FrancophonIA/ELRC3.0 huggingface dataset:
English: 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,
Danish: 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.
English: 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.
Danish: 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.
English: After reconstitution, each ml of concentrated solution contains 15 mg of telavancin.
Danish: Efter rekonstitution indeholder hver ml koncentreret opløsning 15 mg telavancin.
English: VIBATIV 750 mg powder for concentrate for solution for infusion Each vial contains 750 mg telavancin (as hydrochloride).
Danish: VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 750 mg telavancin (som hydrochlorid).
English: Talk to your doctor or nurse before you are given VIBATIV if you have kidney problems.
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger VIBATIV
English: 4.9 Overdose
Danish: Superinfektion
English: Progress on enrolment will be submitted with the PSURs.
Danish: Rekrutteringsstatus vil blive sendt samtidig med PSUR.
English: There is no known cross-resistance between telavancin and other non-glycopeptide classes of antibiotics.
Danish: Der er ingen kendt krydsresistens mellem telavancin og andre non
English: Not known: frequency cannot be estimated from the available data severe allergic reactions (anaphylaxis).
Danish: Ikke kendt: kan ikke estimeres ud fra forhåndenværende data.
English: If not used immediately, in use storage times are the responsibility of the user and should not be longer than
Danish: 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.
English: VIBATIV 750 mg powder for concentrate for solution for infusion 1 vial of 50 ml with 750 mg telavancin
Danish: VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas på 50 ml med 750 mg telavancin
English: You have to use effective contraception during
Danish: Du skal anvende sikker prævention, mens du er i behandling
English: VIBATIV 250 mg powder for concentrate for solution for infusion 1 vial of 30 ml with 250 mg telavancin
Danish: VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas på 30 ml med 250 mg telavancin.
English: Hypersensitivity reactions, including anaphylaxis, have been reported with telavancin, and may be life-threatening.
Danish: Der er rapporteret overfølsomhedsreaktioner, inklusive anafylaksi, under behandling med telavancin.
English: 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.
Danish: Den endelige rapport skal sendes senest 31. maj 2017.
English: Activated partial thromboplastin time
Danish: Internationalt normaliseret ratio Aktiveret partiel tromboplastintid Aktiveret koagulationstid Koagulation baseret på faktor Xa tests
English: 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.
Danish: 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.
English: Body mass index (BMI) at baseline was found to influence telavancin pharmacokinetics in the population pharmacokinetic analysis in healthy (without infection) adult subjects.
Danish: En populationsfarmakokinetisk analyse hos raske voksne forsøgspersoner (uden infektion) viste, at BMI (body mass index) ved baseline har indvirkning på telavancins farmakokinetik.
English: 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
Danish: 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
English: flushing, hypertension, hypotension, phlebitis Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Luftveje, thorax og mediastinum Ikke almindelig:
English: 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.
Danish: Egnede infusionsopløsninger omfatter: dextrose 50 mg/ml (5 %) injektionsvæske, opløsning, natriumchlorid 9 mg/ml (0,9 %) injektionvæske, opløsning, eller Ringer-laktat injektionsvæske, opløsning.
English: deafness
Danish: Kvalme
English: 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.
Danish: 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”
English: VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion
Danish: VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT VIBATIV 250 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN VIBATIV 250 mg pulver til koncentrat til infusionvæske, opløsning
English: Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum).
Danish: 5.1 for information om det antibakterielle spektrum).
English: NAME OF THE MEDICINAL PRODUCT VIBATIV 750 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN VIBATIV 750 mg pulver til koncentrat til infusionvæske, opløsning
English: The macrophages were shown to contain telavancin and
Danish: Det blev vist, at makrofagerne indeholdt telavancin og HP-β-CD.
English: if you are at greater risk of developing kidney disorders or if you are receiving other medicines that can affect your kidney.
Danish: hvis du har en større risiko for at udvikle en nyrelidelse.
English: 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.
Danish: 5.3), på trods af der ikke er rapporteret nogen virkning på fertilitet, parring eller tidlig fosterudvikling.
English: dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain
Danish: Erytem, ansigtsødem, hyperhidrose, urticaria
English: VIBATIV 750 mg powder for concentrate for solution for infusion
Danish: VIBATIV 750 mg pulver til koncentrat til infusionsvæske, opløsning
English: VIBATIV 250 mg powder for concentrate for solution for infusion
Danish: VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning
English: 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).
Danish: 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).
English: 250 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 250 mg telavancin (som hydrochlorid) Efter rekonstitution indeholder hver ml 15 mg telavancin
English: 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).
Danish: 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).
English: 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
Danish: 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
English: Powder for concentrate for solution for infusion
Danish: Pulver til koncentrat til infusionsvæske, opløsning.
English: 750 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 750 mg telavancin (som hydrochlorid) Efter rekonstitution indeholder hver ml 15 mg telavancin
English: International normalised ratio
Danish: Forhøjet international normaliseret ratio * Baseret på post-marketing-rapporter.
English: 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.
Danish: VIBATIV 250 mg pulver til koncentrat til infusionvæske, opløsning VIBATIV 750 mg pulver til koncentrat til infusionvæske, opløsning telavancin
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: The dilution is to be made under
Danish: Fortyndingen skal foretages under aseptiske forhold.
English: 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
Danish: 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).
English: 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.
Danish: 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.
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: --1 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein2,3,4
Danish: --1 1 dose (0,5 ml) indeholder: Humant papillomvirus1 type 16 L1-protein2,3,4
English: 1Human Papillomavirus = HPV adjuvanted by AS04 containing:
Danish: 1Humant papillomvirus = HPV adjuveret med AS04 indeholdende:
English: 10 pre-filled syringes
Danish: 10 fyldte injektionsspøjter
English: 50 micrograms 3adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ in total
Danish: 3adsorberet på aluminiumhydroxidhydrat (Al(OH)3)
English: Content (concentration)
Danish: Indhold Paknings-størrelse
English: 1 vial
Danish: EU-nummer.
English: NAO-1 stabiliser
Danish: NAO-1-stabilisator
English: Revaccination: Revaccinate every three months to maintain immunity.
Danish: Revaccination: Revaccinér hver 3. måned for at opretholde immuniteten.
English: In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
Danish: 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.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift, om nødvendigt)
English: Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE.
Danish: Purpura haemorrhagica er ikke set i nogle af de sikkerhedsstudier, der er udført under udviklingen af Equilis StrepE.
English: An additional antibiotic treatment should be considered for safety reasons.
Danish: Af sikkerhedsgrunde skal en supplerende antibiotisk behandling overvejes.
English: Do not use antibiotics within one week after vaccination.
Danish: Antibiotika bør ikke anvendes inden for en uge efter vaccination.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/04/043/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/04/043/001
English: As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Danish: Da hyppigheden af purpura haemorrhagica er meget lav, kan dens forekomst derfor ikke udelukkes fuldstændigt.
English: Ensure that the lyophilisate is completely reconstituted before use.
Danish: Man bør sikre sig, at lyofilisatet er fuldstændigt opløst inden anvendelse.
English: The sensitivity of the vaccine strain to antibiotics is listed above.
Danish: Vaccinestammens følsomhed over for antibiotika er nævnt ovenfor..
English: Allow the sterile solvent to reach room temperature (15-25 °C).
Danish: Lad solvensen opnå rumtemperatur (15-25C).
English: Special precautions for use in animals Only healthy horses should be vaccinated.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Kun raske heste bør vaccineres.
English: 10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
Danish: 10 x 1 dosis vaccine 10 x 1 dosis solvens 10 applikatorer 10 sprøjter med kanyler
English: It is recommended that all horses stabled together are vaccinated.
Danish: Det anbefales at vaccinere alle heste, der er opstaldet sammen.
English: Only healthy horses should be vaccinated.
Danish: Kun raske heste bør vaccineres.
English: The duration of immunity is up to 3 months.
Danish: Immuniteten varer i op til 3 måneder.
English: Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Danish: Må ikke blandes med andre veterinære lægemidler bortset fra den medfølgende solvens, der er beregnet til brug sammen med vaccinen.
English: In very rare cases depression may develop.
Danish: I meget sjældne tilfælde kan der udvikles nedstemthed.
English: PACKAGE SIZE 10 x 1 dose
Danish: PAKNINGSSTØRRELSE 10 x 1 dosis
English: From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection.
Danish: Fra litteraturen vides at meget få heste kan udvikle purpura haemorrhagica, hvis de vaccineres kort efter en infektion.
English: Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
Danish: Udskillelse af vaccinestammen fra injektionsstedet kan ses i en periode på fire dage efter vaccination.
English: 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.
Danish: 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.
English: Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Danish: En basisvaccination, der gives under et sygdomsudbrud, er ikke effektiv, da immuniteten ikke er tilstrækkelig før basisvaccinationen er gennemført.
English: Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Danish: Derudover kan der forekomme forhøjet rektal temperatur på op til 2,5C på vaccinationsdagen.
English: Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Danish: Antiinflammatorisk behandling er indiceret selv om kun en lille mængde af produktet er injiceret.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pr. dosis af 0,2 ml vaccine:
English: In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Danish: I meget sjældne tilfælde kan der udvikles abscesser på injektionsstedet eller i de lokale lymfeknuder.
English: Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Danish: Lette forstørrelser af de retropharyngeale og mandibulære lymfeknuder, som kan være midlertidigt smertefulde, kan forekomme nogle få dage efter vaccinationerne.
English: Duration of immunity: up to 3 months.
Danish: Immunitetens varighed: Immuniteten varer i op til 3 måneder.
English: Slight apathy may occasionally be observed one day after vaccination.
Danish: Lettere sløvhed ses lejlighedsvis dagen efter vaccination.
English: To stimulate immunity against Streptococcus equi.
Danish: Til stimulering af immunitet mod Streptococcus equi.
English: Accidental self-injection may result in an inflammatory reaction with severe pain and swelling.
Danish: Uforsætlig selvinjektion kan medføre en inflammatorisk reaktion med alvorlig smerte og hævelse.
English: 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.
Danish: 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.
English: Solvent:
Danish: Solvens
English: Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Danish: Når man anbringer applikatoren på kanylen, skal der udvises særlig forsigtighed for at undgå stikskader.
English: Solvent: This medicinal product does not require any special storage conditions.
Danish: Solvens: Ingen særlige forholdsregler vedrørende opbevaringen.
English: DATE OF FIRST AUTHORISATION Date of first authorization: 07.05.2004 Date of last renewal: 10.04.2014
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 7. maj 2004
English: Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
Danish: Endvidere kan den rektale temperatur stige med op til 2C på vaccinationsdagen.
English: This medicinal product does not require any special storage conditions.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Ingen særlige forholdsregler vedrørende opbevaringen.
English: The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4).
Danish: Vaccinestammens følsomhed over for antibiotika er nævnt i afsnit 4.8.
English: The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Danish: Der løber pus fra bylden i to uger efter vaccination, men den heles uden behandling inden for en måned herefter.
English: After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Danish: Efter vaccination dannes der indenfor 4 timer en diffus hævelse, der kan være varm eller smertefuld, på injektionsstedet.
English: Submucosal vaccination with 0.2 ml of reconstituted product.
Danish: Submukøs vaccination med 0,2 ml opløst produkt.
English: Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Danish: Levende deletions-mutant Streptococcus equi stamme TW928 10
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger kun begrænsede oplysninger om sikkerhed og effekt ved brug af vaccinen sammen med andre vacciner.
English: TARGET SPECIES Horses.
Danish: DYREARTER Heste.
English: The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
Danish: Vaccinestammen er følsom over for penicilliner, tetracykliner, makrolider og lincomycin.