natgillin/translations-raw huggingface dataset:
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
razcepljen virus influence, inaktiviran, ki vsebuje antigene, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek * Antigen: uporabljen sev (NIBRG-14), ki je podoben sevu A/VietNam/1194/2004 (H5N1)
Immune response to A/Indonesia/5/2005 3 to 5 years
Imunski odziv proti A/Indonesia/5/2005 3 do 5 let
Day 42 N=42
42. dan n=42
The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
A/Indonesia/5/2005 21. dni po obnovitvenem cepljenju je bil 100 %, delež serokonverzije po obnovitvenem cepljenju 99,7 % in faktor obnovitve 123,8.
A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose.
preiskovancev 21 dni po prvem odmerku, pri 67,3 % 21 dni po drugem odmerku in pri 44,9 % 6 mesecev po drugem odmerku.
Month N=35
mesec 12 n=35
Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
Preiskovance v D-Pan-H5N1-002 so spremljali glede trajanja imunskega odziva.
Full dose N=34
Polni odmerek n=34
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Adjuvans AS03, ki je sestavljen iz skvalena, DL-α-tokoferola in polisorbata 80.
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, tiomersal ali zaostanke
Common: may affect less than 1 in 10 people
Pogosti: pojavijo se lahko pri manj kot 1 od 10 oseb
Half dose (N=37)
Polovični odmerek (n=37)
Double dose N=43
Dvojni odmerek n=43
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
V klinični študiji (D-Pan-H5N1-012) so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA bodisi iz A/Vietnam/1194/2004 bodisi Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
Half dose (N=47)
Polovični odmerek (n=47)
Posology
protitelesa
There are no data with Adjupanrix using the subcutaneous route.
Podatkov o subkutani uporabi cepiva Adjupanrix ni.
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
povečanja po drugem odmerku ni bilo, ne glede na to, ali so otroci prejeli polovični odmerek za odrasle ali odmerek za odrasle.
Single dose N=49
Enojni odmerek n=49
Full dose (N=29)
Polni odmerek (n=29)
Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Resni neželeni učinki, ki niso navedeni na seznamu (SOC, HLT, PT), stratificirani po vrsti prijave (medicinsko potrjena ali ni medicinsko potrjena), za obdobje, ki ga zajema poročilo, in kumulativno.
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Adjupanrix je na voljo v dveh vsebnikih:
• Sleeplessness
* hemaglutinin
In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows:
V klinični študiji (Q-Pan-H5N1-001), v kateri je 140 preiskovancev, starih od 18 do 60 let, dobilo dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005, je bil odziv anti-HA protiteles naslednji:
Half dose (N=27)
Polovični odmerek (n=27)
• Inflammation of your blood vessels (vasculitis).
• vnetje žil (vaskulitis).
Half dose N=49
Polovični odmerek n=49
Immune response to A/Vietnam/1194/2004 6-9 years 21 days after 2nd dose 6 months after vaccination
Imunski odziv proti A/Vietnam/1194/2004 6 do 9 let 21 dni po 2. odmerku 6 mesecev po cepljenju
Talk to your doctor or nurse before you are given Adjupanrix
Če karkoli od navedenega velja za vas (ali če ste v dvomih) se posvetujte z zdravnikom ali medicinsko sestro preden boste dobili cepivo Adjupanrix.
Half dose N=42
Polovični odmerek n=42
• Sleepiness
• nespečnost.
Half dose N=47
Polovični odmerek n=47
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively.
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 6 mesecev, delež serološke zaščite proti A/Vietnam/1194/2004
Full dose N=44
Polni odmerek n=44
Day 42 N=140
42. dan n=140
Psychiatric disorders
Bolezni živčevja
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively.
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 12 mesecev, delež serološke zaščite proti
• Swollen glands in your neck, armpit or groin
• mravljinčenje ali odrevenelost v rokah ali nogah,
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
Pomožne snovi: natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid voda za injekcije
Rare: may affectless than 1 in 1,000 people
Redki: pojavijo se lahko pri manj kot 1 od 1.000 oseb
Very common: may affect more than 1 in 10 people
Drugi neželeni učinki: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 oseb
Suspension and emulsion for emulsion for injection
FARMACEVTSKA OBLIKA suspenzija in emulzija za emulzijo za injiciranje
Half dose N=40
Polovični odmerek n=40
3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
3Obnovitveni dejavnik; razmerje geometrične sredine titra (GMT) po obnovitvenem odmerku in GMT pred obnovitvenim odmerkom.
Full dose (N=27)
Polni odmerek (n=27)
• Increased sweating, shivering, flu-like symptoms
• občutek toplote, srbenje ali modrica na mestu injiciranja, • močnejše znojenje, drgetanje, gripi podobni simptomi,
It is essentially sodium- and potassium-free.
V bistvu je “brez natrija” in “brez kalija”.
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
haemagglutination inhibition) ≥ 1:40. anti-HA protitelesa
Full dose N=42
Polni odmerek N=42
Half dose N=43
Polovični odmerek n=43
A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
4-kraten porast titra nevtralizirajočih protiteles v serumu proti A/Indonesia/5/2005 so ugotovili pri
Full dose N=43
Polni odmerek n=43
• Aching muscles, joint pain
• bolečine v mišicah, bolečine v sklepih.
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (antiHA) antibody responses were as follows:
3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 pri preiskovancih starih 18-60 let, so bili odzivi antihemaglutininskih (anti-HA) protiteles naslednji:
The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Po mešanju je količina cepiva Adjupanrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
Contents of the pack and otherinformation
Shranjevanje cepiva Adjupanrix Vsebina pakiranja in dodatne informacije
Other side effects:
• Zdravilna učinkovina:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for
IME ZDRAVILA IN POT(I) UPORABE Emulzija adjuvansa za cepivo Adjupanrix i.m.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
In another clinical study (D-Pan-H5N1-038), 387 subjects aged 18-60 years received 1 dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 36 months after they had received two doses of A/Vietnam/1194/2004.
V klinični študiji (D-Pan-H5N1-038) je 387 preiskovancev, starih od 18 do 60 let, prejelo 1 odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 36
Booster seroconversion rate2
Delež serokonverzije2 Faktor serokonverzije3
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition) ≥ 1:40;
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 92.0% and 100%, respectively.
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 12 mesecev,
Immune response to A/Vietnam/1194/2004 Day 21
Imunski odziv proti A/Vietnam/1194/2004
This medicinal product has been authorised under ‘exceptional circumstances'.
Navodilo je bilo nazadnje revidirano dne Zdravilo je pridobilo dovoljenje za promet v 'izjemnih okoliščinah'.
Uncommon: insomnia
Psihiatrične motnje Občasni: nespečnost
In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
V drugi klinični študiji (D-Pan-H5N1-015) je 39 preiskovancev, starih od 18 do 60 let, dobilo cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz
Full dose
Polni odmerek za odrasle
Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Imunski odziv proti A/Vietnam/1194/2004 21. dan n = 140
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
Emulzijo morate pred uporabo zmešati izključno s suspenzijo antigena.
Split influenza virus inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Suspenzija antigena za cepivo Adjupanrix sev (NIBRG-14) podoben sevu A/VietNam/1194/2004 (H5N1) i.m.
Seropositivity rate2
Delež seropozitivnosti2
A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms** per 0.5 ml dose
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo: uporabljenemu sevu (NIBRG-14), ki je podoben sevu A/Vietnam/1194/2004 (H5N1) 3,75 mikrogramov**na 0,5 ml odmerek * namnožen v jajcih ** izražen v mikrogramih hemaglutinina
AESIs will be defined as follows:
Pogostnosti so navedene kot:
Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Delež serološke zaščite1 1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI
Immune response to A/Vietnam/1194/2004 6 months after the 1st dose
Imunski odziv proti A/Vietnam/1194/2004 6 mesecev po prvem odmerku n=256
In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Otroci, stari od 3 do 9 let V klinični študiji (D-Pan-H5N1-009) so otroci, stari od 3 do 5 in od 6 do 9 let, dvakrat dobili bodisi polni odmerek (0,5 ml) bodisi polovični odmerek (0,25 ml) cepiva z adjuvansom AS03 z vsebnostjo
Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Delež serološke zaščite1 1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
2Delež serokonverzije: delež preiskovancev, ki so bili seronegativni pred cepljenjem in imajo zaščitni titer po cepljenju ≥1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra.
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 6 months apart were 83.3% and 100%, respectively.
6 mesecev, delež serološke zaščite 83,3 % in delež odziva na cepivo 100 %.
2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre;
2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra;
Seroconversion factor
Obnovitveni delež serokonverzije2
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension and emulsion to be mixed before administration
Suspenzijo in emulzijo morate pred uporabo zmešati skupaj.
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40.
Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
Imunski odziv proti A/Vietnam/1194/2004 (D42)
(* equivalent to titre prior to inactivation)
(* ekvivalentno titru pred inaktivacijo)
1 dose per year.
En odmerek na leto.
Each ml of vaccine contains:
Vsak ml cepiva vsebuje:
Milton Keynes, MK7 7AJ UK
Milton Keynes, MK7 7AJ ZDRUŽENO KRALJESTVO
White or pinkish-white.
Bela ali rozasto-bela.
{DD/MM/YYYY}
{DD/MM/LLLL}
Date of first authorisation: 21/11/2017
Datum pridobitve dovoljenja za promet: 21/11/2017
0.1 mg For the full list of excipients, see section 6.1.
0,1 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Transient fever was observed in rare cases.
Prehodno vročino so opazili v redkih primerih.
Hypersensitivity reactions are very rarely observed.
Zelo redko so opazili preobčutljivostne reakcije.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
*(vrednost v krvnem obtoku (Ct) ≥ 36 po validirani metodi RT-PCR, ki kaže na odsotnost kužnega virusa)
Thiomersal
tiomersal
It lasted not longer than 24 to 48 hours.
Povišana telesna temperatura traja od 24 do 48 ur.
Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Za vsako revakcinacijo mora dati soglasje pristojni organ ali odgovorni veterinar, upoštevajoč lokalno epidemiološko situacijo.
In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Pri tej kategoriji živali je treba uporabiti cepivo samo na podlagi ocene razmerja korist-tveganje odgovornega veterinarja in/ali nacionalnega pristojnega organa, odvisno od veljavnega programa cepljenja proti virusu bolezni modrikastega jezika (BTV).
Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Včasih lahko maternalna protitelesa pri ovcah minimalne priporočene starosti ovirajo zaščito, ki jo povzroči cepivo.
Duration of immunity: 1 year after the second dose.
Trajanje imunosti: 1 leto po drugem odmerku.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Če cepivo uporabite pri drugih domačih in divjih vrstah prežvekovalcev, za katere menite, da jih ogroža okužba, je treba cepivo uporabiti previdno in ga pred masovnim cepljenjem testirati na majhnem številu živali.
Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Tega zdravila ne smete uporabljati po datumu izteku roka uporabnosti, navedenega na nalepki/škatli.
PSUR submissions for Bovilis Blue-8 shall be synchronised and submitted at the same frequency as for Bluevac BTV8.
PSUR poročila za Bovilis Blue-8 se sinhronizirajo in oddajajo enako pogosto kot za Bluevac BTV8.
No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Ni podatkov o uporabi cepiva pri seropozitivnem govedu, vključno s tistimi z maternalnimi protitelesi.
An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Povprečno povišanje telesne temperature, ki varira med 0,5 in 1,0 °C, je pogosta reakcija pri ovcah in govedu.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.
Manufacturer responsible for batch release: Intervet UK Ltd
Proizvajalec, odgovoren za sproščanje serij: Intervet UK Ltd
Sheep from 2.5 months of age:
Ovce od 2,5 mesecev starosti:
Cattle from 2.5 months of age:
Govedo od 2,5 mesecev starosti:
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da: a) bi uporaba zdravila 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.
Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
V zelo redkih primerih se pojavijo začasne lokalne reakcije na mestu injiciranja, v obliki bule premera 0,5 do 1 cm pri ovcah in 0,5 do 3 cm pri govedu, ki pa izgine najkasneje v 14 dneh in ki je lahko boleča.V zelo redkih primerih lahko pride tudi do izgube teka.
Store and transport refrigerated (2 ºC - 8 ºC).
Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC).
The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Varnost in učinkovitost cepiva nista bili dokazani pri plemenskih samcih (ovce in govedo).
Purified saponin (Quil A)
6 mg prečiščen saponin (Quil A)
Inactivated BTV8: 106.5 CCID50/ml
Inaktiviran BTV8: 106,5 CCID50/ml
Each ml contains: Inactivated BTV8: 106.5 CCID50
Vsak ml vsebuje: Inaktiviran BTV8: 106,5 CCID50
Cattle and sheep
Govedo in ovce.
Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Bovilis Blue-8 vzbuja aktivno imunost proti serotipu 8 virusa bolezni modrikastega jezika.
Package sizes:
Velikosti pakiranj:
Pharmacotherapeutic group: Immunologicals for Bovidae/Ovidae, inactivated bluetongue virus vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae) /ovce, inaktivirano virusno cepivo proti bolezni modrikastega jezika
Pregnancy: Can be used during pregnancy.
Brejost: Cepivo se lahko uporablja v obdobju brejosti.
Bovilis Blue-8 suspension for injection for cattle and sheep
Bovilis Blue-8 suspenzija za injiciranje za govedo in ovce
Can be used during pregnancy.
Cepivo se lahko uporablja v obdobju brejosti.
Marketing authorisation holder: Intervet International BV
Imetnik dovoljenja za promet z zdravilom: Intervet International BV
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Po cepljenju z dvojnim odmerkom se občasno pojavi rahlo povišanje temperature (0,5 ºC do 1,0 ºC), ki traja 24 do 48 ur.
Bluetongue virus inactivated, serotype 8: 106.5 CCID50* (* equivalent to titre prior to inactivation)
virus modrega jezika, inaktiviran, serotip 8: 106,5 CCID50* (*ekvivalentno titru pred inaktivacijo)
Administer two doses of 2 ml subcutaneously with a 3 week interval.
Dva odmerka po 2 ml subkutano s tritedenskim razmikom.
Administer two doses of 4 ml subcutaneously with a 3 week interval.
Dva odmerka po 4 ml subkutano s tritedenskim razmikom.
High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.
Plastenke iz polietilena visoke gostote (HDPE) po 52 ml, 100 ml ali 252 ml z bromobutilnimi zamaški in aluminijastimi zaporkami.
EXP {month/year} Once broached use within 10 hours.
EXP {mesec/leto} Načeto zdravilo uporabite v 10 urah.