FrancophonIA/ELRC3.0 huggingface dataset:
English: The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
Slovenian: faze‟, raziskovalna študija, s katero so želeli preveriti, ali bi bilo zdravilo vredno nadalje raziskati.
English: During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits.
Slovenian: Med ponovnim pregledom, pri katerem varnost zdravila ni bila v ospredju, je imel Odbor še vedno velike pomisleke glede koristi zdravila.
English: Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Masican (masitinib) EMA/167920/2014
English: Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to.
Slovenian: Poleg tega so se pojavili pomisleki o nadzoru kakovosti zdravila med proizvodnjo, kar je vodilo do negotovosti glede nečistot, ki bi jim bili izpostavljeni bolniki.
English: The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Slovenian: Študija je vključevala skupino bolnikov, ki so prejemali zdravljenje z zdravilom Masican, in eno skupino, ki je prejemala zdravljenje s sunitinibom, drugim zdravilom iz istega razreda.
English: What is Masican?
Slovenian: Kaj je zdravilo Masican?
English: The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
Slovenian: CHMP je prav tako izrazil pomislek, da so bili podatki o varnosti na voljo samo za nekaj bolnikov, ki so prejemali zdravljenje z zdravilom Masican v predlaganem odmerku, in da to ni omogočilo ustrezne ocene neželenih učinkov zdravila.
English: On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 21. novembra 2013 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Masican, namenjenim za zdravljenje malignega gastrointestinalnega stromalnega tumorja (gastrointestinal stromal tumourGIST).
English: Refusal of the marketing authorisation for Masican (masitinib)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Masican (masitinib)
English: Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Slovenian: Zdravilo Masican naj bi se uporabljalo za zdravljenje gastrointestinalnega stromalnega tumorja, raka želodca in črevesja pri odraslih, pri katerih raka ni mogoče kirurško odstraniti ali pa se je razširil in se stanje slabša kljub zdravljenju z imatinibom, drugim zdravilom za zdravljenje te vrste raka.
English: Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Slovenian: Čeprav se je zdelo, da so bolniki iz skupine, ki je prejemala zdravljenje z zdravilom Masican, živeli dlje od bolnikov, ki so prejemali zdravljenje s sunitinibom, možnosti, da je bila to zgolj naključna ugotovitev, ni bilo mogoče izključiti zaradi raziskovalne narave študije in zaradi pomanjkanja drugih podpornih dokazov.
English: Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Slovenian: Odbor CHMP je zato zaključil, da koristi zdravila Masican niso večje od z njim povezanih tveganj, in ostal pri svojem prejšnjem priporočilu, da naj se dovoljenje za promet zanj zavrne.
English: The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment.
Slovenian: Predlagatelj je predstavil rezultate glavne študije pri 44 bolnikih z gastrointestinalnim stromalnim tumorjem, ki ga ni bilo mogoče kirurško odstraniti ali se je razširil in je bil odporen na zdravljenje z imatinibom.
English: The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Slovenian: Zdravilna učinkovina zdravila Masican, masitinib, je zaviralec tirozin-kinaze.
English: Masican is an anticancer medicine that contains the active substance masitinib.
Slovenian: Masican je zdravilo proti raku, ki vsebuje zdravilno učinkovino masitinib.
English: What was Masican expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Masican uporabljalo?
English: Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Slovenian: Zdravilo Masican je bilo dne 21. decembra 2004 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za zdravljenje malignega gastrointestinalnega stromalnega tumorja.
English: How is Masican expected to work?
Slovenian: Kako naj bi zdravilo Masican delovalo?
English: surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Slovenian: Ti encimi so na nekaterih receptorjih na površini rakavih celic, med drugim tudi na receptorjih, ki pospešujejo nenadzorovano deljenje celic.
English: It is given to newborn calves once a day for one week.
Slovenian: Daje se novorojenim teletom enkrat na dan v obdobju enega tedna.
English: The infection is known as cryptosporidiosis.
Slovenian: Okužba je znana kot kriptosporidioza.
