FrancophonIA/ELRC3.0 huggingface dataset:
English: o Need for appropriate physical activity, non-smoking and healthy diet
Slovenian: Aclasta, o potrebnost ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja;
English: • Patient information pack
Slovenian: • Komplet podatkov o zdravilu za bolnika.
English: • Package leaflet
Slovenian: • Navodilo za uporabo,
English: Further information on Mektovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Mektovi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These side effects occurred in more than 1 in 4 patients.
Slovenian: Ti neželeni učinki so se pojavili pri več kot 1 bolniku od 4.
English: What measures are being taken to ensure the safe and effective use of Mektovi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mektovi?
English: The European Medicines Agency therefore decided that Mektovi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Mektovi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Mektovi
Slovenian: Druge informacije o zdravilu Mektovi
English: Mektovi is available as 15 mg tablets.
Slovenian: Zdravilo Mektovi je na voljo v obliki 15-miligramskih tablet.
English: Patients who took this combination lived on average for nearly 15 months without the disease getting worse.
Slovenian: Bolniki, ki so jemali to kombinacijo, so brez poslabšanja bolezni povprečno živeli skoraj 15 mesecev.
English: Patients normally take 45 mg (3 tablets) by mouth twice a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Slovenian: Bolniki običajno jemljejo 45 mg (tri tablete) peroralno dvakrat na dan, vendar se lahko odmerek zmanjša ali zdravljenje začasno prekine, če se pri njih pojavijo neprijetni neželeni učinki.
English: What benefits of Mektovi have been shown in studies?
Slovenian: Kakšne koristi zdravila Mektovi so se pokazale v študijah?
English: The dose of the other medicine, encorafenib, may also have to be reduced.
Slovenian: Morda je treba zmanjšati tudi odmerek druge učinkovine, enkorafeniba.
English: As for all medicines, data on the use of Mektovi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Mektovi stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mektovi have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mektovi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The side effects seen with Mektovi are similar to those seen with other medicines in the same class and are considered manageable.
Slovenian: Neželeni učinki, ki so jih opazili pri zdravilu Mektovi, so podobni tistim, ki so jih opazili pri drugih zdravilih istega razreda, in veljajo za obvladljive.
English: An overview of Mektovi and why it is authorised in the EU
Slovenian: Pregled zdravila Mektovi in zakaj je odobreno v EU
English: What is Mektovi and what is it used for?
Slovenian: Kaj je zdravilo Mektovi in za kaj se uporablja?
English: What are the risks associated with Mektovi?
Slovenian: Kakšna tveganja so povezana z zdravilom Mektovi?
English: Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Slovenian: Mektovi je zdravilo, ki se uporablja za zdravljenje melanoma (kožnega raka), ki se je razširil ali ga ni mogoče kirurško odstraniti.
English: Why is Mektovi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Mektovi odobreno v EU?
English: Side effects reported with Mektovi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Mektovi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Treatment with Mektovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Slovenian: Zdravljenje z zdravilom Mektovi lahko traja, dokler ima bolnik od njega korist in se pri njem ne pojavljajo nesprejemljivi neželeni učinki.
English: The most common side effects with Mektovi and encorafenib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Slovenian: Najpogostejši neželeni učinki kombinacije zdravila Mektovi in enkorafeniba pri največjih priporočenih odmerkih so utrujenost, navzeja (slabost), driska, bruhanje, odstop mrežnice (težava z očmi, ki privede do poslabšanja vida), bolečine v trebuhu, bolečine v sklepih, bolečine v mišicah in povečane vrednosti encima, imenovanega kreatin kinaza, kar lahko kaže na težave z mišicami.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Mektovi with encorafenib prolongs the length of time patients live without their disease getting worse.
Slovenian: Študija s 577 bolniki z melanomom z mutacijo BRAF V600, ki se je razširil ali ga ni bilo mogoče kirurško odstraniti, je pokazala, da zdravilo Mektovi skupaj z enkorafenibom podaljša preživetje bolnikov brez poslabšanja bolezni.
English: For more information about using Mektovi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Mektovi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Slovenian: Do 50 % bolnikov z metastatskim melanomom ima mutacijo v genu BRAF, najpogosteje mutacijo V600.
English: Mektovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Mektovi je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje s predpisovanjem zdravil za zdravljenje raka.
English: Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Slovenian: Zdravilo Mektovi se uporablja v kombinaciji z drugo učinkovino, enkorafenibom (zdravilom Braftovi), in je namenjeno samo bolnikom, katerih celice imajo v svojih genih posebno mutacijo (spremembo), imenovano BRAF V600.
English: The active substance in Mektovi, binimetinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer.
Slovenian: Učinkovina v zdravilu Mektovi, binimetinib, deluje tako, da neposredno zavira beljakovino MEK, beljakovini BRAF pa prepreči, da bi jo aktivirala, s čimer upočasni rast in širjenje raka.
English: Mektovi in combination with encorafenib can help prolong the time these patients live without their disease getting worse.
Slovenian: Zdravilo Mektovi lahko v kombinaciji z enkorafenibom pripomore k podaljšanju preživetja bolnikov brez poslabšanja bolezni.
English: It contains the active substance binimetinib.
Slovenian: Zdravilo vsebuje učinkovino binimetinib.
English: How is Mektovi used?
Slovenian: Kako se zdravilo Mektovi uporablja?
English: How does Mektovi work?
Slovenian: Kako zdravilo Mektovi deluje?
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Slovenian: Bolniki, ki so jemali samo enkorafenib, so brez poslabšanja bolezni živeli nekaj več kot 9,5 meseca, bolniki, ki so jemali drugo učinkovino, imenovano vemurafenib, pa malo več kot sedem mesecev.
English: 15 months
Slovenian: 15 mesecev
English: (EEC) No 2377/90 does not apply.
Slovenian: št. 2377/90 ne velja.
English: Under field conditions, sporadic local and systemic clinical reactions have been reported.
Slovenian: V razmerah na farmi so poročali o sporadičnih lokalnih in sistemskih kliničnih reakcijah.
English: Use sterile vaccination equipment.
Slovenian: Uporabite sterilno opremo za cepljenje.
English: Polysorbate 80
Slovenian: Polisorbat 80
English: Any person intending to import, sell, supply and/or use the product must consult the relevant Member States Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati izdelek, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
English: Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Slovenian: Zato njegova varnost in učinkovitost pri sočasni uporabi z drugimi cepivi (isti dan ali ob drugem času) ni dokazana.
English: No information is available on the compatibility of this vaccine with any other.
Slovenian: O kompatibilnosti tega cepiva z drugimi cepivi ni podatkov.
English: Do not use in birds in lay (see section 4.3).
Slovenian: Izdelka ne smemo uporabljati v obdobju valjenja (glejte poglavje 4.3).
English: Excludes aromatic and unsaturated compounds
Slovenian: Ne vsebuje aromatskih in nenasičenih spojin.
English: • For the active principle of biological origin intended to produce immunity, Council Regulation
Slovenian: • Za zdravilno učinkovino biološkega izvora, namenjeno za vzbujanje imunosti, Uredba Sveta (EGS)
English: Vaccination scheme:
Slovenian: Shema cepljenja:
English: Traces of formaldehyde
Slovenian: Sledi formaldehida
English: Do not mix with any other vaccine/immunological product.
Slovenian: Ne mešajte z nobenim drugim cepivom ali imunološkim izdelkom.
English: For a list of excipients, see section 6.1
Slovenian: Za seznam pomožnih snovi glejte poglavje 6.1.
English: 500 ml (2000 doses)
Slovenian: 500 ml (2000 odmerkov)
English: The import, sale, supply and/or use of the product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba izdelka je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: 1 OJ No L272 of 25.10.1996, p. 2 OJ No L 61 of 18.3.1995, p. 1
Slovenian: 1 OJ št. L 272 z dne 25.10.1996, str. 2 1 OJ št. L 61 z dne 18.3.1995, str. 1
English: SPECIAL WARNING(S), IF NECESSARY Oil adjuvanted vaccine
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA Cepivo z oljnim adjuvansom
English: Pharmacotherapeutic group: Inactivated bacterial vaccine ATCvet code: QI 01AB07
Slovenian: Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo Oznaka ATCvet: QI01AB07
English: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: The first injection can be administered at an age of 6 - 12 weeks.
Slovenian: Prvi odmerek lahko dajemo pri starosti 6 do 12 tednov.
English: EXPIRY DATE (Month/Year) ……/…..
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: (mesec/leto)……./………
English: PHARMACEUTICAL FORM Emulsion for injection
Slovenian: FARMACEVTSKA OBLIKA Emulzija za injiciranje
English: In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination.
Slovenian: Pri laboratorijskih preskusih so pri posmrtni preiskavi zasledili prehodno lokalno oteklino pri 40 % živali, ki je trajala najmanj 14 dni po subkutanem cepljenju.
English: Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Slovenian: Intervet International Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: Light liquid paraffin: 107.21 mg
Slovenian: Redko tekoči parafin: 107,21 mg
English: The second injection has to be administered at least 6 weeks later at an age of 14 - 18 weeks.
Slovenian: Drugega odmerka ne smemo dati prej kot najmanj 6 tednov po prvem, pri starosti 14 do 18 tednov.
English: to Council Directive 95/2/EC2.
Slovenian: Sveta 95/2/ES2).
English: Per dose of 0.25 ml:
Slovenian: V odmerku po 0,25 ml:
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Slovenian: Nenamerno injiciranje/samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
English: Occasionally hardened minor local swellings (0.5 - 2.0 cm) were observed which disappeared within 21 days after vaccination.
Slovenian: Občasno so zasledili manjše otekline v obliki zatrdlin (0,5 do 2,0 cm), ki so minile v 21 dneh po cepljenju.
English: Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution 6.2 Incompatibilities
Slovenian: Redko tekoči parafin, polisorbat 80, sorbitan oleat, vodna raztopina s sulfatnim pufrom 6.2 Inkompatibilnosti
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Slovenian: Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Slovenian: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: Marketing authorisation holder and manufacturer:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec:
English: Accidental injection is dangerous - see package insert before use.
Slovenian: Nenamerno injiciranje je nevarno - pred uporabo preberite priloženo navodilo.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: Store and transport at 2 - 8°C.
Slovenian: Shranjujte in prevažajte pri temperaturi 2-8 ºC.
English: SPECIAL STORAGE CONDITIONS Store and transport at 2 - 8°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi 2-8 °C.
English: Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.
Slovenian: V razmerah na farmi se pasivna imunost prenaša v obdobju valjenja 43 tednov po zadnjem cepljenju brojlerskih matičnih jat, tako da traja pasivna imunost brojlerjev najmanj 14 dni po izvalitvi.
English: • Sorbitan oleate (E 494), Potassium dihydrogen phosphate (E 340), Disodium hydrogen phosphate (E 339) and Potassium chloride (E 508) are approved as additives in foodstuffs for human consumption and therefore covered by Annex II of Council Regulation (EEC) No. 2377/90 for substances with an E- number1 (with the exception of preservatives listed in part C of Annex III
Slovenian: • Sorbitan oleat (E 494), kalijev dihidrogenfosfat (E 340), natrijev dihidrogenfosfat (E 339) in kalijev klorid (E 508) so odobreni prehrambeni dodatki, zato jih ureja Dodatek II Uredbe Sveta (EGS) št.
English: MANUFACTURER'S BATCH NUMBER Lot: ……
Slovenian: IZDELOVALČEVA ŠTEVILKA Serija:………
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 0.25 ml:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGE(IH) SESTAVIN V odmerku po 0,25 ml:
English: Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Slovenian: Mineralni ogljikovodiki, majhne do velike viskoznosti: mikrokristalni voski, približno C10-C60; alifatske, razvejane alifatske in aliciklične spojine vse živalske vrste, namenjene za prehrano ljudi
English: Nobilis OR inac emulsion for injection for chickens
Slovenian: Nobilis OR inac, emulzija za injiciranje za piščance
English: • The adjuvants and excipients listed are included in Annex II of Council Regulation (EEC) No
Slovenian: • Naštete dodatke in pomožne snovi vsebuje Dodatek II Uredbe Sveta (EGS) št. 2377/90.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 250 ml (1000 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 250 ml (1000 odmerkov)
English: Allow vaccine to reach room temperature (15-25°C) before using the vaccine.
Slovenian: Cepivo pred uporabo ogrejte na sobno temperaturo (15-25 °C).
English: No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine.
Slovenian: Dvojni odmerek v primerjavi z enojnim odmerkom cepiva ni povzročil dodatnih neželenih učinkov.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis OR inac emulsion for injection for chickens
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis OR inac, emulzija za injiciranje za piščance
English: The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast.
Slovenian: Shema cepljenja je dve injekciji z odmerkom po 0,25 ml subkutano na vratu ali intramuskularno v prsni predel.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Slovenian: NAVEDBA ZDRAVILNE UČIKOVINE IN DRUGIH SNOVI
English: All food producing species
Slovenian: vse živalske vrste, namenjene za prehrano ljudi
English: Pharmacologically active substance Animal Species
Slovenian: Farmakološko aktivna snov
English: For animal treatment only -to be supplied only on veterinary prescription.
Slovenian: Samo za živali - oskrba le na podlagi veterinarskega recepta.
English: The product contains the inactivated whole cells of Ornithobacterium rhinotracheale serotype A, strain B3263/91 mixed with an oil adjuvant.
Slovenian: Izdelek vsebuje inaktivirane celice bakterije Ornithobacterium rhinotracheale, serotip A, sev B3263/91 v obliki mešanice z oljnim adjuvansom.
English: 1 PET vial with 250 ml (1000 doses) 1 PET vial with 500 ml (2000 doses)
Slovenian: 1 viala iz polietilen tereftalata (PET) po 250 ml (1000 odmerkov) 1 viala iz polietilen tereftalata (PET) po 500 ml (2000 odmerkov)
English: Accidental self-injection is dangerous - see package insert
Slovenian: Nenamerno injiciranje je nevarno - preberite priloženo navodilo.
English: EU Number EU/2/02/036/001 (250 ml) EU/2/02/036/002 (500 ml)
Slovenian: Številka EU EU/2/02/036/001 (250 ml) EU/2/02/036/002 (500 ml)
English: Shelf life after first opening: Use immediately after opening
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj po odpiranju.
English: 4.4 Special warnings
Slovenian: 4.4 Posebna opozorila
English: ACTIVE SUBSTANCE(S) Inactivated whole cell suspension of O. rhinotracheale Light liquid paraffin
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE Inaktivirana suspenzija celic bakterije O. rhinotracheale Redko tekoči parafin
English: NAME OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
English: Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91 1 x 107 cells *
Slovenian: Inaktivirana suspenzija celic bakterije Ornithobacterium rhinotracheale, serotip A, sev B3263/91 1 x 107 celic*
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous injection in the neck or intramuscular injection in the breast of one dose of 0.25 ml.
Slovenian: NAČIN IN POT(I) UPORABE En odmerek po 0,25 ml subkutano na vratu ali intramuskularno v prsni predel
English: 6.5 Nature and composition of immediate packaging Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: Zloženka z eno vialo iz polietilen tereftalata (PET) po 250 ml (1000 odmerkov) ali po 500 ml (2000 odmerkov), zaprto z zamaškom iz sintetične gume in aluminijasto zaporko s šifro.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/02/036/001-002
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: 4.2 Indications for use, specifying the target species For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Pasivna imunizacija brojlerjev z aktivno imunizacijo živali ženskega spola v brojlerskih matičnih jatah za zmanjšanje okužbe z Ornithobacterium rhinotracheale serotipa A, kadar je ta bakterija prisotna.
English: CONTRAINDICATIONS Do not use for birds in lay
Slovenian: KONTRAINDIKACIJE Ne uporabite v obdobju valjenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/036/001 (250 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/02/036/001 (250 ml)