FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical trials directly examined the risk of pneumonia with ICS head to head, and only indirect comparison in metaanalyses/systematic reviews or from observational studies is available.
Slovenian: V nobenem kliničnem preskušanju niso z neposredno primerjavo preučevali tveganja za pljučnico pri različnih IKS; na voljo so samo posredne primerjave iz metaanaliz/sistematičnih pregledov ali opazovalnih študij.
English: Overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used.
Slovenian: Koristi inhalacijskih kortikosteroidnih zdravil pri zdravljenju KOPB v splošnem še naprej presegajo tveganja in načina njihove uporabe ni treba na noben način spreminjati.
English: • Patients should be advised to report any increased breathing difficulties or other symptoms suggestive of infection.
Slovenian: • Bolnikom je treba svetovati, naj sporočijo vsakršne težave z dihanjem ali druge simptome, ki kažejo na okužbo.
English: Beclomethasone, budesonide, flunisolide, fluticasone propionate and fluticasone furoate are corticosteroids authorised and marketed as inhalation formulations for use in COPD.
Slovenian: Beklometazon, budezonid, flunizolid, flutikazonpropionat in flutikazonfuroat so kortikosteroidi, ki so odobreni in se tržijo kot inhalacijski pripravki za zdravljenje KOPB.
English: Due to the variability in the clinical data and multiple uncertainties with study methodologies, this does not provide conclusive evidence for intra-class differences in the magnitude of risk.
Slovenian: Zaradi variabilnosti kliničnih podatkov in več z metodami proučevanja povezanih negotovosti ni nespornih kliničnih dokazov za razlike med velikostmi tveganja v skupini.
English: These symptoms can be like those of an exacerbation (an episode of worsening COPD) and include fever or chills, increased amounts of mucus (phlegm) or a change in its colour, or worsening of cough or breathing difficulties.
Slovenian: Simptomi so podobni simptomom poslabšanja (epizoda poslabšanja KOPB) in vključujejo povišano telesno temperaturo ali mrzlico, povečano količino sluzi (izmečka) ali spremembo njegove barve in poslabšanje kašlja ali težave z dihanjem.
English: The review was carried out by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which recommended that the product information for these medicines should be updated to adequately reflect current knowledge about the risks.
Slovenian: Pregled je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je priporočil, naj se informacije o zdravilu za ta zdravila posodobijo, da bodo primerno podajala sedanje vedenje o tveganjih.
English: • The product information for all medicines of the class will be updated to reflect current knowledge about pneumonia risk.
Slovenian: • Informacije o zdravilu bodo pri vseh zdravilih te skupine posodobljene, da bodo podajale sedanje vedenje o tveganju za pljučnico.
English: Patients with COPD and their doctors should however be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.
Slovenian: Bolniki s KOPB in njihovi zdravniki naj bodo kljub temu pozorni na znake in simptome pljučnice, pri čemer naj upoštevajo, da se klinične značilnosti pljučnice prekrivajo z značilnostmi poslabšanja (eksacerbacije) osnovne bolezni.
English: • EMA has reviewed the risk of pneumonia in COPD patients using corticosteroid inhalers and has concluded that this risk applies to all medicines of this class.
Slovenian: • Agencija EMA je pregledala tveganje za pljučnico pri bolnikih s KOPB, ki uporabljajo kortikosteroidne inhalatorje, in zaključila, da je tveganje prisotno pri vseh zdravilih te skupine.
English: In the EU, the available products include the active substances beclomethasone, budesonide, flunisolide, fluticasone furoate or fluticasone propionate.
Slovenian: Zdravila, ki so dostopna v EU, vsebujejo zdravilne učinkovine beklometazon, budezonid, flunizolid, flutikazonfuroat in flutikazonpropionat.
English: COPD is a long-term disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked, leading to breathing difficulties.
Slovenian: KOPB je dolgotrajna bolezen pljuč, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, zaradi česar je dihanje oteženo.
English: • It has been known for some time that inhaled corticosteroid medicines increase the risk of pneumonia (infections of the lungs) in patients taking these medicines for the long-term lung disease COPD (chronic obstructive pulmonary disease).
Slovenian: • Že nekaj časa je znano, da inhalacijska kortikosteroidna zdravila povečajo nevarnost pljučnice (okužbe pljuč) pri bolnikih, ki ta zdravila jemljejo zaradi dolgotrajne pljučne bolezni KOPB (kronična obstruktivna pljučna bolezen).
English: • Corticosteroid inhalers reduce inflammation and swelling in the lungs and so help breathing in patients with COPD.
Slovenian: • Kortikosteroidni inhalatorji zmanjšujejo vnetje in otekanje pljuč in s tem pomagajo bolnikom s KOPB pri dihanju.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
English: On 28 April 2016 EMA completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD).
Slovenian: Dne 28. aprila 2016 je agencija EMA zaključila pregled znanega tveganja za pljučnico (okužbo pljuč) pri bolnikih, ki prejemajo inhalacijska kortikosteroidna zdravila za zdravljenje kronične obstruktivne pljučne bolezni (KOPB).
English: The CHMP's opinion was then sent to the European Commission, which issued a final legally-binding decision valid throughout the EU.
Slovenian: Mnenje odbora CHMP je bilo nato posredovano Evropski komisiji, ki je izdala pravno zavezujoč sklep, veljaven v vsej EU.
English: When taken by inhalation they attach to receptors in the airways and cause a reduction in lung inflammation, which makes breathing easier.
Slovenian: Pri inhalaciji se pritrdijo na receptorje v dihalnih poteh in zavrejo pljučno vnetje, s čimer postane dihanje lažje.
English: • Following a review of the available data, EMA has confirmed the risk of pneumonia with inhaled corticosteroids (ICS) in patients with COPD.
Slovenian: • Po pregledu razpoložljivih podatkov je agencija EMA potrdila tveganje za pljučnico pri uporabi inhalacijskih kortikosteroidov (IKS) pri bolnikih s KOPB.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which adopted the Agency's opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki je sprejel končno mnenje agencije.
English: • Healthcare professionals should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Slovenian: • Pri bolnikih s KOPB naj zdravstveni delavci ostanejo pozorni na morebiten razvoj pljučnice, saj se klinične značilnosti takih okužb prekrivajo s simptomi poslabšanj KOPB.
English: The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
English: The evidence did not confirm any differences in risk between products.
Slovenian: Dokazi niso potrdili razlik v tveganju med zdravili.
English: Corticosteroid inhalers are widely used in the European Union (EU) to treat COPD and pneumonia is a common side effect of such treatment.
Slovenian: Inhalacijski kortikosteroidi se v Evropski uniji (EU) pogosto uporabljajo za zdravljenje KOPB.
English: The review did not find any conclusive evidence of differences in this risk for different products.
Slovenian: Pregled ni prinesel prepričljivih dokazov o razlikah v tveganju med različnimi zdravili.
English: Review finds no differences between products in risk of pneumonia
Slovenian: Pregled ni pokazal razlik med zdravili glede tveganja za pljučnico.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS products.
Slovenian: Za razlike med velikostmi tveganja med zdravili iz skupine IKS ni nobenih trdnih kliničnih dokazov.
English: Both populations received multivitamin supplements.
Slovenian: Obe populaciji sta prejemali multivitaminske dodatke.
English: It is not known whether these findings translate into long-term clinical benefits.
Slovenian: Ni znano, ali te ugotovitve pomenijo dolgoročno klinično korist.
English: Diverticulitis.
Slovenian: Divertikulitis.
English: The capsule should be swallowed with water.
Slovenian: Kapsulo je treba pogoltniti z vodo.
English: Lack of interactions
Slovenian: Odsotnost interakcij
English: It has not been demonstrated that the effect on HbA1c is independent from weight reduction.
Slovenian: Ni dokazano, da bi bil vpliv na HbA1c neodvisen od zmanjšanja telesne mase.
English: Date of latest renewal: 17 June 2008
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 17. junij 2008
English: Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Slovenian: Zdravljenje z orlistatom je treba zato pričeti po skrbnem premisleku glede možnega vpliva na te bolnike.
English: Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.
Slovenian: Navadno ti simptomi izginejo, če nadaljujete zdravljenje in vzdržujete priporočeno dieto.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ciklosporin
English: This can lead to a decrease of immunosuppressive efficacy.
Slovenian: To lahko zmanjša imunosupresivno učinkovitost.
English: Do not take a double dose.
Slovenian: Odmerka ne smete podvojiti.
English: • Medicines to treat HIV.
Slovenian: • zdravil za zdravljenje okužbe s HIV;
English: The undigested fat cannot be absorbed and is eliminated by your body.
Slovenian: Neprebavljena maščoba se ne more absorbirati in se iz telesa izloči.
English: You may ask your doctor for advice.
Slovenian: Za nasvet povprašajte zdravnika;
English: In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases.
Slovenian: Pri bolnikih, ki jemljejo amiodaron, klinični pomen tega učinka še ni znan, lahko pa postane klinično pomemben v nekaterih primerih.
English: Xenical has been studied in long-term clinical studies of up to 4 years duration.
Slovenian: Zdravilo Xenical so preskušali v dolgotrajnih kliničnih študijah, ki so potekale do 4 let.
English: This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
Slovenian: To je pomembno, ker se lahko med hkratnim jemanjem več zdravil poveča ali zmanjša njihov učinek.
English: Xenical with food and drink
Slovenian: Zdravilo Xenical skupaj s hrano in pijačo
English: Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
Slovenian: Prosimo, obrnite se na svojega zdravnika, če menite, da se je pogostost in/ali resnost konvulzij spremenila, ko ste sočasno jemali zdravilo Xenical in antiepileptike.
English: Upper respiratory infection Lower respiratory infection
Slovenian: okužba zgornjih dihal okužba spodnjih dihal
English: These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat.
Slovenian: Ti simptomi so navadno blagi, pojavijo se na začetku zdravljenja in so še posebej izraženi po obrokih, ki vsebujejo veliko maščob.
English: • The active substance is orlistat.
Slovenian: • Zdravilna učinkovina je orlistat.
English: • Amiodarone.
Slovenian: • amiodarona.
English: Increase in liver transaminases and in alkaline phosphatase.
Slovenian: Povečanje vrednosti jetrnih transaminaz in alkalne fosfataze.
English: • Iodine salts and/or levothyroxine.
Slovenian: • jodovih soli in/ali levotiroksina.
English: See Chapter 2, take special care with Xenical.
Slovenian: Glejte poglavje 2, Bodite posebno pozorni pri jemanju zdravila Xenical.
English: 17498 Mesekenhagen Germany or
Slovenian: 17498 Mesekenhagen
English: The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Slovenian: Porazdelitvenega volumna ni mogoče določiti, ker se absorbira le neznatna količina zdravila, in ker nima opredeljene sistemske farmakokinetike.
English: • if you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),
Slovenian: • če imate kronični malabsorpcijski sindrom (nezadostna absorpcija hranil iz prebavil),
English: • Ciclosporin.
Slovenian: • ciklosporina.
English: Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.
Slovenian: Približno 97 % vnesenega odmerka se izloči z blatom, od tega 83 % kot nespremenjen orlistat.
English: Therefore the combination is not recommended (see section 4.4).
Slovenian: Kombinacije zato ne priporočamo (glejte poglavje 4.4).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 July 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 29. julij 1998
English: Ciclosporin blood levels should be monitored until stabilised.
Slovenian: Koncentracije ciklosporina v krvi je treba spremljati, dokler se ne uravnovesijo.
English: Skin blistering (including blisters that burst).
Slovenian: Kožni mehurji (vključno z mehurji, ki pokajo).
English: The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.
Slovenian: Odsotnost teh interakcij so dokazali v specifičnih interakcijskih študijah zdravilo-zdravilo.
English: Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor's advice in taking a well balanced diet rich in fruit and vegetables.
Slovenian: Zdravilo Xenical zmanjša absorpcijo pripravkov nekaterih v maščobi topnih hranil, zlasti beta karotena in vitamina E, zato morate upoštevati zdravnikov nasvet o uravnovešeni prehrani z veliko sadja in zelenjave.
English: The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Slovenian: Primarni cilj študije je bila sprememba v indeksu telesne mase (ITM) od začetka do zaključka študije.
English: Common side effects (affects 1 to 10 users in 100)
Slovenian: Pogosti neželeni učinki (prizadenejo 1 do 10 od 100 uporabnikov)
English: Increases in the levels of some liver enzymes may be found in blood tests.
Slovenian: Zvišana raven nekaterih jetrnih encimov pri krvnih testih.
English: The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.
Slovenian: Razlog za to je razlika, da je pet 2 leti trajajočih študij vključevalo uvajalno obdobje 4 tednov diete in placeba, v katerem so bolniki v povprečju izgubili 2,6 kg pred začetkom zdravljenja.
English: This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time.
Slovenian: To pomeni, da boste običajno vzeli trikrat po eno kapsulo (pri zajtrku, kosilu in večerji).
English: The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
Slovenian: V kliničnih študijah je velika večina bolnikov, ki so se zdravili z orlistatom do štirih let, imela ravni vitaminov A, D, E in K ter beta karotena v normalnem območju.
English: Inform your doctor whether you suffer from problems with your kidney.
Slovenian: Zdravniku povejte, če imate težave z ledvicami.
English: Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
Slovenian: Odmerki orlistata, večji od 120 mg trikrat na dan, niso pokazali dodatne terapevtske koristi.
English: Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal.
Slovenian: Zdravilo Xenical se veže na encime v prebavnem sistemu (lipaze) in jim prepreči, da bi razgradili nekaj maščobe, ki ste jo zaužili med obrokom.
English: The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/m2 in favour of orlistat).
Slovenian: Rezultati so bili signifikantno boljši v skupini, ki je prejemala orlistat (razlika v ITM za 0,86 kg/m2 v prid orlistatu).
English: Do not change the prescribed dose yourself unless your doctor tells you to.
Slovenian: Odmerka ne spreminjajte, če vam tega ni svetoval zdravnik.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano {MM/LLLL}.
English: • Medicines for depression, psychiatric disorders or anxiousness
Slovenian: • zdravil za zdravljenje depresije, psihiatričnih bolezni in tesnobe.
English: Some fatal cases or cases requiring liver transplantation have been reported.
Slovenian: ki so se končali s smrtjo ali primerih, ki so zahtevali presaditev jeter.
English: If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times.
Slovenian: Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite, če od zadnjega obroka hrane ni preteklo več kot eno uro.
English: The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease.
Slovenian: Uporaba orlistata je lahko povezana z nastankom ledvičnih kamnov pri bolnikih, ki imajo kronično ledvično bolezen.
English: Other medicines and Xenical
Slovenian: Druga zdravila in zdravilo Xenical
English: To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
Slovenian: Učinek zdravila je najboljši, če med glavnimi obroki ne uživate živil, ki vsebujejo maščobe, kot so piškoti, čokolada in drugi prigrizki.
English: Your doctor may need to monitor your ciclosporin blood levels more frequently than usual.
Slovenian: Vaš zdravnik bo zato mogoče po potrebi opravil več meritev ravni ciklosporina v krvi kot ponavadi;
English: For orlistat no clinical data on exposed pregnancies are available.
Slovenian: Klinični podatki nosečnic, ki so bile izpostavljene orlistatu, niso na voljo.
English: Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Slovenian: Po končanem zdravljenju se vsebnost maščobe v blatu običajno v 48 do 72 urah povrne na vrednosti pred zdravljenjem.
English: What Xenical is and what it is used for What you need to know before you take Xenical How to take Xenical
Slovenian: Kaj je zdravilo Xenical in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xenical Kako jemati zdravilo Xenical
English: If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
Slovenian: Če ste vzeli večji odmerek zdravila Xenical, kot bi smeli Če ste vzeli več kapsul, kot vam je predpisal zdravnik, ali je kapsule nenamerno zaužila tretja oseba, se posvetujte z zdravnikom, farmacevtom ali pokličite v bolnišnico, ker boste morda potrebovali medicinsko pomoč.
English: • if you have cholestasis (liver disorder)
Slovenian: • če imate holestazo (motnjo jetrnega delovanja),
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.
Slovenian: Simptomi lahko vključujejo porumenelost kože in oči, srbenje, temno obarvan urin, bolečino v trebuhu in otrdela jetra (pojavi se bolečina pod sprednjim delom reber na vaši desni strani), včasih je prisotna tudi izguba teka.
English: An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Slovenian: Dodatna kontracepcijska metoda je priporočljiva v primeru hude driske (glejte poglavje 4.4).
English: Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur.
Slovenian: Redko se lahko pojavi hipotiroidizem in/ali zmanjšana kontrola hipotiroidizma.
English: Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Slovenian: Bolnikom svetujemo, naj upoštevajo dietna navodila (glejte poglavje 4.2).
English: Contents of the pack and other information What XENICAL contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Xenical
English: INFORMATION IN BRAILLE xenical
Slovenian: PODATKI V BRAILLOVI PISAVI xenical
English: PHARMACEUTICAL FORM AND CONTENTS 21 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 21 trdih kapsul
English: The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal.
Slovenian: Odrasli Priporočeni odmerek orlistata je ena 120-mg kapsula, ki naj jo bolnik vzame z vodo tik pred ali med vsakim glavnim obrokom ali do eno uro po njem.
English: 84 hard capsules
Slovenian: 84 trdih kapsul
English: M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
Slovenian: M1 in M3 imata odprt betalaktonski obroč in skrajno šibak zaviralni učinek na lipazo (1000- oziroma 2500-krat šibkejši od orlistata).
English: This risk is increased in patients with underlying chronic kidney disease and/or volume depletion (see section 4.8).
Slovenian: To tveganje je večje pri bolnikih s kronično ledvično boleznijo in/ali izgubo tekočine (glejte poglavje 4.8).
English: However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases.
Slovenian: Orlistat lahko posredno zmanjša razpoložljivost peroralnih kontraceptivov, kar lahko v posameznih primerih pripelje do nenačrtovane nosečnosti.
English: Xenical may modify the activity of
Slovenian: Zdravilo Xenical lahko spremeni delovanje:
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Slovenian: Zdravljenje z orlistatom lahko potencialno vpliva na absorpcijo vitaminov, topnih v maščobah (A, D,
English: If you forget to take XENICAL
Slovenian: Če ste pozabili vzeti zdravilo Xenical
English: Children Xenical is not intended to be used in children.
Slovenian: Otroci Zdravilo Xenical ni namenjeno zdravljenju otrok.
English: Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Slovenian: Izsledki študij pri človeku in živalih kažejo, da morebitni sistemski zaviralni učinki na lipaze, ki jih lahko pripišemo orlistatu, hitro izzvenijo.