FrancophonIA/ELRC3.0 huggingface dataset:
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Slovenian: Pri manj kot 10 % goveda, zdravljenega v kliničnih študijah, so opazili le blago, prehodno oteklino na mestu injiciranja pod kožo.
English: Therefore, possible reduction in absorption cannot be excluded.
Slovenian: Zato ni mogoče izključiti možnega zmanjšanja absorpcije.
English: Current available data are described in section 5.1.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavju 5.1.
English: ATC code: V03A E02.
Slovenian: Oznaka ATC: V03A E02.
English: Appropriate symptomatic treatment should be provided.
Slovenian: Poskrbeti je treba za ustrezno simptomatsko zdravljenje.
English: Your doctor will advise you if you are taking these medicines.
Slovenian: Vaš zdravnik vam bo svetoval, če jemljete ta zdravila.
English: Date of first authorisation: 10 June 2009 Date of latest renewal: 20 February 2019
Slovenian: Datum prve odobritve: 10. junij 2009 Datum zadnjega podaljšanja: 20. februar 2019
English: Do not chew.
Slovenian: Ne žvečite.
English: o The remaining powder may be used within 24 hours for the next dose.
Slovenian: o Preostanek praška lahko v 24 urah uporabite za naslednji odmerek.
English: The exact starting dose and regimen will be determined by your doctor.
Slovenian: Natančni začetni odmerek in režim bo določil vaš zdravnik.
English: Not data are available.
Slovenian: Podatkov ni na voljo.
English: >0.75 to <1.2
Slovenian: >0,75 do < 1,2
English: Frequency is not known (frequency cannot be estimated from the available data).
Slovenian: Pogostnost ni znana (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: Component of a multipack, can't be sold separately.
Slovenian: Posameznih komponent skupnega pakiranja se ne sme prodajati ločeno.
English: The decrease in cholesterol has been observed after 2 weeks of treatment and is maintained with long-term treatment.
Slovenian: Zmanjšanje holesterola je bilo vidno po 2 tednih zdravljenja, vzdržuje pa se ga z dolgoročnim zdravljenjem.
English: Since this medicine does not contain calcium your doctor might prescribe additional calcium tablets.
Slovenian: Ker to zdravilo ne vsebuje kalcija, vam utegne zdravnik predpisati dodatne kalcijeve tablete.
English: Frequency is not known.
Slovenian: Pogostnost ni znana.
English: Therefore it is currently not recommended for use in these patients.
Slovenian: Zaradi tega uporaba zdravila trenutno ni priporočljiva pri teh bolnikih.
English: Follow the diet prescribed by your doctor.
Slovenian: Držite se diete, ki vam jo je predpisal zdravnik.
English: However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded.
Slovenian: Vendar pa možne absorpcije in kopičenja sevelamerja med dolgotrajnim kroničnim zdravljenjem (več kot eno leto) ni mogoče povsem izključiti.
English: This medicine should not be given on an empty stomach and should be taken with meals or snacks.
Slovenian: Tega zdravila se ne sme dajati na prazen želodec, ampak ga je treba vzeti z obroki ali prigrizki.
English: • adult patients on dialysis (a blood clearance technique).
Slovenian: • odraslih bolnikih na dializi (tehnika čiščenja krvi).
English: • you have low levels of phosphate in your blood (your doctor will check this for you)
Slovenian: • če imate nizke ravni fosforja v krvi (vaš zdravnik bo opravil pregled)
English: Elderly population No dosage adjustment is necessary in the elderly population.
Slovenian: Starejša populacija Pri starejši populaciji odmerjanja ni treba prilagoditi.
English: Renvela should be taken with food and not on an empty stomach.
Slovenian: Zdravilo Renvela je treba jemati s hrano, ne na prazen želodec.
English: • have a low amount of vitamin D in your blood.
Slovenian: • pojavi nizka količina vitamina D v krvi.
English: Titration and maintenance *Adults
Slovenian: Titriranje in vzdrževanje *Odrasli
English: In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile for adults.
Slovenian: Na splošno so varnostne značilnosti pri otrocih in mladostnikih (starih od 6 do 18 let) podobne kot pri odraslih.
English: *Plus subsequent titrating, see section “Titration and maintenance”
Slovenian: *In nadaljnje titriranje, glejte poglavje “Titriranje in vzdrževanje”
English: The potential risk of Renvela during human pregnancy is unknown.
Slovenian: Možno tveganje zdravila Renvela med nosečnostjo pri človeku ni znano.
English: Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Slovenian: Bolnike na peritonealni dializi je treba skrbno nadzirati, da se zagotovi pravilna uporaba ustreznih aseptičnih tehnik in hitro prepoznavanje in obravnavanje vseh znakov in simptomov, povezanih s peritonitisom.
English: • develop low or high levels of calcium in your blood.
Slovenian: • pojavijo nizke ali visoke ravni kalcija v krvi.
English: There are no data from the effect of sevelamer on fertility in humans.
Slovenian: Ni podatkov o učinku sevelamera na plodnost pri ljudeh.
English: Titration increases/decreases
Slovenian: Titriranje s povečanjem/zmanjšanjem
English: It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.
Slovenian: Pomembno je, da spijete vso tekočino in morda bo treba kozarec sprati z vodo in spiti tudi to, da zagotovite, da ste zaužili ves prašek.
English: Drink within 30 minutes of being prepared.
Slovenian: Spijte v 30 minutah od priprave.
English: Digoxin, warfarin, enalapril or metoprolol
Slovenian: Digoksin, varfarin, enalapril ali metoprolol
English: Serum phosphorus level in patients
Slovenian: Ravni serumskega fosforja pri bolnikih
English: Your doctor will check for interactions between Renvela and other medicines on a regular basis.
Slovenian: Zdravnik bo redno preverjal medsebojno delovanje zdravila Renvela in ostalih zdravil.
English: It is unknown whether Renvela is excreted in breast milk and may affect your baby.
Slovenian: Ni znano, ali se zdravilo Renvela izloča v materino mleko in tako morda vpliva na vašega otroka.
English: This information was obtained from studies in which sevelamer hydrochloride was used.
Slovenian: Ta informacija je bila pridobljena v študijah, kjer so uporabili sevelamerijev klorid.
English: The safety and efficacy of sevelamer carbonate have not been established in patients with the following disorders:
Slovenian: Varnosti in učinkovitosti sevelamerijevega karbonata niso ugotavljali pri bolnikih z naslednjimi boleznimi:
English: • major gastrointestinal tract surgery Treatment of these patients with Renvela should only be initiated after careful benefit/risk assessment.
Slovenian: • velika operacija gastrointestinalnega trakta Zdravljenje takšnih bolnikov z zdravilom Renvela se sme začeti le po skrbnem pretehtanju koristi in tveganj.
English: Titration and maintenance
Slovenian: Titriranje in vzdrževanje
English: It can be an early symptom of a blockage in your intestine.
Slovenian: Lahko je zgodnji simptom blokade v črevesju.
English: The sachets are packaged in an outer carton.
Slovenian: Vrečice so pakirane v zunanjo škatlo.
English: *post-marketing experience
Slovenian: *izkušnje po začetku trženja
English: OTHER SPECIAL WARNING, IF NECESSARY EXPIRY DATE
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: What Renvela is and what it is used for 2.
Slovenian: Kaj je zdravilo Renvela in za kaj ga uporabljamo 2.
English: Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see sections 4.4 and 5.3).
Slovenian: Pokazalo se je tudi, da sevelamer zmanjšuje absorpcijo številnih vitaminov, vključno s folno kislino (glejte poglavji 4.4 in 5.3).
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer carbonate treatment.
Slovenian: Trenutno ni dovolj podatkov, da bi izključili možnost pomanjkanja folatov med dolgotrajnim zdravljenjem s sevelamerijevim karbonatom.
English: The effects may be secondary to vitamin D depletion.
Slovenian: Učinki so lahko sekundarni po pomanjkanju vitamina D.
English: The safety and efficacy in children (below the age of 6 years) have not been studied.
Slovenian: Varnosti in učinkovitosti pri otrocih (starih manj kot 6 let) niso preučevali.
English: Do not use this medicine after the expiry date stated on the bottle and carton after the letters “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in škatli poleg oznake „EXP“.
English: Only for bottle label of 180 tablets: PC:
Slovenian: Samo za nalepko na vsebniku s 180 tabletami: PC:
English: Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.
Slovenian: Povečane ravni fosforja v serumu lahko povzročijo srbečo kožo, rdeče oči, bolečine v kosteh in zlome.
English: These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body.
Slovenian: Ti depoziti lahko stiskajo vaše krvne žile in otežujejo črpanje krvi po telesu.
English: Sevelamer carbonate is not absorbed and may affect the bioavailability of other medicinal products.
Slovenian: Sevelamerijev karbonat se ne absorbira in lahko vpliva na biološko uporabnost drugih zdravil.
English: Special note for patients on peritoneal dialysis
Slovenian: Posebno opozorilo za bolnike na peritonealni dializi
English: • you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Take Renvela after your meal or with food.
Slovenian: Zdravilo Renvela vzemite po obroku ali s hrano.
English: As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended.
Slovenian: Kot del dobre klinične prakse se zato priporoča nadziranje ravni bikarbonata v serumu.
English: In some cases where Renvela should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake.
Slovenian: V nekaterih primerih, ko je treba zdravilo Renvela vzeti sočasno z drugim zdravilom, vam bo zdravnik morda svetoval, da vzamete drugo zdravilo 1 uro pred ali 3 ure po vnosu zdravila Renvela.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renvela.
Slovenian: • Če jemljete zdravila zaradi težav s srčnim ritmom ali zaradi epilepsije, se o jemanju zdravila Renvela posvetujte z zdravnikom.
English: Always use the dosing spoon provided in the carton.
Slovenian: Vedno uporabite žličko, ki se nahaja v škatli.
English: This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
Slovenian: To zdravilo se uporablja za nadzor hiperfosfatemije (visoke ravni fosfata v krvi) pri:
English: Patients with CKD are predisposed to developing metabolic acidosis.
Slovenian: Bolniki s KBL so nagnjeni k razvoju metabolične acidoze.
English: The effects of sevelamer on phosphorus and calcium were proven to be maintained throughout a study with one year follow-up.
Slovenian: Dokazali so, da se učinki sevelamera na fosfat in kalcij ohranijo ves čas študije z enoletnim spremljanjem.
English: 27% of paediatric patients reached their age appropriate serum phosphorus level at end of treatment.
Slovenian: 27 % pediatričnih bolnikov je ob koncu zdravljenja doseglo za svojo starost primerno koncentracijo fosforja v serumu.
English: The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including mainly constipation and other known gastrointestinal disorders.
Slovenian: Simptomi, ki so jih opažali v primeru prevelikega odmerjanja, so podobni neželenim učinkom, naštetim v poglavju 4.8, in obsegajo predvsem zaprtost in druge znane prebavne motnje.
English: Your doctor can rather prescribe Renvela powder for oral suspension
Slovenian: Zdravnik vam lahko raje predpiše zdravilo Renvela prašek za peroralno suspenzijo.
English: The non-absorbed nature of sevelamer indicates that excretion of sevelamer in breast milk is unlikely.
Slovenian: Narava sevelamera, da se ne absorbira, kaže na to, da izločanje sevelamera v mleko ni verjetno.
English: In clinical trials of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%.
Slovenian: V kliničnih preskušanjih sevelamera je povprečna vrednost skupnega holesterola in holesterola LDL upadla za 15-39 %.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: If the therapy is initiated, patients suffering from these disorders should be monitored.
Slovenian: V primeru uvedbe zdravljenja je treba bolnike s temi boleznimi/motnjami kontrolirati.
English: The powder may also be pre-mixed with cold beverage or unheated food (see section 4.2).
Slovenian: Prašek se lahko predhodno pomeša s hladno pijačo ali nesegreto hrano (glejte poglavje 4.2).
English: For children, the powder is preferred, as tablets are not appropriate in this population.
Slovenian: Pri otrocih ima prašek prednost, ker tablete za to populacijo niso primerne.
