natgillin/translations-raw huggingface dataset:
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)
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)
Andre bivirkninger
Other side effects:
Data fra pandemisk beredskabsvaccinationen vil støtte den vaccinationsstrategi, der sandsynligvis vil blive anvendt til den pandemiske vaccine.
Data obtained with the pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
En oversigt over alle spontane hændelser efter organklasse (SOC), High Level Term (HLT) og foretrukket term (PT), opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), og indeholdende antal af fatale rapporter, i rapporteringsperioden og kumulativt.
An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or nonmedically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
enkeltdosis n = 13
Single dose N=13
- to pakker med 25 hætteglas (type I-glas), hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi).
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
21 dage efter anden dosis n = 924
21 days after 2nd dose N = 924
Der findes ingen data fra subkutan administration med Adjupanrix.
There are no data with Adjupanrix using the subcutaneous route.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Emulsionen skal sammenblandes med antigen, suspension før administration.
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
fuld dosis (n = 41)
Full dose (N=41)
fuld dosis (n = 35)
Full dose (N=35)
fuld dosis n = 35
Full dose N=35
7 dage efter anden dosis n = 47
7 days after 2nd dose N = 47
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststofferne (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine.
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
dobbeltdosis n = 54
Double dose N=54
Du må ikke få Adjupanrix:
Adjupanrix should not be given
Før injektion skal de to væsker sammenblandes.
Before the vaccine is given, the two parts will be mixed together.
Seroprotektionsrate1 1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Snæver SMQ ”Kramper”
narrow SMQ “Convulsions”
LÆGEMIDLETS NAVN Emulsion til Adjupanrix injektionsvæske, emulsion
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Adjupanrix
Split influenzavirus, inaktiveret, indeholdende antigen svarende til: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)
Split influenza virus inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Meget almindelig: hovedpine Ikke almindelig: paræstesi, somnolens, svimmelhed
Uncommon: paraesthesia, somnolence, dizziness
halv dosis n = 36
Half dose N=36
- Demyelinering:
- Encephalitis:
Immunrespons mod A/Indonesia/05/2005
Immune response to A/Indonesia/05/2005
Immunrespons mod A/Vietnam/1194/2004 6-9 år
Immune response to A/Vietnam/1194/2004 6-9 years
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Adjupanrix i.m.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for
halv dosis n = 38
Half dose N=38
Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat Kaliumchlorid Magnesiumchlorid Vand til injektionsvæsker
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
Immunrespons mod A/Vietnam/1194/2004 3-5 år
Immune response to A/Vietnam/1194/2004 3-5 years
fuld dosis (n = 34)
Full dose (N=34)
Immunrespons mod A/Indonesia/5/2005 3-5 år
Immune response to A/Indonesia/5/2005 3 to 5 years
Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved administrationsstedet, rødme og feber) efter anden dosis til børn under 6 år blev observeret i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik zoonotisk influenzavaccine (H5N1 A/Indonesien/05/2005 fremstillet i Dresden, Tyskland).
In other clinical studies where children 6 months to 17 years received zoonotic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
fuld dosis n = 27
Full dose N=27
fuld dosis (n = 26)
Full dose (N=26)
LÆGEMIDLETS NAVN Suspension til Adjupanrix injektionsvæske, emulsion
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Adjupanrix
Immunrespons mod A/Indonesia/5/2005 6-9 år måned 6
Immune response to A/Indonesia/5/2005 6 to 9 years
• Søvnløshed
• Sleepiness
Feberkramper
Breast-feeding
halv dosis n = 37
Half dose N=37
Den neutraliserende antistoftiter 12 og 24 måneder efter vaccination var følgende:
Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
I et andet klinisk studie (D-Pan-H5N1-038) fik 387 personer i alderen 18-60 år én dosis AS03adjuveret vaccine indeholdende 3,75 µg HA fra A/Indonesia/5/2005 36 måneder efter at have fået to doser indeholdende A/Vietnam/1194/2004.
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.
I et klinisk studie (Q-Pan-H5N1-001), hvor 140 personer i alderen 18-60 år fik to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21, var anti-HAantistofresponset følgende:
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:
fuld dosis n = 26
Full dose N=26
Spørg din læge eller sygeplejersken, hvis der er noget, du er i tvivl om, før du får denne vaccine.
If you are not sure, talk to your doctor or nurse before having this vaccine.
21 dage efter den anden dosis var seroprotektionsraten og vaccineresponsraten henholdsvis 83,3 % og 100 % for personer, som havde modtaget vaccinen med 6 måneders interval.
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.
enkeltdosis n = 49
Single dose N=49
1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40;
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Suspensionen skal sammenblandes med adjuvans, emulsion før administration.
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat Kaliumchlorid Vand til injektionsvæsker
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
halv dosis (n = 27)
Half dose (N=27)
halv dosis (n = 37)
Half dose (N=37)
halv dosis (n = 47)
Half dose (N=47)
21 dage efter den anden dosis var seroprotektionsraten og vaccineresponsraten henholdsvis 84,0 % og 100 % for personer, som havde modtaget vaccinen med 12 måneders interval.
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.
I et andet klinisk studie (D-Pan-H5N1-010) fik 297 personer over 60 år (stratificeret i grupper fra 6170 år, 71-80 år og > 80 år) enten en enkelt- eller en dobbeltdosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) på dag 0 og 21.
In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
For at lette udtagningen af al adjuvans i hætteglasset skal hætteglasset holdes med bunden opad.
The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
I et klinisk studie (D-Pan-H5N1-012) fik personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra enten A/Vietnam/1194/2004 eller A/Indonesia/05/2005 6 måneder efter administration af en eller to primære doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på henholdsvis dag 0 eller på dag 0 og 21.
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.
Alvorlige uventede hændelser (SOC, HLT, foretrukket term) opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), i rapporteringsperioden og kumulativt.
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.
AESI defineres som følgende: - Nervebetændelse:
AESIs will be defined as follows:
Alle spontane hændelser (SOC, HLT, foretrukket term) hos gravide opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), i rapporteringsperioden og kumulativt.
All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
fuld dosis n = 34
Full dose N=34
Antigen suspension til injektionsvæske.
Immunisation should be carried out by intramuscular injection.
Serokonverteringsrate2
Seroconversion rate2
fuld dosis (n = 29)
Full dose (N=29)
fuld dosis (n = 27)
Full dose (N=27)
Sådan får du Adjupanrix
How to store Adjupanrix
1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40; 2 serokonverteringsrate: andelen af personer, som enten var seronegative før vaccination og opnår en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnår en firdobbelt stigning af titer;
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 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;
Adjupanrix indeholder thiomersal som konserveringsmiddel.
Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
I et andet studie (D-Pan-H5N1-007) med 50 personer i alderen 18-60 år var anti-HA-antistofseroprotektionsraten 20 % mod A/Indonesia/05/2005 21 dage efter den anden dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004, 35 % mod A/Anhui/01/2005 og 60 %
In a different study (D-Pan-H5N1-007) in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne > 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
dobbeltdosis n = 43
Double dose N=43
halv dosis n = 49
Half dose N=49
A/Vietnam/1194/2004 (H5N1)
A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
En dosis på 0,5 ml gives i.m.
One dose of 0.5 ml at an elected date.
fuld dosis n = 42
Full dose N=42
Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved injektionsstedet, rødme og feber) hos børn under 6 år blev set i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik en lignende pandemisk influenzavaccine (A/Indonesien/05/2005).
In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
halv dosis n = 43
Half dose N=43
halv dosis n = 40
Half dose N=40
fuld dosis n = 44
Full dose N=44
halv dosis n = 47
Half dose N=47
Hos 297 personer i alderen over 60 år var anti-HA-antistof-serobeskyttelsen og serokonverteringsraten 23 % mod A/Indonesia/05/2005 på dag 42 efter to doser AS03-adjuveret vaccine indeholdende 3,75
In 297 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
halv dosis n = 42
Half dose N=42
A/Indonesia/05/2005 på dag 0 og 21 til 140 personer i alderen 18-60 år var anti-HA-antistof-respons mod A/Vietnam/1194/2004 følgende:
After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
2 serokonverteringsrate: andelen af personer, som enten var seronegative før vaccination og opnår en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnår en firdobbelt stigning af titer;
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;
Hvis dette er nødvendigt, vil vaccinerne blive givet i hver sin arm.
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
Hyppigheden pr. dosis af bivirkninger er anført i tabellen:
The per-dose frequency of adverse reactions was as follows:
Døsighed
Irritability
Adjupanrix suspension og emulsion til injektionsvæske, emulsion
Suspension and emulsion for emulsion for injection
Pakningsstørrelser og yderligere oplysninger Adjupanrix indeholder
Other medicines and Adjupanrix
Personerne i studie D-Pan-H5N1-002 blev fulgt og undersøgt for et vedvarende immunrespons.
Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
fuld dosis n = 43
Full dose N=43
SUSPENSION HÆTTEGLAS
Antigen suspension for
Personerne i studie D-Pan-H5N1-010 blev fulgt og undersøgt for et vedvarende immunrespons.
Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Personerne i studie D-Pan-H5N1-009 blev fulgt og undersøgt for vedvarende immunrespons.
Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Immunrespons mod A/Vietnam/1194/2004 dag 21 n = 140
Immune response to A/Vietnam/1194/2004 Day 21
For yderligere oplysninger, se pkt.
For adjuvants, see section 2.
• Træthedsfornemmelse
• Sleeplessness
• Betændelse af blodkar.
• Inflammation of your blood vessels (vasculitis).
adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1), var anti-HA
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
- Kramper:
- Neuritis:
LISTE OVER HJÆLPESTOFFER
Vaccine distribution report
Tel:+ 39 (0)45 9218 111
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Ikke almindelige (kan forekomme hos mellem 1 og 10 ud af 1.000 personer):
Rare: may affectless than 1 in 1,000 people
Alle spontane hændelser opdelt i aldersgrupper og opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), i rapporteringsperioden og kumulativt.
All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1)
Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Seroprotektionsraten ved måned 6, 12 og 24 var følgende: anti-HA-antistof
The seroprotection rate at month 6, 12 and 24 were as follows:
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Suspension og emulsion til injektionsvæske, emulsion.
PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
6-9 år dag 42 n = 46
Day 42 N=46
Seroprotektionsrate1 Booster serokonverteringsrate2
Booster seroconversion rate2
A/Vietnam/1194/2004 (H5N1) fik børn i alderen 3-5 år og 6-9 år administreret fuld dosis (0,5 ml) på dag 0 og dag 21 eller administreret halv dosis (0,25 ml) på dag 0 og dag 21.
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.
Amning
Shivering
”Angioødem” - Hjernebetændelse:
Nervous system disorders Febrile convulsions
• Få blodplader i blodet.
• Low blood platelet count.
(*svarende til titer før inaktivering)
(* equivalent to titre prior to inactivation)
1 dosis om året.
1 dose per year.
Dato for første markedsføringstilladelse: 21/11/2017
Date of first authorisation: 21/11/2017
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten/kartonen.
Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Overfølsomhedsreaktioner observeres meget sjældent.
Hypersensitivity reactions are very rarely observed.
Denne temperaturstigning varede kun mellem 24 og 48 timer.
It lasted not longer than 24 to 48 hours.
*(Cyklusværdi (Ct) ≥ 36 med en valideret RT-PCR-metode, som ikke indikerer tilstedeværelse af viralt genom)
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
En ml vaccine indeholder:
Each ml of vaccine contains:
Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjældne (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Navn og adresse på fremstillere af det biologisk aktive stof CZ Veterinaria, S.A.
Name and address of the manufacturer of the biological active substance CZ Veterinaria, S.A.
Ethvert revaccinationsprogram bør godkendes af den ansvarlige myndighed eller den ansvarlige dyrlæge, der tager den lokale epidemiologiske situation i betragtning.
Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or 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.
Effekten hos andre dyrearter kan variere fra den, der er observeret hos får og kvæg.
The level of efficacy for other species may differ from that observed in sheep and cattle.
Hvid eller rosa-hvid.
White or pinkish-white.
I visse tilfælde kan tilstedeværelsen af maternelle antistoffer i får, der har den anbefalede minimumsalder, interferere med den af vaccinen inducerede beskyttelse.
Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Indsendelser af PSUR for Bovilis Blue-8 skal være synkroniseret og indsendt med same frekvens som Bluevac BTV8.
PSUR submissions for Bovilis Blue-8 shall be synchronised and submitted at the same frequency as for Bluevac BTV8.
En gennemsnitlig stigning i kropstemperaturen på mellem 0,5 og 1,0 ºC er en almindelig reaktion er observeret hos får og kvæg.
An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Fremstiller ansvarlig for batchfrigivelse: Intervet UK Ltd
Manufacturer responsible for batch release: Intervet UK Ltd
Renset saponin (Quil A)
Purified saponin (Quil A)
I meget sjældne tilfælde kan der forekomme appetitløshed.
Loss of appetite can occur in very rare cases.
Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetonguevirus (BTV).
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).
ATCvet-kode:
ATCvet codes:
BILAG II A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
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