natgillin/translations-raw huggingface dataset:
In radiolabeled studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the faeces.
V radioaktivno označenih študijah pri podganah in psih partiromer ni bil sistemsko absorbiran in se je izločil v blatu.
add more water, stir and drink immediately.
premešajte in takoj popijte.
Take within 1 hour after preparation of suspension.
Zaužijte v 1 uri po pripravi suspenzije.
Follow-Up (day)
Kontrola (dan)
Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be monitored.
Ker lahko preveliki odmerki zdravila Veltassa povzročijo hipokaliemijo, je treba spremljati ravni kalija v serumu.
This may be repeated as needed to ensure the entire dose is administered.
To je treba ponavljati toliko časa, kolikor bo potrebno, da se vzame celoten odmerek.
Number of Subjects: Lower K+ Stratum:
Število preiskovancev: Nižji sloj K+:
Never heat Veltassa or add it to heated foods or liquids.
Zdravila Veltassa nikoli ne segrevajte in ga ne dodajajte segreti hrani oziroma tekočini.
In patients randomised to patiromer, the mean daily dose was 21 g at the start of Part B and during Part B.
Pri bolnikih, ki so bili naključno razvrščeni v skupino, ki je prejemala patiromer, je bil povprečni dnevni odmerek 21 g na začetku dela B in v času trajanja dela B.
Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5).
Med dajanjem zdravila Veltassa in dajanjem drugih peroralnih zdravil morajo miniti 3 ure (glejte poglavje 4.5).
Do not stop taking the medicine without your doctor's approval, as your potassium blood level may increase.
Zdravila Veltassa ne prenehajte jemati brez dovoljenja zdravnika, saj se lahko raven kalija v vaši krvi zviša.
Veltassa has no or negligible influence on your ability to drive and use machines.
Zdravilo Veltassa nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
No special dose and administration guidelines are recommended for this population.
Za to populacijo ni priporočenih posebnih smernic za odmerjanje in jemanje zdravila.
When discontinuing patiromer, serum potassium levels may rise, especially if RAAS inhibitor treatment is continued.
Po prenehanju jemanja patiromera se lahko ravni kalija v serumu dvignejo, zlasti če se nadaljuje zdravljenje z zaviralcem RAAS.
Your doctor will check the magnesium level during treatment with Veltassa for at least 1 month and may prescribe a magnesium supplement if required.
Med zdravljenjem z zdravilom Veltassa bo vaš zdravnik najmanj 1 mesec preverjal raven magnezija in vam bo predpisal dodatek magnezija, če bo to potrebno.
The European Medicines Agency has deferred the obligation to submit the results of studies with patiromer in one or more subsets of the paediatric population in the treatment of hyperkalaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s patiromerom za vse podskupine pediatrične populacije pri zdravljenju hiperkaliemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What you need to know before you take Veltassa Do not take Veltassa
Kaj morate vedeti, preden boste vzeli zdravilo Veltassa Ne jemljite zdravila Veltassa
In an open-label study, 114 patients with hyperkalaemia were randomized to patiromer once daily with food or without food.
V odprti študiji je 114 bolnikov s hiperkaliemijo, randomiziranih v skupino, ki je patiromer jemala enkrat dnevno skupaj s hrano, ali skupino, ki je patiromer jemala enkrat dnevno brez hrane.
The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer.
Vsebnost sorbitola je približno 4 g (10,4 kcal) na 8,4 g patiromera.
In vitro studies have shown potential interaction of patiromer with quinidine.
Študije in vitro so pokazale potencialno medsebojno delovanje patiromera s kinidinom.
You should drink only moderate amounts (less than 400 mL per day) of cranberry juice as it can affect other medicines.
Brusnični sok pijte le v zmernih količinah (manj kot 400 ml na dan), saj lahko vpliva na druga zdravila.
This prevents potassium from entering your bloodstream and lowers potassium levels in your blood back to normal.
To preprečuje, da bi kalij prišel v krvni obtok, hkrati pa se raven kalija v vaši krvi zniža nazaj na normalno.
For either storage condition, Veltassa should not be used after the expiry date printed on the sachet.
V obeh primerih shranjevanja se zdravila Veltassa ne sme uporabljati po izteku roka uporabnosti, ki je natisnjen na vrečici.
Approximately 97% of patients had hypertension, 57% had type 2 diabetes, and 42% had heart failure.
Približno 97 % bolnikov je imelo visok krvni tlak, 57 % bolnikov je imelo sladkorno bolezen tipa 2, 42 % bolnikov pa je imelo srčno popuščanje.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
In an open label study to assess the time to onset of action, a statistically significant reduction in serum potassium in hyperkalaemic patients was observed at 7 hours after the first dose.
Odprta študija, v kateri so ocenjevali čas do začetka aktivnosti, je pri bolnikih s hiperkaliemijo pokazala statistično pomembno zmanjšanje kalija v serumu 7 ur po prvem odmerku.
Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.
Magnezij v serumu je treba spremljati vsaj 1 mesec po začetku zdravljenja, razmisliti pa je treba tudi o dodajanju magnezija pri bolnikih z nizkimi ravnmi magnezija v serumu.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih neželenih učinkov v zvezi z vplivom na razmnoževanje (glejte poglavje 5.3).
Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or less.
Povprečno znižanje vrednosti magnezija v serumu je bilo 0,17 mg/dl (0,070 mmol/l) ali manj.
Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the patiromer dose is titrated.
Raven kalija v serumu je treba spremljati, kadar je klinično indicirano, in sicer tudi potem, ko so zdravila spremenjena tako, da vplivajo na koncentracijo kalija v serumu (npr. zaviralci RAAS ali diuretiki), in potem, ko je odmerek patiromera titriran.
Limitations of the clinical data
Omejitve klinčnih podatkov
Adverse reactions are listed below by system organ class and by frequency.
Neželeni učinki so navedeni spodaj po organskih sistemih in pogostnosti.
Do not use this medicine after the expiry date which is stated on the carton or sachet after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali vrečici poleg oznake „Uporabno do“.
The onset of action of Veltassa occurs 4 - 7 hours after administration.
Zdravilo Veltassa začne učinkovati 4-7 ur po dajanju.
Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion.
Patiromer je neabsorptiven, kationski izmenjevalni polimer, ki vsebuje kompleks kalcija in sorbitola kot protiiona.
In Part B, serum potassium in patients on placebo increased significantly relative to patients who remained on patiromer (p<0.001).
V delu B se je raven kalija v serumu pri bolnikih, ki so prejemali placebo, pomembno zvišala glede na bolnike, ki so še naprej jemali patiromer (p < 0,001).
Apple juice or cranberry juice can be used instead of water to prepare the mixture.
Namesto vode za pripravo mešanice se lahko uporabi jabolčni ali brusnični sok.
100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex France
100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex Francija
• Prepare about 40 mL (3 tablespoons) of water in a glass.
• V kozarec nalijte približno 40 ml (3 jedilne žlice) vode.
Information about sorbitol
Podatki o sorbitolu
Severe hyperkalaemia
Huda hiperkaliemija
Mix Veltassa with water and stir until it is thoroughly mixed, as follows:
Zdravilo Veltassa zmešajte z vodo in mešajte, dokler ni dobro premešano, in sicer takole:
The mixture should be taken within 1 hour of initial suspension.
Mešanico je treba vzeti v 1 uri po pripravi začetne suspenzije.
In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients treated with patiromer.
V kliničnih študijah so bile vrednosti magnezija v serumu < 1,4 mg/dl (0,58 mmol/l) prisotne pri 9 % bolnikov, ki so jemali patiromer.
