FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of some of these may have to be adjusted while you are on Fareston.
Slovenian: Morda bo med jemanjem zdravila Fareston potrebna prilagoditev odmerka teh zdravil.
English: Fareston should not be used during lactation.
Slovenian: Zdravila Fareston ne smete uporabljati med dojenjem.
English: - The other ingredients are maize starch, lactose monohydrate, povidone, sodium starch glycolate,
Slovenian: - Druge sestavine zdravila so: koruzni škrob, laktoza monohidrat, povidon, natrijev karboksimetilškrob, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid in magnezijev stearat.
English: tablet 30 tablets 100 tablets
Slovenian: 100 tablet
English: Fareston 60 mg tablets toremifene
Slovenian: Navodilo za uporabo Fareston 60 mg tablete toremifen
English: - if you have a thickening of the womb lining - if you have severe liver problems - if you were born with or have had any condition which causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG) - if you have a salt imbalance in the blood, especially low concentrations of potassium in the blood
Slovenian: - če imate neravnovesje elektrolitov v krvi, še zlasti nizko koncentracijo kalija v krvi
English: Toremifene is readily absorbed after oral administration.
Slovenian: Po peroralni uporabi se toremifen hitro absorbira.
English: Skin and subcutaneous tissue disorders sweating rash, itching alopecia
Slovenian: Potenje izpuščaji, srbečica alopecija
English: Respiratory, thoracic and mediastinal disorders dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalne dispneja ga prostora Bolezni prebavil navzea, bruhanje zaprtje
English: Gastrointestinal disorders nausea, vomiting constipation
Slovenian: Očesne bolezni začasna motnost roženice
English: pimozide, sertindole, haloperidol and sultopride - medicines used to treat infections (antimicrobials); such as moxifloxacin, erythromycin (infusion)
Slovenian: vorikonazol, posakonazol - zdravila, ki se uporabljajo za zdravljenje bakterijskih bolezni (antibiotiki), kot so eritromicin,
English: The patients then lose their ability to control their movements reliably.
Slovenian: Bolniki zaradi tega izgubijo zmožnost zanesljivega nadzora nad svojimi gibi.
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Slovenian: Z vsakim odmerkom drugega zdravila je treba vzeti eno tableto, in sicer do največ 10 tablet na dan.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Slovenian: Nihanja se pojavijo, ko učinki zdravila pojenjajo in se simptomi ponovno pojavijo.
English: It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Slovenian: Ne sme se uporabljati s kombinacijami s prirejenim sproščanjem (ko se levodopa počasi sprošča več ur).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entacapone Teva on 18 February 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Entacapone Teva, veljavno po vsej Evropski uniji, izdala dne 18. februarja 2011.
English: The full EPAR for Entacapone Teva 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 Entacapone Teva je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Entacapone Teva entacapone
Slovenian: Entacapone Teva entakapon
English: This means that Entacapone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Comtess.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Comtess.
English: For more information about treatment with Entacapone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Entacapone Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Entacapone Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entacapone Teva.
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 Entacapone Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Slovenian: Povezana so z zmanjšanim učinkom levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giba (stanje „on“), in stanjem, ko ima z gibanjem težave (stanje „off“).
English: When patients first add Entacapone Teva to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Slovenian: Ko bolniki zdravilo Entacapone Teva prvič dodajo zdravilom, ki jih jemljejo, bodo morda morali vzeti nižji dnevni odmerek levodope, in sicer tako, da jo vzamejo manj pogosto ali zmanjšajo njeno količino v vsakem odmerku.
English: The active substance in Entacapone Teva, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Slovenian: Zdravilna učinkovina zdravila Entacapone Teva, entakapon, deluje tako, da ponovno vzpostavi raven dopamina v delu možganov, ki nadzoruje gibanje in koordinacijo.
English: Because Entacapone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Entacapone Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Entacapone Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Entacapone Teva?
English: Entacapone Teva is used to treat patients with Parkinson's disease.
Slovenian: Zdravilo Entacapone Teva se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
English: Entacapone Teva is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Slovenian: Zdravilo Entacapone Teva se uporablja skupaj z levodopo (bodisi s kombinacijo levodope in benserazida ali kombinacijo levodope in karbidope) pri bolnikih z „nihanji“ proti koncu obdobja med dvema odmerkoma običajne kombinacije zdravil.
English: Other information about Entacapone Teva
Slovenian: Druge informacije o zdravilu Entacapone Teva
English: The CHMP concluded that, in accordance with EU requirements, Entacapone Teva has been shown to have comparable quality and to be bioequivalent to Comtess.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Entacapone Teva primerljivo raven kakovosti kot zdravilo Comtess ter da mu je biološko enakovredno.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Slovenian: Parkinsonova bolezen je napredujoča okvara možganov, ki povzroča tresenje, upočasnjeno izvajanje gibov in otrdelost mišic.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Slovenian: Deluje samo v kombinaciji z levodopo, kopijo živčnega prenašalca dopamina, ki se lahko jemlje peroralno.
English: Because Entacapone Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Comtess.
Slovenian: Ker je zdravilo Entacapone Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Comtess.
English: Therefore, the CHMP's view was that, as for Comtess, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Comtess, odtehtajo znana tveganja.
English: Entacapone Teva is used when these fluctuations cannot be treated with the standard levodopa-containing combination alone.
Slovenian: Zdravilo Entacapone Teva se uporablja, kadar teh nihanj ni možno zdraviti samo s standardno kombinacijo, ki vsebuje levodopo.
English: Entacapone Teva is a medicine that contains the active substance entacapone.
Slovenian: Entacapone Teva je zdravilo, ki vsebuje zdravilno učinkovino entakapon.
English: Entacapone Teva is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Slovenian: Zdravilo Entacapone Teva se uporablja samo v kombinaciji z levodopo in benserazidom oziroma levodopo in karbidopo.
English: The Committee recommended that Entacapone Teva be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Entacapone Teva izda dovoljenje za promet.
English: Entacapone Teva is a ‘generic medicine'.
Slovenian: Zdravilo Entacapone Teva je „generično zdravilo“.
English: Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Slovenian: Zdravilo Entacapone Teva zavira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
English: Entacapone Teva can only be used with conventional combinations of levodopa.
Slovenian: Zdravilo Entacapone Teva se lahko uporablja le z običajnimi kombinacijami z levodopo.
English: Why has Entacapone Teva been approved?
Slovenian: Zakaj je bilo zdravilo Entacapone Teva odobreno?
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Slovenian: Posledično ostane levodopa aktivna dlje časa, kar pomaga izboljšati simptome Parkinsonove bolezni, kot sta otrdelost mišic in upočasnjeno izvajanje gibov.
English: What is Entacapone Teva?
Slovenian: Kaj je zdravilo Entacapone Teva?
English: How has Entacapone Teva been studied?
Slovenian: Kako je bilo zdravilo Entacapone Teva raziskano?
English: How is Entacapone Teva used?
Slovenian: Kako se zdravilo Entacapone Teva uporablja?
English: What is Entacapone Teva used for?
Slovenian: Za kaj se zdravilo Entacapone Teva uporablja?
English: How does Entacapone Teva work?
Slovenian: Kako zdravilo Entacapone Teva deluje?
English: 20 October 2015 EMA/498568/2015
Slovenian: oktober 2015 EMA/498568/2015
English: Caraway fruit medicines should only be used in adults and adolescents over the age of 12 years.
Slovenian: Plod navadne kumine se lahko uporablja samo pri odraslih in mladostnikih, starejših od 12 let.
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Slovenian: Če simptomi med zdravljenjem trajajo dlje kot dva tedna, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Caraway fruit EMA/498568/2015
Slovenian: Plod navadne kumine EMA/498568/2015
English: This summary is not intended to provide practical advice on how to use medicines containing caraway fruit.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo plod navadne kumine.
English: Caraway fruit is the common name for the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the fruit for medicinal use.
Slovenian: Plod navadne kumine je splošno ime za plod rastline Carum carvi L. Rastlina se goji ali nabira za pridobivanje plodov za medicinsko uporabo.
English: The HMPC noted the lack of clinical studies on the effects of caraway fruit in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Slovenian: Odbor HMPC je izpostavil pomanjkanje kliničnih študij o učinkih ploda navadne kumine pri bolnikih, vendar je upošteval dobro dokumentirano uporabo tega zdravila rastlinskega izvora za zgoraj navedene težave.
English: Caraway fruit medicines must not be used in patients who are hypersensitive (allergic) to caraway fruit or other plants of the Apiaceae (Umbelliferae) family (fennel, anise, celery, coriander and dill), to mugwort or birch.
Slovenian: Plod navadne kumine se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) plod navadne kumine ali za druge rastline iz družine kobulnic - Apiaceae (Umbelliferae) (navadni komarček, janež, zelena, koriander in navadni koper), na pelin ali brezo.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway fruit.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo ploda navadne kumine.
English: The HMPC conclusions on the use of caraway fruit medicines for the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC glede uporabe zdravil, ki vsebujejo plod navadne kumine, za lajšanje težav s prebavili, kot so napenjanje in vetrovi, temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
English: Further information on the risks associated with caraway fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo plod navadne kumine, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji 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 caraway fruit.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo plod navadne kumine.
English: How are caraway fruit medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo plod navadne kumine, odobrena v EU?
English: Information on the use and licensing of caraway fruit 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 plod navadne kumine, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Any applications for the licensing of medicines containing caraway fruit 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 plod navadne kumine, 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: Further information on the HMPC assessment of caraway fruit 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 plod navadne kumine, 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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: What is caraway fruit?
Slovenian: Kaj je plod navadne kumine?
English: What evidence supports the use of caraway fruit medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo plod navadne kumine?
English: Herbal medicines containing whole or comminuted (reduced into tiny pieces) caraway fruit are usually available as a herbal tea to be drunk.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo cele ali zdrobljene plodove navadne kumine, so navadno na voljo kot zdravilni čaji za pitje.
English: Detailed instructions on how to take caraway fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo plod navadne kumine, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: What are the risks associated with caraway fruit medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo plod navadne kumine?
English: Caraway fruit
Slovenian: Plod navadne kumine
English: For more information about treatment with caraway fruit 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 plod navadne kumine, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: The HMPC concluded that, on the basis of its long-standing use, caraway fruit medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Slovenian: Odbor HMPC je na podlagi dobro uveljavljene uporabe ploda navadne kumine zaključil, da se lahko zdravila, ki vsebujejo plod navadne kumine, uporabljajo za lajšanje težav s prebavili, kot so napenjanje in vetrovi.
English: Other information about caraway fruit medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo plod navadne kumine
English: For practical information about using caraway fruit 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: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is
Slovenian: To pomeni, da je kljub nezadostnim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
English: Powder: 3 years.
Slovenian: Prašek: 3 leta.
English: − At the request of the EMEA
Slovenian: − Na zahtevo EMEA.
English: You do not need to stay in a darkened room.
Slovenian: Ni vam treba ostati v zatemnjenem prostoru.
English: If more than this is required, the system should be checked.
Slovenian: Če se zahteva več kot toliko, je treba preveriti sistem.
English: Use Before or After Radiotherapy
Slovenian: Uporaba pred ali po radioterapiji
English: Your doctor will decide how to proceed with the treatment.
Slovenian: Vaš zdravnik se bo odločil kako nadaljevati zdravljenje.
English: The following key elements should be included in the educational materials:
Slovenian: Naslednji ključni elementi morajo biti priloženi izobraževalnemu gradivu:
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo takoj uporabiti.
English: The potential risk for humans is unknown.
Slovenian: Morebitno tveganje za zdravje ljudi ni znano.
English: If you have liver problems, this period might be longer.
Slovenian: Če imate težave z jetri, bo to obdobje morda trajalo dlje.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C.
Slovenian: Kemično in fizikalno stabilnost med uporabo so dokazovali 3 ure pri 23°C.
English: * see section c.
Slovenian: * glejte poglavje c.
English: Date of latest renewal: 4 March 2009
Slovenian: Datum zadnjega podaljšanja: 4. marec 2009
English: Frequencies are defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not known (cannot be estimated from the available data).
Slovenian: Pogostost je opredeljena kot: zelo pogosti (>1/10); pogosti (>1/100, <1/10); občasni (>1/1000, <1/100); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: − When new information is received that may impact on the current Safety Specification,
Slovenian: − Če se ugotovijo novi podatki, ki vplivajo na trenutne varnostne lastnosti in zahteve,
English: − Patients should NOT be treated with porfimer if:
Slovenian: − Bolnikov se NE sme zdraviti s porfirini, če:
English: Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment.
Slovenian: Podatki o dolgotrajnem učinku PhotoBarra (več kot dve leti) trenutno niso na voljo.
English: In case of an allergic reaction, appropriate measures (standard of care) should be taken and the PDT treatment should not be repeated.
Slovenian: V primeru alergijske reakcije je treba ustrezno ukrepati (standardna oskrba) in zdravljenje PDT se ne sme ponoviti.
English: There are no human data available to support or rebut these possibilities.
Slovenian: Podatkov pri ljudeh, ki bi podprli ali ovrgli te možnosti, ni na voljo.
English: Such pain may be of sufficient intensity to warrant the shortterm prescription of opiate analgesics.
Slovenian: Tovrstna bolečina je lahko dovolj močna, da upraviči kratkotrajno predpisovanje opiatnih analgetikov.
English: The tissue around the eyes may be more sensitive, and therefore, it is not recommended that the face be used for testing.
Slovenian: Tkivo v okolici oči je morda bolj občutljivo, zato ni priporočljivo, da se za preskušanje uporablja obraz.
English: Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks).
Slovenian: Zato morate uživati tekočo hrano le nekaj dni (v nekaterih primerih pa do 4 tedne).
English: The necrotic reaction and associated inflammatory response evolve over several days.
Slovenian: Nekrotična reakcija in z njo povezana vnetna reakcija nastajata več dni.
English: Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
Slovenian: Spol ni imel nobenega vpliva na farmakokinetične parametre, razen na tmax, ki je bil približno 1,5 ure pri ženskah in 0,17 ur pri moških.
English: Do not use other diluents.
Slovenian: Ne uporabljajte drugih razredčil.
English: Research in animals and in cell culture has suggested that many active substances could influence the effects of PDT, possible examples of which are described below.
Slovenian: Raziskave na živalih ter raziskave celične kulture so pokazale, da lahko številne aktivne snovi vplivajo na učinke PDT, katerih možni primeri so opisani spodaj.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 March 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 25. marec 2004
English: In addition, an updated RMP should be submitted:
Slovenian: Poleg tega je treba posodobljen RPM oddati v naslednjih primerih:
English: Physicians should be trained in the use of PDT.
Slovenian: Zdravnike je treba usposobiti za uporabo PDT.