English: • Renvela should not be taken at the same time as ciprofloxacin (an antibiotic).
Slovenian: • Zdravila Renvela ne smete jemati sočasno s ciprofloksacinom (antibiotik).
English: Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day).
Slovenian: Študije karcinogenosti s sevelamerijevim kloridom, danim peroralno, so izvajali na miših (odmerki do 9 g/kg/dan) in podganah (0,3, 1 ali 3 g/kg/dan).
English: It is important to drink all of the liquid to ensure that all of the powder is swallowed.
Slovenian: Pomembno je, da popijete vso tekočino, da boste res zaužili ves prašek.
English: Preparation using a dosing spoon
Slovenian: Priprava z uporabo odmerne žličke
English: Most of these adverse reactions were mild to moderate in intensity.
Slovenian: Večina neželenih učinkov je bila po intenzivnosti blaga do zmerna.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: čeopazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
English: Each carton contains 60 or 90 sachets.
Slovenian: Vsaka škatla vsebuje 60 ali 90 vrečic.
English: This is a very rare side effect (may affect up to 1 in 10,000 people).
Slovenian: To je zelo redek neželen učinek (pojavi se lahko pri največ 1 od 10.000 oseb).
English: In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on iPTH.
Slovenian: Med kliničnimi študijami pri bolnikih, ki se zdravijo s hemodializo, sam sevelamer ni imel trajnega in klinično pomembnega učinka na iPTH.
English: This risk can be reduced by careful adherence to sterile techniques during bag changes.
Slovenian: To tveganje lahko zmanjšate s skrbnim upoštevanjem sterilnih tehnik med menjavo vrečke.
English: Each bottle contains 30 tablets or 180 tablets.
Slovenian: Vsak vsebnik vsebuje 30 tablet ali 180 tablet.
English: The recommended starting dose of Renvela tablets for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Slovenian: Priporočen začetni odmerek zdravila Renvela tablete za odrasle in starejše sta ena do dve tableti 800 mg z vsakim obrokom, trikrat dnevno.
English: Other medicines and Renvela
Slovenian: Druga zdravila in zdravilo Renvela
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal.
Slovenian: Možnosti medsebojnega delovanja ni mogoče izključiti, zato je treba razmisliti o skrbnem nadziranju koncentracij ciklosporina, mofetilmikofenolata in takrolimusa v krvi v času uporabe te kombinacije in po prekinitvi.
English: Tablets must be swallowed whole.
Slovenian: Tablete je treba pogoltniti cele.
English: Do not crush, chew or break into pieces.
Slovenian: Tablet ne drobite, ne žvečite in ne lomite na koščke.
English: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Slovenian: Tablete se jemljejo cele in se jih ne sme zdrobiti, prežvečiti ali zlomiti v kose pred uporabo.
English: Further instructions are detailed in the patient leaflet.
Slovenian: Nadaljnja navodila so podrobno opisana v navodilu za uporabo.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Slovenian: Po stopnji poročanja so razvrščeni kot 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 (ni mogoče oceniti iz razpoložljivih podatkov).
English: Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone.
Slovenian: Sevelamer ne vsebuje kalcija in zmanjšuje pojavnost epizod hiperkalcemije v primerjavi z bolniki, ki uporabljajo samo vezalce fosfata na podlagi kalcija.
English: These figures were 23% and 15% in the subgroup of patients on hemodialysis and peritoneal dialysis, respectively.
Slovenian: Ta delež je bil v podskupini bolnikov na hemodializi 23 % in v podskupini bolnikov na peritonealni dializi 15 %.
English: Consequently, sevelamer carbonate should not be taken simultaneously with ciprofloxacin.
Slovenian: Zato se sevelamerijevega karbonata ne sme jemati sočasno s ciprofloksacinom.
English: If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal.
Slovenian: Če pozabite vzeti odmerek, ga izpustite in naslednji odmerek vzemite kot običajno s hrano.
English: Sevelamer has no or negligible influence on the ability to drive and use machines.
Slovenian: Sevelamer nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The suspension should be ingested within 30 minutes after being prepared.
Slovenian: Suspenzijo je treba zaužiti v 30 minutah po pripravi.
English: What you need to know before you take Renvela 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Renvela 3.
English: Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Slovenian: Zato je treba ravni kalcija v serumu redno nadzirati in po potrebi dodajati elementarni kalcij.
English: Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality.
Slovenian: Bolniki na dializi so izpostavljeni nekaterim tveganjem za okužbe, ki so odvisne od načina dialize, ki jo prejemajo.
English: It is unknown whether sevelamer/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se sevelamer/presnovki izločajo v mleko pri človeku.
English: Intestinal obstruction and ileus/subileus
Slovenian: Obstrukcija črevesja in ileus/subileus
English: The powder should not be heated (e.g. microwave).
Slovenian: Praška se ne sme segrevati (npr. mikrovalovna pečica).
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
Slovenian: Lahko se uporablja pri bolnikih na hemodializi (uporaba stroja za filtracijo krvi) ali na peritonealni dializi (tekočina se črpa v trebuh, notranja telesna membrana pa filtrira kri);
English: A total of 101 patients (6 to 18 years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study.
Slovenian: V študijo je bil v celoti randomiziran 101 bolnik (starost od 6 do 18 let in razpon telesne površine od 0,8 do 2,4 m2).
English: Additional treatments Due to either your kidney condition or your dialysis treatment you may:
Slovenian: Dodatno zdravljenje Zaradi težav z ledvicami ali zdravljenjem z dializo se lahko:
English: • paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician).
Slovenian: • pediatričnih bolnikih s kronično (dolgotrajno) boleznijo ledvic, starejših od 6 let ter nad določeno telesno višino in telesno maso (ta dva podatka zdravnik uporabi za izračun telesne površine).
English: Contact your doctor who will decide on continuing the treatment or not.
Slovenian: Obrnite se na svojega zdravnika, ki bo presodil, ali naj zdravljenje nadaljujete ali ne.
English: It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food.
Slovenian: Ni mogoče izključiti, da lahko sevelamerijev karbonat veže v maščobi topne vitamine v zaužiti hrani.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Sevelamer carbonate should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Slovenian: Sevelamerijev karbonat naj nosečnice uporabljajo le, če ga nujno potrebujejo, in po skrbni presoji razmerja med koristmi in tveganjem za mater in plod.
English: Talk to your doctor who will decide if you can continue the treatment with Renvela.
Slovenian: Posvetujte se s svojim zdravnikom, ki bo presodil, ali lahko nadaljujete zdravljenje z zdravilom Renvela.
English: Adverse reactions that occurred during clinical trials or that were spontaneously reported from postmarketing experience are listed by frequency in the table below.
Slovenian: Neželeni učinki, ki so se pojavili med kliničnimi študijami in tisti, ki so bili spontano poročani med izkušnjami v obdobju trženja so po pogostnosti našteti v spodnji preglednici.
English: Fat-soluble vitamins and folate deficiency
Slovenian: V maščobi topni vitamini in pomanjkanje folatov
English: What Renvela is and what it is used for
Slovenian: Kaj je zdravilo Renvela in za kaj ga uporabljamo
English: (Instructions for presentation WITHOUT dosing spoon)
Slovenian: (Navodila za obliko BREZ odmerne žličke)
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after sevelamer carbonate, or the physician should consider monitoring blood levels.
Slovenian: Pri dajanju katerih koli zdravil, pri katerih ima lahko zmanjšana biološka uporabnost klinično značilen vpliv na varnost ali učinkovitost, je treba zdravilo uporabiti vsaj eno uro pred ali tri ure po uporabi sevelamerijevega karbonata, ali pa mora zdravnik razmisliti o nadzoru ravni v krvi.
English: These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.
Slovenian: Ti protonirani amini vežejo ione z negativnim nabojem kot so dietni fosfati v črevesju.
English: Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Slovenian: Bolniki, ki jemljejo antiaritmična zdravila za nadzor aritmij in antiepileptična zdravila za nadzor epileptičnih napadov, so bili izključeni iz kliničnih preskušanj.