The majority of the adverse reactions (ARs) reported from trials were gastrointestinal disorders, with the most frequently reported ARs being constipation (6.2%), diarrhoea (3%), abdominal pain (2.9%), flatulence (1.8%) and hypomagnesaemia (5.3%).
Večina neželenih učinkov, o katerih so poročali v preskušanjih, so bile bolezni prebavil, najpogosteje pa so poročali o zaprtosti (6,2 %), driski (3 %), bolečinah v trebuhu (2,9 %), vetrovih (1,8 %) in hipomagneziemiji (5,3 %).
The powder for oral suspension is off white to light brown, with occasional white particles.
Prašek za peroralno suspenzijo je belkaste do svetlo rjave barve z občasnimi belimi delci.
Information about calcium
Podatki o kalciju
OM Pharma S.A. R. da Indústria, 2 Quinta Grande Amadora, 2610-088 Portugal
Quinta Grande Amadora, 2610-088 Portugalska
Take all medicines taken by mouth at least 3 hours before or after you take Veltassa, unless your doctor or pharmacist gives you different advice.
Vsa zdravila, ki jih jemljete peroralno, vzemite vsaj 3 ure prej ali po tem, ko vzamete zdravilo Veltassa, razen če vam je zdravnik ali farmacevt svetoval drugače.
Daily urinary calcium excretion increased from baseline by 53 mg/day.
Dnevno izločanje kalija z urinom se je glede na izhodiščno vrednost povečalo za 53 mg/dan.
Decreases in serum potassium with patiromer treatment were maintained over 1 year of chronic treatment as shown in Figure 1, with a low incidence of hypokalaemia (2.3%) and the majority of subjects reaching (97.7%) and maintaining target serum potassium levels (overall during maintenance period, serum potassium was within the target range for approximately 80% of the time).
Zmanjšane ravni kalija v serumu pri bolnikih, zdravljenih s patiromerom, so bile ohranjene 1 leto pri kroničnem zdravljenju, kot prikazuje slika 1, pri čemer je bila pojavnost hipokaliemije nizka (2,3 %), večina preiskovancev pa je dosegla (97,7 %) in ohranila ciljne ravni kalija v serumu (v celotnem obdobju ohranjevanja je bila raven kalija v serumu znotraj ciljnega območja približno 80 % časa).
Other liquids cannot be used as they may contain high amounts of potassium.
Ne sme se uporabiti druge tekočine, saj lahko vsebuje visoke ravni kalija.
No special dose and administration guidelines were applied to these patients in clinical studies.
V kliničnih študijah niso uporabljali nobenih posebnih smernic za odmerjanje in dajanje zdravila pri teh bolnikih.
Veltassa is used to treat adults with high levels of potassium in their blood.
Zdravilo Veltassa se uporablja za zdravljenje odraslih bolnikov z visokimi ravnmi kalija v krvi.
Patiromer has the potential to bind some oral co administered medicinal products, which could decrease their gastrointestinal absorption.
Patiromer lahko veže nekatera peroralna zdravila, ki se jemljejo sočasno, kar lahko zniža njihovo gastrointestinalno absorpcijo.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, reproduktivne in razvojne toksičnosti ne kažejo posebnega tveganja za ljudi.
In healthy adult subjects, patiromer caused a dose dependent increase in faecal potassium excretion, and a corresponding decrease in urinary potassium excretion with no change in serum potassium.
Pri zdravih odraslih je patiromer povečal izločanje kalija z blatom, ki je bilo odvisno od odmerka, in ustrezno zmanjšal izločanje kalija z urinom, pri čemer ni bilo sprememb kalija v serumu.
If a dose is missed, the missed dose should be taken as soon as possible on the same day.
Če bolnik pozabi vzeti odmerek, je treba zamujeni odmerek vzeti čim prej isti dan. Zamujenega odmerka se ne sme vzeti skupaj z naslednjim odmerkom.
There are no data from the use of patiromer in pregnant women.
Podatki o uporabi patiromera pri nosečnicah niso na voljo.
If you stop taking Veltassa
Če ste prenehali jemati zdravilo Veltassa
• Add about 40 mL (3 tablespoons) of additional water and stir thoroughly.
• Dolijte še približno 40 ml (3 jedilne žlice) vode in temeljito premešajte.
There is limited data on the use of Veltassa in patients on dialysis.
Bolniki na dializi Na voljo so omejeni podatki o uporabi zdravila Veltassa pri bolnikih na dializi.
If you forget to take Veltassa
Če ste pozabili vzeti zdravilo Veltassa
The ability of patiromer to enable concomitant spironolactone treatment was investigated in a randomised, double-blind, placebo-controlled study in heart failure patients who were clinically indicated to receive AA.
Sposobnost patiromera, da omogoči sočasno zdravljenje s spironolaktonom, so raziskali v randomizirani, dvojno slepi študiji, kontrolirani s placebom, pri bolnikih s srčnim popuščanjem, pri katerih je bilo prejemanje AA klinično indicirano.
PHARMACEUTICAL FORM AND CONTENTS powder for oral suspension
FARMACEVTSKA OBLIKA IN VSEBINA prašek za peroralno suspenzijo
What Veltassa is and what it is used for What you need to know before you take Veltassa How to take Veltassa
Kaj je zdravilo Veltassa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Veltassa Kako jemati zdravilo Veltassa Možni neželeni učinki
5.1 to <5.5 mEq/L (n=90)
med 5,1 in < 5,5 mEq/l (n = 90)
Following discontinuation of patiromer, potassium levels remained stable for 24 hours after the last dose, then rose again during a 4-day observation period.
Po prekinitvi jemanja patiromera so ravni kalija ostale stabilne 24 ur po zadnjem odmerku, nato pa so se v 4
Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal transit time.
Patiromer se izloči po približno 24 do 48 urah, odvisno od povprečnega časa prehoda gastrointestinalnega trakta.
Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin.
Sočasno jemanje patiromera je pokazalo zmanjšano biološko uporabnost ciprofloksacina, levotiroksina in metformina.
Patiromer is excreted approximately 24 to 48 hours after intake, based on average gastrointestinal transit time.
Patiromer se izloči po približno 24 do 48 urah po jemanju, odvisno od povprečnega časa prehoda gastrointestinalnega trakta.
Take Veltassa at least 3 hours before or after other medicines taken by mouth unless your doctor or pharmacist gives you different advice.
Zdravilo Veltassa vzemite vsaj 3 ure pred ali po tem, ko vzamete drugo peroralno zdravilo, razen če vam zdravnik ali farmacevt svetuje drugače.
• ciprofloxacin: a medicine to treat bacterial infections
• ciprofloksacin: zdravilo za zdravljenje bakterijskih okužb;
Veltassa contains sorbitol.
Zdravilo Veltassa vsebuje sorbitol.
If powder remains in the glass after drinking,
Če po pitju v kozarcu ostane prašek, dodajte še malo vode,
Hypomagnesaemia was mild to moderate, with no patient developing a serum magnesium level <1 mg/dL (0.4 mmol/L).
Hipomagneziemija je bila blaga do srednja, pri čemer pri nobenem bolniku raven magnezija v serumu ni padla na < 1 mg/dl (0,4 mmol/l).
Overall, in the phase 2 and 3 clinical studies, 99.4% of patients were receiving RAAS inhibitor therapy at baseline, 81.2% had CKD with eGFR <60 mL/min/1.73 m2, 72.8% had diabetes mellitus and 48.7% had heart failure.
Skupno se je v fazi 2 in 3 klinične študije ob izhodišču 99,4 % bolnikov zdravilo z zaviralcem RAAS, 81,2 % je imelo kronično ledvično bolezen z eGFR < 60 ml/min/1,73 m², 72,8 % bolnikov je imelo sladkorno bolezen, 48,7 % bolnikov pa srčno popuščanje.
Of the 105 patients who were randomised and received study treatment (patiromer 56; placebo 49), mean age was 68.3 years, 60.6% were men, 97.1% were Caucasian, and mean eGFR was 81.3 mL/min.
Pri 105 bolnikih, ki so bili randomizirani in so prejeli študijsko zdravilo (patiromer 56; placebo 49), je bila povprečna starost 68,3 leta, 60,6 % je bilo moških, 97,1 je bilo belcev, povprečna vrednost eGFR pa je bila 81,3 ml/min.
Mean baseline serum potassium values were 4.71 mEq/L for patiromer and 4.68 mEq/L for placebo.
Povprečna izhodiščna vrednost kalija v serumu je bila 4,71 mEq/l pri patiromeru in 4,68 mEq/l pri placebu.
Off white to light brown powder, with occasional white particles.
Prašek belkaste do svetlo rjave barve z občasnimi belimi delci.
Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.
Vezava kalija zmanjšuje koncentracijo prostega kalija v gastrointestinalnem lumnu, zaradi česar se zmanjšajo ravni kalija v serumu.
There were also fewer patients in the patiromer group with serum potassium values >5.5 mEq/L (7.3% vs. 24.5%; p=0.027) and more patients on spironolactone 50 mg/day (90.9% versus 73.5%, p=0.022).
V skupini, ki je prejemala patiromer, je bilo tudi manj bolnikov z vrednostmi kalija v serumu > 5,5 mEq/l (7,3 % proti 24,5 %; p = 0,027) in več bolnikov, ki so prejemali 50 mg/dan spironolaktona (90,9 % proti 73,5 %, p = 0,022).
25.2 g of patiromer, administered once daily for 6 days, resulted in a mean increase in faecal potassium excretion of 1283 mg/day, and a mean decrease in urinary potassium excretion of 1438 mg/day.
Odmerek 25,2 g patiromera enkrat dnevno 6 dni je povzročil povprečno povečanje izločanja kalija z blatom 1283 mg/dan in povprečno zmanjšanje izločanja kalija z urinom 1438 mg/dan.
What Veltassa looks like and contents of the pack
Izgled zdravila Veltasa in vsebina pakiranja
• metformin: a medicine to treat diabetes
• metformin: zdravilo za zdravljenje sladkorne bolezni;
The benefits and risks of administering this medicinal product should be carefully evaluated in patients at risk of hypercalcaemia.
Pri bolnikih s tveganjem za hiperkalciemijo je treba skrbno pretehtati koristi in tveganja jemanja tega zdravila.
The mean age of patients was 64 years (54% aged 65 and over, 17% aged 75 and over), 58% of patients were men, and 98% were Caucasian.
Povprečna starost bolnikov je bila 64 let (54 % bolnikov starih 65 let in več, 17 % bolnikov starih 75 let in več), 58 % bolnikov je bilo moških, 98 % bolnikov je bilo belcev.
Once you have received Veltassa, it can be stored below 25°C for up to 6 months.
Ko zdravilo Veltassa dobite, ga lahko shranjujete pri temperaturi do 25 °C do 6 mesecev.
Gastrointestinal disorder reactions were generally mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with treatment, and none were reported as serious.
Težave s prebavili so bile na splošno blage do srednje, niso bile povezane z odmerkom, običajno so izginile same od sebe ali z zdravljenjem, noben od teh neželenih učinkov pa ni bil resen.
• quinidine: a medicine to treat irregular heart rhythm.
• kinidin: zdravilo za zdravljenje srčne aritmije.
There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Izkušenj pri bolnikih s koncentracijo kalija v serumu, ki so višje od 6,5 mmol/l, je malo.
As precautionary measure, and based on the data summarised below, administration of patiromer should therefore be separated by at least 3 hours from other oral medicinal products.
Zato je treba preventivno in na podlagi podatkov, povzetih v nadaljevanju, patiromer vzeti vsaj 3 ure prej oziroma kasneje kot druga peroralna zdravila.
Discontinuing patiromer
Prekinitev jemanja patiromera
Patients initiated spironolactone at 25 mg/day at the same time as their randomised treatment (patiromer 12.6 g BID or placebo), and were up-titrated to 50 mg/day after Day 14 if serum potassium was >3.5 and ≤5.1 mEq/L.
Bolniki so začeli prejemati spironolakton v odmerku 25 mg/dan sočasno z njihovim randomiziranim zdravljenjem (bodisi 12,6 g patiromera dvakrat dnevno bodisi placebo) in so nato prejemali navzgor titrirane odmerke do 50 mg/dan po 14. dnevu, če je bila raven kalija v serumu > 3,5 in ≤ 5,1 mEq/l.
Mean (95% Cl) Serum Potassium (mEq/L)
Mediani (95% IZ) serumski kalij (mEq/l)
Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to the following steps:
Zdravilo Veltassa je treba mešati z vodo in ga premešati, tako da nastane suspenzija enotne konsistence.
Patiromer was not genotoxic in the reverse mutation test (Ames assay), chromosome aberration or rat micronucleus assays.
Patiromer pri testu reverzne mutacije (Amesov test), kromosomske aberacije ali testu mikrojeder pri podgani ni bil genotoksičen.
Patiromer works by binding potassium in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy.
Patiromer veže kalij v prebavnem traktu, tako da njegova koncentracija v serumu ni pomembna za učinkovitost zdravila.
8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
8,4 g, 16,8 g ali 25,2 g patiromera v obliki praška v vrečicah, sestavljenih iz petih plasti: polietilena,
Serum potassium at the end of treatment, the change from baseline in serum potassium, and the mean dose of patiromer were similar between groups.
Raven kalija v serumu ob koncu zdravljenja, sprememba ravni kalija v serumu glede na izhodišče in povprečni odmerek patiromera so bili v obeh skupinah podobni.
Can be stored below 25°C for up to 6 months.
Zdravilo lahko shranjujete pri temperaturi do 25 °C do 6 mesecev.
Metabolism and nutrition disorders
Presnovne in prehranske motnje hipomagneziemija
• levothyroxine: a medicine to treat thyroid hormone deficiency
• levotiroksin: zdravilo za zdravljenje pomanjkanja ščitničnega hormona;
Veltassa is indicated for the treatment of hyperkalaemia in adults.
4.1 Terapevtske indikacije Zdravilo Veltassa je indicirano za zdravljenje hiperkaliemije pri odraslih.
Baseline Serum K+ > 5.5 to < 6.0 mEq/L
Izhodiščni serumski K+ med > 5,5 in < 6,0 mEq/l
Concomitant administration of patiromer did however not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin.
Glede na meritve območja pod krivuljo (AUC) sočasno jemanje patiromera ni vplivalo na biološko uporabnost amlodipina, cinakalceta, klopidogrela, furosemida, litija, metoprolola, trimetoprima,
It should not be heated (e.g. microwaved) or added to heated foods or liquids.
v mikrovalovni pečici) ali ga dodajati segreti hrani oziroma tekočini.
Veltassa contains calcium as part of the counterion complex.
Zdravilo Veltassa vsebuje kalcij kot del protiionskega kompleksa.
INFORMATION IN BRAILLE VELTASSA 25.2 G
PODATKI V BRAILLOVI PISAVI VELTASSA 25,2 G
The following side effects have been reported: Common, may affect up to 1 in 10 people:
Pogosti, pojavijo se lahko pri največ 1 od 10 bolnikov:
Veltassa contains sorbitol as part of the counterion complex.
Zdravilo Veltassa vsebuje sorbitol kot del protiionskega kompleksa.
Patients may store Veltassa below 25°C for up to 6 months.
Bolniki lahko zdravilo Veltassa shranjujejo pri temperaturi do 25 °C do 6 mesecev.