FrancophonIA/ELRC3.0 huggingface dataset:
English: An overview of Afinitor and why it is authorised in the EU
Slovenian: Pregled zdravila Afinitor in zakaj je odobreno v EU
English: Afinitor is a cancer medicine used to treat the following cancers:
Slovenian: Afinitor je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih vrst rakavih obolenj:
English: Side effects reported with Afinitor are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Afinitor, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The most common side effects with Afinitor (which may affect more than 1 in 10 people) are rash, itching, nausea, decreased appetite, dysgeusia (taste disturbances), headache, weight loss, peripheral oedema (swelling, especially of the ankles and feet), cough, anaemia (low red blood cell counts), tiredness, diarrhoea, weakness, infections, stomatitis (inflammation of the lining of the mouth), hyperglycaemia (high blood glucose levels), hypercholesterolaemia (high blood cholesterol levels), pneumonitis (inflammation of the lungs) and nosebleeds.
Slovenian: Najpogostejši neželeni učinki zdravila Afinitor (ki lahko prizadenejo več kot eno osebo od 10) so izpuščaji, srbenje, slabost, zmanjšan tek, disgevzija (motnje v okušanju), glavobol, izguba telesne mase, periferni edem (otekanje, zlasti gležnjev in stopal), kašelj, anemija (nizko število rdečih krvnih telesc), utrujenost, driska, šibkost, okužbe, stomatitis (vnetje ustne sluznice) hiperglikemija (visoke ravni glukoze v krvi), hiperholesterolemija (visoka raven holesterola v krvi), pneumonitis (vnetje pljuč) in krvavitve iz nosu.
English: What is Afinitor and what is it used for?
Slovenian: Kaj je zdravilo Afinitor in za kaj se uporablja?
English: Afinitor can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer treatments.
Slovenian: Predpisovanje in izdaja zdravila Afinitor je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: Afinitor is used together with a medicine called exemestane after other treatments called ‘nonsteroidal aromatase inhibitors' have not worked;
Slovenian: Uporablja se skupaj z zdravilom, imenovanim eksemestan, potem ko druga zdravila, imenovana „nesteroidni zaviralci aromataze“, niso bila uspešna;
English: For more information about using Afinitor, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Afinitor glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • breast cancer that is advanced (has started to spread) in women who have been through their menopause.
Slovenian: • napredovalega raka dojke (ki se je začel širiti) pri ženskah po menopavzi.
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply.
Slovenian: Ker beljakovina mTOR sodeluje pri nadzoru delitve celic in rasti krvnih žil, zdravilo Afinitor preprečuje delitev tumorskih celic ter zmanjšuje njihovo oskrbo s krvjo.
English: Afinitor must not be used in people who are hypersensitive (allergic) to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients.
Slovenian: Zdravila Afinitor ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) derivate rapamicina (zdravila s podobno sestavo kot everolimus) ali katero koli drugo sestavino zdravila.
English: Afinitor is available as tablets (2.5, 5 and 10 mg) and the recommended dose is 10 mg once a day.
Slovenian: Zdravilo je na voljo v obliki tablet (2,5 mg, 5 mg in 10 mg), priporočeni začetni odmerek pa je 10 mg enkrat na dan. Zdravljenje je treba nadaljevati, dokler deluje ali dokler neželeni učinki ne postanejo nesprejemljivi.
English: In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Slovenian: Everolimus se v telesu najprej veže na beljakovino v celicah, imenovano FKBP-12, in z njo tvori „skupek“.
English: Afinitor contains the active substance everolimus.
Slovenian: Zdravilo Afinitor vsebuje učinkovino everolimus.
English: Breast cancer
Slovenian: Rak dojke
English: How does Afinitor work?
Slovenian: Kako zdravilo Afinitor deluje?
English: Afinitor is used in breast cancer that is ‘hormone receptor-positive' (when the cancer cells have oestrogen receptors on their surface) and ‘HER2/neu negative' (when the cancer cells do not contain high levels of the HER2/neu [human epidermal growth factor receptor-2] protein).
Slovenian: Zdravilo Afinitor se uporablja pri zdravljenju raka dojke, pozitivnega na hormonske receptorje (kadar imajo rakave celice na površini receptorje za estrogen) in negativnega na HER2/neu (ko rakave celice ne vsebujejo visokih ravni beljakovine HER2/neu [receptorja-2 za humani epidermalni rastni dejavnik]).
English: Afinitor slowed down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma and hormone-receptorpositive advanced breast cancer.
Slovenian: Zdravilo Afinitor je upočasnilo napredovanje bolezni pri bolnikih z napredovalim nevroendokrinim tumorjem pankreatičnega izvora, napredovalim rakom ledvičnih celic in napredovalim rakom dojke, pozitivnim na hormonske receptorje.
English: • neuroendocrine tumours originating in the lungs or gut, when the cancer cells are welldifferentiated and the cancer is metastatic or cannot be removed by surgery.
Slovenian: • nevroendokrinega tumorja pljučnega ali črevesnega izvora, kadar so rakave celice zelo diferencirane, rak je metastatski ali ga ni mogoče kirurško odstraniti;
English: A study in 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin compared Afinitor with placebo.
Slovenian: V študiji, v katero je bilo vključenih 410 bolnikov z napredovalim ali zmerno diferenciranim nevroendokrinim tumorjem pankreatičnega izvora, so zdravilo Afinitor primerjali s placebom.
English: • advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a ‘VEGF-targeted' medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).
Slovenian: • napredovalega raka ledvičnih celic (ledvičnega raka), kadar se je rak poslabšal kljub zdravljenju s tarčnim zdravilom, ki je usmerjeno proti žilnemu endotelijskemu rastnemu dejavniku (VEGF) (vrsti zdravila, ki zavira učinke beljakovin žilnega endotelijskega rastnega dejavnika).
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells).
Slovenian: • nevroendokrinega tumorja pankreatičnega izvora (tumorja celic trebušne slinavke, ki tvorijo hormone), kadar so rakaste celice zelo ali zmerno diferencirane (kar pomeni, da so razpoznavno drugačne od normalnih celic trebušne slinavke).
English: The active substance in Afinitor, everolimus, blocks an enzyme called ‘mammalian target of rapamycin' (mTOR).
Slovenian: Učinkovina zdravila Afinitor, everolimus, deluje z zaviranjem beljakovine, imenovane „tarča rapamicina pri sesalcih“ (mTOR).
English: The Agency also concluded that the 7-month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was valuable, despite the known side effects of Afinitor.
Slovenian: Agencija je poleg tega zaključila, da je sedemmesečno podaljšanje časa brez napredovanja bolezni pri bolnikih z nevroendokrinim tumorjem pljučnega ali črevesnega izvora pomembno, kljub znanim neželenim učnikom zdravila Afinitor.
English: How is Afinitor used?
Slovenian: Kako se zdravilo Afinitor uporablja?
English: This complex then blocks mTOR.
Slovenian: Ta skupek nato zavira beljakovino mTOR.
English: Pancreatic neuroendocrine tumours
Slovenian: Nevroendokrini tumor pankreatičnega izvora
English: Patients who received Afinitor and best supportive treatments lived for an average of 11 months without the disease getting worse compared with around 4 months for patients who received placebo and best supportive treatments to relieve disease symptoms.
Slovenian: Bolniki, ki so prejeli zdravilo Afinitor in najboljše podporno zdravljenje, so v povprečju živeli 11 mesecev brez poslabšanja bolezni v primerjavi s štirimi meseci pri tistih, ki so prejemali placebo in najboljše podporno zdravljenje za lajšanje simptomov bolezni.
English: Afinitor in combination with exemestane has been studied in 724 patients with hormone receptorpositive and HER2/neu-negative advanced breast cancer which had got worse after treatment with letrozole and anastrazole (non-steroidal aromatase inhibitors).
Slovenian: V študijo, v kateri so uporabili zdravilo Afinitor in eksemestan, je bilo vključenih 724 bolnic z napredovalim rakom dojke, pozitivnim na hormonske receptorje in negativnim na HER2/neu, ki se je poslabšal po zdravljenju z letrozolom in anatrazolom (nesteroidnima zaviralcema aromataze).
English: Afinitor was studied in 416 patients with advanced renal cell carcinoma that had got worse despite treatment with VEGF-targeted medicines (sunitinib, sorafenib or both).
Slovenian: Tretja študija je vključevala 416 bolnikov z napredovalim rakom ledvičnih celic, ki se je poslabšal kljub zdravljenju z zdravili, ki so usmerjena proti žilnemu endotelijskemu rastnemu dejavniku (sunitinibom, sorafenibom ali kombinacijo obeh).
English: Afinitor was studied in 302 patients with advanced neuroendocrine tumours of lung or gut origin.
Slovenian: Zdravilo Afinitor so proučevali v študiji, v katero sta bila vključena 302 bolnika z nevroendokrinim tumorjem pljučnega ali črevesnega izvora.
English: For the full list of side effects of Afinitor, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Afinitor, glejte navodilo za uporabo.
English: Patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.
Slovenian: Bolniki, ki so prejemali zdravilo Afinitor, so v povprečju brez poslabšanja bolezni živeli 4,9 meseca v primerjavi z 1,9 meseca pri tistih, ki so prejemali placebo.
English: Patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo (a dummy treatment).
Slovenian: Bolnice, ki so prejemale zdravilo Afinitor, so v povprečju 7,8 meseca živele brez poslabšanja bolezni v primerjavi s 3,2 meseca pri tistih, ki so prejemale placebo (zdravilo brez učinkovine).
English: Neuroendocrine tumours originating in the lung or gut
Slovenian: Nevroendokrini tumor pljučnega ali črevesnega izvora
English: Patients who took Afinitor lived for an average of 11.0 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
Slovenian: Bolniki, ki so prejemali zdravilo Afinitor, so v povprečju brez poslabšanja bolezni živeli 11,0 meseca v primerjavi s 4,6 meseca pri tistih, ki so prejemali placebo.
English: MA (EU) Number
Slovenian: Številka (EU)
English: 400 mg / 100 mg Film-coated tablet
Slovenian: 400 mg/100 mg Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE) 28 tablet
English: This is more likely if:
Slovenian: To je verjetneje:
English: Treatment should not exceed 4 months.
Slovenian: Zdravljenje ne sme trajati več kot 4 mesece.
English: After the fourth day of treatment:
Slovenian: Po 4. dnevu zdravljenja:
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Luxemburg, Malta, Netherlands, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Targocid
Slovenian: To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija, Belgija, Bolgarija, Češka, Danska, Francija, Nemčija, Grčija, Madžarska, Irska, Luksemburg, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Švedska, Velika Britanija: Targocid Italija, Portugalska: Targosid
English: No specific interaction studies have been performed.
Slovenian: Specifičnih študij medsebojnega delovanja niso izvedli.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
English: The highest values of Vss are observed in the recent studies where the sampling period was superior to 8 days.
Slovenian: Najvišjo vrednost Vss so ugotovili v novejših študijah, v katerih je obdobje vzorčenja presegalo 8 dni.
English: The duration of treatment should be decided based on the clinical response.
Slovenian: Trajanje zdravljenja je treba določiti glede na klinični odziv.
English: The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 3.1, February 11, 2013 are displayed in the following table:
Slovenian: Mejne vrednosti MIC po EUCAST (European Committee on Antimicrobial Susceptibility Testing), verzija 3.1, 11. februar 2013, so prikazane v naslednji preglednici:
English: • Paediatric population
Slovenian: • Pediatrična populacija
English: If the solution does become foamy, then it should be left to stand for about 15 minutes.
Slovenian: Če raztopina postane penasta, jo je treba pustiti stati približno 15 minut.
English: Paediatric population The dose recommendations are the same in adults and children above 12 years of age.
Slovenian: Pediatrična populacija Priporočila za odmerjanje so pri odraslih in otrocih po 12. letu enaka.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Slovenian: Po izdaji Sklepa komisije kompetentni urad države članice skupaj z refernčno državo članico posodobi informacije o zdravilu kot zahtevano.
English: Targocid is an antibiotic.
Slovenian: Zdravilo Targocid je antibiotik.
English: For infective endocarditis a minimum of 21 days is usually considered appropriate.
Slovenian: Za infekcijski endokarditis po navadi velja za primerno uporaba vsaj 21 dni.
English: c IE indicates that there is insufficient evidence that the species in question is a good target for therapy with the drug.
Slovenian: c ND pomeni, da ni dovolj dokazov, da je zadevna vrsta dober cilj za zdravljenje s tem zdravilom.
English: • hearing loss, ringing in the ears or a feeling that you, or things around you are moving
Slovenian: • poslabšanje sluha, zvonjenje v ušesih ali občutek, da se gibljete vi ali stvari okrog vas
English: From a microbiological point of view, the medicine should be used immediately.
Slovenian: Z mikrobiološkega stališča je zdravilo treba uporabiti takoj.
English: • Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium.
Slovenian: • Spremenjena zgradba cilja: Ta oblika odpornosti se je pojavila zlasti pri Enterococcus faecium.
English: Mechanism of resistance Resistance to teicoplanin can be based on the following mechanisms:
Slovenian: Mehanizem odpornosti Odpornost proti teikoplaninu lahko temelji na naslednjih mehanizmih:
English: <Detailed information on this medicinal product is available on the website of {name of MS/Agency}>
Slovenian: <Podrobne informacije o zdravilu so objavljene na spletni strani {ime DČ/agencije}>
English: It works by killing the bacteria that cause infections in your body.
Slovenian: Deluje tako, da uniči bakterije, ki povzročajo okužbe v telesu.
English: Shelf life of powder as packaged for sale: 3 years
Slovenian: Rok uporabnosti praška, kot je pakiran za prodajo: 3 leta.
English: • getting more infections than usual - these could be signs of a decrease in your blood cell count
Slovenian: • več okužb kot po navadi - to je lahko znak zmanjšanega števila krvnih celic
English: Targeted trough concentrations at day 3 to 5
Slovenian: Ciljna najnižja koncentracija od 3. do 5. dne
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Slovenian: Identifikacijo in preiskave antimikrobne občutljivosti je na takšnih izolatih treba ponoviti; če je rezultat potrjen, je treba izolat poslati v referenčni laboratorij.
English: It is unlikely that your doctor or nurse will give you too much medicine.
Slovenian: Ni verjetno, da bi vam zdravnik ali medicinska sestra dala preveč zdravila.
English: Patients experiencing these undesirable effects should not drive or use machines.
Slovenian: Bolniki, ki se jim pojavijo takšni neželeni učinki, ne smejo voziti in upravljati s stroji.
English: What Targocid is and what it is used for 2.
Slovenian: Kaj je zdravilo Targocid in za kaj ga uporabljamo 2.
English: Therefore, teicoplanin should not be used during pregnancy unless clearly necessary.
Slovenian: Zato se teikoplanina med nosečnostjo ne sme uporabljati, če ni nedvomno potrebno.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some of types of infections is questionable.
Slovenian: Glede na potrebe je treba poiskati nasvet strokovnjaka, če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva.
English: Adults and elderly patients with normal renal function
Slovenian: Odrasli in starejši bolniki z normalnim delovanjem ledvic
English: Do not use Targocid if: • you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Targocid: • če ste alergični na teikoplanin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Not known (cannot be estimated from available data)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo protibakterijskih zdravil.
English: Your doctor or nurse will have instructions about when to give you Targocid.
Slovenian: Zdravnik ali medicinska sestra imata navodila, kdaj vam morata dati zdravilo Targocid.
English: Practical information for healthcare professionals on preparation and handling of Targocid.
Slovenian: Praktične informacije za zdravstvene delavce o pripravi in ravnanju z zdravilom Targocid.
English: Teicoplanin is mainly bound to human serum albumin.
Slovenian: Teikoplanin je v glavnem vezan na človeški serumski albumin.
English: • you are allergic to an antibiotic called ‘vancomycin'
Slovenian: • če ste alergični na antibiotik, ki se imenuje "vankomicin",
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Slovenian: Prevalenca odpornosti za izbrane vrste se lahko razlikuje geografsko in v času, zato so zaželene lokalne informacije o odpornosti, zlasti pri zdravljenju hudih okužb.
English: Information about storage and the time to use Targocid, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Targocid'.
Slovenian: Informacije o shranjevanju in času za uporabo zdravila Targocid, potem ko je že pripravljeno za uporabo, so navedene v poglavju "Praktične informacije za zdravstvene delavce o pripravi in ravnanju z zdravilom Targocid".
English: Teicoplanin can cause dizziness and headache.
Slovenian: Teikoplanin lahko povzroči omotico in glavobol.
English: • your treatment will last for a long time
Slovenian: • če bo vaše zdravljenje dolgotrajno,
English: Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.
Slovenian: Antimikrobna aktivnost teikoplanina je ključno odvisna od trajanja časa, med katerim je koncentracija snovi višja od minimalne inhibitorne koncentracije (MIC) patogena.
English: Spectrum of antibacterial activity
Slovenian: Spekter protibakterijskega delovanja
English: Treatment of teicoplanin overdose should be symptomatic.
Slovenian: Zdravljenje prevelikega odmerjanja teikoplanina mora biti simptomatsko.
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Slovenian: Dokler ni dokazov o kliničnem odzivu za potrjene izolate z MIC nad trenutnimi mejnimi vrednostmi odpornosti, jih je treba prijaviti kot odporne.
English: The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the teicoplanin concentrations.
Slovenian: Vezava na beljakovine v serumu pri človeku je od 87,6 do 90,8 %, brez variabilnosti v odvisnosti od koncentracije teikoplanina.
English: This medicine is for single use only.
Slovenian: To zdravilo je samo za enkratno uporabo.
English: • Aminoglycosides as they must not be mixed together with Targocid in the same injection.
Slovenian: • aminoglikozide, ker se jih ne sme mešati z zdravilom Targocid v isti injekciji.
English: Powder as packaged for sale: This medicinal product does not require any special storage condition.
Slovenian: Prašek, kot je pakiran za prodajo: Za shranjevanje zdravila niso potrebni posebni pogoji.
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).
Slovenian: Možnega tveganja za okvaro notranjega ušesa in okvaro ledvic pri plodu ni mogoče izključiti (glejte poglavje 4.4).
English: If you forget to have Targocid
Slovenian: Če ste pozabili prejeti Targocid
English: In people who are given Targocid for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this.
Slovenian: Pri osebah, ki dolgo časa prejemajo zdravilo Targocid, se lahko prekomerno razmnožijo bakterije, na katere ta antibiotik ne vpliva - vaš zdravnik bo to preveril.
English: You may have regular tests to check if your blood, kidneys and/or liver are working properly (see ‘Other medicines and Targocid').
Slovenian: Zdravnik bo morda naročil redne preiskave, s katerimi bo preveril, ali vam kri, ledvice in/ali jetra delujejo ustrezno (glejte "Druga zdravila in zdravilo Targocid").
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality.
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri velikih odmerkih (glejte poglavje 5.3): pri podganah so ugotovili večjo incidenco mrtvorojenosti in neonatalne umrljivosti.
English: This is because Targocid can affect the way some other medicines work.
Slovenian: Zdravilo Targocid namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: Not known (frequency cannot be estimated from the available data) • problems where the injection was given - such as reddening of the skin, pain or swelling
Slovenian: Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • težave na mestu injiciranja zdravila - na primer pordelost kože, bolečina ali oteklost
English: The medicine will normally be given to you by a doctor or nurse.
Slovenian: To zdravilo vam bo praviloma dal zdravnik ali medicinska sestra.
English: The powder is packaged:
Slovenian: Prašek je pakiran:
English: However, there is no evidence of synergistic toxicity in combinations with teicoplanin.
Slovenian: Vendar ni dokazov o sinergistični toksičnosti v kombinacijah s teikoplaninom.