FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC conclusions on the use of chicory root medicines for the relief of symptoms of mild digestive disorders and temporary loss of appetite are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo korenino navadnega potrošnika, za lajšanje simptomov blagih prebavnih težav in pri začasni izgubi teka temeljijo na njihovi „tradicionalni uporabi“.
English: Further information on the HMPC assessment of chicory root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo korenino navadnega potrošnika, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing chicory root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino navadnega potrošnika.
English: Any applications for the licensing of medicines containing chicory root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo korenino navadnega potrošnika, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: The HMPC concluded that, on the basis of its long-standing use, chicory root can be used for the relief of symptoms of mild digestive disorders (such as feeling full, flatulence and slow digestion) and temporary loss of appetite.
Slovenian: Odbor HMPC je zaključil, da se na podlagi dolgotrajne uporabe korenina navadnega potrošnika lahko uporablja za lajšanje simptomov blagih prebavnih težav (kot so občutek napihnjenosti, napenjanje, vetrovi in počasna prebava) in pri začasni izgubi teka.
English: Information on the use and licensing of chicory root medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo korenino navadnega potrošnika, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Chicory root can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Korenina navadnega potrošnika je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Chicory root preparations are obtained by comminuting the roots (reducing them into tiny pieces).
Slovenian: Pripravki, ki vsebujejo korenino navadnega potrošnika, se pridobivajo z drobljenjem korenine (zmanjšanjem na drobne delce).
English: In its assessment, the HMPC took into account the well documented use of chicory root in digestive disorders and loss of appetite.
Slovenian: Pri oceni je odbor HMPC upošteval izčrpno dokumentirano uporabo korenine navadnega potrošnika pri prebavnih težavah in izgubi teka.
English: Other information about chicory root medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo korenino navadnega potrošnika
English: What evidence supports the use of chicory root medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo korenino navadnega potrošnika?
English: How are chicory root medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo korenino navadnega potrošnika, odobrena v EU?
English: Herbal medicines containing chicory root are usually available as herbal tea to be drunk.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo korenino navadnega potrošnika, so navadno na voljo v obliki zdravilnih čajev za pitje.
English: For more information about treatment with chicory root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo korenino navadnega potrošnika, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: For practical information about using chicory root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: What are the risks associated with chicory root medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo korenino navadnega potrošnika?
English: What is chicory root?
Slovenian: Kaj je korenina navadnega potrošnika?
English: Committee on Herbal Medicinal Products (HMPC)
Slovenian: EMA/HMPC/286842/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: Very rare, not known
Slovenian: Zelo redki ali ni znano
English: • if you are in your last trimester of pregnancy.
Slovenian: • če ste v zadnjem trimesečju nosečnosti.
English: Caution required due to ASA
Slovenian: Previdnost, potrebna zaradi ASA
English: Gastrointestinal (GI)
Slovenian: Gastrointestinalni (GI)
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Slovenian: Absolutno tveganje za kardiovaskularne malformacije se je povečalo iz manj kot 1 % na približno 1,5 %.
English: It may be given with or without food.
Slovenian: Zaužijete jo lahko s hrano ali brez nje.
English: Rhone 69800, France
Slovenian: Rhone 69800, Francija
English: • In children under 18 years of age, there is a possible association between ASA and Reye's syndrome.
Slovenian: • Pri otrocih, mlajših od 18 let, obstaja možna povezanost med ASA in Reyevim sindromom.
English: You should take your medicine at the same time each day.
Slovenian: Zdravilo morate jemati redno in vsak dan ob istem času.
English: • Third trimester of pregnancy (see section 4.6).
Slovenian: • tretje trimesečje nosečnosti (glejte poglavje 4.6).
English: These may be due to rare decrease of some blood cells.
Slovenian: To so lahko znaki redkega zmanjšanja števila določenih krvnih celic,
English: Given that children, infants and toddlers are often only seen at a late stage of intoxication, they will usually have already reached the acidosis stage.
Slovenian: Ker otroci, dojenčki in mali otroci pogosto pridejo do zdravnika šele v pozni fazi zastrupitve, so po navadi že v fazi acidoze.
English: If you have had a heart attack, it should be prescribed for at least four weeks.
Slovenian: Če ste imeli srčno kap, morate zdravilo jemati najmanj štiri tedne.
English: Following toxic doses (10-20 g), the plasma half-life may be increased to over 20 hours.
Slovenian: Po toksičnih odmerkih (10 - 20 g) se lahko razpolovni čas v plazmi podaljša na več kot 20 ur.
English: • You should tell your doctor if a surgery (including dental) is planned.
Slovenian: • morate povedati zdravniku: - če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom).
English: Other interactions with ASA
Slovenian: Druge interakcije z ASA
English: The risk is believed to increase with dose and duration of therapy.
Slovenian: Tveganje se verjetno povečuje z odmerkom in trajanjem zdravljenja.
English: 117 Allée des Parcs, 69 800 Saint Priest, France
Slovenian: 117 Allée des Parcs, 69 800 Saint Priest, Francija
English: Contact your doctor immediately if you experience:
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo:
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne{MM/LLLL}
English: There is an increased risk of bleeding due to the potential additive effect.
Slovenian: Obstaja večje tveganje za krvavitve zaradi možnega aditivnega učinka.
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Slovenian: Pri nizkih koncentracijah (< 100 µg/ml) je približno 90 % salicilne kisline vezane na albumin.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Natisnjeno navodilo za uporabo za zdravilo mora vsebovati ime in naslov proizvajalca, ki je odgovoren za sprostitev določene serije.
English: Initial hyperventilation leads to respiratory alkalosis.
Slovenian: Začetna hiperventilacija povzroči respiratorno alkalozo.
English: If a toxic dose has been ingested then admission to hospital is necessary.
Slovenian: V primeru zaužitja toksičnega odmerka je potreben sprejem v bolnišnico.
English: Treat other signs of intoxication symptomatically.
Slovenian: Druge znake zastrupitve je treba zdraviti simptomatsko.
English: ASA is poorly bound to plasma proteins and its apparent volume of distribution is low (10 l).
Slovenian: ASA je le malo vezana na beljakovine v plazmi in njen navidezni volumen porazdelitve je majhen (10 l).
English: Contains lactose and Allura Red AC. See leaflet for further information.
Slovenian: Vsebuje laktozo in barvilo rdeče AC. Za dodatne informacije glejte navodilo za uporabo.
English: It is preferable not to take this medicine during first and second trimesters of pregnancy.
Slovenian: Po možnosti tega zdravila ne jemljite v prvem in drugem trimesečju nosečnosti.
English: Their frequency is defined using the following conventions: 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), not known (cannot be estimated from the available data).
Slovenian: Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000) ali ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: • In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Slovenian: • Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice: zdravljenje je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
English: In addition, your doctor may identify changes in your blood or urine tests.
Slovenian: Poleg tega lahko zdravnik ugotovi spremenjene izvide preiskav krvi ali urina.
English: Posology Adults and elderly
Slovenian: Odrasli in starejši
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Slovenian: TTP je lahko smrtno nevarna in zahteva takojšnje zdravljenje vključno s plazmaferezo.
English: The clinical relevance is unknown.
Slovenian: Klinični pomen tega ni znan.
English: Platelets are very small structures in the blood which clump together during blood clotting.
Slovenian: Trombociti so zelo majhne strukture v krvi, ki se zlepljajo pri strjevanju krvi.
English: Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Slovenian: Bolnike je potrebno skrbno spremljati zaradi znakov krvavitve, vključno z okultno krvavitvijo, zlasti prve tedne zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
English: Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Slovenian: Klinične študije kažejo, da so odmerki do 100 mg/dan pri restriktvni obstetrični rabi, ki zahteva poseben nadzor, varni.
English: Acetylsalicylic acid (ASA):
Slovenian: Acetilsalicilna kislina (ASA):
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Slovenian: McDermott Laboratories Limited posluje kot Gerard Laboratories posluje kot Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska.
English: Single-dose studies have shown that the oral toxicity of ASA is low.
Slovenian: Študije posamičnih odmerkov so pokazale, da je peroralna toksičnost ASA majhna.
English: Haemodialysis is the preferred treatment for severe intoxication.
Slovenian: Hemodializa je prednosten način zdravljenja hude zastrupitve.
English: Contact your doctor before stopping or restarting your treatment.
Slovenian: Posvetujte se s svojim zdravnikom, preden prekinete zdravljenje ali preden ponovno začnete z zdravljenjem.
English: Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Slovenian: Zato spodnja priporočila za odmerke 500 mg/dan in več veljajo tudi za to odmerno območje.
English: Depression of the nervous system can lead to coma, cardiovascular collapse and respiratory arrest.
Slovenian: Depresija živčevja lahko povzroči komo, kardiovaskularni kolaps in zastoj dihanja.
English: • if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.
Slovenian: • če imate anamnezo astme ali alergijskih reakcij, vključno z alergijo na katero koli zdravilo, ki ste ga jemali,
English: Medicinal products associated with bleeding risk
Slovenian: Zdravila, povezana s tveganjem za krvavitve:
English: Manufacturers
Slovenian: Proizvajalca
English: In addition, due to the presence of ASA, its use is also contraindicated in:
Slovenian: Dodatno je zaradi vsebnosti ASA uporaba kontraindicirana tudi:
English: • if you drink alcohol, because of the increased risk of bleeding or gastrointestinal injury.
Slovenian: • če uživate alkohol, zaradi povečanega tveganja za krvavitev ali za gastrointestinalno poškodbo,
English: Other interactions with clopidogrel and ASA
Slovenian: Druge interakcije s klopidogrelom in ASA
English: • In patients with a history of asthma or allergic disorders since they are at increased risk of hypersensitivity reactions.
Slovenian: • Pri bolnikih z anamnezo astme ali alergijskih bolezni, ker imajo večje tveganje preobčutljivostnih reakcij.
English: Alkalising of the urine (250 mmol sodium bicarbonate for 3 hours) while monitoring the urine pH is indicated.
Slovenian: Indicirana je alkalizacija urina (250 mmol natrijevega bikarbonata 3 ure) ob kontroliranju pH urina.
English: • if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
Slovenian: • če imate motnjo, imenovano pomanjkanje glukoza-6-fosfat-dehidrogenaze (G6PD), ker obstaja tveganje za določeno vrsto anemije (majhno število rdečih krvnih celic).
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se vam krvavitev ustavi.
English: Thus, the results from this subset are in line with the overall trial results.
Slovenian: Pri tej podskupini bolnikov so rezultati v skladu s celotnimi rezultati preskušanj.
English: Although no formal carcinogenicity studies have been performed with ASA, it has been shown that it is not a tumour promoter.
Slovenian: Formalnih študij kancerogenosti z ASA ni bilo, vendar je dokazano, da snov ni promotor tumorjev.
English: A patient with poor metaboliser status will possess two loss-of function alleles as defined above.
Slovenian: Bolnik, ki je slab metabolizator, ima dva hipofunkcijska alela, kot je pojasnjeno zgoraj.
English: • if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na klopidogrel, acetilsalicilno kislino (ASA) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medical product containing clopidogrel /acetylsalicyclic acid in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveznosti po predložitvi rezultatov študij z referenčnim zdravilom, ki vsebuje klopidogrel/acetilsalicilno kislino, pri vseh podskupinah pediatrične populacije za zdravljenje koronarne ateroskleroze (glejte poglavje 4.2 za informacije o pediatrični uporabi).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganja (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 posodobitvah RMP.
English: With severe intoxication, serious disturbances of the acid-base equilibrium occur.
Slovenian: Pri hudi zastrupitvi se lahko pojavijo resne motnje acido-baznega ravnotežja.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, popolno odsotnostjo encima laktaza ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Patients should inform physicians and dentists that they are taking Clopidogrel/Acetylsalicylic acid Mylan before any surgery is scheduled and before any new medicinal product is taken.
Slovenian: Bolniki morajo obvestiti zdravnika in zobozdravnika, da jemljejo Klopidogrel/acetilsalicilna kislina Mylan, pred vsakim načrtovanjem kirurškega posega in preden vzamejo katero koli novo zdravilo.
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.
Slovenian: • če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh,
English: Other concomitant therapy with ASA Interactions with the following medicinal products have been reported with ASA:
Slovenian: Drugo sočasno zdravljenje z ASA Opisane so interakcije med ASA in naslednjimi zdravili:
English: The safety and efficacy of clopidogrel/acetylsalicylic acid in children and adolescents under 18 years old have not been established.
Slovenian: Varnost in učinkovitost klopidogrela/acetilsalicilne kisline pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acylglucuronides of salicylic acid.
Slovenian: Po terapevtskih odmerkih se približno 10 % izloči v urinu kot salicilna kislina, 75 % kot salicilurična kislina, 10 % kot fenolni glukuronid in 5 % kot acilglukuronid salicilne kisline.
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions.
Slovenian: Številne druge klinične študije so izvedli s klopidogrelom in drugimi sočasno danimi zdravili, da bi proučili potencial za farmakodinamične in farmakokinetične interakcije.
English: Reye's syndrome is a very rare disease which can be fatal.
Slovenian: Reyev sindrom je zelo redka bolezen, ki je lahko smrtna.
English: • anti-retroviral medicines (medicines used to treat HIV infections)
Slovenian: • protiretrovirusna zdravila (zdravila za zdravljenje okužbe z virusom HIV),
English: In a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Slovenian: V klinični študiji, izvedeni pri zdravih osebah, klopidogrel ni zahteval spremembe odmerka heparina ali spremenil učinka heparina na koagulacijo.
English: Other concomitant therapy with clopidogrel
Slovenian: Drugo sočasno zdravljenje s klopidogrelom
English: Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Slovenian: Specifične farmakokinetične študije, izvedene z radioaktivno označenim klopidogrelom, so pokazale, da se matična spojina ali njeni metaboliti izločajo v mleko.
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Slovenian: Populacijo bolnikov je sestavljalo 27,8 % žensk, 58,4 % bolnikov starost ≥ 60 let (26 % ≥ 70 let) in 54,5 % bolnikov, ki so dobivali fibrinolitike.
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone) Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Slovenian: Urikozuriki (benzbromaron, probenecid, sulfinpirazon) Potrebna je previdnost, kajti ASA lahko zavre učinek urikozuričnih zdravil s kompetitivno eliminacijo sečne kisline.
English: Its metabolite, salicylic acid, is highly bound to plasma proteins, but its binding is concentration dependent (nonlinear).
Slovenian: Njen presnovek, salicilna kislina, je v veliki meri vezana na beljakovine v plazmi, vendar je njena vezava odvisna od koncentracije (nelinearna).
English: With moderate intoxication an attempt can be made to induce vomiting; if this fails, gastric lavage is indicated.
Slovenian: V primeru zmerne zastrupitve je mogoče poskusiti izzvati bruhanje; če to ne uspe, je indicirano izpiranje želodca.
English: As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Slovenian: Ker kliničnih podatkov o izpostavljenosti klopidogrelu med nosečnostjo ni, je kot previdnostni ukrep zaželeno, da klopidogrela med nosečnostjo ne uporabljate.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: • preobčutljivosti na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial.
Slovenian: To kombinacijo je zato izven kliničnih stanj, pri katerih se je izkazala za učinkovito, potrebno uporabiti s previdnostjo.
English: Biotransformation and Elimination
Slovenian: Biotransformacija in izločanje:
English: Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
Slovenian: Podatki o vplivu na sposobnost razmnoževanja kažejo teratogenost ASA pri več laboratorijskih živalih.
English: Although the clinical relevance of these findings is uncertain, there have been spontaneous reports of HIV-infected patients treated with boosted ART, who have experienced re-occlusive events after de-obstruction or have suffered thrombotic events under a clopidogrel loading treatment schedule.
Slovenian: Čeprav je klinični pomen teh opažanj negotov, obstajajo spontana poročila o bolnikih, okuženih z virusom HIV, zdravljenih z okrepljenim protiretrovirusnim zdravljenjem, ki so doživeli ponovne okluzivne dogodke po odpravi obstrukcije ali so doživeli trombotične dogodke med zdravljenjem s polnilnim odmerkom klopidogrela.
English: If you forget for more than 12 hours, simply take the next single dose at the usual time.
Slovenian: Če tableto pozabite za več kot 12 ur, preprosto vzemite naslednjo tableto ob običajnem času.
English: There is a possible association between acetylsalicylic acid (ASA) and Reye's Syndrome when products containing ASA are given to children or adolescents with a viral infection.
Slovenian: Obstaja možna povezava med acetilsalicilno kislino (ASA) in Reyevim sindromom, če otroci ali mladostniki dobijo zdravila z ASA pri virusni okužbi.