natgillin/translations-raw huggingface dataset:
Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat. 
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
- Lægen har ordineret Avandia til dig personligt. 
- This medicine has been prescribed for you.
Jernoxid rød E172 
Iron oxide red E172
EU/1/00/137/013 168 filmovertrukne tabletter 
EU/1/00/137/013 168 tablets
EU/1/00/137/016 180 filmovertrukne tabletter 
EU/1/00/137/016 180 tablets
Indholdsstofferne kan blive udskilt i modermælken 
The ingredients may pass into breast milk and so may harm your baby.
7, 28, 56, 84, 90 eller 112 filmovertrukne tabletter eller 56 filmovertrukne tabletter, enkeltdosispakning. 
7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
Avandia kan tages sammen med et måltid eller på tom mave. 
You can take Avandia with or without food.
Hvis du har glemt at tage Avandia 
BEFORE YOU TAKE AVANDIA
Nedsat leverfunktion, primært kommet til udtryk ved forhøjede leverenzymer5 
Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare
EU/1/00/137/003 112 filmovertrukne tabletter 
EU/1/00/137/003 112 tablets
MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet er receptpligtigt. 
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
EU/1/00/137/002 56 filmovertrukne tabletter 
EU/1/00/137/002 56 tablets
Tabletterne findes i blisterpakninger indeholdende 7, 28, 56, 84, 90 og 112 filmovertrukne tabletter eller som 56 filmovertrukne tabletter i enkeltdosis blister (unit dose). 
The tablets are provided in blister packs containing 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets in a unit dose pack.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, 
Î Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Almindelig Almindelig leukopeni trombocytopeni granulocytopeni 
Common thrombocytopaenia
Forekomsten er højere ved 8 mg rosiglitazon sammenlignet med 4 mg rosiglitazon (som total daglig dosis). 
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Det kan være nødvendigt at øge overvågningen af patienten og at reducere dosis af sulfonylurinstof/insulin. 
Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
LÆGEMIDLETS NAVN AVANDIA 8 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets.
• mavesmerter 
• constipation
EU/1/00/137/004 56 filmovertrukne tabletter, enkeltdosispakning 
EU/1/00/137/004 56 tablet unit dose pack
I kliniske undersøgelser med rosiglitazon har der været evidens for dosis-relateret vægtøgning. 
In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Det er ikke sikkert, at Avandia er den rigtige behandling til dig. 
Î Check with your doctor, as Avandia may not be suitable for you.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
Filmovertrukken tablet Orange filmovertrukne tabletter præget med "GSK" på den ene side og "4" på den anden side. 
Orange film-coated tablets debossed with “GSK” on one side and "4" on the other side.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 2 mg rosiglitazon. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone.
Filmovertrukken tablet Lyserøde filmovertrukne tabletter præget med "GSK" på den ene side og "2" på den anden side. 
Pink film-coated tablets debossed with “GSK” on one side and "2" on the other side.
Patienter med nedsat nyrefunktion (se afsnit 4.4 Væskeretention og hjerteinsufficiens): 
Patients with renal impairment (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in patients with mild and moderate renal insufficiency.
LÆGEMIDLETS NAVN AVANDIA 2 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets.
LÆGEMIDLETS NAVN AVANDIA 4 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets.
Hjerte hjerteinsufficiens2 
• heart failure
Fortæl det til din læge eller på apoteket, hvis du tager nogen af disse. 
Check with your doctor or pharmacist if you are not sure.
Som tripel-kombinationsbehandling med - metformin og et sulfonylurinstof, til patienter (særligt overvægtige patienter) med insufficient glykæmisk kontrol trods kombinationsbehandling (se afsnit 4.4). 
as monotherapy - in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with - metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Vægtøgningen var større, når rosiglitazon blev anvendt i kombination med insulin. 
Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin.
Lactosemonohydrat 
Myocardial Ischaemia
Filmovertrukken tablet Rødbrune filmovertrukne tabletter præget med "GSK" på den ene side og "8" på den anden side. 
Red-brown film-coated tablets debossed with “GSK” on one side and "8" on the other side.
Hvis du holder op med at tage Avandia 
Don't stop taking Avandia
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien. 
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Mikrokrystallinsk cellulose Lactosemonohydrat Magnesiumstearat 
Lactose monohydrate Glycerol triacetate
Almene symptomer og reaktioner på administrationsstedet ødem 
General disorders and administration site conditions oedema
Indehaveren af markedsføringstilladelsen: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien. 
Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018 
MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
LÆGEMIDLETS NAVN AVANDIA 8 mg tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg tablets rosiglitazone
Avandia 2 mg tabletter er lyserøde og præget ”GSK” på den ene side og ”2” på den anden. 
What Avandia looks like and contents of the pack Avandia 2 mg tablets are pink and marked "GSK" on one side and "2" on the other.
LÆGEMIDLETS NAVN AVANDIA 2 mg tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg tablets rosiglitazone
Øjne Makulaødem 
Eye disorders
LÆGEMIDLETS NAVN AVANDIA 4 mg tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg tablets rosiglitazone
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Storbritannien. 
MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
• hævet og kløende udslæt (nældefeber) 
• chest pain (angina)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder rosiglitazonmaleat svarende til 2 mg rosiglitazon 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone
LÆGEMIDLETS NAVN AVANDIA 8 mg filmovertrukne tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets rosiglitazone
LÆGEMIDLETS NAVN AVANDIA 4 mg filmovertrukne tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets rosiglitazone
Filmovertræk (Opadry lyserød OY-L-24802): Hypromellose 6cP 
Film coating (Opadry pink OY-L-24802):
LÆGEMIDLETS NAVN AVANDIA 2 mg filmovertrukne tabletter rosiglitazon 
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets rosiglitazone
Tripel-kombinationsbehandling 
Triple oral therapy
Meget 
Others
Oversigt over indlægssedlen: Det skal du vide, før du begynder at tage Avandia 
What Avandia is and what it is used for Before you take Avandia How to take Avandia Possible side effects
Hudreaktioner (for eksempel nældefeber, kløe, udslæt) 
Very rare skin reactions (e.g. urticaria, pruritus, rash)
GlaxoSmithKline Pharmaceuticals S.A. Tel.: + 48 (0)22 576 9000 
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Exp 
Excipient
Almindelig Almindelig leukopeni trombocytopeni agranulocytose 
Common hypertriglyceridaemia Common
− nedsat leverfunktion 
Weight gain
ATC kode: QI04AA02. 
ATCvet code QI04AA02.
Revaccination Årligt. 
Revaccination Annual.
Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum. 
The periodic safety update report (PSUR) cycle should be re-started for submission of 6 monthly reports (covering all authorised presentations of this product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Indehaveren af markedsføringstilladelsen bør anvende et passende system til kvantificering af de aktive ingredienser så hurtigt som muligt ved blandestadiet. 
The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.
En injektion: fra 1-månedsalderen hos naive dyr (eller fra 2,5 måneders-alderen for dyr født af immune får). 
One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Anvendelse af dette veterinærlægemiddel kan kun tillades under særlige omstændigheder fastsat af det europæiske fællesskabs lovgivning om kontrol med bluetongue. 
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Opbevaringstid for det veterinære lægemiddel i salgspakning: 18 måneder. 
Shelf life of the veterinary medicinal product as package for sale: 18 months.
Effektiviteten hos andre dyrearter kan variere fra den, der er observeret hos får. 
The level of efficacy for other species may differ from that observed in sheep.
De aktive stoffer, der hovedsageligt er af biologisk oprindelse med det formål at give aktiv immunitet, er ikke omfattet af Forordning (EF) nr. 470/2009. 
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af det immunologiske veterinærlægemiddel på hele eller en del af sit område, hvis det godtgøres: 
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States 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 their territory if it is established that:
Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel. 
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.
a) at behandling af dyr med lægemidlet 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 national programmes for the diagnosis, control and 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.
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Storbritannien 
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ UNITED KINGDOM
Forbigående temperaturforhøjelse, der normalt ikke overstiger et gennemsnit på 1,1oC, kan forekomme inden for 24 timer efter vaccination. 
A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Dette lægemiddel må ikke anvendes efter den udløbsdato, der er angivet på æsken eller etiketten efter EXP. 
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN 
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES 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
Navn og adresse på fremstillerne af det biologisk aktive stoffer 
Name and address of the manufacturers of the biological active substances
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet (2°C - 8°C). 
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
Immunitetens varighed:1 år efter primær vaccinations program. 
The duration of immunity is 1 year after primary vaccination course.
Adjuvanser: Aluminiumhydroxid 
Aluminium hydroxide
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Frankrig 
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest FRANCE
Særlige forsigtighedsregler vedrørende brug til dyr: Vacciner kun raske dyr. 
Special precautions for use in animals: Vaccinate healthy animals only.
Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af BTVPUR AlSap 2-4 er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning. 
The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Silikone antifoam Fosfatbuffer Glycinbuffer Aluminiumhydroxid Saponin 
Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.
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 bluetongue virus (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).
Farmakoterapeutisk gruppe: Inaktiveret bluetonguevirus vaccine, til får. 
Pharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep.
**hæmolytiske enheder Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer. 
**Haemolytic units For the full list of excipients, see section 6.1.
Immunitet er påvist 3 og 5 uger efter basisvaccinationsprogrammet for henholdsvis serotype 4 og serotype 2. 
Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende BTVPUR Alsap 2-4 skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted. 
Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vaccination kan forårsage en mindre lokal hævelse på injektionsstedet (max. 24 cm2) i en kort periode (max. 14 dage). 
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm2) for a short period (at most 14 days).
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske à 10 eller 50 ml 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 or 50 ml
* under detektionsgrænsen for den validerede RT-PCR metode på 3,68 log10 RNA-kopier/ml, der indikerer, at der ikke er nogen infektiøs virustransmission.. 
*below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Opbevaringstid efter første åbning af den indre emballage: Anvendes umiddelbart. 
Shelf life after first opening the immediate packaging: use immediately.
Anvendelse under drægtighed, laktation: Kan anvendes under drægtighed og laktation. 
Pregnancy and lactation: Can be used during pregnancy and lactation.
*(under detektionsgrænsen for den validerede RT-PCR- metode på 3,68 log10 RNA-kopier/ml, der indikerer, at der ikke er nogen infektiøs virustransmission). 
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/108/005 
MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/005
30 HU** *Cell culture infectious dose 50% svarende til titer før inaktivering (log10) **hæmolytiske enheder 
*Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
Polypropylenflaske à 50 eller 100 ml med butylelastomer-prop 
Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
Den inducerer en aktiv og specifik immunitet over for bluetonguevirus serotype 2 og 4 i vaccinerede dyr. 
It induces an active and specific immunity against bluetongue virus serotypes 2 and 4 in the vaccinated animals.
Aktiv immunisering af får for at forebygge viræmi* og nedsætte kliniske symptomer forårsaget af bluetonguevirus serotype 2 og 4. 
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
50 doser (50 ml) 
50 doses (50 ml)
ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver dosis på 1 ml vaccine indeholder: 
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1ml of vaccine contains:
Vaccinen indeholder inaktiveret bluetonguevirus serotype 2 og 4 med aluminiumhydroxid og saponin som adjuvans. 
The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants.
INDLÆGSSEDDEL: BTVPUR AlSap 2-4 suspension til injektion til får 
PACKAGE LEAFLET FOR: BTVPUR AlSap 2-4 suspension for injection for sheep
Får. 
Sheep
VETERINÆRLÆGEMIDLETS NAVN BTVPUR AlSap 2-4 suspension til injektion til får. 
NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/108/001 (1 flaske á 100 ml) EU/2/10/108/002 (10 flasker á 100 ml) 
MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
PAKNINGSSTØRRELSE 10 doser (10 ml) 
PACKAGE SIZE 10 doses (10 ml)
Efter en dobbeltdosis med vaccinen er der ikke observeret andre bivirkninger end dem, der er nævnt i sektion 4.6. 
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOFFER OG FREMSTILLER 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bluetongue virus serotype 2 antigen ............................................................................. 6,8 - 9,5 CCID50* Bluetongue virus serotype 4 antigen ............................................................................. 7,1 - 8,5 CCID50* Aluminiumhydroxid 
Bluetongue virus serotype 2 antigen .............................................................................. 6.8-9.5 CCID50*, Bluetongue virus serotype 4 antigen .............................................................................. 7.1-8.5 CCID50*, Aluminium hydroxide
EU/2/10/108/003 (1 flaske á 50 ml) EU/2/10/108/004 (10 flasker á 50 ml) EU/2/10/108/001 (1 flaske á 100 ml) EU/2/10/108/002 (10 flasker á 100 ml) 
EU/2/10/108/003 (1 bottle of 50 ml) EU/2/10/108/004 (10 bottles of 50 ml) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
10 flasker à 50 doser (10 x 50 ml) 100 doser (100 ml) 10 flasker à 100 doser (10 x 100 ml) 
10 bottles of 50 doses (10 x 50 ml) 100 doses (100 ml) 10 bottles of 100 doses (10 x 100 ml)
Æske med 1 flaske à 50 ml Eller med 10 flasker à 50 ml Eller med 1 flaske à 100 ml Eller med 10 flasker à 100 ml 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 1 bottle of 50 ml, or of 10 bottles of 50 ml, or of 1 bottle of 100 ml, or of 10 bottles of 100 ml
Æske med 1 flaske à 50 doser (1 x 50 ml) Æske med 10 flasker à 50 doser (10 x 50 ml) Æske med 1 flaske à 100 doser (1 x 100 ml) Æske med 10 flasker à 100 doser (10 x 100 ml) 
Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Administrer en dosis på 1 ml subkutant i henhold til følgende vaccinationsprogram: Basisvaccination 
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer one dose of 1 ml subcutaneously according to the following vaccination scheme: Primary vaccination
Basisvaccination 
Primary vaccination