English: Halagon halofuginone
Slovenian: Halagon halofuginon
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom tega parazita, ki se širijo z iztrebki telet.
English: The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Halagon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Halagon primerljivo raven kakovosti kot zdravilo Halocur.
English: The company provided data on the quality and manufacture of Halagon.
Slovenian: Družba je priskrbela podatke o kakovosti in proizvodnji zdravila Halagon.
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Slovenian: Za preprečevanje driske je treba zdravljenje uvesti 24 do 48 ur po skotitvi, za zmanjševanje driske pa v 24 urah po pojavu driske.
English: This is a summary of the European public assessment report (EPAR) for Halagon.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Halagon.
English: What are the benefits and risks of Halagon?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Halagon?
English: Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Slovenian: Halagon je zdravilo, ki se uporablja za zdravljenje novorojenih telet za preprečevanje in zmanjševanje driske, ki jo povzroča organizem, imenovan Cryptosporidium parvum.
English: The withdrawal period for meat from newborn calves treated with Halagon is 13 days.
Slovenian: Karenca za meso novorojenih telet, zdravljenih z zdravilom Halagon, je 13 dni.
English: Halagon is a ‘generic medicine'.
Slovenian: Zdravilo Halagon je „generično zdravilo“.
English: It is not intended to provide practical advice on how to use Halagon.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum.
Slovenian: Zdravilna učinkovina v zdravilu Halagon, halofuginon, preprečuje rast parazita Cryptosporidium parvum.
English: Halagon should be given after feeding.
Slovenian: Zdravilo Halagon je treba dajati po hranjenju.
English: This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Halocur.
English: Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Slovenian: Izdaja zdravila Halagon je le na recept in je na voljo v obliki peroralne raztopine (tekočine, ki se daje skozi usta).
English: The Committee recommended that Halagon be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Halagon odobri za uporabo v EU.
English: What is Halagon and what is it used for?
Slovenian: Kaj je zdravilo Halagon in za kaj se uporablja?
English: Halagon EMA/664633/2016
Slovenian: EMA/848943/2016 Halagon stran 2/2
English: The medicine contains the active substance halofuginone.
Slovenian: Zdravilo vsebuje zdravilno učinkovino halofuginon.
English: Why is Halagon approved?
Slovenian: Zakaj je bilo zdravilo Halagon odobreno?
English: Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Halagon generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea.
Slovenian: To je parazit, ki spada v družino protozojev in vdre v prebavni sistem ter povzroča drisko.
English: Other information about Halagon?
Slovenian: Druge informacije o zdravilu Halagon
English: It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces.
Slovenian: Prav tako omejuje širjenje bolezni, tako da preprečuje nastajanje oocist, tj. stopnje v življenjskem ciklu
English: For more information about treatment with Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Slovenian: Ker je zdravilo Halagon generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: For practical information about using Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Halocur odtehtajo znana tveganja.
English: How does Halagon work?
Slovenian: Kako zdravilo Halagon deluje?
English: No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Slovenian: Ker je zdravilo Halagon peroralna raztopina na osnovi vode, ki vsebuje enako zdravilno učinkovino in sestavine v enakih koncentracijah kot referenčno zdravilo, niso bile potrebne nobene dodatne študije.
English: How is Halagon used?
Slovenian: Kako se zdravilo Halagon uporablja?
English: The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Halagon, veljavno po vsej Evropski uniji, izdala
English: How has Halagon been studied?
Slovenian: Kako je bilo zdravilo Halagon raziskano?
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Slovenian: Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
English: The Healthcare Professional Guide should contain the following key messages:
Slovenian: Priročnik za zdravstveno osebje mora vsebovati naslednja ključna sporočila:
English: The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Slovenian: Države članice se dogovorijo o končnem izobraževalnem gradivu z imetnikom dovoljenja za promet pred začetkom trženja zdravila na njihovem območju.
English: • That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis.
Slovenian: • Da se pri zdravilu Vibativ pojavlja tveganje za nefrotoksičnost, vključno s povečanim tveganjem smrtnosti pri bolnikih s predhodno akutno ledvično odpovedjo in je zato kontraindicirano pri bolnikih s predhodno akutno ledvično odpovedjo ter pri bolnikih z očistkom kreatinina < 30ml/min, vključno z bolniki na hemodializi.
