FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients (including adjuvants) 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 (inklusive adjuvanser) som er anført i punkt 6.1 af 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: EXP {month/year} Once opened, use within 10 hours.
Danish: Anvendes før {måned/år} Efter åbning anvendes inden for 10 timer.
English: EU/2/17/209/001 (25 doses) EU/2/17/209/002 (50 doses)
Danish: EU/2/17/209/001 (25 doser) EU/2/17/209/002 (50 doser)
English: Generally, maternally-derived antibodies induced by vaccination last for approximately 5-8 weeks after birth.
Danish: Generelt holder antistoffer, der overføres fra moderdyret ved vaccination, i cirka 5-8 uger efter fødslen.
English: Shelf life after first opening the vial: 10 hours.
Danish: Opbevaringstid efter første åbning af hætteglasset : 10 timer.
English: Pharmacotherapeutic group: Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus.
Danish: Farmakoterapeutisk gruppe: Immunologiske lægemidler, inaktiverede virale vacciner til svin, svineinfluenzavirus.
English: It induces neutralising and haemagglutination-inhibiting antibodies against this subtype.
Danish: Den inducerer neutraliserende og hæmagglutinationshæmmende antistoffer mod denne undertype.
English: In cases of exposure of the sows to antigens (from either field infections and/or vaccination) the antibodies transmitted to the piglets can interfere with active immunisation at 12 weeks of age.
Danish: I tilfælde af eksponering af søerne for antigener (fra enten feltinfektioner og/eller vaccination), kan de antistoffer, der overføres til smågrisene, påvirke den aktive immunisering i 12-ugers alderen.
English: 25 ml (25 doses) 50 ml (50 doses)
Danish: 25 ml (25 doser) 50 ml (50 doser)
English: Efficacy of the vaccine was examined in laboratory challenge studies in pigs without maternallyderived antibodies and was demonstrated against the following strains:
Danish: Vaccinens effekt blev undersøgt i laboratorie challengeundersøgelser på svin uden antistoffer overført fra moderdyret og blev påvist mod følgende stammer:
English: 1 HU - haemagglutinating units.
Danish: 1HE = hæmagglutinerende enheder.
English: 0.1 mg Clear to slightly turbid, reddish to pale-pink coloured suspension.
Danish: 0,1 mg Klar til let uklar, rødlig eller lyserød farvet suspension.
English: A transient swelling up to 2 cm3 may occur at the site of injection: these reactions are common but resolve within 5 days.
Danish: En forbigående hævelse på op til 2 cm3 kan forekomme på injektionsstedet: disse reaktioner er almindelige, men forsvinder inden for 5 dage.
English: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin), FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).
Danish: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human oprindelse), FLUAV/svin/Schallern/IDT19989/2014 (H1N1)pdm09 (svineoprindelse) og FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (svineoprindelse).
English: A transient swelling up to 2 cm3 may occur at the site of injection, these reactions are common but resolve within 5 days.
Danish: En forbigående hævelse på op til 2 cm3 kan forekomme på injektionsstedet, disse reaktioner er almindelige, men forsvinder inden for 5 dage.
English: Maternally-derived antibodies in piglets interfere with the RESPIPORC FLUpan H1N1 mediated immunity.
Danish: Antistoffer, der overføres til smågrisene fra moderdyret, påvirker den RESPIPORC FLUpan H1N1medierede immunitet.
English: Active immunisation of pigs from the age of 8weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and virus excretion.
Danish: Aktiv immunisering af svin fra 8-ugers alderen og fremefter mod pandemisk H1N1 svineinfluenzavirus for at reducere virusbelastningen i lungerne og virusudskillelse.
English: RESPIPORC FLUpan H1N1 suspension for injection for pigs
Danish: RESPIPORC FLUpan H1N1 injektionsvæske, suspension til grise
English: Neutralising antibodies in serum have been detected in more than 75% of the immunised pigs on day 7 after primary immunisation lasting in more than 75% of the pigs for over 3 months.
Danish: Der er detekteret neutraliserende antistoffer i serum hos mere end 75 % af de immuniserede svin på dag 7 efter den primære immunisering med en varighed på mere end 3 måneder hos mere end 75 % af svinene.
English: The antibody responses mentioned in the following have been documented in pigs without maternally-derived immunity.
Danish: De antistofresponser, der nævnt i det følgende, er dokumenteret hos svin uden immunitet overført fra moderdyret.
English: Aluminium flanged caps
Danish: Aluminiumlåg med kant
English: Haemagglutination-inhibiting antibodies have been detected in 15100% of the immunised pigs on day 7 after primary immunisation which disappeared in the majority of animals within 1 to 4 weeks thereafter.
Danish: Hæmagglutinationshæmmende antistoffer er detekteret hos 15-100 % af de immuniserede svin på dag 7 efter primær immunisering, som forsvandt hos hovedparten af dyrene inden for 1 til 4 uger derefter.
English: 7 days after primary vaccination.
Danish: Indtræden af immunitet: 7 dage efter primær vaccination.
English: The vaccine stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009 (H1N1)pandemic09-like virus.
Danish: Vaccinen stimulerer en aktiv immunitet mod pandemisk svineinfluenza A/Jena/VI5258/2009 (H1N1)pandemic09-lignende virus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 25 ml, 50 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske til 25 ml, 50 ml
English: 25 ml polyethylene terephthalate (PET) vials 50 ml PET vials
Danish: 25 ml polyethylenterephthalat (PET) hætteglas 50 ml PET- hætteglas
English: PACKAGE LEAFLET FOR: RESPIPORC FLUpan H1N1 suspension for injection for pigs
Danish: INDLÆGSSEDDEL: RESPIPORC FLUpan H1N1 injektionsvæske, suspension til grise
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of 25 ml and 50 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med 25 ml og 50 ml
English: Bromobutyl rubber stoppers
Danish: Brombutylgummipropper
English: Clear to slightly turbid, reddish to pale-pink coloured suspension.
Danish: Klar til let uklar, rødlig eller lyserød farvet suspension.
English: Active substance:
Danish: Aktivt stof (Aktive stoffer):
English: 4.2 Indication for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: Cardboard box with 1 polyethylene terephthalate (PET) vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.
Danish: Kartonæsker med 1 polyethylenterephthalat (PET)- hætteglas a 25 doser (25 ml) eller 50 doser (50 ml) med gummiprop og låg med kant.
English: PET vials:
Danish: PET- hætteglas:
English: Cardboard box with 1 vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.
Danish: Kartonæsker med 1 hætteglas a 25 doser (25 ml) eller 50 doser (50 ml) med gummiprop og låg med kant.
English: Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09: ≥ 16 HU
Danish: Inaktiveret influenza A-virus/human, stamme A/Jena/VI5258/2009(H1N1)pdm09: ≥ 16 HE
English: Inactivated influenza A virus/human Strain: A/Jena/VI5258/2009(H1N1)pdm09
Danish: Inaktiveret influenza A-virus/human Stamme: A/Jena/VI5258/2009(H1N1)pdm09
English: Stoppers:
Danish: Hætter:
English: Excipient:
Danish: Propper:
English: Adjuvant:
Danish: Adjuvans (Adjuvanser):
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lantus on 9 June 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lantus den 9. juni 2000.
English: The full EPAR for Lantus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lantus findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This document is a summary of the European Public Assessment Report (EPAR) for Lantus.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lantus.
English: It should be given in the evening in patients aged less than 18 years.
Danish: Til patienter på under 18 år bør det gives om aftenen.
English: In adults (aged 18 years or over), it can be given at any time, provided that it is at the same time each day.
Danish: Til voksne (på 18 år og derover) har det ingen betydning, hvornår det gives i løbet af dagen, når blot det altid gives på samme tidspunkt.
