natgillin/translations-raw huggingface dataset:
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Pomožne snovi so mikrokristalna celuloza, premreženi natrijev karmelozat, laktoza monohidrat, magnezijev stearat, koloidni hidratirani silicijev dioksid, predgelirani koruzni škrob in poloksamer 188.
Ear and labyrinth disorders: Tinnitus
Ušesne bolezni, vključno z motnjami labirinta: Tinitus
Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Oslabljeno delovanje ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4.4)
HOW TO TAKE IRBESARTAN BMS
KAKO JEMATI ZDRAVILO IRBESARTAN BMS
Irbesartan BMS should not be given to children under 18 years of age.
Otroci ne smejo jemati zdravila Irbesartan BMS Otroci in mladostniki, mlajši od 18 let, zdravila Irbesartan BMS ne smejo jemati.
INFORMATION IN BRAILLE Irbesartan BMS 75 mg
PODATKI V BRAILLOVI PISAVI Irbesartan BMS 75 mg
Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
Ena tableta zdravila Irbesartan BMS 75 mg vsebuje 75 mg irbesartana.
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Pri bolnikih na hemodializi se mora pretehtati možnost uporabe nižjega začetnega odmerka (75 mg) (glejte poglavje
Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.
Ena tableta zdravila Irbesartan BMS 150 mg vsebuje 150 mg irbesartana.
Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.
Ena tableta zdravila Irbesartan BMS 300 mg vsebuje 300 mg irbesartana.
INFORMATION IN BRAILLE Irbesartan BMS 300 mg
PODATKI V BRAILLOVI PISAVI Irbesartan BMS 300 mg
INFORMATION IN BRAILLE Irbesartan BMS 150 mg
PODATKI V BRAILLOVI PISAVI Irbesartan BMS 150 mg
Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje: irbesartan 75 mg
Because no information is available regarding the use of Irbesartan BMS during breast-feeding, Irbesartan BMS is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Irbesartan BMS med dojenjem ni na voljo, zato uporaba zdravila Irbesartan BMS med dojenjem ni priporočljiva.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje: irbesartan 150 mg
Gastrointestinal disorders: Dysgeusia
Bolezni prebavil: Paragevzija
MARKETING AUTHORISATION NUMBERS EU/1/06/375/006-010
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/006-010
MARKETING AUTHORISATION NUMBERS EU/1/06/375/001-005
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/001-005
MARKETING AUTHORISATION NUMBERS EU/1/06/375/028-033
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/028-033
Excipient: 25.50 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi: 25,50 mg laktoze monohidrata na filmsko obloženo tableto.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje: irbesartan 300 mg
Excipient: 61.50 mg of lactose monohydrate per tablet.
Pomožna snov: 61,50 mg laktoze monohidrata na tableto.
Excipient: 102.00 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi: 102,00 mg laktoze monohidrata na filmsko obloženo tableto.
MARKETING AUTHORISATION NUMBERS EU/1/06/375/011-015
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/011-015
Excipient: 30.75 mg of lactose monohydrate per tablet.
Pomožna snov: 30,75 mg laktoze monohidrata na tableto.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 75 mg irbesartana.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 75 mg irbesartana.
Cartons of 56 x 1 tablet; 7 blister cards of 8 x 1 tablet each in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 tableto: 7 perforiranih pretisnih omotov iz PVC/PVDC/aluminija za enkratni odmerek z 8 x 1 tableto.
Excipient: 15.37 mg of lactose monohydrate per tablet.
Pomožna snov: 15,37 mg laktoze monohidrata na tableto.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets irbesartan
IME ZDRAVILA Irbesartan BMS 75 mg tablete irbesartan
HOW TO STORE IRBESARTAN BMS
SHRANJEVANJE ZDRAVILA IRBESARTAN BMS
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1filmsko obloženo tableto: 7 perforiranih pretisnih omotov iz PVC/PVDC/aluminija za enkratni odmerek z 8 x 1 filmsko obloženo tableto.
