natgillin/translations-raw huggingface dataset:
Parareg brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Zdravilo Parareg je zmanjšalo ravni paratiroidnega hormona za 42% v primerjavi s povečanjem za 8% pri bolnikih, ki so jemali placebo.
Parareg produced a decrease in blood calcium of more than 1 mg/ dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism(15 out of 17).
Zdravilo Parareg je privedlo do znižanja ravni kalcija v krvi za več kot 1 mg/ dl pri 62% bolnikov z rakom (pri 18 bolnikih od 29) in pri 88% bolnikov s primarnim hiperparatiroidizmom (pri 15 bolnikih od 17).
The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg’ s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Parareg večje od z njim povezanih tveganj pri zdravljenju sekundarnega hiperparatiroidizma pri dializnih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju in za zmanjšanje hiperkalciemije pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom, pri katerih bi bila kirurška odstranitev obščitnic indicirana na osnovi ravni kalcija v krvi, vendar pa taka odstranitev zanje ni klinično ustrezna ali je kontraindicirana.
2/ 3 Other information about Parareg:
2/ 3 Druge informacije o zdravilu Parareg:
The marketing authorisation holder is Dompé Biotec S. p. A.
Imetnik dovoljenja za promet je družba Dompé Biotec S. p. A.
Parareg 30 mg film-coated tablets.
Parareg 30 mg filmsko obložene tablete
Parareg may be used as part of a therapeutic regimen including phosphate binders and/ or Vitamin D sterols, as appropriate (see section 5.1).
Parareg je mogoče uporabiti v terapevtski shemi, ki vključuje vezalce fosfatov in/ ali sterole vitamina D, kot je primerno (glejte poglavje 5. 1).
It is recommended that Parareg 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).
Parareg je priporočljivo vzeti s hrano ali kmalu po jedi, kajti študije so pokazale, da je biološka uporabnost cinakalceta večja, če je uporabljen s hrano (glejte poglavje 5. 2).
Parareg 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).
Pri bolnikih z zmerno do hudo okvaro jeter je treba Parareg uporabljati previdno, zdravljenje pa med titriranjem odmerka in nadaljevanjem zdravljenja natančno nadzirati (glejte poglavji 4. 4 in 5. 2).
Parareg 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.
Parareg 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 do 31, 8 pmol/ l) izmerjeno s testom intaktnega PTH (iPTH).
PTH levels should be assessed at least 12 hours after dosing with Parareg.
Med zadnjim odmerkom Pararega in meritvijo koncentracije PTH mora miniti vsaj 12 ur.
2 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
2 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Pararega.
Either the intact PTH (iPTH) or bio- intact PTH (biPTH) may be used to measure PTH levels; treatment with Parareg does not alter the relationship between iPTH and biPTH.
Za merjenje koncentracije PTH je mogoče uporabimo intaktni PTH (iPTH) ali biointaktni PTH (biPTH); zdravljenje s Pararegom ne spremeni razmerja med iPTH in biPTH.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Parareg.
Med titriranjem odmerka pogosto kontrolirajte koncentracijo kalcija v serumu; prav tako jo kontrolirajte v 1 tednu po začetku zdravljenja oz. po prilagoditvi odmerka Pararega.
The recommended starting dose of Parareg for adults is 30 mg twice per day.
Priporočeni začetni odmerek Pararega za odrasle je 30 mg dvakrat na dan.
The dosage of Parareg 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.
Odmerjanje Pararega 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.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Kalcij v serumu je treba izmeriti v 1 tednu po začetku zdravljenja oz. prilagoditvi odmerka Pararega.
After titration to the maximum dose of Parareg, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Parareg therapy should be considered (see section 5.1).
(glejte poglavje 5. 1).
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline.
V treh kliničnih študijah bolnikov s kronično boleznijo ledvic na dializi je anamnezo konvulzivne motnje izhodiščno navedlo 5% bolnikov, tako v skupini s Pararegom kot v skupini s placebom. Pararega V teh študijah so konvulzije opažali pri 1, 4% bolnikov, zdravljenih s Pararegom, in 0, 4% bolnikov, ki so dobivali placebo.
In these studies, seizures were observed in 1.4% of Parareg treated patients and 0.4% of placebo-treated patients.
Zakaj ta razlika v pojavljanju konvulzij, ni jasno; res pa je, da bistveno znižanje koncentracije kalcija v serumu zniža prag za konvulzije.
While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.
Pri teh primerih vzročne povezave s cinakalcetom ni bilo mogoče popolnoma izključiti, povzročal bi jih lahko preko
Parareg treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Zdravljenja s Pararegom ne smete začeti pri bolnikih, ki imajo kalcij v serumu (korigiran za albumin) pod spodnjo mejo normalnega območja.
In CKD patients receiving dialysis who were administered Parareg, 4% of serum calcium values were less than 7.5 mg/ dl (1.875 mmol/ l).
Pri bolnikih s kronično boleznijo ledvic, ki so se zdravili z dializo in so dobivali zdravilo Mimpara, so bile serumske koncentracije kalcija nižje od 7, 5 mg/ dl (1, 875 mmol/ l) pri 4% bolnikov.
If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg..
Če hipokalciemija traja, zmanjšajte odmerek Pararega ali njeno prekinite.
If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/ or vitamin D sterols should be reduced or therapy discontinued.
Če se pri bolnikih, zdravljenih z Parareg, koncentracija PTH zniža pod priporočeno ciljno območje, odmerek Pararega in/ ali sterolov vitamina D zmanjšajte ali terapijo prekinite.
In a clinical study of 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 bolnikov s končno odpovedjo ledvic na dializi se je koncentracija prostega testosterona po 6 mesecih zdravljenja z Parareg znižala za mediano 31, 3%, po 6 mesecih uporabe placeba pa za mediano 16, 3%.
An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Odprto podaljšanje te študije med 3- letnim obdobjem ni pokazalo dodatnega znižanja koncentracije prostega in celotnega testosterona pri bolnikih, ki so dobivali Parareg.
The clinical significance of these reductions in serum testosterone is unknown.
Klinični pomen tega znižanaj testosterona v serumu ni znan.
Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment (Child-Pugh classification), Parareg should be used with caution in these patients and treatment should be closely monitored (see sections 4.2 and 5.2).
Zato je trebas Pararegom pri teh bolnikih uporabljati previdno, zdravljenje pa natančno nadzirati (glejte poglavji 4. 2 in 5. 2).
Caution should be exercised when administering Parareg concomitantly with strong inhibitors or inducers of CYP3A4 and/ or CYP1A2.
Med sočasno uporabo Pararega in močnih zaviralcev ali induktorjev CYP3A4 in/ ali CYP1A2 je potrebna previdnost.
Dose adjustment of Parareg may be necessary (see section 4.5).
Potrebna utegne biti prilagoditev odmerka Pararega (glejte poglavje 4. 5).
Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
Previdnost je potrebna, če je Parareg uporabljena z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6.
Dose adjustment of Parareg may be required if a patient receiving Parareg initiates or discontinues therapy with a strong inhibitor (e. g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Če bolnik, ki dobiva Parareg, začne ali preneha uporabljati terapijo z močnim zaviralcem tega encima (npr. ketokonazolom, itrakonazolom, telitromicinom, vorikonazolom, ritonavirjem) ali njegovim induktorjem (npr. rifampicinom), utegne biti potrebna prilagoditev dmerka Pararega (glejte poglavje 4. 4).
Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e. g., flecainide, propafenone, metoprolol given in heart failure, desipramine, nortriptyline, clomipramine) (see section 4.4).
Če bolnik dobiva Parareg hkrati z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol pri srčnem popuščanju, dezipramin, nortriptilin, klomipramin), utegne biti potrebna prilagoditev odmerka sočasno rabljenih zdravil (glejte poglavje 4. 4).
Parareg should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Parareg naj bi med nosečnostjo uporabljati le, če možne koristi upravičujejo potencialno tveganje za plod.
Following careful benefit/ risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Parareg.
Po natančni oceni koristi in tveganj se je treba odločiti bodisi za prenehanje dojenja bodisi prenehanje zdravljenja s Pararegom.
Data presented from controlled studies include 656 patients who received Parareg and 470 patients who received placebo for up to 6 months.
Prikazani podatki iz kontroliranih kliničnih študij zajemajo 656 bolnikov, ki so dobivali Parareg, in 470 bolnikov, ki so dobivali placebo, in sicer do 6 mesecev.
The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Parareg and 19% placebo treated patients, and 27% Parareg and 15% placebo treated patients, respectively.
Najpogosteje opisana neželena učinka sta bila navzeja (pojavila se je pri 31% prejemnikov Pararega in 19% prejemnikov placeba) in bruhanje (pojavilo se je pri 27% prejemnikov Pararega in 15% prejemnikov placeba).
The safety profile of Parareg in these patient populations is generally consistent with that seen in patients with Chronic Kidney Disease.
Varnostne značilnosti Pararega v teh populacijah bolnikov se v glavnem skladajo z značilnostmi pri bolnikih s kronično boleznijo ledvic.
Overdosage of Parareg may lead to hypocalcaemia.
Preveliko odmerjanje Pararega lahko povzroči hipokalciemijo.
PTH levels in Parareg clinical trials were measured at the end of the dosing interval.
Koncentracijo PTH so v kliničnih preskušanjih Pararega merili na koncu odmernega intervala.
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.
Te študije kažejo, da je tveganje za hipokalciemijo večje pri bolnikih s kronično boleznijo ledvic, ki niso na dializi in prejemajo cinakalcet, kot pri dializiranih bolnikih s končno odpovedjo ledvic, ki so na dializi in prejemajo cinakalcet.
In a key study,46 patients (29 with parathyroid carcinoma and 17 with primary HPT (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)..
V ključni študiji je 46 bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom (pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 leta (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
After oral administration of Parareg, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Cinakalcet doseže največjo koncentracijo v plazmi v približno 2 do 6 urah po peroralni uporabi Pararega.
Administration of Parareg with food results in an approximate 50 – 80% increase in cinacalcet bioavailability.
Zaužitje Pararega s hrano poveča biološko uporabnost cinakalceta za približno 50 do 80%.
9 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
9 eksperimentalnimi pogoji.
Parareg 60 mg film-coated tablets.
Parareg 60 mg filmsko obložene tablete
It is recommended that Parareg 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).
Parareg je priporočljivo vzetis hrano ali kmalu po jedi, kajti študije so pokazale, da je biološka uporabnost cinakalceta večja, če je uporabljen s hrano (glejte poglavje 5. 2).
Parareg 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).
Pri bolnikih z zmerno do hudo okvaro jeter je treba Parareg uporabljati previdno, zdravljenje pa med titriranjem odmerka in nadaljevanjem zdravljenja natančno nadzirati( glejte poglavji 4. 4 in 5. 2).
12 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
12 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Pararega.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Parareg.
Med titriranjem odmerka pogosto kontrolirajte koncentracijo kalcija v serumu; Pararega prav tako jo kontrolirajte v 1 tednu po začetku zdravljenja oz. po prilagoditvi odmerka Pararega.
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline.
V treh kliničnih študijah bolnikov s kronično boleznijo ledvic na dializi je anamnezo konvulzivne motnje izhodiščno navedlo 5% bolnikov, tako v skupini s Pararegom kot v skupini s placebom. Pararega V teh študijah so konvulzije opažali pri 1, 4% bolnikov, zdravljenih z Parareg, in 0, 4% bolnikov, ki so dobivali placebo.
If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg.
Če hipokalciemija traja, zmanjšajte odmerek Pararega ali njeno uporaboprekinite.
If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/ or vitamin D sterols should be reduced or therapy discontinued.
Če se pri bolnikih, zdravljenih s Pararegom, koncentracija PTH zniža pod priporočeno ciljno območje, odmerek Pararega in/ ali sterolov vitamina D zmanjšajte ali terapijo prekinite. Pararega
Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e. g., flecainide, propafenone, metoprolol given in heart failure, desimipramine, nortriptyline, clomipramine) (see section 4.4).
Če bolnik dobiva Parareg hkrati z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol pri srčnem popuščanju, dezipramin, nortriptilin, klomipramin), utegne biti potrebna prilagoditev odmerka sočasno rabljenih zdravil (glejte poglavje 4. 4).
Parareg 90 mg film-coated tablets.
Parareg 90 mg filmsko obložene tablete
Reduction of hypercalcaemia in patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Zmanjšanje hiperkalciemije pri bolnikih s: • paratiroidnim karcinomom. • primarnim hiperparatiroidizmom, pri katerih bi bila glede na koncentracijo kalcija v serumu indicirana paratiroidektomija (kot je opredeljeno v ustreznih smernicah za zdravljenje), a ta pri njih ni klinično primerna ali je kontraindicirana.
22 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
22 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Pararega.
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline.
V treh kliničnih študijah bolnikov s kronično boleznijo ledvic na dializi je anamnezo konvulzivne motnje izhodiščno navedlo 5% bolnikov, tako v skupini s Pararegom kot v skupini s placebom.
In these studies, seizures were observed in 1.4% of Parareg treated patients and 0.4% of placebo-treated patients.
V teh študijah so konvulzije opažali pri 1, 4% bolnikov, zdravljenih z Parareg, in 0, 4% bolnikov, ki so dobivali placebo.
If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg..
Če hipokalciemija traja, zmanjšajte odmerek Pararega ali njeno uporaboPararega prekinite.
If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/ or vitamin D sterols should be reduced or therapy discontinued.
Če se pri bolnikih, zdravljenih s Pararegom, koncentracija PTH zniža pod priporočeno ciljno območje, odmerek Pararega in/ ali sterolov vitamina D zmanjšajte ali terapijo prekinite.
In a clinical study of 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 bolnikov s končno odpovedjo ledvic na dializi se je koncentracija prostega testosterona po 6 mesecih zdravljenja s Pararegom znižala za mediano 31, 3%, po 6 mesecih uporabe placeba pa za mediano 16, 3%.
Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
Previdnost je potrebna, če je Parareg uporabljen z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6.
29 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
V študijah toksičnosti pri ponavljajočih se odmerkih in študijah kancerogenega potenciala pri glodalcih so ugotavljali katarakte in motnjave leč; takšnih sprememb niso ugotovili pri psih in opicah in tudi ne v kliničnih študijah, v katerih so spremljali nastajanje katarakt.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 1, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo na trgu.
Parareg 30 mg film-coated tablets Cinacalcet
Parareg 30 mg filmsko obložene tablete cinakalcet
Parareg 30 mg tablet Cinacalcet
Parareg 30 mg tableta cinakalcet
Parareg 60 mg film-coated tablets Cinacalcet
Parareg 60 mg filmsko obložene tablete cinakalcet
Parareg 60 mg tablet Cinacalcet
Parareg 60 mg tableta cinakalcet
Parareg 90 mg film-coated tablets Cinacalcet
Parareg 90 mg filmsko obložene tablete cinakalcet
Parareg 90 mg tablet Cinacalcet
Parareg 90 mg tableta cinakalcet
Parareg 30 mg film-coated tablets Parareg 60 mg film-coated tablets Parareg 90 mg film-coated tablets Cinacalcet
Parareg 30 mg filmsko obložene tablete Parareg 60 mg filmsko obložene tablete Parareg 90 mg filmsko obložene tablete cinakalcet
What Parareg is and what it is used for 2.
Kaj je zdravilo Parareg in za kaj ga uporabljamo 2.
Before you take Parareg 3.
Kaj morate vedeti, preden boste vzeli zdravilo Parareg 3.
How to take Parareg 4.
Kako jemati zdravilo Parareg 4.
Possible side effects 5 How to store Parareg 6.
Možni neželeni učinki 5 Shranjevanje zdravila Parareg 6.
WHAT PARAREG IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PARAREG IN ZA KAJ GA UPORABLJAMO
Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Parareg deluje tako, da v telesu uravnava koncentracijo paratiroidnega hormona (PTH), kalcija in fosforja.
Parareg is used: • to treat secondary hyperparathyroidism in patients with kidney disease on dialysis. • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.
Parareg uporabljamo: • za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z boleznijo ledvic na dializi. • za zmanjšanje hiperkalciemije (zvišane koncentracije kalcija v krvi) pri bolnikih z rakom obščitnic. • za zmanjšanje zvišane koncentracije kalcija v krvi (hiperkalciemije) pri bolnikih s primarnim hipertiroidizmom, ki imajo koncentracijo kalcija zvišano tudi po odstranitvi obščitnic, ali če odstranitev teh žlez ni mogoča.
BEFORE YOU TAKE PARAREG
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PARAREG
Do not take Parareg:
Ne jemljite zdravila Parareg:
• DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
NE JEMLJITE ZDRAVILA Parareg, če ste alergični na (preobčutljivi za) cinakalcet ali katerokoli sestavino zdravila Parareg.
58 Before you start taking Parareg, tell your doctor if you have or have ever had
58 Bodite posebno pozorni pri jemanju zdravila Parareg:
The risk of having seizures is higher if you have had them before; • liver problems
Tveganje za pojav konvulzij je večje, če ste jih imeli že kdaj prej. • težave z jetri.