English: Lantus is given once a day.
Danish: Lantus gives en gang dagligt.
English: Other information about Lantus:
Danish: Andre oplysninger om Lantus:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lantus.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Lantus.
English: The effectiveness of Lantus was seen regardless of the time of the injection.
Danish: Lantus var effektivt uanset tidspunktet for injektionen.
English: The patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Danish: Patientens blodsukkerniveau (glukose) skal kontrolleres regelmæssigt for at fastsætte den laveste effektive dosis.
English: For more information about treatment with Lantus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lantus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: EPAR summary for the public insulin glargine
Danish: EPAR sammendrag for offentligheden insulin glargin
English: The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Danish: Denne forskel bevirker, at det optages langsommere og jævnere af kroppen efter en injektion, og at det virker længe.
English: The CHMP decided that Lantus's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Lantus opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.
Danish: Reaktioner på injektionsstedet (rødme, smerte, kløe og hævelse) og hudreaktioner (udslæt) kunne observeres oftere hos børn end hos voksne.
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Danish: Injektionsstedet skal ændres ved hver injektion for at undgå forandringer i huden (såsom fortykkelse), der kan bevirke, at insulinet ikke virker så godt som forventet.
English: Insulin glargine is very slightly different from human insulin.
Danish: Insulin glargin adskiller sig en smule fra humant insulin.
English: All of the studies measured the level of ‘fasting' blood glucose (measured when the patients had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: I alle undersøgelserne måltes blodsukkerniveauet ‘fastende' (målt, når patienterne ikke havde spist i mindst otte timer), eller man målte et stof i blodet kaldet glykosyleret hæmoglobin (HbA1c), som giver en indikation af, hvor godt blodsukkeret reguleres.
English: Lantus doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Danish: Det kan også være nødvendigt at justere dosis af Lantus, når det gives sammen med visse andre lægemidler, der kan indvirke på blodsukkerniveauet.
English: Patients can inject themselves with Lantus if they have been trained appropriately.
Danish: Patienterne kan godt selv give injektionerne, hvis de er behørigt instrueret heri.
English: The active substance in Lantus, insulin glargine, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.
Danish: Det aktive stof i Lantus, insulin glargin, fremstilles via en metode, der kaldes "rekombinant dnateknologi": Det fremstilles af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere insulin glargin.
English: The most common side effect with Lantus (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Lantus (som ses hos mere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodsukkerniveau).
English: Further studies have also been carried out to compare Lantus and human insulin NPH in patients with type 1 diabetes aged between five and 18 years, 200 of whom received Lantus, and in children aged two to six years, 61 of whom received Lantus.
Danish: Der blev gennemført yderligere undersøgelser for at sammenligne Lantus med humant insulin NPH hos patienter på mellem fem og 18 år, hvoraf 200 fik Lantus, og hos børn i alderen to til seks år, hvoraf 61 fik Lantus.
English: Injections of fast-acting insulin were also used at mealtimes.
Danish: Der blev også givet injektioner af hurtigtvirkende insulin i forbindelse med måltider.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Danish: Diabetes er en sygdom, hvor kroppen ikke danner tilstrækkeligt insulin til at regulere blodsukkermængden.
English: Lantus led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin.
Danish: Lantus medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau, der svarede til det, der var observeret for humant insulin.
English: Lantus was originally studied in 10 studies, in both type 1 diabetes (when the pancreas cannot produce insulin) and type 2 diabetes (when the body is unable to use insulin effectively).
Danish: Lantus blev oprindeligt undersøgt i 10 undersøgelser hos patienter med enten type 1-diabetes (hvor bugspytkirtlen ikke kan producere insulin) eller type 2-diabetes (hvor kroppen ikke kan udnytte insulinet effektivt).
English: The full list is available in the package leaflet.
Danish: Den fuldstændige liste fremgår af indlægssedlen.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet fungerer på samme måde som naturligt produceret insulin og hjælper sukkeret (glukosen) til at trænge ind i cellerne fra blodet.
