FrancophonIA/ELRC3.0 huggingface dataset:
English: Innovation Center BioCity Nottingham Pennyfoot Street
Slovenian: Innovation Center BioCity Nottingham Pennyfoot Street Nottingham
English: Generally the number is higher the first weeks post-vaccination and lower once the flock has achieved a proper protection.
Slovenian: Na splošno je število večje v prvih tednih po cepljenju in nižje, ko jata pridobi ustrezno zaščito.
English: Severe overdose (10-fold) may result in a temporary reduction in daily live weight gain within the first week without any consequences on the final performances.
Slovenian: Močno preveliko odmerjanje (10-kratno) lahko povzroči začasno zmanjšanje dnevnega prirasta žive telesne mase v prvem tednu brez kakršnih koli posledic za končne zmogljivosti.
English: Additionally, the enhancement of protection produced by oocyst re-infections would also be limited.
Slovenian: Poleg tega bi bilo omejeno tudi izboljšanje zaščite, ki ga povzročijo oocistične reinfekcije.
English: Vaccinate healthy chickens only.
Slovenian: Cepite samo zdrave piščance.
English: HIPRA FRANCE
Slovenian: France HIPRA FRANCE
English: After this time, place the chicks carefully in the litter and continue with regular management practices.
Slovenian: Po tem obdobju previdno položite piščance na steljo in nadaljujte z običajnimi načini upravljanja.
English: Suspension: White turbid suspension.
Slovenian: Suspenzija: bela motna suspenzija.
English: The correct replication of the vaccine oocysts and consequently, the development of a solid immunity could be hindered.
Slovenian: Ustrezno razmnoževanje vakcinalnih oocist in posledično razvoj stabilne imunosti bi bilo lahko ovirano.
English: See the manufacturer's instructions to ensure proper disinfection and maintenance of the device.
Slovenian: Za zagotavljanje ustreznega razkuževanja in vzdrževanja pripomočka glejte izdelovalčeva navodila.
English: Before starting the preparation, make certain to have a clean container available with sufficient capacity for preparing the diluted vaccine suspension.
Slovenian: Preden začnete s pripravo, se prepričajte, da imate na voljo čist vsebnik z zadostno kapaciteto za pripravo razredčene suspenzije cepiva.
English: * Number of sporulated oocysts derived from precocious attenuated lines of coccidia, according to in vitro procedures of the manufacturer at the time of blending.
Slovenian: * Število sporuliranih oocist, ki izhajajo iz zgodaj zrelih oslabljenih linij kokcidija, glede na postopke in vitro izdelovalca v času mešanja.
English: A copy of example certificates of analysis should be provided to confirm compliance.
Slovenian: Za potrditev skladnosti je treba priložiti kopijo vzorčnih potrdil analize.
English: To improve the uniformity of the vaccination maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.
Slovenian: Za izboljšanje enovitosti cepljenja naj piščanci ostanejo v transportni škatli vsaj 1 uro, da zaužijejo vse kapljice cepiva.
English: 10,000 doses
Slovenian: 10 000 odmerkov
English: Dilute the vaccine with the corresponding volumes:
Slovenian: Cepivo razredčite z ustreznimi količinami:
English: Pharmacotherapeutic group: Immunological for Aves, live parasitic vaccines for domestic fowl.
Slovenian: Farmakoterapevtska skupina: Imunološko zdravilo za ptice, živa parazitarna cepiva za domačo perutnino.
English: - Sodium chloride
Slovenian: - kalijev klorid
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
Slovenian: Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Onset of immunity: 3 weeks post-vaccination.
Slovenian: Nastop imunosti: 3 tedne po cepljenju.
English: Shake the vaccine vial and dilute the content into the previous solution.
Slovenian: Pretresite vialo s cepivom in razredčite vsebino v prejšnjo raztopino.
English: Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Slovenian: Napolnite rezervoar razpršilnika z vso pripravljeno količino suspenzije cepiva.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in nalepki.
English: Date of first authorisation: 18/04/2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 18/041/2016
English: It is normal to find vaccinal oocysts in the intestine or litter of vaccinated flocks.
Slovenian: Normalno je, da najdemo vakcinalne oociste v črevesju ali stelji cepljenih jat.
English: Shelf life after dilution according to directions: 10 hours.
Slovenian: Rok uporabnosti po razredčenju v skladu z navodili: 10 ur.
English: It is recommended that litter should be removed and facilities and material cleaned between production cycles to reduce field infections.
Slovenian: Priporočljivo je, da se med proizvodnimi cikli odstrani stelja ter očistijo objekti in materiali, da se zmanjšajo okužbe iz okolja.
English: Evalon (vaccine)
Slovenian: Evalon (cepivo)
English: The vaccine will not protect species other than chickens against coccidiosis and is only effective against the Eimeria species indicated.
Slovenian: Cepivo drugih živalskih vrst razen piščancev ne ščiti pred za kokcidiozo in je učinkovito samo proti navedenim vrstam Eimeria.
English: Do not use in birds in lay and within 2 weeks before the onset of the laying period
Slovenian: Ne uporabite pri pticah v obdobju nesnosti in 2 tedna pred začetkom obdobja nesnosti.
English: HIPRAMUNE T, solvent for Evalon
Slovenian: HIPRAMUNE T vehikel za Evalon
English: Special precautions for use in animals Chickens must be strictly floor-reared in the first 3 weeks after vaccination.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Piščanci morajo biti strogo v talni reji v prvih 3 tednih po cepljenju.
English: Brilliant Blue (E133) Red AC (E129) Vanillin
Slovenian: - briljantno modro (E133) - rdeče AC (E129)
English: Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.
Slovenian: Razredčeno suspenzijo cepiva vzdržujte v stalni homogenizaciji, tako da uporabite magnetno mešalo, medtem ko se cepivo daje piščancem s pršenjem z večjimi kapljicami.
English: Chickens must be strictly floor-reared in the first 3weeks after vaccination.
Slovenian: Piščanci morajo biti strogo v talni reji v prvih 3 tednih po cepljenju.
English: Evalon (vaccine):
Slovenian: Evalon (cepivo):
English: Alignment of the supplier's specifications for Foetal Bovine Serum (FBS) with the applicant's internal specifications for FBS, ensuring Ph. Eur.
Slovenian: Uskladitev dobaviteljevih specifikacij za fetusni serum goveda (FBS) in predlagateljevih internih specifikacij za FBS, da se zagotovi skladnost s Ph.Eur.
English: EXP {month/year} Once diluted use within 10 hours.
Slovenian: Razredčeno zdravilo uporabite v 10 urah.
English: Alignment of the manufacturers' specifications for the plastic containers with the applicant's internal specifications for the plastic containers, ensuring Ph. Eur.
Slovenian: Uskladitev proizvajalčevih specifikacij za plastične vsebnike in predlagateljevih internih specifikacij za plastične vsebnike, da se zagotovi skladnost s Ph.Eur.
English: HIPRAMUNE T (solvent):
Slovenian: HIPRAMUNE T (vehikel):
English: MANUFACTURER'S BATCH NUMBER
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Serija {številka}
English: Store and transport refrigerated (2 ºC - 8 ºC).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: 1,000 doses 5,000 doses
Slovenian: 1 000 odmerkov 5 000 odmerkov
English: - 02 51 80 77 91 Fax - 02 51 8082 20 e-mail: france@hipra.com
Slovenian: - 02 51 80 77 91 Fax - 02 51 8082 20
English: Dilute the content of the vial with clean room temperature water into an appropriate container.
Slovenian: V ustreznem vsebniku razredčite vsebino viale s čisto vodo sobne temperature.
English: 10 ml, 50 ml or 100 ml type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
Slovenian: 10 ml, 50 ml ali 100 ml viale iz brezbarvnega stekla tipa I, ki vsebujejo 7 ml, 35 ml ali 70 ml suspenzije (1 000, 5 000 in 10 000 odmerkov), zaprte z zamaškom iz polimernega elastomera tipa I in aluminijasto zaporko.
English: HIPRA EΛΛAΣ A.E. Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
Slovenian: Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661
English: Each dose (0.007 ml) of undiluted vaccine contains:
Slovenian: En odmerek (0,007 ml) nerazredčenega cepiva vsebuje:
English: ARBUSET, Produtos Farmacêuticos e Sanitários De Uso Animal, Lda
Slovenian: Portugal ARBUSET, Produtos Farmacêuticos e Sanitários
English: One dose of vaccine (0.007 ml) from 1 day of age.
Slovenian: En odmerek cepiva (0,007 ml) od starosti 1 dneva.
English: The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200-250 µm and working pressure: 2 to 3 bars).
Slovenian: Pot uporabe: Način uporabe zdravila je pršenje z večjimi kapljicami z uporabo primernega pripomočka (količina dovajanja: 28 ml/100 piščancev, velikost kapljic: 200-250 µm in delovni tlak: 2 do 3 bare).
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Slovenian: Ne mešajte z nobenim drugim zdravilom razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
English: Shelf life of HIPRAMUNE T as packaged for sale: 2 years.
Slovenian: Rok uporabnosti HIPRAMUNE T v pakiranju za prodajo: 2 leti.
English: Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Slovenian: Shema cepljenja: En odmerek cepiva (0,007 ml) od starosti 1 dneva.
English: Phosphate buffered solution (PBS): - Potassium chloride - Disodium phosphate dodecahydrate - Potassium dihydrogen phosphate
Slovenian: - natrijev hidrogenfosfat dodekahidrat - kalijev dihidrogenfosfat
English: Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij: Laboratorios Hipra, S.A.
English: Polypropylene (PP) vials containing 50 ml, 250 ml and 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Slovenian: Hipramune T (vehikel) Polipropilenske (PP) viale, ki vsebujejo 50 ml, 250 ml in 500 ml vehikla, zaprte z zamaškom iz polimernega elastomera tipa I in aluminijasto zaporko.
English: The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Učinkovine biološkega izvora namenjene vzbujanju aktivne imunosti, niso vključene v Uredbo (ES)
English: HIPRAMUNE T (solvent)
Slovenian: HIPRAMUNE T (vehikel)
English: No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following vaccination of the chickens.
Slovenian: Najmanj 3 tedne po cepljenju piščancev se ne sme v hrani ali vodi uporabiti nobenih kokcidiostatikov ali drugih sredstev s kokcidiostatskim delovanjem.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial of 50 ml, 250 ml or 500 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH Viala z vehiklom s 50 ml, 250 ml ali 500 ml
English: To be mixed with the solvent.
Slovenian: Za mešanje z vehiklom.
English: To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Slovenian: Za stimulacijo aktivne imunosti proti kokcidozi, ki jo povzročijo Eimeria acervulina, Eimeria brunetti,
English: La Selva 135, Amer, 17170 Gerona, Spain
Slovenian: La Selva 135, Amer, 17170 Gerona, Španija
English: PACKAGE SIZE
Slovenian: Velikosti pakiranja
English: Evalon suspension for oral spray for chickens.
Slovenian: Evalon suspenzija za peroralno pršilo za piščance.
English: Carretera C-63, km 48.300, Polígono Industrial El Rieral Amer, 17170 Gerona, Spain
Slovenian: Carretera C-63, km 48.300, Polígono Industrial El Rieral
English: Tel.: +34 972 430660 Fax: +34 972 430661 E-mail: hipra@hipra.com
Slovenian: Fax: +34 972 430661
English: HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle
Slovenian: Adequat Business Center Brusselsesteenweg 159
English: HIPRA DEUTSCHLAND GmbH Münsterstraße 306
Slovenian: Münsterstraße 306
English: For active immunisation of chicks from 1 day of age to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Slovenian: Za aktivno imunizacijo piščancev od 1. dne starosti, za zmanjšanje kliničnih znakov (diareje), intestinalnih lezij in tvorbe oocist, povezanih s kokcidozo, ki jo povzročajo Eimeria acervulina,
English: BELGIUM e-mail: benelux@hipra.com
Slovenian: e-mail: benelux@hipra.com
English: Doses
Slovenian: Odmerki
English: Eimeria acervulina, strain 003 ......................................... 332-450 Eimeria brunetti, strain 034 ............................................. 213-288 Eimeria maxima, strain 013 ............................................. 196-265 Eimeria necatrix, strain 033 ............................................. 340-460 Eimeria tenella, strain 004 ............................................... 276-374
Slovenian: Eimeria acervulina, sev 003 ............................................. 332-450 Eimeria brunetti, sev 034 ................................................. 213-288 Eimeria maxima, sev 013 ................................................. 196-265 Eimeria necatrix, sev 033 ................................................. 340-460 Eimeria tenella, sev 004 ................................................... 276-374
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Viala s cepivom z 10 000 odmerki
English: Shake the solvent vial.
Slovenian: Pretresite vialo z vehiklom.
English: Not applicable.
Slovenian: Niso znane
English: Cardboard box with one vial of 5,000 doses (35 ml) and one vial with 250 ml of solvent.
Slovenian: Kartonasta škatla z eno vialo s 5 000 odmerki (35 ml) in eno vialo z 250 ml vehikla.
English: compliance.
Slovenian: Crta.
English: Shelf life of Evalon as packaged for sale: 10 months.
Slovenian: Ne shranjujte zamrzovalniku Rok uporabnosti zdravila Evalon v pakiranju za prodajo: 10 mesecev.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Eimeria acervulina, strain 003 ..................................... 332 - 450* Eimeria brunetti, strain 034 ......................................... 213 - 288* Eimeria maxima, strain 013 ......................................... 196 - 265* Eimeria necatrix, strain 033 ......................................... 340 - 460* Eimeria tenella, strain 004 ........................................... 276 - 374*
Slovenian: Eimeria acervulina, sev 003 ........................................... 332-450* Eimeria brunetti, sev 034 ............................................... 213-288* Eimeria maxima, sev 013 ............................................... 196-265* Eimeria necatrix, sev 033 ............................................... 340-460* Eimeria tenella, sev 004 ................................................. 276-374*
English: Cardboard box with one vial of 10,000 doses (70 ml) and one vial with 500 ml of solvent.
Slovenian: Kartonasta škatla z eno vialo z 10 000 odmerki (70 ml) in eno vialo s 500 ml vehikla.
English: Evalon suspension and solvent for oral spray for chickens.
Slovenian: Evalon suspenzija in vehikel za peroralno pršilo za piščance.
English: Portela de Mafra e Fontaínha - Abrunheira 2665 - 191 Malveira e-mail: portugal@hipra.com
Slovenian: 2665 - 191 Malveira e-mail: portugal@hipra.com
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vaccine vial of 1,000 or 5,000 doses
Slovenian: Viala s cepivom s 1 000 ali 5 000 odmerki
English: Cardboard box with one vial of 1,000 doses (7 ml) and one vial with 50 ml of solvent.
Slovenian: Kartonasta škatla z eno vialo s 1 000 odmerki (7 ml) in eno vialo s 50 ml vehikla.
English: de Susqueda, Amer, 17170 Gerona, Spain
Slovenian: de Susqueda, Amer, 17170 Gerona, Španija Laboratorios Hipra, S.A.
English: The method of administration is by coarse spray.
Slovenian: Način uporabe je pršenje z velikimi kapljicami.
English: Eimeria acervulina, strain 003 .................................... 332 - 450 * Eimeria brunetti, strain 034 ........................................ 213 - 288 * Eimeria maxima, strain 013 ........................................ 196 - 265 * Eimeria necatrix, strain 033 ........................................ 340 - 460 * Eimeria tenella, strain 004 .......................................... 276 - 374 *
Slovenian: En odmerek (0,007 ml) nerazredčenega cepiva vsebuje Eimeria acervulina, sev 003 .......................................... 332-450 * Eimeria brunetti, sev 034 .............................................. 213-288 * Eimeria maxima, sev 013 .............................................. 196-265 * Eimeria necatrix, sev 033 .............................................. 340-460 * Eimeria tenella, sev 004 ................................................ 276-374 * * Število sporuliranih oocist, ki izhajajo iz zgodaj zrelih oslabljenih linij kokcidija, glede na postopke in vitro izdelovalca v času mešanja.
English: NG1 1GF e-mail: ukandireland@hipra.com
Slovenian: e-mail: ukandireland@hipra.com
English: One vial of 10,000 doses and one vial with 500 ml of HIPRAMUNE T (solvent).
Slovenian: Ena viala z 10 000 odmerki in ena viala s 500 ml HIPRAMUNE T (vehikel).
English: One vial of 5,000 doses and one vial with 250 ml of HIPRAMUNE T (solvent).
Slovenian: Ena viala s 5 000 odmerki in ena viala z 250 ml HIPRAMUNE T (vehikel).
English: One vial of 1,000 doses and one vial with 50 ml of HIPRAMUNE T (solvent).
Slovenian: Ena viala s 1 000 odmerki in ena viala s 50 ml HIPRAMUNE T (vehikel).
English: Suspension and solvent for oral spray.
Slovenian: Suspenzija in vehikel za peroralno pršilo.
English: Keep out of the sight and reach of children.
Slovenian: Shranjujte nedosegljivo otrokom
English: Excipients:
Slovenian: Nesnost:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po uporabi umijte in razkužite roke in opremo.
English: PACKAGE LEAFLET: Evalon suspension and solvent for oral spray for chickens
Slovenian: NAVODILO ZA UPORABO Evalon suspenzija in vehikel za peroralno pršilo za piščance.
English: SOLVENT
Slovenian: vanilin
English: 02-954 - WARSZAWA e-mail: admin.polska@hipra.com
Slovenian: e-mail: admin.polska@hipra.com
English: Name and address of the manufacturer of the biological active substances
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE
English: Coarse spray.
Slovenian: Pršenje z velikimi kapljicami.
English: NG1 1GF - UNITED KINGDOM e-mail: ukandireland@hipra.com
Slovenian: NG1 1GF - UNITED KINGDOM
English: Solvent: Dark brownish solution.
Slovenian: Vehikel: temna rjavkasta raztopina.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi umijte in razkužite roke in opremo.
English: Suspension for oral spray.
Slovenian: FARMACEVTSKA OBLIKA Suspenzija za peroralno pršilo.
English: Vaccine
Slovenian: Voda Cepivo Vehikel
English: EU/1/12/785/001 Zinforo
Slovenian: EU/1/12/785/001 Zinforo mg prašek za koncentrat za raztopino za infiundiranje intravenska uporaba viala (steklena) 10 vial
English: Pharmaceutical
Slovenian: Jakost Farmacevtska oblika
English: EU Number
Slovenian: Števika EU (Izmišljeno) ime
English: Powder for concentrate
Slovenian: Pot uporabe Primarna ovojnina
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Slovenian: Države članice morajo zagotoviti, da so implementirani vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisani spodaj.
English: The MAH shall provide physicians prior to launch with an educational material that will include the following components of information:
Slovenian: Imetnik dovoljenja za promet mora pred vpeljavo zdravila na trg zdravnikom dati izobraževalni material, ki bo vključeval naslednje informacije:
English: • The MAH's offer of testing or re-testing antibody (AB) status in a reference laboratory.
Slovenian: • Ponudbo imetnika dovoljenja za promet za testiranje ali ponovno testiranje statusa protiteles v referenčnem laboratoriju.
English: • A questionnaire to gather detailed ADR report documentation.
Slovenian: • Vprašalnik, s katerim bo zbrana podrobna dokumentacija o neželenem učinku.
English: • Need and clinical importance of adverse drug reaction (ADR) reporting in general.
Slovenian: • Potrebo in klinični pomen poročanja o neželenih učinkih na splošno.
English: • List of diagnoses or adverse events (AE) terms that trigger ADR reporting for MIRCERA .
Slovenian: • Seznam diagnoz ali terminov za neželene dogodke, ki so pogoj za poročanje o neželenih učinkih za zdravilo MIRCERA.
English: AEAB-mediated PRCA, the diagnostic work-up of potential AEAB-mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of
Slovenian: • Literaturo z informacijami o izgubi učinka in različnih vzrokoh zanjo; definicijo čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu; diagnostični postopek pri sumu na čisto aplazijo rdečih krvnih celic, povzročeno s protitelesi proti eritropoetinu; potrebo po prekinitvi zdravljenja z zdravili za spodbujanje eritropoeze zaradi navzkrižne reaktivnosti z drugimi zdravili za sprodbujanje eritropoeze na podlagi diagnoze čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu.
English: • Background data on erythropoietin antibody-mediated pure red cell aplasia (AEAB-mediated
Slovenian: • Ozadje čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu, ki je povezana z zdravljenjem z zdravili za spodbujanje eritropoeze.
English: These objections were considered to be of serious public health concern.
Slovenian: Ti pomisleki zbujajo resno skrb glede javnega zdravja.
English: A positive opinion was adopted by consensus on 15 November
Slovenian: Pozitivno mnenje je bilo soglasno sprejeto dne 15. novembra
English: The Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Greece, Ireland, Poland and Spain.
Slovenian: Referenčna država članica je bilo Združeno kraljestvo, zadevne države članice pa Belgija, Grčija, Irska, Poljska in Španija.
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Michał Pirożynski.
Slovenian: Poročevalec je bil dr. Ian Hudson, soporočevalec pa dr. Michał Pirożynski.
English: The Mutual Recognition Procedure started on 17 October 2006.
Slovenian: Postopek medsebojnega priznavanja se je začel 17. oktobra 2006.
English: The United Kingdom referred the reasons for disagreement to the EMEA on 29 March 2007.
Slovenian: Združeno kraljestvo je agenciji EMEA posredovalo razloge za nesoglasje dne 29. marca 2007.