FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP defined the target patient population as women of established postmenopausal status and patients with ER-positive tumours, patients whose tumours are HER-2 (Human Epidermal Growth Factor Receptor 2) negative and patients who are unable to tolerate or who refuse to take neoadjuvant chemotherapy as well as patient for whom immediate surgery is not an option.
Slovenian: CHMP je za ciljno populacijo bolnikov opredelil ženske z določenim pomenopavznim statusom in bolnice s ER-pozitivnimi tumorji, bolnice s HER-2 (Human Epidermal Growth Factor Receptor 2) negativnimi tumorji, bolnice, ki neoadjuvantne kemoterapije ne prenašajo ali jo zavračajo, ter bolnice, za katere takojšnja operacija ne pride v poštev.
English: 4) Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Slovenian: 4) Napredovali rak dojke po ponovitvi ali napredovanju bolezni pri ženskah z naravno ali umetno sproženim pomenopavznim endokrinim statusom, ki so se že zdravile z antiestrogeni.
English: Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with antioestrogens.
Slovenian: • Napredovali rak dojke po ponovitvi ali napredovanju bolezni pri ženskah z naravno ali umetno sproženim pomenopavznim endokrinim statusom, ki so se že zdravile z antiestrogeni.
English: 2) Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Slovenian: 2) Podaljšano adjuvantno zdravljenje hormonsko odvisnega invazivnega raka dojke pri ženskah po menopavzi, ki so predhodno 5 let prejemale standardno adjuvantno obliko zdravljenja s tamoksifenom.
English: 3) First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Slovenian: 3) Prva linija zdravljenja pri pomenopavznih ženskah s hormonsko odvisnim napredovalim rakom dojke.
English: In addition, it is essential to avoid pregnancy during letrozole therapy because of the risk of embryotoxicity and foetotoxicity.
Slovenian: Poleg tega je zaradi nevarnosti embriotoksičnosti in fetotoksičnosti pomembno, da ženska med terapijo letrozola ne zanosi.
English: 5) Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Slovenian: 5) Neoadjuvantno zdravljenje HER-2 negativnega raka dojke s pozitivnimi hormonskimi receptorji pri pomenopavznih ženskah, pri katerih kemoterapija ni primerna in takojšnja operacija ni indicirana.
English: Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Slovenian: • Podaljšano adjuvantno zdravljenje hormonsko odvisnega invazivnega raka dojke pri ženskah po menopavzi, ki so predhodno 5 let prejemale standardno adjuvantno obliko zdravljenja s tamoksifenom.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Slovenian: • je bil namen napotitve uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo,
English: The CHMP therefore concluded that the current data, including long-term follow-up information, is sufficient to support the neoadjuvant (pre-operative) treatment indication for Femara, in particular with the aim to down-size hormone receptor-positive tumours to allow BCS or to allow inoperable tumours to become operable.
Slovenian: CHMP je pregledal vse razpoložljive podatke in menil, da je letrozol glede na tamoksifen pokazal značilno boljšo stopnjo kliničnega odziva, mamografskega odziva, odziva z ultrazvokom dojk in stopnjo ohranitvene operacije dojke CHMP je zato sklenil, da trenutni podatki za zdravilo Femara, vključno z dolgoročnimi informacijami o spremljanju, zadoščajo za podporo indikacije neoadjuvantnega (predoperativnega) zdravljenja, zlasti z namenom zmanjšanja tumorjev s pozitivnimi hormonskimi receptorji, da se omogoči ohranitvena operacija dojke ali operacijo tumorjev, ki jih prej ni bilo mogoče operirati.
English: Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Slovenian: • Neoadjuvantno zdravljenje HER-2 negativnega raka dojke s pozitivnimi hormonskimi receptorji, pri pomenopavznih ženskah, pri katerih kemoterapija ni primerna in takojšnja operacija ni indicirana.
English: First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Slovenian: • Prva linija zdravljenja pri pomenopavznih ženskah s hormonsko odvisnim napredovalim rakom dojke.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Slovenian: Razlogi za dopolnilo povzetka glavnih značilnosti zdravila, označevanje in navodila za uporabo
English: 1) Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Slovenian: 1) Adjuvantno zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
English: The CHMP also noted that the wording was consistent with the wording in most nationally approved SmPCs.
Slovenian: CHMP je opazil tudi, da je bilo besedilo skladno z besedilom v večini povzetkov glavnih značilnosti zdravila, odobrenih na nacionalni ravni.
English: The CHMP also noted that the wording was largely consistent with the nationally approved SmPCs.
Slovenian: CHMP je opazil tudi, da je besedilo večinoma skladno z besedilom v povzetkih glavnih značilnosti zdravila, odobrenih na nacionalni ravni.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Femara and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I) so navedeni v Prilogi III za zdravilo Femara in z njim povezana imena.
English: Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer.”
Slovenian: Učinkovitost ni bila dokazana pri bolnicah z rakom dojke z negativnimi hormonskimi receptorji.“ Poglavje 4.2 - Odmerjanje in način uporabe
English: Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Slovenian: • Adjuvantno zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
English: 28 June 2013
Slovenian: 28. junij 2013
English: The company that applied for authorisation is Laboratoires SMB s.a.
Slovenian: Vlogo za pridobitev dovoljenja je predložila družba Laboratoires SMB s.a.
English: The effects of Labazenit were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Labazenit so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
Slovenian: FEV1 je največji volumen zraka, ki ga lahko posameznik izdihne v eni sekundi, medtem ko je PEF najvišja hitrost, s katero lahko posameznik izdihne zrak iz pljuč.
English: The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Slovenian: Primarna merila učinkovitosti so temeljila na forsiranih ekspiracijskih volumnih (FEV1) bolnikov ali največjem pretoku zraka med izdihom (PEF) po zdravljenju.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.
Slovenian: Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 27. junija 2013 potrdil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
English: On 21 March 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 Labazenit, intended for the treatment of asthma.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je dne 21. marca 2013 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Labazenit, namenjenim zdravljenju astme.
English: The two active substances in Labazenit are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Slovenian: Zdravilni učinkovini v zdravilu Labazenit sta dobro znani in sta prisotni v več zdravilih, ki se bodisi samostojno bodisi v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme.
English: The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Slovenian: Družba je CHMP obvestila, da v času izdaje mnenja v Evropi niso potekala nobena klinična preskušanja z zdravilom Labazenit.
English: Salmeterol is a long-acting beta-2 agonist and it works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Slovenian: Salmeterol je dolgodelujoč agonist beta-2, ki deluje tako, da se veže na receptorje, imenovane receptorji beta-2, ki se nahajajo v dihalnih mišicah.
English: The company presented results of two main studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and one main study comparing Labazenit with budesonide alone in 375 patients.
Slovenian: Družba je predložila rezultate dveh glavnih študij s skupno 83 bolniki z astmo, v katerih so zdravilo Labazenit primerjali s samim salmeterolom, in ene glavne študije s 375 bolniki, v kateri so zdravilo Labazenit primerjali s samim budezonidom.
English: Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Slovenian: Budezonid je kortikosteroid, ki deluje protivnetno.
English: In addition, data from another study indicated that lower amounts of budesonide may reach the lungs when Labazenit is used.
Slovenian: Poleg tega so podatki iz druge študije pokazali, da lahko pri uporabi zdravila Labazenit pljuča dosežejo manjše količine budezonida.
English: It was to be available as capsules containing powder for inhalation.
Slovenian: Na voljo naj bi bilo v obliki kapsul s praškom za vdihavanje.
English: The CHMP's main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.
Slovenian: Glavni zadržek odbora CHMP je bil, da študija primerjave zdravila Labazenit s samim budezonidom ni potrdila zadovoljivega protivnetnega učinka zdravila Labazenit.
English: The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: CHMP je zato zaključil, da koristi zdravila Labazenit niso večje od z njim povezanih tveganj, in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z njim.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Slovenian: Z vezavo na omenjene receptorje povzroči, da se mišice sprostijo, s čimer odpre dihalne poti in bolniku olajša dihanje.
English: Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Slovenian: Izvedeni sta bili tudi dve obsežnejši podporni študiji s 601 bolnikom, v katerih so zdravilo Labazenit primerjali z drugimi zdravili s kombinacijo kortikosteroida in agonista beta-2.
English: When inhaled, it reduces inflammation in the airways, thereby helping to keep the patients' airways clear and allowing them to breathe more easily.
Slovenian: Ob vdihavanju zmanjša vnetje dihalnih poti, s čimer pomaga sprostiti dihalne poti bolnikov in jim tako omogoči lažje dihanje.
English: Labazenit was expected to be used in the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required.
Slovenian: Zdravilo Labazenit naj bi se uporabljalo za zdravljenje astme pri odraslih, ki potrebujejo kombinirano zdravilo, ki vsebuje inhalacijski kortikosteroid in dolgodelujoč agonist beta-2.
English: What is Labazenit?
Slovenian: Kaj je zdravilo Labazenit?
English: What was Labazenit expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Labazenit uporabljalo?
English: Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Slovenian: Labazenit je zdravilo, ki vsebuje zdravilni učinkovini budezonid in salmeterol.
English: How is Labazenit expected to work?
Slovenian: Kako naj bi zdravilo Labazenit delovalo?
English: Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Slovenian: Datum prve odobritve: 06. april 2006 Datum zadnjega podaljšanja: 16. december 2015
English: North Carolina 27712 U.S.A.
Slovenian: North Carolina 27712 ZDA
English: Several adverse events were solicited in the clinical studies and are designated with the symbol (
Slovenian: Posamezni neželeni dogodki, o katerih v kliničnih študijah niso poročali spontano, so označeni s simbolom(
English: Concomitant use with other vaccines:
Slovenian: Sočasna uporaba z drugimi cepivi:
English: The antibodies help protect against diseases caused by these viruses.
Slovenian: Protitelesa pomagajo ščititi pred boleznimi, ki jih povzročajo ti virusi.
English: * See section c c. Description of selected adverse reactions
Slovenian: * Glejte poglavje c c. Opis izbranih neželenih učinkov
English: • An allergic reaction to eggs or anything that contained egg.
Slovenian: • Alergijska reakcija na jajca ali na karkoli, kar vsebuje jajca.
English: Children in these studies were monitored for six weeks post vaccination.
Slovenian: Otroke so v teh študijah spremljali šest tednov po cepljenju.
English: • Individuals with a lowered resistance to diseases.
Slovenian: • Osebami z zmanjšano odpornostjo proti boleznim.
English: The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.
Slovenian: Primeren čas cepljenja in število odmerkov bo določil zdravnik v skladu z uradnimi priporočili.
English: Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Slovenian: Tudi starejše ženske (stare 35 do 45 let) te neželene učinke večinoma dobro prenašajo in le redko jih motijo pri običajnih dejavnostih.
English: The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Slovenian: Pogostnost teh neželenih učinkov je opredeljena kot "neznana", ko pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
English: These data were confirmed by a post-marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Slovenian: Te podatke so potrdili v postmarketinški opazovalni študiji, sponzorirani s strani Centrov za nadzor in preprečevanje bolezni
English: • Individuals less than 9 months of age
Slovenian: • Posamezniki, mlajši od 9 mesecev
English: d. Other special populations
Slovenian: d. Druge posebne skupine
English: The vaccine may contain traces of recombinant human albumin (rHA).
Slovenian: To cepivo lahko v sledeh vsebuje rekombinantni humani albumin (rHA).
English: Social circumstances Activities of daily living impaired
Slovenian: Socialne okoliščine motene vsakodnevne dejavnosti redki
English: It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
Slovenian: Pomembno je, da za vsakogar uporabite drugo sterilno brizgo in iglo, da preprečite prenos okužb z enega posameznika na drugega.
English: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katero koli drugo zdravilo (ali drugo cepivo).
English: The safety and efficacy of ProQuad in children under 9 months of age have not been established.
Slovenian: Varnost in učinkovitost cepiva ProQuad pri otrocih, mlajših od 9 mesecev, nista bili dokazani.
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Not known (cannot be estimated from the available data)
Slovenian: Zelo pogosti ( 1/10), pogosti ( 1/100, < 1/10), občasni ( 1/1.000, < 1/100), redki ( 1/10.000, < 1/1.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Slovenian: Z ovrednotenjem serološkega statusa bolnika se lahko ugotovi, ali so potrebni dodatni odmerki cepiva ali ne.
English: • If the person to be vaccinated has active untreated tuberculosis.
Slovenian: • Če ima oseba, ki naj bi bila cepljena, aktivno nezdravljeno tuberkulozo.
English: • An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
Slovenian: • Okužba s človeškim virusom imunske pomanjkljivosti (HIV) brez znakov bolezni HIV.
English: Vaccination should be postponed during any illness with fever >38.5C.
Slovenian: Cepljenje je treba odložiti pri kateri koli bolezni z zvišano telesno temperaturo > 38,5 C.
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Slovenian: Profil varnosti po 1. in 2. odmerku je bil na splošno primerljiv za vse starostne skupine.
English: Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
Slovenian: Navodila za pripravo, namenjena zdravstvenemu osebju, so navedena na koncu navodila.
English: See also section 3 How to use ProQuad.
Slovenian: Glejte tudi poglavje 3 Kako uporabljati cepivo ProQuad.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BD54.
Slovenian: Farmakoterapevtska skupina: cepiva, virusna cepiva; oznaka ATC: J07BD54.
English: Investigations Weight loss
Slovenian: Preiskave izguba teže redki
English: Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Slovenian: Zdravniku povejte, če je bil vaš otrok pred kratkim cepljen ali če naj bi bil cepljen v bližnji prihodnosti.
English: Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
Slovenian: Trenutno imunosupresivno zdravljenje (vključno z velikimi odmerki kortikosteroidov) (glejte poglavje 4.8).
English: Allergic reactions (hives) may occur.
Slovenian: Lahko se pojavijo alergijske reakcije (koprivnica).
English: If you or your child have an allergic reaction, call your doctor right away.
Slovenian: Če imate vi ali vaš otrok alergijsko reakcijo, se takoj posvetujte z zdravnikom.
English: However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Slovenian: Cepljenje je namreč lahko manj učinkovito kot pri neokuženih osebah (glejte S cepivom ProQuad se ne sme cepiti).
English: There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Slovenian: Ni potrjenih dokazov, ki bi kazali, da se tak virus prenaša na za rdečke dovzetne osebe, ki so v stiku s cepljenimi posamezniki.
English: • If the person to be vaccinated is allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6).
Slovenian: • Če je oseba, ki naj bi bila cepljena, alergična na katero koli sestavino tega cepiva (vključno z neomicinom ali katero koli drugo sestavino, navedeno v poglavju 6).
English: • If the person to be vaccinated has a blood disorder or any type of cancer that affects the immune system.
Slovenian: • Če ima oseba, ki naj bi bila cepljena, bolezen krvi ali katero koli vrsto raka, ki vpliva na imunski sistem.
English: Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics (SmPC).
Slovenian: Običajne predklinične študije varnosti niso bile opravljene, ni pa predkliničnih zadržkov, ki bi jih smatrali za pomembne za klinično varnost, razen podatkov, vključenih v drugih poglavjih Povzetka glavnih značilnosti zdravila (SmPC).
English: What ProQuad is and what it is used for
Slovenian: Kaj je cepivo ProQuad in za kaj ga uporabljamo
English: There are insufficient data to support the use of ProQuad with any other vaccines.
Slovenian: Ni dovolj podatkov v podporo uporabi cepiva ProQuad s katerim koli drugim cepivom.
English: - This vaccine has been prescribed for you or your child only.
Slovenian: - To cepivo je bilo predpisano samo vam ali vašemu otroku in ga ne smete dajati drugim.
English: Persistence of Immune Response
Slovenian: Trajanje imunskega odziva
English: In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
Slovenian: V obsežni študiji primerov in kontrol (case-control study) so ocenili, da je cepivo 85 % učinkovito proti vsem oblikam noric ter 97 % učinkovito proti zmerno hudi in hudi bolezni.
English: These included:
Slovenian: Ti so vključevali:
English: What you need to know before you receive ProQuad
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo ProQuad
English: The safety profiles of the administered vaccines were comparable (see section 4.8).
Slovenian: Varnostni profili prejetih cepiv so bili primerljivi (glejte poglavje 4.8).
English: No studies on the effects on the ability to drive or use machinery have been performed.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
English: • If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).
Slovenian: • Če je oseba, ki naj bi bila cepljena, nosečnica (poleg tega 1 mesec po cepljenju ne smete zanositi, glejte Nosečnost in dojenje).
English: • If the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
Slovenian: • Če oseba, ki naj bi bila cepljena, prejema terapijo ali jemlje zdravila, ki lahko oslabijo imunski sistem (razen majhnih odmerkov kortikosteroidov pri astmi ali kot nadomestno zdravljenje).
English: Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Slovenian: Rezultati so pokazali postopno upadanje deleža noric za skupno 90 % do 95 % (približno 10- do 20-kratno) od leta 1995 do leta 2009 v vseh starostnih skupinah, tako pri cepljenih kot pri necepljenih otrocih in mladostnikih.
English: • immunocompromised individuals (see section 4.3),
Slovenian: • osebe s pomanjkljivo imunostjo (glejte poglavje 4.3),
English: • A history or family history of allergies or of convulsions (fits).
Slovenian: • Družinska anamneza alergij ali konvulzij (krčev).