FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Alvorlige uventede hændelser (SOC, HLT, foretrukket term) opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), i rapporteringsperioden og kumulativt.
English: AESIs will be defined as follows:
Danish: AESI defineres som følgende: - Nervebetændelse:
English: 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.
Danish: 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.
English: Full dose N=34
Danish: fuld dosis n = 34
English: Immunisation should be carried out by intramuscular injection.
Danish: Antigen suspension til injektionsvæske.
English: Seroconversion rate2
Danish: Serokonverteringsrate2
English: Full dose (N=29)
Danish: fuld dosis (n = 29)
English: Full dose (N=27)
Danish: fuld dosis (n = 27)
English: How to store Adjupanrix
Danish: Sådan får du Adjupanrix
English: 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;
Danish: 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;
English: Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Adjupanrix indeholder thiomersal som konserveringsmiddel.
English: 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.
Danish: 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 %
English: 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.
Danish: 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
English: Double dose N=43
Danish: dobbeltdosis n = 43
English: Half dose N=49
Danish: halv dosis n = 49
English: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Danish: A/Vietnam/1194/2004 (H5N1)
English: One dose of 0.5 ml at an elected date.
Danish: En dosis på 0,5 ml gives i.m.
English: Full dose N=42
Danish: fuld dosis n = 42
English: 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.
Danish: 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).
English: Half dose N=43
Danish: halv dosis n = 43
English: Half dose N=40
Danish: halv dosis n = 40
English: Full dose N=44
Danish: fuld dosis n = 44
English: Half dose N=47
Danish: halv dosis n = 47
English: 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.
Danish: 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
English: Half dose N=42
Danish: halv dosis n = 42
English: 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:
Danish: 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:
English: 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;
Danish: 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;
English: 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.
Danish: Hvis dette er nødvendigt, vil vaccinerne blive givet i hver sin arm.
English: The per-dose frequency of adverse reactions was as follows:
Danish: Hyppigheden pr. dosis af bivirkninger er anført i tabellen:
English: Irritability
Danish: Døsighed
English: Suspension and emulsion for emulsion for injection
Danish: Adjupanrix suspension og emulsion til injektionsvæske, emulsion
English: Other medicines and Adjupanrix
Danish: Pakningsstørrelser og yderligere oplysninger Adjupanrix indeholder
English: Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
Danish: Personerne i studie D-Pan-H5N1-002 blev fulgt og undersøgt for et vedvarende immunrespons.
English: Full dose N=43
Danish: fuld dosis n = 43
English: Antigen suspension for
Danish: SUSPENSION HÆTTEGLAS
English: Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Danish: Personerne i studie D-Pan-H5N1-010 blev fulgt og undersøgt for et vedvarende immunrespons.
English: Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Danish: Personerne i studie D-Pan-H5N1-009 blev fulgt og undersøgt for vedvarende immunrespons.
English: Immune response to A/Vietnam/1194/2004 Day 21
Danish: Immunrespons mod A/Vietnam/1194/2004 dag 21 n = 140
English: For adjuvants, see section 2.
Danish: For yderligere oplysninger, se pkt.
English: • Sleeplessness
Danish: • Træthedsfornemmelse
English: • Inflammation of your blood vessels (vasculitis).
Danish: • Betændelse af blodkar.
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Danish: adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1), var anti-HA
English: - Neuritis:
Danish: - Kramper:
English: Vaccine distribution report
Danish: LISTE OVER HJÆLPESTOFFER
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Danish: Tel:+ 39 (0)45 9218 111
English: Rare: may affectless than 1 in 1,000 people
Danish: Ikke almindelige (kan forekomme hos mellem 1 og 10 ud af 1.000 personer):
English: 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.
Danish: Alle spontane hændelser opdelt i aldersgrupper og opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), i rapporteringsperioden og kumulativt.
English: Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Danish: AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1)
English: The seroprotection rate at month 6, 12 and 24 were as follows:
Danish: Seroprotektionsraten ved måned 6, 12 og 24 var følgende: anti-HA-antistof
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Suspension og emulsion til injektionsvæske, emulsion.
English: Day 42 N=46
Danish: 6-9 år dag 42 n = 46
English: Booster seroconversion rate2
Danish: Seroprotektionsrate1 Booster serokonverteringsrate2
English: 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.
Danish: 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.
English: Shivering
Danish: Amning
English: Nervous system disorders Febrile convulsions
Danish: ”Angioødem” - Hjernebetændelse:
English: • Low blood platelet count.
Danish: • Få blodplader i blodet.
English: (* equivalent to titre prior to inactivation)
Danish: (*svarende til titer før inaktivering)
English: 1 dose per year.
Danish: 1 dosis om året.
English: Date of first authorisation: 21/11/2017
Danish: Dato for første markedsføringstilladelse: 21/11/2017
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten/kartonen.
English: Hypersensitivity reactions are very rarely observed.
Danish: Overfølsomhedsreaktioner observeres meget sjældent.
English: It lasted not longer than 24 to 48 hours.
Danish: Denne temperaturstigning varede kun mellem 24 og 48 timer.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Danish: *(Cyklusværdi (Ct) ≥ 36 med en valideret RT-PCR-metode, som ikke indikerer tilstedeværelse af viralt genom)
English: Each ml of vaccine contains:
Danish: En ml vaccine indeholder:
English: 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)
Danish: 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)
English: Name and address of the manufacturer of the biological active substance CZ Veterinaria, S.A.
Danish: Navn og adresse på fremstillere af det biologisk aktive stof CZ Veterinaria, S.A.
English: Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Danish: Ethvert revaccinationsprogram bør godkendes af den ansvarlige myndighed eller den ansvarlige dyrlæge, der tager den lokale epidemiologiske situation i betragtning.
English: 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.
Danish: 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,
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Danish: Effekten hos andre dyrearter kan variere fra den, der er observeret hos får og kvæg.
English: White or pinkish-white.
Danish: Hvid eller rosa-hvid.
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Danish: I visse tilfælde kan tilstedeværelsen af maternelle antistoffer i får, der har den anbefalede minimumsalder, interferere med den af vaccinen inducerede beskyttelse.
English: PSUR submissions for Bovilis Blue-8 shall be synchronised and submitted at the same frequency as for Bluevac BTV8.
Danish: Indsendelser af PSUR for Bovilis Blue-8 skal være synkroniseret og indsendt med same frekvens som Bluevac BTV8.
English: An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Danish: En gennemsnitlig stigning i kropstemperaturen på mellem 0,5 og 1,0 ºC er en almindelig reaktion er observeret hos får og kvæg.
English: Manufacturer responsible for batch release: Intervet UK Ltd
Danish: Fremstiller ansvarlig for batchfrigivelse: Intervet UK Ltd
English: Purified saponin (Quil A)
Danish: Renset saponin (Quil A)
English: Loss of appetite can occur in very rare cases.
Danish: I meget sjældne tilfælde kan der forekomme appetitløshed.
English: 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).
Danish: 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).
English: ATCvet codes:
Danish: ATCvet-kode:
English: 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
Danish: 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
English: Cattle from 2.5 months of age:
Danish: Kvæg fra 2,5-månedersalderen:
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSLER, OM NØDVENDIGT
English: 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.
Danish: Lejlighedsvis kan der observeres en let temperaturstigning (0,5 ºC - 1,0 ºC) i 24-48 timer efter indgivelsen af en dobbeltdosis af vaccinen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette veterinære lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Batch {number}
Danish: Batch: {nummer}
English: The NETHERLANDS
Danish: Holland
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Danish: Der foreligger ingen oplysninger om brugen af vaccinen til seropositive kvæg, herunder dyr med maternelle antistoffer.
English: La Relva s/n, 36400 Porriño
Danish: 36400 Porriño
English: Transient fever was observed in rare cases.
Danish: I sjældne tilfælde er der observeret forbigående feber.
English: The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Danish: Sikkerhed og virkning af vaccinen er endnu ikke fastlagt hos avlshanner (får og kvæg).
English: Aluminium hydroxide Purified saponin (Quil A) Thiomersal
Danish: Aluminiumhydroxid Renset saponin (Quil A) Thiomersal
English: 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.
Danish: hvor tabel 1 i bilaget til Kommissionens Forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller hjælpestoffer som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes som i dette veterinærlægemiddel.
English: 20 days after the second dose.
Danish: 20 dage efter anden dosis.
English: Onset of immunity:
Danish: Immunitetens varighed:
English: Withdrawal period: Zero days
Danish: Tilbageholdelsestid: Nul dage
English: 31 days after the second dose.
Danish: 31 dage efter anden dosis.
English: Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Danish: Fosfatbufferet saltvandsopløsning (natriumchlorid, dinatriumfosfat og kaliumfosfat, vand til injektionsvæsker)
English: Store and transport refrigerated (2 ºC - 8 ºC).
Danish: Opbevares og transporteres nedkølet (2 ºC - 8 ºC).
English: 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.
Danish: I meget sjældne tilfælde, midlertidige lokale reaktioner opstår på injektionsstedet i form af en knude på mellem 0,5 og 1 cm hos får og på mellem 0,5 og 3 cm hos kvæg, som forsvinder i løbet af maksimalt 14 dage og som kan være smertefuldt.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Danish: Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Sheep from 2.5 months of age:
Danish: Får fra 2,5-månedersalderen:
English: Cattle: QI02AA08 / Sheep: QI04AA02 Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Danish: Kvæg: QI02AA08 / Får: QI04AA02 Bovilis Blue-8 stimulerer aktiv immunitet mod bluetonguevirus, serotype 8.
English: Marketing authorisation holder: Intervet International BV
Danish: Indehaver af markedsføringstilladelsen: Intervet International B.V.
English: Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Danish: Bovilis Blue-8 stimulerer aktiv immunitet mod bluetonguevirus, serotype 8.
English: Inactivated BTV8: 106.5 CCID50/ml
Danish: Inaktiveret BTV8: 106,5 CCID50/ml
English: High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.
Danish: Flasker af højdensitetspolyethylen (HDPE) à 52 ml, 100 ml eller 252 ml med bromobutylpropper og aluminiumforsegling.
English: Bovilis Blue-8 suspension for injection for cattle and sheep
Danish: Bovilis Blue-8 suspension til injektion, til kvæg og får
English: Each ml contains: Inactivated BTV8: 106.5 CCID50
Danish: Hver ml vaccine indeholder: Inaktiveret BTV8: 106,5 CCID50
English: Avoid multiple vial broaching.
Danish: Undgå anbrud af flere hætteglas på samme tid.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 52 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske à 52 ml
English: Box with 1 bottle of 52 ml, 100 ml or 252 ml.
Danish: Æske med en flaske à 52 ml, 100 ml eller 252 ml.
English: STATEMENT OF ACTIVE SUBSTANCES
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER
English: PACKAGE LEAFLET: Bovilis Blue-8 suspension for injection for cattle and sheep
Danish: INDLÆGSSEDDEL: Bovilis Blue-8 suspension til injektion, til kvæg og får
English: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Danish: Indgiv to doser på 4 ml subkutant med 3 ugers mellemrum.
English: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Danish: Indgiv to doser på 2 ml subkutant med 3 ugers mellemrum.
English: Bluetongue virus inactivated, serotype 8: 106.5 CCID50* (* equivalent to titre prior to inactivation)
Danish: Inaktiveret bluetonguevirus, serotype 8: 106,5 CCID50* (*svarende til titer før inaktivering)
English: EXP {month/year} Once broached, use within 10 hours.
Danish: Efter anbrud, brug inden for 10 timer.
English: Lactation: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Danish: Laktation: Anvendelse af vaccinen hos diegivende får og køer har ingen negativ indvirkning på mælkeydelsen.
English: Pharmacotherapeutic group: Immunologicals for Bovidae/Ovidae, inactivated bluetongue virus vaccines.
Danish: Farmakoterapeutisk gruppe: Vacciner mod bluetonguevirus, inaktiveret.
English: 0.1 mg For the full list of excipients, see section 6.1.
Danish: 0,1 mg Alle hjælpestoffer er anført under pkt.
English: Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Danish: Wim de Körverstraat 35, 5831 AN Boxmeer HOLLAND
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Danish: Der kan lejlighedsvis forekomme smertefri hævelser med en størrelse på op til 2 cm hos får og på op til 4,5 cm hos kvæg efter en dobbeltdosis.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 252 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske à 100 ml og 252 ml
English: Name and address of the manufacturers responsible for batch release
Danish: SPANIEN Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indre emballage: 10 timer.
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after administration of a double dose.
Danish: Der kan lejlighedsvis forekomme smertefri hævelser med en størrelse på op til 2 cm hos får og på op til 4,5 cm hos kvæg efter indgivelse af en dobbeltdosis.
English: Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml).
Danish: Æske med 1 flaske indeholdende enten 126 fåredoser eller 63 kvægdoser (252 ml)
English: Cardboard box with 1 bottle containing either 26 sheep doses or 13 cattle doses (52 ml).
Danish: Æske med 1 flaske indeholdende enten 26 fåredoser eller 13 kvægdoser (52 ml)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Karton (52 ml, 100 ml og 252 ml)
English: Cardboard box with 1 bottle containing either 50 sheep doses or 25 cattle doses (100 ml).
Danish: Æske med 1 flaske indeholdende enten 50 fåredoser eller 25 kvægdoser (100 ml)
English: Pregnancy: Can be used during pregnancy.
Danish: Drægtighed Kan anvendes under drægtighed