FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 13: Store inhaler Make sure there are no capsules in the inhaler
Slovenian: 13. korak: Shranite inhalator.
English: Delusion
Slovenian: demenca
English: Upper respiratory tract infection,
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj okužba zgornjih dihal,
English: Step 8: Breathe in deeply to inhale powder While keeping the inhaler level, close your lips firmly around the mouthpiece.
Slovenian: 8. korak: Globoko vdihnite, da inhalirate prašek.
English: Worsening of Parkinson's disease,
Slovenian: - amantadin za zdravljenje gripe ali Parkinsonove bolezni.
English: Oedema peripheral, Asthenia,
Slovenian: nespečnost, psihiatrična motnja,
English: Inbrija has not specifically been studied in patients with renal impairment.
Slovenian: Zdravila Inbrija niso posebej proučevali pri bolnikih z okvaro ledvic.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa (see section 4.4).
Slovenian: Pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, ki vsebujejo levodopo, se lahko pojavijo patološko igranje iger na srečo, povečan libido,
English: The median time to maximal plasma concentration of levodopa was 30 minutes after a dose of Inbrija 66 mg (2 x 33 mg capsules) compared to 45 minutes after a dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets.
Slovenian: (2 × 33 mg kapsula) zdravila Inbrija in 45 minut po odmerku karbidope/levodope 25 mg/100 mg tableta s takojšnjim sproščanjem.
English: Headache,
Slovenian: - kašelj.
English: Gastrointestinal disorders
Slovenian: propilenglikol kalijev hidroksid
English: Inbrija has not specifically been studied in patients with hepatic impairment.
Slovenian: Zdravila Inbrija niso posebej proučevali pri bolnikih z okvaro jeter.
English: Nausea, Vomiting
Slovenian: bruksizem, paranoja, blodnje
English: Daily OFF-time (h)
Slovenian: Dnevni čas izklopa (ure)
English: Hold the inhaler upright using the handle.
Slovenian: Pokrovček povlecite naravnost z inhalatorja.
English: Inbrija has not been studied in patients with renal impairment.
Slovenian: Zdravila Inbrija niso proučevali pri bolnikih z okvaro ledvic.
English: - The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.
Slovenian: - Druge sestavine praška in kapsule so kolfoscerilpalmitat (DPPC), natrijev klorid, hipromeloza,
English: Capsule shell
Slovenian: 1 kapsulo iz ovojnine.
English: Psychotic disorder, Impulse-control disorder (see section 4.4),
Slovenian: Srčne bolezni motnje srčnega ritmaa (glejte poglavje 4.4), palpitacije
English: Confusional state, Hallucination,
Slovenian: ataksija, disgevzija, kognitivna motnja,
English: You must be sure that you do not get sudden sleep attacks, dizziness and drowsiness before you drive again or use machines.
Slovenian: Preden ponovno začnete voziti ali uporabljati stroje, morate biti prepričani, da se pri vas ne pojavljajo več nenadni napadi spanca,
English: Do not swallow Inbrija capsules.
Slovenian: Kapsul zdravila Inbrija ne smete pogoltniti.
English: How to use Inbrija
Slovenian: Zdravilo Inbrija
English: Attach the cap over the mouthpiece.
Slovenian: Nataknite pokrovček na ustnik.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem,
English: - a carton containing 60 hard capsules (15 blister strips) and one inhaler - a carton containing 92 hard capsules (23 blister strips) and one inhaler
Slovenian: - škatla, ki vsebuje 92 trdih kapsul (23 pretisnih trakov) in en inhalator.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Acorda Therapeutics Ireland Limited
English: Inbrija has not been studied in patients with hepatic impairment.
Slovenian: Zdravila Inbrija niso proučevali pri bolnikih z okvaro jeter.
English: Ready for storage
Slovenian: - Navodilo shranite.
English: OTHER
Slovenian: trizem
English: Inbrija may cause dyskinesia.
Slovenian: Diskinezija Zdravilo Inbrija lahko povzroči diskinezijo.
English: What you need to know before you use Inbrija Do not use Inbrija:
Slovenian: Kaj je zdravilo Inbrija in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Inbrija Kako uporabljati zdravilo Inbrija
English: The Inbrija inhaler is to be thrown away after all the capsules have been used.
Slovenian: Ko se porabijo vse kapsule, je treba inhalator za zdravilo Inbrija zavreči.
English: Date of latest renewal: 9 July 2011
Slovenian: Datum zadnjega podaljšanja: 09. julij 2011
English: Adequate hydration should be maintained.
Slovenian: Vzdrževati je treba ustrezno hidracijo.
English: The combination should be used with caution.
Slovenian: Kombinacijo je treba uporabljati previdno.
English: It is best to take tablets at the same time each day.
Slovenian: Najbolje je, da jih jemljete vsak dan ob istem času.
English: If you forget to take a dose, take it as soon as possible.
Slovenian: Če ste pozabili vzeti odmerek, ga vzemite čim prej.
English: This should be taken into account when treating infections caused by H. influenzae.
Slovenian: To je treba upoštevati pri zdravljenju okužb, ki jih povzroča H. influenzae.
English: Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
Slovenian: Vaš zdravnik vam bo povedal, koliko tablet zdravila Ketek jemljite, kdaj in kako dolgo.
English: The mechanisms are incompletely known.
Slovenian: Mehanizem ni v popolnosti znan.
English: Not known (cannot be estimated from the available data)*
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)*
English: In the event of acute overdose the stomach should be emptied.
Slovenian: V primeru akutnega prevelikega odmerjanja je treba izprazniti želodec.
English: The significance of these findings for humans is unknown.
Slovenian: Pomen teh izsledkov za človeka ni znan.
English: The patients should be carefully observed and given symptomatic and supportive treatment.
Slovenian: Bolnike je treba natančno opazovati in jim zagotoviti simptomatsko in podporno zdravljenje.
English: The in vitro protein binding is approximately 60% to 70%.
Slovenian: In vitro je vezava na beljakovine približno 60 do 70 %.
English: Ketek is indicated for the treatment of the following infections:
Slovenian: Ketek je indiciran za zdravljenje naslednjih okužb:
English: If you are pregnant do not take Ketek as the safety of this medicine in pregnancy is insufficiently established.
Slovenian: Če ste noseči, ne jemljite zdravila Ketek, ker varnost tega zdravila med nosečnostjo ni zadostno dokazana.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
English: These visual disturbances may happen suddenly and last several hours.
Slovenian: Takšne motnje vida lahko nastopijo nenadoma in trajajo več ur.
English: The volume of distribution is 2.9±1.0 l/kg.
Slovenian: Volumen porazdelitve je 2,9 ± 1,0 l/kg.
English: The tablets should be swallowed whole with a sufficient amount of water.
Slovenian: Tablete je treba pogoltniti cele, z zadostno količino vode.
English: There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Slovenian: Pomembnih sprememb v parametrih EKG ni bilo in znakov toksičnosti digoksina niso opažali.
English: However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Slovenian: Če pa je že blizu čas za naslednji odmerek, preskočite izpuščeni odmerek in vzemite naslednjo tableto ob običajnem času.
English: The non-renal clearance is decreased as the dose is increased.
Slovenian: Neledvični očistek se zmanjšuje, ko se odmerek povečuje.
English: Telithromycin is widely distributed throughout the body.
Slovenian: Telitromicin se široko porazdeljuje po vsem telesu.
English: Swallow the tablets whole with a glass of water.
Slovenian: Tablete pogoltnite cele s kozarcem vode.
English: In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Slovenian: Pri pljučnicah, dobljenih v domačem okolju, je bila učinkovitost dokazana pri omejenem številu bolnikov z dejavniki tveganja, kakršna sta pnevmokokna bakteriemija ali starost nad 65 let.
English: Ketek is not recommended for use in children less than 12 years old.
Slovenian: Uporaba zdravila Ketek ni priporočljiva pri otrocih pod 12 let.
English: Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Slovenian: Dokončajte celotno zdravljenje, ki vam ga je predpisal zdravnik, tudi če se začnete počutiti bolje, še preden ste porabili vse.
English: Most events were mild to moderate; however, severe cases have been reported.
Slovenian: Večina dogodkov je bila blagih do zmernih, vendar pa so poročali tudi o hudih primerih.
English: There are no adequate data from the use of Ketek in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Ketek pri nosečnicah.
English: The above serious side effects may require urgent medical attention.
Slovenian: Zgoraj omenjeni resni neželeni utegnejo zahtevati nujno medicinsko pomoč.
English: The safety and efficacy of Ketek in children below 12 years of age have not been established (see section 5.2).
Slovenian: Varnost in učinkovitost zdravila Ketek pri otrocih starih do 12 let ni bila dokazana (glejte poglavje 5.2).
English: - hallucination (seeing or hearing things that are not there)
Slovenian: - halucinacije (slišanje in videnje stvari, ki jih ni),
English: They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
Slovenian: Značilno so se pojavile v nekaj urah po prvem ali drugem odmerku, se ponovile po nadaljnjem odmerjanju, trajale nekaj ur in bile povsem reverzibilne bodisi med zdravljenjem ali po njegovem koncu.
English: Do not use this medicine after the expiry date which is stated on the pack.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Ketek should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Ketek ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Slovenian: Bolnike je treba opozoriti na potencialne učinke takšnih dogodkov glede zmožnosti vožnje ali
English: Antibiotics stop the growth of bacteria which cause
Slovenian: Antibiotiki ustavijo rast bakterij, ki povzročajo okužbe.
English: ∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications.
Slovenian: * Klinična učinkovitost je bila dokazana za občutljive izolate pri odobrenih kliničnih indikacijah.
English: - if you are allergic to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na telitromicin, kateri koli makrolidni antibiotik ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Slovenian: Morda gre za znak vnetja črevesa, ki se lahko pojavi po zdravljenju z antibiotiki.
English: If possible, take your tablets or the box with you to show the doctor or pharmacist.
Slovenian: Če je mogoče, vzemite s seboj tablete ali škatlico, da jih boste pokazali zdravniku ali farmacevtu.
English: If you stop taking the tablets too soon, the infection may return, or your
Slovenian: Če tablete nehate jemati prekmalu, se okužba lahko vrne ali se vam stanje
English: • dronedarone (for atrial fibrillation)
Slovenian: • dronedaron (za atrijsko fibrilacijo)
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: - increase of certain white blood cells, detected by blood test (eosinophilia).
Slovenian: - povečanje števila določenih belih krvnih celic, ugotovi se s preiskavo krvi (eozinofilija).
English: What you need to know before you take Ketek
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ketek
English: What Ketek is and what it is used for What you need to know before you take Ketek
Slovenian: Kaj je zdravilo Ketek in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ketek
English: They are available in packs of 10, 14, 20 and 100 tablets.
Slovenian: Na voljo so v pakiranjih po 10, 14, 20 in 100 tablet.
English: More than 80% of MRSA express cMLSB.
Slovenian: Več kot 80 % MRSA ima izraženo
English: Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place.
Slovenian: Zaradi možnega podaljšanja intervala QT in večjega tveganja za aritmije je potreben nadzor z EKG.
English: In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Slovenian: Pri 2.461 bolnikih, zdravljenih z zdravilom Ketek v kliničnih preskušanjih III. faze in med postmarketinško izkušnjo, so bili opisani naslednji neželeni učinki, ki so morda ali verjetno povezani s telitromicinom in so navedeni v tabeli.
English: The midazolam halflife was increased about 2.5-fold.
Slovenian: Razpolovni čas midazolama se je podaljšal za približno 2,5-krat.
English: Blood electrolytes (especially potassium) must be controlled.
Slovenian: Kontrolirati je treba elektrolite v krvi (zlasti kalij).
English: In clinical trials the effect on QTc was small (mean of approximately 1 msec).
Slovenian: V kliničnih preskušanjih je bil učinek na QTc majhen (v povprečju približno 1 milisekundo).
English: • pimozide (psychiatric problems)
Slovenian: • pimozid (pri psihiatričnih težavah)
English: This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Slovenian: Takšna uporaba ustreza sistemski izpostavljenosti proste zdravilne učinkovine in sicer vsaj 9-kratni pričakovani ravni pri človeku po 1 mesecu in manj kot 1kratni pričakovani ravni pri človeku po 6 mesecih.
English: You may experience this within a few hours of taking your daily dose of Ketek the first or second time.
Slovenian: Doživite jih lahko v nekaj urah po tem, ko prvič ali drugič zaužijete dnevni odmerek zdravila Ketek.
English: Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Slovenian: Podatki, ki jih je za pediatrične bolnike, stare od 13 do 17 let, malo, kažejo, da so koncentracije telitromicina v tej starostni skupini podobne koncentracijam pri bolnikih, starih od 18 do 40 let.
English: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Slovenian: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY Francija
English: Available as packs of 10, 14, 20 and 100 tablets.
Slovenian: Na voljo so pakiranja po 10, 14, 20 in 100 tablet.
English: Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Slovenian: Glede na podatke je odmerek 600 mg približno ekvivalenten ciljni izpostavljenosti opazovani pri zdravih osebah.
English: The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Slovenian: Stopnjo inhibicije z različnimi substrati CYP3A4 je težko predvideti.
English: The marketing authorisation holder of Ketek is:
Slovenian: Imetnik dovoljenja za promet z zdravilom Ketek je:
English: Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Slovenian: Večina jih je blagih in prehodnih, toda poročali so o zelo redkih primerih resnih škodljivih jetrnih reakcij in odpovedi jeter, vključno s smrtnimi primeri.
English: Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Slovenian: Približno ena tretjina telitromicina se je izločila nespremenjenega; 20% z blatom in 12% z urinom.
English: Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Slovenian: Njegov glavni presnovek v obtoku predstavlja približno 13% AUC telitromicina in ima v primerjavi z matičnim zdravilom majhno protimikrobno delovanje.
English: In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
Slovenian: V predelih z veliko incidenco odpornosti proti eritromicinu A je posebno pomembno upoštevati razvoj vzorca dovzetnosti za telitromicin in druge antibiotike.
English: These changes in pharmacokinetics do not necessitate dosage adjustment.
Slovenian: Te spremembe farmakokinetike ne zahtevajo prilagoditve odmerka.
English: If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures
Slovenian: Če obstaja sum na psevdomembranski kolitis, je treba zdravljenje takoj prekiniti, bolnika pa zdraviti s podpornimi ukrepi
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, as some of them could affect or be
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda zečeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ker lahko nekatera
English: Patients should be informed that these adverse reactions may occur as early as after the first dose of medicinal product.
Slovenian: Bolnike je treba seznaniti, da seti neželeni učinki lahko pojavijo že po prvem odmerku zdravila.
English: The onset of the visual reaction may be sudden.
Slovenian: Nastop motnje vida je lahko nenaden.
English: Ketek is used to treat infections due to bacteria against which the medicine is active.
Slovenian: Ketek se uporablja za zdravljenje okužb z bakterijami, proti katerim to zdravilo deluje.
English: - medicines known to affect the way your heart beats (drugs that prolong the QT interval).
Slovenian: - zdravila, za katera je znano, da vplivajo na bitje vašega srca (zdravila, ki podaljšajo interval QT).
English: The 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
Slovenian: 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.
English: These symptoms may appear as early as after the first dose of Ketek.
Slovenian: Takšni simptomi se lahko pojavijo že po prvem odmerku zdravila Ketek.
English: Previous history of hepatitis and/or jaundice associated with the use of telithromycin.
Slovenian: Anamneza hepatitisa in/ali zlatenice, povezanih z uporabo telitromicina.
English: Visual disturbances (<1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate, but severe reactions have also been reported.
Slovenian: Motnje vida (< 1%), povezane z uporabo zdravila Ketek, vključno z nejasnim vidom, težavami pri fokusiranju in diplopijo, so bile večinoma blage do zmerne, vendar so poročali tudi o hudih primerih.
English: Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient should be undertaken.
Slovenian: Intravenski odmerek midazolama je treba prilagoditi, če je potrebno, bolnika pa je potrebno nadzirati.
English: If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Slovenian: Če tablete nehate jemati prekmalu, lahko poleg tega povzročite razvoj odpornosti bakterij proti
English: The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Slovenian: Povečana izpostavljenost metoprololu bi lahko bila klinično pomembna pri bolnikih s srčnim popuščanjem, zdravljenih z metoprololom.
English: When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Slovenian: Pri predpisovanju zdravila Ketek je treba upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil in podatke o lokalni prevalenci odpornosti (glejte tudi poglavji 4.4 in 5.1).
English: In similarity to some macrolides, telithromycin caused a prolongation of QTc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Slovenian: Podobno kot nekateri makrolidi je telitromicin povzročil podaljšanje QTc intervala pri psih ter trajanje akcijskega potenciala v kunčjih Purkinjevih vlaknih in vitro.
English: Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Slovenian: Telitromicin se izloča z mlekom doječih živali v koncentracijah, ki so približno 5-krat tolikšne kot v materini plazmi.
English: If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Slovenian: Če kaj od tega velja za vas ali če niste gotovi, se posvetujte z zdravnikom preden vzamete zdravilo
English: - if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
Slovenian: - če imate vi ali kdo v vaši družini v elektrokardiogramu (EKG) nepravilnost, imenovano "sindrom podaljšanega intervala QT".
English: The same precautions should also apply to the other benzodiazepines which are metabolised by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
Slovenian: Ista opozorila je treba upoštevati pri drugih benzodiazepinih, ki se presnavljajo s CYP3A4 (zlasti pri triazolamu, v manjši meri pa tudi pri alprazolamu).
English: Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.
Slovenian: Previdnost je potrebna, če je domnevni patogen S. aureus in je glede na lokalno epidemiologijo verjetno, da je odporen proti eritromicinu.
English: Hypokalaemia and quinidine had additive/supraadditive effects in vitro while potentiation was evident with sotalol.
Slovenian: Hipokaliemija in kinidin sta imela in vitro aditivne/supraaditivne učinke, pri sotalolu pa je bila opazna potenciacija.