FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients aged 6 to 11 years 1 tablet of 100 mg/125 mg in the morning +
Slovenian: 1 tableto po 100 mg/125 mg zjutraj +
English: One lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours lumacaftor 200 mg/ ivacaftor 250 mg
Slovenian: 100 mg/ivakaftor 125 mg na 12 ur lumakaftor 200 mg/
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 100 mg + ivacaftor 125 mg For patients aged 2 to5 years and ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
Slovenian: stare 2 do 5 let, ki tehtajo manj kot 14 kg; lumakaftor 150 mg/ivakaftor 188 mg za bolnike, stare 2 do
English: For patients aged 12 years and older 1 tablet of 200 mg/125 mg in the morning +
Slovenian: 1 tableto po 200 mg/125 mg zjutraj +
English: Your doctor may perform some eye examinations prior to and during treatment with Orkambi.Orkambi is not recommended in patients who have undergone an organ transplant.
Slovenian: Mogoče bo zdravnik pred zdravljenjem z zdravilom Orkambi in med njim naredil nekatere očesne preiskave.
English: Placebo (n = 187)
Slovenian: (n = 187)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Slovenian: Ena vrečica vsebuje 150 mg lumakaftorja (lumacaftorum) in 188 mg ivakaftorja (ivacaftorum).
English: Talk to your doctor or pharmacist before taking Orkambi.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Orkambi se posvetujte z zdravnikom ali farmacevtom.
English: Two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg
Slovenian: 125 mg na 12 ur lumakaftor 800 mg/
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg tablets lumacaftor/ivacaftor
Slovenian: Orkambi 100 mg/125 mg tablete lumacaftorum/ivacaftorum
English: Day 1: lumacaftor 200 mg + ivacaftor 250 mg Day 2: lumacaftor 100 mg + ivacaftor 125 mg
Slovenian: 2. dan: 150 mg lumakaftorja +
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 200 mg lumakaftorja in 125 mg ivakaftorja.
English: Breast-feeding
Slovenian: repaglinid
English: For patients aged 2 to 5 years and ≥ 14 kg Day 1: lumacaftor 300 mg + ivacaftor 376 mg Day 2: lumacaftor 150 mg + ivacaftor 188 mg
Slovenian: Za bolnike, stare 2 do 5 let in ≥ 14 kg 1. dan: 300 mg lumakaftorja +
English: 12 years and older Orkambi 200 mg/125 mg
Slovenian: Orkambi 200 mg/125 mg
English: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Slovenian: Okvara jeter Pri bolnikih z blago okvaro jeter (razred A po Child-Pughovi lestvici) ni potrebno prilagajanje odmerjanja.
English: • Moderate liver problems: the dose may be reduced on alternate days: two sachets on one day
Slovenian: • Zmerne težave z jetri: odmerek se lahko zmanjša vsak drugi dan: dve vrečici na en dan (zjutraj in zvečer), eno vrečico naslednjega dne (samo zjutraj).
English: United Kingdom
Slovenian: Irska
English: For patients aged 12 years and older 600 mg lumacaftor + 375 mg ivacaftor
Slovenian: Za bolnike, stare 12 let ali več 600 mg lumakaftorja +
English: Hormonal contraceptives: ethinyl estradiol, norethindrone, and other progestogens
Slovenian: noretindron in drugi progestogeni
English: Concomitant medicinal products of most clinical relevance Anti-allergics: montelukast
Slovenian: Klinični komentar Sočasno uporabljena zdravila z največjo klinično pomembnostjo
English: Absolute change from baseline in weight (kg)
Slovenian: Absolutna sprememba telesne mase (kg) od izhodišča n = 57
English: Content Package size Withdrawal period
Slovenian: Vsebina Velikost pakiranja
English: 1 pre-filled syringe Not applicable
Slovenian: 1 napolnjena brizga
English: No other concern was notified by the reference Member State.
Slovenian: Referenčna država članica ni priglasila nobenega drugega pomisleka.
English: The calf should be younger than 1 month old, 2.)
Slovenian: tele mora biti mlajše od enega meseca; 2.)
English: For the mutual recognition procedure (MRP), Belgium acted as a reference Member State and Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom were concerned Member States.
Slovenian: Pri postopku z medsebojnim priznavanjem je bila Belgija referenčna država članica, Bolgarija, Hrvaška, Francija, Nemčija, Irska, Italija, Nizozemska, Poljska, Portugalska, Romunija, Slovenija, Španija in Združeno kraljestvo pa so bile zadevne države članice.
English: This thorough investigations includes: 1.
Slovenian: Takšna natančna raziskava vključuje:
English: − PSURs shall be provided every 6 months for the first 5 years of commercialisation.
Slovenian: − poročilo PSUR se pripravi vsakih šest mesecev v prvih petih letih trženja zdravila;
English: Additionally, a surveillance and monitoring strategy has been proposed, which together with the suggested studies is deemed adequate and proportionate to the identified risk.
Slovenian: Poleg tega je bila predlagana strategija nadzora in spremljanja, ki se skupaj s predlaganima študijama šteje za ustrezno in sorazmerno ugotovljenim tveganjem.
English: However, a concern remains and the MAH committed to further investigate this result in two additional similar studies.
Slovenian: Vendar pa zaskrbljenost ostaja, zato se je imetnik dovoljenja za promet z zdravilom zavezal, da bo ta rezultat podrobneje raziskal v dveh dodatnih podobnih študijah.
English: Data have been provided to demonstrate the efficiency of the filtration step.
Slovenian: Posredovani podatki so prikazovali učinkovitost filtriranja.
English: The proposed measures, which will be included in a risk management plan, are considered proportionate and the most efficient way to tackle the BNP risk.
Slovenian: Predlagani ukrepi, ki bodo vključeni v načrt za obvladovanje tveganj, veljajo za sorazmerne in so najučinkovitejši način za odpravo tveganja za BNP.
English: Animal species Route of administration
Slovenian: Živalska vrsta Način uporabe
English: Vaccines are important tools to combat Bovine Herpesvirus Type 1 Infection which is a notifiable disease in several Member States, e.g. Austria, Denmark, Germany.
Slovenian: Cepiva so pomembno sredstvo za boj proti okužbi z bovinim herpesvirusom tipa 1, pri kateri gre za bolezen, ki jo je treba prijaviti v številnih državah članicah, kot so Avstrija, Danska in Nemčija.
English: Exclusion of infectious, toxic or any other cause in live animals, to be further detailed in the risk management plan.
Slovenian: 1. izključitev infekcioznega, toksičnega ali katerega koli drugega vzroka v živih živalih, ki se nadalje podrobno opiše v načrtu za obvladovanje tveganj;
English: With Commission Decisions 5694 of 10/08/2010 and 7077 of 07/10/2010 the marketing authorisations for PregSure BVD were suspended.
Slovenian: Z odločbama Komisije 5694 z dne 10. avgusta 2010 in 7077 z dne 7. oktobra 2010 so bila dovoljenja za promet s cepivom PregSure BVD začasno preklicana.
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Slovenian: Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
English: − Show that there is no impact of the scaling-up (considering a worst-case scenario, i.e. the maximum commercial batch) on the efficiency of consistently decreasing the total protein content.
Slovenian: − dokaže, da ni vpliva povečanja (ob upoštevanju najslabšega mogočega primera, tj. največje komercialne serije) na učinkovitost dosledno padajoče skupne vsebnosti beljakovin;
English: • The marketing authorisation holder shall implement a single risk management plan addressing the following risk mitigation and surveillance measures:
Slovenian: • imetnik dovoljenja za promet z zdravilom izvaja en načrt za obvladovanje tveganj, ki vsebuje naslednje ukrepe za zmanjševanje tveganja in nadzor:
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States
Slovenian: Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, živalske vrste, način uporabe, vlagatelj/imetnik dovoljenja za promet z zdravilom v državah članicah
English: Risk management measures
Slovenian: Ukrepi za obvladovanje tveganja
English: To address the concerns on alloantibody response the marketing authorisation holder should ensure that the results of the study can be reliably interpreted.
Slovenian: Zaradi obravnavanja vprašanja odziva aloprotiteles mora imetnik dovoljenja za promet z zdravilom zagotoviti, da bo mogoče rezultate študije zanesljivo razložiti.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med postopkom usklajevalne skupine.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Slovenian: Ta vprašanja so ostala nerazrešena, zato je bil sprožen napotitveni postopek v skladu s členom 33(1) Direktive 2001/82/ES, ki je bil predložen Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
English: The limit should be equal to or below the quantity of total protein of the CattleMarker IBR vaccine used in hyperimmunisation study 9134R-08-11-457.
Slovenian: Meja mora biti enaka ali nižja od količine skupne vsebnosti beljakovin v cepivu CattleMarker IBR, ki se uporablja v študiji hiperimunizacije 9134R-08-11-457;
English: Should proposals for alternative immunisation schemes, indications, or contraindications be necessary, these regulatory measures should also be handled consistently with the normal operating practices for adverse event reports and variations associated with veterinary medicinal products.
Slovenian: Če so potrebni predlogi za nadomestni program cepljenja, indikacije ali kontraindikacije, se ti regulativni ukrepi prav tako obravnavajo v skladu z običajnimi praksami ukrepanja v zvezi s poročili o neželenih učinkih in spremembami, povezanimi z zdravili za uporabo v veterinarski medicini;
English: Since the issues raised by Germany remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation CattleMarker IBR Inactivated and consequently the matter was referred to the CVMP on 29 September 2015 under Article 33(4) of Directive 2001/82/EC.
Slovenian: Ker pa so ostala vprašanja, ki jih je izpostavila Nemčija, nerazrešena, zadevne države članice niso dosegle soglasja v zvezi z dovoljenjem za promet s cepivom CattleMarker IBR Inactivated, zato je bila zadeva 29. septembra 2015 v skladu s členom 33(4) Direktive 2001/82/ES predložena odboru CVMP.
English: − Clinically validate the upper limit for total protein content.
Slovenian: − klinično ovrednoti zgornjo mejo skupne vsebnosti beljakovin.
English: A large scale post-marketing prospective survey is deemed less effective to identify whether the level of BNP is acceptable when compared with the surveillance and monitoring strategy proposed, because the number of animals to be enrolled in such a study would exceed several thousands of animals (due to the estimated BNP frequency of around 0.01%) and the time span anticipated for BNP cases to occur consecutive to vaccination would not be shorter.
Slovenian: Obsežna prospektivna študija v obdobju trženja bi bila manj učinkovita pri ugotavljanju, ali je stopnja BNP sprejemljiva v primerjavi s predlagano strategijo nadzora in spremljanja, ker bi število živali, vključenih v tako študijo, preseglo nekaj tisoč (zaradi ocenjene pogostnosti BNP okrog 0,01 %), časovni razpon, predviden za pojav primerov BNP po cepljenju, pa ne bi bil krajši.
English: Active immunisation of female cattle from 6 months of age is also indicated:
Slovenian: Indicirano je tudi za aktivno imunizacijo goveda ženskega spola, starega šest mesecev ali več, zaradi:
English: According to the definition of BNP, for a calf to be diagnosed with the disease, the following three criteria need to be associated: 1.)
Slovenian: V skladu z opredelitvijo pancitopenije novorojenega goveda morajo teleta z diagnozo bolezni izpolnjevati naslednje tri pogoje: 1.)
English: As lack of alloantibody response would be anticipated leading to negative results they should be compared with the available data on Pregsure BVD and with an appropriate internal positive control.
Slovenian: Ker se v primeru pomanjkanja odziva aloprotiteles pričakujejo negativni rezultati, jih je treba primerjati z razpoložljivimi podatki o cepivu PregSure BVD in z ustrezno notranjo pozitivno kontrolo.
English: To set this specification the marketing authorisation holder shall:
Slovenian: Za oblikovanje te specifikacije imetnik dovoljenja za promet z zdravilom:
English: • to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Slovenian: • zmanjšanja pojavov zvrgavanja, povezanih z okužbami z virusom BoHV-1, kot je bilo dokazano v drugem trimesečju brejosti po provokaciji.
English: The risk management plan should be submitted to the national competent authorities within 6 months of the Commission Decision and maintained until such time as the concerned national competent authorities consider that the risk profile of the product has been sufficiently characterised and all appropriate risk mitigation and surveillance measures have been implemented.
Slovenian: Načrt za obvladovanje tveganj se predloži pristojnim nacionalnim organom v šestih mesecih od izdaje sklepa Komisije in se izvaja, dokler zadevni pristojni nacionalni organi ne sklenejo, da je bil profil tveganja cepiva zadovoljivo opredeljen, ter dokler se ne izvedejo vsi ustrezni ukrepi za zmanjševanje tveganja in nadzor.
English: The marketing authorisation holder (MAH), Zoetis Belgium SA, submitted an application for mutual recognition of the marketing authorisation granted by Belgium in accordance with Article 32 of Directive 2001/82/EC.
Slovenian: Imetnik dovoljenja za promet z zdravilom, družba Zoetis Belgium SA, je predložil vlogo za medsebojno priznavanje dovoljenja za promet z zdravilom, ki je bilo izdano v Belgiji skladno s členom 32 Direktive 2001/82/ES.
English: Due to the efficiency and safety of the gE deleted IBR vaccines currently on the market the eradication of IBR is making good progress and several European countries are on the way towards freedom from BoHV-1.
Slovenian: Zaradi učinkovitosti in varnosti cepiv proti tej bolezni, ki imajo delecijo specifičnega gena (gE) in so trenutno na tržišču, njeno izkoreninjenje dobro napreduje, več evropskih držav pa je na poti k odpravi BoHV-1.
English: The epidemiology of the disease is difficult to describe as a number of potential biases may have influenced the results.
Slovenian: Epidemiologijo bolezni je težko opisati, ker so lahko rezultati iz številnih razlogov pristranski.
English: Considering that the frequency of BNP is anticipated to be much lower than 0.01% (PregSure BVD BNP frequency) these measures, which will be included in a RMP, are considered the most efficient way to tackle this risk.
Slovenian: Ker je ocena pogostnosti BNP bistveno nižja od 0,01 % (pogostnost BNP ob uporabi cepiva PregSure BVD), so ti ukrepi, ki bodo vključeni v načrt za obvladovanje tveganj, najučinkovitejši način za obvladovanje tega tveganja.
English: There have been great variations in pharmacovigilance reporting and it is difficult to conclude whether they are related to genuine variations of frequency of BNP occurrence or because of the differences of the information gathered on the condition.
Slovenian: Poročila o farmakovigilanci se med seboj močno razlikujejo, zato je težko ugotoviti, ali so te razlike povezane z dejanskimi razlikami v pogostnosti pojava BNP ali z razlikami med zbranimi informacijami o bolezenskem stanju.
English: other non-immune diseases/conditions with similar clinical signs included in the differential diagnosis (such as BVD, nitrofuran treatment) should be excluded.
Slovenian: izključiti je treba druge neimunske bolezni/stanja s podobnimi kliničnimi znaki, ki so vključena v diferencialno diagnozo (kot sta bovina virusna diareja (BVD), zdravljenje z nitrofuranom).
English: The frequency of this condition had been dramatically exacerbated by PregSure BVD vaccination in the 2000's leading to the characterisation of a strong association between the occurrence of BNP and the use of Pregsure BVD; however the frequency of BNP disease caused by PregSure BVD vaccination has not been solidly determined, varying from 5% to 0.004% according to the source; the CVMP approximated this frequency to be around 0.01% during the Article 78 procedure.
Slovenian: Pogostnost tega stanja je močno povečalo cepljenje s cepivom PregSure BVD v prvem desetletju 21. stoletja, zaradi česar je bila določena močna povezava med pojavom BNP in uporabo cepiva PregSure BVD; pogostnost bolezni BNP, povzročene s cepljenjem s cepivom PregSure BVD, pa ni bila trdno dokazana, saj se je v različnih virih gibala od 5 % do 0,004 %; odbor CVMP je med postopkom v skladu s členom 78 to pogostnost približno ocenil na 0,01 %.
English: Overall summary of the scientific evaluation of CattleMarker IBR Inactivated (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja cepiva CattleMarker IBR Inactivated (glejte Prilogo I)
English: The CVMP was asked to consider the issues raised by Germany and conclude whether marketing authorisations for CattleMarker IBR Inactivated should be granted.
Slovenian: Odbor CVMP je bil naprošen, da preuči vprašanja, ki jih je izpostavila Nemčija, in ugotovi, ali je treba izdati dovoljenja za promet s cepivom CattleMarker IBR Inactivated.
English: Onset of protection for female cattle is 2 weeks or 19 days prior to breeding or insemination and duration is 12 months post primary vaccination.
Slovenian: Pri govedu ženskega spola se zaščita razvije dva tedna ali 19 dni pred parjenjem ali osemenitvijo in traja 12 mesecev po osnovnem cepljenju.
English: − Prior to launch of the vaccine on the market and annually thereafter, provide specific training to the bovine sales and technical teams on the CattleMarker IBR Inactivated product safety profile, BNP and pharmacovigilance obligations.
Slovenian: − pred dajanjem cepiva na trg in nato enkrat letno zagotovi posebno usposabljanje za skupine, ki se ukvarjajo s prodajo govedine in tehnične skupine, glede varnostnega profila cepiva CattleMarker IBR Inactivated, BNP in obveznosti glede farmakovigilance;
English: Prior to placing CattleMarker IBR Inactivated on the EU market the results should be submitted to the national competent authorities to be assessed by the authorities to their satisfaction.
Slovenian: Pred dajanjem cepiva CattleMarker IBR Inactivated na trg EU je treba rezultate predložiti pristojnim nacionalnim organom, da jih ocenijo kot zadovoljive;
English: Annex IV Conditions of the marketing authorisations
Slovenian: Priloga IV Pogoji dovoljenj za promet z zdravilom
English: A filtration step using three filtration membranes has been integrated into the production process for clarification of the antigen preparations.
Slovenian: Zaradi pojasnitve antigenskih pripravkov je bilo v postopek proizvodnje vključeno filtriranje z uporabo treh filtrirnih membran.
English: Updates to the risk management plan should be proposed as required as soon as any issues arise, otherwise the risk management plan should be reviewed on a yearly basis at least, in conjunction with the PSUR submission.
Slovenian: V skladu z zahtevami se posodobitve načrta za obvladovanje tveganj predložijo nemudoma ob pojavu morebitnih težav, sicer pa je treba načrt za obvladovanje tveganj pregledati vsaj enkrat letno, in sicer ob predložitvi redno posodobljenih poročil o varnosti zdravila.
English: Any confirmed BNP calves will also be assessed for MHC-I alloantibodies.
Slovenian: Vsako tele, pri katerem se potrdi okužba z BNP, se prav tako oceni glede aloprotiteles MHC-I.
English: An association between BNP and alloimune reaction to Antigens Not related to the Active Substance (ANAS) (e.g. bovine kidney cell line derived antigens and all antigenic substances remaining from the manufacturing process) is widely accepted.
Slovenian: Povezava med BNP in aloimunsko reakcijo na antigene, ki niso povezani z zdravilno učinkovino (ANAS) (npr. antigeni, pridobljeni iz ledvične celične linije, pridobljene iz goveda, in vse antigenske snovi, ki so ostale po postopku izdelave), je splošno sprejeta.
English: In 2010, due to these concerns, a procedure under Article 78 of Directive 2001/82/EC was initiated in which the CVMP concluded that although the aetiology of BNP had yet to be determined there was evidence to suggest that PregSure BVD may be associated with BNP and that the benefit-risk balance for the product was unfavourable.
Slovenian: V zvezi s ti zadržki je bil leta 2010 sprožen postopek v skladu s členom 78 Direktive 2001/82/ES, v katerem je odbor CVMP ugotovil, da so kljub še neugotovljeni etiologiji BNP obstajali dokazi, da je cepivo PregSure BVD lahko povezano z BNP in da je razmerje med tveganji in koristmi cepiva neugodno.
English: Nonetheless in the assessment in the frame of this procedure under Article 78 of Directive 2001/82/EC the frequency of the BNP caused by PregSure BVD was approximated to be around 0.01% by the CVMP.
Slovenian: Ne glede na to je odbor CVMP v okviru tega postopka v skladu s členom 78 Direktive 2001/82/ES ocenil, da je pogostnost BNP, ki jo povzroči cepivo PregSure BVD, približno 0,01 %.
English: BNP is a disease which can be fatal in neonatal calves and which has been experimentally reproduced by the intake of colostrum from dams which have alloantibodies.
Slovenian: BNP je bolezen, ki je lahko smrtna za novorojena teleta in ki so jo poskusno ponovili z vnosom kolostruma iz samic z aloprotitelesi.
English: If dead, bone marrow histopathology shows trilineage hypoplasia.
Slovenian: 2. če je žival mrtva, se s histopatologijo kostnega mozga dokaže trilinijska hipoplazija;
English: These results show that the overall protein content per ml is higher in BVDV-1 antigen batches than in BoHV1 antigen batches.
Slovenian: Rezultati kažejo, da je celokupna vsebnost beljakovin na mililiter v serijah antigena BVDV-1 višja kot v serijah antigena BoHV-1.
English: the calf should have a blood pancytopenia consecutive to bone marrow aplasia, 3.)
Slovenian: tele mora imeti pancitopenijo, ki je posledica aplazije kostnega mozga; 3.)
English: • The marketing authorisation holder shall include a new specification in the finished product of a maximum total protein content.
Slovenian: • imetnik dovoljenja za promet z zdravilom vključi v končno zdravilo novo specifikacijo najvišje skupne vsebnosti beljakovin.
English: Scientific conclusions and grounds for the granting of the marketing authorisations
Slovenian: Priloga II Znanstveni zaključki in podlaga za izdajo dovoljenj za promet
English: − In addition to the usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated, to conduct thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of CattleMarker IBR Inactivated.
Slovenian: − poleg običajnega sistema farmakovigilance za spremljanje živali, cepljenih s cepivom CattleMarker IBR Inactivated, izvaja natančne raziskave vsake nepojasnjene smrti mladičev cepljenih živali po zabeleženi uporabi cepiva CattleMarker IBR Inactivated.