natgillin/translations-raw huggingface dataset:
- Patienter med detekterbart HCV-RNA i enten uge 4 eller 12 skal behandles i yderligere 36 uger med pegyleret interferon-alfa og ribavirin alene, så den samlede behandlingsvarighed bliver 
- Patients with detectable HCV RNA at either weeks 4 or 12 receive an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
Kutane reaktioner - omfang og symptomer 
Extent and features of Cutaneous Reactions
Tidligere partial responders Tidligere null responders omfatter kun data om patienter med resultater for HCV-RNA i uge 4 
only includes data on patients who had week 4 HCV RNA available
Pbo/PR48: Placebo i 16 uger i kombination med pegyleret interferon-alfa-2a og ribavirin i 48 uger. 
Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks
Hvis det først opdages mere end 6 timer efter det sædvanlige tidspunkt for indgift af INCIVO, skal den glemte dosis springes over, og det sædvanlige 
If the missed dose is noticed more than 6 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
til behandling af skizofreni, bipolar (maniodepressiv) sygdom og svære depressive episoder sovemidler og/eller angstdæmmende midler til at behandle epileptiske anfald (antiepileptika) 
to treat schizophrenia, bipolar disorder and major depressive disorder midazolam (taken by mouth), triazolam (taken to help you sleep and/or relieve anxiety (sedatives/hypnotics)
Brugsanvisning 
Absorption
Se også produktresuméerne for pegyleret interferon-alfa og ribavirin for alvorlige hudreaktioner i forbindelse 
Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin for severe skin reactions associated with
dabigatran 
INCIVO
SVR-rater for patienter med eller uden cirrose 
SVR rates for patients with or without cirrhosis Patients without cirrhosis 65.5% (38/58)
Klinisk kontrol og laboratorieundersøgelser for hyperbilirubinæmi anbefales (se pkt. 
Clinical and laboratory monitoring for hyperbilirubinaemia is recommended (see section 4.4 and 4.8).
Anvendelse af INCIVO i kombination med peginterferon og ribavirin anbefales ikke til patienter med 
INCIVO in combination with peginterferon and ribavirin is not recommended in patients with platelets < 90,000/mm
methadon til afvænning fra opioidmisbrug (narkotikamisbrug) 
metformin to treat diabetes (antidiabetics)
Seponeres permanent behandling med INCIVO, pegyleret interferon-alfa og ribavirin. 
INCIVO treatment completed Permanently discontinue treatment with INCIVO, peginterferon alfa, and ribavirin.
parenteral anvendelse af midazolam* 
tenofovir disoproxil fumarate*
58% af patienterne var mænd, 23% havde et body mass index ≥ 30 kg/m2, 9% var sorte, 11% var af latinamerikansk afstamning, 77% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 15% havde brofibrose, 6% havde cirrose, 59% havde HCV af genotype 1a og 40% havde HCV af genotype 1b. 
The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Hvis du holder op med at tage INCIVO 
If you take more INCIVO than you should
INCIVO skal anvendes i kombination med pegyleret interferon-alfa og ribavirin. 
INCIVO must be used in combination with peginterferon alfa and ribavirin.
Virkningen på koncentrationer af ubundet telaprevir er 
Discontinuation of INCIVO combination treatment is not
4.5 skal følges nøje. 
Drug interactions need to be carefully taken into account, see sections 4.4 and 4.5.
Hos patienter med HCV-RNA mellem 100 IE/ml og 1.000 IE/ml i uge 12 opnåedes SVR hos 2 ud af 8 patienter (25%). 
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12,
Behandlingen med INCIVO skal indledes i kombination med pegyleret interferon-alfa og ribavirin og gives i 12 uger (se figur 1). 
Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
Se produktresuméerne for pegyleret interferon-alfa og ribavirin, som skal gives sammen med 
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be
Dosismodifikation af INCIVO er ikke nødvendig, når lægemidlet anvendes til patienter med hepatitis C og let nedsat leverfunktion 
Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6).
Behandling med INCIVO skal indledes i kombination med pegyleret interferon-alfa og ribavirin og gives i 12 uger, hvorefter der behandles med pegyleret interferon-alfa og ribavirin alene (uden INCIVO), indtil den samlede behandlingsvarighed er 48 uger (se figur 2). 
Duration of treatment - Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
60% af patienterne var mænd, 32% havde et body mass index ≥ 30 kg/m2, 14% var sorte, 10% var af latinamerikansk afstamning, 82% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 16% havde brofibrose, 11% havde cirrose, 72% havde HCV af genotype 1a og 27% havde HCV af genotype 1b. 
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
abacavir zidovudin 
abacavir
4.2, 4.5, Immunsupprimerende midler, 4.8 og 5.1 for oplysninger om brugen af INCIVO i kombination med pegyleret interferon alfa og ribavirin til behandlingsnaive og behandlingserfarne HCV-1-inficerede patienter, som var levertransplantatmodtagere og i stabil behandling med de immunsupprimerende midler tacrolimus eller ciclosporin. 
For information on the use of INCIVO in combination with peginterferon alfa and ribavirin in treatment-naïve and treatment-experienced HCV-1 infected patients who were liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A, see sections 4.2,
clarithromycin, erythromycin, telithromycin, troleandomycin til at behandle bakterielle infektioner (antibiotika) blodfortyndende midler til at forebygge blodpropper (antikoagulantia) til at behandle humørforandringer (antidepressiva) til at behandle diabetes (sukkersyge) (antidiabetika) til at behandle kvalme og opkastning (antiemetika) til at behandle svampeinfektioner (antimykotika) 
clarithromycin, erythromycin, telithromycin, troleandomycin to treat bacterial infections (antibacterials)
Tabel 3: Bivirkninger af INCIVO (taget i kombination med pegyleret interferon-alfa og ribavirin) hos HCV-inficerede patienter i kliniske studier a og efter markedsføring Bivirkninger 
Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Forsigtighed tilrådes, og klinisk kontrol med laboratorieundersøgelser anbefales. 
Caution is warranted, laboratory and clinical monitoring is recommended.
INCIVO i kombination med pegyleret interferon alfa og ribavirin blev evalueret hos 74 HCV-1inficerede levertransplanterede patienter uden cirrose, som fik enten tacrolimus eller ciclosporin. 
INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant.
Hæmoglobinværdier < 8,5 g/dl blev observeret hos 8%, der fik INCIVO 
Haemoglobin values of < 8.5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin.
Anæmi 
Elderly
filiāle Latvijā 
Hispanic Latino
Levertransplantatmodtagere 
IMMUNOSUPPRESSANTS
AUC 1,17 (0,97-1,43) Cmax 0,85 (0,73-0,98) Cmin 1,85 (1,40-2,44) telaprevis hæmmer CYP3A 
AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir
INCIVO skal tages i kombination med pegyleret interferon-alfa og ribavirin. 
INCIVO must be taken in combination with peginterferon alfa and ribavirin.
Særlige krav vedrørende graviditet og kontraception Eftersom INCIVO skal anvendes i kombination med pegyleret interferon-alfa og ribavirin, gælder kontraindikationerne og advarslerne for disse lægemidler også for kombinationsbehandlingen. 
Because INCIVO must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those medicinal products are applicable to combination
4.5 og 4.6. 
For additional information, see sections 4.5 and 4.6.
Fortæl det til lægen, hvis du bliver træt eller svækket eller lider af kortåndethed, svimmelhed og/eller hjertebanken. 
- Anaemia (decrease in your red blood cells) Tell your doctor if you experience tiredness, weakness, shortness of breath, light-headedness, and/or the feeling of the heart racing.
Blandt patienterne med tidligere relapse i T12/PR24-gruppen, som havde ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i behandlingsuge 4 og 12, var SVR-raten 
Among prior relapsers in the T12/PR24 treatment group who had undetectable HCV RNA
Tidligere behandlede patienter efter undergruppe Tidligere relapsers N = 29 % (n/N) 
Prior Relapsers N = 29 % (n/N)
Vedrørende påviste og andre potentielt signifikante lægemiddelinteraktioner henvises til pkt. 
Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Efter at du har gennemført INCIVO-behandlingen, kan du læse om det fortsatte behov for prævention i 
Following the end of the INCIVO treatment, please see the ribavirin package leaflet regarding continued contraception
behandling af anæmi, kan der fortsat behandles med pegyleret interferon-alfa og ribavirin. 
If INCIVO is discontinued for anaemia, patients may continue treatment with peginterferon alfa and ribavirin.
IMMUNSUPPRIMERENDE MIDLER ciclosporin* tacrolimus* sirolimus 
HORMONAL CONTRACEPTIVES/OESTROGEN ethinylestradiol* norethindrone*
Se Vejledning i seponering af behandling med INCIVO, pegyleret interferon-alfa og ribavirin i tabel 1. 
See table 1 for Guidelines for Discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin Treatment.
AUC 0,80 (0,76-0,85) Cmax 0,79 (0,74-0,84) Cmin 0,85 (0,75-0,98) ↑ atazanavir 
AUC 0.53 (0.47-0.60) Cmax 0.68 (0.60-0.77) Cmin 0.32 (0.25-0.42) ↑ phenytoin
til at behandle visse mavesygdomme (midler, der påvirker mave-tarm-kanalens funktion) 
to treat some stomach conditions (gastrointestinal motility agents)
Se produktresuméerne for pegyleret interferon-alfa og ribavirin inklusive behov for graviditetsprøver 
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin, including pregnancy testing requirements (see section 4.6).
INCIVO skal tages sammen med pegyleret interferon-alfa og ribavirin for at forebygge 
INCIVO must be taken with peginterferon alfa and ribavirin to prevent treatment failure.
Fosamprenavir/ritonavir anbefales ikke anvendt sammen med telaprevir (se pkt. 
It is not recommended to co-administer fosamprenavir/ritonavir and telaprevir (see section 4.4).
AUC 0,68 (0,58-0,79) Cmax 0,79 (0,70-0,90) Cmin 0,53 (0,44-0,65) ↔ carbamazepin AUC 1,10 (0,99-1,23) Cmax 1,09 (0,98-1,21) Cmin 1,10 (0,97-1,24) carbamazepin inducerer CYP3A, 
↓ ethinylestradiol AUC 0.72 (0.69-0.75) Cmax 0.74 (0.68-0.80) Cmin 0.67 (0.63-0.71) ↔ norethindrone AUC 0.89 (0.86-0.93) Cmax 0.85 (0.81-0.89) Cmin 0.94 (0.87-1.00) mechanism unknown
↑ ciclosporin AUC 4,64 (3,90-5,51) Cmax 1,32 (1,08-1,60) ↑ tacrolimus AUC 70,3 (52,9-93,4)** Cmax 9,35 (6,73-13,0)** ↑ sirolimus 
AUC 1.00 (0.94-1.07) Cmax 1.01 (0.96-1.05) Cmin 1.03 (0.93-1.14) ↑ tenofovir
- hvis du får andre symptomer samtidig med udslættet såsom: 
Also contact your doctor immediately: - if your rash worsens, OR - if you develop other symptoms with a rash such as:
)/PR: INCIVO 1.125 mg to gange dagligt i 12 uger med pegyleret interferon-alfa-2a og ribavirin i 24 eller 48 uger. 
)/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Lopinavir/ritonavir anbefales ikke anvendt sammen med telaprevir (se pkt. 
It is not recommended to co-administer lopinavir/ritonavir and telaprevir (see section 4.4).
Alle patienter omfatter de 322 patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12 
SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
2, 5% var sorte, 11% var af latinamerikansk afstamning, 89% havde HCV-RNA ≥ 800.000 IE/ml ved baseline, 22% havde brofibrose, 26% havde cirrose, 54% havde HCV af genotype 1a og 46% havde HCV af genotype 1b. 
The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
Telaprevir kan indgives oralt med samtidig fødeindtagelse som 375 mg tabletter, dvs. 1.125 mg to gange dagligt i 12 uger, i kombination med pegyleret interferon-alfa og ribavirin. 
Telaprevir can be administered orally with food as 375 mg tablets, 1,125 mg twice daily (b.i.d.)
Cirrose 
Rash
T12/PR24: INCIVO i 12 uger med pegyleret interferon-alfa-2a og ribavirin i 48 uger. 
T12/PR24: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 weeks; T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR: INCIVO i 12 uger med pegyleret interferon-alfa-2a og ribavirin i 24 eller 48 uger. 
T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Responsraterne for T12/PR48- og Pbo/PR48-gruppen fremgår af tabel 15. 
Table 15 shows the response rates for the T12/PR48 and the Pbo/PR48 arms.
Spørg eventuelt 
Do not
T12/PR48: INCIVO i 12 uger sammen med pegyleret interferon-alfa-2a og ribavirin i 48 uger. 
T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and ribavirin for 48 weeks;
Tabel 10: SVR-rater ved forskellige grader af leverfibrose ved baseline: Studie 111 Patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12 
Table 10: SVR rates by extent of liver fibrosis at baseline: Study 111
- Hududslæt 
Hepatic impairment
3), eller de havde stabil, kontrolleret hiv (hiv-RNA < 50 kopier/ml, CD4 
3), or had stable controlled HIV
↓ telaprevir 750 mg hver 8. time AUC 0,84 (0,71-0,98) Cmax 0,90 (0,79-1,02) Cmin 0,75 (0,61-0,92) 
AUC 0.96 (0.84-1.10) Cmax 0.80 (0.69-0.93) Cmin 1.06 (0.87-1.30)
INCIVO skal tage i kombination med pegyleret interferon-alfa og ribavirin. 
INCIVO must be administered with peginterferon alfa and ribavirin.
Almindelige aseptiske procedurer skal følges. 
Follow usual aseptic procedures.
I henhold til artikel 71 i Rådets direktiv 2001/82/EC kan en medlemsstat forbyde indførsel, salg, levering og/eller anvendelse af det veterinære lægemiddel på hele eller en del af sit område, hvis det a) at behandling af dyr med det veterinære lægemiddel vil gribe forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, kontrol eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra b) at den sygdom som det veterinære lægemiddel er beregnet til at fremkalde immunitet imod, stort set ikke forekommer i det pågældende område 
According to Article 71 of Directive 2001/82/EC as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Triethanolamin (i doser op til 0,25 mg/kg legemsvægt) vurderes ikke at være inden for rammerne af 
Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council
Wim de Körverstraat 35 5831AN Boxmeer Holland 
Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The Netherlands
Sprøjter og kanyler skal være sterile inden brug. 
Syringes and needles must be sterile before use.
Vaccine mod nekrotisk enterit 
Vaccine against necrotic enteritis
Efter anden vaccination kan hævelsen vare ved i mindst 35 døgn. 
Following the second vaccination swelling may persist for at least 35 days.
Utilsigtet injektion er farlig - læs indlægssedlen inden brug. 
Accidental injection is dangerous - read package leaflet before use.
Ved brug af dobbelt dosis kan lokalreaktioner forværres let. 
After administration of a double dose, local reactions may increase slightly.
Der er ikke set nogen systemiske reaktioner på vaccinationen ved intramuskulær injektion. 
No systemic reactions to vaccination were seen following intramuscular vaccination.
Hvis du ved et uheld injiceres med dette produkt, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tag indlægssedlen med dig. 
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER 
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
500 ml sammenklappelig flaske af HDPE (high density polyetylen), lukket med en klorobutyl gummiprop og aluminiumsforsegling med åbning i midten. 
500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held in place with an aluminium seal with centre hole.
Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne 
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
Første dosis (0,5 ml) skal gives ved 10-14 ugers alderen. 
One dose of 0.5 ml should be given at 10 to 14 weeks of age.
En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde 
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Hjælpestof Thiomersal 
Thiomersal
Vaccination kan give moderat hævelse i brystvævet, men hævelsen forsvinder inden for 30 døgn. 
Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days.
Clostridium perfringens Type A alfa toksoid: ≥ 6,8 IE* 
Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU*
Vaccinen kan anvendes til æglæggende og ynglende fugle. 
The vaccine is safe for use in laying and breeding birds.
Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller 
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Til aktiv immunisering af kyllinger for at sikre overførsel af passiv immunitet til afkommet mod nekrotisk enterit under æglægningsperioden. 
For the active immunization of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period.
Clostridium perfringens Type A alfa toksoid minimum 6.8 IE * 
Clostridium perfringens Type A alpha toxoid Not less than 6.8 IU *
Varigheden af den passivt overførte immunitet: 51 uger efter afsluttet vaccination. 
The duration of passive transfer of immunity: 51 weeks following completion of the vaccination
Indtræden af den passive overførsel af immunitet: 6 uger efter afsluttet vaccination. 
The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure
Opbevares og transporteres nedkølet (2ºC - 8°C). 
Store and transport refrigerated (2ºC - 8°C).
0.31 ml 
1 x 500ml
TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR 
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder Opbevaringstid efter første åbning af den indre emballage: 8 timer. 
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.
*Internationale enheder pr. ml kaninserum fastsat ved hæmolyseinhibitionsanalyse 
* International units per ml of rabbit serum determined by haemolysis inhibition assay
Opbevares og transporteres nedkølet (2ºC - 8°C) 
Store and transport refrigerated (2ºC- 8ºC).
FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR 
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Alle fødevareproducerende dyr Bilag II til Rådets forordning (EEC) No. 
Annex II of Council Regulation (EEC)
Kyllinger skal vaccineres intramuskulært i brystmuskulaturen. 
Vaccinate chickens by the intramuscular route into the breast.
A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA 
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
ATCvet-kode: QI01AB08 
Pharmacotherapeutic group: Immunologicals for aves, ATC vet code: QI01AB08
Til reduktion af dødelighed, samt hyppighed og sværhedsgrad af læsioner ved nekrotisk enterit forårsaget af Clostridium perfringens Type A. Virkningen er vist ved smittebelastning af ca. 3 uger 
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis.
Til stimulering af aktiv immunitet hos kyllinger for overførsel af passiv immunitet til afkommet mod nekrotisk enterit forårsaget af Clostridium perfringens Type A. 
To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis.
Må ikke anvendes efter den udløbsdato, som er angivet på etiketten Opbevaringstid efter første åbning af den indre emballage: 8 timer. 
Shelf-life after first opening the immediate packaging: 8 hours
Anden dosis (0,5 ml) skal gives 4-10 uger senere, men ikke senere end 6 uger før æglægning begynder. 
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination.