FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo o obliki in vsebini izobraževalnega gradiva za zdravstvene delavce dogovoril s pristojnim nacionalnim organom pred prihodom zdravila na trg v posamezni državi članici.
English: In absence of IR, an additional Zalmoxis dose has to be administered with an interval of 30 days up to a maximum number of four doses.
Slovenian: V odsotnosti IR je treba dati dodatni odmerek zdravila Zalmoxis v 30
English: The shipping is performed in liquid nitrogen vapour.
Slovenian: Pošiljka je shranjena v hlapih tekočega dušika.
English: It is recommended not to breast-feed during or after treatment with Zalmoxis therapy.
Slovenian: Med zdravljenjem z zdravilom Zalmoxis ali po njem se dojenje ne priporoča.
English: Pyrexia
Slovenian: OVOJNINAH
English: 6.6 Special precautions for disposal and other handling Zalmoxis is a patient specific medicinal product.
Slovenian: Zdravilo Zalmoxis je zdravilo, specifično za bolnika.
English: Immune cells are excreted in human milk in low amounts.
Slovenian: Dojenje Podatkov o uporabi zdravila Zalmoxis med dojenjem ni. Imunske celice se v materino mleko izločajo v majhnih količinah.
English: The recommended dose and schedule is 1 ± 0.2 x 107 cells/kg given as an intravenous infusion at a time interval of 21-49 days from transplantation, in the absence of spontaneous immune reconstitution and/or development of graft-versus-host disease (GvHD).
Slovenian: 21 do 49 dni od presaditve, v odsotnosti spontane imunske reaktivacije in/ali razvoja reakcije presadka proti gostitelju (GvHD-graft-versus-host disease).
English: Maximum time elapsed from thawing and infusion is 2 hours at room temperature (15 °C - 30 °C).
Slovenian: Med odtajanjem in infundiranjem zdravila lahko pretečeta največ 2 uri pri sobni temperaturi (15 °C do 30 °C).
English: Globally, acute episodes of GvHD occurred in 10 patients (33%) with a median time to onset of 90 days after HSCT and 42 days after last infusion of Zalmoxis cells.
Slovenian: Po vsem svetu so se akutne epizode GvHD pojavile pri 10 bolnikih (33 %) z mediano časa do začetka
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zalmoxis 5-20x106 cells/mL dispersion for infusion Intravenous use
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Zalmoxis 5-20 x 106 celic/ml disperzija za infundiranje intravenska uporaba
English: Human serum albumin Dimethyl sulfoxide
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid humani serumski albumin dimetil sulfoksid
English: Opaque, off-white frozen dispersion.
Slovenian: FARMACEVTSKA OBLIKA disperzija za infundiranje Neprosojna, belkasta zamrznjena disperzija
English: Obligation to complete post-authorisation measures
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
English: The clinical status of the patient and the ADR profile of Zalmoxis should be born in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Slovenian: Pri tehtanju bolnikove sposobnosti izvajanja nalog, pri katerih so potrebni presoja in motorične ali kognitivne spretnosti, je treba upoštevati klinično stanje bolnika in profil neželenih učinkov zdravila Zalmoxis.
English: Each bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL.
Slovenian: Ena vreča vsebuje 10 do 100 ml zamrznjene disperzije v koncentraciji 5 do 20 x 106 celic/ml.
English: The safe use of Zalmoxis has not been demonstrated during pregnancy and breast-feeding.
Slovenian: Med nosečnostjo in dojenjem varna uporaba zdravila Zalmoxis ni bila dokazana.
English: Human serum albumine, dimethyl sulphoxide, sodium chloride.
Slovenian: SEZNAM POMOŽNIH SNOVI humani serumski albumin, dimetil sulfoksid, natrijev klorid Glejte navodilo za uporabo za več informacij.
English: Blood and lymphatic system disorders
Slovenian: Infekcijske in parazitske bolezni bronhitis
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZALMOXIS Do not use Zalmoxis: - If you are allergic to the active substance or any of the ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Each bag of Zalmoxis contains a volume of 10-100 mL of frozen dispersion at the concentration of 5-20 x 106 cells/mL.
