FrancophonIA/ELRC3.0 huggingface dataset:
English: As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Danish: Da tilmicosin forbliver i vævet i flere dage, skal det kardiovaskulære system nøje overvåges, og støttende behandling gives.
English: Cross resistance between tilmicosin and other macrolides and lincomycin has been observed.
Danish: Krydsresistens mellem tilmicosin og andre makrolider samt lincomycin er blevet observeret.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Skal udfyldes i det enkelte land.
English: INJECTION OF TILMICOSIN IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY
Danish: INJEKTION AF TILMICOSIN HOS MENNESKER KAN VÆRE DØDELIG - VÆR YDERST FORSIGTIG FOR AT UNDGÅ UTILSIGTET SELVINJEKTION OG FØLG ANVISNINGERNE FOR INDGIVELSE SAMT VEJLEDNINGEN NEDENFOR NØJAGTIGT.
English: Sometimes (1 in 12) a pain reaction was seen after subcutaneous injection of tilmicosin.
Danish: Undertiden (1 ud af 12) var der smertereaktion efter subkutan injektion af tilmicosin.
English: • Withdrawal period.
Danish: • tilbageholdelsestid.
English: The overall benefit-risk balance of the product for use in cattle and sheep was deemed positive subject to the recommended changes in the product information (see annex III).
Danish: Det overordnede benefit/risk-forhold for produktet til anvendelse hos kvæg og får anses for at være positivt under forudsætning af de anbefalede ændringer af produktinformationen (se bilag III).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke findes undersøgelser af forligeligheder, må dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: NOTE TO THE PHYSICIAN
Danish: NOTAT TIL LÆGEN
English: Clear solution.
Danish: Klar opløsning.
English: Following oral or parenteral administration of tilmicosin the main target organ for toxicity is the heart.
Danish: Efter oral eller parenteral indgivelse af tilmicosin, er hovedmålet for toksicitet hjertet.
English: 40 kg animals 28-50 kg animals
Danish: 40 kg dyr 28-50 kg dyr
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Danish: Videnskabelige resultater antyder, at makrolider virker synergistisk med værtens immunsystem.
English: Macrolides appear to enhance phagocyte killing of bacteria.
Danish: Makrolider lader til at øge fagocyt-drab af bakterier.
English: • May cause sensitisation by skin contact.
Danish: • Kan give overfølsomhed ved kontakt med huden.
English: Administration of intravenous calcium chloride should only be considered if there is positive confirmation of exposure to tilmicosin.
Danish: Intravenøs indgivelse af kalciumklorid bør kun overvejes, hvis der er positiv bekræftelse af eksponering for tilmicosin.
English: Protect from direct sunlight
Danish: Beskyttes mod direkte sollys
English: INJECTION OF TILMICOSIN IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES.
Danish: INJEKTION AF TILMICOSIN HOS MENNESKER HAR VÆRET FORBUNDET MED DØDSFALD.
English: Tilmicosin in vitro microbiological data of European isolates from respiratory disease in bovines were presented for several periods (2002-2004; 2004-2006 and 2009-2013).
Danish: Der blev forelagt mikrobiologiske in vitro-data for tilmicosin for europæiske isolater fra kvæg med luftvejssygdom for forskellige perioder (2002-2004, 2004-2006 og 2009-2013).
English: Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poison Information Service on: ... relevant national number stated (to be completed nationally)
Danish: Læger, som behandler patienter, der har været udsat for dette præparat, tilrådes at diskutere klinisk behandling med Giftlinjen på: ... relevant telefonnummer for det pågældende land angivet (skal udfyldes i hvert enkelt land)
English: This restriction in sheep seems difficult to “coexist” with an authorisation in rabbits whose weight is less than 5 kg (rabbits are generally slaughtered around 2.5 kg).
Danish: Denne begrænsning hos får synes at være vanskelig at kombinere med en godkendelse til kaniner med en vægt på under 5 kg (kaniner slagtes sædvanligvis ved en vægt på ca. 2,5 kg).
English: 10 DATE OF REVISION OF THE TEXT To be completed nationally.
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN Skal udfyldes i det enkelte land.
English: This led the CVMP in 2005 to limit the use of Micotil to sheep weighing more than 15 kg and to be administered by veterinary surgeons only (referral procedure under Article 35 of Directive 2001/82/EC, for Micotil 300 (EMEA/V/A/010)).
Danish: Dette fik i 2005 CVMP til at begrænse anvendelsen af Micotil til kun at omfatte får over 15 kg og kun administreret af dyrlæge (indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF for Micotil 300 (EMEA/V/A/010)).
English: Biotransformation: Several metabolites are formed, the predominant one being identified as T1 (Ndemethyl tilmicosin).
Danish: Biologisk omdannelse: Der dannes flere metabolitter, hvoraf den fremherskende er en metabolit identificeret som T1 (N-demethyl tilmicosin).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Skal udfyldes i det enkelte land.
English: Accurate weighing of lambs is important to avoid overdose.
Danish: Nøjagtig vejning af lam er vigtigt for at undgå overdosering.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlets navne, lægemiddelformer, styrker, dyrearter, indgivelsesvej, indehaverne af markedsføringstilladelse i medlemsstaterne
English: As expected, oedema developed at the site of injection.
Danish: Som forventet udvikledes der ødem på injektionsstedet.
English: With regard to P. multocida it can be concluded that based on the information available for cattle this pathogen should remain in the indication.
Danish: Hvad angår P. multocida kan det konkluderes, at denne patogen bør forblive i indikationen på grundlag af de foreliggende oplysninger for kvæg.
English: Milk: 18 days
Danish: Mælk: 18 dage
English: The clinical studies used naturally infected cattle with interdigital necrobacillosis without a bacteriological diagnosis.
Danish: De kliniske undersøgelser blev udført hos naturligt inficeret kvæg med interdigital necrobacillose uden bakteriologisk diagnose.
English: Minimum inhibition concentration measured in recently (2009-2012) isolated European field strains, derived from respiratory bovine disease.
Danish: Mindste hæmmende koncentration målt i nyligt (2009-2012) isolerede europæiske vild virusstammer afledt fra luftvejsinfektioner hos kvæg.
English: The Netherlands referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Micotil 300 mg/ml Injectie and its associated names.
Danish: Nederlandene indbragte sagen, fordi der som følge af divergerende nationale afgørelser i EU-medlemsstaterne er uoverensstemmelser i produktinformationen for Micotil 300 mg/ml Injectie og relaterede navne.
English: The use of the product should be based on susceptibility tests.
Danish: Anvendelsen af produktet skal ske på baggrund af en følsomhedstest.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening of the immediate packaging: 28 days
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indvendige emballage: 28 dage
English: Administration of dobutamine should also be considered due to its positive inotropic effects although it does not influence tachycardia.
Danish: Indgivelse af dobutamin bør også overvejes pga. de positive inotropiske virkninger, selvom det ikke har indflydelse på takykardi.
English: Overall summary of the scientific evaluation of Micotil 300 mg/ml Injectie and its associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Micotil 300 mg/ml Injectie og relaterede navne (se bilag I)
English: Do not use “product name (to be completed nationally)” if you notice any foreign particulate matter and/or abnormal physical appearance.
Danish: Anvend ikke “produktnavn (skal udfyldes i det enkelte land)”, hvis De bemærker fremmedpartikler og/eller et unormalt fysisk udseende.
English: The results show that, when administered as recommended to calves and sheep by subcutaneous injection over the dorso-lateral chest, the main parameters are:
Danish: Resultaterne viser, at når produktet indgives som anbefalet til kvæg og får ved subkutan injektion over den dorsolaterale brystkasse, er hovedparametrene:
English: Do not administer to primates
Danish: Må ikke indgives til primater.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight.
Danish: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf injektion af tilmicosin i en dosis på 10 mg/kg kropsvægt.
English: Milk: 36 days
Danish: Mælk: 36 dage
English: Use only according to the benefit/risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefitforholdet.
English: On 24 April 2012, the Netherlands sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Micotil 300 mg/ml Injectie and its associated names.
Danish: Den 24. april 2012 foretog Nederlandene i medfør af artikel 34, stk. 1, i direktiv 2001/83/EF, som ændret, en indbringelse for CVMP/Det Europæiske Lægemiddelagentur vedrørende Micotil 300 mg/ml Injectie og relaterede navne.
English: Other symptoms observed were: difficulty in moving, reduced appetite and tachycardia.
Danish: Følgende andre symptomer blev observeret: bevægelsesbesvær, nedsat appetit og takykardi.
English: Higher doses (150 mg/kg body weight) caused ataxia, lethargy and the inability to raise the head.
Danish: Højere doser (150 mg/kg legemsvægt) forårsagede ataksi, letargi og en manglende evne til at løfte hovedet.
English: Treatment of interdigital necrobacillosis.
Danish: Behandling af interdigital necrobacillose.
English: Bordetella bronchiseptica was not isolated in any clinical or preclinical study and no in vitro study has been performed with this bacteria.
Danish: Der blev ikke isoleret Bordetella bronchiseptica i nogen klinisk eller præklinisk undersøgelse, og der er ikke udført nogen in vitro-undersøgelse med denne bakterie.
English: Injection of the product in goats and pigs has been fatal.
Danish: Injektion af produktet hos geder og svin har været dødelig.
English: Do not administer to lambs weighing less than 15 kg.
Danish: Må ikke indgives til lam, der vejer under 15 kg.
English: 10 mg/kg body weight 10 mg/kg body weight
Danish: 10 mg/kg legemsvægt 10 mg/kg legemsvægt
English: Tilmicosin is a mainly bactericidal semi-synthetic antibiotic of the macrolide group.
Danish: Tilmicosin er primært et bakteriedræbende halv-syntetisk antibiotikum i makrolidgruppen.
English: NOTE TO PHYSICIAN: please see inside of label or package leaflet for details.
Danish: NOTAT TIL LÆGEN: Se indersiden af etiketten eller indlægssedlen for nærmere oplysninger.
English: Distribution: Following subcutaneous injection, tilmicosin is distributed throughout the body, but especially high levels are found in the lung.
Danish: Fordeling: Efter subkutan injektion fordeles tilmicosin gennem hele kroppen, men særligt høje niveauer findes i lungen.
English: Staphylococcus aureus was not isolated in any preclinical study or clinical trial.
Danish: Staphylococcus aureus blev ikke isoleret i nogen præklinisk eller klinisk undersøgelse.
English: The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy).
Danish: De primære effekter på hjertet er øget hjertefrekvens (takykardi) og reduceret sammentrækningsevne (negativ inotropi).
English: A rabbit doe of 5 kg body weight would require a dose of 0.1 ml of product and a growing rabbit a volume around 0.05 ml.
Danish: En hunkanin med en kropsvægt på 5 kg vil kræve en dosis på 0,1 ml af produktet, og en kanin i opvækst et volumen på cirka 0,05 ml.
English: This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain Gram-negative ones and Mycoplasma of a bovine and ovine origin.
Danish: Denne antibakterielle aktivitet er hovedsagligt rettet mod Gram-positive mikroorganismer med aktivitet rettet mod visse Gram-positive mikroorganismer og mycoplasma hos kvæg eller får.
English: Therefore it is difficult to assess the efficacy of tilmicosin since no bacteriological diagnosis was conducted and both tilmicosin as well as the positive control were administered as a preventive therapeutic, five days before parturition.
Danish: Det er derfor vanskeligt at vurdere virkningen af tilmicosin, da der ikke blev foretaget en bakteriologisk diagnose, og da både tilmicosin og det positive kontrolprodukt blev givet som forebyggende behandling fem dage før fødsel.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial - base label (fold out label details are the same as the package leaflet)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas - basisetiket (oplysningerne på foldeetiketten er de samme som på indlægssedlen)
English: The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade.
Danish: Det kardiovaskulære system er genstanden for toksicitet, og denne toksicitet kan være forårsaget af kalciumkanalblokering.
English: The MIC90 data from recently isolated European strains should be included in SPC section 5.1 Pharmacodynamic properties.
Danish: MIC90-data for nyligt isolerede europæiske stammer bør indgå i produktresuméets punkt 5.1 Farmakodynamiske egenskaber.
English: The vial should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: Hætteglasset skal efterses visuelt for eventuelle fremmedpartikler og/eller et unormalt fysisk udseende.
English: Cardiovascular toxicity may be due to calcium channel blockade.
Danish: Kardiovaskulær toksicitet kan skyldes kalciumkanalblokering.
English: • This product should only be administered by a veterinary surgeon.
Danish: • Produktet må kun indgives af en dyrlæge.
English: DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
Danish: UNDLAD AT INDGIVE ADRENALIN ELLER BETABLOKKERE SÅSOM PROPRANOLOL.
English: When administered by injection, tilmicosin has a narrow safety of margin.
Danish: Når tilmicosin administreres ved injektion, har det en meget snæver sikkerhedsmargin.
English: Furthermore, the text in the proposed indication “…and other microorganisms sensitive to tilmicosin” is not in accordance with recommendations in the CVMP reflection paper on macrolides, lincosamides and streptogramins
Danish: Desuden er teksten i den ansøgte indikation “… og andre tilmicosin-følsomme organismer” ikke i overensstemmelse med anbefalingerne i CVMP's oplæg om makrolider, lincosamider og streptograminer
English: Apply a cold pack (not ice directly) to the injection site.
Danish: Anbring en ispose (ikke is direkte) over injektionsstedet.
English: The safety of the veterinary medicinal product has not been established during pregnancy.
Danish: Veterinærlægemidlets sikkerhed under drægtighed er ikke fastlagt.
English: 1030 Wien
Danish: 1030 Vienna
English: METHOD AND ROUTE(S) OF ADMINISTRATION FOR SUBCUTANEOUS INJECTION ONLY.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) KUN TIL SUBKUTAN INJEKTION.
English: Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml “product name (to be completed nationally)” per 30 kg body weight).
Danish: Brug 10 mg tilmicosin per kg legemsvægt (svarende til 1 ml “produktnavn (skal udfyldes i det enkelte land)” per 30 kg legemsvægt).
English: In rare cases recumbency, incoordination and convulsions have been observed.
Danish: I sjældne tilfælde er der blevet set dyr i liggende stilling, koordinationssvigt og kramper.
English: Pre-clinical data and an isolated clinical report suggest that calcium chloride infusion may help to reverse tilmicosin induced changes in blood pressure and heart rate in humans.
Danish: Prækliniske data og en isoleret klinisk rapport antyder, at infusion af kalciumklorid kan hjælpe til at reversere ændringer i blodtryk og hjertefrekvens induceret af tilmicosin hos mennesker.
English: The second clinical trial which studied efficacy of tilmicosin against reproductive diseases showed no inferiority towards the positive control (penicillin combined with an aminoglycoside) however no negative controls were included.
Danish: Den anden kliniske undersøgelse af tilmicosins virkning ved sygdomme i reproduktionssystemet viste ingen inferioritet i forhold til den positive kontrol (penicillin kombineret med et aminoglykosid), men der var ingen negativ kontrol.
English: • In case of self-injection SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or the package leaflet with you.
Danish: • I tilfælde af selvinjektion, SØG STRAKS LÆGE og tag hætteglasset eller indlægssedlen med Dem.
English: In milk, a concentration of tilmicosin of 1.2 µg/ml at day 3 has been measured indicating a concentration above most MIC values of the pathogens.
Danish: I mælk er målt en koncentration af tilmicosin på 1,2 µg/ml på dag 3, dvs. en koncentration over de fleste MIC-værdier for patogenerne.
English: A slight increase in MIC levels could be observed for Mannheimia haemolytica isolates over the last decade, most of isolates (83%) were clinically susceptible to tilmicosin.
Danish: I det seneste årti er der set en let stigning i MIC-værdierne for isolater af Mannheimia haemolytica; størstedelen af isolaterne (83 %) var klinisk følsomme over for tilmicosin.
English: Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Danish: Tilmicosin er et makrolidantibiotikum, der syntetiseres af tylosin og har et antibakterielt spektrum svarende til tylosin med øget aktivitet over for Pasteurella multocida og Mannheimia haemolytica.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic Group: antibacterials for systemic use, macrolides.
Danish: Farmakoterapeutisk gruppe: antibakterielle stoffer til systemisk brug, makrolider.
English: Dobutamine partially offset the negative inotropic effects induced by tilmicosin in dogs.
Danish: Dobutamin opvejede delvist de negative inotropiske virkninger induceret af tilmicosin hos hunde.
English: Elimination: Following subcutaneous injection, tilmicosin is excreted mainly via the bile into the faeces, but a small proportion is excreted via the urine.
Danish: Eliminering: Efter subkutan injektion udskilles tilmicosin hovedsagligt via galden til afføringen, men en lille del udskilles via urinen.
English: MIC measured in these isolates did not show an increase in MIC levels for Pasteurella multocida (97% of the isolates were susceptible to tilmicosin), therefore from the data provided no trend in resistance increase could be observed for one of the major pathogens for respiratory diseases in cattle.
Danish: Målingerne for disse isolater viste ingen stigning i MIC-værdierne for Pasteurella multocida (97 % af isolaterne var følsomme for tilmicosin); af de forelagte data ses således ikke tendens til øget resistens af en af de vigtigste patogener ved luftvejssygdomme hos kvæg.
English: Manufacturer responsible for batch release: To be completed nationally
Danish: Fremstiller ansvarlig for batchfrigivelse: Skal udfyldes i det enkelte land
English: Tolerance studies clearly demonstrate that a dosage of 20 mg/kg body weight subcutaneous tilmicosin injection in lambs (7-11 kg) was toxic, leading to deaths.
Danish: Toleranceundersøgelser viste klart, at en dosering på 20 mg/kg kropsvægt subkutant af tilmicosin til lam (7-11 kg) var toksisk og medførte dødsfald.
English: The needle should be connected to the syringe only when filling the syringe or administering the injection.
Danish: Kanylen må kun være påsat injektionssprøjten, når injektionssprøjten fyldes eller ved indgivelse af injektionen.
English: Do not administer to pigs.
Danish: Må ikke indgives til svin.
English: Since no dose-finding studies in rabbits were provided it cannot be concluded from the data available that Pasteurellosis can be treated with the recommended tilmicosin dosage of 10 mg/kg body weight.
Danish: Da der ikke er forelagt en dosisfastsættelsesundersøgelse hos kaniner, kan det af de foreliggende data ikke konkluderes, at pasteurellose kan behandles med den anbefalede dosering af tilmicosin på 10 mg/kg kropsvægt.
English: Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Danish: Micotil 300 mg/ml Injectie og relaterede navne er veterinærlægemidler, der er godkendt til anvendelse hos måldyrearterne kvæg, får og kaniner til behandling af forskellige infektioner forårsaget af tilmicosin-følsomme mikroorganismer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papkarton
English: OTHER INFORMATION “product name (to be completed nationally)” is contained in 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
Danish: ANDRE OPLYSNINGER "produktnavn (skal udfyldes i det enkelte land)" leveres i 25 ml, 50 ml, 100 ml eller 250 ml ravfarvede hætteglas (Type I eller Type II) forseglet med en gummiprop og et oversegl af aluminium.
English: Intravenous injection of 4.5 to 5.6 mg tilmicosin/kg body weight followed by intravenous injection of 1 ml epinephrine (1/1000) 2 to 6 times resulted in death of all 6 injected pigs.
Danish: Intravenøs injektion af 4,5 til 5,6 mg tilmicosin/kg legemsvægt efterfulgt af intravenøs injektion af 1 ml epinefrin (1/1000) 2 til 6 gange resulterede i dødsfald hos alle 6 injicerede svin.
English: Sheep weighing 40 kg were more resistant and survived a subcutaneous dose of 150 mg/kg body weight, showing ataxia and lethargy.
Danish: Får med en vægt på 40 kg var mere modstandsdygtige og overlevede en subkutan dosis på 150 mg/kg kropsvægt, men udviste ataksi og letargi.
English: A dose of 30 mg/kg body weight resulted in increased respiratory rate.
Danish: En dosis på 30 mg/kg kropsvægt medførte forhøjet respirationsfrekvens.
English: The CVMP concluded that, due to limited availability of alternative veterinary medicinal products for this indication and in the absence of reports on suspected lack of efficacy, the indication “for treatment of ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae” should be maintained, but in a modified manner to better reflect the study results, to “treatment of acute ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae”.
Danish: CVMP konkluderede, at på grund af den begrænsede rådighed over andre veterinærlægemidler til denne indikation og i fravær af indberetninger om formodet manglende virkning bør indikationen “behandling af mastitis hos får associeret med Staphylococcus aureus og Mycoplasma agalactiae” opretholdes, men affattes på en måde, der bedre afspejler undersøgelsens resultater, dvs. “behandling af akut mastitis hos får associeret med Staphylococcus aureus og Mycoplasma agalactiae”.
English: Avoid introduction of contamination into the vial during use.
Danish: Undgå introduktion af kontamination i hætteglasset under brug.