FrancophonIA/ELRC3.0 huggingface dataset:
English: o 1 ml of X contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
Danish: o 1 ml X indeholder 40 mg articainhydrochlorid og 5 mikrogram adrenalin (som adrenalintartrat).
English: Box containing glass cartridges 50 x 1.7 ml.
Danish: Æske med glascylinderampuller 50 x 1,7 ml.
English: o 1 ml of Y contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
Danish: o 1 ml Y indeholder 40 mg articainhydrochlorid og 10 mikrogram adrenalin (som adrenalintartrat).
English: Allodynia
Danish: Urticaria
English: Frequency Adverse Reactions
Danish: MedDRA systemorganklasse Hyppighed
English: Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Danish: Der er risiko for bidtraume (læber, kinder, slimhinder og tunge), særligt hos børn.
English: Box containing glass cartridges, self-aspirating 50 x 1.7 ml.
Danish: Æske med glascylinderampuller, selvaspirerende 50 x 1,7 ml.
English: Injection site exfoliation / necrosis Fatigue, asthenia (weakness)/ Chills Not known Local swelling Feeling hot, Feeling cold c) Description of selected adverse reactions
Danish: Eksfoliation/nekrose på injektionsstedet Træthed, asteni (svaghed)/kuldegysninger
English: Enophthalmos
Danish: Nystagmus
English: 1 NAME OF THE MEDICINAL PRODUCT
Danish: Oversigt over indlægssedlen
English: Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Danish: Hver cylinderampul med 1,7 ml indeholder 68 mg articainhydrochlorid og 8,5 mikrogram adrenalin (som adrenalintartrat).
English: Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Danish: Hver cylinderampul med 1,7 ml indeholder 68 mg articainhydrochlorid og 17 mikrogram adrenalin (som adrenalintartrat).
English: • difficulty breathing
Danish: • vejrtrækningsbesvær
English: • exfoliation and ulceration of the gums
Danish: • afskalning og sårdannelse på tandkødet
English: Cardiac disorders
Danish: myokardieinfarkt.
English: Miosis
Danish: Miosis Enoftalmus
English: • Hypotension
Danish: • hæshed
English: {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection
Danish: LÆGEMIDLETS NAVN {(Sær)navn og relaterede navne (se bilag I)} 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning
English: [(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection]
Danish: {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Danish: LÆGEMIDLETS NAVN {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning articainhydrochlorid/adrenalin
English: [(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection]
Danish: {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Danish: LÆGEMIDLETS NAVN {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning articainhydrochlorid/adrenalin
English: The lowest dose leading to effective anaesthesia should be used.
Danish: Der bør anvendes den laveste dosis, der resulterer i effektiv anæstesi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning articainhydrochlorid/adrenalin
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) {Særnavn og relaterede navne (se bilag I)} 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning articainhydrochlorid/adrenalin
English: o Each cartridge of 1.7-ml of solution for injection of X contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Danish: o Hver cylinderampul med X 1,7 ml injektionsvæske, opløsning indeholder 68 mg articainhydrochlorid og 8,5 mikrogram adrenalin (som adrenalintartrat).
English: • epilepsy;
Danish: • hvis du har epilepsi
English: 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
Danish: 1 ml injektionsvæske, opløsning, indeholder 40 mg articainhydrochlorid og 5 mikrogram adrenalin (som adrenalintartrat).
English: o Each cartridge of 1.7-ml of solution for injection of Y contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Danish: o Hver cylinderampul med Y 1,7 ml injektionsvæske, opløsning indeholder 68 mg articainhydrochlorid og 17 mikrogram adrenalin (som adrenalintartrat).
English: For all populations, the lowest dose leading to effective anaesthesia should be used.
Danish: Den laveste dosis, der fører til effektiv anæstesi, bør anvendes til alle populationer.
English: Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Danish: Hver cylinderampul med 1,7 ml injektionsvæske, opløsning indeholder 68 mg articainhydrochlorid og 8.5 mikrogram adrenalin (som adrenalintartrat).
English: 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
Danish: 1 ml injektionsvæske, opløsning, indeholder 40 mg articainhydrochlorid og 10 mikrogram adrenalin (som adrenalintartrat).
English: Uncommon Rash (eruption) Pruritus
Danish: Ikke almindelig Udslæt Pruritus
English: (7.0 cartridges)
Danish: 0,123 12,3 (7,0 cylinderampuller)
English: Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Danish: Hver cylinderampul med 1,7 ml injektionsvæske, opløsning, indeholder 68 mg articainhydrochlorid og 17 mikrogram adrenalin (som adrenalintartrat).
English: • severely overfunctioning thyroid (thyrotoxicosis);
Danish: • hvis din skjoldbruskkirtel er meget overaktiv (for højt stofskifte/tyreotoksikose)
English: Ageusia
Danish: Eufori
English: Vascular disorders Common
Danish: Vaskulære sygdomme
English: Muscle twitching4
Danish: Nervøsitet/angst4
English: • swelling of cheeks and local swelling
Danish: • hævelse af kinder og lokal hævelse
English: • use other local anaesthetics, medicines that cause reversible loss of sensation (including volatile anaesthetics such as halothane);
Danish: • hvis du bruger andre lokalbedøvende midler, der forårsager midlertidigt (reversibelt) følelsestab
English: • problems with your kidneys;
Danish: • hvis du har nyreproblemer
English: • Patients with uncontrolled diabetes: This medicinal product should be used cautiously due to hyperglycemic effect of adrenaline.
Danish: Dette lægemiddel skal anvendes med forsigtighed på grund af adrenalinets hyperglykæmiske virkning.
English: It was to be available as tablets (0.5, 1 and 2 mg).
Danish: Det skulle leveres som tabletter (0,5, 1 og 2 mg).
English: The company had not yet responded to the last round of questions at the time of the withdrawal.
Danish: Virksomheden havde ikke besvaret den sidste række af spørgsmål på tidspunktet for tilbagetrækningen.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Det betyder, at CHMP havde evalueret den dokumentation, som virksomheden havde fremlagt, og udarbejdet lister med spørgsmål.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Repaglinide Sun could not have been approved.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Repaglinid Sun ikke kunne være blevet godkendt.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Repaglinide Sun did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP af den opfattelse, at fordelene ved Repaglinid Sun ikke opvejede risiciene.
English: This means that Repaglinide Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called NovoNorm.
Danish: Det betyder, at det var hensigten, at Repaglinid Sun skulle være identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder NovoNorm.
English: The CHMP was concerned about an impurity in the medicine and about the way the company had analysed the results of the bioequivalence study.
Danish: CHMP var betænkelig ved en urenhed i lægemidlet samt den måde, hvorpå virksomheden havde analyseret resultaterne af bioækvivalensundersøgelsen.
English: Repaglinide Sun is a medicine that contains the active substance repaglinide.
Danish: Repaglinid Sun er et lægemiddel, der indeholder det aktive stof repaglinid.
English: Repaglinide Sun was expected to be used in patients who have type 2 diabetes.
Danish: Repaglinid Sun forventedes anvendt til patienter med type 2-diabetes.
English: What is Repaglinide Sun?
Danish: Hvad er Repaglinid Sun?
English: Because Repaglinide Sun was developed as a generic medicine, the company presented the results of a study carried out to investigate whether it is ‘bioequivalent' to the reference medicine or not.
Danish: Fordi Repaglinid Sun blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af en undersøgelse, som er udført for at undersøge, hvorvidt det er ‘bioækvivalent' med referencelægemidlet.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, som opstår, når bugspytkirtlen enten ikke danner tilstrækkeligt insulin til at regulere blodsukkeret, eller når kroppen ikke er i stand til at udnytte insulinet effektivt.
English: Repaglinide Sun was developed as a ‘generic medicine'.
Danish: Repaglinid Sun blev udviklet som et generisk lægemiddel.
English: Repaglinide Sun was to be used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) could not be controlled by diet, weight reduction and exercise.
Danish: Repaglinid Sun skulle anvendes sammen med diæt og motion til at sænke blodglukoseniveauet (sukker) hos patienter, hvis hyperglykæmi (højt blodglukoseniveau) ikke kan kontrolleres med diæt, vægttab og motion.
English: Repaglinide Sun is expected to work in the same way as the reference medicine, NovoNorm, by helping the pancreas to produce more insulin at mealtimes.
Danish: Repaglinid Sun forventes at virke på samme måde som referencelægemidlet NovoNorm ved at få bugspytkirtlen til at producere mere insulin i forbindelse med måltider.
English: What was Repaglinide Sun expected to be used for?
Danish: Hvad forventedes Repaglinid Sun anvendt til?
English: Repaglinide Sun was also to be used together with metformin (another antidiabetes medicine) in type 2 diabetes patients whose blood glucose levels were not satisfactorily controlled on metformin alone.
Danish: Repaglinid Sun skulle også anvendes i kombination med metformin (et andet lægemiddel mod diabetes) til patienter med type 2-diabetes, hvis glukoseniveau ikke er tilstrækkeligt kontrolleret med metformin alene.
English: How is Repaglinide Sun expected to work?
Danish: Hvordan forventes Repaglinid Sun at virke?
English: On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Repaglinide Sun for the treatment of type 2 diabetes.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Repaglinid Sun til behandling af type 2-diabetes tilbage.
English: What did the company present to support its application?
Danish: Hvad fremlagde virksomheden i forbindelse med ansøgningen?
English: Name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddel-form Indgivelsesvej
English: Package size bottle (HDPE)
Danish: Tabletbeholder (HDPE)
English: ATCvet code: QJ01FA96.
Danish: ATCvet-kode: QJ01FA96.
English: The effect is generally time-dependent.
Danish: Virkningen er almindeligvis tidsafhængig.
English: The active substance in Zuprevo is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Zuprevo er en godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: S: susceptible; I: intermediate; R: resistant
Danish: S: følsom; I: middelfølsom; R: resistent
English: BATCH NUMBER Batch:
Danish: BATCHNUMMER Batch:
English: However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.
Danish: Imidlertid er der ikke vist dokumentation for selektiv udviklings- eller reproduktionseffekt i nogle af laboratorieundersøgelserne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 6 May 2011.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 6. maj 2011.
English: 60 μg - - - 16
Danish: 60 µg - - - 16
English: Injection should be given in a horizontal direction and a 90° angle to the body axis.
Danish: Injektion skal gives horisontalt med en vinkel på 90 ° til kroppens akse.
English: The injection volume should not exceed 5 ml per injection site.
Danish: Injektionsvolumen bør ikke overstige 5 ml pr. injektionssted.
English: The mean terminal half-life is 4.4 days.
Danish: Den gennemsnitlige terminale halveringstid er 4,4 døgn.
English: Tildipirosin may cause sensitisation by skin contact.
Danish: Tildipirosin kan forårsage overfølsomhed ved hudkontakt.
English: Do not use in automatically powered syringes which have no additional protection system.
Danish: Må ikke anvendes i injektorer med automatisk dosisafgivelse, som ikke har ekstra sikkerhedsanordning.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefitforholdet.
English: The excipients 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i 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.
English: 85716 Unterschleissheim GERMANY
Danish: 85716 Unterschleissheim Tyskland
English: Disk content
Danish: Indhold i disken
English: Macrolides in general are bacteriostatic antibiotics but for certain pathogens can be bactericidal.
Danish: Makrolider er almindeligvis bakteriostatiske antibiotika, men kan for nogle patogener være baktericide.
English: In line with responsible use principles, metaphylactic use of Zuprevo is only indicated in severe outbreaks of SRD caused by the indicated pathogens.
Danish: I henhold til principper for ansvarlig brug er metafylaktisk brug af Zuprevo kun indiceret i tilfælde af alvorlige udbrud af SRD forårsaget af de angivne patogener.
English: The recommended injection site is the location just behind the ear at the highest point of the base of the ear, at the transition from bald to hairy skin.
Danish: Det anbefalede injektionssted er lige bag øret på det højeste punkt ved starten af øret ved overgangen fra ikke behåret til behåret hud.
English: The mean terminal half-life is approximately 9 days.
Danish: Den gennemsnitlige terminale halveringstid er ca. 9 døgn.
English: These swellings resolved within 1 to 6 days.
Danish: Hævelsen forsvandt inden for 1 til 6 døgn.
English: Otherwise, the use of a multiple-dose syringe is recommended.
Danish: Alternativt anbefales brug af flerdosissprøjte.
English: Data were collected on zoonotic bacteria and commensals.
Danish: Data blev indsamlet for zoonotiske og kommensale bakterier.
English: Tildipirosin is a 16-membered semi-synthetic macrolide antimicrobial agent.
Danish: Tildipirosin er et 16-leddet semisyntetisk makrolid-antibiotika.
English: The antimicrobial activity spectrum of tildipirosin includes:
Danish: Tildipirosins antimikrobielle virkningsspektrum inkluderer:
English: Marketing authorisation holder: Intervet International B. V.
Danish: Indehaver af markedsføringstilladelsen: Intervet International B.V.
English: Mortality was observed at doses of 25 mg/kg body weight and higher.
Danish: Dødelighed blev set ved doser på 25 mg/kg kropsvægt og derover.
English: Macrolides are characterised by their extensive partitioning into tissues.
Danish: Makrolider er kendetegnet ved udtalt fordeling til væv.
English: Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Danish: Hvis muligt, bør lægemidlet kun bruges på grundlag af resistensundersøgelse.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette veterinære lægemiddel ikke blandes med andre lægemidler.
English: MANUFACTURER'S BATCH NUMBER Batch:
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: Do not administer intravenously.
Danish: Må ikke gives intravenøst.
English: The product has a long duration of action; however, the exact clinical effect duration after a single injection is unknown.
Danish: Imidlertid er den eksakte varighed af den kliniske effekt efter en enkelt injektion ikke fastlagt.
English: Recommended needle size and diameter per production stage
Danish: Anbefalet størrelse og diameter af nål pr. produktionstrin
English: 4.7 Use during pregnancy and lactation
Danish: 4.7 Anvendelse under drægtighed og laktation
English: Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group).
Danish: Efter metafylaktisk brug forblev ca. 86% af de raske dyr fri for kliniske tegn på sygdom (sammenholdt med ca. 65% af dyrene i den ubehandlede kontrolgruppe).
English: The following tildipirosin breakpoints have been established for swine respiratory disease (according to CLSI Guideline VET02 A3):
Danish: Følgende breakpoints for tildipirosin er fastlagt for luftvejsinfektioner hos svin (i henhold til CLSI Guideline VET02 A3):
English: Three amine substituents at the macrocyclic lactone ring result in a tri-basic character of the molecule.
Danish: Tre amingrupper substitueret til den makrocykliske laktonring giver molekylet en trible basisk karakter.
English: MIC values for Salmonella were reported to be in the range of 4-16 µg/ml, and all strains were wild type.
Danish: MIC-værdier for Salmonella blev angivet at være i området 4-16 µg/ml, og alle stammer var vild-typer.
English: The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days.
Danish: Hævelserne er forbigående og vil sædvanligvis forsvinde inden for 7 til 16 døgn; hos enkelte dyr vil hævelsen vedvare i op til 21 døgn.
English: Manufacturer for the batch release: Intervet International GmbH Feldstrasse 1 a
Danish: Fremstiller ansvarlig for batchfrigivelse: Intervet International GmbH Feldstrasse 1 a
English: Citric acid monohydrate Propylene glycol Water for injections
Danish: Citronsyremonohydrat Propylenglycol Vand til injektionsvæsker
English: In very rare cases, transient lethargy in piglets has been observed.
Danish: I meget sjældne tilfælde er der observeret forbigående letargi hos smågrise.
English: Ask your veterinary surgeon/pharmacist how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge eller apoteket vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: They inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA and act by blocking the prolongation of the peptide chain.
Danish: De inhiberer biosyntesen af essentielle proteiner ved selektiv binding til bakteriens ribosomale RNA, hvorved forlængelsen af peptidkæden blokeres.
English: In vitro binding of tildipirosin to porcine plasma proteins is limited with approximately 30 %.
Danish: In vitro er binding af tildipirosin til proteiner i plasma hos svin begrænset til ca. 30%.
English: There is cross resistance with other macrolides.
Danish: Der er krydsresistens til andre macrolider.
English: Do not store above 25 °C.
Danish: Må ikke opbevares over 25 °C.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af utilsigtet selvinjektion søges lægehjælp øjeblikkeligt, og indlægssedlen eller etiketten vises til lægen.
English: Intervet International GmbH Feldstrasse 1 a 85716 Unterschleissheim GERMANY
Danish: Intervet International GmbH Feldstrasse 1 a 85716 Unterschleissheim Tyskland
English: For treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Danish: Ved behandling af kvæg over 450 kg kropsvægt deles dosis, således at der ikke gives mere end 10 ml på ét injektionssted.
English: In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.
Danish: I meget sjældne tilfælde kan der forekomme anafylaktiske reaktioner med potentiel dødelig udgang.
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Danish: (µg/ml) MIC90 (µg/ml)
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: If accidental eye exposure occurs, flush eyes immediately with clean water.
Danish: I tilfælde af kontakt med øjnene skylles øjeblikkeligt med rent vand.
English: Do not use after the expiry date which is stated on the vial after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på hætteglasset.
English: Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streptogramins is to be expected.
Danish: Krydsresistens mellem tildipirosin og andre makrolider, lincosamider og streptograminer må almindeligvis forventes.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Sikkerheden af dette veterinære lægemiddel er ikke fastlagt under drægtighed og laktation.