FrancophonIA/ELRC3.0 huggingface dataset:
English: Propylene glycol Red iron oxide (E172)
Slovenian: Rdeči železov oksid (E172)
English: Embolism pulmonary, oedema, oedema peripheral
Slovenian: možganske krvavitve, hipertenzija pljučna embolija, edem, periferni edem
English: Hard gelatin capsules, with white opaque cap and body, imprinted in black ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo s črnim potiskom.
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Slovenian: zmedenost, omotica, motnje spomina, zmanjšanje miselne zbranosti, disfazija, nevrološke motnje (NOS), nevropatija,
English: Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo z modrim potiskom.
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Slovenian: zvišana telesna temperatura, astenija, mrzlica, slabo počutje, bolečine, motnje okusa
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Slovenian: alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, edem obraza, bolečine, motnje okusa alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, bolečine
English: Temozolomide SUN 140 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid SUN 140 mg
English: Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Slovenian: Zdravilo Temozolomid SUN se uporablja za zdravljenje določenih vrst možganskih tumorjev:
English: Your doctor will work out your dose of Temozolomide SUN.
Slovenian: Odmerek zdravila Temozolomid SUN bo določil zdravnik.
English: Package Leaflet: Information for the user Temozolomide SUN 250 mg hard capsules temozolomide
Slovenian: Navodilo za uporabo Temozolomid SUN 250 mg trde kapsule temozolomid
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, titanium dioxide (E171), blue #1/Brilliant Blue FCF Aluminium Lake (E133).
Slovenian: ovoj kapsule: želatina, titanov dioksid (E171), natrijev lavrilsulfat črnilo: šelak, propilenglikol, titanov dioksid (E171), modro aluminijevo barvilo FCF št.1 (E133)
English: Infections and infestations Common:
Slovenian: Očesne bolezni Pogosti:
English: Temozolomide SUN 100 mg hard capsules have a white opaque body and cap, imprinted in pink ink.
Slovenian: Temozolomid 100 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo z rožnatim potiskom.
English: Propylene glycol Black iron oxide (E172)
Slovenian: Črni železov oksid (E172)
English: Hard gelatin capsules, with white opaque cap and body, imprinted in red ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo z rdečim potiskom.
English: Stomatitis, diarrhoea,
Slovenian: nevtropenija, trombocitopenija,
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Slovenian: Ne jemljite zdravila Temozolomid SUN - če ste alergični na temozolomid ali katerokoli sestavino tega zdravila (navedeno v poglavju 6); - če ste kdaj imeli alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemoDTIC); med znaki alergijske reakcije vključujejo srbenje, zasoplost ali hropenje,
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia,
Slovenian: somnolenca, afazija, motnje ravnotežja, omotica,
English: EU/1/11/697/017 (5 hard capsules) EU/1/11/697/018 (20 hard capsules)
Slovenian: EU/1/11/697/017 (5 kapsul v pretisnem omotu) EU/1/11/697/018 (20 kapsul v pretisnem omotu)
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, yellow iron oxide (E172), blue #1/Brilliant Blue FCF Aluminium Lake (E133).
Slovenian: ovoj kapsule: želatina, titanov dioksid (E171), natrijev lavrilsulfat črnilo: šelak, propilenglikol, rumeni železov oksid (E172), Modro aluminijevo barvilo FCF št.1 (E133)
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Slovenian: ovoj kapsule: želatina, titanov dioksid (E171), natrijev lavrilsulfat črnilo: šelak, propilenglikol, rdeči železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171)
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multiorgan failure and death.
Slovenian: Med prijavljenimi neželenimi učinki so bili pancitopenija, pireksija, odpoved več organov in smrt.
English: Temozolomide SUN 180 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid SUN 180 mg
English: Hard gelatin capsules, with white opaque cap and body, imprinted in green ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo z zelenim potiskom.
English: Deutschland tel. +49 214 403 990
Slovenian: Italia tel. +39 02 33 49 07 93
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN,
Slovenian: Pred začetkom jemanja zdravila Temozolomid SUN se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Slovenian: Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
English: EU/1/11/697/015 (5 hard capsules) EU/1/11/697/016 (20 hard capsules)
Slovenian: EU/1/11/697/015(5 kapsul v pretisnem omotu) EU/1/11/697/016 (20 kapsul v pretisnem omotu)
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Slovenian: hemipareza, ataksija, motnje kognitivnih procesov, disfazija,nenormalna hoja, hiperestezija, hipoestezija,
English: Pneumocystis jiroveciipneumonia
Slovenian: periferna nevropatija
English: EU/1/11/697/023 (5 hard capsules) EU/1/11/697/024 (20 hard capsules)
Slovenian: EU/1/11/697/023 (5 kapsul v pretisnem omotu) EU/1/11/697/024 (20 kapsul v pretisnem omotu)
English: EU/1/11/697/019 (5 hard capsules) EU/1/11/697/020 (20 hard capsules)
Slovenian: EU/1/11/697/019 (5 kapsul v pretisnem omotu) EU/1/11/697/020 (20 kapsul v pretisnem omotu)
English: EU/1/11/697/021 (5 hard capsules) EU/1/11/697/022 (20 hard capsules)
Slovenian: EU/1/11/697/021 (5 kapsul v pretisnem omotu) EU/1/11/697/022 (20 kapsul v pretisnem omotu)
English: EXPIRY DATE
Slovenian: periferni edem
English: Slovenija/Slovenská republika/Suomi/Finland/Sverige
Slovenian: Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
English: EU/1/11/697/013 (5 hard capsules) EU/1/11/697/014 (20 hard capsules)
Slovenian: EU/1/11/697/013 (5 kapsul v pretisnem omotu) EU/1/11/697/014 (20 kapsul v pretisnem omotu)
English: Then you will have 23 days without Temozolomide SUN.
Slovenian: Nato 23 dni ne boste jemali zdravila Temozolomid SUN. Skupaj je to 28-dnevni cikel zdravljenja.
English: Hard gelatin capsule, with white opaque cap and body, imprinted in yellow ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo z rumenim potiskom.
English: Hard gelatin capsules, with white opaque cap and body, imprinted in pink ink.
Slovenian: Trde želatinske kapsule imajo bel neprosojen pokrovček in telo z rožnatim potiskom.
English: Temozolomide SUN 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid SUN 100 mg
English: You should stop breast-feeding while receiving treatment with Temozolomide SUN.
Slovenian: V nekaterih primerih je treba zdravljenje z zdravilom Temozolomid SUN končati.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: Läkemedelsform Administreringssätt Innerförpackning Förpackningsstorlek
English: Pack size
Slovenian: Styrka
English: Route of Administration
Slovenian: Läkemedlets namn
English: ATCvet code: QI06AJ05.
Slovenian: Oznaka ATCvet: QI06AJ05.
English: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Shranjujte in prevažajte v hladilniku (2°C - 8°C).
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Slovenian: V naravi je infektivna le podskupina A. Imunizacija proti podskupini A pa omogoča popolno zaščito proti A, B in C. Po inokulaciji virus izraža zaščitne proteine, ne da bi se v mački pomnoževal.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar ne zmešano z
English: * less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports.
Slovenian: *manj kot 1 žival od 10.000 živali kaže neželene učinke med trajanjem enega zdravljenja, vključujoč posamezne primere.
English: EU/2/04/047/001 lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/047/002 lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Slovenian: EU/2/04/047/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/047/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Slovenian: Ne mešajte z nobenim drugim zdravilom razen s topilom, ki je priloženo za uporabo s tem cepivom.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis and feline leukaemia components and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Slovenian: Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti za vse komponente eno leto po osnovnem cepljenju, - nadaljnja ponovna cepljenja je potrebno opraviti: vsako leto za komponenti klamidioza in leukemija mačk in v obdobjih do 3 leta za komponente rinotraheitisa, kaliciviroze in panleukopenije.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - pogosti (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 10.000 živali)
English: The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Slovenian: Cepivo dokazano zmanjša izločanje kalicivirusa mačk ob nastopu imunosti in do enega leta po cepljenju.
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Slovenian: Posledica tega je, da cepivo vzpodbudi imunski odgovor proti virusu mačje levkemije.
English: The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Slovenian: Sev virusa v cepivu proti mačji levkemiji je rekombinantni poxvirus kanarčkov, ki izraža env in gag gene FeLV-A.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection
Slovenian: Purevax RCPCh FeLV liofilizat in vehikel za suspenzijo za injiciranje
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis and feline leukaemia components.
Slovenian: Trajanje imunosti je 3 leta po zadnjem ponovnem cepljenju za komponente kužnega rinotraheitisa, kaliciviroze in panleukopenije, ter 1 leto za komponenti Chlamydophila felis in leukemija mačk.
English: Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
Slovenian: Natrijev hidrogenfosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat
English: For the full list of excipients, see section 6.1.
Slovenian: 2 50% infektivni odmerek za embrionirana kokošja jajca Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Slovenian: Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte odmerek (1-ml) cepiva v podkožje, po naslednjem razporedu:
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Slovenian: Aktivna imunizacija 8 tednov starih mačk in starejših: - proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj, - proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj,
English: In very rare* cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Slovenian: V zelo redkih primerih* sta se en teden do tri tedne po ponovnem cepljenju pri odraslih mačkah pojavili prehodna hipertermija in letargičnost, včasih tudi v povezavi s šepanjem.
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Slovenian: Pred cepljenjem je priporočljivo opraviti test na prisotnost antigenov FeLV v krvi.
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis, feline panleucopenia virus and feline leukaemia virus.
Slovenian: Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa, kalicivirusu, Chlamydophila felis, ter virusu panleukopenije in leukemije mačk.
English: 2 egg infective dose 50%
Slovenian: 1 50% infektivni odmerek za celično kulturo 2 50% infektivni odmerek za embrionirana kokošja jajca
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Slovenian: Inaktivirani antigeni kalici virusa mačk (seva FCV 431 in G1) ....................... ≥ 2,0 enot v testu ELISA Atenuirana Chlamydophila felis (sev 905) ......................................................................... ≥ 103,0 EID502 Atenuiran virus panleukopenije mačk (PLI IV) .............................................................. ≥ 103,5 CCID501
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1or 2 days).
Slovenian: Pri normalnih pogojih uporabe se lahko občasno pojavijo prehodna apatija in neješčnost.
English: Manufacturer responsible for the batch release: MERIAL
Slovenian: Izdelovalec, odgovoren za sproščanje serij:
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Slovenian: ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
English: Laboratoire Porte des Alpes Rue de l'Aviation
Slovenian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCIJA
English: Special precautions for use in animals:
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis, feline panleucopenia and feline leukaemia.
Slovenian: Cepivo proti virusnemu rinotraheitisu, kalicivirusu, klamidiozi, panleukopeniji in leukemiji mačk.
English: FeLV recombinant canarypox virus (vCP97) .................................................................. ≥ 107.2 CCID501 1 cell culture infective dose 50%.
Slovenian: (vCP97) ............................................................................................................................. ≥ 107,2 CCID501
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Slovenian: V odmerku po 1 ml: FHV (sev F2) ..................................................................................................................... ≥ 104,9 CCID50
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Slovenian: Lahko se pojavi tudi povišana telesna temperatura (običajno traja 1 do 2 dni).
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Slovenian: Imunost proti kužnemu rinotraheitisu, okužbam s kalicivirusi, okužbam s Chlamydophila felis in panleukopeniji mačk nastopi 1 teden po osnovnem cepljenju.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Slovenian: panleukopenije ali Chlamydophile (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam,
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Potassium chloride
Slovenian: Natrijev hidrogenfosfat Kalijev dihidrogenfosfat, brezvodni Kalijev klorid
English: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Slovenian: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Slovenian: Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in G1) ......................... ≥ 2,0 enot v testu ELISA
English: Gentamicin, at most .......................................................................................................................... 34 µg Solvent:
Slovenian: Gentamicin, največ ........................................................................................................................... 34 µg Vehikel:
English: As the company had supplied additional information requested, the ‘exceptional circumstances' ended on 6 May 2013.
Slovenian: Ker je podjetje predložilo zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 6. maja 2013.
English: Further information on BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu BTVPUR so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about BTVPUR:
Slovenian: Druge informacije o zdravilu BTVPUR:
English: BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.
Slovenian: Zdravilo BTVPUR je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 12. aprila 2016.
English: The second injection is given three to four weeks later.
Slovenian: Drugi odmerek se živalim injicira od tri do štiri tedne pozneje.
English: BTVPUR is a vaccine.
Slovenian: Zdravilo BTVPUR je cepivo.
English: The European Medicines Agency decided that BTVPUR's benefits are greater that its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila BTVPUR večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What is BTVPUR and what is it used for?
Slovenian: Kaj je zdravilo BTVPUR in za kaj se uporablja?