FrancophonIA/ELRC3.0 huggingface dataset:
English: Among all paediatric subjects exposed to cinacalcet in clinical studies a total of 19 subjects (24.1%; 64.5 per 100 subject years) had at least one adverse event of hypocalcaemia.
Croatian: Od svih pedijatrijskih ispitanika koji su bili izloženi cinakalcetu u kliničkim ispitivanjima, ukupno je 19 ispitanika (24,1 %; 64,5 na 100 ispitanik-godina) imalo najmanje jedan štetni događaj hipokalcemije.
English: The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Croatian: Učestalosti pojedinih standardnih izraza uključujući angioedem i urtikariju ne mogu se procijeniti iz dostupnih podataka.
English: It is recommended that Mimpara be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).
Croatian: Preporučuje se lijek Mimpara uzeti s hranom ili neposredno nakon obroka jer su ispitivanja pokazala kako je bioraspoloživost cinakalceta povećana kad se uzima s hranom (vidjeti dio 5.2).
English: If you forget to take Mimpara
Croatian: Ako ste zaboravili uzeti lijek Mimpara
English: After taking Mimpara a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
Croatian: Nakon uzimanja lijeka Mimpara vrlo mali broj bolesnika sa zatajenjem srca doživjelo je pogoršanje stanja i/ili niski krvni tlak (hipotenziju).
English: PTH levels in Mimpara clinical trials were measured at the end of the dosing interval.
Croatian: Vrijednosti PTH-a u kliničkim ispitivanjima s lijekom Mimpara bile su mjerene na kraju intervala doziranja.
English: Mimpara daily dose in paediatric patients Patient dry weight (kg)
Croatian: Dnevna doza lijeka Mimpara u pedijatrijskih bolesnika Suha tjelesna težina bolesnika (kg)
English: Instructions for taking Mimpara granules
Croatian: Upute za uzimanje Mimpara granula.
English: • Tap the capsule gently so the contents settle on the bottom of the capsule (white part of capsule).
Croatian: • Lagano tapkajte kapsulu kako bi se sadržaj slegao na dno kapsule (bijeli dio kapsule).
English: If Mimpara treatment has been stopped for more than 14 days, restart at the recommended starting dose.
Croatian: Ako je liječenje lijekom Mimpara bilo prekinuto više od 14 dana, ponovno započnite preporučenom početnom dozom lijeka.
English: The mean age at baseline was 13 (range 6 to 18) years.
Croatian: Srednja dob na početku ispitivanja bila je 13 godina (raspon od 6 do 18 godina).
English: Capsules should be opened by gently squeezing and twisting the coloured top from the white body of the capsule, having first tapped the capsule gently so the contents settle in the bottom of the capsule (white part of the capsule).
Croatian: Kapsule se trebaju otvoriti laganim stiskanjem i odvrtanjem obojene kapica od bijelog tijela kapsule, nakon prethodnog laganog tapkanja kapsule kako bi se sadržaj kapsule slegnuo na dno (bijeli dio kapsule).
English: d) Paediatric population
Croatian: d) Pedijatrijska populacija
English: Inform paediatric patients and/or their caregivers about the symptoms of hypocalcaemia and about the importance of adherence to instructions about serum calcium monitoring, and posology and method of administration.
Croatian: Informirajte pedijatrijske bolesnike i/ili njihove skrbnike o simptomima hipokalcemije i važnosti pridržavanja uputa za kontrolu vrijednosti serumskog kalcija, te o doziranju i načinu primjene.
English: Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
Croatian: Cinakalcet se izlučuje u mlijeku ženke štakora u laktaciji uz visok omjer između mlijeka i plazme.
English: Prior to initiating cinacalcet and during treatment, consider the risks and benefits of treatment and the ability of the patient to comply with the recommendations to monitor and manage the risk of hypocalcaemia.
Croatian: Prije nego što započnete liječenje cinakalcetom i za vrijeme liječenja, razmotrite rizike i koristi liječenja te sposobnost bolesnika da se pridržava preporuka za praćenje i zbrinjavanje rizika od hipokalcemije.
English: A daily dose of 3.9 mg/kg was prescribed to a paediatric patient receiving dialysis in a clinical study with subsequent mild stomach ache, nausea and vomiting.
Croatian: Dnevna doza od 3,9 mg/kg bila je propisana pedijatrijskom bolesniku na dijalizi u kliničkom ispitivanju, uz naknadnu blagu bol u trbuhu, mučninu i povraćanje.
English: Effect of other medications on cinacalcet
Croatian: Učinak drugih lijekova na cinakalcet
English: PHARMACEUTICAL FORM AND CONTENTS Granules in capsules for opening 30 capsules
Croatian: OBLIK I SADRŽAJ Granule u kapsulama za otvaranje 30 kapsula
English: iPTH concentrations from baseline were reduced by ≥ 30% in 71% (12 out of 17) of patients in the study.
Croatian: Početna vrijednost iPTH-a smanjena je za ≥ 30 % u 71 % (12 od 17) bolesnika u ispitivanju.
English: Smoking: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-mediated metabolism.
Croatian: Pušenje: Klirens cinakalceta veći je u pušača nego kod nepušača, najvjerojatnije zbog indukcije metabolizma posredovanog putem CYP1A2.
English: Patients receiving concomitant medications known to prolong the corrected QT interval were excluded from the study.
Croatian: Bolesnici koji su istodobno primjenjivali lijekove za koje je poznato da produljuju korigirani QT interval bili su isključeni iz ispitivanja.
English: Mimpara should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Mimpara se smije koristiti tijekom trudnoće samo ako moguća korist nadmašuje mogući rizik za fetus.
English: Mimpara is also available as tablets.
Croatian: Mimpara je također dostupna u obliku tableta.
English: You should not receive Mimpara together with etelcalcetide.
Croatian: Ne smijete uzimati lijek Mimpara zajedno s etelkalcetidom.
English: Mimpara contains lactose
Croatian: Mimpara sadrži laktozu
English: The recommended starting dose for children aged ≥ 3 years to < 18 years is ≤ 0.20 mg/kg once daily based on the patient's dry weight (see table 1).
Croatian: Preporučena početna doza za djecu u dobi ≥ 3 godine do < 18 godina je ≤ 0,20 mg/kg jednom dnevno na temelju suhe tjelesne težine bolesnika (vidjeti Tablicu 1).
English: - The active substance is cinacalcet.
Croatian: - Djelatna tvar je cinakalcet.
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Croatian: Dokazano je da cinakalcet prolazi placentarnu barijeru u kunića.
English: Seventeen patients received at least one dose of cinacalcet and 11 completed at least 12 weeks of treatment.
Croatian: Sedamnaest (17) bolesnika je primilo najmanje jednu dozu cinakalceta, a 11 je završilo najmanje 12 tjedana liječenja.
English: Do not swallow the capsules whole.
Croatian: Nemojte progutati kapsule cijele.
English: The starting dose of cinacalcet was 0.20 mg/kg.
Croatian: Početna doza cinakalceta bila je 0,20 mg/kg.
English: Effect of cinacalcet on other medications
Croatian: Učinak cinakalceta na druge lijekove
English: If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Mimpara and during treatment with Mimpara.
Croatian: Ako Vam je potrebno liječenje za sekundarni hiperparatireoidizam, Vaš bi liječnik trebao kontrolirati vrijednosti kalcija prije početka liječenja lijekom Mimpara i za vrijeme liječenja lijekom Mimpara.
English: Flush with adequate volume for the used enteral tube.
Croatian: Treba isprati dovoljnom količinom tekućine predviđenom za korištenu enteralnu cjevčicu.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: The capsules should not be swallowed.
Croatian: Kapsule se ne smiju progutati.
English: Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Croatian: Cinakalcet je kalcimimetik koji direktno smanjuje vrijednost PTH-a, povećavajući osjetljivost receptora za izvanstanični kalcij.
English: Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Croatian: Mimpara može biti dio terapijskog režima koji uključuje tvari koje vežu fosfate i/ili vitamin D, kao što je preporučeno (vidjeti dio 5.1).
English: If you experience these side effects, do not drive or operate machines.
Croatian: Ako ste imali navedene nuspojave, ne upravljajte vozilom ili strojevima.
English: They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.
Croatian: Ovalnog su oblika i imaju oznaku „30“, „60“ ili „90“ na jednoj i „AMG“ na drugoj strani.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci.
English: • 4 to 6 capsules a day use at least 2 tablespoons (30 mL)
Croatian: • 4 do 6 kapsula dnevno najmanje 2 jušne žlice (30 ml)
English: Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis without adverse outcome.
Croatian: Doze titrirane do 300 mg jednom dnevno bile su primijenjene kod odraslih bolesnika na dijalizi bez štetnih ishoda.
English: • Povidone
Croatian: • povidon
English: Mixing granules in water for oral use is not recommended as it may lead to a bitter taste.
Croatian: Miješanje granula s vodom za primjenu kroz usta nije preporučljivo jer može ostaviti gorak okus lijeka.
English: • Magnesium stearate
Croatian: • magnezijev stearat
English: What Mimpara contains - The active substance is cinacalcet.
Croatian: Što Mimpara sadrži - Djelatna tvar je cinakalcet.
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Croatian: Mjera primarnog ishoda ispitivanja bila je smanjenje serumskog kalcija za ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: Both primary and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Croatian: Oba, i primarni i sekundarni hiperparatireoidizam mogu uzrokovati gubitak kalcija iz kosti, što može biti uzrok bolova u kostima i prijeloma, poremećaja krvi i oštećenja srčanih krvnih žila, nastanka bubrežnih kamenaca, psihičkih poremećaja i kome.
English: Mimpara may affect how medicines such as the following work:
Croatian: Mimpara može utjecati na djelovanje sljedećih lijekova:
English: The safety and efficacy of Mimpara in children aged less than 3 years for the treatment of secondary hyperparathyroidism have not been established.
Croatian: Sigurnost i djelotvornost lijeka Mimpara u djece mlađe od 3 godine za liječenje sekundarnog hiperparatireoidizma nisu još ustanovljene.
English: Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Croatian: Kako se cinakalcet u visokoj mjeri veže za proteine, hemodijaliza nije učinkovita u liječenju predoziranja.
English: Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
Croatian: Na osnovi in vitro podataka, cinakalcet je snažan inhibitor CYP2D6, ali nije inhibitor drugih CYP enzima u koncentracijama koje se postižu kliničkom primjenom, uključujući CYP1A2, CYP2C8, CYP2C9, CYP2C19 i CYP3A4 niti je induktor CYP1A2, CYP2C19 i CYP3A4.
English: • If iPTH is < 150 pg/mL (15.9 pmol/L) and ≥ 100 pg/mL (10.6 pmol/L), decrease the dose of Mimpara to the next lower dose.
Croatian: • Ako je iPTH < 150 pg/ml (15,9 pmol/l) i ≥ 100 pg/ml (10,6 pmol/l), sniziti dozu lijeka Mimpara na sljedeću nižu dozu.
English: • Gently squeeze the top and twist slightly to remove, taking care not to spill the contents.
Croatian: • Lagano stisnite kapicu i polako odvrnite za otvaranje, pritom pazeći da ne prosipate sadržaj.
English: 10, 15, 30, 60, 90, and 120 15, 30, 60, 90, 120, and 180
Croatian: 10, 15, 30, 60, 90 i 120 15, 30, 60, 90, 120 i 180
English: Overdose of Mimpara may lead to hypocalcaemia.
Croatian: Predoziranje lijekom Mimpara može uzrokovati hipokalcemiju.
English: The normal calcium range may differ depending on the methods used by your local laboratory.
Croatian: Granice referentnih vrijednosti kalcija mogu se razlikovati ovisno o metodama koje koristi lokalni laboratorij.
English: The dose of Mimpara should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Croatian: Dozu lijeka Mimpara treba titrirati svaka 2 do 4 tjedna, u sekvencijalnim dozama od 30 mg dva puta dnevno, 60 mg dva puta dnevno, 90 mg dva puta dnevno i 90 mg tri ili četiri puta dnevno, prema potrebi kako bi se snizile vrijednosti serumskog kalcija do gornje granice referentnih vrijednosti ili ispod nje.
English: Patients receiving Mimpara should not be given etelcalcetide (see section 4.4).
Croatian: Bolesnicima koji primaju lijek Mimpara ne smije se dati etelkalcetid (vidjeti dio 4.4).
English: • Amorphous silicon dioxide
Croatian: • amorfni silicijev dioksid
English: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of all-cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis.
Croatian: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) je bilo randomizirano, dvostruko slijepo, kliničko ispitivanje u kojem se procjenjivao cinakalcet naspram placeba u smanjenju rizika od mortaliteta svih uzroka i kardiovaskularnih događaja u 3883 bolesnika sa sekundarnim hiperparatireoidizmom i kroničnom bolešću bubrega na dijalizi.
English: • For patients who have nasogastric or gastrostomy tubes, the granules can be administered with a small amount (at least 5 mL) of water using PVC tubing.
Croatian: • Bolesnici koji imaju ugrađenu nazogastričnu sondu ili gastrostomu mogu primijeniti granule uz malu količinu (najmanje 5 ml) vode putem PVC cjevčice.
English: What you need to know before you take Mimpara Do not take Mimpara if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Mimpara ako ste alergični na cinakalcet ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): Cinacalcet is a strong inhibitor of CYP2D6.
Croatian: Lijekovi koje metabolizira enzim P450 2D6 (CYP2D6): Cinakalcet je jak inhibitor enzima CYP2D6.
English: The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
Croatian: Granice referentnih vrijednosti kalcija mogu se razlikovati ovisno o metodama koje koristi lokalni laboratorij i dobi djeteta/bolesnika.
English: Mimpara with food and drink Mimpara should be taken with or shortly after food.
Croatian: Mimpara s hranom i pićem Lijek Mimpara treba uzeti s hranom ili neposredno nakon obroka.
English: †see section 4.4 *see section c c) Description of selected adverse reactions
Croatian: †vidjeti dio 4.4 *vidjeti dio c c)
English: Reduction of hypercalcaemia in adult patients with:
Croatian: Smanjenje hiperkalcijemije u odraslih bolesnika s:
English: Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Croatian: Cinakalcet se metabolizira putem više enzima, pretežno s CYP3A4 i CYP1A2 (doprinos CYP1A2 nije klinički okarakteriziran).
English: • a medicine used to treat high blood pressure (metoprolol).
Croatian: • lijeka koji se koristi za liječenje visokoga krvnog tlaka (metoprolol).
English: • Over a clean work surface remove from the bottle the number of capsules your doctor or pharmacist told you to use.
Croatian: • Iznad čiste radne površine istresite iz bočice broj kapsula koji
English: Renal Insufficiency: The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers.
Croatian: Renalna insuficijencija: Farmakokinetički profil cinakalceta u bolesnika s blagom, umjerenom i teškom renalnom insuficijencijom, kao i u bolesnika na hemodijalizi ili peritonejskoj dijalizi, usporediv je s onim u zdravih dobrovoljaca.
English: The capsules have a white body and coloured caps “1 mg” (dark green cap), “2.5 mg” (yellow cap) or “5 mg” (blue cap) marked on one side and “AMG” on the other side.
Croatian: Kapsule imaju bijelo tijelo i obojene kapice s oznakom „1 mg“ (tamnozelena kapica), „2,5 mg“ (žuta kapica) ili „5 mg“ (plava kapica) na jednoj strani i oznakom „AMG“ na drugoj strani.
English: For patients who cannot swallow, you can administer the granules through a tube into the stomach (“nasogastric” or “gastrostomy” tubes, made of polyvinylchloride) in a small amount of water (at least 5 mL).
Croatian: Za bolesnike koji ne mogu gutati, granule se mogu primijeniti putem cjevčice u želudac (tzv. ”nazogastrična sonda” ili ”gastrostoma”, izrađena od polivinilklorida) uz malu količinu vode (najmanje 5 ml).
English: Cinacalcet is metabolised in part by the enzyme CYP3A4.
Croatian: Cinakalcet se djelomično metabolizira pomoću enzima CYP3A4.
English: Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Mimpara.
Croatian: Djeca mlađa od 18 godina s karcinomom paratireoidnih žlijezda i primarnim hiperparatireoidizmom ne smiju uzimati lijek Mimpara.
English: Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment.
Croatian: Sniženje iPTH-a i Ca x P održalo se tijekom 12 mjeseci liječenja.
English: 25 subjects received at least one dose of cinacalcet and the mean maximum daily dose of cinacalcet was 0.55 mg/kg/day.
Croatian: Dvadesetpet (25) ispitanika je primilo najmanje jednu dozu cinakalceta, a srednja maksimalna dnevna doza cinakalceta bila je 0,55 mg/kg/dan.
English: Ensure serum calcium levels are within the normal range before Mimpara is initiated (see sections 4.4 and 4.8).
Croatian: Uvjerite se da su razine serumskog kalcija unutar normalnog raspona prije početka davanja lijeka Mimpara (vidjeti dijelove 4.4 i 4.8).
English: • Make sure remaining content from the top is also emptied on the food or liquid.
Croatian: • Uvjerite se da je preostali sadržaj iz gornjeg dijela kapsule također ispražnjen na hranu ili tekućinu.
English: A small bowl, cup or spoon with soft food (such as apple sauce or yogurt) or liquid (such as apple juice or renal infant formula).
Croatian: Zdjelica, šalica ili žlica mekane hrane (npr. jabučni pire ili jogurt) ili tekućine (npr. jabučni sok ili početna hrana za dojenčad s bubrežnim oboljenjima).
English: The safety and efficacy of Mimpara in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established.
Croatian: Sigurnost i djelotvornost lijeka Mimpara u djece za liječenje paratireoidnog karcinoma i primarnog hiperparatireoidizma nisu ustanovljene.
English: The mean dry weight at baseline was 12 kg.
Croatian: Srednja suha težina na početku ispitivanja bila je 12 kg.
English: After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Croatian: Nakon peroralne primjene lijeka Mimpara, maksimalna koncentracija cinakalceta u plazmi postiže se nakon otprilike 2 do 6 sati.
English: Dose adjustment based on PTH levels
Croatian: Prilagodba doze na temelju vrijednosti PTH-a
English: The switch from etelcalcetide to Mimpara and the appropriate wash out period has not been studied in patients.
Croatian: Prelazak s etelkalcetida na lijek Mimpara i odgovarajuće razdoblje ispiranja lijeka nije ispitano u bolesnika.
English: If you have forgotten a dose of Mimpara, you should take your next dose as normal.
Croatian: Ako zaboravite uzeti dozu lijeka Mimpara, nastavite sa sljedećom redovnom dozom.
English: Mimpara is also available as granules for paediatric use.
Croatian: Mimpara je također dostupna u obliku granula za pedijatrijsku primjenu.
English: Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum human dose for secondary HPT (180 mg daily).
Croatian: Cinakalcet nije imao teratogeno djelovanje kod kunića kojima je dana doza od 0,4 puta maksimalne humane doze za sekundarni HPT (180 mg dnevno) na osnovi AUC.
English: Dose adjustment in paediatric patients ≥ 3 to < 18 years of age Corrected Serum calcium value or clinical symptoms of hypocalcaemia
Croatian: Tablica 2. Prilagodba doze u pedijatrijskih bolesnika u dobi od ≥ 3 do < 18 godina Korigirana vrijednost serumskog kalcija ili klinički simptomi hipokalcemije
English: In patients who have discontinued etelcalcetide, Mimpara should not be initiated until at least three subsequent haemodialysis sessions have been completed, at which time serum calcium should be measured.
Croatian: U bolesnika koji su prestali uzimati etelkalcetid, lijek Mimpara ne smije se početi uzimati sve dok se ne završe najmanje tri uzastopne hemodijalize, nakon čega treba izmjeriti serumski kalcij.
English: Closely monitor serum calcium levels (see section 4.2) and patient compliance during treatment with cinacalcet.
Croatian: Pomno pratite vrijednosti serumskog kalcija (vidjeti dio 4.2) i suradljivost bolesnika tijekom liječenja cinakalcetom.
English: • 1 to 3 capsules a day use at least 1 tablespoon (15 mL)
Croatian: • 1 do 3 kapsule dnevno najmanje 1 jušna žlica (15 ml)
English: • reduced testosterone levels
Croatian: • snižena vrijednost testosterona
English: The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto-induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Croatian: Izostanak učinka cinakalceta na farmakokinetiku R- i S-varfarina i izostanak autoindukcije nakon višestrukih doza u bolesnika, ukazuje da cinakalcet nije induktor CYP3A4, CYP1A2 ili CYP2C9 kod ljudi.
English: The study consisted of a 24-week dose titration period followed by a 6-week efficacy assessment phase (EAP), and a 30-week openlabel extension.
Croatian: Ispitivanje se sastojalo od perioda titracije doze u trajanju od 24 tjedna, nakon čega je uslijedila faza ocjene djelotvornosti u trajanju od 6 tjedana, te otvoreni nastavak ispitivanja u trajanju od 30 tjedana.
English: Mimpara should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/mL (15.9-31.8 pmol/L) in the intact PTH (iPTH) assay.
Croatian: Dozu lijeka Mimpara treba titrirati svaka 2 do 4 tjedna, do maksimalne doze od 180 mg, primijenjene jednom dnevno da bi se u dijaliznih bolesnika postigla ciljna vrijednost paratireoidnog hormona (PTH) između 150 i 300 pg/ml (15,9-31,8 pmol/l), u testu intaktnog PTH (iPTH).
English: If serum calcium levels decrease below the normal range or symptoms of hypocalcaemia occur, appropriate dose adjustment steps should be taken as shown in table 2 below:
Croatian: Ako se vrijednost serumskog kalcija spusti ispod granica referentnih vrijednosti ili nastupe simptomi hipokalcemije, potrebno je provesti odgovarajuće korake prilagodbe doze kako je prikazano u Tablici 2 niže: