natgillin/translations-raw huggingface dataset:
Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH).
Ultomiris je zdravilo, ki se uporablja za zdravljenje odraslih s paroksizmalno nočno hemoglobinurijo (PNH).
The most serious side effect is meningococcal infection, a bacterial infection caused by Neisseria meningitidis that can cause meningitis and blood poisoning.
Najresnejši neželeni učinek je okužba z meningokoki, bakterijska okužba, ki jo povzroča bakterija Neisseria meningitidis, ki lahko povzroči meningitis in zastrupitev krvi.
The most common side effects with Ultomiris (which may affect more than 1 in 10 people) are upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat) and headache.
Najpogostejši neželeni učinki zdravila Ultomiris (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužba zgornjih dihal (okužba nosu in grla), nazofaringitis (vnetje nosu in žrela) in glavobol.
An overview of Ultomiris and why it is authorised in the EU
Pregled zdravila Ultomiris in zakaj je odobreno v EU
For more information about using Ultomiris, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ultomiris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Ultomiris are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ultomiris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Because patients treated with Ultomiris are more prone to infections, including severe meningococcal disease, Ultomiris must not be used in patients who have an ongoing meningococcal infection.
Ker so bolniki, zdravljeni z zdravilom Ultomiris, bolj nagnjeni k okužbam, vključno s hudo meningokokno boleznijo, se zdravilo Ultomiris ne sme uporabljati pri bolnikih, ki imajo meningokokno okužbo.
In PNH, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells.
Pri PNH beljakovine, imenovane „sistem komplementa“, ki je del imunskega sistema, zaradi genske mutacije postanejo preveč aktivne in začnejo napadati bolnikove lastne rdeče krvne celice.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ultomiris have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ultomiris upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Ultomiris?
Kakšna tveganja so povezana z zdravilom Ultomiris?
What is Ultomiris and what is it used for?
Kaj je zdravilo Ultomiris in za kaj se uporablja?
The company that markets Ultomiris will ensure that the medicine is only made available to patients when healthcare professionals have made a written declaration that they have been vaccinated or are receiving antibiotic treatment to prevent meningococcal disease.
Podjetje, ki trži zdravilo Ultomiris, bo zagotovilo, da je zdravilo bolnikom na voljo le, če zdravstveni delavci pisno izjavijo, da so bili cepljeni ali prejemajo zdravljenje z antibiotiki za preprečevanje meningokokne bolezni.
As for its safety, Ultomiris has similar side effects to eculizumab.
Kar zadeva varnost, ima zdravilo Ultomiris podobne neželene učinke kot ekulizumab.
Patients will also be given a special card that explains the symptoms of meningococcal infection, instructing patients to seek medical care immediately if they experience them.
Bolniki bodo prejeli tudi posebno kartico, v kateri so pojasnjeni simptomi meningokokne okužbe, in navodila, da takoj poiščejo zdravniško pomoč, če se pojavijo.
PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels.
PNH je potencialno življenjsko nevarna bolezen, pri kateri prihaja do čezmerne razgradnje rdečih krvnih celic, kar povzroča težave, kot so anemija (nizko število rdečih krvnih celic), težave z ledvicami in krvni strdki v krvnih žilah.
The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if re-vaccination is needed for patients taking Ultomiris.
Zdravnikom, ki predpisujejo zdravilo, in bolnikom bo podjetje priskrbelo tudi informacije o varnosti zdravila ter poslala opomnike zdravnikom, ki predpisujejo zdravilo, in farmacevtom, da preverijo, ali je za bolnike, ki prejemajo zdravilo Ultomiris, potrebno kakršno koli ponovno cepljenje.
Ultomiris is used in patients who have symptoms of the disease as well as in patients who have stable blood levels of the enzyme lactate dehydrogenase (LDH), which gives an indication of how many red blood cells are being broken down.
Zdravilo Ultomiris se uporablja pri bolnikih, ki imajo simptome bolezni, in pri bolnikih, ki imajo stabilne ravni encima laktat dehidrogenaze (LDH) v krvi, kar kaže, koliko rdečih krvnih celic je razgrajenih.
The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.
Učinkovina zdravila Ultomiris, ravulizumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se veže na beljakovino C5, ki je del sistema komplementa.
Ultomiris is given as an infusion (drip) into a vein and the recommended dose depends on the patient's bodyweight.
Zdravilo Ultomiris se daje z infundiranjem (kapalno infuzijo) v veno, priporočeni odmerek pa je odvisen od telesne mase bolnika.
The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with blood disorders.
Predpisovanje in izdaja zdravila Ultomiris je le na recept, dajati pa ga je treba pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem krvnih bolezni.
In the second study in 195 patients with PNH who did not have symptoms after at least 6 months of treatment with eculizumab, patients either continued treatment with eculizumab or switched to Ultomiris.
V drugi študiji s 195 bolniki s paroksizmalno nočno hemoglobinurijo, ki niso imeli simptomov po najmanj šestmesečnem zdravljenju z ekulizumabom, so ti zdravljenje bodisi nadaljevali z ekulizumabom ali pa so prešli na zdravilo Ultomiris.
In addition, none of the patients treated with Ultomiris had a flare-up of symptoms during this time, in comparison to 5 of those continuing with eculizumab.
Poleg tega pri nobenem od bolnikov, ki so bili zdravljeni z zdravilom Ultomiris, v tem času simptomi niso ponovno izbruhnili, medtem ko se je to zgodilo pri petih bolikih, ki so nadaljevali z jemanjem ekulizumaba.
For the full list of side effects and restrictions with Ultomiris, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ultomiris glejte navodilo za uporabo.
In the first study, 246 patients with PNH who previously had not been treated with a medicine blocking the complement system, such as eculizumab, received either Ultomiris or eculizumab.
V prvi študiji je 246 bolnikov s paroksizmalno nočno hemoglobinurijo, ki prej niso bili zdravljeni z zdravilom, ki zavira sistem komplementa, kot je ekulizumab, prejemalo zdravilo Ultomiris ali ekulizumab.
Ultomiris is as effective as eculizumab in treating patients with PNH, reducing the breakdown of red blood cells and avoiding the need for transfusions.
Zdravilo Ultomiris je enako učinkovito kot ekulizumab pri zdravljenju bolnikov s PNH, saj zmanjšuje razgradnjo rdečih krvnih celic in preprečuje potrebo po transfuzijah.
Ultomiris was shown in 2 studies to be as effective as eculizumab in reducing the breakdown of red blood cells and avoiding the need for transfusions in patients with PNH.
Zdravilo Ultomiris se je v dveh študijah izkazalo enako učinkovito kot ekulizumab pri zmanjševanju razgradnje rdečih krvnih celic in izogibanju potrebi po transfuzijah pri bolnikih s paroksizmalno nočno hemoglobinurijo.
How is Ultomiris used?
Kako se zdravilo Ultomiris uporablja?
How does Ultomiris work?
Kako zdravilo Ultomiris deluje?
Ultomiris contains the active substance ravulizumab.
Zdravilo Ultomiris vsebuje učinkovino ravulizumab.
Adults and elderly (> 65 years)
Odrasli in starejši (> 65 let)
Please tell your doctor immediately:
Nemudoma obvestite zdravnika:
Other pharmaceutical forms may be available for this population.
Za to populacijo so morda na voljo druge farmacevtske oblike.
The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution.
Volumen porazdelitve je velik (približno 1000 litrov), kar kaže na obširno porazdelitev.
The risk of having seizures is higher if you have had them before;
Tveganje za pojav napadov krčev je večje, če ste jih imeli že kdaj prej;
Date of first authorisation: 19 November 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 19 november 2015
Reference should be made to current treatment guidelines.
Upoštevati je treba veljavne smernice za zdravljenje.
Tell your doctor if you are taking the following medicines.
Zdravniku morate povedati, če jemljete naslednja zdravila.
For additional information see section 4.
Za dodatne informacije glejte poglavje 4.
No change in starting dose is necessary.
Začetnega odmerka ni treba spremeniti.
A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics.
Izvedli so populacijsko farmakokinetično analizo za oceno vplivov demografskih značilnosti.
The normal calcium range may differ depending on the methods used by your local laboratory.
Razpon normalne koncentracije kalcija se lahko razlikuje glede na metodo, ki jo uporablja vaš lokalni laboratorij.
Clearance of cinacalcet may be lower in women than in men.
Očistek cinakalceta je pri ženskah morda manjši kot pri moških.
Hypocalcaemia (see sections 4.2 and 4.4).
Hipokalciemija (glejte poglavji 4.2 in 4.4).
Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development.
Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, porod ali postnatalni razvoj.
Cinacalcet did not show any genotoxic or carcinogenic potential.
Cinakalcet ni pokazal genotoksičnega ali kancerogenega potenciala.
Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.
Zdravnik vam bo med zdravljenjem redno jemal kri, da bo nadziral potek, in če bo potrebno, vam bo prilagodil odmerek.
Other possible side effects:
Ostali možni neželeni učinki:
Increases in plasma cinacalcet concentration are similar, regardless of the fat content of the meal.
Zvišanje koncentracije cinakalceta v plazmi je podobno, ne glede na vsebnost maščob v obroku.
66% of patients were receiving vitamin D sterols at study entry, and > 90% were receiving phosphate binders.
66 % bolnikov je ob vključitvi v študijo dobivalo sterole vitamina D, > 90 % pa jih je dobivalo vezalce fosfatov.
You should inform your doctor if you experience any of the signs of low calcium levels as described above.
Zdravnika morate obvestiti, če se vam pojavi kateri koli znak nizke koncentracije kalcija, kot je opisano zgoraj.
The clinical significance of these reductions in serum testosterone is unknown.
Klinični pomen teh znižanj testosterona v serumu ni znan.
At doses above 200 mg, the absorption was saturated probably due to poor solubility.
V odmerkih nad 200 mg se absorpcija zasiti, verjetno zaradi slabe topnosti.
Treatment should be reinitiated using the next lowest dose of cinacalcet.
Zdravljenje je treba ponovno začeti z naslednjim najnižjim odmerkom cinakalceta.
Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Zelo pogosti: pojavijo se lahko pri najmanj 1 od 10 bolnikov • navzea in bruhanje; ta neželena učinka sta ponavadi blaga in ne trajata dolgo.
Approximately 80% of the dose was recovered in the urine and 15% in the faeces.
Približno 80 % odmerka se je pojavilo v urinu in 15 % v blatu.
In the event of overdose, patients should be monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and supportive.
V primeru prevelikega odmerka je treba bolnike spremljati glede znakov in simptomov hipokalciemije, zdravljenje pa mora biti simptomatsko in podporno.
Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment.
Znižanje iPTH in Ca x P se je ohranilo do 12 mesecev zdravljenja.
The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Pogostnosti posameznih prednostnih izrazov, vključno z angioedemom in urtikarijo, iz razpoložljivih podatkov ni mogoče oceniti.
The clinical relevance is unknown, however, the potential for cinacalcet to act on these secondary targets cannot be fully excluded.
Klinični pomen tega ni znan, ni pa mogoče povsem izključiti možnosti delovanja cinakalceta na te sekundarne cilje.
Reduce or withhold dose of cinacalcet.
Zmanjšajte ali zadržite odmerek cinakalceta.
Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Kajenje inducira CYP1A2; očistek cinakalceta pri kadilcih je za 36 - 38 % večji kot pri nekadilcih.
Do not take Cinacalcet Mylan if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Cinakalcet Mylan, če ste alergični na cinakalcet ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
If you experience these side effects do not drive or operate machines.
Če se vam pojavijo ti neželeni učinki, ne upravljajte vozil in strojev.
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 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.
It is used to treat problems with organs called parathyroid glands.
Uporabljamo ga za zdravljenje težav z organi, ki jih imenujemo obščitnične žleze.
The maximum dose used in clinical trials was 90 mg four times daily.
Največji odmerek, uporabljen v kliničnih preskušanjih, je bil 90 mg štirikrat na dan.