Slovenian: Zdravilo Zalmoxis vsebuje 10 do 100 ml zamrznjene disperzije v koncentraciji 5 do 20 x 106 celic/ml.
English: NAME OF THE MEDICINAL PRODUCT Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Slovenian: IME ZDRAVILA Zalmoxis 5-20 x 106 celic/ml disperzija za infundiranje
English: Intestinal haemorrhage
Slovenian: Bolezni prebavil krvavitev v prebavilih
English: Practical information for medical or healthcare professionals on the handling and administration of Zalmoxis.
Slovenian: Praktične informacije za medicinsko ali zdravstveno osebje o ravnanju z zdravilom Zalmoxis in dajanju zdravila Zdravilo Zalmoxis je treba dajati pod nadzorom zdravnika z izkušnjami v presaditvi krvotvornih matičnih celic pri hematoloških malignostih.
English: Febrile neutropenia Haemoglobin decreased Platelet count decreased
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija zmanjšanje vrednosti hemoglobina zmanjšanje števila trombocitov
English: Donor code:
Slovenian: Koda darovalca:
English: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Slovenian: Alogenske celice T, gensko spremenjene z retrovirusnim vektorjem, kodirane za skrajšano obliko človeškega receptorja živčnega rastnega faktorja z nizko afiniteto (ΔLNGFR-low affinity nerve growth factor receptor) in timidin-kinazo virusa herpesa simpleksa I (HSV-TK Mut2).
English: • Conditional marketing authorisation
Slovenian: POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: EXPIRY DATE Expiry date:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Datum izteka roka uporabnosti zdravila::
English: Only one 17-year-old male, affected by T lymphoblastic lymphoma, was treated in the TK007 trial with two infusions of Zalmoxis.
Slovenian: Z dvema infuzijama zdravila Zalmoxis je bil v preskušanju TK007 zdravljen le en 17-letni bolnik moškega spola s limfoblastnim limfomom celic
English: Due date
Slovenian: 30 dni.
English: Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Slovenian: Navodilo za uporabo Zalmoxis 5-20 x 106 celic/ml disperzija za infundiranje
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: See leaflet for further information.
Slovenian: in predložiti njene rezultate.
English: The active substance consists of allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Slovenian: Učinkovina so alogenske celice T, gensko spremenjene z retrovirusnim vektorjem, kodirane za skrajšano obliko človeškega receptorja živčnega rastnega faktorja z nizko afiniteto (ΔLNGFR-low affinity nerve growth factor receptor) in timidin-kinazo virusa herpesa simpleksa I (HSV-TK Mut2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL
Slovenian: Vreča vsebuje 10 do 100 ml zamrznjene disperzije v koncentraciji 5 do 20 x 106 celic/ml.
English: Not applicable
Slovenian: POSTOPEK UPORABE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PLASTIC BAG
Slovenian: PLASTIČNA VREČA
English: Store in liquid nitrogen vapour.
Slovenian: Shranjujte v hlapih tekočega dušika.
English: Furthermore, the proposed indication was not supported by the provided literature, and the target population was considered not sufficiently characterised.
Slovenian: Poleg tega predložena literatura predlagane indikacije ne podpira, ciljna populacija pa ni bila zadostno opredeljena.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was doing so for commercial reasons.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za to odločila zaradi poslovnih razlogov.
English: This leads to difficulty breathing and poor growth, and later in life can result in frequent infections of the airways and long-term lung problems.
Slovenian: To privede do težav z dihanjem in slabe rasti, pozneje v življenju pa lahko povzroča pogoste okužbe dihalnih poti in dolgotrajne težave s pljuči.
English: Another concern was that the applicant did not demonstrate the so-called well-established use (systematic and documented use in the EU for more than 10 years) of caffeine citrate for the prevention of bronchopulmonary dysplasia.
