FrancophonIA/ELRC3.0 huggingface dataset:
English: This slows down the medicine's removal from the body and allows the medicine to be given less often.
Slovenian: To upočasni odstranjevanje filgrastima iz telesa in omogoča manj pogosto dajanje zdravila.
English: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer and blood disorders.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka in krvnih motenj.
English: The Agency therefore decided that Lonquex's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Lonquex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Lonquex?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lonquex?
English: Lonquex received a marketing authorisation valid throughout the EU on 25 July 2013.
Slovenian: Za zdravilo Lonquex je bilo 25. julija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonquex have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lonquex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: As for all medicines, data on the use of Lonquex are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lonquex stalno spremljajo.
English: One 6-mg dose is given in each chemotherapy cycle around 24 hours after chemotherapy.
Slovenian: Za vsak cikel kemoterapije se da en 6-miligramski odmerek, približno 24 ur po kemoterapiji.
English: Other information about Lonquex
Slovenian: Druge informacije o zdravilu Lonquex
English: The most common side effects with Lonquex (which may affect more than 1 in 10 patients) are nausea as well as bone and muscle pain.
Slovenian: Najpogostejši neželeni učinki zdravila Lonquex (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so navzeja (slabost) in bolečine v kosteh in mišicah.
English: Side effects reported with Lonquex are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Lonquex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The injections should be given under the skin in the abdomen, upper arm or thigh.
Slovenian: Injekcije je treba injicirati v podkožje v trebuh, nadlaket ali stegno.
English: The European Medicines Agency noted that the studies had shown that Lonquex is effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases.
Slovenian: Evropska agencija za zdravila je ugotovila, da so študije pokazale, da je zdravilo Lonquex učinkovito pri skrajševanju trajanja hude nevtropenije in zmanjševanju števila primerov febrilne nevtropenije.
English: An overview of Lonquex and why it is authorised in the EU
Slovenian: Pregled zdravila Lonquex in zakaj je odobreno v EU
English: Why is Lonquex authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Lonquex odobreno v EU?
English: What benefits of Lonquex have been shown in studies?
Slovenian: Kakšne koristi zdravila Lonquex so se pokazale v študijah?
English: In a main study in 202 breast cancer patients Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was around 17 hours with Lonquex compared with around 19 hours with the other medicine.
Slovenian: V glavni študiji, v katero sta bila vključena 202 bolnika z rakom dojke, so zdravilo Lonquex primerjali z drugim pegiliranim filgrastimom: huda nevtropenija med kemoterapijo je pri zdravljenju z zdravilom Lonquex v povprečju trajala približno 17 ur v primerjavi s približno 19 urami pri zdravljenju z drugim zdravilom.
English: Cytotoxic chemotherapy (medicines that kill fast growing cells) commonly causes neutropenia because in addition to cancer cells, it also kills other fast-growing cells such as neutrophils, leaving the patient at risk of infections.
Slovenian: Citotoksična kemoterapija (zdravila, ki uničijo hitro rastoče celice) pogosto povzroča nevtropenijo, saj poleg rakavih celic uničuje tudi druge hitro rastoče celice, kot so nevtrofilci, zaradi česar je bolnik izpostavljen tveganju za okužbe.
English: What is Lonquex and what is it used for?
Slovenian: Kaj je zdravilo Lonquex in za kaj se uporablja?
English: Lonquex is a medicine that contains the active substance lipegfilgrastim.
Slovenian: Lonquex je zdravilo, ki vsebuje učinkovino lipegfilgrastim.
English: What are the risks associated with Lonquex?
Slovenian: Kakšna tveganja so povezana z zdravilom Lonquex?
English: Another main study in 376 patients compared Lonquex with placebo (a dummy treatment).
Slovenian: V drugi glavni študiji, v katero je bilo vključenih 376 bolnikov, so zdravilo Lonquex primerjali s placebom (zdravilom brez učinkovine).
English: The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte colony stimulating factor (G‑ CSF), a naturally occurring protein in the body that stimulates the production of white blood cells including neutrophils in the bone marrow.
Slovenian: Učinkovina zdravila Lonquex, lipegfilgrastim, je podobna granulocitne kolonije spodbujajočemu faktorju (G-CSF), ki je naravno prisotna beljakovina v telesu, ki spodbuja nastajanje belih krvnih celic, vključno z nevtrofilci, v kostnem mozgu.
English: Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) and myelodysplastic syndromes (a disease that can develop into a leukaemia).
Slovenian: Zdravilo Lonquex se ne uporablja pri bolnikih, ki prejemajo kemoterapijo za kronično mieloično levkemijo (raka belih krvnih celic) in mielodisplastične sindrome (bolezen, ki se lahko razvije v levkemijo).
English: It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.
Slovenian: Uporablja se za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvnih celic) in zmanjšanje pogostosti pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri odraslih bolnikih z rakom, ki prejemajo citotoksično kemoterapijo.
English: For the full list of side effects of Lonquex, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Lonquex glejte navodilo za uporabo.
English: Lipegfilgrastim acts in the same way as G‑CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and the occurrence of febrile neutropenia (a sign of infection) in patients receiving chemotherapy.
Slovenian: Lipegfilgrastim deluje enako kot G-CSF, in sicer povečuje nastajanje nevtrofilcev in tako pomaga skrajšati trajanje nevtropenije ter zmanjšati pogostost pojavljanja febrilne nevtropenije (znaka okužbe) pri bolnikih, ki prejemajo kemoterapijo.
English: Lonquex is available as an injection in pre-filled syringes.
Slovenian: Zdravilo Lonquex je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah.
English: In Lonquex, the filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu Lonquex je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.
Slovenian: Zdravilo Lonquex so z drugim zdravilom primerjali tudi v številu primerov febrilne nevtropenije: v skupini, ki je prejemala zdravilo Lonquex, je bil tak primer eden, v primerjalni skupini pa trije.
English: Lonquex was effective in reducing the duration of neutropenia and the number of febrile neutropenia cases among patients undergoing chemotherapy.
Slovenian: Zdravilo Lonquex je bilo učinkovito pri skrajševanju trajanja nevtropenije in zmanjševanju števila primerov febrilne nevtropenije med bolniki, ki se zdravijo s kemoterapijo.
English: How does Lonquex work?
Slovenian: Kako zdravilo Lonquex deluje?
English: Patients receiving Lonquex recovered from neutropenia more quickly and fewer patients suffered severe neutropenia.
Slovenian: Bolniki, ki so prejemali zdravilo Lonquex, so od nevtropenije okrevali hitreje in manj jih je obolelo za hudo nevtropenijo, kot v skupini, ki je prejemala placebo.
English: How is Lonquex used?
Slovenian: Kako se zdravilo Lonquex uporablja?
English: It is also used for the treatment of vomiting.
Slovenian: Uporablja se tudi za zdravljenje bruhanja.
English: It is also available in the EU as generic haloperidol.
Slovenian: V EU je na voljo tudi kot generični haloperidol.
English: Haldol and associated names (such as Aloperidin and Serenase) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and United Kingdom, and also in Iceland and Norway.
Slovenian: Zdravilo Haldol in povezana imena (kot sta Aloperidin in Serenase) se tržijo v Avstriji, Belgiji, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, Romuniji,na Cipru, Danskem, Finskem, Malti, Nizozemskem, Portugalskem, Švedskem in v Združenem kraljestvu ter tudi na Islandiji in Norveškem.
English: Why was Haldol reviewed?
Slovenian: Zakaj je bilo zdravilo Haldol pregledano?
English: Haldol is authorised in the EU via national procedures.
Slovenian: Zdravilo Haldol je bilo v EU odobreno po nacionalnih postopkih.
English: What is Haldol?
Slovenian: Kaj je zdravilo Haldol?
English: In children and adolescents, for:
Slovenian: Pri otrocih in mladostnikih se lahko uporablja za:
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol.
Slovenian: Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Haldol.
English: In adults, for:
Slovenian: Pri odraslih se lahko uporablja za:
English: In particular, Haldol must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Slovenian: Zdravilo Haldol se še zlasti ne sme uporabljati pri bolnikih s srčnimi boleznimi, kot so določene težave s srčnim ritmom, srčnim popuščanjem in nedavnim srčnim infarktom, ter pri bolnikih z depresijo centralnega živčevja (zmanjšano aktivnostjo možganov, ki upočasni dihanje in srčni utrip ter zmanjša budnost).
English: It contains the active substance haloperidol and is available as tablets, oral solutions, and injection.
Slovenian: Vsebuje zdravilno učinkovino haloperidol in je na voljo v obliki tablet, peroralnih raztopin in injekcije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Haldol v Evropski uniji (EU).
English: Alzheimer's dementia and vascular dementia when non-pharmacological treatments have not worked and when there is a risk of harm to the patient or to others;
Slovenian: Alzheimerjevo demenco in vaskularno demenco, kadar nefarmakološko zdravljenje ni delovalo in kadar obstaja tveganje, da bo bolnik poškodoval sebe ali druge;
English: The CHMP agreed that Haldol should no longer be used for the treatment of delirium, delusions or hallucinations which follow alcohol withdrawal because the medicine has not proven effective for treating the underlying condition and there is inadequate evidence that it is of benefit when used with a benzodiazepine.
Slovenian: Odbor CHMP je soglašal, da se zdravilo Haldol ne sme več uporabljati za zdravljenje delirija, blodenj ali prividov, ki sledijo odtegnitvi alkohola, saj se zdravilo ni izkazalo za učinkovito pri zdravljenju osnovne bolezni in ni dovolj dokazov, da je koristno ob sočasni uporabi z benzodiazepini.
English: Haldol is an antipsychotic medicine used in adults and children for a number of mental and other brain disorders including schizophrenia, mania (feeling elated or over-excited), aggression, Tourette's syndrome and tics (repeated and uncontrollable movements) and choreatic movements (jerky and uncontrolled movements mainly of the face and hands).
Slovenian: Haldol je antipsihotično zdravilo, ki se uporablja pri odraslih in otrocih za številne duševne in druge možganske motnje, vključno s shizofrenijo, manijo (občutkom vznesenosti ali čezmerne razburjenosti), agresivnostjo, Tourettovim sindromom in tiki (ponavljajočimi se in nenadzorovanimi gibi) ter horeatičnimi zgibki (sunkovitimi in nenadzorovanimi gibi, predvsem obraza in dlani).
English: The CHMP harmonised the starting, maintenance and maximum doses for each of the different uses of Haldol in adults, elderly patients and in children and adolescents.
Slovenian: Odbor CHMP je uskladil začetni, vzdrževalni in največji odmerek za vsako posamezno uporabo zdravila Haldol pri odraslih, starejših bolnikih ter pri otrocih in mladostnikih.
English: The section was also harmonised with information on when Haldol's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Slovenian: Poglavje je bilo usklajeno tudi z informacijami o tem, kdaj se lahko pojavijo neželeni učinki zdravila Haldol, ki prizadenejo premikanje, podatki o smrtnosti pri starejših in učinki na možgane in srce.
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol and other medicines (section 4.5), information on pregnancy, lactation and fertility (section 4.6) and added angioedema as a side effect (section 4.8).
Slovenian: Odbor CHMP je uskladil druga poglavja povzetka glavnih značilnosti zdravila, vključno z medsebojnim delovanjem med zdravilom Haldol in drugimi zdravili (poglavje 4.5), informacijami o nosečnosti, dojenju in plodnosti (poglavje 4.6), med neželene učinke pa je dodal angioedem (poglavje 4.8).
English: The CHMP harmonised the SmPC to include a warning that patients with bipolar disorders may suffer sudden depression, calling for close supervision of such patients.
Slovenian: Odbor CHMP je uskladil povzetek glavnih značilnosti zdravila in vanj vključil opozorilo, da se pri bolnikih z bipolarnimi motnjami lahko pojavi nenadna depresija, zato je potreben skrben nadzor takih bolnikov.
English: The CHMP agreed to harmonisation of Haldol's contra-indications.
Slovenian: Odbor CHMP je soglašal z uskladitvijo kontraindikacij za zdravilo Haldol.
English: The CHMP agreed that Haldol injection can be used in adults as follows:
Slovenian: Odbor CHMP je soglašal, da se zdravilo Haldol v obliki injekcij lahko uporablja pri odraslih v naslednjih primerih:
English: • treatment of persistent aggression and psychotic symptoms in patients with moderate to severe
Slovenian: • zdravljenje trdovratne agresivnosti in psihotičnih simptomov pri bolnikih z zmerno do resno
English: The CHMP agreed that starting dose in the elderly should be as low as possible and harmonised advice on the starting doses of Haldol in those with liver or kidney disorders.
Slovenian: Odbor CHMP je soglašal, da mora biti začetni odmerek pri starejših čim manjši, in je uskladil nasvet o začetnih odmerkih zdravila Haldol pri bolnikih z boleznimi jeter ali ledvic.
English: • for short-term treatment of delirium when non-pharmacological treatments have not worked;
Slovenian: • za kratkotrajno zdravljenje delirija, kadar nefarmakološko zdravljenje ni delovalo;
English: • treatment of schizophrenia and schizoaffective disorder;
Slovenian: • zdravljenje shizofrenije in shizoafektivne motnje;
English: • acute treatment of delirium when non-pharmacological treatments (treatments that do not involve medicines) have not worked;
Slovenian: • akutno zdravljenje delirija, kadar nefarmakološko zdravljenje (zdravljenje, ki ne vključuje zdravil)
English: • persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have not worked or cause unacceptable side effects;
Slovenian: • trdovratno, hudo agresivnost pri otrocih in mladostnikih, starih od 6 do 17 let, z avtizmom ali pervazivno razvojno motnjo, kadar druga zdravila niso delovala ali so imela nesprejemljive neželene učinke;
English: • schizophrenia in adolescents aged 13 to 17 years when other medicines have not worked or cause unacceptable side effects;
Slovenian: • shizofrenijo pri mladostnikih, starih od 13 do 17 let, kadar druga zdravila niso delovala ali so imela nesprejemljive neželene učinke;
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol and associated names in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Haldol in povezanimi imeni v EU, je 18. junija 2014 zadevo napotila na odbor CHMP.
English: • treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder;
Slovenian: • zdravljenje akutne psihomotorične agitacije, povezane s psihotično motnjo ali maničnimi epizodami bipolarne motnje tipa I;
English: • for rapid control of severe acute psychomotor agitation linked to psychotic disorder or manic episodes of bipolar I disorder when medicines cannot be given by mouth;
Slovenian: • za hitro obvladanje resne akutne psihomotorične agitacije, povezane s psihotično motnjo ali maničnimi epizodami bipolarne motnje tipa I, kadar zdravil ni mogoče dajati peroralno;
English: • treatment of moderate to severe manic episodes associated with bipolar I disorder;
Slovenian: • zdravljenje zmernih do resnih maničnih epizod, povezanih z bipolarno motnjo tipa I;
English: The CHMP agreed that Haldol tablets and oral solutions can be used as follows.
Slovenian: Odbor CHMP je soglašal, da se zdravilo Haldol v obliki tablet in peroralnih raztopin lahko uporablja v naslednjih primerih.
English: • for treatment of mild to moderate chorea in Huntington's disease, when other medicines are ineffective or have unacceptable side effects and when medicines cannot be given by mouth;
Slovenian: • za zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, kadar so druga zdravila neučinkovita ali imajo nesprejemljive neželene učinke in kadar zdravil ni mogoče dajati peroralno;
English: • alone or with other medicines, for prevention of nausea and vomiting after surgery in those who are at moderate to high risk, when other medicines do not work or have unacceptable side effects;
Slovenian: • samostojno ali z drugimi zdravili za preprečevanje navzee in bruhanja po kirurškem posegu pri bolnikih z zmernim do velikim tveganjem, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke;
English: • treatment of mild to moderate chorea in Huntington's disease, when other medicines do not work or have unacceptable side effects.
Slovenian: • zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke.
English: • with other medicines, for treatment of nausea and vomiting after surgery when other medicines do not work or have unacceptable side effects.
Slovenian: • z drugimi zdravili za zdravljenje navzee in bruhanja po kirurškem posegu, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke.
English: Haldol was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Haldol potrebno usklajevanje.
English: • tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational and psychological treatments and other medicines have not worked.
Slovenian: • motnje s tiki, vključno s Tourettovim sindromom, pri otrocih in mladostnikih, starih od 10 do
English: • treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational and psychological treatments and other medicines have not worked;
Slovenian: • zdravljenje motenj s tiki, vključno s Tourettovim sindromom, pri bolnikih z resno okvaro, po tem,
English: --1 Porcine circovirus type 2 orf-2 protein 2.3-12.4 RP* * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine
Slovenian: --1 Prašičji cirko virus tip I z izraženim proteinom ORF2 2.3-12.4 RP* * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
English: Route of administration
Slovenian: 4 viale
English: Livensa testosterone
Slovenian: Livensa testosteron
English: The marketing authorisation holder is Warner Chilcott Deutschland GmbH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Warner Chilcott Deutschland GmbH.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Livensa on 28 July 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Livensa, veljavno po vsej Evropski uniji, odobrila dne 28. julija 2006.
English: The patch remains on the skin for three or four days and is then replaced by a new patch in a different place.
Slovenian: Obliž ostane na koži tri ali štiri dni, nato pa se nadomesti z novim na drugem mestu.
English: Because testosterone is a well-known substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Slovenian: Ker je testosteron dobro znana učinkovina, ki se uporablja tudi v drugih zdravilih, je družba uporabila podatke iz objavljene literature, izvedla pa je tudi lastne študije.
English: Livensa was more effective than placebo.
Slovenian: Zdravilo Livensa je bilo učinkovitejše od placeba.
English: What measures are being taken to ensure the safe use of Livensa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Livensa?
English: This document is a summary of the European public assessment report (EPAR) for Livensa.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Livensa.
English: The two main studies involved 1,095 women with an average age of 49 years who received Livensa for up to a year.
Slovenian: V dveh glavnih študijah je sodelovalo 1 095 žensk s povprečno starostjo 49 let, ki so zdravilo Livensa prejemale v obdobju do enega leta.
English: Other information about Livensa:
Slovenian: Druge informacije o zdravilu Livensa:
English: Livensa is used as a continuous treatment, as one patch twice a week.
Slovenian: Zdravilo Livensa se uporablja za kontinuirano zdravljenje z aplikacijo enega obliža dvakrat tedensko.
English: For more information about treatment with Livensa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Livensa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Slovenian: Nizka raven testosterona je povezana z nizkim spolnim poželenjem ter zmanjšanjem spolnih misli in spolnega vzburjenja.
English: What benefit has Livensa shown during the studies?
Slovenian: Kakšne koristi je zdravilo Livensa izkazalo med študijami?