natgillin/translations-raw huggingface dataset:
The medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Zdravila boste morda jemali istočasno ali pa ob različnih časih, odvisno od tega, kaj vam je predpisal zdravnik.
A total of 85% of the patients were on either atorvastatin (50% of whom received 80 mg dose) or rosuvastatin (72% of whom received 40 mg dose).
Skupno 85 % bolnikov je prejemalo bodisi atorvastatin (50 % od njih je prejemalo odmerek 80 mg) bodisi rosuvastatin (72 % od njih je prejemalo odmerek 40 mg).
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 <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Navedba pogostosti neželenih učinkov je označena kot zelo pogosto (≥1/10), pogosto (≥1/100 do <1/10), občasno (≥1/1.000 do <1/100), redko (≥1/10.000 do <1/1.000), zelo redko (<1/10.000) in kot neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached..
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
In general
Splošno
Since Cholestagel is not absorbed, the risk of systemic toxicity is low.
Ker se zdravilo Cholestagel ne absorbira, je tveganje sistemske toksičnosti nizko.
* see section below for further information ** adverse reactions from post-marketing experience
* za več informacij glejte poglavje spodaj ** neželeni učinki iz obdobja po prihodu na trg
The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established.
Varnost in učinkovitost zdravila Cholestagel pri otrocih, starih 0 do 17 let, še nista bili dokazani.
The tablets should be swallowed whole and not broken, crushed or chewed.
Tablete je treba pogoltniti cele in se jih ne sme deliti, drobiti ali žvečiti.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
When administering medicinal products for which alterations in blood levels could have a clinically significant effect on safety or efficacy, physicians should consider monitoring serum levels or effects.
Pri uporabi zdravil, pri katerih spremembe koncentracije v krvi lahko klinično značilno vplivajo na varnost ali učinkovitost, bi morali zdravniki spremljati koncentracije v serumu ali učinke.
Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Cholestagel ni povzročil klinično pomembnega zmanjšanja absorpcije vitaminov A, D, E ali K med kliničnimi študijami, ki so trajale do enega leta.
A concomitant increase in very low density lipoprotein synthesis can occur.
Hkrati se lahko poveča sinteza lipoproteinov zelo nizke gostote.
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Your doctor may increase your dose to 7 tablets per day.
Zdravnik vam bo morda povečal odmerek na 7 tablet dnevno.
Secondary causes of hypercholesterolaemia
Sekundarni vzroki hiperholesterolemije
Cholestagel may affect the way in which the following medicines work:
Zdravilo Cholestagel lahko vliva na delovanje naslednjih zdravil:
Do not use this medicine after the expiry date which is stated on the carton and bottle label after “EXP''
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na škatli in plastenki poleg oznake "Uporabno do".
The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
Učinki kombinacije fenofibrata in zdravila Cholestagel na tveganje za miopatijo ali hepatotoksičnost niso poznani.
What Cholestagel is and what it is used for
Kaj je zdravilo Cholestagel in za kaj ga uporabljamo
6.6 Instructions precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Common: Headache
Pogosto: glavobol
Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4).
Svetujemo, da pozorno nadzorujete vrednosti ciklosporina v krvi (glejte tudi poglavje 4.4).
Manufacturer Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Izdelovalec Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
Safety and efficacy are not established for patients with triglyceride levels greater than 3.4 mmol/L, since such patients were excluded from the clinical studies.
Varnost in učinkovitost uporabe še nista potrjeni pri bolnikih, ki imajo koncentracije trigliceridov nad 3,4 mmol/L, ker so bili taki bolniki izključeni iz kliničnih študij.
A study conducted in rats did not result in any differences in reproductive parameters between the groups that might imply reproductive effects attributable to colesevelam.
Študije na podganah niso pokazale kakršnihkoli razlik v reproduktivnih parametrih med skupinami, ki bi lahko kazale na učinke na razmnoževanje in jih je mogoče pripisati holesevelamu.
If you need to take other medicines more than once a day, remember that your Cholestagel tablets can be taken once a day.
Če morate vzeti druga zdravila več kot enkrat na dan, je pomembno, da si zapomnite, da lahko tablete Cholestagel vzamete enkrat na dan.
Not known: Intestinal obstruction*,** Musculoskeletal and connective tissue disorders Uncommon: Myalgia
Neznano: intestinalna obstrukcija*,** Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasno: mialgija
• Oral contraceptives (medicines to prevent pregnancy) It is important you take Cholestagel at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected.
• peroralni kontraceptivi (zdravila za preprečevanje nosečnosti) (pomembno je, da vzamete zdravilo Cholestagel najmanj 4 ure potem, ko ste vzeli peroralno kontracepcijsko tabletko, da ne bi zmanjšali učinkovitosti kontracepcijske tabletke),
Your doctor may stop your medicine.
Zdravnik se bo morda odločil, da morate prenehati jemati zdravilo.
Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered.
Razmisliti morate o spremljanju kliničnih učinkov zdravljenja z ursodeoksiholno kislino.
• Verapamil or olmesartan (medicines used to treat high blood pressure).
• verapamil ali olmesartan (zdravili za zdravljenje visokega krvnega tlaka).
In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.
V kontroliranih kliničnih študijah, v katerih je sodelovalo približno 1400 bolnikov, in v obdobju trženja zdravila so poročali o naslednjih neželenih učinkih pri bolnikih, ki so prejemali zdravilo Cholestagel.
Furthermore, Cholestagel should always be administered at the same times consistently since the timing of intake of Cholestagel and ciclosporin could theoretically influence the degree of reduced bioavailability of ciclosporin.
Nadalje naj se zdravilo Cholestagel vedno dosledno jemlje ob istem času, saj lahko časovni razpored jemanja zdravila Cholestagel in ciklosporina teoretično vpliva na stopnjo zmanjšane biološke uporabnosti ciklosporina.
HDL-C and hsCRP levels were also not significantly different compared to placebo at 12 weeks.
Koncentraciji holesterola HDL in hsCRP se v primerjavi s placebom po 12 tednih prav tako nista pomembno razlikovali.
Cholestagel has no or negligible influence on the ability to drive and use machines.
Zdravilo Cholestagel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Description of selected adverse events
Opis izbranih neželenih dogodkov
If you take a medicine called either Neoral® or ciclosporin, please ensure to take it with Cholestagel in a consistent pattern over the day; either always together or always separate for a set number of hours.
Če jemljete zdravilo z imenom Neoral® oziroma ciklosporin, ga morate jemati z zdravilom Cholestagel dosledno skladno s predpisanim dnevnim odmerjanjem: ali vedno skupaj ali vedno v predpisanem razmaku števila ur.
• Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide).
• antidiabetična zdravila (zdravila za zdravljenje sladkorne bolezni, kot so metformin v obliki tablet s podaljšanim sproščanjem (ER extended-release), glimepirid, glipizid, pioglitazon, repaglinid ali gliburid).
If you are going to take Cholestagel and one of these medicines, your doctor may want to do tests to make sure that Cholestagel does not interfere with these medicines.
Če boste jemali zdravilo Cholestagel in katero od teh zdravil, bo zdravnik morda želel opraviti teste, da bi se prepričal, da zdravilo Cholestagel ne ovira njihovega delovanja.
It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5).
Pomembno je zagotoviti, da se zdravilo Cholestagel vzame najmanj 4 ure po jemanju peroralnih kontracepcijskih tabletk za zmanjšanje tveganja kakršnegakoli medsebojnega vplivanja (glejte tudi poglavje 4.5).
The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Na nevarnost obstipacije morate biti posebno pozorni pri bolnikih s koronarno srčno boleznijo in z angino pektoris.
A major portion of bile acids is then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.
Večji del se jih nato absorbira iz prebavil in vrne v jetra prek enterohepatičnega obtoka.
No clinical data are available on the use of Cholestagel in pregnant women.
Klinični podatki o uporabi zdravila Cholestagel pri nosečnicah niso na voljo.
However, formal interaction studies with ursodeoxycholic acid have not been performed.
Formalne študije interakcij z ursodeoksiholno kislino niso bile opravljene.
Cholestagel may affect the bioavailability of other medicinal products.
Zdravilo Cholestagel lahko vpliva na biološko uporabnost drugih zdravil.
If you are prescribed Cholestagel and a statin together it is important that you tell your doctor if you are pregnant or if you are planning to become pregnant because statins must not be used during pregnancy; the patient information leaflet that comes with that particular statin should be consulted.
Če so vam skupaj predpisali zdravilo Cholestagel in statin, je pomembno, da poveste zdravniku, če ste noseči ali če nameravate zanositi, kajti statinov med nosečnostjo ne smete jemati; pozorno preberite navodilo za uporabo določenega statina.
For concomitant medications which require administration via divided doses, it should be noted that the required dose of Cholestagel can be taken once a day.
Pri sočasno uporabljenih zdravilih, ki zahtevajo odmerjanje v razdeljenih odmerkih, je treba upoštevati, da se odmerek zdravila Cholestagel lahko vzame enkrat na dan.
In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Pri njih priporočamo spremljanje koncentracije vitaminov A, D in E ter oceno stanja količine vitamina K z meritvami parametrov koagulacije ter po potrebi nadomeščanje vitaminov.
So far, no studies have been conducted that directly demonstrate whether treatment with Cholestagel as monotherapy or combination therapy has any effect on cardiovascular morbidity or mortality.
Do sedaj niso bile izvedene študije, ki bi neposredno pokazale kakršenkoli vpliv zdravljenja z zdravilom Cholestagel, samostojno ali v kombinaciji, na srčnožilno obolevnost ali umrljivost.
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Obstajajo zelo redka poročila o znižanih vrednostih fenitoina pri bolnikih, ki so prejemali zdravilo Cholestagel skupaj z fenitoinom.
• Ciclosporin (a medicine used to suppress the immune system).
• ciklosporin (zdravilo, ki se uporablja za zmanjšanje delovanja imunskega sistema).
The tablets are packed in plastic bottles with child resistant closures.
Tablete so pakirane v plastenke z za otroke varno zaporko.
Consequently, caution should be exercised when Cholestagel is used in patients with these disorders.
Zato morate biti pri uporabi zdravila Cholestagel pri bolnikih s temi motnjami posebno pozorni.
INFORMATION IN BRAILLE Cholestagel
PODATKI V BRAILLOVI PISAVI Cholestagel
The maximum recommended dose is 7 tablets per day.
Najvišji priporočeni odmerek je 7 tablet dnevno.
However, in one study triglycerides tended to increase more when Cholestagel was given as a single dose with breakfast.
Vendar je pri eni študiji prišlo do večjega zvišanja koncentracije trigliceridov pri jemanju zdravila Cholestagel v obliki enojnega odmerka ob zajtrku.
Common: Serum triglycerides increased Uncommon :Serum transaminases increased
Pogosto: povišana koncentracija serumskih trigliceridov Občasno: povišana koncentracija serumskih transaminaz
Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.
Samo o obstipaciji in dispepsiji so poročali v višjem odstotku pri tistih, ki so prejemali zdravilo Cholestagel v primerjavi s placebom.
Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Farmakoterapevtska skupina: Zdravila, ki spreminjajo raven lipidov, adsorbenti žolčnih kislin, oznaka ATC: C10AC04
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Bowel or biliary obstruction
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, • zapora črevesa ali zapora odtoka žolča.
Studies examining administration of Cholestagel as a single dose with breakfast, a single dose with dinner, or as divided doses with breakfast and dinner did not show significant differences in LDL-C reduction for different dosing schedules.
Študije, v katerih so preučevali uporabo zdravila Cholestagel v obliki enojnega odmerka ob zajtrku, enojnega odmerka ob večerji ali ločenih odmerkov ob zajtrku in večerji, niso pokazale pomembnih razlik v znižanju koncentracije holesterola LDL pri različnih urnikih odmerjanja.
Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown.
Sočasno jemanje zdravil Cholestagel in repaglinid ni imelo nobenega vpliva na vrednosti AUC, povzročilo pa je znižanje vrednosti Cmax repaglinida za 19 %, vendar pa klinična pomembnost le-tega ni znana.
Since there is a high degree of variability in the bioavailability of verapamil, the clinical significance of this finding is unclear.
Biološka uporabnost verapamila se zelo spreminja, zato klinična pomembnost teh rezultatov ni povsem jasna.
These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease).
Mednje sodijo slabo nadzorovana sladkorna bolezen, nezdravljeni hipotiroidizem (nizke koncentracije tiroidnega hormona, za kar trenutno ne jemljete zdravil), beljakovine v urinu (nefrotski sindrom), spremenjene koncentracije beljakovin v krvi (disproteinemije) in zapora izločanja žolča v žolčnik (obstruktivna jetrna bolezen).
In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin.
V študiji medsebojnega delovanja pri zdravih prostovoljcih Cholestagel ni imel učinka na biološko uporabnost digoksina, metoprolola, kinidina, valprojske kisline in varfarina.
Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted.
Znižanje so opazili tudi pri vrednostih holesterola ne-HDL, celokupnega holesterola in Apo B. Opazili so manjše 5% neznačilno zvišanje trigliceridov.
Effects on triglyceride levels
Učinek na koncentracije trigliceridov
Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets.
Velikosti pakiranj so 24 (1 x 24), 100 (2 x 50) in 180 (1 x 180) tablet.
Oral contraceptive pill
Peroralna kontracepcijska tabletka
Other medicines and Cholestagel
Druga zdravila in zdravilo Cholestagel
Cholestagel can induce or worsen present constipation.
Cholestagel lahko izzove ali poslabša že prisotno obstipacijo.
Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously.
Zdravilo Cholestagel lahko vpliva na biološko uporabnost peroralnih kontracepcijskih tabletk, če se jemljejo sočasno.
There are no data on the effect of Cholestagel on fertility in humans.
Ni podatkov o vplivu zdravila Cholestagel na plodnost pri ljudeh.
This causes an increased demand for cholesterol in the liver cells, resulting in the dual effects of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, and increasing the number of hepatic low-density lipoprotein receptors.
To povzroči povečano potrebo po holesterolu v jetrnih celicah, kar ima dvojni učinek: poveča se prepis in aktivnost encima za biosintezo holesterola, hidroksimetil-glutaril-koencima A (HMG-CoA) reduktaze, in v jetrih se poveča število receptorjev za lipoproteine nizke gostote.
The mechanism of action for the activity of colesevelam, the active substance in Cholestagel, has been evaluated in several in vitro and in vivo studies.
Mehanizem delovanja holesevelama, zdravilne učinkovine v zdravilu Cholestagel, so ocenili v več in vitro in in vivo študijah.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development,
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
During normal digestion, bile acids are secreted into the intestine.
Med normalno prebavo se žolčne kisline izločajo v črevo.
The safety of Cholestagel has not been established in breast-feeding women.
Varnost zdravila Cholestagel ni bila potrjena pri ženskah, ki dojijo.
In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone.
V 6-tedenski študiji so 129 bolnikom z mešano hiperlipidemijo naključno dajali kombinacijo 160 mg fenofibrata in 3,8 g zdravila Cholestagel ali pa samo fenofibrat.
The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Prav tako nista potrjeni varnost in učinkovitost zdravila Cholestagel pri bolnikih z disfagijo, motnjami požiranja, hudimi motnjami gibljivosti prebavil, vnetno boleznijo črevesa, okvaro jeter ali večjo operacijo prebavil.
Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.
Sivo-bele filmsko obložene tablete v obliki kapsul z napisom »C625« na eni strani.
Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Posebne klinične študije medsebojnega delovanja med holesevelamom in vitaminom K niso bile izvedene.
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption.
Vendar morate biti previdni pri zdravljenju bolnikov, pri katerih sumite na pomanjkanje vitamina K ali v maščobah topnih vitaminov, kot so na primer bolniki z okvarjeno absorpcijo.
Talk to your doctor or pharmacist before taking Cholestagel - if your triglyceride levels (a blood fat) are greater than 3.4 mmol/L - if you have difficulty in swallowing, or have a major stomach or intestinal disorder - if you suffer from constipation, as Cholestagel may induce or worsen this condition.
Pred začetkom jemanja zdravila Cholestagel se posvetujte s svojim zdravnikom ali farmacevtom, - če je koncentracija trigliceridov (maščob v krvi) večja od 3,4 mmol/l, - če imate težave pri požiranju ali imate resno trebušno ali črevesno bolezen, - če imate težave z zapeko, saj lahko zdravilo Cholestagel povzroči ali poslabša to težavo; to je še posebej pomembno pri bolnikih s koronarno srčno boleznijo in angino pektoris.
These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans.
Študije so pokazale, da se holesevelam veže na žolčne kisline, vključno z glikoholno, glavno žolčno kislino pri človeku.
If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel.
Če menite, da to velja za vas, se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati Cholestagel.
Before starting therapy with Cholestagel, your physician should make sure that certain conditions do not contribute to your elevated cholesterol levels.
Pred začetkom zdravljenja z zdravilom Cholestagel se mora vaš zdravnik prepričati, da k vaši zvišani koncentraciji holesterola ne prispevajo določene bolezni.
What Cholestagel is and what it is used for What you need to know before you take Cholestagel How to take Cholestagel
Kaj je zdravilo Cholestagel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cholestagel Kako jemati zdravilo Cholestagel Možni neželeni učinki
If you forget to take Cholestagel
Če ste pozabili vzeti zdravilo Cholestagel
These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
Ti kompenzirajoči učinki povzročijo povečanje očistka holesterola LDL iz krvi, kar pripelje do znižanja koncentracije holesterola LDL v serumu.
Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be coadministered or dosed apart.
Klinična preskušanja so pokazala, da se lahko zdravilo Cholestagel jemlje skupaj ali ločeno s statini in skupaj ali ločeno z ezetimibom.
No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Niso opazili medsebojnega delovanja ob sočasnem jemanju zdravila Cholestagel in pioglitazon pri zdravih prostovoljcih.
In a clinical study Cholestagel did not affect the faecal excretion of endogenous (hydrophilic) ursodeoxycholic acid.
V klinični študiji zdravilo Cholestagel ni vplivalo na izločanje endogene (hidrofilne) ursodeoksiholne kisline v fecesu.