FrancophonIA/ELRC3.0 huggingface dataset:
English: Before taking your first injection with a new pre-filled pen you have to add a needle and mix the medicine by following the instructions in this leaflet.
Slovenian: Pred prvo injekcijo z novim napolnjenim injekcijskim peresnikom morate dodati iglo in zmešati zdravilo v skladu z navodili v tej brošuri.
English: • with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism
Slovenian: • s predhodno obstoječo hiperkalciemijo in drugimi motnjami fosfokalcijeve presnove
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: When the dose counter is at 0, the pre-filled pen is empty and you must take a new pre-filled pen.
Slovenian: Ko je števec odmerkov na 0, je peresnik prazen in morate vzeti nov napolnjen injekcijski peresnik.
English: The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
Slovenian: Farmakodinamični učinki Učinki obščitničnega hormona na okostje so odvisni od vzorca sistemske izpostavljenosti.
English: In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Slovenian: V 24-mesečni študiji zdravljenja s kombinacijo z alendronatom (PaTH) so učinke zdravila Preotact na arhitekturo prav tako ovrednotili s QCT.
English: Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.
Slovenian: Zdravilo Preotact zmanjša tveganje zloma hrbteničnih kosti, ker izboljša kakovost in moč kostnine.
English: • if you have cancer of the bones;
Slovenian: • če imate kostnega raka;
English: Other medicines and Preotact
Slovenian: Druga zdravila in zdravilo Preotact:
English: Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
Slovenian: Podatki podpirajo neprekinjeno zdravljenje z zdravilom Preotact do 24 mesecev (glejte poglavje 4.4).
English: Parathyroid hormone is not excreted from the body in its intact form.
Slovenian: Obščitnični hormon se iz telesa ne izloča v nespremenjeni obliki.
English: The dose counter now shows 14 and the pre-filled pen is ready to use.
Slovenian: Števec odmerkov zdaj kaže 14 in napolnjen injekcijski peresnik je pripravljen za uporabo.
English: Reconstituted solution: chemical and physical in-use stability has been demonstrated for 28 days at 28°C.
Slovenian: Pripravljena raztopina: kemijska in fizikalna obstojnost je dokazana za 28 dni pri 2 °C -8 °C.
English: DO NOT SHAKE; shaking may cause denaturation of the active substance.
Slovenian: NE STRESAJTE; stresanje lahko povzroči denaturacijo zdravilne učinkovine.
English: There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture: 5.52% for Preotact vs. 5.86% for placebo.
Slovenian: Med skupinama preiskovank ni bilo statistično značilnih razlik v pojavnosti kakršnegakoli nevretenčnega kliničnega zloma: 5,52% za zdravilo Preotact v primerjavi s 5,86% za placebo.
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).
Slovenian: Ko to storite, je Preotact napolnjen injekcijski peresnik pripravljen za uporabo in zdravilo je pripravljeno za injiciranje v trebuh (pod kožo).
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.
Slovenian: Osteosarkom se je pojavil le pri odmerkih, ki so povzročili sistemsko izpostavitev, ki je bila ≥ 27-krat večja od izpostavitve pri človeku po odmerku 100 µg.
English: A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Slovenian: Dokazano je bilo zmanjšanje pojavnosti vretenčnih zlomov, ne pa zlomov kolka.
English: Pharmacotherapeutic group: Calcium homeostatis, parathyroid hormones and analogues, ATC code: H05AA03.
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija, obščitnični hormoni in analogi, oznaka ATC: H05AA03.
English: • Do not shake the pre-filled pen (neither before nor after injection) as it may destroy the effect of the medicine.
Slovenian: • Ne stresajte napolnjenega injekcijskega peresnika (bodisi pred injiciranjem bodisi po injiciranju), saj se lahko izniči delovanje zdravila.
English: After reconstitution the liquid should be clear and colourless.
Slovenian: Po pripravi mora nastati tekočina, ki je bistra in brez barve.
English: Effects on serum calcium concentrations
Slovenian: Učinki na serumske koncentracije kalcija
English: Animal studies of reproductive toxicity are incomplete (see section 5.3).
Slovenian: Študije vpliva na sposobnost razmnoževanja pri živalih so nepopolne (glejte poglavje 5.3).
English: The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Slovenian: Absolutna biološka dostopnost 100 µg obščitničnega hormona po podkožnem dajanju v trebuh je 55%.
English: The recommended dose of Preotact is 100 micrograms per day.
Slovenian: Priporočeni odmerek zdravila Preotact je 100 mikrogramov na dan.
English: Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.
Slovenian: Serumske koncentracije kalcija dosežejo najvišjo vrednost od 6 do 8 ur po odmerku, nato pa se običajno vrnejo na izhodiščno raven 20 do 24 ur po prejemu obščitničnega hormona.
English: Urine calcium/creatinine ratio increased Urine calcium increased
Slovenian: Zvišano razmerje urinskega kalcija/kreatinina Zvišana raven kalcija v urinu
English: Parathyroid hormone N=1341
Slovenian: N=1341
English: Therefore if any blood samples are taken from a patient for monitoring of calcium levels, this should be done at least 20 hours after the most recent injection.
Slovenian: To pomeni, da je treba vse vzorce krvi bolnic za spremljanje ravni kalcija odvzeti najmanj 20 ur po zadnjem injiciranju.
English: Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
Slovenian: O hiperkalciemiji so poročali pri 25,3% bolnic, o hiperkalciuriji pa pri 39,3% bolnic, ki so prejemale Preotact.
English: If you forget to use Preotact
Slovenian: Če ste pozabili uporabiti zdravilo Preotact
English: The Preotact pre-filled pen has been designed especially to make it easy for you to take your osteoporosis treatment.
Slovenian: Preotact napolnjen injekcijski peresnik je posebno oblikovan z namenom, da vam olajša zdravljenje osteoporoze.
English: Dosage adjustment based on age is not required.
Slovenian: Odmerka ni treba prilagajati glede na starost.
English: • Take your daily dose or store the pre-filled pen
Slovenian: • Vzamete svoj dnevni odmerek ali shranite napolnjen injekcijski peresnik
English: • with skeletal malignancies or bone metastases.
Slovenian: • s skeletnimi malignostmi ali kostnimi metastazami
English: • with hypersensitivity to parathyroid hormone or to any of the excipients (see section 6.1)
Slovenian: • s preobčutljivostjo za obščitnični hormon ali katerokoli pomožno snov (glejte poglavje 6.1)
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.
Slovenian: 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.
English: • smell disturbance, taste disturbance.
Slovenian: • motnje vonjanja, motnje okušanja.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10);
Slovenian: Neželeni učinki so razvrščeni v naslednje kategorije na podlagi pogostnosti: zelo pogosti (≥ 1/10); pogosti
English: It has not been shown that Preotact reduces the risk of breaking your hip.
Slovenian: Ni bilo dokazano, da zdravilo Preotact zmanjša tveganje za zlom kolka.
English: Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e.g. hyperparathyroidism).
Slovenian: Bolnice s trajno zvišanimi serumskimi ravnmi kalcija (nad zgornjo mejno vrednostjo normalnega območja) moramo preiskati za osnovne bolezni (npr. hiperparatiroidizem).
English: Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
Slovenian: Hiperkalciemija in/ali hiperkalciurija odražata znane farmakodinamične učinke obščitničnega hormona v prebavnih poteh, ledvicah in kosteh.
English: Preparing the new pre-filled pen for use - releasing air (priming)
Slovenian: Pripravljanje novega napolnjenega injekcijskega peresnika za uporabo - sproščanje zraka (priprava)
English: No potential for drug interactions was identified in the clinical program.
Slovenian: V kliničnem programu niso odkrili potenciala za interakcije z zdravili.
English: Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Slovenian: Zdravilo Preotact vsebuje rekombinantni človeški obščitnični hormon, ki je identičen celotnemu zaporedju nativnega polipeptida iz 84 aminokislin.
English: 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.
Slovenian: 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.
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”).
Slovenian: Pred prvo uporabo je treba zdravilo v Preotact napolnjenem injekcijskem peresniku zmešati (glejte »Navodila za uporabo«).
English: Preotact contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
English: In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria.
Slovenian: Pri teh bolnicah je bolj verjetno, da zdravljenje z zdravilom Preotact poslabša stanje hiperkalciurije.
English: You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Slovenian: Zdravilo Preotact je treba uporabljati previdno, če jemljete zdravila za srce (npr. digoksin, znan tudi kot digitalis).
English: This will release most of the air in the pre-filled pen and is called ‘priming'.
Slovenian: S tem boste sprostili večino zraka iz napolnjenega injekcijskega peresnika in to imenujemo priprava peresnika.
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).
Slovenian: Obščitnični hormon je naravni peptid, ki ga ne presnavljajo zdravila presnavljajoči mikrosomski encimi (npr. izoencimi citokroma P450).
English: Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Slovenian: Krožeče fragmente s karboksi-konci filtrirajo ledvice, vendar se kasneje med ponovnim privzemom v tubulih razcepijo v še manjše fragmente.
English: What Preotact is and what it is used for What you need to know before you use Preotact
Slovenian: Kaj je zdravilo Preotact in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Preotact Kako uporabljati zdravilo Preotact
English: • Add a needle
Slovenian: • Dodate iglo
English: The mean baseline lumbar T score was approximately -3.0 in each treatment group.
Slovenian: Povprečna izhodiščna lumbalna vrednost T je bila v vsaki skupini -3,0.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Slovenian: Previdnost je potrebna pri bolnicah, ki prejemajo srčne glukozide zaradi nevarnosti za toksičnost digitalisa, če se pojavi hiperkalciemija (glejte poglavje 4.5).
English: White to off-white powder and clear, colourless solvent.
Slovenian: Bel do umazano bel prašek in bister, brezbarven vehikel.
English: • Protect the medicine and pre-filled pen against direct sunlight.
Slovenian: • Zaščitite zdravilo in napolnjen injekcijski peresnik pred neposredno sončno svetlobo.
English: • Always attach a new needle before use
Slovenian: • Pred uporabo vedno namestite novo iglo.
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.
Slovenian: Pri opicah, ki so prejemale dnevne podkožne odmerke 6 mesecev, so pri ravneh izpostavitve pod kliničnimi opazili povečano pojavnost mineralizacije v ledvičnih tubulih.
English: 5 How to store Preotact Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Preotact Vsebina pakiranja in dodatne informacije
English: The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Slovenian: Kombinacija je bila učinkovita ne glede na starost, izhodiščnim razmerjem med razgradnjo in tvorbo kosti ali izhodiščni BMD.
English: • If you drop your pre-filled pen you must replace it.
Slovenian: • Če vam napolnjen injekcijski peresnik pade na tla, ga morate zamenjati.
English: Elderly Dose adjustment based upon age is not required (see section 5.2).
Slovenian: Starostniki Odmerka ni treba prilagajati glede na starost (glejte poglavje 5.2).
English: Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Slovenian: Volumetrični trabekularni BMD v ledvenem predelu hrbtenice se je v 18 mesecih od izhodiščnih vrednosti povečal za 38%.
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.
Slovenian: V izhodišču je skupno 165 žensk (69%) imelo vrednost T pod -2,5 in 112 žensk (47%) je navedlo najmanj en zlom po menopavzi.
English: Peel off the protective paper from the needle cover.
Slovenian: Odstranite papirnato zaščito s pokrovčka igle.
English: The pen can be used with standard injection pen needles.
Slovenian: Peresnik se lahko uporablja s standardno injekcijsko iglo.
English: There is no relevant use of Preotact in paediatric patients for the treatment of osteoporosis at high risk of fractures
Slovenian: Preotact ni primerno za uporabo pri pediatričnih bolnikih za zdravljenje osteoporoze z visokim tveganjem za zlome.
English: Pull both needle covers off. Save the outer needle cover as you will need it to remove the needle after the injection.
Slovenian: Shranite zunanji pokrovček igle, ker ga boste potrebovali za odstranitev igle po injekciji.
English: Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
Slovenian: Posvetujte se s svojim zdravnikom, če nameravate predčasno končati zdravljenje z zdravilom Preotact.
English: Parathyroid hormone should not be used in women of childbearing potential, during pregnancy or breast-feeding.
Slovenian: Obščitnični hormon se ne sme uporabljati pri ženskah v rodni dobi, med nosečnostjo ali med dojenjem.
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.
Slovenian: 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.
English: 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%).
Slovenian: 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%).
English: There are no studies of foetal, developmental, perinatal or postnatal toxicity.
Slovenian: Študije toksičnosti za plod, telesni razvoj, perinatalno obdobje in postnatalno obdobje niso opravili.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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
English: Patients with urolithiasis
Slovenian: Bolnice z urolitiazo
English: For patients with pre-existing fractures, number needed to treat (NNT) is 21 patients.
Slovenian: 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.
English: • Do not use this medicine for more than 28 days after it has been mixed.
Slovenian: Ne uporabljajte zdravila več kot 28 dni zatem, ko je bilo pripravljeno.
English: Preotact has been studied in patients with pre-existing hypercalciuria.
Slovenian: Zdravilo Preotact je bilo preučeno pri bolnicah s predhodno obstoječo hiperkalciurijo.
English: Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Effect on fracture incidence
Slovenian: Klinična učinkovitost Učinek na pojavnost zlomov
English: • Mix the medicine
Slovenian: • Zmešate zdravilo
English: • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism
Slovenian: • s presnovnimi boleznimi kosti razen osteoporoze (vključno s hiperparatiroidizmom in
English: 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.
Slovenian: 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.
English: • who are receiving or who has previously received radiation therapy to the skeleton
Slovenian: • ki prejemajo ali z anamnezo terapije z obsevanjem okostja
English: The solvent contains
Slovenian: Vehikel vsebuje
English: • Do not use the medicine if it is cloudy or coloured (if it is unclear).
Slovenian: • Ne uporabljajte zdravila, če je motno ali obarvano (ni bistrega videza).
English: Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Slovenian: Približno 71,4% bolnic, ki so prejemale obščitnični hormon, je navedlo najmanj en neželen učinek.
English: If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.
Slovenian: 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.
English: • reddening of the skin (erythema) at injection site,
Slovenian: • pordelost kože (eritem) na mestu injiciranja,
English: When you receive your pre-filled pen the dose counter is at , to show that it is full.
Slovenian: Ko prejmete svoj napolnjen injekcijski peresnik, je števec odmerkov na , kar pomeni, da je poln.
English: The dose is administered as a subcutaneous injection into the abdomen.
Slovenian: Odmerek se injicira subkutano v abdomen.
English: For instructions on how to use the pre-filled pen, please read the ”Instructions for use”..
Slovenian: Za informacije o uporabi napolnjenega injekcijskega peresnika, preberite »Navodila za uporabo«.
English: Preotact should not be used if the reconstituted solution is cloudy, coloured or contains particles.
Slovenian: Zdravila Preotact se ne sme uporabljati, če je pripravljena raztopina motna, obarvana ali vsebuje vidne delce.
English: If you stop taking Preotact
Slovenian: Če ste prenehali uporabljati zdravilo Preotact