FrancophonIA/ELRC3.0 huggingface dataset:
English: If the doctor thinks they may be related to a hypersensitivity reaction, you will be told never again to take Triumeq, or any other medicine containing abacavir or dolutegravir.
Danish: Hvis lægen mener, de kan være relateret til en overfølsomhedsreaktion, vil lægen råde dig til aldrig mere at tage Triumeq eller nogen anden medicin, der indeholder abacavir eller dolutegravir.
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV)
Danish: Efter en enkelt dosis på 600 mg abacavir er den gennemsnitlige (CV) Cmax 4,26 µg/ml (28 %), og det gennemsnitlige (CV) AUC∞ er 11,95 µg*t/ml (21 %).
English: Lamivudine: AUC ↑43% Cmax ↑7%
Danish: AUC ↑ 43 % Cmax ↑ 7 %
English: The most severe adverse event possibly related to the treatment with dolutegravir and abacavir/lamivudine, seen in individual patients, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4 and Description of selected adverse reactions in this section).
Danish: Den alvorligste bivirkning, der blev set hos en enkelt patient og muligvis var relateret til behandlingen med dolutegravir og abacavir/lamivudin, var en overfølsomhedsreaktion, der omfattede udslæt og svære levereffekter (se pkt.
English: Asymptomatic creatine phosphokinase (CPK) elevations mainly in association with exercise have also been reported with dolutegravir therapy.
Danish: Der er også rapporteret asymptomatiske stigninger i kreatinkinase (CK) ved behandling med dolutegravir, primært i forbindelse med fysisk aktivitet.
English: Animal studies indicate no effects of dolutegravir, abacavir or lamivudine on male or female fertility (see section 5.3).
Danish: I dyrestudier er der ikke set nogen virkning af dolutegravir, abacavir eller lamivudin på fertiliteten hos hanner eller hunner (se pkt.
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.74 times the 50mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Danish: Oral administration af dolutegravir til drægtige kaniner i doser op til 1.000 mg/kg dagligt fra dag 6-18 i drægtighedsperioden udløste ikke udviklingstoksicitet eller teratogenicitet (0,74 gange den humane kliniske eksponering ved 50 mg, når det blev administreret i kombination med abacavir og lamivudin, baseret på AUC).
English: Elevated liver function tests, hepatitis, hepatic failure
Danish: Forhøjede levertal, hepatitis, leversvigt
English: What Triumeq contains - The active substances are dolutegravir, abacavir and lamivudine.
Danish: Triumeq indeholder: - Aktive stoffer: dolutegravir, abacavir og lamivudin.
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Danish: Feber, svær udmatning, utilpashed, ødem, hævede lymfeknuder, hypotension, conjunktivitis, anafylaksi
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir, the coadministration of tipranavir/ritonavir with Triumeq is not recommended.
Danish: Da den anbefalede dosis af dolutegravir er 50 mg to gange daglig, når det administreres samtidigt med tipranavir/ritonavir, anbefales samtidig administration af tipranavir/ritonavir og Triumeq ikke.
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Danish: Sandsynligheden for metaboliske interaktioner mellem lamivudin og andre lægemidler er lav på grund af den begrænsede metabolisering i leveren
English: RAL 400mg twice daily + 2 NRTI N=411
Danish: 400 mg RAL to gange daglig + 2 NRTI N = 411
English: Both abacavir and dolutegravir are associated with a risk for hypersensitivity reactions (HSR), which were observed more commonly with abacavir.
Danish: Både abacavir og dolutegravir er forbundet med en risiko for udvikling af overfølsomhedsreaktioner (se pkt.
English: Triumeq is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Triumeq anbefales ikke til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: • lactic acidosis (excess lactic acid in the blood).
Danish: • for meget mælkesyre i blodet (laktacidose).
English: Other common symptoms are: nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Danish: Andre almindelige symptomer: kvalme, opkastning, diarré, mavesmerter, udtalt træthed.
English: How to take Triumeq
Danish: Sådan skal du tage Triumeq
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers, DTG/ABC/3TC FDC is not recommended for patients taking these metabolic inducers.
Danish: Da den anbefalede dolutegravirdosis er 50 mg to gange daglig ved administration sammen med disse metaboliske inducere, anbefales DTG/ABC/3TC FDC ikke til patienter, som tager disse metaboliske inducere.
English: WOCBP who are taking Triumeq should use effective contraception throughout treatment.
Danish: Fertile kvinder, der tager dolutegravir, bør anvende sikker prævention under hele behandlingen.
English: Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. (See also Section 3).
Danish: Tag ikke et antacida, i 6 timer før du tager Triumeq, eller i mindst 2 timer efter at du har taget Triumeq.
English: In the primary 48 weeks analysis, the proportion of patients with virologic suppression in the dolutegravir + ABC/3TC arm, was superior to the EFV/TDF/FTC arm, p=0.003, the same treatment difference was observed in subjects defined by baseline HIV RNA level (< or > 100,000 copies/mL).
Danish: I den primære analyse efter 48 uger var andelen af patienter med virologisk suppression i armen med dolutegravir + ABC/3TC bedre end i armen med EFV/TDF/FTC, p = 0,003.
English: Virologic Outcomes of Randomized Treatment of SINGLE at 48 Weeks (Snapshot algorithm)
Danish: Tabel 3 Virologiske udfald af randomiseret behandling i SINGLE efter 48 uger (snapshotalgoritme)
English: Table 5: Demographics and Week 48 virologic outcomes of randomized treatment of FLAMINGO (snapshot algorithm)
Danish: Tabel 5: Demografi og virologiske udfald efter 48 ugers randomiseret behandling i FLAMINGO (snapshot-algoritme)
English: → If you think this applies to you, tell your doctor.
Danish: → Fortæl lægen, hvis du tror, at dette gælder for dig.
English: Abacavir is metabolised primarily by the liver.
Danish: Abacavir metaboliseres primært af leveren.
English: Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Danish: I tilfælde hvor ophør med eller dosisjustering af en af de aktive substanser er indiceret, er separate præparater med dolutegravir, abacavir eller lamivudin tilgængelige.
English: DTG 50 mg once daily + 2 NRTI N=411
Danish: 50 mg DTG én gang daglig + 2 NRTI N = 411
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir, abacavir or lamivudine, apart from those listed as adverse reactions.
Danish: Foruden de beskrevne bivirkninger er der ikke identificeret nogen specifikke symptomer eller tegn efter akut overdosering med dolutegravir, abacavir eller lamivudin.
English: Iron supplements/Dolutegravir Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Danish: Dolutegravir ↓ AUC ↓ 54 % Cmax ↓ 57 % C24 ↓ 56 % (Kompleks binding til polyvalente ioner).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 50 mg dolutegravir (som natrium), 600 mg abacavir (som sulfat) og 300 mg lamivudin.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with carbamazepine, DTG/ABC/3TC FDC is not recommended for patients taking carbamazepine.
Danish: Da den anbefalede dolutegravirdosis er 50 mg to gange daglig ved administration sammen med carbamazepin, anbefales DTG/ABC/3 TC FDC ikke til patienter, som tager carbamazepin.
English: Poly(vinyl) alcohol - partially hydrolysed titanium dioxide macrogol talc iron oxide black iron oxide red
Danish: Polyvinylalkohol - delvist hydrolyseret Titandioxid
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of Triumeq.
Danish: Fertile kvinder bør have taget en graviditetstest inden påbegyndelse af behandling med dolutegravir.
English: Triumeq contains dolutegravir, abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Triumeq.
Danish: Alle interaktioner, som er identificeret for disse individuelt, er derfor relevante for Triumeq.
English: Since the recommended dose of dolutegravir is 50 mg twice daily for patients taking etravirine without boosted protease inhibitors, Triumeq is not recommended for patients taking etravirine without co-administration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir (see further below in table).
Danish: Triumeq anbefales ikke til patienter, som tager etravirin uden samtidig administration af atazanavir/ritonavir, darunavir/ritonavir eller lopinavir/ritonavir (se længere nede i tabellen).
English: WARNING In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Danish: Kontakt STRAKS lægen i tilfælde af symptomer, der tyder på overfølsomhedsreaktioner.
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra fase IIb- og fase III-studier af voksne, viste ingen klinisk relevant effekt af race på eksponeringen for dolutegravir.
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Danish: AUC ↑ 1 % Cmax ↓ 3 % Cτ ↓ 8 % Tenofovir ↔
English: Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Danish: Tabel 6: Demografiske data og virologisk udfald efter 48 ugers randomiseret behandling i ARIA (snapshot algoritme)
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir.
Danish: Farmakokinetiske populationsanalyser, hvor der blev brugt sammenlagte farmakokinetiske data fra fase IIb- og fase III-studier af voksne, viste ingen klinisk relevant effekt af køn på eksponeringen for dolutegravir.
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg tablets dolutegravir/abacavir/lamivudine
Danish: Triumeq 50 mg/600 mg/300 mg tabletter dolutegravir/abacavir/lamivudin
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
Danish: Hver tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir, 600 mg abacavir (som sulfat) og 300 mg lamivudin.
English: Median Age (years) Female Non-white Hepatitis B and/or C CDC class C ABC/3TC backbone Week 48 efficacy results HIV-1 RNA <50 copies/mL Treatment difference*
Danish: Hepatitis B og/eller C CDC-klasse C ABC/3TC-backbone Effektresultater ved uge 48 Hiv-1-RNA < 50 kopier/ml Behandlingsforskel*
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR GlaxoSmithKline Pharmaceuticals S.A., UL.Grunwaldzka 189, 60-322 Poznan, Poland.
Danish: Eller GlaxoSmithKline Pharmaceuticals S.A., UL.Grunwaldzka 189, 60-322 Poznan, Polen.
English: Since the dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, the co-administration of rifampicin with Triumeq is not recommended.
Danish: Da dosis af dolutegravir er 50 mg to gange daglig, når det administreres samtidigt med rifampicin, anbefales samtidig administration af rifampicin og Triumeq ikke.
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50mg QD:
Danish: Dolutegravir ↔ Ved administration sammen med dolutegravir 50 mg én gang daglig: Metformin
English: Since the dose of dolutegravir is 50 mg twice daily when coadministered with nevirapine, the coadministration of nevirapine with Triumeq is not recommended.
Danish: Da dosis af dolutegravir er 50 mg to gange daglig, når det administreres samtidigt med nevirapin, anbefales samtidig administration af nevirapin og Triumeq ikke.
English: The bottle contains a desiccant to reduce moisture.
Danish: Beholderen indeholder et tørremiddel til at beskytte mod fugt.
English: • stomach ache
Danish: • stive led
English: Adults and adolescents (weighing at least 40kg) The recommended dose of Triumeq in adults and adolescents is one tablet once daily.
Danish: Den anbefalede dosis af Triumeq til voksne og unge er 1 tablet én gang daglig.
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Danish: Efavirenz ↔ (historiske kontroller) (induktion af UGT1A1og CYP3A-enzymer)
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir, lamivudine and abacavir separately.
Danish: Nedsat nyrefunktion Der er indhentet farmakokinetiske data på dolutegravir, abacavir og lamivudin hver for sig.
English: - Triumeq must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected.
Danish: - Behandling Triumeq skal omgående ophøre ved mistanke om en overfølsomhedsreaktion, også selv om patienten er HLA-B*5701-allel-negativ.
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with St. John's wort, DTG/ABC/3TC FDC is not recommended.
Danish: Da den anbefalede dolutegravirdosis er 50 mg 2 gange daglig ved administration sammen med perikon, anbefales DTG/ABC/3TC FDC ikke.
