FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of hypoglycaemia was significantly lower in the vildagliptin group (1.7%) than in the glimepiride group (16.2%).
Danish: Forekomsten af hypoglykæmi var signifikant lavere i vildagliptin-gruppen (1,7 %) end i glimepiridgruppen (16,2 %).
English: In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations  3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
Danish: I data fra kontrollerede monoterapi- og tillægsbehandlingsstudier af op til 24 ugers varighed var incidensen af ALAT- eller ASAT-forhøjelser > 3x ULN (klassificeret som til stede ved mindst 2 fortløbende målinger eller ved det sidste behandlingsbesøg) 0,2 % for vildagliptin 50 mg en gang daglig, 0,3 % for vildagliptin 50 mg to gange daglig og 0,2 % for alle sammenligningsstofferne.
English: Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice.
Danish: Der blev observeret akkumulering af skumlignende alveolære makrofager i lungerne hos rotter og mus.
English: Table 8 Key efficacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population)
Danish: Tabel 8 Nøgleresultater for vildagliptins virkning i placebokontrollerede monoterapiforsøg og forsøg med tillægskombinationsbehandling (primær ITT-population)
English: Do not take Jalra:
Danish: Tag ikke Jalra:
English: No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).
Danish: Der kræves ingen dosisjustering til ældre patienter (se også pkt.
English: • The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate
Danish: • Øvrige indholdsstoffer: vandfri lactose, mikrokrystallinsk cellulose, natriumstivelseglycolat
English: An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and 100 mg/kg (16-fold human exposure), respectively.
Danish: Der blev observeret en stigning i incidensen af mammært adenokarcinom og hæmangiosarkom med en nuleffektdosis på henholdsvis 500 mg/kg (59 gange den humane eksponering) og 100 mg/kg (16 gange den humane eksponering).
English: Accordingly, the metabolic clearance of vildagliptin is not anticipated to be affected by co-medications that are CYP 450 inhibitors and/or inducers.
Danish: Derfor forventes vildagliptin ikke at blive påvirket af samtidig administration af præparater, som er CYP 450-hæmmere og/eller -induktorer.
English: In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
Danish: I sammenlignende, kontrollerede monoterapistudier var hypoglykæmi ikke almindelig, idet det blev rapporteret hos 0,4 % (7 af 1.855) af de patienter, som blev behandlet med vildagliptin 100 mg daglig, sammenlignet med 0,2 % (2 af 1.082) af patienterne i de grupper, der blev behandlet med et aktivt sammenligningsstof eller placebo.
English: In these studies, vildagliptin was administered to more than 9,000 patients at daily doses of 50 mg once daily, 50 mg twice daily or 100 mg once daily.
Danish: I disse forsøg blev vildagliptin givet til mere end 9.000 patienter med en daglig dosis på 50 mg én gang daglig, 50 mg to gange daglig eller 100 mg én gang daglig.
English: Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2).
Danish: Jalra må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN (se også pkt.
English: Therefore Jalra should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Danish: Derfor skal Jalra anvendes med forsigtighed til disse patienter (se også pkt.
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Jalra 100 mg daily were 1.4 and 2.7 kg, respectively.
Danish: I pioglitazon-tillægsstudiet var den absolutte vægtstigning 1,4 for placebo og 2,7 kg for Jalra 100 mg daglig.
English: The incidence of peripheral oedema was lower in the vildagliptin group than in the rosiglitazone group (2.1% vs. 4.1% respectively).
Danish: Forekomsten af perifert ødem var lavere i vildagliptin-gruppen end i rosiglitazon-gruppen (henholdsvis 2,1 % mod 4,1 %).
English: Vildagliptin was associated with fewer hypoglycaemic events (0.7%) than gliclazide (1.7%).
Danish: Behandling med vildagliptin var forbundet med færre hypoglykæmiske tilfælde (0,7 %) end behandling med gliclazid (1,7 %).
English: Combination with metformin and a sulphonylurea
Danish: Kombination med metformin og et sulfonylurinstof
English: An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Danish: Der blev observeret en øget incidens af bølgede ribben hos rotter i forbindelse med reducerede maternelle legemsvægtparametre med en nuleffektdosis på 75 mg/kg (10 gange human eksponering).
English: “EXP”.
Danish: ”EXP”/”Udløbsdato”.
English: In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/kg (9-fold human exposure).
Danish: Hos kaniner blev der kun bemærket øget føtal vægt og skeletvariationer, som kunne tyde på forsinket udvikling i forbindelse med svær maternel toksicitet med en nuleffektdosis på 50 mg/kg (9 gange human eksponering).
English: After two years, mean reduction in HbA1c was -0.5% for vildagliptin and -0.6% for gliclazide, from a mean baseline HBA1c of 8.6%.
Danish: Efter 2 år var middelreduktionen i HbA1c -0,5 % for vildagliptin og -0,6 % for gliclazid fra en middel-baseline HbA1c på 8,6 %.
English: A 52-week multi-centre, randomised, double-blind trial was conducted in patients with type 2 diabetes and congestive heart failure (NYHA functional class I-III) to evaluate the effect of vildagliptin 50 mg twice daily (N=128) compared to placebo (N=126) on left-ventricular ejection fraction (LVEF).
Danish: Et 52-ugers randomiseret, dobbeltblindet multicenter-studie hos patienter med type 2-diabetes og kongestiv hjerteinsufficiens (NYHA funktionsklasse I-III) blev udført for at evaluere virkningen af vildagliptin 50 mg to gange daglig (N=128) på venstre ventrikels uddrivningsfraktion (LVEF) sammenlignet med placebo (N=126).
English: No severe hypoglycaemic events were reported in the vildagliptin arms.
Danish: Der er ikke rapporteret nogen svære hypoglykæmiske bivirkninger i vildagliptinarmene.
English: A 24-week, multi-centre, randomised, double-blind, placebo-controlled trial was conducted to evaluate the treatment effect of vildagliptin 50 mg once daily compared to placebo in 515 patients with type 2 diabetes and moderate renal impairment (N=294) or severe renal impairment (N=221).
Danish: Et 24-ugers, multicenter, randomiseret, dobbelt-blindet, placebokontrolleret studie blev udført for at vurdere behandlingseffekten af vildagliptin 50 mg en gang daglig versus placebo hos 515 patienter med type 2-diabetes og moderat nedsat nyrefunktion (N=294) eller svært nedsat nyrefunktion (N=221).
English: By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion.
Danish: Vildagliptin forbedrer også alfacellernes følsomhed over for glucose ved at øge de endogene GLP-1niveauer, og det resulterer i mere glucosepassende glukagonsekretion.
English: What Jalra is and what it is used for What you need to know before you take Jalra How to take Jalra
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Jalra Sådan skal du tage Jalra Bivirkninger
English: In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%).
Danish: I kliniske studier var forekomsten af hypoglykæmi ikke almindelig blandet de patienter, der fik vildagliptin + pioglitazon (0,6 %), men almindelig blandt de patienter, som fik placebo + pioglitazon (1,9 %).
English: Vildagliptin significantly decreased HbA1c compared with placebo (difference of 0.6%) from a mean baseline of 7.8% at week 16.
Danish: Vildagliptin reducerede HbA1c signifikant sammenlignet med placebo (forskel på 0,6 %) fra en middel-baseline-værdi på 7,8 % efter 16 uger.
English: In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Danish: I kontrollerede monoterapistudier med vildagliptin var den samlede hyppighed af udtræden på grund af bivirkninger ikke større for de patienter, der fik behandling med vildagliptin-doser på 100 mg daglig (0,3 %) end for de patienter, der fik placebo (0,6 %) eller sammenligningsstoffer (0,5 %).
English: If you have questions about how long to take this medicine, talk to your doctor.
Danish: Tal med din læge, hvis du har spørgsmål til, hvor længe du skal tage medicinen.
English: In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group.
Danish: I kontrollerede studier af kombinationen af vildagliptin 50 mg daglig + et sulfonylurinstof, var den samlede udtræden af studierne på grund af bivirkninger 0,6 % for gruppen, der fik vildagliptin 50 mg + et sulfonylurinstof, mod 0 % for gruppen, der fik placebo + et sulfonylurinstof.
English: In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to glimepiride (up to 6 mg/day - mean dose at 2 years: 4.6 mg) in patients treated with metformin (mean daily dose: 1894 mg).
Danish: I et klinisk forsøg af 2 års varighed blev vildagliptin (50 mg to gange daglig) sammenlignet med glimepirid (op til 6 mg daglig - gennemsnitlig dosis ved 2 år: 4,6 mg) hos patienter behandlet med metformin (gennemsnitlig daglig dosis: 1.894 mg).
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Jalra is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Danish: Hos patienter med moderat til svært nedsat nyrefunktion eller med nyresygdom i sidste stadie (end-stage renal disease: ESRD) er den anbefalede dosis 50 mg én gang daglig (se også pkt.
English: How long to take Jalra
Danish: Så længe skal du tage Jalra
English: In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride.
Danish: I kliniske studier var forekomsten af hypoglykæmi 1,2 %, når 50 mg vildagliptin én gang daglig blev kombineret med glimepirid mod 0,6 % for placebo + glimepirid.
English: In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to gliclazide (up to 320 mg/day).
Danish: I et klinisk forsøg af 2 års varighed blev vildagliptin (50 mg 2 gange daglig) sammenlignet med gliclazid (op til 320 mg daglig).
English: In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
Danish: I kliniske studier var forekomsten af hypoglykæmi almindelig blandt de patienter, der fik vildagliptin 100 mg daglig kombineret med metformin (1 %) og ikke almindelig blandt de patienter, som fik placebo + metformin (0,4 %).
English: After 1 year mean reductions in HbA1c were -0.4% with vildagliptin added to metformin and -0.5% with glimepiride added to metformin, from a mean baseline HbA1c of 7.3%.
Danish: Efter 1 år var middelreduktionen i HbA1c -0,4 % med vildagliptin lagt til metformin og -0,5 % med glimepirid lagt til metformin fra en middel-baseline HbA1c på 7,3 %.
English: Other side effects Some patients have had the following side effects while taking Jalra and metformin:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra og metformin:
English: • Uncommon: Constipation
Danish: • Ikke almindelig: Forstoppelse
English: In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
Danish: I et 24-ugers dobbeltblindet kontrolleret forsøg blev vildagliptin (50 mg to gange daglig) sammenlignet med rosiglitazon (8 mg én gang daglig).
English: In patients with moderate renal impairment vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.53%) from a mean baseline of 7.9%.
Danish: Hos patienter med moderat nedsat nyrefunktion reducerede vildagliptin HbA1c-værdien signifikant sammenlignet med placebo (difference på -0,53 %) fra en gennemsnitlig baseline-værdi på 7,9 %.
English: Table 6 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Danish: Tabel 6 Bivirkninger, der blev rapporteret hos patienter, der fik Jalra 100 mg dagligt i kombination med insulin (med eller uden metformin) i dobbeltblindede studier (N=371)
English: • Common (may affect up to 1 in 10 people): Trembling, headache, dizziness, nausea, low blood glucose
Danish: • Almindelige (kan forekomme hos op til 1 ud af 10 personer): Rysten, hovedpine, svimmelhed,
English: Table 5 Adverse reactions reported in patients who received Jalra 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Danish: Tabel 5 Bivirkninger, der blev rapporteret hos patienter, der fik Jalra 50 mg to gange dagligt i kombination med metformin og et sulfonylurinstof (N=157)
English: The amount of Jalra people have to take varies depending on their condition.
Danish: Så meget Jalra skal du tage, og hvornår du skal tage det Den mængde Jalra, du skal tage, afhænger af din sygdomstilstand.
English: In a 24-week trial, vildagliptin (50 mg twice daily) was compared to pioglitazone (30 mg once daily) in patients inadequately controlled with metformin (mean daily dose: 2020 mg).
Danish: I et 24-ugers forsøg blev vildagliptin (50 mg to gange daglig) sammenlignet med pioglitazon (30 mg én gang daglig) hos patienter, der var utilstrækkeligt kontrolleret med metformin (gennemsnitlig daglig dosis: 2.020 mg).
English: How to take Jalra
Danish: Sådan skal du tage Jalra
English: • Common: Trembling, headache, dizziness, weakness, low blood glucose
Danish: • Almindelige: Rysten, hovedpine, svimmelhed, svækkelse, lavt blodsukker
English: In controlled clinical trials with the combination of vildagliptin 100 mg daily + metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + metformin or the placebo + metformin treatment groups.
Danish: I kontrollerede studier af kombinationen af vildagliptin 100 mg daglig + metformin, blev der ikke rapporteret nogen udtræden af studierne på grund af bivirkninger, hverken i gruppen, der fik vildagliptin 100 mg daglig + metformin, eller i gruppen, der fik placebo + metformin.
English: • Uncommon: Headache, weakness, low blood glucose
Danish: • Ikke almindelige: Hovedpine, svækkelse, lavt blodsukker
English: CARTON OF UNIT PACK
Danish: ÆSKE MED ENKELTPAKNING
English: • Uncommon : Diarrhoea, flatulence
Danish: • Ikke almindelige: Diare, luftafgang fra tarmen
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Danish: I kliniske studier ændrede vægten sig ikke fra baseline, når 100 mg vildagliptin blev givet daglig sammen med metformin (+0,2 kg og -1,0 kg for henholdsvis vildagliptin og placebo).
English: In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of 7.7%.
Danish: Hos patienter med svært nedsat nyrefunktion reducerede vildagliptin HbA1c-værdien signifikant sammenlignet med placebo (difference på -0,56 %) fra en gennemsnitlig baseline-værdi på
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Danish: I kliniske studier ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev givet som monoterapi (-0,3 kg og -1,3 kg for henholdsvis vildagliptin og placebo).
English: Table 1 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with metformin in double-blind studies (N=208)
Danish: Tabel 1 Bivirkninger rapporteret hos patienter, der fik Jalra 100 mg daglig i kombination med metformin i dobbeltblindede studier (N=208)
English: Table 4 Adverse reactions reported in patients who received Jalra 100 mg daily as monotherapy in double-blind studies (N=1,855)
Danish: Tabel 4 Bivirkninger rapporteret hos patienter, der fik Jalra 100 mg daglig som monoterapi i dobbeltblindede studier (N=1.855)
English: In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively).
Danish: I kliniske studier ændrede vægten sig ikke fra baseline, når vildagliptin 50 mg daglig blev givet sammen med glimepirid (-0,1 kg og -0,4 kg for henholdsvis vildagliptin og placebo).
English: What Jalra contains
Danish: Jalra indeholder:
English: • Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn
Danish: • Almindelige: Hovedpine, kuldegysninger, kvalme, lavt blodsukker, halsbrand
English: Table 2 Adverse reactions reported in patients who received Jalra 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Danish: Tabel 2 Bivirkninger rapporteret hos patienter, der fik Jalra 50 mg daglig i kombination med et sulfonylurinstof i dobbeltblindede studier (N=170)
English: Weight increase
Danish: Nedsat leverfunktion
English: In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.
Danish: I kontrollerede studier af kombinationen af vildagliptin 100 mg daglig + et glitazon, blev der ikke rapporteret nogen udtræden af studierne på grund af bivirkninger, hverken i gruppen, der fik vildagliptin 100 mg daglig + et glitazon, eller i gruppen, der fik placebo + et glitazon.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Jalra Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Danish: Forsinket ventrikeltømning er en kendt virkning af forhøjede GLP-1-niveauer.
English: Constipation Musculoskeletal and connective tissue disorders Uncommon
Danish: Knogler, led, muskler og bindevæv Ikke almindelig Artralgi
English: Infections and infestations Very rare
Danish: Infektioner og parasitære sygdomme Meget sjælden Snue Metabolisme og ernæring Almindelig
English: Table 3 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Danish: Tabel 3 Bivirkninger rapporteret hos patienter, der fik Jalra 100 mg daglig i kombination med et glitazon i dobbeltblindede studier (N=158)
English: If you need to see a doctor or go to the hospital, take the pack with you.
Danish: Medbring pakningen, hvis du skal til læge eller på hospitalet.
English: Gender
Danish: Etnisk gruppe
English: Vascular disorders Uncommon
Danish: Mave-tarm-kanalen Ikke almindelig Forstoppelse
English: Vascular disorders Common
Danish: Mave-tarm-kanalen Almindelig
English: • Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose Some patients have had the following side effects while taking Jalra and a glitazone:
Danish: • Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): Ondt i halsen, løbende næse
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen, apotekspersonalet eller-sundhedspersonalet, hvis der er mere, du vil vide.
English: EU/1/08/485/011 336 tablets (3 packs of 112)
Danish: 336 tabletter (3 pakker a 112)
English: Nasopharyngitis Metabolism and nutrition disorders Uncommon
Danish: Infektioner og parasitære sygdomme Meget sjælden Infektion i de øvre luftveje Meget sjælden Nasopharyngitis Metabolisme og ernæring Ikke almindelig Hypoglykæmi Nervesystemet Almindelig
English: • Uncommon (may affect up to 1 in 100 people): Tiredness Some patients have had the following side effects while taking Jalra and a sulphonylurea:
Danish: • Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): Træthed
English: In case of such reactions, appropriate treatment is recommended.
Danish: I tilfælde af sådanne reaktioner anbefales det at iværksætte passende behandling.
English: ATCvet code: QI09AA07
Danish: ATCvet-kode: QI09AA07
English: Use vaccination devices according to the manufacturer's instructions.
Danish: Vaccinationsudstyr skal bruges i henhold til producentens anvisninger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 07/02/2018.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 07/02/2018.
English: White homogenous emulsion.
Danish: Hvid, homogen emulsion.
English: Shake well before administration and intermittently during the process of vaccination.
Danish: Rystes godt før administration og med mellemrum gennem hele vaccinationsforløbet.
English: These clinical signs normally resolve without treatment.
Danish: Disse kliniske tegn forsvinder normalt af sig selv uden behandling.
English: The vaccine is to be administered aseptically.
Danish: Vaccinen skal administreres aseptisk.
English: Shelf life of the veterinary medicinal product as package for sale: 18 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En eventuel beslutning om at anvende vaccinen før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: Pigs (for fattening)
Danish: Svin (til opfedning)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og hætteglasset efter EXP.
English: The use of a multi-dosing syringe is recommended.
Danish: Det anbefales at bruge flerdosissprøjter.
English: MARKETING AUTHORISATION NUMBERS EU/2/17/223/001-006
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/17/223/001-006
English: Administer one dose of 2 ml to pigs in the neck behind the ear.
Danish: Administrer én dosis på 2 ml til svin i nakken, bag øret.
English: Anaphylaxis may occur in very rare cases.
Danish: Der kan i meget sjældne tilfælde opstå anafylaksi.
English: Vaccination schedule: One injection from 3 weeks of age.
Danish: Vaccinationsplan: Én injektion fra 3-ugers alderen.
English: The area of local tissue reactions is in general below 2 cm in diameter.
Danish: Området med lokale vævsreaktioner er normalt under 2 cm i diameter.