Slovenian: Nadaljnji pomislek je bil, da predlagatelj ni dokazal t.i. dobro uveljavljene medicinske uporabe (sistematske in dokumentirane uporabe v EU že več kot 10 let) kofeinijevega citrata pri preprečevanju bronhopulmonalne displazije.
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) EMA/188385/2017
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Blectifor (kofeinijev citrat) EMA/188385/2017
English: Blectifor is a medicine that contains the active substance caffeine citrate.
Slovenian: Blectifor je zdravilo, ki vsebuje zdravilno učinkovino kofeinijev citrat.
English: On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Slovenian: Družba Viridian Pharma Ltd je 9. marca 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Blectifor, namenjenim preprečevanju bronhopulmonalne displazije.
English: The active substance in Blectifor, caffeine citrate, is a stimulant of the nervous system and is currently authorised in the EU as Peyona for the treatment of a breathing disorder called primary apnoea in
Slovenian: Zdravilna učinkovina zdravila Blectifor, kofeinijev citrat, je spodbujevalec živčnega sistema in je trenutno odobrena v EU kot zdravilo Peyona, namenjeno zdravljenju motnje dihanja, imenovane primarna apneja pri nedonošenčkih.
English: In addition, caffeine citrate may also have other effects in the lungs, such as reducing inflammation, which are expected to prevent the damage that leads to bronchopulmonary dysplasia.
Slovenian: Poleg tega ima kofeinijev citrat morda še druge učinke na pljuča, kot je na primer zmanjševanje vnetja, kar naj bi preprečilo poškodbe, ki privedejo do bronhopulmonalne displazije.
English: It was to be available as a solution for injection, which can also be given by mouth.
Slovenian: Na voljo naj bi bilo v obliki raztopine za injiciranje, ki se lahko daje tudi peroralno.
English: In these babies, the continuous high pressure and high concentration of the oxygen supplied through mechanical ventilation may cause inflammation and injury to the lungs and prevent normal development of the alveoli (air sacs in the lungs).
Slovenian: Pri teh dojenčkih lahko stalen visok tlak in visoka koncentracija kisika, ki se dovaja z mehanskim predihavanjem, povzročita vnetje in poškodbe pljuč ter preprečita normalen razvoj alveolov (pljučnih mešičkov).
English: Additionally, the facility designated to test the stability of Blectifor was not certified to comply with good manufacturing practices (GMP).
Slovenian: Poleg tega ustanova, kjer so preskušali stabilnost zdravila Blectifor, ni imela certifikata skladnosti z dobro proizvodno prakso.
English: The company presented data from the published scientific literature mainly on the use of caffeine citrate for the treatment of primary apnoea in premature babies; several articles also provided data on the development of bronchopulmonary dysplasia in these patients.
Slovenian: Družba je predložila podatke iz objavljene znanstvene literature, zlasti o uporabi kofeinijevega citrata za zdravljenje primarne apneje pri nedonošenčkih; podatki o razvoju bronhopulmonalne displazije pri teh bolnikih pa so na voljo v številnih člankih.
English: The Committee considered that the role of caffeine citrate in the prevention of the disease had not been sufficiently demonstrated, and no definite conclusion on the effect of caffeine citrate for the prevention of bronchopulmonary dysplasia could be drawn.
Slovenian: Odbor je ocenil, da vloga kofeinijevega citrata pri preprečevanju te bolezni ni bila dovolj dokazana in da ni mogoče podati dokončnih zaključkov o učinku kofeinijevega citrata na preprečevanje bronhopulmonalne displazije.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 March 2017 EMA/188385/2017 EMEA/H/C/004100
Slovenian: marec 2017 EMA/188385/2017 EMEA/H/C/004100
English: What was Blectifor expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Blectifor uporabljalo?
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Blectifor (kofeinijev citrat)
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Blectifor.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Blectifor.
English: Blectifor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2014 for the prevention of bronchopulmonary dysplasia.
Slovenian: Zdravilo Blectifor je bilo dne 11. aprila 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za preprečevanje bronhopulmonalne displazije.
English: Blectifor was expected to be used to prevent bronchopulmonary dysplasia, a lung disease affecting premature babies who have been on prolonged mechanical ventilation (using a machine that supplies oxygen to support breathing).
Slovenian: Zdravilo Blectifor naj bi se uporabljalo za preprečevanje bronhopulmonalne displazije, tj. bolezni pljuč, ki prizadene nedonošenčke, ki so bili na dolgotrajnem mehanskem predihavanju (s pomočjo aparata, ki dovaja kisik in podpira dihanje).
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that, based on the data submitted by the company, Blectifor could not have been approved for the prevention of bronchopulmonary dysplasia.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da na podlagi podatkov, ki jih je predložila družba, zdravila Blectifor ni mogoče odobriti za preprečevanje bronhopulmonalne displazije.
English: What is Blectifor?
Slovenian: Kaj je zdravilo Blectifor?
English: In the prevention of bronchopulmonary dysplasia, caffeine citrate is expected to act mainly by stimulating the part of the brain that controls breathing, which is thought to help babies breathe on their own and reduce the time spent on mechanical ventilation.
Slovenian: citrat deloval predvsem tako, da naj bi spodbudil del možganov, ki nadzoruje dihanje, kar naj bi dojenčkom pomagalo pri samostojnem dihanju in skrajšalo čas mehanskega predihavanja.
English: How does Blectifor work?
Slovenian: Kako zdravilo Blectifor deluje?
English: EU/1/18/1350/001 Vantobra
Slovenian: EU/1/18/1350/001
English: 170 mg Nebuliser solution Inhalation use ampoule (LDPE)
Slovenian: 170 mg inhalacijska raztopina za nebulator za inhaliranje ampula (PE) 1,7 ml
English: 56 ampoules + 1 administration device
Slovenian: 56 ampul x 1 pripomoček za aplikacijo
English: Pack size
Slovenian: Vantobra
English: After opening: 3 hours.
Slovenian: Po odpiranju: 3 ure.
English: Thereby the following instructions should be used:
Slovenian: Upoštevati je treba naslednja navodila:
English: Member State/EEA
Slovenian: Država članica/EEA
English: This was regarded as the worst case scenario using the most susceptible animals.
Slovenian: To je najslabši možni scenarij, ki vključuje najbolj občutljive živali.
English: The inactivated vaccine is a suspension for injection.
Slovenian: Inaktivirano cepivo je suspenzija za injiciranje.
English: The marketing authorisation holder has complied with these requirements with the design of this study.
Slovenian: Imetnik dovoljenja za promet z zdravilom je te zahteve izpolnil z zasnovo te študije.
English: 1210 Wien Austria
Slovenian: 1210 Dunaj Avstrija
English: 3) the minimum efficacious titre is 4.0 TCID50
Slovenian: 3) najmanjši učinkovit titer je 4,0 TCID50
English: The animals return to normal the next day.
Slovenian: Pri vseh živalih se naslednji dan zniža na normalno vrednost.
English: Agualva-Cacém Portugal
Slovenian: Agualva-Cacém Portugalska
English: The specific claims for finishing pigs to improve the rearing results have not been demonstrated.
Slovenian: Specifične zahteve za prašiče, ki se redijo za zakol, glede izboljšanja rezultata pri vzreji niso bile dokazane.
English: ADVERSE REACTIONS
Slovenian: NEŽELENE REAKCIJE
English: 2) the apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Slovenian: 2) očitno zmanjšanje po 1 uri iz titra ob sprostitvi (6,4/6,2 TCID50) je 0,12/-0,02
English: 2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products.
Slovenian: 2.3 Potencialni vpliv na parameter učinkovitosti „trajanje imunosti“ zaradi interference, ki jo povzroči mešanje obeh zdravil.
English: Given that a lack of interference has been demonstrated a specific time point the duration of immunity remains the same as originally proven.
Slovenian: Ker je bilo dokazano pomanjkanje medsebojnih vplivov, ostaja specifična časovna točka trajanja imunosti enaka, kot je bila dokazana na začetku.
English: The general claim to reduce viraemia has only been demonstrated in laboratory studies.
Slovenian: Splošna zahteva (zmanjšanje viremije) je bila dokazana le v laboratorijskih študijah.
English: In isolated cases hypersensitivity reactions may occur.
Slovenian: Možni so posamični primeri preobčutljivostnih reakcij.
English: 1) the claimed in-use shelf life for the “mixed” product is one hour;
Slovenian: 1) predlagani rok uporabnosti „mešanega“ zdravila je ena ura;
English: Following the absence of agreement between the Reference Member State (the United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Slovenian: Ker ni bilo strinjanja med referenčno državo članico (Združeno kraljestvo je delovalo v imenu Francije kot referenčna država članica v dogovoru o delitvi dela) in eno od zadevnih držav članic (Španija) na 90. dan postopka, ki ga je pripravila Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini, je bila zadeva dne 2. oktobra 2009 napotena na CVMP.
English: Koerverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: 5831 AN Boxmeer Nizozemska
English: Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.
Slovenian: Cepivo pred uporabo ogrejemo na sobno temperaturo (15-25 °C) in ga dobro pretresemo.
English: and EU guidelines require safety studies to use animals which are seronegative for the antigens of the vaccine components.
Slovenian: Evropska farmakopeja in smernice EU zahtevajo, da se študije varnosti izvedejo z živalmi, ki so seronegativne za antigene komponent cepiva.
English: The marketing authorisation holder has demonstrated that there is no immunological interference when the vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Slovenian: Imetnik dovoljenja za promet z zdravilom je dokazal, da ni imunološkega medsebojnega vpliva ob mešanju cepiv, kar pomeni, da se ohrani ista raven učinkovitosti ob preučevanju enega parametra učinkovitosti „zmanjšanje viremije“ (zmanjšanje za 70-75 % po sočasni uporabi in zmanjšanje za 72-75 % po samostojni uporabi zdravila Porcilis PRRS).
English: After mixing with Porcilis PRRS: 1 hour (at room temperature)
Slovenian: Po mešanju s Porcilisom PRRS: 1 uro (pri sobni temperaturi)
English: CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Slovenian: CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) (Smernica CVMP glede podatkov za podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini med njihovo uporabo)http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
English: Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton
Slovenian: represented by Intervet UK Ltd Walton Manor Walton
English: The first injection can be given from an age of 1 week onwards.
Slovenian: Prvi odmerek lahko dajemo od starosti 1 tedna naprej.
English: For simultaneous use with Porcilis PRRS in finishing pigs from 4 weeks of age (3 weeks after priming) the vaccine may be used for reconstitution shortly before vaccination.
Slovenian: Pri sočasni uporabi s Porcilisom PRRS pri prašičih pitancih po starosti 4 tednov (3 tedne po prvem cepljenju), lahko cepivo uporabimo za rekonstitucijo tik pred cepljenjem.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS M HYO (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PORCILIS M HYO (GLEJTE DODATEK I)
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis M Hyo in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Slovenian: Imetnik dovoljenja za promet z zdravilom Intervet International BV je predložil vlogo za spremembo tipa II, ki jo ureja postopek z medsebojnim priznavanjem za dovoljenja za promet z zdravilom Porcilis M Hyo za uporabo v veterinarski medicini v okviru člena 6 Uredbe Komisije (ES) št. 1084/2003.
English: A transient swelling/redness (max. diameter 5 cm) may occur at the injection site diminishing over a period of maximally 14 days.
Slovenian: Na mestu injiciranja se lahko pojavi prehodna oteklina ali rdečina (premera največ 5 cm), ki se po največ 14 dneh zmanjša.
English: However the argumentation provided by the marketing authorisation holder to date raises some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Slovenian: Vendar pa utemeljitev, ki jo je doslej predložil imetnik dovoljenja za promet z zdravilom, zbuja določene pomisleke, da z mešanjem zdravil nekatere zahteve učinkovitosti monovalentnih zdravil ne bi bile izpolnjene.
English: The proposed vaccination scheme for the mixed product is:
Slovenian: Predlagana shema cepljenja za mešano zdravilo: