FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, serum calcium levels should be closely monitored in patients receiving cinacalcet, particularly in patients with a history of a seizure disorder.
Slovenian: Zato je treba bolnikom, ki prejemajo cinakalcet, natančno kontrolirati koncentracijo kalcija v serumu, to pa še posebej velja za bolnike z anamnezo konvulzivnih motenj.
English: Other medicines and Cinacalcet Mylan
Slovenian: Druga zdravila in zdravilo Cinakalcet Mylan
English: The threshold for seizures is lowered by significant reductions in serum calcium levels.
Slovenian: Prag za konvulzije se zniža s pomembnim znižanjem koncentracije kalcija v serumu.
English: A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 4.4).
Slovenian: Pri bolniku s hudo hipokalciemijo v pediatričnem kliničnem preskušanju so poročali o smrtnem izidu (glejte poglavje 4.4).
English: Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet 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 cinakalcet, 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 cinakalceta.
English: Administer cinacalcet with caution in patients receiving any other medicinal products known to lower serum calcium.
Slovenian: Cinakalcet je treba previdno uporabljati pri bolnikih, ki prejemajo kakšna druga zdravila, ki znižujejo kalcij v serumu.
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: Pantoprazole: Co-administration of pantoprazole (80 mg, once daily) did not alter the pharmacokinetics of cinacalcet.
Slovenian: Pantoprazol: Sočasna uporaba pantoprazola (80 mg na dan) ni spremenila armakokinetike cinakalceta.
English: Cinacalcet Mylan must be taken orally, with or shortly after food.
Slovenian: Zdravilo Cinakalcet Mylan morate zaužiti, in sicer s hrano ali kmalu po jedi.
English: Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of cinacalcet (see section 4.4).
Slovenian: Prilagoditev odmerka glede na koncentracijo kalcija v serumu Meriti in nadzirati je treba koncentracijo korigiranega kalcija v serumu, le-ta mora biti pred uporabo prvega odmerka cinakalceta na spodnji meji normalnega območja ali nad njo (glejte poglavje 4.4).
English: In pregnant rats, there were slight decreases in body weight and food consumption at the highest dose.
Slovenian: Ob največjem odmerku sta se rahlo zmanjšali telesna masa in uživanje hrane brejih podgan.
English: Concurrent administration may result in severe hypocalcaemia.
Slovenian: Sočasna uporaba lahko povzroči hudo hipokalciemijo.
English: Secondary hyperparathyroidism:
Slovenian: Sekundarni hiperparatiroidizem:
English: • seizures (fits or convulsions).
Slovenian: • napade krčev (epileptične napade ali konvulzije).
English: Administration of cinacalcet with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Slovenian: Zaužitje cinakalceta s hrano poveča biološko uporabnost cinakalceta za približno 50 - 80 %.
English: • muscle pain (myalgia)
Slovenian: • bolečine v mišici (mialgija),
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 presnavljalcih s CYP2D6 izpostavljenost dezipraminu povečala značilno, in sicer za 3,6-krat (90 % IZ: 3,0, 4,4).
English: Cinacalcet 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.
Slovenian: Priporočeni začetni odmerek za odrasle je 30 mg enkrat na dan. Cinakalcet titrirajte na 2 do 4 tedne do največjega odmerka 180 mg enkrat na dan, tako da pri bolnikih na dializi dosežete ciljno koncentracijo paratiroidnega hormona (PTH) med 150-300 pg/ml (15,9-31,8 pmol/l) izmerjeno s testom intaktnega PTH (iPTH).
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: • 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 krči in konvulzije.
English: Cinacalcet 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 cinakalcet uporabljati previdno, zdravljenje pa je treba med titriranjem odmerka in nadaljevanjem zdravljenja natančno nadzirati (glejte poglavji 4.4 in 5.2).
English: There are no clinical data from the use of cinacalcet in pregnant women.
Slovenian: O uporabi cinakalceta pri nosečnicah ni kliničnih podatkov.
English: 100 Film-coated tablets
Slovenian: filmsko obložena tableta 100 filmsko obloženih tablet
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet.
Slovenian: Kalcij v serumu je treba izmeriti v 1 tednu po začetku zdravljenja ali prilagoditvi odmerka cinakalceta.
English: 28 Film-coated tablets 28 x 1 Film-coated tablets 30 x 1 Film-coated tablets 84 x 1 Film-coated tablets 100 Film-coated tablets
Slovenian: 28 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta 100 filmsko obloženih tablet
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 cinakalceta merili na koncu odmernega intervala.
English: Medicinal products known to reduce serum calcium Concurrent administration of other medicinal products known to reduce serum calcium and cinacalcet may result in an increased risk of hypocalcaemia (see section 4.4).
Slovenian: Sočasna uporaba drugih zdravil, ki zmanjšujejo koncentracijo kalcija v serumu, in cinakalceta lahko poveča tveganje za hipokalciemijo (glejte poglavje 4.4).
English: 28 Film-coated tablets 28 x 1 Film-coated tablets 30 x 1 Film-coated tablets 84 x 1 Film-coated tablets
Slovenian: 28 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta
English: Testosterone levels are often below the normal range in patients with end-stage renal disease.
Slovenian: Pri bolnikih s končno odpovedjo ledvic je koncentracija testosterona pogosto pod normalnim območjem.
English: Discontinuation of therapy as a result of undesirable effects was mainly due to nausea and vomiting.
Slovenian: Navzea in bruhanje sta bila glavna razloga za prenehanje zdravljenja, ki je bilo posledica neželenih učinkov.
English: Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT receiving dialysis.
Slovenian: Podatki raziskovalnih študij pri bolnikih s kronično boleznijo ledvic in sekundarnim hiperparatiroidizmom brez dializnega zdravljenja kažejo, da cinakalcet zniža koncentracijo PTH v podobni meri kot pri bolnikih s končno odpovedjo ledvic in sekundarnim hiperparatiroidizmom, ki so na dializi.
English: Anorexia Decreased appetite
Slovenian: Presnovne in prehranske motnje anoreksija zmanjšanje apetita
English: Cases of seizures have been reported in patients treated with cinacalcet (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s cinakalcetom, so poročali o primerih konvulzij (glejte poglavje 4.8).
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
Slovenian: hipromeloza titanov dioksid (E171) triacetin indigotin (E132) rumeni železov oksid (E172)
English: Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment.
Slovenian: Za zvišanje kalcija v serumu je mogoče glede na klinično presojo uporabiti vezalce fosfatov, ki vsebujejo kalcij, sterole vitamina D in/ali prilagoditev koncentracije kalcija v dializni tekočini.
English: • heart failure.
Slovenian: • srčno popuščanje.
English: Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.
Slovenian: Zdravilo Cinakalcet Mylan 30 mg filmsko obložene tablete je na voljo v plastenkah s 100 tabletami.
English: Reductions in PTH levels correlate with cinacalcet concentration.
Slovenian: Znižanje koncentracije PTH korelira s koncentracijo cinakalceta.
English: Cellulose, microcrystalline Silica, colloidal anhydrous Povidone
Slovenian: mikrokristalna celuloza brezvodni koloidni silicijev dioksid povidon krospovidon magnezijev stearat
English: Cinacalcet Mylan 30 mg, 60 mg and 90 mg film-coated tablets PVC/PVdC/Alu blisters of 28 tablets and perforated unit dose blisters of 28 x 1, 30 x 1 and 84 x 1 tablets.
Slovenian: Zdravilo Cinakalcet Mylan 30 mg, 60 mg in 90 mg filmsko obložene tablete PVC/PVdC/aluminijevi pretisni omoti z 28 tabletami in perforirani enoodmerni pretisni omoti z 28 x 1, 30 x 1 in 84 x 1 tableto.
English: The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Slovenian: V razponu odmerkov od 30 do 180 mg enkrat na dan se AUC in Cmax cinakalceta povečujeta približno linearno.
English: Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
Slovenian: Možni znaki prevelikega odmerjanja so: omrtvelost ali mravljinčenje okrog ust, bolečine v mišičah ali mišični krči in epileptični napadi.
English: After oral administration of cinacalcet, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Slovenian: Cinakalcet doseže največjo koncentracijo v plazmi v približno 2 do 6 urah po peroralni uporabi cinakalceta.
English: Tabulated list of adverse reactions
Slovenian: b) Tabelarični prikaz neželenih učinkov
English: Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Slovenian: Pri večini bolnikov sta bila navzea in bruhanje blaga do zmerna huda in prehodne narave.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg, 60 mg ali 90 mg cinakalceta (v obliki cinakalcet klorida).
English: Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking cinacalcet (see section 4.4).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Pri bolnikih, ki so jemali cinakalcet, so poročali o omotici in konvulzijah, ki imajo lahko pomemben vpliv na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.4).
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.
Slovenian: CYP, vključno s CYP1A2, CYP2C8, CYP2C9, CYP2C19 in CYP3A4 in ne inducira CYP1A2, CYP2C19 in CYP3A4.
English: Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dl [2.1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Slovenian: V raziskovalnih študijah se je pokazalo, da je pri bolnikih s kronično boleznijo ledvic, ki se ne zdravijo z dializo, prejemajo pa cinakalcet, tveganje za hipokalciemijo (koncentracije kalcija v serumu < 84 mg/l [2,1 mmol/l]) večje v primerjavi z bolniki s kronično boleznijo ledvic, ki se zdravijo z dializo in prejemajo cinakalcet.
English: Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs of 28 tablets and perforated unit dose blister packs of 28 x 1, 30 x 1 and 84 x 1 tablets.
Slovenian: Zdravilo Cinakalcet Mylan 30 mg, 60 mg, 90 mg filmsko obložene tablete so na voljo v pretisnih omotih z 28 tabletami in perforiranih enoodmernih pretisnih omotih s po 28 x 1, 30 x 1 in 84 x 1 filmsko obloženo tableto.
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of cinacalcet.
Slovenian: Med titriranjem odmerka pogosto kontrolirajte koncentracijo kalcija v serumu; prav tako jo kontrolirajte v 1 tednu po začetku zdravljenja ali po prilagoditvi odmerka cinakalceta.
English: What Cinacalcet Mylan looks like and contents of the pack
Slovenian: Izgled zdravila Cinakalcet Mylan in vsebina pakiranja
English: Cinacalcet Mylan 30 mg
Slovenian: Cinakalcet Mylan 30 mg
English: OUTER CARTON (BLISTERS AND BOTTLES)
Slovenian: ŠKATLE (ZA PRETISNE OMOTE IN PLASTIČNE VSEBNIKE)
English: Cinacalcet Mylan is used:
Slovenian: Zdravilo Cinakalcet Mylan uporabljamo:
English: Dose adjustments of concomitant medicinal products may be required when cinacalcet is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine).
Slovenian: Če bolnik dobiva cinakalcet sočasno z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol, dezipramin, nortriptilin, klomipramin), je lahko potrebna prilagoditev odmerka sočasno uporabljenih zdravil.
English: • if you start or stop smoking, as this may affect the way Cinacalcet Mylan works.
Slovenian: Med zdravljenjem z zdravilom Cinakalcet Mylan morate zdravniku povedati: • če začnete ali prenehate kaditi, kajti to lahko vpliva na delovanje zdravila Cinakalcet Mylan.
English: Hypersensitivity reactions*
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije*
English: Hypersensitivity reactions including angioedema and urticaria have been identified during postmarketing use of cinacalcet.
Slovenian: Med uporabo cinakalceta v obdobju trženja zdravila so bile ugotovljene preobčutljivostne reakcije, vključno z angioedemom in urtikarijo.
English: Secondary Hyperparathyroidism
Slovenian: Sekudarni hiperparatiroidizem
English: Cinacalcet Mylan 90 mg
Slovenian: Cinakalcet Mylan 90 mg
English: Cinacalcet Mylan 60 mg
Slovenian: Cinakalcet Mylan 60 mg
English: Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s cinakalcetom, so poročali o primerih podaljšanja intervala QT in ventrikularni aritmiji (glejte poglavje 4.8).
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: How to take Cinacalcet Mylan
Slovenian: Kako jemati zdravilo Cinakalcet Mylan
English: Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with cinacalcet.
Slovenian: Pri odraslih in pediatričnih bolnikih, zdravljenih s cinakalcetom, so bili opisani življensko ogrožujoči dogodki in smrtni izidi, povezani s hipokalciemijo.
English: EU/1/15/1054/001 EU/1/15/1054/002 EU/1/15/1054/003 EU/1/15/1054/004 EU/1/15/1054/005 EU/1/15/1054/006 EU/1/15/1054/007 EU/1/15/1054/008 EU/1/15/1054/009 EU/1/15/1054/010 EU/1/15/1054/011 EU/1/15/1054/012
Slovenian: EU/1/15/1054/001 EU/1/15/1054/002 EU/1/15/1054/003 EU/1/15/1054/004 EU/1/15/1054/005 EU/1/15/1054/006 EU/1/15/1054/007 EU/1/15/1054/008 EU/1/15/1054/009 EU/1/15/1054/010 EU/1/15/1054/011 EU/1/15/1054/012 EU/1/15/1054/013
English: Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI30, CI60 or CI90 on the other side.
Slovenian: Zdravilo Cinakalcet Mylan 30 mg, 60 mg, 90 mg filmsko obložene tablete so zelene, ovalne, bikonveksne teblete z zaobljenim robom in oznako "M" na eni strani in "CI30", "CI60" ali "CI90", na drugi strani.
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Slovenian: Cinakalcet pri kunkah dokazano prehaja skozi placentno pregrado.
English: • high potassium levels in the blood (hyperkalaemia)
Slovenian: • visoke vrednosti kalija v krvi (hiperkaliemija),
English: Three, 6 month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1,136).
Slovenian: Pri dializnih bolnikih s končno odpovedjo ledvic in neobvladanim sekundarnim hiperparatiroidizmom (N = 1.136) so opravili tri 6-mesečne, dvojno slepe, s placebom nadzorovane klinične študije.
English: Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in patients treated with cinacalcet.
Slovenian: Pri bolnikih, zdravljenih s cinakalcetom, so poročali o življensko ogrožujočih dogodkih in smrtnih izidih, povezanih z nizko koncentracijo kalcija (hipokalciemijo).
English: Crospovidone Magnesium stearate
Slovenian: povidon, krospovidon, magnezijev stearat.
English: Cinacalcet Mylan 30 mg film-coated tablets Cinacalcet Mylan 60 mg film-coated tablets Cinacalcet Mylan 90 mg film-coated tablets cinacalcet
Slovenian: Cinakalcet Mylan 30 mg filmsko obložene tablete Cinakalcet Mylan 60 mg filmsko obložene tablete Cinakalcet Mylan 90 mg filmsko obložene tablete cinakalcet
English: The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Slovenian: Glavni regulator izločanja PTH so receptorji, ki zaznavajo kalcij, na površini glavnih celic obščitnic.
English: • indigestion (dyspepsia)
Slovenian: • šibkost (astenija),
English: Upper respiratory infection Dyspnoea
Slovenian: Žilne bolezni hipotenzija
English: Cinacalcet Mylan 90 mg film-coated tablets Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride).
Slovenian: Zdravilo Cinakalcet Mylan 90 mg filmsko obložene tablete Ena filmsko obložena tableta tableta vsebuje 90 mg cinakalceta (v obliki cinakalcet klorida).
English: In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands.
Slovenian: Oba, primarni in sekundarni hiperparatiroidizem, lahko povzročita izgubljanje kalcija iz kosti.
English: Dyspepsia Diarrhoea Abdominal pain
Slovenian: Bolezni živčevja konvulzije omotica parestezija glavobol
English: • numbness or tingling sensation (paraesthesia)
Slovenian: • omrtvelost ali mravljinčenje (parestezija),
English: Cinacalcet Mylan 60 mg film-coated tablets Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).
Slovenian: Zdravilo Cinakalcet Mylan 60 mg filmsko obložene tablete Ena filmsko obložena tableta tableta vsebuje 60 mg cinakalceta (v obliki cinakalcet klorida).
English: • seizures (convulsions or fits)
Slovenian: • konvulzije (epileptični napadi),
English: Decreased foetal weights were seen in rats at doses where dams had severe hypocalcaemia.
Slovenian: Ob odmerkih, pri katerih so imele breje samice hudo hipokalciemijo, so ugotovili zmanjšanje telesne mase plodov.
English: There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the frequencies of which cannot be estimated from available data.
Slovenian: Hipotenzija in/ali poslabšanje srčnega popuščanja Med varnostnim spremljanjem v obdobju trženja zdravila so bila pri bolnikih, ki so imeli okvarjeno delovanje srca in so se zdravili s cinakalcetom, poročila o idiosinkratičnih primerih hipotenzije in/ali poslabšanja srčnega popuščanja.
English: These studies show that CKD patients not undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Slovenian: Te študije kažejo, da je tveganje za hipokalciemijo večje pri bolnikih s kronično boleznijo ledvic, ki niso na dializi in prejemajo cinakalcet, kot pri bolnikih s končno odpovedjo ledvic, ki so na dializi in prejemajo cinakalcet.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora okužba zgornjih dihal dispneja kašelj
English: How to store Cinacalcet Mylan
Slovenian: Shranjevanje zdravila Cinakalcet Mylan
English: Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg cinakalceta (v obliki cinakalcet klorida).
English: What Cinacalcet Mylan contains
Slovenian: Kaj vsebuje zdravilo Cinakalcet Mylan
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels (see section 4.8).
Slovenian: Pri teh primerih vzročne povezave s cinakalcetom ni bilo mogoče popolnoma izključiti, povzročal bi jih lahko preko znižanih koncentracij kalcija v serumu (glejte poglavje 4.8).
English: Cinacalcet Mylan 30 mg film-coated tablets Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilo Cinakalcet Mylan 30 mg filmsko obložene tablete Ena filmsko obložena tableta tableta vsebuje 30 mg cinakalceta (v obliki cinakalcet klorida).
English: • a medicine used to relieve cough (dextromethorphan)
Slovenian: • zdravilo za lajšanje kašlja (dekstrometorfan),
English: Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg cinakalceta (v obliki cinakalcet klorida).
English: Cinacalcet Mylan 30 mg film-coated tablets cinacalcet
Slovenian: Cinakalcet Mylan 30 mg filmsko obložene tablete cinakalcet
English: Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 60 mg cinakalceta (v obliki cinakalcet klorida).
English: Dizziness and seizures have been reported by patients taking cinacalcet.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri bolnikih, ki so jemali cinakalcet, so poročali o omotici in napadih krčev.