FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric Population: The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age.
Slovenian: Pediatrična populacija: Farmakokinetiko cinakalceta so raziskali pri pediatričnih bolnikih s končno odpovedjo ledvic, zdravljenih z dializo, starih od 3 do 17 let.
English: Mimpara granules can be administered orally or through nasogastric or gastrostomy tubes.
Slovenian: Zrnca zdravila Mimpara je mogoče uporabiti peroralno ali po nazogastrični ali gastrostomijski sondi.
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.
Slovenian: Pri bolnikih, ki so se prenehali zdraviti z etelkalcetidom, se zdravila Mimpara ne sme uvesti tako dolgo, dokler niso opravljeni vsaj trije nadaljnji postopki hemodialize.
English: Each bottle contains 30 capsules.
Slovenian: Ena plastenka vsebuje 30 kapsul.
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/013 - 1 mg capsules for opening EU/1/04/292/014 - 2.5 mg capsules for opening EU/1/04/292/015 - 5 mg capsules for opening
Slovenian: EU/1/04/292/013 - 1 mg kapsule za odpiranje EU/1/04/292/014 - 2,5 mg kapsule za odpiranje EU/1/04/292/015 - 5 mg kapsule za odpiranje
English: 90 mg tablets are approximately 13.9 mm long and 8.7 mm wide.
Slovenian: 90 mg tablete so približno 13,9 mm dolge in 8,7 mm široke.
English: 60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
Slovenian: 60 mg tablete so približno 12,2 mm dolge in 7,6 mm široke.
English: Capsule Printing ink: iron oxide black, shellac, propylene glycol
Slovenian: Kapsula Črnilo: črni železov oksid, šelak, propilenglikol
English: High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton.
Slovenian: Plastenka iz polietilena velike gostote (HDPE) z bombažnim navojem ter za otroke varno polipropilensko zaporko z indukcijskim pečatom, pakirana v škatli.
English: They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.
Slovenian: Tablete so ovalne oblike in imajo na eni strani oznako "30", "60" ali "90", na drugi strani pa napis "AMG".
English: Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Slovenian: Kalcijev karbonat: Sočasna uporaba kalcijevega karbonata (posamičen 1.500 mg odmerek) ni spremenila farmakokinetike cinakalceta.
English: In patients with parathyroid carcinoma, mean serum calcium declined from 14.1 mg/dL to 12.4 mg/dL (3.5 mmol/L to 3.1 mmol/L), while in patients with primary HPT, serum calcium levels declined from 12.7 mg/dL to 10.4 mg/dL (3.2 mmol/L to 2.6 mmol/L).
Slovenian: Pri bolnikih s paratiroidnim karcinomom se je povprečna koncentracija kalcija v serumu znižala s 14,1 mg/dl na 12,4 mg/dl (s 3,5 mmol/l na 3,1 mmol/l), pri bolnikih s primarnim hiperparatiroidizmom pa se je koncentracija kalcija v serumu znižala z 12,7 mg/dl na 10,4 mg/dl (s 3,2 mmol/l na 2,6 mmol/l).
English: The efficacy and safety of cinacalcet for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study.
Slovenian: Učinkovitost in varnost cinakalceta za zdravljenje sekundarnega HPT pri pediatričnih bolnikih s končno odpovedjo ledvic na dializnem zdravljenju so ocenili v dveh randomiziranih kontroliranih študijah in v eni študiji z eno samo skupino.
English: The safety of Mimpara for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study (see section 5.1).
Slovenian: Varnost zdravila Mimpara za zdravljenje sekundarnega HPT pri pediatričnih bolnikih s končno odpovedjo ledvic na dializnem zdravljenju so ocenili v dveh randomiziranih kontroliranih študijah in v eni študiji z eno samo skupino (glejte poglavje 5.1).
English: Therefore, serum calcium levels should be closely monitored in patients receiving Mimpara, particularly in patients with a history of a seizure disorder.
Slovenian: Zato je treba bolnikom, ki prejemajo zdravilo Mimpara, natančno kontrolirati koncentracijo kalcija v serumu, to pa še posebej velja za bolnike z anamnezo konvulzivnih motenj.
English: Elderly: There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Slovenian: Starejši: V farmakokinetiki cinakalceta ni klinično pomembnih razlik glede na starost.
English: 30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.
Slovenian: 30 mg tablete so približno 9,7 mm dolge in 6,0 mm široke.
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class
Slovenian: Pogostnosti neželenih učinkov iz kontroliranih kliničnih študij in iz obdobja trženja zdravila so:
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.
Slovenian: V klinični študiji so pri pediatričnem bolniku, zdravljenem z dializo, predpisali dnevni odmerek 3,9 mg/kg, ki je nato doživel blago bolečino v želodcu, navzeo in bruhanje.
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.
Slovenian: Posledice so lahko bolečine v kosteh in zlomi kosti, težave s krvnimi in srčnimi žilami, ledvični kamni, duševna bolezen in koma.
English: A significantly higher percentage of cinacalcet-treated patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dL (2.57 mmol/L) and ≥ 1 mg/dL (0.25 mmol/L) decrease from baseline in mean corrected total serum calcium concentration, when compared with the placebo-treated patients (75.8% versus 0% and 84.8% versus 5.9% respectively).
Slovenian: V primerjavi z bolniki, ki so prejemali placebo, je signifikatno večji delež bolnikov, ki so prejemali cinakalcet, dosegel povprečno korigirano celotno koncentracijo kalcija v serumu ≤ 10,3 mg/dl (2,57 mmol/l) in ≥ 1 mg/dl (0,25 mmol/l) znižanje od povprečne korigirane celotne koncentracije kalcija v serumu v primerjavi z izhodiščem (75,8 % v primerjavi z 0 % in 84,8 % v primerjavi s 5,9 %).
English: • medicines used to treat changes in heart rate (flecainide and propafenone);
Slovenian: • zdravila za zdravljenje motenj srčnega ritma (flekainid in propafenon),
English: The capsules are provided in High Density Polyethylene (HDPE) bottle with a foil induction seal and a child-resistant polypropylene cap, packed into a carton.
Slovenian: Kapsule so opremljene v plastenkah iz polietilena visoke gostote (HDPE) z indukcijsko zapečateno folijo in za otroke varno polipropilensko zaporko, pakiranih v škatlah.
English: Withhold administration of Mimpara until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved.
Slovenian: Odložite uporabo zdravila Mimpara, dokler koncentracija kalcija v serumu ne doseže 8,0 mg/dl (2,0 mmol/l) in/ali dokler simptomi hipokalciemije ne izginejo.
English: Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis without adverse outcome.
Slovenian: Z dializo zdravljeni odrasli bolniki so dobivali odmerke, titrirane do 300 mg enkrat na dan, brez neželenih učinkov.
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).
Slovenian: Kapsulo je treba prijeti tako, da je obarvani del zgoraj, in obnjo rahlo potrkati, da se vsebina pomakne v spodnji del kapsule (beli del kapsule).
English: • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer.
Slovenian: • za zmanjšanje zvišane koncentracije kalcija v krvi (hiperkalciemije) pri odraslih bolnikih z rakom obščitnic,
English: • Tap the capsule gently so the contents settle on the bottom of the capsule (white part of capsule).
Slovenian: • Rahlo potrkajte ob kapsulo, da se njena vsebina pomakne v spodnji (beli) del kapsule.
English: • to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products, whose condition is not controlled with other treatments.
Slovenian: • za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resno boleznijo ledvic, ki za odstranjevanje odpadnih snovi iz krvi potrebujejo dializo in stanja nimajo urejenega z drugimi zdravljenji.
English: In one study,46 adult patients (29 with parathyroid carcinoma and 17 with primary HPT and severe hypercalcaemia who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
Slovenian: V eni študiji je 46 odraslih bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom in hudo hiperkalciemijo, pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 let (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
English: Granules are provided in capsules for opening.
Slovenian: Zrnca so na voljo v kapsulah za odpiranje.
English: Administer Mimpara with caution in patients receiving any other medicinal products known to lower serum calcium.
Slovenian: Zdravilo Mimpara je treba previdno uporabljati pri bolnikih, ki prejemajo kakšna druga zdravila, ki znižujejo kalcij v serumu.
English: Dose adjustment of Mimpara may be required if a patient receiving Mimpara initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme.
Slovenian: Če bolnik, ki dobiva zdravilo Mimpara, začne ali preneha uporabljati terapijo z močnim zaviralcem tega encima (npr. ketokonazolom, itrakonazolom, telitromicinom, vorikonazolom, ritonavirjem) ali njegovim induktorjem (npr. rifampicinom), je lahko potrebna prilagoditev odmerka zdravila Mimpara.
English: Administration of Mimpara with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Slovenian: Zaužitje zdravila Mimpara s hrano poveča biološko uporabnost cinakalceta za približno 50-80 %.
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);
Slovenian: • zdravila za zdravljenje kožnih in glivičnih okužb (ketokonazol, itrakonazol in vorikonazol),
English: • Magnesium stearate
Slovenian: • magnezijev stearat,
English: • Titanium dioxide (E171) (1 mg, 2.5 mg and 5 mg capsules)
Slovenian: • titanov dioksid (E171) (1 mg, 2,5 mg in 5 mg kapsule)
English: Dispose of the capsule shells.
Slovenian: Ovojnico kapsule zavrzite.
English: Concurrent administration of other medicinal products known to reduce serum calcium and Mimpara may result in an increased risk of hypocalcaemia (see section 4.4).
Slovenian: Sočasna uporaba drugih zdravil, ki zmanjšujejo koncentracijo kalcija v serumu, in zdravila Mimpara lahko poveča tveganje za hipokalciemijo (glejte poglavje 4.4).
English: ≥ 36 to < 50
Slovenian: ≥ 36 do < 50
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Slovenian: • otekanje obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave s požiranjem ali dihanjem
English: • to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products.
Slovenian: • za zdravljenje sekundarnega hiperparatiroidizma pri odraslih bolnikih z resno boleznijo ledvic, ki za odstranjevanje odpadnih snovi iz krvi potrebujejo dializo,
English: Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
Slovenian: Dezipramin: Sočasna uporaba 90 mg cinakalceta enkrat na dan in 50 mg dezipramina (tricikličnega antidepresiva, ki se primarno presnavlja s CYP2D6) je pri izrazitih metabolizatorjih s CYP2D6 izpostavljenost dezipraminu povečala značilno, in sicer za 3,6-krat (90 % IZ: 3,0, 4,4).
English: Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate,
Slovenian: Opadry II zelena: (laktoza monohidrat, hipromeloza, titanov dioksid (E171), triacetin, indigotin
English: Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
Slovenian: Med možnimi znaki prevelikega odmerjanja so omrtvelost ali mravljinčenje okrog ust, bolečine ali krči v mišicah in napadi krčev.
English: Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Slovenian: Pantoprazol: Sočasna uporaba pantoprazola (80 mg na dan) ni spremenila farmakokinetike cinakalceta.
English: Mimpara should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z zmerno do hudo okvaro jeter je treba zdravilo Mimpara uporabljati previdno, zdravljenje pa je treba med titriranjem odmerka in nadaljevanjem zdravljenja natančno nadzirati (glejte poglavji 4.4 in 5.2).
English: Co-administration of 200 mg bid ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
Slovenian: Sočasna uporaba 200 mg ketokonazola (močnega zaviralca CYP3A4) dvakrat na dan je povzročila približno 2-kraten porast koncentracije cinakalceta.
English: • Indigo carmine (E132) (1 mg and 5 mg capsules)
Slovenian: • indigotin (E132) (1 mg in 5 mg kapsule)
English: Mimpara is also available as granules in capsules for opening.
Slovenian: Zdravilo Mimpara je na voljo tudi v obliki zrnc v kapsulah za odpiranje.
English: Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).
Slovenian: Zdravljenje sekundarnega hiperparatiroidizma (HPT) pri otrocih, starih 3 leta ali več, s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju, ki sekundarnega HPT nimajo ustrezno urejenega z običajnim zdravljenjem (glejte poglavje 4.4).
English: Sevelamer: Co-administration of sevelamer (2,400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Slovenian: Sevelamer: Sočasna uporaba sevelamera (2.400 mg trikrat na dan) ni vplivala na farmakokinetiko cinakalceta.
English: Ensure serum calcium levels are within the normal range before Mimpara is initiated (see sections 4.4 and 4.8).
Slovenian: Pred uvedbo zdravila Mimpara se prepričajte, da je koncentracija kalcija v serumu v normalnem območju (glejte poglavji 4.4 in 4.8).
English: • Printing ink: iron oxide black, shellac, propylene glycol
Slovenian: • črnilo: črni železov oksid, šelak, propilenglikol,
English: None had corrected serum calcium < 8.4 mg/dL (2.1 mmol/L) for ages 2-5 years.
Slovenian: Nobeden v starosti od 2 do 5 let ni imel korigiranega kalcija v serumu < 8,4 mg/dl (2,1 mmol/l).
English: Parathyroid carcinoma and primary hyperparathyroidism in adults
Slovenian: Paratiroidni karcinom in primarni hiperparatiroidizem pri odraslih
English: INFORMATION IN BRAILLE mimpara 1 mg
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 1 mg
English: INFORMATION IN BRAILLE mimpara 2.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI mimpara 2,5 mg
English: Corrected serum calcium is at or below age-specified lower limit of normal or if symptoms of hypocalcaemia occur, regardless of calcium level.
Slovenian: Korigirani kalcij v serumu je na spodnji meji za starost normalnega območja ali pod njo ali če se pojavijo simptomi hipokalciemije, ne glede na koncentracijo kalcija
English: • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
Slovenian: • Opadry zeleno (vsebuje laktozo monohidrat, hipromelozo, titanov dioksid (E171), gliceroltriacetat, indigotin (E132) in rumeni železov oksid (E172)),
English: • Iron oxide yellow (E172) (1 mg and 2.5 mg capsules)
Slovenian: • rumeni železov oksid (E172) (1 mg in 2,5 mg kapsule)
English: Eighteen (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Slovenian: Osemnajstim (18) od 29 bolnikov (62 %) s paratiroidnim karcinomom in 15 od 17 preiskovancev (88 %) s primarnim hiperparatiroidizmom se je kalcij v serumu znižal za ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: How to take Mimpara
Slovenian: Kako jemati zdravilo Mimpara
English: Mimpara should only be initiated for the treatment of secondary HPT in children ≥ 3 years old with ESRD on maintenance dialysis therapy, in whom secondary HPT is not adequately controlled with standard of care therapy, where serum calcium is in the upper range of, or above, the age-specified reference interval.
Slovenian: Zdravilo Mimpara se sme uvesti za zdravljenje sekundarnega HPT pri otrocih, starih ≥ 3 let, s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju, ki sekundarnega HPT nimajo ustrezno urejenega z običajnim zdravljenjem, le če ima kalcij v serumu v zgornjem razponu ali nad referenčnim intervalom, ki je specifičen za starost.
English: • muscle pain (myalgia)
Slovenian: • bolečina v mišici (mialgija),
English: Instructions for taking Mimpara granules
Slovenian: Navodila za jemanje zrnc zdravila Mimpara
English: Cases of seizures have been reported in patients treated with Mimpara (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Mimpara, so poročali o primerih konvulzij (glejte poglavje 4.8).
English: PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
Slovenian: PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka zdravila Mimpara.
English: The mean dry weight at baseline was 12 kg.
Slovenian: Povprečna izhodiščna pusta telesna masa je bila 12 kg.
English: ≥ 50 to < 75
Slovenian: ≥ 50 do < 75
English: White to off-white granules in capsules for opening.
Slovenian: Bela ali skoraj bela zrnca v kapsulah za odpiranje.
English: Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/mL (77.8 and 72.4 pmol/L) for the cinacalcet and placebo groups, respectively.
Slovenian: Povprečna izhodiščna koncentracija iPTH za vse 3 študije je bila v skupinah s cinakalcetom 733 pg/ml (77,8 pmol/l) in v skupinah s placebom 683 pg/ml (72,4 pmol/l).
English: The mean serum calcium levels during the EAP were within the normal range for the cinacalcet treatment group.
Slovenian: Povprečna koncentracija kalcija v serumu je bila med EAP v skupini s cinakalcetom v normalnem območju.
English: • Gelatin
Slovenian: • želatino
English: Corrected Serum calcium value or clinical symptoms of hypocalcaemia
Slovenian: Vrednost korigiranega kalcija v serumu ali klinični simptomi hipokalciemije
English: Mimpara is available in bottles of 1 mg, 2.5 mg or 5 mg capsules, inside a carton.
Slovenian: Zdravilo Mimpara je na voljo v plastenkah z 1 mg, 2,5 mg ali 5 mg kapsulami, plastenka je v škatli.
English: ≥ 25 to < 36
Slovenian: ≥ 25 do < 36
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.9 (0.5) mg/dL for the cinacalcet group and 9.9 (0.6) mg/dL for the placebo group.
Slovenian: Povprečna (standardni odklon) korigirana koncentracija celokupnega kalcija v serumu je bila izhodiščno 9,9 (0,5) mg/dl v skupini s cinakalcetom in 9,9 (0,6) mg/dl v skupini s placebom.
English: Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules.
Slovenian: Otroci, ki potrebujejo odmerke, manjše od 30 mg, in otroci, ki ne morejo pogoltniti tablet, morajo dobiti zdravilo Mimpara v obliki zrnc.
English: Each 90 mg tablet contains 8.21 mg of lactose.
Slovenian: Mimpara 90 mg filmsko obložene tablete Ena 90 mg tableta vsebuje 8,21 mg laktoze.
English: • Crospovidone
Slovenian: • krospovidon,
English: (Hypromellose, macrogol)
Slovenian: Opadry prozorna: (hipromeloza, makrogol)
English: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
Slovenian: Granule predgelirani škrob (koruzni) mikrokristalna celuloza povidon krospovidon amorfni silicijev dioksid
English: Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Slovenian: Zdravljenje sekundarnega hiperparatiroidizma (HPT) pri odraslih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju.
English: PTH levels should be assessed at least 12 hours after dosing with Mimpara and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
Slovenian: Prilagoditev odmerka glede na koncentracijo PTH Med odmerjanjem zdravila Mimpara in meritvijo koncentracije PTH mora miniti vsaj 12 ur, iPTH pa je treba izmeriti od 1 do 4 tedne po uvedbi ali prilagoditvi odmerka zdravila Mimpara.
English: PHARMACEUTICAL FORM AND CONTENTS One bottle containing 30 tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Ena plastenka vsebuje 30 tablet.
English: Anorexia Decreased appetite
Slovenian: Presnovne in prehranske motnje pogosti anoreksija zmanjšanje apetita
English: • If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures.
Slovenian: • če se vam začnejo pojavljati omrtvelost ali mravljinčenje okrog ust, bolečine v mišicah ali krčiin konvulzije.
English: Different strengths of granules should not be mixed, in order to avoid dosing errors.
Slovenian: Da bi preprečili napake pri odmerjanju, se ne sme mešati zrnc različnih jakosti.
English: What Mimpara looks like and contents of the pack Mimpara granules are white to off-white in appearance and are presented in capsules for opening.
Slovenian: Zrnca zdravila Mimpara so bela ali skoraj bela in so na voljo v kapsulah za odpiranje.
English: Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once daily dosing interval.
Slovenian: Ko začne koncentracija cinakalceta upadati, se koncentracija PTH zvišuje do 12 ur po odmerku zdravila, nato ostane supresija PTH približno stalna do konca odmernega intervala enkrat na dan. Koncentracijo PTH so v kliničnih preskušanjih zdravila Mimpara merili na koncu odmernega intervala.
English: Each 60 mg tablet contains 5.47 mg of lactose.
Slovenian: Mimpara 60 mg filmsko obložene tablete Ena 60 mg tableta vsebuje 5,47 mg laktoze.
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Slovenian: To so lahko znakiprenizke koncentracije kalcija (hipokalciemija).
English: 5, 10, 15, 30, 60, and 90
Slovenian: 5; 10; 15; 30; 60 in 90
English: (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Slovenian: Osemnajstim od 29 bolnikov (62 %) s paratiroidnim karcinomom in 15 od 17 preiskovancev (88 %) s primarnim hiperparatiroidizmom se je kalcij v serumu znižal za ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate and severe hepatic impairment, respectively.
Slovenian: Pri bolnikih z zmerno okvaro jeter je povprečni razpolovni čas cinakalceta podaljšan za 33 % in pri bolnikih s hudo okvaro jeter za 70 % .
English: 5, 10, 15, 30, and 60
Slovenian: 5; 10; 15; 30 in 60
English: Do not swallow the capsules whole.
Slovenian: Kapsul ne smete zaužiti celih.