natgillin/translations-raw huggingface dataset:
If PTH levels decrease below the recommended target range in patients treated with Mimpara, the dose of Mimpara and/or vitamin D sterols should be reduced or therapy discontinued.
Če se pri bolnikih, zdravljenih z zdravilom Mimpara, koncentracija PTH zniža pod priporočeno ciljno območje, zmanjšajte odmerek zdravila Mimpara in/ali sterolov vitamina D ali prekinite terapijo.
10, 15, 30, 60, 90, and 120 15, 30, 60, 90, 120, and 180
10; 15; 30; 60; 90 in 120 15; 30; 60; 90; 120 in 180
This study was terminated early due to a fatality with severe hypocalcaemia in the cinacalcet group (see section 4.8).
To študijo so predčasno končali zaradi smrtnega primera zaradi hude hipokalciemije v skupini s cinakalcetom (glejte poglavje 4.8).
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).
Priporočeni začetni odmerek za otrokev starosti od ≥ 3 let do < 18 let je ≤ 0,20 mg/kg enkrat na dan na podlagi bolnikove puste telesne mase (glejte preglednico 1).
Study 3 was a 26-week, open-label, single-arm safety study in patients aged 8 months to < 6 years (mean age 3 years).
Študija 3 je bila 26-tedenska študija varnosti z načrtom odprtega zdravljenja in eno samo skupino bolnikov, starih od 8 mesecev do < 6 let (povprečna starost: 3 leta).
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).
Bolnikom, ki ne morejo požirati, lahko daste zrnca po sondi v želodec ("nazogastrični" ali "gastrostomijski" sondi, izdelani iz polivinilklorida) v majhni količini vode (vsaj 5 ml).
- The active substance is cinacalcet.
- Učinkovina je cinakalcet.
The safety and efficacy of Mimpara in children aged less than 3 years for the treatment of secondary hyperparathyroidism have not been established.
Varnost in učinkovitost zdravila Mimpara za zdravljenje sekundarnega hiperparatiroidizma pri otrocih, mlajših od 3 let, nista dokazani.
The safety and efficacy of Mimpara in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established.
Varnost in učinkovitost zdravila Mimpara za zdravljenje paratiroidnega karcinoma in primarnega hiperparatiroidizma pri otrocih nista dokazani.
• 1 to 3 capsules a day use at least 1 tablespoon (15 mL)
• Od 1 do 3 kapsule na dan uporabite vsaj 1 veliko žlico (15 ml)
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.
Pediatrične bolnike in/ali osebe, ki zanje skrbijo, seznanite s simptomi hipokalciemije in s pomembnostjo upoštevanja navodil glede kontrol kalcija v serumu, glede odmerjanja zdravila in glede načina njegove uporabe.
Hypocalcaemia† Hyperkalaemia Reduced testosterone levels†
Preiskave pogosti hipokalciemija† hiperkaliemija znižane koncentracije testosterona†
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.
Na podlagi podatkov in vitro cinakalcet močno zavira CYP2D6, a v klinično doseženih koncentracijah ne zavira drugih encimov CYP, vključno s CYP1A2, CYP2C8, CYP2C9, CYP2C19 in CYP3A4 in ne inducira CYP1A2, CYP2C19 in CYP3A4.
Dose adjustment in paediatric patients ≥ 3 to < 18 years of age
Preglednica 2: Prilagoditev odmerka pri pediatričnih bolnikih, starih od ≥ 3 let do < 18 let
In a clinical study of adult ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
V klinični študiji odraslih bolnikov s končno odpovedjo ledvic na dializi se je koncentracija prostega testosterona po 6 mesecih zdravljenja z zdravilom Mimpara znižala za mediano 31,3 %, po 6 mesecih uporabe placeba pa za mediano 16,3 %.
• If iPTH < 100 pg/mL (10.6 pmol/L), stop Mimpara treatment, restart Mimpara at the next lower dose once the iPTH is > 150 pg/mL (15.9 pmol/L).
• Če je iPTH < 100 pg/ml (10,6 pmol/l), prenehajte zdravljenje z zdravilom Mimpara; zdravljenje z zdravilom Mimpara znova začnite z naslednjim nižjim odmerkom, ko je iPTH > 150 pg/ml (15,9 pmol/l).
Hepatic Insufficiency: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Insuficienca jeter: Blaga okvara jeter ni pomembneje vplivala na farmakokinetiko cinakalceta.
If you take more Mimpara than you should you must contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Mimpara, kot bi smeli Če vzamete več zdravila Mimpara, kot bi je smeli, se morate takoj posvetovati z zdravnikom.
• Povidone
• povidon,
Mimpara is also available as tablets.
Zdravilo Mimpara je na voljo tudi v obliki tablet.
In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/mL (≤ 26.5 pmol/L)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
V posameznih študijah je primarni cilj (delež bolnikov z iPTH ≤ 250 pg/ml (≤ 26,5 pmol/l)) doseglo 41 %, 46 % oz. 35 % bolnikov, ki so dobivali cinakalcet, in 4 %, 7 % oz. 6 % bolnikov, ki so prejemali placebo.
Switch from etelcalcetide to Mimpara
Prehod z etelkalcetida na zdravilo Mimpara
Children who require doses of 30 mg or more and who are able to swallow tablets may receive appropriate doses of Mimpara tablets.
Otroci, ki potrebujejo odmerek 30 mg ali več in zmorejo pogoltniti tablete, lahko prejemajo ustrezne odmerke tablet zdravila Mimpara.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti pa etelkalcetid ali kakšna druga zdravila, ki znižujejo koncentracijo kalcija v krvi.
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.
Dejstvo, da cinakalcet ne vpliva na farmakokinetiko R- in S-varfarina in da večkratno odmerjanje pri bolnikih ne povzroči avtoindukcije, kaže, da cinakalcet pri človeku ne inducira CYP3A4, CYP1A2 ali CYP2C9.
The majority of patients (89%) were using vitamin D sterols at baseline.
Večina bolnikov (89 %) je izhodiščno uporabljala sterole vitamina D.
*If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days
*V primeru prenehanja uporaba zdravila je treba korigirani kalcij v serumu izmeriti v 5 do 7 dneh.
Study 2 was an open-label study in which 55 patients aged 6 to < 18 years (mean 13 years) were randomised to receive either cinacalcet in addition to standard of care (SOC, n = 27) or SOC alone (n = 28).
Študija 2 je bila študija z načrtom odprtega zdravljenja, v kateri so 55 bolnikov, starih od 6 do < 18 let (povprečno 13 let), randomizirali bodisi na prejemanje cinakalceta poleg običajnega zdravljenja (SOC - Standard of Care, n = 27) bodisi le na SOC (n = 28).
Each bottle contains 30 tablets.
Vsaka plastenka vsebuje 30 tablet.
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.
Študija EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) je bila randomizirana, dvojno slepa klinična študija, v kateri so ocenjevali cinakalcet klorid v primerjavi s placebom za zmanjšanje tveganja za umrljivost zaradi vseh vzrokov in za kardiovaskularne dogodke pri 3.883 bolnikih s sekundarnim hiperparatiroidizmom in kronično boleznijo ledvic, ki so na dializi.
The percentage of patients who achieved the primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 25 to 30) was 55% in the cinacalcet group and 19.0% in the placebo group (p = 0.02).
Odstotek bolnikov, ki so dosegli primarni cilj študije (≥ 30 % znižanje povprečnega iPTH v plazmi v primerjavi z izhodiščem med EAP; 25. do 30. teden), je bil 55 % v skupini s cinakalcetom in 19,0 % v skupini s placebom (p = 0,02).
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.
Priporočeni začetni odmerek zdravila Mimpara za odrasle je 30 mg dvakrat na dan. Odmerjanje zdravila Mimpara je treba titrirati na 2 do 4 tedne z zaporednimi odmerki 30 mg dvakrat na dan, 60 mg dvakrat na dan, 90 mg dvakrat na dan in 90 mg trikrat ali štirikrat na dan, kot je potrebno za znižanje koncentracije kalcija v serumu na zgornjo mejo normalnega območja ali pod njo.
• to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the gland is not possible.
• za zmanjšanje zvišane koncentracije kalcija v krvi (hiperkalciemije) pri odraslih bolnikih s primarnim hiperparatiroidizmom, kadar odstranitev žlez ni mogoča.
Flush with adequate volume for the used enteral tube.
Sondo nato splaknite z ustrezno količino vode, ki ustreza uporabljeni enteralni sondi.
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:
Če se koncentracija kalcija v serumu zniža pod normalno območje, ali če se pojavijo simptomi hipokalciemije, je treba uporabiti ustrezno prilagoditev odmerka, kot prikazuje preglednica 2 spodaj:
Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Mimpara.
Zdravniku morate povedati, če se vam med zdravljenjem z zdravilom Mimpara pojavi kar koli od naslednjega, ker so to možni znaki nizke koncentracije kalcija: spazmi, trzanje ali krči v mišicah, omrtvičenost ali mravljinčenje v prstih rok ali nog ali okrog ust ali napadi krčev (konvulzije), zmedenost ali izguba zavesti.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
In the event that corrected serum calcium levels fall below 8.4 mg/dL (2.1 mmol/L) and/or symptoms of hypocalcaemia occur the following management is recommended:
V primeru, da se koncentracija korigiranega kalcija v serumu zniža pod 8,4 mg/dl (2,1 mmol/l) in/ali se pojavijo simptomi hipokalciemije, je priporočljivo sledeče ukrepanje:
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.
Zdravilo Mimpara 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).
• Opadry clear (containing hypromellose, macrogol)
• Opadry prozorno (vsebuje hipromelozo in makrogol).
In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.
Če zanosite, se bo zdravnik morda odločil, da vam zdravljenje prilagodi, ker lahko zdravilo Mimpara škoduje plodu.
The mean maximum daily dose of cinacalcet was 1.0 mg/kg/day.
Povprečni največji dnevni odmerek cinakalceta je bil 1,0 mg/kg/dan.
You should take the granules with food or liquid.
Zrnca morate vzeti s hrano ali pijačo.
In CKD patients receiving dialysis who were administered Mimpara, approximately 30% of patients had at least one serum calcium value less than 7.5 mg/dL (1.9 mmol/L).
Pri bolnikih s kronično boleznijo ledvic, ki so se zdravili z dializo in so prejemali zdravilo Mimpara, je imelo približno 30 % bolnikov vsaj eno vrednost kalcija v serumu manj kot 7,5 mg/dl (1,9 mmol/l).
Mimpara is also available as granules for paediatric use.
Zdravilo Mimpara je na voljo tudi v obliki zrnc za pediatrično uporabo.
Dose adjustment in paediatric patients ≥ 3 to < 18 years of age Corrected Serum calcium value or clinical symptoms of hypocalcaemia
Preglednica 2: Prilagoditev odmerka pri pediatričnih bolnikih, starih od ≥ 3 let do < 18 let Vrednost korigiranega kalcija v serumu ali klinični simptomi hipokalciemije
If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) twice per day.
Če se zdravite zaradi raka na obščitnici ali primarnega hiperparatiroidizma Običajni začetni odmerek zdravila Mimpara pri odraslih je 30 mg (ena tableta) dvakrat na dan.
• a medicine used to treat HIV infection and AIDS (ritonavir);
• zdravilo za zdravljenje okužbe s HIV in AIDS (ritonavir),
Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Zdravilo Mimpara deluje tako, da v telesu uravnava koncentracijo paratiroidnega hormona (PTH), kalcija in fosforja.
QT prolongation and ventricular arrhythmia secondary to hypocalcaemia QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during post-marketing use of Mimpara, the frequencies of which cannot be estimated from available data (see section 4.4).
Podaljšanje intervala QT in ventrikularna aritmija zaradi hipokalciemije Med uporabo zdravila Mimpara v obdobju trženja zdravila sta bili ugotovljeni podaljšanje intervala QT in ventrikularna aritmija zaradi hipokalciemije; njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov (glejte poglavje 4.4).
• medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);
• zdravila za zdravljenje depresije (amitriptilin, dezipramin, nortriptilin in klomipramin),
Mimpara contains lactose
Zdravilo Mimpara vsebuje laktozo
• medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin);
• zdravila za zdravljenje bakterijskih okužb (telitromicin, rifampicin in ciprofloksacin),
If you are being treated for secondary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) once per day.
Če se zdravite zaradi sekundarnega hiperparatiroidizma Običajni začetni odmerek zdravila Mimpara pri odraslih je 30 mg (ena tableta) enkrat na dan.
Patients receiving Mimpara should not be given etelcalcetide.
Bolniki, ki prejemajo zdravilo Mimpara, ne smejo dobiti etelkalcetida.
≤ 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia and Vitamin D cannot be increased
≤ 7,5 mg/dl (1,9 mmol/l) ali persistentni simptomi hipokalciemije, vitamina D pa ni mogoče zvišati
Worsening heart failure† QT prolongation and ventricular arrhythmia secondary to hypocalcaemia†
poslabšanje srčnega popuščanja† podaljšanje intervala QT in ventrikularna aritmija zaradi hipokalciemije†
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.
Kapsule imajo belo telo in obarvan pokrovček z oznako "1 mg" (temnozelen pokrovček), "2,5 mg" (rumen pokrovček) ali "5 mg" (moder pokrovček) na eni strani in oznako "AMG" na drugi strani.
Mimpara with food and drink Mimpara should be taken with or shortly after food.
Zdravilo Mimpara skupaj s hrano in pijačo Zdravilo Mimpara morate vzeti s hrano ali kmalu po jedi.
The capsule must be opened and the entire contents of a capsule should be sprinkled in food or liquid and administered.
Kapsulo je treba odpreti in njeno celotno vsebino stresti v hrano ali tekočino, ki se jo zaužije.
Soon after dosing, PTH begins to decrease until a nadir at approximately 2 to 6 hours post-dose, corresponding with cinacalcet Cmax.
Kmalu po uporabi zdravila začne koncentracija PTH upadati in doseže najnižjo točko približno 2 do 6 ur po odmerku, kar ustreza Cmax cinakalceta.
• Empty the entire contents of the bottom of the capsule onto the food or liquid.
• Stresite celotno količino iz spodnjega dela kapsule v hrano ali tekočino.
Mimpara reduces calcium levels.
Zdravilo Mimpara znižuje koncentracije kalcija.
• Gently squeeze the top and twist slightly to remove, taking care not to spill the contents.
• Previdno stisnite in rahlo zasučite njen zgornji del, da ga boste odstranili; pazite, da vsebine kapsule ne raztresete.
• low calcium levels in the blood (hypocalcaemia).
• nizka koncentracija kalcija v krvi (hipokalciemija).
In a 28 week placebo-controlled study, 67 adult patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dL (2.82 mmol/L) but ≤ 12.5 mg/dL (3.12 mmol/L), but who were unable to undergo parathyroidectomy were included.
V 28-tedensko, s placebom kontrolirano študijo, je bilo vključenih 67 odraslih bolnikov s primarnim hiperparatiroidizmom, ki so izpolnjevali merila za paratiroidektomijo na podlagi korigiranega celotnega kalcija v serumu (> 11,3 mg/dl (2,82 mmol/l), toda ≤ 12,5 mg/dl (3,12 mmol/l), a jim ni bilo mogoče narediti paratiroidektomije.
Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.
Dekstrometorfan: Večkratni odmerki 50 mg cinakalceta so pri izrazitih metabolizatorjih s CYP2D6 povečali AUC 30 mg dekstrometorfana (ki se primarno presnavlja s CYP2D6) za 11-krat.
Paediatric Population: The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age.
Pediatrična populacija: Farmakokinetiko cinakalceta so raziskali pri pediatričnih bolnikih s končno odpovedjo ledvic, zdravljenih z dializo, starih od 3 do 17 let.
Mimpara granules can be administered orally or through nasogastric or gastrostomy tubes.
Zrnca zdravila Mimpara je mogoče uporabiti peroralno ali po nazogastrični ali gastrostomijski sondi.
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.
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.
Each bottle contains 30 capsules.
Ena plastenka vsebuje 30 kapsul.
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
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
90 mg tablets are approximately 13.9 mm long and 8.7 mm wide.
90 mg tablete so približno 13,9 mm dolge in 8,7 mm široke.
60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
60 mg tablete so približno 12,2 mm dolge in 7,6 mm široke.
Capsule Printing ink: iron oxide black, shellac, propylene glycol
Kapsula Črnilo: črni železov oksid, šelak, propilenglikol
High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton.
Plastenka iz polietilena velike gostote (HDPE) z bombažnim navojem ter za otroke varno polipropilensko zaporko z indukcijskim pečatom, pakirana v škatli.
They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.
Tablete so ovalne oblike in imajo na eni strani oznako "30", "60" ali "90", na drugi strani pa napis "AMG".
Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Kalcijev karbonat: Sočasna uporaba kalcijevega karbonata (posamičen 1.500 mg odmerek) ni spremenila farmakokinetike cinakalceta.
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).
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).
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.
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.
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).
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).
Therefore, serum calcium levels should be closely monitored in patients receiving Mimpara, particularly in patients with a history of a seizure disorder.
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.
Elderly: There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Starejši: V farmakokinetiki cinakalceta ni klinično pomembnih razlik glede na starost.
30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.
30 mg tablete so približno 9,7 mm dolge in 6,0 mm široke.
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class
Pogostnosti neželenih učinkov iz kontroliranih kliničnih študij in iz obdobja trženja zdravila so:
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.
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.
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.
Posledice so lahko bolečine v kosteh in zlomi kosti, težave s krvnimi in srčnimi žilami, ledvični kamni, duševna bolezen in koma.
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).
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 %).