pred uporabo vedno namestite novo iglo.
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.
Pri opicah, ki so prejemale dnevne podkožne odmerke 6 mesecev, so pri ravneh izpostavitve pod kliničnimi opazili povečano pojavnost mineralizacije v ledvičnih tubulih.
5 How to store Preotact Contents of the pack and other information
5 Shranjevanje zdravila Preotact Vsebina pakiranja in dodatne informacije
The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Kombinacija je bila učinkovita ne glede na starost, izhodiščnim razmerjem med razgradnjo in tvorbo kosti ali izhodiščni BMD.
• If you drop your pre-filled pen you must replace it.
• Če vam napolnjen injekcijski peresnik pade na tla, ga morate zamenjati.
Elderly Dose adjustment based upon age is not required (see section 5.2).
Starostniki Odmerka ni treba prilagajati glede na starost (glejte poglavje 5.2).
Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Volumetrični trabekularni BMD v ledvenem predelu hrbtenice se je v 18 mesecih od izhodiščnih vrednosti povečal za 38%.
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.
V izhodišču je skupno 165 žensk (69%) imelo vrednost T pod -2,5 in 112 žensk (47%) je navedlo najmanj en zlom po menopavzi.
Peel off the protective paper from the needle cover.
Odstranite papirnato zaščito s pokrovčka igle.
The pen can be used with standard injection pen needles.
Peresnik se lahko uporablja s standardno injekcijsko iglo.
There is no relevant use of Preotact in paediatric patients for the treatment of osteoporosis at high risk of fractures
Preotact ni primerno za uporabo pri pediatričnih bolnikih za zdravljenje osteoporoze z visokim tveganjem za zlome.
Pull both needle covers off. Save the outer needle cover as you will need it to remove the needle after the injection.
Shranite zunanji pokrovček igle, ker ga boste potrebovali za odstranitev igle po injekciji.
Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
Posvetujte se s svojim zdravnikom, če nameravate predčasno končati zdravljenje z zdravilom Preotact.
Parathyroid hormone should not be used in women of childbearing potential, during pregnancy or breast-feeding.
Obščitnični hormon se ne sme uporabljati pri ženskah v rodni dobi, med nosečnostjo ali med dojenjem.
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.
Sistemski očistek obščitničnega hormona (45,3 l/uro) po intravenskem odmerku je podoben običajnemu jetrnemu plazemskemu toku in skladen z obsežno presnovo zdravilne učinkovine v jetrih.
One year of therapy, showed the following results: the increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Eno leto zdravljenja je dalo naslednje rezultate: Povečki BMD ledvenega predela hrbtenice nad izhodiščnimi vrednostmi so bili podobni v skupini, ki je prejemala zdravilo Preotact (6,3%), in v skupini, ki je prejemala kombinacijsko zdravljenje (6,1%), ampak nekoliko manjši v skupini, ki je prejemala alendronat (4,6%).
There are no studies of foetal, developmental, perinatal or postnatal toxicity.
Študije toksičnosti za plod, telesni razvoj, perinatalno obdobje in postnatalno obdobje niso opravili.
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.
Prehodna zvišanja ravni obščitničnega hormona po podkožnem injiciranju zdravila Preotact spodbudijo tvorbo nove kostnine na trabekularnih in kortikalnih (periostalnih in/ali endostalnih) ploskvah kosti s prednostno stimulacijo aktivnosti osteoblastov pred osteoklasti.
Be careful not to push the yellow release button while you handle the pre-filled pen - if you accidentally do so, the blue injection button will pop out.
Pazite, da med rokovanjem z napolnjenim injekcijskim peresnikom ne pritisnete rumenega sprožilnega gumba - če se vam to nenamerno zgodi, se bo modri injekcijski gumb privzdignil.
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.
Najpomembnejše zmanjšanje zlomov so opazili pri bolnicah s povečanim tveganjem za zlome, kot so bolnice s predhodnimi zlomi, in bolnice z lumbalno vrednostjo T < - 3.
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.
Pri bolnicah, ki so drugo leto prejemale placebo, je bilo povprečno povečanje 4,1% glede na izhodišče, vendar se je nekoliko zmanjšalo, če primerjamo z zaključkom 12-mesečnega zdravljenja z zdravilom
Patients with urolithiasis
Bolnice z urolitiazo
For patients with pre-existing fractures, number needed to treat (NNT) is 21 patients.
Za bolnice z obstoječimi zlomi je bilo število preiskovank, ki jih je treba zdraviti za preprečitev enega ali več novih vretenčnih zlomov (NNT - "number needed to treat"), 21.
• Do not use this medicine for more than 28 days after it has been mixed.
Ne uporabljajte zdravila več kot 28 dni zatem, ko je bilo pripravljeno.
Preotact has been studied in patients with pre-existing hypercalciuria.
Zdravilo Preotact je bilo preučeno pri bolnicah s predhodno obstoječo hiperkalciurijo.
Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Če se sumi na preveliko odmerjanje, naj zdravljenje vključuje začasno prekinitev zdravljenja z zdravilom Preotact, spremljanje serumske ravni kalcija in uvedba ustreznih podpornih ukrepov, kot je nadomeščanje tekočine.
Once the product is reconstituted it can be stored outside the refrigerator at temperatures below 25°C for up to 7 days during the 28 day use period (see section 6.3).
Ko je vsebina zdravila pripravljena, lahko zdravilo shranjujete izven hladilnika pri temperaturi do 25 °C do 7 dni v 28dnevnem obdobju uporabnosti (glejte poglavje 6.3).
Effect on fracture incidence
Klinična učinkovitost Učinek na pojavnost zlomov
• Mix the medicine
• Zmešate zdravilo
• with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism
• s presnovnimi boleznimi kosti razen osteoporoze (vključno s hiperparatiroidizmom in
Rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
Pri podganah, ki so skoraj celo življenje prejemale dnevne odmerke, se je pokazala povečana tvorba kostnine, ki je bila sorazmerna z odmerkom, in povečana pojavnost tumorjev kosti (vključno z osteosarkomom), ki je najverjetneje posledica epigenetskega mehanizma.
• who are receiving or who has previously received radiation therapy to the skeleton
• ki prejemajo ali z anamnezo terapije z obsevanjem okostja
The solvent contains
Vehikel vsebuje
• Do not use the medicine if it is cloudy or coloured (if it is unclear).
• Ne uporabljajte zdravila, če je motno ali obarvano (ni bistrega videza).
Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Približno 71,4% bolnic, ki so prejemale obščitnični hormon, je navedlo najmanj en neželen učinek.
If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.
Če ste uporabili večji odmerek zdravila Preotact, kot bi smeli Če ste si pomotoma injicirali več kot en odmerek zdravila Preotact na dan, se nemudoma obrnite na svojega zdravnika ali farmacevta.
• reddening of the skin (erythema) at injection site,
• pordelost kože (eritem) na mestu injiciranja,
When you receive your pre-filled pen the dose counter is at , to show that it is full.
Ko prejmete svoj napolnjen injekcijski peresnik, je števec odmerkov na , kar pomeni, da je poln.
The dose is administered as a subcutaneous injection into the abdomen.
Odmerek se injicira subkutano v abdomen.
For instructions on how to use the pre-filled pen, please read the ”Instructions for use”..
Za informacije o uporabi napolnjenega injekcijskega peresnika, preberite »Navodila za uporabo«.
Preotact should not be used if the reconstituted solution is cloudy, coloured or contains particles.
Zdravila Preotact se ne sme uporabljati, če je pripravljena raztopina motna, obarvana ali vsebuje vidne delce.
If you stop taking Preotact
Če ste prenehali uporabljati zdravilo Preotact
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.
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.
• Point the needle end straight up
• Usmerite konec z iglo naravnost navzgor.
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.
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.
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%).
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%).
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).
V kliničnem programu je bila obravnavana z laboratorijskim spremljanjem ravni in predhodno določenim algoritmom obravnave (glejte poglavja 4.3 in 4.4).
• Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
• Zdravilo Preotact si injicirajte kmalu potem, ko napolnjen injekcijski peresnik vzamete iz hladilnika.
• if you suffer from high calcium levels in your blood or other disturbances in the calcium
• če imate visoke ravni kalcija v krvi ali druge motnje fosfokalcijeve presnove;
• irritation of the skin at the injection site,
• draženje kože na mestu injiciranja,
• Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
• Po vsaki dnevni injekciji odstranite iglo in položite napolnjen injekcijski peresnik v hladilnik na temperaturo od 2 °C - 8 °C.
Patients with pre-existing hypercalciuria
Bolnice s predhodno obstoječo hiperkalciurijo
Put the cap back on the pre-filled pen and place it in the refrigerator.
Nataknite pokrov nazaj na napolnjen injekcijski peresnik in ga položite v hladilnik.
Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Rezultati raziskav na podganah kažejo povečano pojavnost osteosarkoma pri dolgotrajnem zdravljenju z zdravilom Preotact (glejte poglavje 5.3).
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.
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.
• The priming should be done every time you mix a new pre-filled pen.
• To je treba napraviti ob vsakem mešanju novega napolnjenega injekcijskega peresnika.
Important information when using Preotact
Pomembni podatki o uporabi zdravila Preotact
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.
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%
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.
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").
Before mixing
Pred mešanjem:
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.
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.
• if you suffer from severe kidney problems;
• če imate hude težave z ledvicami;
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.
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.
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.
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.
Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
5 let in ki so bile stare 45-54 let (2-3%).
Citric acid monohydrate Sodium chloride
Citronska kislina monohidrat Natrijev klorid
Management of elevated serum calcium
Obravnavanje zvišanih serumskih ravni kalcija
The only other very commonly reported ADR was nausea.
Drugi zelo pogosto navajan neželeni učinek je bil slabost.
During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
V 28dnevnem časovnem obdobju se lahko pripravljena raztopina shranjuje do 7 dni pri temperaturi do 25 °C.
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).
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).
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.
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.
• Store in a refrigerator (2-8°C).
• Shranjujte v hladilniku (2 °C -8 °C).
Preotact increases serum uric acid concentrations.
Zdravilo Preotact zviša serumske koncentracije sečne kisline.
Gender The medicinal product has only been studied in postmenopausal women.
Zdravilo je bilo preučeno le pri ženskah po menopavzi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (2 napolnjena injekcijska peresnika)
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection.
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje.
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.
Lahko nadaljujete in si takoj vbrizgate dnevno injekcijo ali pa shranite napolnjen injekcijski peresnik v hladilniku, kot je opisano v poglavju
Preotact is contraindicated in patients
4.3 Kontraindikacije Zdravilo Preotact je kontraindicirano pri bolnicah
Preotact has not been studied in patients with active urolithiasis.
Uporaba zdravila Preotact ni bila raziskana pri bolnicah z aktivno urolitiazo.
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.
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.