English: Lantus was effective in managing diabetes in adults and children aged two years and above.
Danish: Lantus var effektivt til behandling af diabetes hos voksne og børn fra 2 år og derover.
English: For the full list of all side effects reported with Lantus, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Lantus fremgår af indlægssedlen.
English: Studies have also been carried out in nearly 1,400 adults with type 1 or type 2 diabetes to measure the effectiveness of Lantus injected at any time during the day, compared with an injection given in the evening.
Danish: Der blev også gennemført undersøgelser af næsten 1 400 voksne patienter med type 1- eller type 2diabetes for at måle virkningen af Lantus injiceret på et givet tidspunkt af dagen sammenlignet med en afteninjektion.
English: What is the risk associated with Lantus?
Danish: Hvilken risiko er der forbundet med Lantus?
English: Lantus must not be used in people who are hypersensitive (allergic) to insulin glargine or to any of the other ingredients.
Danish: Lantus må ikke anvendes af patienter, der er overfølsomme (allergiske) over for insulin glargin eller andre af indholdsstofferne.
English: The main studies compared Lantus given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day.
Danish: I hovedundersøgelserne blev Lantus givet en gang dagligt ved sengetid sammenlignet med humant insulin NPH (et middellangt virkende insulin) givet en eller to gange dagligt.
English: Lantus is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder).
Danish: Lantus gives som injektion under huden i bugvæggen (maven), låret eller deltamuskelregionen (skulderen).
English: Lantus is a replacement insulin that is very similar to the insulin made by the body.
Danish: Lantus er en insulinerstatning, der er næsten identisk med det insulin, der produceres af kroppen.
English: It is available as vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).
Danish: Det leveres i hætteglas, cylinderampuller og fyldte engangspenne (OptiSet og SoloStar).
English: A total of 2,106 patients received Lantus in all trials combined.
Danish: I undersøgelserne blev i alt 2 106 patienter behandlet med Lantus.
English: What is Lantus?
Danish: Hvad er Lantus?
English: Lantus is a solution for injection that contains the active substance insulin glargine.
Danish: Lantus er en injektionsvæske, opløsning, der indeholder det aktive stof insulin glargin.
English: In one study, patients with type 2 diabetes also received antidiabetes medicines by mouth.
Danish: I en undersøgelse fik patienter med type 2-diabetes også lægemidler mod diabetes, som indtages oralt.
English: Why has Lantus been approved?
Danish: Hvorfor blev Lantus godkendt?
English: Lantus is used to treat diabetes in patients aged two years or older.
Danish: Lantus anvendes til behandling af diabetes hos patienter på to år og derover.
English: How has Lantus been studied?
Danish: Hvordan blev Lantus undersøgt?
English: What is Lantus used for?
Danish: Hvad anvendes Lantus til?
English: What benefit has Lantus shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Lantus?
English: Lantus can also be given together with antidiabetes medicines taken by mouth in patients who have type 2 diabetes.
Danish: Til patienter med type 2-diabetes kan Lantus også gives sammen med lægemidler mod diabetes, som indtages oralt.
English: How is Lantus used?
Danish: Hvordan anvendes Lantus?
English: How does Lantus work?
Danish: Hvordan virker Lantus?
English: This did not affect long-term development of colonies.
Danish: Dette har ikke påvirket den langsigtede udvikling af kolonierne.
English: ATCvet code: QP53AG03
Danish: ATCvet-kode: QP53AG03
English: Remove contaminated clothing immediately.
Danish: Forurenet tøj aftages straks.
English: No MRL required
Danish: MRL kræves ikke
English: Repeated treatments are not well tolerated by bees.
Danish: Gentagne behandlinger tåles ikke godt af bierne.
English: Advice on correct administration:
Danish: Råd om korrekt administration:
English: Dosing should be done carefully and overdosing should be avoided.
Danish: Doseringen bør foretages omhyggeligt, og overdosering bør undgås.
English: The active substance in Oxybee is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Det aktive stof i Oxybee er et tilladt stof, der er beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
English: Do not eat, drink or smoke whilst handling and applying the veterinary medicinal product.
Danish: Undlad at spise, drikke eller ryge under håndtering og påføring af dette veterinærlægemiddel.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 colonies treated displaying adverse reaction(s)) - common (more than 1 but less than 10 colonies in 100 colonies treated) - uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated) - rare (more than 1 but less than 10 colonies in 10,000 colonies treated) - very rare (less than 1 colony in 10,000 colonies treated, including isolated reports.
Danish: Hyppigheden af bivirkninger er defineret som: - meget almindelig (mere end 1 ud af 10 behandlede kolonier udviser en eller flere bivirkninger) - almindelig (mere end 1, men mindre end 10 kolonier af hver 100 behandlede kolonier) - ikke almindelig (mere end 1, men mindre end 10 kolonier af hver 1 000 behandlede kolonier) - sjælden (mere end 1, men mindre end 10 kolonier af hver 10 000 behandlede kolonier) - meget sjælden (mindre end 1 koloni af hver 10 000 behandlede kolonier, herunder enkeltstående indberetninger).
English: The outside temperature during treatment with Oxybee should be at least 3 °C.
Danish: Den udendørs temperatur skal ved behandlingen med Oxybee være mindst 3 °C.
English: The overdose did not significantly affect the development of the colonies in the long term, as shown by the development of the colonies in spring.
Danish: Denne overdosis påvirkede ikke koloniernes udvikling på lang sigt, som det fremgik af udviklingen af kolonier om foråret.
English: The total amount of product administered to a colony should not exceed 54 ml.
Danish: Den samlede mængde lægemiddel, der påføres en koloni, bør højst være 54 ml.
English: In case of eye contact, immediately rinse the eye thoroughly with water (remove contact lenses first).
Danish: Ved øjenkontakt skylles øjnene straks grundigt med vand (kontaktlinser fjernes først).
English: The major contributor to the acaricidal effects is the low pH of the dispersion, as opposed to the volume of dispersion administered.
Danish: Den vigtigste faktor, der bidrager til de akaricide virkninger, er dispersionens lave pH, frem for den mængde dispersion, der administreres.
English: Close the bottle tightly and shake it until the sucrose is completely dissolved.
Danish: Luk flasken tæt, og omryst den, indtil saccharosen er fuldstændig opløst.
English: An overdose of 53% of the dispersion per treatment resulted in a temporary, short-term increase in bee mortality.
Danish: En overdosis på 53 % af dispersionen pr. behandling medførte en forbigående kortvarig stigning i dødeligheden hos bierne.
English: In case the final dispersion had been stored, it should be well shaken before use.
Danish: Hvis den færdige dispersion har været opbevaret, skal den omrystes grundigt før brug.
English: STATEMENT OF ACTIVE SUBSTANCES One bottle contains:
Danish: ANGIVELSE AF AKTIVE STOFFER Én flaske indeholder:
English: Therefore, if necessary, the dose per seam should be reduced in order not to exceed the maximum total amount administered per colony (calculation: maximum dose per colony/number of occupied seams= x.x ml/seam).
Danish: Dosis pr. tavle bør derfor om nødvendigt nedsættes for ikke at overskride den maksimale totale mængde, der administreres pr. koloni (beregnet som maksimal dosis pr. koloni/antal beboede tavler = x,x ml/tavle).
English: 6.2 Major incompatibilities
Danish: 6.2 Vigtige uforligeligheder
English: The high proportion of sugar in this product increases the viscosity of the dispersion and hence its adhesion to the bees.
Danish: Det høje sukkerindhold i produktet øger dispersionens viskositet og dermed dens adhæsion til bierne.
English: Other precautions:
Danish: Andre forholdsregler: