natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende 
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Regler for destruktion og anden håndtering Før brug skal pulveret rekonstitueres og det opnåede koncentrat skal straks derefter fortyndes 
6.6 Special precautions for disposal and other handling The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Telavancin demonstrerede virkning mod methicillinfølsomme Staphylococcus aureus (MSSA) og MRSA i to randomiserede, kontrollerede studier hos patienter med nosokomiel pneumoni, herunder respiratorassocieret pneumoni. 
Telavancin demonstrated efficacy against MSSA and MRSA in two randomised controlled studies in patients with nosocomial pneumonia, including ventilator-associated pneumonia, involving 751 patients who received telavancin.
I disse præ- og postnatale studier sås et øget antal 
An increase in the number of stillborn pups was observed in these pre- and post-natal studies (see section 4.3).
Natriumhydroxid (til pH justering) (E524) 
Sodium hydroxide (for pH adjustment) (E524) Hydrochloric acid (for pH adjustment) (E507)
Antibiotikaassocieret colitis og pseudomembranøs colitis er blevet rapporteret med næsten alle antibakterielle lægemidler, inklusive telavancin (se pkt. 
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including telavancin (see section 4.8), and may range in severity from mild to life-threatening.
Den gennemsnitlige maksimale (SD) telavancinkoncentration (Cmax) er 108 (26) µg/ml ved steady-state ved administration af en daglig dosis på 10 mg/kg indgivet over 1 time (tmax). 
The mean (SD) maximum telavancin concentration (Cmax) amounts to 108 (26) µg/ml at steady state at a once daily dose of 10 mg/kg infused over a period of 1 h (tmax) and then falls to a trough value of 8.55 (2.84) µg/ml (C24h ).
VIBATIV er indiceret til behandling af voksne med nosokomiel pneumoni (NP), herunder respiratorassocieret pneumoni, når infektionen vides eller formodes at være forårsaget af methicillinresistente Staphylococcus aureus (MRSA). 
VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant
Hos raske forsøgspersoner, som fik en dosis på 15 mg/kg, blev der set en højere incidens af bivirkninger forbundet med telavancin: smagsforstyrrelser, kvalme, opkastning, rødmen på injektionsstedet, hovedpine, makuløst hududslæt og ”red man syndrome”. 
In healthy volunteers who received a dose of 15 mg/kg, a higher incidence of adverse reactions to telavancin was seen: dysgeusia, nausea, vomiting, injection site erythema, headache, macular rash, and red man syndrome.
Forsigtighed er desuden berettiget, når der bruges telavancin til patienter med medfødt langt QT syndrom, kendt forlængelse af QTc-intervallet, inkompenseret hjerteinsufficiens eller svær venstre ventrikulær hypertrofi. 
In addition, caution is warranted when using telavancin to treat patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure,
Medlemsstaterne skal sikre, at MAH sender et brev med direkte information (DHPC), hvor brevets tekst er vedhæftet CHMP-vurderingen, til alle læger, som forventes at ordinere eller anvende Vibativ. 
The MAH shall ensure that at the launch of Vibativ, all physicians who are expected to prescribe or use Vibativ are provided with a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Efter rekonstitution indeholder hver ml koncentreret opløsning 15 mg telavancin. 
After reconstitution, each ml of concentrated solution contains 15 mg of telavancin.
VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 750 mg telavancin (som hydrochlorid). 
VIBATIV 750 mg powder for concentrate for solution for infusion Each vial contains 750 mg telavancin (as hydrochloride).
Kontakt lægen eller sundhedspersonalet, før du bruger VIBATIV 
Talk to your doctor or nurse before you are given VIBATIV if you have kidney problems.
Superinfektion 
4.9 Overdose
Rekrutteringsstatus vil blive sendt samtidig med PSUR. 
Progress on enrolment will be submitted with the PSURs.
Der er ingen kendt krydsresistens mellem telavancin og andre non 
There is no known cross-resistance between telavancin and other non-glycopeptide classes of antibiotics.
Ikke kendt: kan ikke estimeres ud fra forhåndenværende data. 
Not known: frequency cannot be estimated from the available data severe allergic reactions (anaphylaxis).
Anvendes opløsningen ikke med det samme, har brugeren ansvar for opbevaringstid under brug, hvilket normalt ikke bør være længere end 24timer ved 2 ºC-8 ºC. 
If not used immediately, in use storage times are the responsibility of the user and should not be longer than
VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas på 50 ml med 750 mg telavancin 
VIBATIV 750 mg powder for concentrate for solution for infusion 1 vial of 50 ml with 750 mg telavancin
Du skal anvende sikker prævention, mens du er i behandling 
You have to use effective contraception during
VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas på 30 ml med 250 mg telavancin. 
VIBATIV 250 mg powder for concentrate for solution for infusion 1 vial of 30 ml with 250 mg telavancin
Der er rapporteret overfølsomhedsreaktioner, inklusive anafylaksi, under behandling med telavancin. 
Hypersensitivity reactions, including anaphylaxis, have been reported with telavancin, and may be life-threatening.
Den endelige rapport skal sendes senest 31. maj 2017. 
The results shall be reported to the CHMP on an annual basis and the final report shall be submitted no later than 31 May 2017.
Internationalt normaliseret ratio Aktiveret partiel tromboplastintid Aktiveret koagulationstid Koagulation baseret på faktor Xa tests 
Activated partial thromboplastin time
Efter tilførsel af enten dextrose 50 mg/ml (5 %) injektionsvæske, opløsning, eller vand til injektionsvæsker eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, blandes indholdet i hætteglasset ved at svinge hætteglasset forsigtigt rundt for at lette rekonstitutionen. 
After addition of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, the contents of the vial are mixed by swirling gently to facilitate reconstitution.
En populationsfarmakokinetisk analyse hos raske voksne forsøgspersoner (uden infektion) viste, at BMI (body mass index) ved baseline har indvirkning på telavancins farmakokinetik. 
Body mass index (BMI) at baseline was found to influence telavancin pharmacokinetics in the population pharmacokinetic analysis in healthy (without infection) adult subjects.
brystsmerter, hjertesvigt, unormal hjerterytme eller hjerteslag rødmen, højt eller lavt blodtryk, betændelse i en vene stakåndethed, hikken, tilstoppet næse, ondt i halsen mavesmerter, mundtørhed, dårlig fordøjelse, oppustethed, følelsesløshed i munden rødmen af huden, hævelse i ansigtet, svedeture, nældefeber ledsmerter, rygsmerter, muskelkramper, muskelsmerter smerte ved vandladning, blod i urinen, lille mængde urin, hyppig vandladning, unormal urinlugt manglende energi, irritation ved infusionsstedet, utilpashed, ubehag i brystet, ophobning af væske i underbenene, smerte, feber, rødmen af huden på overkroppen 
Uncommon: may affect up to 1 in 100 people intestinal bacterial infection; urinary tract infection anaemia, changes in white blood cell counts; changes in blood platelet counts decreased appetite; changes in blood levels of glucose; changes in blood levels of potassium and restlessness; anxiety; confusion; depression loss of taste, migraine, abnormal touch sensation, smell disturbance, sleepiness, trembling chest pain; heart failure; abnormal heart rhythm or heart beat flushing; high or low blood pressure; inflammation of a vein breathlessness, hiccups, nasal congestion, sore throat abdominal pain; dry mouth; indigestion, bloating; numbness of the mouth skin redness; swelling of face; sweating, hives joint pain; back pain; muscle cramp; muscle pain painful urination; blood in urine; low urine output, frequent urination; abnormal urine odour lack of energy; irritation at infusion site; feeling unwell; chest discomfort; accumulation of fluid in the lower legs; pain; fever; skin flushing of upper body
Luftveje, thorax og mediastinum Ikke almindelig: 
flushing, hypertension, hypotension, phlebitis Respiratory, thoracic and mediastinal disorders Uncommon:
Egnede infusionsopløsninger omfatter: dextrose 50 mg/ml (5 %) injektionsvæske, opløsning, natriumchlorid 9 mg/ml (0,9 %) injektionvæske, opløsning, eller Ringer-laktat injektionsvæske, opløsning. 
Appropriate infusion solutions include: dextrose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or lactated Ringer's solution for injection.
Kvalme 
deafness
Akut nyresvigt, forhøjet kreatinin i blodet, skummende urin (”low level term” Forhøjet urinstof i blodet, dysuri, hæmaturi, mikroalbuminuri, oliguri, pollakisuri, nedsat nyrefunktion, abnorm urinlugt Almene symptomer og reaktioner på administrationsstedet Asteni, reaktioner på infusionsstedet, utilpashed, ikke hjerterelaterede brystsmerter, perifert ødem, smerte, pyreksi, ”red man syndrome” 
nausea constipation, diarrhoea, vomiting abdominal pain, dry mouth, dyspepsia, flatulence, hypoaesthesia alanine aminotransferase increased, aspartate aminotransferase erythema, face oedema, hyperhidrosis, urticaria Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramp, myalgia renal failure acute, blood creatinine increased, foamy urine (lower blood urea increased, dysuria, haematuria, microalbuminuria, oliguria, pollakiuria, renal impairment, urine odour abnormal General disorders and administration site conditions asthenia, infusion site reactions, malaise, non-cardiac chest pain, peripheral oedema, pain, pyrexia, Red Man syndrome international normalised ratio increased * Based on post-marketing reports.
VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning 
VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion
LÆGEMIDLETS NAVN VIBATIV 250 mg pulver til koncentrat til infusionvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT VIBATIV 250 mg powder for concentrate for solution for infusion
5.1 for information om det antibakterielle spektrum). 
Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum).
LÆGEMIDLETS NAVN VIBATIV 750 mg pulver til koncentrat til infusionvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT VIBATIV 750 mg powder for concentrate for solution for infusion
Det blev vist, at makrofagerne indeholdt telavancin og HP-β-CD. 
The macrophages were shown to contain telavancin and
hvis du har en større risiko for at udvikle en nyrelidelse. 
if you are at greater risk of developing kidney disorders or if you are receiving other medicines that can affect your kidney.
5.3), på trods af der ikke er rapporteret nogen virkning på fertilitet, parring eller tidlig fosterudvikling. 
Telavancin has been shown to affect sperm quantity and quality of male rats (see section 5.3) although no effect on fertility, mating, or early embryogenesis has been reported.
Erytem, ansigtsødem, hyperhidrose, urticaria 
dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain
VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning 
VIBATIV 750 mg powder for concentrate for solution for infusion
VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning 
VIBATIV 250 mg powder for concentrate for solution for infusion
VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning Indholdet af hætteglasset med 250 mg telavancin skal rekonstitueres med 15 ml enten dextrose 50 mg/ml (5 %) injektionsvæske, opløsning, eller vand til injektionsvæsker eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, for at opnå en koncentration på ca. 15 mg/ml (samlet volumen ca. 17 ml). 
VIBATIV 250 mg powder for concentrate for solution for infusion The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 17 ml).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 250 mg telavancin (som hydrochlorid) Efter rekonstitution indeholder hver ml 15 mg telavancin 
250 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Tilberedning af det rekonstituerede koncentrat (VIBATIV 750 mg hætteglas) Indholdet af hætteglasset med 750 mg telavancin skal rekonstitueres med enten 45 ml dextrose 50 mg/ml(5%) injektionsvæske, opløsning eller vand til injektionsvæsker eller natriumchlorid 9 mg/ml(0,9%) injektionsvæske, opløsning, for at opnå en koncentration på ca. 15 mg/ml (samlet volumen ca. 50 ml). 
Preparation of the reconstituted concentrate (VIBATIV 750 mg vial) The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 50 ml).
VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning Indholdet af hætteglasset med 750 mg telavancin skal rekonstitueres med 45 ml enten dextrose 50 mg/ml (5 %) injektionsvæske, opløsning, eller vand til injektionsvæsker eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, for at opnå en koncentration på ca. 15 mg/ml (samlet 
VIBATIV 750 mg powder for concentrate for solution for infusion The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of
Pulver til koncentrat til infusionsvæske, opløsning. 
Powder for concentrate for solution for infusion
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 750 mg telavancin (som hydrochlorid) Efter rekonstitution indeholder hver ml 15 mg telavancin 
750 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Forhøjet international normaliseret ratio * Baseret på post-marketing-rapporter. 
International normalised ratio
VIBATIV 250 mg pulver til koncentrat til infusionvæske, opløsning VIBATIV 750 mg pulver til koncentrat til infusionvæske, opløsning telavancin 
VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion telavancin This medicine is subject to additional monitoring.
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide. 
If you have any further questions, ask your doctor or pharmacist.
Fortyndingen skal foretages under aseptiske forhold. 
The dilution is to be made under
Tilberedning af det rekonstituerede koncentrat (VIBATIV 250 mg hætteglas) Indholdet af hætteglasset med 250 mg telavancin skal rekonstitueres med enten 15 ml dextrose 50 mg/ml (5%) injektionsvæske, opløsning eller vand til injektionsvæsker eller natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning, for at opnå en koncentration på ca. 15 mg/ml (samlet volumen ca. 17 ml). 
Preparation of the reconstituted concentrate (VIBATIV 250 mg vial) The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml
4L1-protein i form af ikke-smitsom viruslignende partikel (VLP) produceret ved hjælp af rekombinant DNA-teknologi med brug af et Baculovirussystem, som anvender Hi-5 Rix4446 celler fra insektet Trichoplusia ni. 
4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
Særnavn Styrke Lægemiddelform Indgivelsesvej 
Strength Pharmaceutical form
--1 1 dose (0,5 ml) indeholder: Humant papillomvirus1 type 16 L1-protein2,3,4 
--1 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein2,3,4
1Humant papillomvirus = HPV adjuveret med AS04 indeholdende: 
1Human Papillomavirus = HPV adjuvanted by AS04 containing:
10 fyldte injektionsspøjter 
10 pre-filled syringes
3adsorberet på aluminiumhydroxidhydrat (Al(OH)3) 
50 micrograms 3adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ in total
Indhold Paknings-størrelse 
Content (concentration)
EU-nummer. 
1 vial
NAO-1-stabilisator 
NAO-1 stabiliser
Revaccination: Revaccinér hver 3. måned for at opretholde immuniteten. 
Revaccination: Revaccinate every three months to maintain immunity.
I de challenge studier, der er udført af Intervet, fandtes utilstrækkelig beskyttelse hos ca. en fjerdedel af de heste, der blev vaccineret med den anbefalede dosis. 
In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
Af sikkerhedsgrunde skal en supplerende antibiotisk behandling overvejes. 
An additional antibiotic treatment should be considered for safety reasons.
Antibiotika bør ikke anvendes inden for en uge efter vaccination. 
Do not use antibiotics within one week after vaccination.
Da hyppigheden af purpura haemorrhagica er meget lav, kan dens forekomst derfor ikke udelukkes fuldstændigt. 
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Vaccinestammens følsomhed over for antibiotika er nævnt ovenfor.. 
The sensitivity of the vaccine strain to antibiotics is listed above.
Lad solvensen opnå rumtemperatur (15-25C). 
Allow the sterile solvent to reach room temperature (15-25 °C).
Særlige forsigtighedsregler vedrørende brug til dyr Kun raske heste bør vaccineres. 
Special precautions for use in animals Only healthy horses should be vaccinated.
10 x 1 dosis vaccine 10 x 1 dosis solvens 10 applikatorer 10 sprøjter med kanyler 
10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
Må ikke blandes med andre veterinære lægemidler bortset fra den medfølgende solvens, der er beregnet til brug sammen med vaccinen. 
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Hver Equilis StrepE karton indeholder: 10 hætteglas med lyofilisat og 10 hætteglas med 0,5 ml solvens, alle i 3 ml hætteglas af Type I glas, lukket med en halogenobutyl gummiprop og forseglet med en kodet aluminiumshætte, 10 applikatorer, 10 sprøjter med kanyler. 
6.5 Nature and composition of immediate packaging Each package of Equilis StrepE contains: 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
Derudover kan der forekomme forhøjet rektal temperatur på op til 2,5C på vaccinationsdagen. 
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Antiinflammatorisk behandling er indiceret selv om kun en lille mængde af produktet er injiceret. 
Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Immunitetens varighed: Immuniteten varer i op til 3 måneder. 
Duration of immunity: up to 3 months.
Ud over de kliniske symptomer, der er nævnt i sektion 5.4, kan en ti gange overdosis medføre en byld i en af de submandibulære lymfeknuder. 
In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Solvens 
Solvent:
Når man anbringer applikatoren på kanylen, skal der udvises særlig forsigtighed for at undgå stikskader. 
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Solvens: Ingen særlige forholdsregler vedrørende opbevaringen. 
Solvent: This medicinal product does not require any special storage conditions.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 7. maj 2004 
DATE OF FIRST AUTHORISATION Date of first authorization: 07.05.2004 Date of last renewal: 10.04.2014
Endvidere kan den rektale temperatur stige med op til 2C på vaccinationsdagen. 
Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
SÆRLIGE OPBEVARINGSBETINGELSER Ingen særlige forholdsregler vedrørende opbevaringen. 
This medicinal product does not require any special storage conditions.
Vaccinestammens følsomhed over for antibiotika er nævnt i afsnit 4.8. 
The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4).
Levende deletions-mutant Streptococcus equi stamme TW928 10 
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Der foreligger kun begrænsede oplysninger om sikkerhed og effekt ved brug af vaccinen sammen med andre vacciner. 
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
DYREARTER Heste. 
TARGET SPECIES Horses.
Vaccinestammen er følsom over for penicilliner, tetracykliner, makrolider og lincomycin. 
The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
Vaccinestammen er resistent over for aminoglykosider, sulfonamider, flumequin og trimethoprim sulfa kombinationer. 
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Basisvaccination: Heste fra 4 måneder vaccineres to gange med én dosis med 4 ugers mellemrum. 
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Aktive bestanddele af biologisk oprindelse beregnet til at fremkalde aktiv eller passiv immunitet er ikke omfattet af lovgivningens område. 
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
BATCHNUMMER <Lot> <Batch> {nummer} 
BATCH NUMBER Batch {number}
Dette produkt indeholder en levende auxotrofisk deletions-mutant Streptococcus equi vaccine-stamme med svækket virulens. 
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Immunitetens indtræden: Immuniteten indtræder 2 uger efter basisvaccination. 
Onset of immunity: 2 weeks after basic vaccination.
SÆRLIG(E) ADVARSEL/ADVARSLER OM NØDVENDIGT Ikke relevant. 
SPECIAL WARNING(S), IF NECESSARY
Wim de Körverstraat 35 Nl-5831 AN Boxmeer Holland 
Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Opløst vaccine skal anvendes inden for 4 timer. 
After reconstitution use within 4 hours.
Den kan i en kort periode multiplicere sig lokalt på det submukøse injektionssted og udskilles til næse- og mundhulen i nogle få dage, men vaccinenstammen overlever ikke på den oro-nasale slimhinde og spredes ikke systemisk ved brug af den anbefalede dosis. 
It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.
BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept. 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.