FrancophonIA/ELRC3.0 huggingface dataset:
English: Injectable veterinary medicinal products containing ivermectin, either as a single active substance or in combination with a second active substance are indicated for use in cattle for the treatment of endoparasitic and ectoparasitic infestations.
Slovenian: Veterinarska zdravila za injiciranje, ki vsebujejo ivermektin, bodisi kot samostojno zdravilno učinkovino ali v kombinaciji z drugo zdravilno učinkovino so indicirana za uporabo pri govedu za zdravljenje endoparazitskih in ektoparazitskih okužb.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 μg ivermectin per kg bodyweight
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA zdravila za uporabo v veterinarski medicini za injiciranje, ki vsebujejo ivermektin in so indicirana za uporabo pri govedu v odmerku 200 μg ivermektina na kg telesne mase
English: Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin.
Slovenian: Na podlagi ovrednotenja trenutno razpoložljivih podatkov in ocene poročevalcev je CVMP menil, da bi morala biti za vsa zdravila za injiciranje za govedo, ki vsebujejo ivermektin, določena enotna karenca 49 dni.
English: Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.
Slovenian: Zato je Odbor dne 11. februarja 2009 sprejel mnenje, v katerem je priporočil spremembo obstoječega dovoljenja za promet v skladu s predlaganimi dopolnitvami povzetka glavnih značilnosti zdravila.
English: Oral explanations were given on 12 May 2009.
Slovenian: Postopek se je začel 15. aprila 2009. 12. maja 2009 so bila podana ustna pojasnila.
English: Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling and package leaflet.
Slovenian: Zato je Odbor dne 5. junija 2009 s pisnim postopkom sprejel mnenje, v katerem je priporočil spremembo obstoječih dovoljenj za promet v skladu s predlaganimi dopolnitvami povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
English: With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended.
Slovenian: Za zdravila, ki vsebujejo ivermektin v kombinaciji s klorsulonom kot drugo zdravilno učinkovino pa je bila za govedo priporočena karenca 66 dni.
English: The withdrawal period of 49 days for cattle would also apply to all concerned injectable products containing ivermectin in combination with closantel as a second active substance.
Slovenian: Enaka karenca 49 dni za govedo bi veljala tudi za vsa zadevna zdravila za injiciranje, ki vsebujejo ivermektin kombinaciji s klosantelom kot drugo zdravilno učinkovino.
English: The Committee confirmed that a withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin as a single active substance.
Slovenian: Odbor je potrdil, da je treba določiti karenco 49 dni za vsa zadevna zdravila za govedo, ki vsebujejo ivermektin kot edino zdravilno učinkovino.
English: The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
Slovenian: Družba Norbrook Laboratories Ltd je 14. aprila 2009 predložila podrobnosti, na podlagi katerih je zahtevala ponovno presojo.
English: The main measure of effectiveness was based on the reduction in the number of episodes of laughing or crying.
Slovenian: Glavno merilo učinkovitosti je temeljilo na zmanjšanju števila epizod smeha ali joka.
English: The CHMP also noted that there is currently no treatment available for this distressing condition.
Slovenian: Upošteval je tudi, da trenutno ni na voljo nobenega zdravljenja za to obremenjujočo bolezen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuedexta on 24 June 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nuedexta, veljavno po vsej Evropski uniji, odobrila Dne 24. Junija 2013.
English: Nuedexta must not be used in patients:
Slovenian: Zdravilo Nuedexta se ne sme uporabljati pri bolnikih:
English: The main safety issues were considered manageable and adequately addressed by risk minimisation measures.
Slovenian: Glavna varnostna tveganja naj bi bila obvladljiva in ustrezno nadzorovana z ukrepi za zmanjšanje tveganja.
English: The study also measured the change in the patients' symptoms, assessed in several ways including using a standard scale (called a CNS-LS score which ranges from 7 to 35).
Slovenian: V študiji so merili tudi spremembe simptomov pri bolnikih, ki so jih ocenjevali na več načinov, vključno s standardno lestvico (imenovano lestvica CNS-LS z rezultati od 7 do 35).
English: The full EPAR for Nuedexta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nuedexta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • who are taking or have taken within the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOI).
Slovenian: • ki jemljejo ali so v zadnjih 14 dneh jemali zdravila proti depresiji, imenovana zaviralci monoaminoksidaze (MAOI).
English: This is a summary of the European public assessment report (EPAR) for Nuedexta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nuedexta.
English: Serious side effects reported include muscle spasticity (excessive stiffness of muscles), respiratory depression (inhibition of breathing) and decreased oxygen saturation (lower-than-normal levels of oxygen) in the blood.
Slovenian: Resni neželeni učinki, o katerih so poročali, vključujejo mišično spastičnost (prekomerna otrdelost mišic), respiratorno depresijo (ovirano dihanje) in zmanjšano nasičenost s kisikom (nižje ravni kisika od običajnih) v krvi.
English: • who are taking the medicine thioridazine used for mental illness;
Slovenian: • ki jemljejo tioridazin, ki se uporablja za zdravljenje duševnih bolezni;
English: • with ‘prolonged QT interval' (a disruption of the electrical activity of the heart);
Slovenian: • s „podaljšanim intervalom QT (motnjo električne aktivnosti srca);
English: In patients whose response is inadequate after four weeks, the higher strength capsule (23mg/9mg) may be used twice a day.
Slovenian: Bolniki, katerih odziv je po štirih tednih nezadosten, lahko jemljejo kapsulo večje jakosti (23 mg/9 mg) dvakrat na dan.
English: PBA is a condition where damage to certain areas of the brain results in sudden and uncontrollable episodes of crying or laughing that do not relate to the patient's real emotional state.
Slovenian: PBP je bolezen, pri kateri se zaradi poškodb nekaterih delov možganov pojavijo nenadne epizode joka ali smeha, ki jih ni mogoče nadzorovati in niso povezane z bolnikovim dejanskim čustvenim stanjem.
English: Other information about Nuedexta
Slovenian: Druge informacije o zdravilu Nuedexta
English: A decrease in the total score indicates an improvement in PBA symptoms.
Slovenian: Znižanje skupnega rezultata pomeni izboljšanje simptomov PBP.
English: Treatment should be started with one lower strength capsule (15mg/9mg) once a day (in the morning), which is increased after one week to twice a day (in the morning and evening, 12 hours apart).
Slovenian: Na začetku zdravljenja se jemlje eno kapsulo manjše jakosti (15 mg/9 mg) enkrat na dan (zjutraj), po enem tednu pa je treba odmerek povečati na dve kapsuli na dan (zjutraj in zvečer, z 12-urnim presledkom).
English: A risk management plan has been developed to ensure that Nuedexta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Nuedexta je bil pripravljen načrt obvladovanja tveganj.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nuedexta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Nuedexta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The most common side effects with Nuedexta (which may affect up to 1 in 10 people) are diarrhoea, nausea (feeling sick), dizziness, headache, somnolence (sleepiness) and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Nuedexta (ki lahko prizadenejo največ 1 osebo od 10) so diareja, navzea (slabost), omotica, glavobol, somnolenca (zaspanost) in utrujenost.
English: Regarding its safety, the CHMP decided that dextromethorphan and quinidine have been marketed as medicines for a number of years and their safety and interactions with other medicines are relatively well known.
Slovenian: V zvezi z varnostjo je CHMP ugotovil, da se dekstrometorfan in kinidin kot zdravili tržita že vrsto let in da je glede njune varnosti in medsebojnega delovanja z drugimi zdravili znanega že relativno veliko.
English: For more information about treatment with Nuedexta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nuedexta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Although the exact cause of PBA is unclear, it is believed that it affects the way signals are transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: Čeprav natančen vzrok PBP ni znan, domnevno vpliva na način prenosa signalov med možganskimi celicami, ki poteka s pomočjo „živčnih prenašalcev , tj. kemičnih snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami.
English: After 12 weeks of treatment with Nuedexta, the CNS-LS score decreased by 8.2 points, compared with a decrease of 5.7 points for placebo.
Slovenian: Po 12 tednih zdravljenja z zdravilom Nuedexta se je rezultat na lestvici CNS-LS znižal za 8,2 točke, medtem ko se je pri placebu znižal za 5,7 točke.
English: What measures are being taken to ensure the safe use of Nuedexta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Nuedexta?
English: The company will also carry out a study on the use of Nuedexta and a study to monitor Nuedexta's safety including its effects on the heart and potential for interactions with other medicines.
Slovenian: Prav tako bo družba izvedla študijo uporabe zdravila Nuedexta in študijo, namenjeno spremljanju varnosti zdravila Nuedexta, vključno z njegovimi učinki na srce in možnostmi medsebojnega delovanja z drugimi zdravili.
English: • who are already being treated with the medicines quinidine, quinine or mefloquine or who have previously developed certain serious problems such as thrombocytopenia (low platelet counts) due to the use of these medicines;
Slovenian: • ki se že zdravijo s kinidinom, kininom ali meflokinom ali pri katerih so se v preteklosti že pojavile nekatere resne bolezni, na primer trombocitopenija (majhno število trombocitov), ki so bile posledica uporabe teh zdravil;
English: Since these neurotransmitters are involved in the control of emotions, dextromethorphan helps to normalise its activity in the brain, reducing the symptoms of PBA.
Slovenian: Ker ta živčna prenašalca sodelujeta pri uravnavanju čustev, dekstrometorfan pomaga normalizirati dejavnosti v možganih, s čimer se zmanjšajo simptomi PBP.
English: Nuedexta is available as capsules (15 mg or 23 mg dextromethorphan and 9 mg quinidine) and can only be obtained with a prescription.
Slovenian: Zdravilo Nuedexta je na voljo v obliki kapsul (15 mg ali 23 mg dekstrometorfana in 9 mg kinidina) in se izdaja le na recept.
English: In addition, the company that makes Nuedexta must ensure that all healthcare professionals who are expected to use Nuedexta receive an information pack and a patient alert card with key safety information.
Slovenian: Poleg tega mora družba, ki izdeluje zdravilo Nuedexta, zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi uporabljali zdravilo Nuedexta, prejeli informativni paket ter opozorilno kartico za bolnike s ključnimi informacijami o varnosti.
English: It is used to treat the symptoms of pseudobulbar affect (PBA) in adults.
Slovenian: Uporablja se za zdravljenje simptomov psevdobulbarne paralize (PBP) pri odraslih.
English: Treatment with Nuedexta was effective in reducing patients' PBA episodes which were reduced by nearly 50% more than in patients treated with placebo.
Slovenian: Zdravljenje z zdravilom Nuedexta je bilo učinkovito pri zmanjšanju števila epizod PBP, ki so se zmanjšale za skoraj 50 % bolj kot pri bolnikih, zdravljenih s placebom.
English: Dextromethorphan / quinidine
Slovenian: Nuedexta dekstrometorfan/kinidin
English: What benefits of Nuedexta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Nuedexta izkazalo v študijah?
English: What is Nuedexta and what is it used for?
Slovenian: Kaj je zdravilo Nuedexta in za kaj se uporablja?
English: Although the exact way dextromethorphan works in PBA is unclear, it attaches to several different nerve cell receptors in the brain such as NMDA receptors and sigma-1 receptors for the neurotransmitter glutamate as well as receptors for the neurotransmitter serotonin.
Slovenian: Natančen način delovanja dekstrometorfana pri PBP ni znan, se pa veže na več različnih živčnih receptorjev v možganih, kot so receptorji NMDA in receptorji sigma-1 za živčni prenašalec glutamat ter receptorji za živčni prenašalec serotonin.
English: Nuedexta has been studied in one main study involving 326 patients with PBA due to multiple sclerosis or amyotrophic lateral sclerosis.
Slovenian: Zdravilo Nuedexta so raziskali v eni glavni študiji, v katero je bilo vključenih 326 bolnikov s PBP, ki je bila posledica multiple skleroze ali amiotrofične lateralne skleroze.
English: • with or at high risk of complete AV block (a type of heart rhythm disorder);
Slovenian: • ki imajo ali pri katerih obstaja veliko tveganje za kompletni AV-blok (vrsto motnje srčnega ritma);
English: The role of quinidine is to prevent dextromethorphan from being broken down early in the body and thereby it prolongs the action of dextromethorphan in the body.
Slovenian: Naloga kinidina je, da prepreči prehitro razgradnjo dekstrometorfana v telesu in tako podaljša čas njegovega delovanja.
English: Nuedexta is a medicine that contains two active substances, dextromethorphan and quinidine.
Slovenian: Nuedexta je zdravilo, ki vsebuje dve zdravilni učinkovini - dekstrometorfan in kinidin.
English: • with a history suggestive of torsades de pointes ventricular tachycardia (abnormal heart rhythms);
Slovenian: • z anamnezo, ki kaže na ventrikularno tahikardijo tipa torsades de pointes (nenormalen srčni ritem);
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nuedexta.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Nuedexta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What is the risk associated with Nuedexta?
Slovenian: Kakšna tveganja so povezana z zdravilom Nuedexta?
English: Why has Nuedexta been approved?
Slovenian: Zakaj je bilo zdravilo Nuedexta odobreno?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nuedexta, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nuedexta vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Nuedexta was compared with placebo (a dummy treatment) for 12 weeks.
Slovenian: Zdravilo Nuedexta so 12 tednov primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: For the full list of all side effects reported with Nuedexta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nuedexta, glejte navodilo za uporabo.
English: How does Nuedexta work?
Slovenian: Kako zdravilo Nuedexta deluje?
English: How is Nuedexta used?
Slovenian: Kako se zdravilo Nuedexta uporablja?
English: The CHMP concluded that Nuedexta is effective in treating the symptoms of PBA based on the studies in patients with PBA caused by multiple sclerosis and amyotrophic lateral sclerosis.
Slovenian: Na podlagi študij pri bolnikih s PBP, ki je bila posledica multiple skleroze in amiotrofične lateralne skleroze, je zaključil, da je zdravilo Nuedexta učinkovito pri zdravljenju simptomov PBP.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Arquiparque-Miraflores 1495-131 Algés Portugal
Slovenian: Arquiparque-Miraflores 1495-131 Algés Portugalska
English: 266 Kifisias Avenue 152 32 Halandri Greece
Slovenian: 266 Kifisias Avenue 152 32 Halandri Grčija
English: GlaxoSmithKline Latvia SIA Duntes iela 11
Slovenian: GlaxoSmithKline Latvija SIA Duntes iela 11
English: GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain
Slovenian: GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Španija
English: 1 g/vial
Slovenian: 1 g/viala
English: Amoxil Syrup SucroseFree /Dye-Free 250mg/5ml
Slovenian: Amoxil Syrup Sucrose-Free /Dye-Free 250mg/5ml
English: Intramuscular
Slovenian: Intramuskularno
English: SmithKline Beecham Limited, 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Slovenian: SmithKline Beecham Limited, 980 Great West Road Brentford
English: Powder for oral suspension (sachet)
Slovenian: Prašek za peroralno suspenzijo (vrečica)
English: Intravenous/ Intramuscular
Slovenian: Intravensko/Intramuskul arno
English: Intramuscular Use 1 g/vial
Slovenian: Intramuskularna uporaba 1 g/viala
English: Amoxil Vials 500mg, powder for solution for injection or infusion
Slovenian: Amoxil Vials 500mg, powder for solution for injection or infusion powder for solution for injection or infusion
English: Dispersible tablet
Slovenian: Disperzibilna Tableta Peroralna uporaba
English: Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension
Slovenian: Paediatric 125mg/1.25m l Powder for Oral
English: Amoxil 3g Powder for Oral Suspension Sachets
Slovenian: Amoxil 3g Powder for Oral
English: Clamoxyl 1g comprimidos 1 g
Slovenian: Clamoxyl 1g comprimidos
English: Intravenous
Slovenian: Intravensko
English: 500 mg Capsule
Slovenian: 500 mg Kapsula
English: 500 mg Capsule, hard
Slovenian: 500 mg Kapsula, trda
English: Stonemasons Way Rathfarnham Dublin 16
Slovenian: GlaxoSmithKline (Irska) Ltd Stonemasons Way Rathfarnham
English: Amoxil Vials for Injection 1 g
Slovenian: Amoxil Vials for Injection
English: Powder for solution for injection
Slovenian: Prašek za raztopino za injiciranje
English: Amoxicilline Biogaran 1 g
Slovenian: Amoxicilline Biogaran
English: Amoxil Capsules 500mg 500 mg Capsule
Slovenian: Amoxil Kapsulas 500mg
English: Amoxil 500 mg kapsulas 500 mg Capsule
Slovenian: Amoxil 500 mg kapsulas
English: Powder and solvent for solution for injection
Slovenian: Prašek in topilo za raztopino za injiciranje
English: Clamoxyl 500 mg cápsulas 500 mg Capsule, hard
Slovenian: Clamoxyl 500 mg cápsulas
English: Amoxicilline Biogaran 250 mg
Slovenian: Amoxil Forte 250 mg
English: United Kingdom250 mg Capsule
Slovenian: 250 mg Kapsula
English: Apo B decreased by 12%.
Slovenian: Koncentracija Apo B se je znižala za 12 %.
English: Very rare: Pancreatitis
Slovenian: Zelo redko: pankreatitis
English: The safety and efficacy in children (below the age of 18 years) has not been studied.
Slovenian: Varnost in učinkovitost tega zdravila pri otrocih (mlajših od 18 let) ni bila preučevana.
English: Other forms of interaction
Slovenian: Druge oblike medsebojnega delovanja
English: Without the recycling process, your liver has to make additional bile acids.
Slovenian: Brez postopka ponovne uporabe morajo vaša jetra ustvariti dodatne žolčne kisline.
English: Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009
Slovenian: Datum zadnjega podaljšanja: 12. marec 2009
English: Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Slovenian: Odmerkov, večjih od najvišjega priporočenega odmerka (4,5 g dnevno (7 tablet)), niso preizkusili.
English: You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.
Slovenian: Lahko vzamete odmerek ob kasnejšem obroku, vendar nikoli ne vzemite več od skupnega števila tablet, ki vam jih je zdravnik predpisal za en dan.
English: The medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Slovenian: Zdravila boste morda jemali istočasno ali pa ob različnih časih, odvisno od tega, kaj vam je predpisal zdravnik.
English: 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).
Slovenian: 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).
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 <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: 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).
English: • 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..
Slovenian: • 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).
English: In general
Slovenian: Splošno
English: Since Cholestagel is not absorbed, the risk of systemic toxicity is low.
Slovenian: Ker se zdravilo Cholestagel ne absorbira, je tveganje sistemske toksičnosti nizko.
English: * see section below for further information ** adverse reactions from post-marketing experience
Slovenian: * za več informacij glejte poglavje spodaj ** neželeni učinki iz obdobja po prihodu na trg
English: The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Cholestagel pri otrocih, starih 0 do 17 let, še nista bili dokazani.
English: The tablets should be swallowed whole and not broken, crushed or chewed.
Slovenian: Tablete je treba pogoltniti cele in se jih ne sme deliti, drobiti ali žvečiti.