MARKETING AUTHORISATION NUMBERS EU/1/06/375/016-021
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/016-021
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 300 mg irbesartana.
Excipient: 51.00 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi: 51,00 mg laktoze monohidrata na filmsko obloženo tableto.
MARKETING AUTHORISATION NUMBERS EU/1/06/375/022-027
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/375/022-027
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets.
IME ZDRAVILA Irbesartan BMS 75 mg filmsko obložene tablete.
OTHER
Sob
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 150 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets.
IME ZDRAVILA Irbesartan BMS 150 mg filmsko obložene tablete.
What Irbesartan BMS contains
Kaj vsebuje zdravilo Irbesartan BMS
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets irbesartan
IME ZDRAVILA Irbesartan BMS 150 mg tablete irbesartan
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 150 mg irbesartana.
The efficacy of Irbesartan BMS is not influenced by age or gender.
Spol in starost ne vplivata na učinkovitost zdravila Irbesartan BMS.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets.
IME ZDRAVILA Irbesartan BMS 300 mg filmsko obložene tablete.
Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets irbesartan
IME ZDRAVILA Irbesartan BMS 300 mg tablete irbesartan
Cartons of 84 film-coated tablets: 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 84 filmsko obloženimi tabletami: 6 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Cartons of 98 tablets: 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 tabletami: 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 56 tablets: 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 56 tabletami: 4 pretisni omoti iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 14 tablets: 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 tabletami: 1 pretisni omot iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 28 tablets: 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 tabletami: 2 pretisna omota iz PVC/PVDC/aluminija s 14 tabletami.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
Cartons of 28 film-coated tablets: 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 filmsko obloženimi tabletami: 2 pretisna omota iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Cartons of 56 film-coated tablets: 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 56 filmsko obloženimi tabletami: 4 pretisni omoti iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Irbesartan BMS 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Irbesartan BMS 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Cartons of 98 film-coated tablets: 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 filmsko obloženimi tabletami: 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Irbesartan BMS 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough
Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasni:
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets.
IME ZDRAVILA Irbesartan BMS 75 mg tablete
Cartons of 14 film-coated tablets: 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 filmsko obloženimi tabletami: 1 pretisni omot iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets irbesartan
Irbesartan BMS 75 mg filmsko obložene tablete irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
EU/1/06/375/011 - 14 tablets EU/1/06/375/012 - 28 tablets EU/1/06/375/013 - 56 tablets EU/1/06/375/014 - 56 x 1 tablets EU/1/06/375/015 - 98 tablets
EU/1/06/375/011 - 14 tablet EU/1/06/375/012 - 28 tablet EU/1/06/375/013 - 56 tablet EU/1/06/375/014 - 56 x 1 tablet EU/1/06/375/015 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets.
IME ZDRAVILA Irbesartan BMS 150 mg tablete
EU/1/06/375/016 - 14 tablets EU/1/06/375/017 - 28 tablets EU/1/06/375/018 - 56 tablets EU/1/06/375/019 - 56 x 1 tablets EU/1/06/375/020 - 84 tablets EU/1/06/375/021 - 98 tablets
EU/1/06/375/016 - 14 tablet EU/1/06/375/017 - 28 tablet EU/1/06/375/018 - 56 tablet EU/1/06/375/019 - 56 x 1 tablet EU/1/06/375/020 - 84 tablet EU/1/06/375/021 - 98 tablet
EU/1/06/375/022 - 14 tablets EU/1/06/375/023 - 28 tablets EU/1/06/375/024 - 56 tablets EU/1/06/375/025 - 56 x 1 tablets EU/1/06/375/026 - 84 tablets EU/1/06/375/027 - 98 tablets
EU/1/06/375/022 - 14 tablet EU/1/06/375/023 - 28 tablet EU/1/06/375/024 - 56 tablet EU/1/06/375/025 - 56 x 1 tablet EU/1/06/375/026 - 84 tablet EU/1/06/375/027 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets irbesartan
Irbesartan BMS 150 mg filmsko obložene tablete irbesartan
EU/1/06/375/006 - 14 tablets EU/1/06/375/007 - 28 tablets EU/1/06/375/008 - 56 tablets EU/1/06/375/009 - 56 x 1 tablets EU/1/06/375/010 - 98 tablets
EU/1/06/375/006 - 14 tablet EU/1/06/375/007 - 28 tablet EU/1/06/375/008 - 56 tablet EU/1/06/375/009 - 56 x 1 tablet EU/1/06/375/010 - 98 tablet
EU/1/06/375/028 - 14 tablets EU/1/06/375/029 - 28 tablets EU/1/06/375/030 - 56 tablets EU/1/06/375/031 - 56 x 1 tablets EU/1/06/375/032 - 84 tablets EU/1/06/375/033 - 98 tablets
EU/1/06/375/028 - 14 tablet EU/1/06/375/029 - 28 tablet EU/1/06/375/030 - 56 tablet EU/1/06/375/031 - 56 x 1 tablet EU/1/06/375/032 - 84 tablet EU/1/06/375/033 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets irbesartan
Irbesartan BMS 300 mg filmsko obložene tablete irbesartan
EU/1/06/375/001 - 14 tablets EU/1/06/375/002 - 28 tablets EU/1/06/375/003 - 56 tablets EU/1/06/375/004 - 56 x 1 tablets EU/1/06/375/005 - 98 tablets
EU/1/06/375/001 - 14 tablet EU/1/06/375/002 - 28 tablet EU/1/06/375/003 - 56 tablet EU/1/06/375/004 - 56 x 1 tablet EU/1/06/375/005 - 98 tablet
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets.
IME ZDRAVILA Irbesartan BMS 300 mg tablete
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Irbesartan BMS 75 mg filmsko obložene tablete irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets irbesartan
NAVODILO ZA UPORABO Irbesartan BMS 75 mg tablete irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Irbesartan BMS 150 mg filmsko obložene tablete irbesartan
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 300 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Irbesartan BMS 300 mg filmsko obložene tablete irbesartan
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 150 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan
NAVODILO ZA UPORABO Irbesartan BMS 150 mg tablete irbesartan
MA (EU) number (Invented) name
Številka( EU) dovoljenja za promet
Strength Pharmaceutical Form Route of Administration Immediate Packaging
Zrnca za peroralno suspenzijo Peroralna uporaba
Protection starts from 25 days after the last injection and lasts for at least a year.
Zaščita je učinkovita od 25. dne po zadnji injekciji in traja vsaj eno leto.
The first injection is given from three months of age and the second injection is given three weeks later.
Prva injekcija se daje od starosti treh mesecev, druga pa tri tedne pozneje.
After the second injection, animals may show a slight, temporary increase in body temperature of 0.4 ºC, in the 24 hours after vaccination.
Po drugem injiciranju cepiva se lahko pri živalih v prvih 24 urah pojavi rahlo in prehodno povišanje telesne temperature za 0,4 ºC.
Results from a series of laboratory safety trials performed with a vaccine of similar composition containing serotypes 1 and 8 and of studies performed with a vaccine of the same composition but of different serotype, used in sheep were presented in order to extrapolate safety conclusions.
Predstavljeni so bili tudi rezultati niza laboratorijskih študij varnosti z uporabo cepiva s podobno sestavo, ki je vsebovalo serotipa 1 in 8, ter študij, opravljenih pri ovcah s cepivom z enako sestavo, vendar z drugačnim serotipom, da bi pridobili zaključke o varnosti.
The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Bovis on 15 January 2010.
Evropska komisija je dovoljenje za promet s cepivom ZULVAC 8 Bovis, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2010.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Bovis to convert to a normal status.
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 8 Bovis dobi običajen status.
The vaccine is given to animals as an injection in the muscle.
Cepivo se živalim injicira v mišico.
When it is given to cattle, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Ko govedo prejme cepivo, imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
ZULVAC 8 Bovis was initially authorised under ‘exceptional circumstances'.
Cepivo ZULVAC 8 Bovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The vaccine is used to prevent viraemia (the presence of the virus in the blood) in cattle from three months of age.
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) pri govedu, starejšem od treh mesecev.
The studies showed that the vaccine is safe for cattle and that it prevents viraemia in animals from three months of age that are infected with bluetongue virus serotype 8.
Študije so pokazale, da je cepivo varno za uporabo pri govedu in preprečuje viremijo pri živalih, starejših od treh mesecev, ki so okužene z virusom bolezni modrikastega jezika, serotip 8.
The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in calves from two and a half months of age.
Učinkovitost cepiva pri govedu so raziskovali v laboratorijski študiji, pri katerih so cepili teleta, starejša od dveh mesecev in pol.
Another laboratory study looked at the duration of the immunity following vaccination with ZULVAC 8 Bovis.
V drugi laboratorijski študiji so raziskovali trajanje odpornosti po cepljenju s cepivom ZULVAC 8 Bovis.
ZULVAC 8 Bovis is a vaccine that is available as a suspension for injection.
Zdravilo ZULVAC 8 Bovis je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
Other information about ZULVAC 8 Bovis:
Druge informacije o zdravilu ZULVAC 8 Bovis:
ZULVAC 8 Bovis contains bluetongue virus of one type (serotype 8).
Cepivo ZULVAC 8 Bovis vsebuje virus bolezni modrikastega jezika enega tipa (serotipa 8).
ZULVAC 8 Bovis is a vaccine.
Zdravilo ZULVAC 8 Bovis je cepivo.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Bovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in cattle from three months of age.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so pri govedu, starejšem od treh mesecev, koristi cepiva ZULVAC 8 Bovis pri preprečevanju viremije, ki jo povzroča serotip 8 virusa bolezni modrikastega jezika, večje od z njim povezanih tveganj.
The withdrawal period for ZULVAC 8 Bovis for meat and milk is zero days.
Karenca za cepivo ZULVAC 8 Bovis za meso in mleko je nič dni.
What benefit has ZULVAC 8 Bovis shown during the studies?
Kakšne koristi je zdravilo ZULVAC 8 Bovis izkazalo med študijami?
It contains inactivated (killed) bluetongue serotype 8 virus.
Vsebuje inaktiviran (uničen) virus modrikastega jezika, serotip 8.
ZULVAC 8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Cepivo ZULVAC 8 Bovis se uporablja pri govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo povzroča virus bolezni modrikastega jezika, prenašajo pa jo trzače.
ZULVAC 8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Cepivo ZULVAC 8 Bovis vsebuje inaktivirane viruse bolezni modrikastega jezika, ki ne povzročajo bolezni.
What is the risk associated with ZULVAC 8 Bovis?
Kakšna tveganja so povezana z zdravilom ZULVAC 8 Bovis?
The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Bovis in cattle.
Varnost cepiva ZULVAC 8 Bovis je bila raziskana v laboratorijskih študijah varnosti z njegovo uporabo na govedu.
Why has ZULVAC 8 Bovis been approved?
Zakaj je bilo zdravilo ZULVAC 8 Bovis odobreno?
How has ZULVAC 8 Bovis been studied?
Kako je bilo zdravilo ZULVAC 8 Bovis raziskano?
What is ZULVAC 8 Bovis?
Kaj je zdravilo ZULVAC 8 Bovis?
Inactivated vaccine against Bluetongue virus, serotype 8
ZULVAC 8 Bovis inaktivirano cepivo proti virusu bolezni modrikastega jezika, serotip 8
How does ZULVAC 8 Bovis work?
Kako zdravilo ZULVAC 8 Bovis deluje?
What is ZULVAC 8 Bovis used for?
Za kaj se zdravilo ZULVAC 8 Bovis uporablja?
This means that it was not possible to obtain complete information about ZULVAC 8 Bovis at the time of the initial authorisation.
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o tem cepivu.
Date of first authorisation: 16 August 2012 Date of latest renewal:
Datum prve odobritve: 16. avgust 2012 Datum zadnjega podaljšanja:
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.