FrancophonIA/ELRC3.0 huggingface dataset:
English: Gender: Clearance of cinacalcet may be lower in women than in men.
Slovenian: Spol: Očistek cinakalceta je pri ženskah morda manjši kot pri moških.
English: What Mimpara is and what it is used for
Slovenian: Kaj je zdravilo Mimpara in za kaj ga uporabljamo
English: The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks.
Slovenian: Odmerek je treba povečevati zaporedno po razpoložljivih ravneh odmerka (glejte preglednico 1) in ne pogosteje kot na vsake 4 tedne.
English: To open the capsule:
Slovenian: Da boste kapsulo odprli:
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov
English: Mimpara is used in children aged 3 years to less than 18 years of age:
Slovenian: Zdravilo Mimpara se uporablja pri otrocih, starih od 3 let do manj kot 18 let:
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Slovenian: Pretisni omot (Aclar/PVC/PVAc/aluminij), ki vsebuje 14 tablet.
English: Available sequential dose levels (mg)
Slovenian: Zaporedne ravni odmerka, ki so na voljo (mg)
English: The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Slovenian: Pogostnosti posameznih prednostnih izrazov, vključno z angioedemom in urtikarijo, ni mogoče oceniti iz razpoložljivih podatkov.
English: Blister: 5 years.
Slovenian: Plastenka: 5 let.
English: - The tablets are coated with:
Slovenian: - Tablete so obložene s:
English: 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.
Slovenian: Zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov • siljenje na bruhanje in bruhanje; ta neželena učinka sta ponavadi blaga in ne trajata dolgo.
English: Mimpara has not been tested in pregnant women.
Slovenian: Zdravilo Mimpara ni preizkušeno pri nosečnicah.
English: Date of latest renewal: 23 September 2009
Slovenian: Datum prve odobritve: 22. oktober 2004 Datum zadnjega podaljšanja: 23. september 2009
English: Reduce or withhold dose of Mimpara.
Slovenian: Zmanjšajte ali zadržite odmerek zdravila Mimpara.
English: Do not take Mimpara if you have low levels of calcium in your blood.
Slovenian: Ne jemljite zdravila Mimpara, če imate nizke koncentracije kalcija v krvi.
English: • Do not mix granules of different strengths to avoid incorrect dosing.
Slovenian: • Ne mešajte zrnc različnih jakosti, da boste preprečili uporabo nepravilnega odmerka.
English: See section 6.1
Slovenian: Glejte poglavje 6.1.
English: It is important that you take your dose of Mimpara as advised by your doctor.
Slovenian: Pomembno je, da vzamete odmerek zdravila Mimpara, kot vam je naročil zdravnik.
English: For instructions on how to use Mimpara granules, read the section at the end of this leaflet.
Slovenian: Za navodila o uporabi zrnc zdravila Mimpara preberite poglavje na koncu tega navodila.
English: Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Slovenian: Kajenje inducira CYP1A2; očistek cinakalceta pri kadilcih je za 36-38 % večji kot pri nekadilcih.
English: Each blister pack contains either 14, 28 or 84 tablets in a carton.
Slovenian: Vsak pretisni omot vsebuje 14, 28 ali 84 tablet v škatli.
English: The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Slovenian: Odmerek je mogoče povečati do največjega odmerka 2,5 mg/kg/dan in celotni dnevni odmerek ne sme preseči 180 mg.
English: Treatment should be reinitiated using the next lowest dose of Mimpara.
Slovenian: Zdravljenje je treba ponovno začeti z naslednjim najnižjim odmerkom zdravila Mimpara.
English: In order to avoid dosing errors, capsules of different strengths (1, 2.5, or 5 mg) should not be mixed to achieve the desired dose.
Slovenian: Da bi se izognili napakam pri odmerjanju, se kapsul različnih jakosti (1; 2,5 ali 5 mg) ne sme mešati, da bi sestavili želeni odmerek.
English: The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
Slovenian: Razpon normalnih vrednosti kalcija se razlikuje glede na metodo, ki jo uporablja vaš lokalni laboratorij, in glede na bolnikovo/otrokovo starost.
English: Your doctor will tell you how much Mimpara you must take.
Slovenian: Zdravnik vam bo povedal, koliko zdravila Mimpara morate jemati.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na plastenki.
English: Restart at the next lower dose.
Slovenian: Znova začnite zdravljenje z naslednjim nižjim odmerkom.
English: The study consisted of a 24-week dose titration period followed by a 6-week efficacy assessment phase (EAP), and a 30-week openlabel extension.
Slovenian: Študija je obsegala 24-tedensko obdobje titriranja odmerka, ki sta mu sledila 6-tedenska faza ocenjevanja učinka (EAP - Efficacy Assessment Phase) in 30 tedensko podaljšanje z načrtom odprtega zdravljenja.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: If Mimpara treatment has been stopped for more than 14 days, restart at the recommended starting dose.
Slovenian: Če je prekinitev zdravljenja z zdravilom Mimpara trajala več kot 14 dni, zdravljenje znova začnite s priporočenim začetnim odmerkom.
English: Granules mixed with soft food or liquid should be administered immediately.
Slovenian: Zrnca, zmešana z mehko hrano ali tekočino, je treba zaužiti takoj.
English: Mixing granules in water for oral use is not recommended as it may lead to a bitter taste.
Slovenian: Mešanje zrnc z vodo za peroralno uporabo ni priporočljivo, ker lahko povzroči grenek okus.
English: b) Tabulated list of adverse reactions
Slovenian: b) Tabeliran seznam neželenih učinkov
English: Prior to initiating cinacalcet and during treatment, consider the risks and benefits of treatment and the ability of the patient to comply with the recommendations to monitor and manage the risk of hypocalcaemia.
Slovenian: Pred uvedbo cinakalceta in med zdravljenjem upoštevajte tveganja in koristi zdravljenja ter bolnikovo zmožnost za upoštevanje priporočil glede nadzora in obvladovanja tveganja za hipokalciemijo.
English: The mean age at baseline was 13 (range 6 to 18) years.
Slovenian: Povprečna izhodiščna starost je bila 13 let (razpon: od 6 do 18 let).
English: Mimpara should be used in paediatric patients only if the potential benefit justifies the potential risk.
Slovenian: Zdravilo Mimpara naj bi pri pediatričnih bolnikih uporabljali le, če možne koristi upravičujejo možno tveganje.
English: EU/1/04/292/001 - 30 mg carton with 14 tablets EU/1/04/292/002 - 30 mg carton with 28 tablets EU/1/04/292/003 - 30 mg carton with 84 tablets EU/1/04/292/004 - 30 mg bottle with 30 tablets EU/1/04/292/005 - 60 mg carton with 14 tablets EU/1/04/292/006 - 60 mg carton with 28 tablets EU/1/04/292/007 - 60 mg carton with 84 tablets EU/1/04/292/008 - 60 mg bottle with 30 tablets EU/1/04/292/009 - 90 mg carton with 14 tablets EU/1/04/292/010 - 90 mg carton with 28 tablets EU/1/04/292/011 - 90 mg carton with 84 tablets EU/1/04/292/012 - 90 mg bottle with 30 tablets
Slovenian: EU/1/04/292/001 - škatla s 14 tabletami po 30 mg EU/1/04/292/002 - škatla z 28 tabletami po 30 mg EU/1/04/292/003 - škatla s 84 tabletami po 30 mg EU/1/04/292/004 - plastenka s 30 tabletami po 30 mg EU/1/04/292/005 - škatla s 14 tabletami po 60 mg EU/1/04/292/006 - škatla z 28 tabletami po 60 mg EU/1/04/292/007 - škatla s 84 tabletami po 60 mg EU/1/04/292/008 - plastenka s 30 tabletami po 60 mg EU/1/04/292/009 - škatla s 14 tabletami po 90 mg EU/1/04/292/010 - škatla z 28 tabletami po 90 mg EU/1/04/292/011 - škatla s 84 tabletami po 90 mg EU/1/04/292/012 - plastenka s 30 tabletami po 90 mg
English: Using water is not recommended as it may make the medicine taste bitter.
Slovenian: Uporaba vode ni priporočljiva, ker lahko povzroči grenek okus zdravila.
English: Reduction of hypercalcaemia in adult patients with:
Slovenian: Zmanjšanje hiperkalciemije pri odraslih bolnikih s:
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Slovenian: Po natančni oceni koristi in tveganj se je treba odločiti bodisi za prenehanje dojenja bodisi prenehanje zdravljenja z zdravilom Mimpara.
English: • loss (anorexia) or decrease of appetite
Slovenian: • izguba apetita (neješčnost) ali zmanjšanje apetita,
English: The switch from etelcalcetide to Mimpara and the appropriate wash out period has not been studied in patients.
Slovenian: Prehoda z etelkalcetida na zdravilo Mimpara in ustreznega obdobja izpiranja pri bolnikih niso raziskali.
English: If you used food to take Mimpara granules, drink something afterwards to make sure all the medicine is swallowed.
Slovenian: Če ste za jemanje zrnc zdravila Mimpara uporabili hrano, potem nekaj popite, tako da boste zagotovo zaužili vse zdravilo.
English: iPTH concentrations from baseline were reduced by ≥ 30% in 71% (12 out of 17) of patients in the study.
Slovenian: Koncentracija iPTH se je v primerjavi z izhodiščem znižala za ≥ 30 % pri 71 % (12 od 17) bolnikov v študiji.
English: • Hold each capsule upright (with the coloured cap on top).
Slovenian: • Držite vsako kapsulo pokonci (tako, da je njen obarvani pokrovček zgoraj).
English: - The capsule shell contains:
Slovenian: - Telo kapsule vsebuje:
English: If 1-3 capsules are used per day use at least 15 mL food; if 4-6 capsules are used per day use at least 30 mL food.
Slovenian: V primeru uporabe 1-3 kapsul na dan je treba uporabiti vsaj 15 ml hrane; v primeru uporabe 4-6 kapsul na dan pa vsaj 30 ml hrane.
English: 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).
Slovenian: Neželeni učinki, ki jih je na podlagi ocene najboljših dokazov o vzročnosti vsaj možno pripisati zdravljenju s cinakalcetom iz študij, kontroliranih 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).
English: 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.
Slovenian: Odprto podaljšanje te študije med 3-letnim obdobjem ni pokazalo dodatnega znižanja koncentracije prostega in celotnega testosterona pri bolnikih, ki so dobivali zdravilo Mimpara.
English: Stop treatment with Mimpara.
Slovenian: Prenehajte zdravljenje z zdravilom Mimpara.
English: Smoking: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-mediated metabolism.
Slovenian: Kajenje: Očistek cinakalceta je pri kadilcih večji kot pri nekadilcih, verjetno zaradi indukcije presnove s CYP1A2.
English: If you experience these side effects, do not drive or operate machines.
Slovenian: Če se vam pojavijo ti neželeni učinki, ne upravljajte vozil in strojev.
English: Mimpara is used in adults:
Slovenian: Zdravilo Mimpara uporabljamo pri odraslih:
English: If you have forgotten a dose of Mimpara, you should take your next dose as normal.
Slovenian: Če ste pozabili odmerek zdravila Mimpara, vzemite naslednji odmerek kot ponavadi.
English: While opening it is recommended to hold the capsule upright over the small amount of soft food or liquid.
Slovenian: Med odpiranjem je kapsulo priporočljivo držati pokonci nad majhno količino mehke hrane ali tekočine.
English: Other medicines and Mimpara
Slovenian: Druga zdravila in zdravilo Mimpara
English: Mimpara should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo Mimpara naj bi med nosečnostjo uporabljati le, če možne koristi upravičujejo potencialno tveganje za plod.
English: Effect of other medications on cinacalcet
Slovenian: Vpliv drugih zdravil na cinakalcet
English: Starting dose (mg)
Slovenian: Začetni odmerek (mg)
English: The granules are not compatible with tubes made of polyurethane and silicone.
Slovenian: Zrnca niso združljiva (kompatibilna) s sondami iz poliuretana in silikona.
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): Cinacalcet is a strong inhibitor of CYP2D6.
Slovenian: Zdravila, ki se presnavljajo z encimom P450 2D6 (CYP2D6): Cinakalcet je močan zaviralec CYP2D6.
English: - The other ingredients are:
Slovenian: - Ostale sestavine zrnc so:
English: Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Slovenian: Zdravilo Mimpara je mogoče uporabiti v terapevtski shemi, ki vključuje vezalce fosfatov in/ali sterole vitamina D, kot je primerno (glejte poglavje 5.1).
English: The recommended starting dose for adults is 30 mg once per day.
Slovenian: Priporočeni začetni odmerek za odrasle je 30 mg enkrat na dan.
English: Do not store Mimpara mixed with food or liquid.
Slovenian: Zdravila Mimpara ne shranjujte zmešanega s hrano ali tekočino.
English: A small bowl, cup or spoon with soft food (such as apple sauce or yogurt) or liquid (such as apple juice or renal infant formula).
Slovenian: Majhno posodico, skodelico ali žlico z mehko hrano (na primer z jabolčno čežano ali jogurtom) ali tekočino (na primer z jabolčnim sokom ali ledvično formulo za dojenčke).
English: You must open the capsules and administer the entire content of granules.
Slovenian: Kapsule morate odpreti in uporabiti celotno vsebino zrnc.
English: Renal Insufficiency: 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.
Slovenian: Insuficienca ledvic: 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.
English: If patient was receiving the lowest dose (1 mg/day) prior to discontinuation, restart at the same dose (1 mg/day).
Slovenian: Če je bolnik pred prekinitvijo zdravljenja prejemal najmanjši odmerek (1 mg/dan), zdravljenje znova začnite s tem odmerkom (1 mg/dan).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je vaš zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Mimpara.
Slovenian: Otroci, mlajši od 18 let, ki imajo raka obščitnic ali primarni hiperparatiroidizem, ne smejo jemati zdravila Mimpara.
English: It is recommended that Mimpara 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).
Slovenian: Zdravilo Mimpara je priporočljivo vzeti s hrano ali kmalu po jedi, kajti študije so pokazale, da je biološka uporabnost cinakalceta večja, če ga vzamemo skupaj s hrano (glejte poglavje 5.2).
English: Patients should drink fluids after oral administration to make sure all of the mixture is swallowed.
Slovenian: Bolniki morajo po zaužitju piti, da se s tem zagotovi, da zaužijejo vso mešanico.
English: The usual starting dose of Mimpara for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.
Slovenian: Običajen začetni odmerek zdravila Mimpara za otroke, stare od 3 let do manj kot 18 let, je največ 0,20 mg/kg telesne mase na dan.
English: After taking Mimpara a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).
Slovenian: Pri zelo majhnem številu bolnikov s srčnim popuščanjem so po uporabi zdravila Mimpara zabeležili poslabšanje njihovega stanja in/ali nizek krvni tlak (hipotenzijo).
English: The starting dose of cinacalcet was 0.20 mg/kg.
Slovenian: Začetni odmerek cinakalceta je bil 0,20 mg/kg.
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolised by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Slovenian: Ti podatki nakazujejo, da naj cinakalcet ne bivplival na farmakokinetiko tistih skupin zdravil, ki se presnavljajo s CYP3A4 in CYP3A5, kot so nekateri imunosupresivi, vključno s ciklosporinom in takrolimusom.
English: Either the intact PTH (iPTH) or bio-intact PTH (biPTH) may be used to measure PTH levels; treatment with Mimpara does not alter the relationship between iPTH and biPTH.
Slovenian: Za merjenje koncentracije PTH je mogoče uporabiti intaktni PTH (iPTH) ali biointaktni PTH (biPTH); zdravljenje z zdravilom Mimpara ne spremeni razmerja med iPTH in biPTH.
English: • 4 to 6 capsules a day use at least 2 tablespoons (30 mL)
Slovenian: • Od 4 do 6 kapsul na dan uporabite vsaj 2 veliki žlici (30 ml)
English: Mimpara treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Slovenian: Zdravljenja z zdravilom Mimpara se ne sme začeti pri bolnikih, ki imajo kalcij v serumu (korigiran za albumin) pod spodnjo mejo normalnega območja.
English: You should not receive Mimpara together with etelcalcetide.
Slovenian: Zdravila Mimpara ne smete prejemati skupaj z etelkalcetidom.
English: • Hold the capsule upright over the soft food or liquid.
Slovenian: • Držite kapsulo pokonci nad mehko hrano ali tekočino.
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Slovenian: Na podlagi primerjav med študijami ocenjujejo, da je absolutna biološka uporabnost cinakalceta pri preiskovancih na tešče okrog 20-25 %.
English: Because doses are titrated for each subject based on safety and efficacy parameters, no additional dose adjustment is necessary for subjects with hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Ker so odmerki titrirani za vsakega bolnika posebej glede na parametre varnosti in učinkovitosti, pri bolnikih z okvaro jeter ni potrebno dodatno prilagajanje odmerka (glejte poglavji 4.2 in 4.4).
English: • If iPTH is < 150 pg/mL (15.9 pmol/L) and ≥ 100 pg/mL (10.6 pmol/L), decrease the dose of Mimpara to the next lower dose.
Slovenian: • Če je iPTH < 150 pg/ml (15,9 pmol/l) in ≥ 100 pg/ml (10,6 pmol/l), zmanjšajte odmerek zdravila Mimpara na naslednji nižji odmerek.
English: Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Slovenian: Velikosti pakiranj z 1 pretisnim omotom (14 tablet), 2 pretisnima omotoma (28 tablet) ali 6 pretisnimi omoti (84 tablet) na škatlo.
English: The dose should be adjusted based on iPTH as shown below:
Slovenian: Odmerek je treba glede na iPTH prilagoditi takole:
English: PHARMACEUTICAL FORM AND CONTENTS Granules in capsules for opening 30 capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA zrnca v kapsulah za odpiranje 30 kapsul
English: Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.
Slovenian: Vaš zdravnik se bo pogovoril z vami o prenehanju bodisi dojenja bodisi zdravljenja z zdravilom Mimpara.
English: If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Mimpara and during treatment with Mimpara.
Slovenian: Če se zdravite zaradi sekundarnega hiperparatiroidizma, vam mora zdravnik kontrolirati koncentracijo kalcija pred začetkom zdravljenja z zdravilom Mimpara in med zdravljenjem s tem zdravilom.
English: What Mimpara is and what it is used for What you need to know before you take Mimpara How to take Mimpara
Slovenian: Kaj je zdravilo Mimpara in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Mimpara Kako jemati zdravilo Mimpara Možni neželeni učinki
English: • Amorphous silicon dioxide
Slovenian: • amorfni silicijev dioksid
English: In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12-fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
Slovenian: V študijah in vitro so za transporter serotonina ugotovili 7-krat večje vrednosti IC50 in za KATP-kanale 12-krat večje vrednosti IC50 kot je bila EC50 za kalcij-zaznavajoče receptorje pod enakimi eksperimentalnimi pogoji.
English: • Carnauba wax
Slovenian: • karnauba voskom,
English: • Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).
Slovenian: • nenavadno hiter ali razbijajoč srčni utrip, ki je lahko povezan z nizkimi koncentracijami kalcija v krvi (podaljšanje intervala QT in ventrikularne motnje srčnega ritma zaradi hipokalciemije).
English: • Make sure remaining content from the top is also emptied on the food or liquid.
Slovenian: • Poskrbite, da boste v hrano ali tekočino stresli tudi preostanek vsebine iz zgornjega dela.
English: ANNEX III LABELLING AND PACKAGING LEAFLET
Slovenian: PRILOGA III OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Effect of cinacalcet on other medications
Slovenian: Vpliv cinakalceta na druga zdravila
English: What you need to know before you take Mimpara Do not take Mimpara if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Mimpara če ste alergični na cinakalcet ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis).
Slovenian: Znižanje PTH je bilo povezano z neznačilnimi znižanji označevalcev presnove kosti (za kosti specifične alkalne fosfataze, N-telopeptida, kostne premene in fibroze kosti).
English: LIST OF EXCIPIENTS Lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI laktoza monohidrat
English: • For patients who have nasogastric or gastrostomy tubes, the granules can be administered with a small amount (at least 5 mL) of water using PVC tubing.
Slovenian: • Bolnikom, ki imajo nazogastrično ali gastrostomijsko sondo, je mogoče zrnca dati z majhno količino (vsaj 5 ml) vode po PVC sondi.
English: Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Mimpara.
Slovenian: Medtem ko jemljete zdravilo Mimpara, morate zdravniku povedati, če opazite nenavadno hiter ali razbijajoč srčni utrip, če imate težave s srčnim ritmom, ali če jemljete zdravila, za katera je znano, da povzročajo težave s srčnim ritmom.
English: * Administer calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols, as clinically indicated.
Slovenian: * Uporabite dodatke kalcija, vezalce fosfatov, ki vsebujejo kalcij, in/ali sterole vitamina D, kot je klinično indicirano.