FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluation and conclusions on the benefit-risk balance Therefore, the Committee considers that in the absence of adequate pre-clinical, clinical and residue depletion data and because the use of these medicinal products could pose a potential risk to animal and human health, the benefit-risk balance for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not favourable.
Slovenian: Vrednotenje in zaključki o razmerju med tveganji in koristmi Zato Odbor meni, da zaradi odsotnosti ustreznih predkliničnih podatkov, kliničnih podatkov in podatkov o izločanju ostankov ter zato, ker uporaba teh zdravil lahko predstavlja morebitno tveganje za zdravje živali in ljudi, razmerje med tveganji in koristmi pri zadevnih zdravilih za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem, ni ugodno.
English: During the aforementioned decentralised procedure, it has been noted that there are different approved indications, posology and withdrawal periods for veterinary medicinal products containing paromomycin to be administered parenterally to pigs across the European Union (EU).
Slovenian: Med prej omenjenim decentraliziranim postopkom je bilo ugotovljeno, da v Evropski uniji (EU) obstajajo različne odobrene indikacije, odmerjanja in karence za zdravila za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem.
English: Furthermore, neither dose determination, nor dose confirmation studies have been made available to confirm the results of the PK/PD analysis and no field trial was made available.
Slovenian: Poleg tega za potrditev rezultatov analize PK/PD niso bili dani na voljo nobene študije določitve ali potrditve odmerka in nobena terenska preskušanja.
English: The quantification of paromomycin in tissues was carried out by validated HPLC-MS/MS analytical methods.
Slovenian: Paromomicin v tkivih je bil količinsko opredeljen s potrjenimi analitičnimi metodami HPLC-MS/MS.
English: • To provide adequate clinical data (including GCP, randomised, blinded field study) in support of the treatment of pleuropneumonia caused by Actinobacillus pleuropneumoniae at the recommended dose and duration of treatment.
Slovenian: • Predložiti ustrezne klinične podatke (vključno z randomizirano in slepo terensko študijo, izvedeno v skladu z dobro klinično prakso) v podporo zdravljenju plevropnevmonije, ki jo povzroča bakterija Actinobacillus pleuropneumoniae, v priporočenem odmerku in s priporočenim trajanjem zdravljenja.
English: The CVMP was also asked to recommend whether in view of the elements described in the referral notification the marketing authorisations for the veterinary medicinal products concerned should be maintained, varied, suspended, or withdrawn.
Slovenian: Odbor CVMP je bil tudi zaprošen, naj priporoči, ali je treba glede na opisano v sporočilu o napotitvi pri zadevnih zdravilih za uporabo v veterinarski medicini dovoljenja za promet z zdravilom obdržati, spremeniti, začasno umakniti ali umakniti.
English: The CVMP was requested to review all available pre-clinical, clinical and residue depletion data for veterinary medicinal products containing paromomycin to be administered parenterally to pigs and recommend appropriate indications, dosing recommendations and withdrawal periods.
Slovenian: Odbor CVMP je bil zaprošen, da pregleda vse razpoložljive predklinične podatke, klinične podatke in podatke o izločanju ostankov pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem, ter da priporoči ustrezne indikacije, odmerjanje in karence.
English: This already poor result is in addition likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against A. pleuropneumoniae.
Slovenian: S tem rezultatom, ki je že sicer slab, bi bila poleg tega učinkovitost paromomicina v priporočenem odmerku precenjena, saj odstotek vezanja paromomicina na plazemske beljakovine ni bil ugotovljen, s tem pa bi se zmanjšal delež paromomicina v plazmi, ki lahko deluje proti bakteriji A. pleuropneumoniae.
English: This result, however is likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against E. coli.
Slovenian: Vendar je učinkovitost paromomicina v priporočenem odmerku s tem rezultatom najverjetneje precenjena, saj odstotek vezanja paromomicina na plazemske beljakovine ni bil ugotovljen, s tem pa bi se zmanjšal delež paromomicina v plazmi, ki lahko deluje proti bakteriji E. coli.
English: 2600 Antwerpen Belgium
Slovenian: 1130 Brussel Belgium
English: • the CVMP considered that the use of veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not supported by pre-clinical, clinical and residue depletion data and the currently recommended indications, dosing regimens and withdrawal period could pose a potential risk to animal and human health;
Slovenian: • odbor CVMP je menil, da predklinični podatki, klinični podatki in podatki o izločanju ostankov ne podpirajo uporabe zdravil za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem, ter da bi trenutno priporočeni indikacije, režimi odmerjanja in karence lahko predstavljali morebitno tveganje za zdravje živali in ljudi;
English: One of the marketing authorisation holders proposed a withdrawal time of 16 days based on a linear regression with kidney as limiting tissue, and 16 days with muscle of injection site by using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Slovenian: Eden od imetnikov dovoljenja za promet z zdravilom je predlagal karenco 16 dni na podlagi linearne regresije, z ledvicami kot omejujočim tkivom, in 16 dni z mišico na mestu injiciranja z uporabo „alternativne“ metode, v skladu s sporočilom odbora CVMP glede priporočil o pristopu k usklajevanju karenc (EMEA/CVMP/036/95).
English: • Treatment of E. coli involved in swine colibacillosis (neonatal diarrhoea, post-weaning diarrhoea, oedema disease) and against Actinobacillus pleuropneumoniae strains with a
Slovenian: • zdravljenje okužbe z bakterijo E. coli pri prašičji kolibacilozi (neonatalna driska, driska po odstavljanju, edemska bolezen) in proti sevom Actinobacillus pleuropneumoniae z minimalno inhibicijsko koncentracijo (MIC) ≤ 4 mg/l.
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Slovenian: Ker ni ustreznih podatkov v podporo indikacijam in odmerjanju, obstaja tveganje, da bo zdravljenje zaradi dajanja zdravila v trenutno priporočenih odmerkih neučinkovito, zdravljene živali pa bodo po nepotrebnem trpele.
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose and duration of treatment will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Slovenian: Ker ni ustreznih podatkov v podporo indikacijam in odmerjanju, obstaja tveganje, da bo zdravljenje zaradi dajanja zdravila v trenutno priporočenih odmerkih in pri trenutno priporočenem trajanju zdravljenja neučinkovito, zdravljene živali pa bodo po nepotrebnem trpele.
English: Consequently, the Committee recommends the suspension of the existing marketing authorisations for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs.
Slovenian: Odbor zato pri zadevnih zdravilih za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem, priporoča začasni umik obstoječih dovoljenj za promet z zdravilom.
English: Relevant clinical data (including GCP, randomised, blinded field study) are required for each claim related to a specific type of Escherichia coli.
Slovenian: Za vsak zahtevek, povezan s specifično vrsto bakterije Escherichia coli, so potrebni relevantni klinični podatki (vključno z randomizirano in slepo terensko študijo, izvedeno v skladu z dobro klinično prakso).
English: Parofor 175 mg/ml
Slovenian: Parofor 175 mg/ml paromomicin 175 mg/ml
English: As no adequate data are available to support indications, posology and withdrawal periods, the CVMP is not able to recommend any appropriate indications, dosage and withdrawal periods for the concerned veterinary medicinal products.
Slovenian: Ukrepi za obvladovanje ali zmanjševanje tveganja Ker ni ustreznih podatkov v podporo indikacijam, odmerjanju in karencam, odbor CVMP pri zadevnih zdravilih za uporabo v veterinarski medicini ne more priporočiti nobenih ustreznih indikacij, odmerkov in karenc.
English: The residue depletion study was performed in pigs with the intramuscular administration of the maximum recommended dose of 14 mg paromomycin/kg bodyweight/day for 5 consecutive days.
Slovenian: Pri prašičih, ki so pet zaporednih dni intramuskularno dobivali največji priporočeni odmerek 14 mg paromomicina/kg telesne mase/dan, je bila izvedena študija izločanja ostankov.
English: For kidney, a withdrawal time rounded to 16 days was determined based on linear regression using the ‘statistical' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Slovenian: Pri ledvicah je bila z uporabo linearne regresije s „statistično“ metodo v skladu s sporočilom odbora CVMP glede priporočil o pristopu k usklajevanju karenc (EMEA/CVMP/036/95) določena karenca, zaokrožena na 16 dni.
English: For injection site, a rounded withdrawal period of 16 days was calculated using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Slovenian: Pri mestu injiciranja je bila z uporabo „alternativne“ metode v skladu s sporočilom odbora CVMP glede priporočil o pristopu k usklajevanju karenc (EMEA/CVMP/036/95) izračunana karenca, zaokrožena na 16 dni.
English: The statistical evaluation to establish withdrawal period was carried out following the CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Slovenian: Po sporočilu odbora CVMP glede priporočil o pristopu k usklajevanju karenc (EMEA/CVMP/036/95) je bilo izvedeno statistično ovrednotenje za določitev karence1.
English: 28 June 2012
Slovenian: 28. junij 2012
English: The European Commission issued a decision on 28 June 2012.
Slovenian: Evropska komisija je odločbo izdala dne 28. junija 2012.
English: However, the Member States were not able to reach an agreement and the UK referred the matter to the CHMP for arbitration on 22 December 2011.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je Združeno kraljestvo 22. decembra 2011 zadevo napotilo odboru CHMP v arbitražni postopek.
English: In the light of this The Netherlands questioned the long-term efficacy of this product in respect of asthma control.
Slovenian: Zaradi tega je Nizozemska podvomila o dolgoročni učinkovitosti tega zdravila, kar zadeva obvladovanje astme.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names.
Slovenian: Evropska agencija za zdravila je 19. aprila 2012 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede odobritve dovoljenj za promet z zdraviloma Flutiform in Iffeza ter povezanimi imeni.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).
Slovenian: To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Finska, Francija, Nemčija, Islandija, Irska, Italija, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška in Švedska).
English: The CHMP looked at all the available evidence on the benefits and risks of the medicine in the treatment of asthma and concluded that the questions raised over its long-term effectiveness had been adequately addressed.
Slovenian: Odbor CHMP je pregledal vse razpoložljive dokaze o koristih in tveganjih pri uporabi zdravila za zdravljenje astme ter ugotovil, da so bila vprašanja o njegovi dolgoročni učinkovitosti ustrezno obravnavana.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da koristi zdravil Flutiform in Iffeza odtehtajo z njima povezana tveganja ter da se dovoljenje za promet lahko odobri v Združenem kraljestvu in naslednjih državah članicah EU: v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, Finskem, v Franciji, Nemčiji, na Islandiji, v Irski, Italiji, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, Slovaški in Švedski.
English: Why were Flutiform and Iffeza reviewed?
Slovenian: Zakaj sta bili zdravili Flutiform in Iffeza pregledani?
English: The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasone propionate being deposited in the lungs.
Slovenian: Razlogi za napotitev so bili zadržki, ki jih je izrazila Nizozemska nad podatki, ki kažejo, da so ravni flutikazon propionata v krvi po odmerjanju zdravil Flutiform in Iffeza nižje, kot če se flutikazon daje samostojno, kar je lahko znak, da se v pljuča odlaga manjša količina flutikazon propionata.
English: Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure.
Slovenian: Družba Napp Pharmaceuticals Ltd je predložila vlogi za pridobitev dovoljenj za promet z zdraviloma Flutiform in Iffeza ter povezanimi imeni regulatorni agenciji za zdravila v Združenem kraljestvu po decentraliziranem postopku.
English: Flutiform will also be marketed as Flofera and Flutiformo.
Slovenian: Zdravilo Flutiform se bo tržilo tudi s tržnima imenoma Flofera in Flutiformo.
English: Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.
Slovenian: Zato je sklenil, da koristi zdravil Flutiform in Iffeza odtehtajo tveganja in da se lahko dovoljenje za promet odobri v vseh zadevnih državah članicah.
English: They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta 2 agonist (such as formoterol fumarate) is appropriate.
Slovenian: Za zdravljenje astme se uporabljata v primerih, kadar je kombinacija inhalacijskega kortikosteroida (kot je flutikazon propionat) in beta-2-agonista z dolgotrajnim delovanjem (kot je formoterol fumarat) primerna.
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)
Slovenian: Vprašanja in odgovori v zvezi z zdraviloma Flutiform in Iffeza (flutikazon propionat/formoterol fumarat, 50/5, 125/5 in 250/10 mikrogramov, inhalacijska raztopina pod tlakom, suspenzija)
English: What are Flutiform and Iffeza?
Slovenian: Kaj sta zdravili Flutiform in Iffeza?
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EMA/550822/2012
Slovenian: Vprašanja in odgovori v zvezi z zdraviloma Flutiform in Iffeza (flutikazon propionat/formoterol fumarat, 50/5, 125/5 in 250/10 mikrogramov, inhalacijska raztopina pod tlakom, suspenzija) EMA/264710/2012
English: When inhaled, formoterol fumarate helps to keep the airways open allowing the patient to breathe more easily.
Slovenian: Formoterol fumarat ob inhalaciji pomaga ohranjati odprte dihalne poti in tako bolniku olajšuje dihanje.
English: Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.
Slovenian: Flutikazon propionat je inhalacijski kortikosteroid z močnim lokalnim protivnetnim delovanjem, ki dokazano zmanjšuje simptome in poslabšanje astme.
English: The selective long-acting beta 2 agonist formoterol fumarate exerts an effect on beta 2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.
Slovenian: Formoterol fumarat, ki je selektiven beta-2-agonist z dolgotrajnim učinkom, z delovanjem na receptorje beta 2 v gladkem mišičnem tkivu pljuč doseže sprostitev dihalnih poti in bronhodilatacijo.
English: Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate.
Slovenian: Flutiform in Iffeza sta zdravili za zdravljenje astme, ki vsebujeta zdravilni učinkovini flutikazon propionat in formoterol fumarat.
English: These measures should be submitted with a risk management plan (RMP):
Slovenian: Te ukrepe je treba predložiti skupaj z načrtom za obvladovanje tveganja (RMP):
English: • the new additional risk minimisation measures.
Slovenian: • novi dodatni ukrepi za zmanjševanje tveganja,
English: The controlled access program should be effectively implemented at the latest:
Slovenian: Program nadzorovanega dostopa mora biti učinkovito uveden najpozneje:
English: • a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information
Slovenian: • opomnik o indikaciji, odmerku, trajanju zdravljenja in kontraindikacijah ter nujnosti upoštevanja informacij o zdravilu,
English: The final study report shall be submitted for assessment by the PRAC:
Slovenian: Končno poročilo o študiji je treba predložiti v oceno odboru PRAC:
English: Each marketing authorisation holder shall complete the below conditions, within the stated timeframe, and the competent authorities shall ensure that the following is fulfilled:
Slovenian: Vsak imetnik dovoljenja za promet z zdravilom izpolni spodnje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
English: The MAHs are strongly encouraged to collaborate to perform a joint study.
Slovenian: Imetnike dovoljenj za promet z zdravilom se močno spodbuja k sodelovanju in izvedbi skupne študije.
English: Protocol to be submitted for assessment by the PRAC:
Slovenian: Protokol je treba predložiti v oceno odboru PRAC:
English: Each MAH shall develop training materials according to the following core elements:
Slovenian: Vsak imetnik dovoljenja za promet z zdravilom pripravi gradiva za usposabljanje v skladu z naslednjimi ključnimi elementi:
English: Each MAH of HES solutions for infusion shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures implemented as an outcome of this referral procedure.
Slovenian: Vsak imetnik dovoljenja za promet z zdravilom za raztopine HES za infundiranje izvede študijo o uporabi zdravila in z njo oceni učinkovitost ukrepov za zmanjševanje tveganja, uvedenih kot izid tega napotitvenega postopka.
English: The MAH should submit and agree with the National Competent Authorities: - the details of the controlled access program and the modalities of its implementation - the final training materials, including communication media and distribution modalities.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pristojnim nacionalnim organom predložiti in se z njimi dogovoriti o naslednjem: - podrobnosti programa nadzorovanega dostopa in načini njegovega izvajanja, - končna različica gradiv za usposabljanje, vključno s sredstvi obveščanja in načini razdeljevanja.
English: • the risks related to the use of HES solutions for infusion outside the terms of the MA
Slovenian: • tveganja, povezana z uporabo raztopin HES za infundiranje zunaj pogojev dovoljenja za promet z zdravilom,
English: The MAH shall implement a controlled access program to ensure that HES solutions for infusion are only delivered to accredited hospitals / centres where healthcare professionals expected to prescribe / administer these medicinal products have been trained on their appropriate use.
Slovenian: Imetnik dovoljenja za promet z zdravilom uvede program nadzorovanega dostopa za zagotavljanje, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom, v katerih so zdravstveni delavci, ki naj bi predpisovali/dajali ta zdravila, usposobljeni za njihovo pravilno uporabo.
English: - managing the accreditation system - ensuring HES solutions for infusion are only delivered to accredited hospital/centres, i.e where all relevant HCPs have been trained.
Slovenian: Usposabljanje je treba redno ponavljati, - vodenje sistema akreditacij, - zagotavljanje, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom, tj. tja, kjer so vsi zadevni zdravstveni delavci usposobljeni.
English: As a consequence, the MAH shall be responsible of: - delivering the training to all relevant HCPs prescribing / administering HES solutions for infusion through agreed training material.
Slovenian: Posledično je imetnik dovoljenja za promet z zdravilom odgovoren za: - izvedbo usposabljanja za vse zadevne zdravstvene delavce, ki predpisujejo/dajejo raztopine HES za infundiranje, s pomočjo dogovorjenega gradiva za usposabljanje.
English: • the results from the DUSs
Slovenian: • rezultati študij o uporabi zdravil.
English: It is available as blue (20 mg) and orange (40 mg) capsules.
Slovenian: Na voljo je v kapsulah modre (20 mg) in oranžne (40 mg) barve.
English: Other information about Yentreve:
Slovenian: Druge informacije o zdravilu Yentreve:
English: The benefit of treatment should be re-assessed at regular intervals.
Slovenian: Koristi zdravljenja je treba redno preverjati.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemikalije, ki živčnim celicam omogočajo medsebojno sporazumevanje.
English: What benefit has Yentreve shown during the studies?
Slovenian: Kakšne koristi je zdravilo Yentreve izkazalo med študijami?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Yentreve, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B.V.
English: The Committee recommended that Yentreve be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Yentreve odobri dovoljenje za promet.