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Slovenian: • Zdravstveno osebje se mora zavedati, da lahko uporaba zdravila Vibativ ovira nekatere teste koagulacije in kakovostne in količinske analize beljakovin v urinu.
English: • The need to counsel patients on important risks associated with Vibativ therapy and appropriate precautions when using the medicine.
Slovenian: • Potreba po svetovanju bolnikom o pomembnih tveganjih, ki so povezana z zdravljenjem z zdravilom Vibativ ter ustrezni varnostni ukrepi ob uporabi zdravila.
English: • That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
Slovenian: • Da obstaja potencialno tveganje za teratogenost in da je zdravilo Vibativ v času nosečnosti kontraindicirano.
English: • That there is an identified risk of ototoxicity and patients developing ototoxicity signs or symptoms or patients receiving other drugs with ototoxic potential should be carefully evaluated and monitored.
Slovenian: • Da obstaja ugotovljeno tveganje za ototoksičnost ter da je potrebno bolnike, pri katerih se razvijejo znaki ali simptomi ototoksičnosti oz. bolnike, ki prejemajo druga zdravila z ototoksičnim potencialom, pozorno oceniti in nadzorovati.
English: • That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine
Slovenian: • Da je potrebno oceniti in spremljati delovanje ledvic, začetni odmerek in prilagoditve odmerka pa je potrebno izračunati na podlagi očistka kreatinina.
English: • There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking drugs known to prolong the QT interval.
Slovenian: • Obstaja tveganje za podaljšanje QTc, zato je potrebno zdravilo Vibativ uporabljati previdno pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšujejo interval QTc.
English: • That the benefit risk balance for the Complicated Skin and Soft Tissue Infections indication was assessed as negative by the Committee for Medicinal Products for Human Use (CHMP), therefore Vibativ should not be used in this or other indications not approved.
Slovenian: • Da je Odbor za zdravila za humano uporabo (CHMP) ocenil kot negativno razmerje med koristmi in tveganji za indikacijo zapletenih okužb kože in mehkega tkiva, zato zdravila Vibativ ne smete uporabljati za to in za druge neodobrene indikacije,.
English: • The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
Slovenian: • Vloga in uporaba kontrolnega seznama za zdravnika, ki predpiše zdravilo je vključena v pakiranje za evidentiranje ugotavljene nosečnosti pred dajanjem zdravila.
English: • The existence and scope of the pregnancy register and details of how to
Slovenian: • Obstoj in obseg registra nosečnosti ter podatki za vnos bolnic vanj.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Slovenian: Imetnik dovoljenja za promet zagotovi, da bo ob začetku trženja zdravila Vibativ priskrbel vsem zdravnikom, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Vibativ, informacije (Direct Healthcare Professional Communication letter DHPC), ki so vključene kot dodatek k poročilu Odbora za zdravila za humano uporabo (CHMP) o oceni zdravila.
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Slovenian: • Da obstaja tveganje za reakcije, povezane z infundiranjem, vključno z reakcijami, ki so
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a health care professional educational pack
Slovenian: Imetnik dovoljenja za promet zagotovi vsem zdravnikom, za katere se lahko pričakuje, da bodo predpisovali zdravilo Vibativ, izobraževalni paket za zdravstveno osebje, ki vsebuje naslednje:
English: The pregnancy status of women of childbearing potential must be established prior to dosing with telavancin and women of childbearing potential must use effective contraception
Slovenian: Pred uvajanjem terapije s telavancinom je potrebno preveriti, ali je bolnica v rodni dobi noseča; bolnice v rodni dobi pa morajo v času zdravljenja uporabljati
English: Vibativ should be used with caution with other
Slovenian: Zdravilo Vibativ je potrebno uporabljati previdno, če uporabljate druga nefrotoksična zdravila.
English: Then continue your treatment as before.
Slovenian: Nato nadaljujte z vašim zdravljenjem kot prej.
English: No fatalities occurred, and all patients recovered.
Slovenian: Smrtnih primerov ni bilo in vsi bolniki so okrevali.
English: • if you are seriously overweight (especially if you're a woman).
Slovenian: • če imate prekomerno telesno težo (še posebej, če ste ženska).
English: Patients at increased risk should be followed closely.
Slovenian: Bolnike s povečanim tveganjem je treba pozorno spremljati.
English: You need to keep taking it every day to stop your illness getting worse.
Slovenian: Morate ga jemati redno in vsak dan, da se vaša bolezen ne bo slabšala.
English: If you notice any of these symptoms:
Slovenian: Če opazite katerega od teh simptomov:
English: It is rare; if it happens, it usually develops after a few months of treatment.
Slovenian: Je zelo redka; če se pojavi, se ponavadi razvije po nekaj mesecih zdravljenja.
English: Do not drive or operate machines unless you are feeling well.
Slovenian: Ne upravljajte vozil in strojev, če se ne počutite dobro.
English: The tablet can be divided into equal halves.
Slovenian: Tableto je mogoče razdeliti na enaki polovici.
English: • deep, rapid, difficult breathing
Slovenian: • globoko, hitro, oteženo dihanje,
English: It also increases the CD4 cell count in your blood.
Slovenian: Poleg tega tudi poveča število celic CD4 v vaši krvi.
English: See Section 4 for more information.
Slovenian: Za več informacij glejte poglavje 4.
English: So it is very important to talk to your doctor about any changes in your health.
Slovenian: Zato je zelo pomembno, da se s svojim zdravnikom pogovorite o vseh spremembah, ki jih opazite glede vašega zdravja.
English: The list below should not be considered exhaustive but is representative of the classes studied.
Slovenian: Spodnji seznam ni izčrpen, temveč reprezentativen za raziskovane skupine.
English: Stay in regular contact with your doctor
Slovenian: Bodite v rednem stiku z vašim zdravnikom
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS)
Slovenian: ANTIHISTAMINIKI (ANTAGONISTI HISTAMINSKIH RECEPTORJEV H1)
English: The effect of food on the rate and extent of absorption was also studied.
Slovenian: Prav tako so proučevali učinek hrane na hitrost in obseg absorpcije.
English: Combination not recommended.
Slovenian: Kombinacija ni priporočljiva.
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 medicines web-portal.
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 portalu o zdravilih.
English: • if they drink alcohol
Slovenian: • ki uživajo alkohol;
English: Your doctor will monitor the effectiveness of your treatment.
Slovenian: Vaš zdravnik bo kontroliral učinovitost vašega zdravljenja.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Slovenian: Opazovan eliminacijski razpolovni čas lamivudina znaša 5 do 7 ur.
English: • methadone, used as a heroin substitute
Slovenian: • metadon, ki se uporablja kot nadomestek heroina;
English: There are no data on their affect on human female fertility.
Slovenian: Podatkov o njunem vplivu na plodnost žensk ni.
English: Do not take other medicines for the infection without your doctor's advice.
Slovenian: Ne jemljite drugih zdravil za zdravljenje okužbe, brez nasveta vašega zdravnika.
English: The adverse reactions profile appears similar for adults and adolescents.
Slovenian: Profil neželenih učinkov je bil podoben pri odraslih in mladostnikih.
English: Autoimmune disorders may occur many months after the start of treatment.
Slovenian: Avtoimunske bolezni se lahko pojavijo veliko mesecev po začetku zdravljenja.
English: Clinically significant interaction unlikely.
Slovenian: Klinično pomembno medsebojno delovanje ni verjetno.
English: You may have problems with your bones
Slovenian: Pojavijo se lahko težave s kostmi
English: If you have any of the symptoms listed above, or any other symptoms that worry you:
Slovenian: Če imate katerikoli simptom, ki je naveden zgoraj, ali katerikoli drug simptom, ki vas skrbi:
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Slovenian: Razpoložljivi klinični podatki so zelo omejeni in ne omogočajo zanesljivih zaključkov na tem področju.