FrancophonIA/ELRC3.0 huggingface dataset:
English: Econor at a dose of 1 to 1.5 mg valnemulin per kg bodyweight per day (i.e. 25 mg per kg feed) effectively prevented the development of the disease.
Slovenian: Zdravilo Econor je v odmerku od 1 mg do 1,5 mg valnemulina/kg telesne mase/dan (tj. 25 mg/kg krme) učinkovito preprečilo razvoj bolezni.
English: Econor can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Econor je le na recept.
English: How is Econor used?
Slovenian: Kako se zdravilo Econor uporablja?
English: If side effects occur, Econor-containing food should be immediately removed; severely affected pigs should be moved to clean, dry pens and given appropriate treatment.
Slovenian: Hudo prizadete prašiče je treba preseliti v čiste in suhe prostore ter jih ustrezno zdraviti.
English: In studies in the treatment and prevention of swine enzootic pneumonia, Econor in feed at a dose of 10 to 12 mg valnemulin per kg bodyweight daily (i.e. 200 mg per kg feed) for up to 4 weeks reduced lung lesions, improved clinical signs and pig growth rates compared to untreated pigs.
Slovenian: V študijah zdravljenja in preprečevanja enozootske pljučnice pri prašičih so z zdravilom Econor v krmi v odmerku od 10 mg do 12 mg valnemulina/kg telesne mase dnevno (tj. 200 mg/kg krme), ki so ga dajali do največ štiri tedne, zmanjšali število lezij v pljučih, izboljšali klinične znake ter povečali rast prašičev.
English: In prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1 to 1.5 mg valnemulin per kg bodyweight daily (i.e. 25 mg per kg feed) was effective in controlling the clinical signs and prevented weight loss caused by the disease in untreated pigs.
Slovenian: Pri preprečevanju spirohetoze debelega črevesa pri prašičih (kolitisa) je bilo zdravilo Econor v krmi v odmerku od 1 mg do 1,5 mg valnemulina/kg telesne mase dnevno (tj. 25 mg/kg krme) učinkovito pri uravnavanju kliničnih znakov in preprečevanju izgube telesne mase, ki jo povzroča bolezen pri nezdravljenih prašičih.
English: For treatment of porcine proliferative enteropathy (ileitis), Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for 10 days improved the clinical condition of the pigs, reduced diarrhoea and reduced weight loss.
Slovenian: Pri zdravljenju proliferativne enteropatije (ileitisa) pri prašičih je zdravilo Econor v krmi v odmerku od 3 mg do 4 mg valnemulina/kg telesne mase dnevno (tj. 75 mg/kg krme) v desetih dneh izboljšalo klinično stanje prašičev, zmanjšalo drisko in zmanjšalo izgubo telesne mase.
English: In studies in the treatment and prevention of swine dysentery, Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for at least 7 days successfully treated swine dysentery.
Slovenian: V študijah zdravljenja in preprečevanja prašičje griže so to bolezen uspešno zdravili z dajanjem zdravila Econor v krmo v odmerku od 3 mg do 4 mg valnemulina na kilogram telesne mase dnevno (tj. 75 mg na kilogram krme) vsaj sedem dni.
English: The dose and length of treatment depend on the condition, the animal for which it is being used and its bodyweight.
Slovenian: Peroralni prašek, ki se uporablja za zdravljenje posameznih prašičev, vmeša v prašičjo krmo lastnik prašičev sam. Odmerek in trajanje zdravljenja sta odvisna od stanja živali, živalske vrste, za katero se zdravilo uporablja, ter telesne mase živali.
English: Direct contact with the skin, mouth and nose should be avoided when mixing Econor and handling the final feed containing the medicine.
Slovenian: Pri mešanju zdravila Econor in rokovanju s pripravljeno krmo, ki vsebuje zdravilo, se izogibajte neposrednemu stiku s kožo, usti in nosom.
English: ‘Advanced' means that the cancer has started to spread;
Slovenian: „Napredovali“ pomeni, da se je rak začel širiti;
English: It is given as an infusion lasting 30 to 60 minutes.
Slovenian: Daje se v obliki infuzije, ki traja od 30 do 60 minut.
English: Further information on Torisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije za zdravilo Torisel so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was how long patients lived without the disease getting worse.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja bolnikov brez poslabšanja bolezni.
English: What measures are being taken to ensure the safe and effective use of Torisel?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Torisel?
English: The European Medicines Agency decided that Torisel's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Torisel večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Torisel received a marketing authorisation valid throughout the EU on 19 November 2007.
Slovenian: Za zdravilo Torisel je bilo 19. novembra 2007 izdano dovoljenje za promet, veljavno po vsej EU.
English: Some side effects can be managed by interrupting treatment or reducing the dose.
Slovenian: Nekatere neželene učinke je mogoče obvladovati s prekinitvijo zdravljenja ali zmanjšanjem odmerka.
English: Other information about Torisel
Slovenian: Druge informacije o zdravilu Torisel
English: As for all medicines, data on the use of Torisel are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Torisel stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Torisel have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Torisel, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renal cell carcinoma: 6 April 2006, expired November 2017; mantle cell lymphoma: 6 November 2006).
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletišču Evropske agencije za zdravila: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (napredovali karcinom ledvičnih celic: 6. april 2006, poteklo novembra 2017; limfom plaščnih celic: 6. november 2006).
English: Torisel must be given under the supervision of a doctor who has experience in the use of cancer medicines.
Slovenian: Zdravilo Torisel je treba dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Each patient received one of two doses of Torisel or the most appropriate alternative cancer medicines chosen by the investigator.
Slovenian: Vsi bolniki so prejemali enega od dveh odmerkov zdravila Torisel ali najprimernejša alternativna zdravila proti raku po izbiri raziskovalca.
English: Why is Torisel authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Torisel odobreno v EU?
English: Torisel is a medicine used to treat patients with the following types of cancer:
Slovenian: Zdravilo Torisel se uporablja za zdravljenje bolnikov z naslednjimi vrstami raka:
English: What are the risks associated with Torisel?
Slovenian: Kakšna tveganja so povezana z zdravilom Torisel?
English: Side effects reported with Torisel are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Torisel, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Torisel and what is it used for?
Slovenian: Kaj je zdravilo Torisel in za kaj se uporablja?
English: What benefits of Torisel have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Torisel izkazalo v študijah?
English: Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.
Slovenian: Bolniki, ki so prejemali zdravilo Torisel, so živeli v povprečju 4,8 meseca, ne da bi se njihova bolezen poslabšala, v primerjavi z 1,9 meseca pri tistih, ki so prejemali alternativno zdravljenje.
English: • mantle cell lymphoma (a cancer of B cells, a type of white blood cell).
Slovenian: • limfomom plaščnih celic (rakom celic B, vrsto belih krvnih celic).
English: An overview of Torisel and why it is authorised in the EU
Slovenian: Pregled zdravila Torisel in zakaj je odobreno v EU
English: For more information about using Torisel, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Torisel glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.
Slovenian: Ker beljakovina mTOR sodeluje pri delitvi celic, zdravilo Torisel onemogoča delitev rakavih celic in tako upočasni rast in širjenje raka.
English: Treatment with Torisel should continue until the medicine is no longer working or causes unacceptable side effects.
Slovenian: Zdravljenje z zdravilom Torisel je treba nadaljevati, dokler je še učinkovito ali dokler ne začne povzročati nesprejemljivih neželenih učinkov.
English: Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel.
Slovenian: Bolnikom se da injekcija antihistaminika približno 30 minut pred vsakim odmerkom zdravila Torisel, da se prepreči alergijska reakcija.
English: These diseases are rare, and Torisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Slovenian: Te bolezni so redke, zato je bilo zdravilo Torisel večkrat določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa.
Slovenian: Bolniki so bili zdravljeni s 25 mg zdravila Torisel, z interferonom alfa ali s 15 mg zdravila Torisel v kombinaciji z interferonom alfa.
English: In the body, temsirolimus attaches to a protein inside cells to make a ‘complex'.
Slovenian: Temsirolimus se v telesu veže na beljakovino v celicah in z njo tvori „kompleks“.
English: Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.
Slovenian: Zdravilo Torisel se uporablja pri odraslih, pri katerih se je limfom ponovil po predhodnem zdravljenju ali če druga zdravljenja niso bila učinkovita.
English: Torisel must not be used in patients with mantle cell lymphoma who have moderate or severe problems with their liver.
Slovenian: Jemanje zdravila Torisel ni priporočljivo za bolnike z limfomom plaščnih celic, ki imajo zmerne ali hude težave z jetri.
English: The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).
Slovenian: Najpogostejši neželeni učinki zdravila Torisel (ki lahko prizadenejo več kot enega od petih bolnikov) so okužbe, pljučnica (okužba pljuč), trombocitopenija (nizka raven trombocitov), anemija (nizka raven rdečih krvničk), zmanjšanje teka, hiperglikemija (visoke ravni sladkorja v krvi), hiperholesterolemija (visoke ravni holesterola v krvi), disgevzija (motnje okusa), oteženo dihanje, krvavenje iz nosu, kašelj, bruhanje, stomatitis (vnetje ustne sluznice), diareja, navzeja (slabost), izpuščaj, pruritus (srbenje), edem (oteklina), utrujenost, oslabelost, povišana telesna temperatura in vnetje sluznic.
English: Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone.
Slovenian: Bolniki, ki so prejemali zdravilo Torisel samostojno, so v povprečju živeli 10,9 meseca v primerjavi s 7,3 meseca pri tistih, ki so prejemali samo interferon alfa.
English: Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
Slovenian: Zdravila Torisel ne smejo jemati osebe, ki so preobčutljive za (alergične na) temsirolimus, na njegove presnovke (snovi, v katere se razgradi), vključno s sirolimusom (zdravilom za preprečevanje zavrnitve presajenih ledvic), na polisorbat 80 ali katero koli drugo sestavino zdravila.
English: For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood.
Slovenian: Pri karcinomu ledvičnih celic je priporočeni odmerek zdravila Torisel 25 mg enkrat na teden, vendar se pri bolnikih s hudimi težavami z jetri, ki imajo visoke ravni trombocitov v krvi, priporoča 10
English: In advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients' survival.
Slovenian: Pri napredovalem karcinomu ledvičnih celic se je zdravilo Torisel v glavni študiji pri 626 bolnikih s slabo prognozo izkazalo za učinkovitejše od interferona alfa (drugega zdravila za zdravljenje raka) pri podaljšanju časa preživetja bolnikov.
English: Torisel contains the active substance temsirolimus.
Slovenian: Zdravilo Torisel vsebuje zdravilno učinkovino temsirolimus.
English: How does Torisel work?
Slovenian: Kako zdravilo Torisel deluje?
English: Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Torisel je na voljo v obliki koncentrata in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.
Slovenian: Pri bolnikih, ki so prejemali nižji odmerek zdravila Torisel v kombinaciji z interferonom alfa, je bil čas preživetja podoben (8,4 meseca) kot pri tistih, ki so jemali samo interferon alfa.
English: In mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked.
Slovenian: Pri limfomu plaščnih celic se je zdravilo Torisel izkazalo za učinkovitejše od alternativnih zdravila proti raku (kot sta gemcitabin ali fludarabin) v glavni študiji pri 162 bolnikih, pri katerih se je bolezen po predhodnem zdravljenju ponovila ali pri njih drugo zdravljenje ni bilo učinkovito.
English: The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).
Slovenian: Najpogostejši resni neželeni učinki zdravila Torisel so alergijske (preobčutljivostne ) reakcije , resne reakcije, do katerih pride med infundiranjem ali kmalu po njem, okužbe, bolezni pljuč, vključno s pljučnico (vnetjem pljuč) in pljučno embolijo (krvnim strdkom v pljučih), krvavitve v možganih, odpoved ledvic, perforacija (raztrganje) črevesja, zapleti pri celjenju ran, hiperglikemija (visoke ravni sladkorja v krvi), trombocitopenija (nizka raven trombocitov), nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) in hiperlipemija (visoke ravni vrste maščobe v krvi).
English: The active substance in Torisel, temsirolimus blocks a protein called ‘mammalian target of rapamycin' (mTOR).
Slovenian: Zdravilna učinkovina zdravila Torisel, temsirolimus, deluje z zaviranjem beljakovine, imenovane „tarča rapamicina pri sesalcih“ (mTOR).
English: For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.
Slovenian: ‑m iligram ski odm er limfomu plaščnih celic je priporočeni odmerek 175 mg enkrat na teden tri tedne, čemur sledijo
English: How is Torisel used?
Slovenian: Kako se zdravilo Torisel uporablja?
English: • advanced renal cell carcinoma (a kidney cancer).
Slovenian: • napredovalim karcinomom ledvičnih celic (rakom ledvic).
English: For the full list of side effects of Torisel, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Torisel, glejte navodilo za uporabo.
English: 10 (10x1) vials (multi-pack)
Slovenian: 10 (10x1) vial (skupno pakiranje)
English: 1 vial + 1 ampoule
Slovenian: 1 viala + 1 ampula
English: 4 vials + 4 ampoules
Slovenian: 4 viale + 4 ampule
English: 10 (10x 1+1) vials + ampoules (multi-pack)
Slovenian: 10 (10x 1+1) vial + ampul (skupno pakiranje)
English: Romania Alapis Romania s.r.l.
Slovenian: Romunija Alapis Romania s.r.l.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATIONS, APPLICANTS IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Bulgaria Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia,
Slovenian: Bolgarija Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia,
English: Germany Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
Slovenian: Nemčija Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
English: Belgium Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
Slovenian: Portugalska Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
English: It must also not be used in breastfeeding mothers.
Slovenian: Prav tako ga ne smejo uporabljati doječe matere.
English: It contains the active substance vinflunine (25 mg/l).
Slovenian: Vsebuje zdravilno učinkovino vinflunin (25 mg/l).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Javlor on 21 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Javlor, veljavno po vsej Evropski uniji, odobrila dne 21. septembra 2009.
English: Javlor vinflunine
Slovenian: Javlor vinflunin
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Slovenian: „Metastatski“ pomeni, da se je rak že razširil na druge dele telesa.
English: The full EPAR for Javlor 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 Javlor je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: However, there was a difference among patients who fulfilled the strict criteria entry requirements for the study.
Slovenian: Vendar pa je bilo opaziti razliko med bolniki, ki so izpolnjevali stroga merila za vključitev v študijo.
English: What benefit has Javlor shown during the studies?
Slovenian: Kakšne koristi je zdravilo Javlor izkazalo med študijami?
English: It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm for the first administration or less than 1,000/mm3 for subsequent administrations or a platelet count less than 100,000 per mm3.
Slovenian: Ne sme se uporabljati pri bolnikih, ki imajo ali so v zadnjih dveh tednih imeli hudo okužbo, ali pri bolnikih s številom nevtrofilcev pod 1 500 na mm pri prvem odmerjanju zdravila oziroma manj kot 1 000/mm3 pri nadaljnjih odmerjanjih ali številom trombocitov pod 100 000
English: Other information about Javlor
Slovenian: Druge informacije o zdravilu Javlor
English: During the study all patients received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines).
Slovenian: Med študijo so bili vsi bolniki deležni tudi najboljše podporne nege (katerih koli zdravil ali tehnik, ki bolnikom pomagajo, a ne vključujejo drugih zdravil proti raku).
English: The study also looked separately at the results in eligible patients who fulfilled strict criteria such as having had a worsening of the disease after treatment with a platinum-containing medicine.
Slovenian: V študiji so ločeno proučevali tudi rezultate pri primernih bolnikih, ki so izpolnjevali določena stroga merila, na primer da se jim je bolezen po zdravljenju z zdravilom, ki vsebuje platino, poslabšala.
English: This is a summary of the European public assessment report (EPAR) for Javlor.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Javlor.
English: What is the risk associated with Javlor?
Slovenian: Kakšna tveganja so povezana z zdravilom Javlor?
English: The CHMP decided that Javlor's benefits are greater than its risks and recommended that Javlor be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Javlor večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 Javlor.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Javlor, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines and is only given in specialised hospital units.
Slovenian: Zdravljenje z zdravilom Javlor je treba začeti pod nadzorom zdravnika, ki je usposobljen za uporabo zdravil proti raku, daje pa se lahko samo v specializiranih bolnišničnih oddelkih.