Cinacalcet Mylan should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo Cinakalcet Mylan naj bi med nosečnostjo uporabljati le, če možne koristi odtehtajo potencialno tveganje za plod.
Reduction of hypercalcaemia in patients with:
Zmanjšanje hiperkalciemije pri bolnikih s:
The safety and efficacy of cinacalcet in the paediatric population have not been established.
Varnost in učinkovitost cinakalceta v pediatrični populaciji nista ugotovljeni.
Low calcium levels can have an effect on your heart rhythm.
Nizke koncentracije kalcija lahko vplivajo na vaš srčni ritem.
• loss (anorexia) or decrease of appetite
• izguba apetita (anoreksija) ali zmanjšanje apetita,
Steady state levels of cinacalcet are achieved within 7 days with minimal accumulation.
Stanje dinamičnega ravnovesja cinakalceta je doseženo v 7 dneh ob minimalnem kopičenju.
* see section c) see section 4.4
* glejte podpoglavje c) † glejte poglavje 4.4
This analysis showed no significant impact of age, sex, race, body surface area, and body weight on cinacalcet pharmacokinetics.
Ta analiza ni pokazala pomembnega vpliva starosti, spola, telesne površine in telesne mase na farmakokinetiko cinakalceta.
Hypotension and/or worsening heart failure
Hipotenzija in/ali poslabšanje srčnega popuščanja
4.8 Undesirable effects a)
4.8 Neželeni učinki a) Povzetek varnostnega profila
Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Neželeni učinki, ki jih je na podlagi ocene najboljših dokazov o vzročnosti vsaj možno pripisati zdravljenju s cinakalcetom iz študij, nadzorovanih s placebom, in študij z enim krakom, so navedeni spodaj ob upoštevanju sledečega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10), občasni; (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are:
Pogostnosti neželenih učinkov iz nadzorovanih kliničnih študij in iz obdobja trženja zdravila so:
However, efficacy, safety, optimal doses and treatment targets have not been established in treatment of predialytic renal failure patients.
Vendar učinkovitost, varnost, optimalni odmerki in terapevtski cilji za zdravljenje predializnih bolnikov z ledvično odpovedjo niso ugotovljeni.
All of these effects were seen at a systemic exposure, on an AUC basis, approximately equivalent to the exposure in patients at the maximum dose for secondary HPT.
Vse te učinke so opazili pri sistemski izpostavljenosti na osnovi AUC, približno enakovredne izpostavljenosti pri bolnikih z največjim odmerkom pri sekundarnem HPT.
Caution is advised in patients with other risk factors for QT prolongation such as patients with known congenital long QT syndrome or patients receiving medicinal products known to cause QT prolongation.
Potrebna je previdnost pri bolnikih, ki imajo druge dejavnike tveganja za podaljšanje intervala QT, kot so bolniki z znanim prirojenim sindromom dolgega intervala QT ali bolniki, ki prejemajo zdravila, za katera je znano, da povzročajo podaljšanje intervala QT.
• parathyroid carcinoma.
• paratiroidnim karcinomom.
Before you start taking Cinacalcet Mylan, tell your doctor if you have or have ever had:
Pred začetkom jemanja zdravila Cinakalcet Mylan, morate zdravniku povedati, če imate ali ste kdaj v preteklosti imeli:
After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Po aplikaciji 75 mg radioaktivno označenega odmerka zdravim prostovoljcem se je cinakalcet hitro in izdatno presnovil z oksidacijo, ki ji je sledila konjugacija.
There were no effects on fertility in animal studies.
Pri študijah na živalih učinkov na plodnost ni bilo.
If a patient stops or starts smoking, cinacalcet plasma levels may change and dose adjustment may be necessary.
Če bolnik preneha ali začne kaditi, se koncentracija cinakalceta v plazmi lahko spremeni in lahko je potrebna prilagoditev odmerka.
In case of pregnancy, your doctor may decide to modify your treatment, as cinacalcet might harm the unborn baby.
Če zanosite, se bo zdravnik morda odločil, da vam zdravljenje prilagodi, ker lahko cinakalcet škoduje vašemu nerojenemu otroku.
• allergic reactions (hypersensitivity)
• alergijske reakcije (preobčutljivost),
Your doctor will tell you how much Cinacalcet Mylan you must take.
Zdravnik vam bo povedal, koliko zdravila Cinakalcet Mylan morate jemati.
Tablets should be taken whole and should not be chewed, crushed or divided.
Tablete je treba vzeti cele in se jih ne sme zgristi, zdrobiti ali deliti.
Do not take Cinacalcet Mylan if you have low levels of calcium in your blood.
Ne jemljite zdravila Cinakalcet Mylan, če imate nizke koncentracije kalcija v krvi.
An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in cinacalcet-treated patients.
Odprto podaljšanje te študije med 3-letnim obdobjem ni pokazalo dodatnega znižanja koncentracije prostega in celotnega testosterona pri bolnikih, ki so dobivali cinakalcet.
Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Cinakalcet je približno 97 % vezan na beljakovine v plazmi in se minimalno porazdeli v eritrocite.
Safety margins from the toxicology studies are small due to the dose-limiting hypocalcaemia observed in the animal models.
Varnostne meje, ugotovljene v toksikoloških študijah, so nizke zaradi hipokalciemije, ki omejuje odmerek in so jo opažali v živalskih modelih.
Dose adjustment may be necessary if a patient starts or stops smoking or when concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.
Prilagoditve odmerka so lahko potrebne, če bolnik začne kaditi ali opusti kajenje; enako velja po uvedbi ali prekinitvi sočasnega zdravljenja z močnimi zaviralci CYP1A2.
PTH should be monitored approximately every 1-3 months during maintenance.
Med vzdrževalnim zdravljenjem je treba PTH kontrolirati približno na 1-3 mesece.
Cinacalcet has not been tested in pregnant women.
Cinakalcet ni preizkušen pri nosečnicah.
Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Zdravilo Cinakalcet Mylan je mogoče uporabiti v terapevtski shemi, ki vključuje vezalce fosfatov in/ali sterole vitamina D, kot je primerno (glejte poglavje 5.1).
Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2mediated metabolism.
Očistek cinakalceta je pri kadilcih večji kot pri nekadilcih, verjetno zaradi indukcije presnove s CYP1A2.
The pharmacokinetics of cinacalcet does not change over time.
Farmakokinetika cinakalceta se s časom ne spreminja.
Either the intact PTH (iPTH) or biointact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the relationship between iPTH and biPTH.
Za merjenje koncentracije PTH je mogoče uporabiti intaktni PTH (iPTH) ali biointaktni PTH (biPTH); zdravljenje s cinakalcetom ne spremeni razmerja med iPTH in biPTH.
The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Študija ni dosegla primarnega cilja in sicer dokazanega zmanjšanja tveganja za umrljivost zaradi vseh vzrokov ali kardiovaskularnih dogodkov, vključno z miokardnim infarktom, hospitalizacijo zaradi nestabilne angine pektoris, srčnim popuščanjem ali perifernim žilnim dogodkom (razmerje ogroženosti 0,93, 95 % interval zaupanja: 0,85, 1,02, p = 0,112).
Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): cinacalcet is a strong inhibitor of CYP2D6.
Zdravila, ki se presnavljajo z encimom P450 2D6 (CYP2D6): cinakalcet je močan zaviralec CYP2D6.
Testosterone levels
Koncentracija testosterona
The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers.
Farmakokinetični profil cinakalceta pri bolnikih z blago, zmerno in hudo insuficienco ledvic ter pri bolnikih na hemodializi ali peritonealni dializi je primerljiv kot pri zdravih prostovoljcih.
Serum calcium
Kalcij v serumu
These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including ciclosporin and tacrolimus.
Ti podatki nakazujejo, da naj cinakalcet ne bi vplival na farmakokinetiko tistih skupin zdravil, ki se presnavljajo s CYP3A4 in CYP3A5, kot so nekateri imunosupresivi, vključno s ciklosporinom in takrolimusom.