English: Late Switch ABC/DTG/3TC FDC N=244 n (%)
Danish: Sen skift ABC/DTG/3TC FDC N=244 n (%)
English: Calcium supplements/Dolutegravir
Danish: Calciumtilskud/dolutegravir
English: Hepatic impairment Pharmacokinetic data has been obtained for dolutegravir, abacavir and lamivudine separately.
Danish: Nedsat leverfunktion Der er indhentet farmakokinetiske data på dolutegravir, abacavir og lamivudin hver for sig.
English: Opioids
Danish: Tabletkerne
English: Since the dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz, the co-administration of efavirenz with Triumeq is not recommended (see section 4.4).
Danish: Da dosis af dolutegravir er 50 mg to gange daglig, når det administreres samtidigt med efavirenz, anbefales samtidig administration af efavirenz og Triumeq ikke (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Danish: Triumeq 50 mg/600 mg/300 mg filmovertrukne tabletter dolutegravir/abacavir/lamivudin
English: Triumeq includes lamivudine, which is active against hepatitis B. Abacavir and dolutegravir lack such activity.
Danish: Triumeq indeholder lamivudin, der er aktivt mod hepatitis B-virus.
English: Early Switch ABC/DTG/3TC FDC N=275 n (%)
Danish: Tidlig skift ABC/DTG/3TC FDC N=275 n (%)
English: If the doctor thinks they may have been, you will then be told never again to take Triumeq, or any other medicine containing abacavir.
Danish: Hvis lægen mener, de kan være forårsaget af en overfølsomhedsreaktion, vil lægen råde dig til aldrig mere at tage Triumeq eller nogen anden medicin, der indeholder abacavir.
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Danish: Ved opstart af behandling med dolutegravir blev der hos nogle patienter, der var co-inficerede med hepatitis B- og/eller C-virus, observeret forhøjede leverparametre, som var i overensstemmelse med immunrekonstitutionssyndrom.
English: AUC ↔ Cmax ↓35% Methadone: CL/F ↑22%
Danish: Methadon: CL/F ↑ 22 %
English: DTG/ABC/3TC FDC - abacavir/dolutegravir/lamivudine fixed-dose combination ATV+RTV+TDF/FTC FDC -atazanavir plus ritonavir plus tenofovir disproxil/emtricitabine fixeddose combination
Danish: Udgik på grund af bivirkninger eller død Udgik på grund af andre årsager Manglende data i vinduet men forsat med i studiet HIV-1 - humant immundefektvirus type 1 DTG/ABC/3TC FDC - abacavir/dolutegravir/lamivudin fast-dosis-kombination ATV+RTV+TDF/FTC FDC -atazanavir plus ritonavir plus tenofovir disproxil/emtricitabin fastdosis-kombination
English: HIV-1 RNA <50 copies/mL by baseline covariates
Danish: Hiv-1-RNA < 50 kopier/ml efter baseline-kovariater Viral belastning i plasma ved baseline (kopier/ml)
English: Lopinavir+ritonavir+etravirine/ Dolutegravir
Danish: Lopinavir + ritonavir + etravirin/dolutegravir
English: MATE2-K. Abacavir is therefore not expected to affect the plasma concentrations of drugs that are substrates of these enzymes or transporters.
Danish: Lægemiddelstoffer, der modulerer disse transportører, forventes derfor ikke at påvirke plasmakoncentrationerne af abacavir.
English: A moderate amount of data on pregnant women taking the individual actives abacavir and lamivudine in combination indicates no malformative toxicity (more than 400 outcomes from first trimester exposures).
Danish: Disse data indikerer ingen tegn på malformationer (baseret på mere end 400 graviditeter, hvor der er forekommet eksponering i første trimester).
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6%
Danish: Dolutegravir ↔ AUC ↑ 11 % Cmax ↑ 6 % Cτ ↑ 17 %
English: In vitro, abacavir was not a substrate of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, MATE1, MATE2-K, MRP2 or MRP4 therefore drugs that modulate these transporters are not expected to affect abacavir plasma concentrations.
Danish: In vitro var abacavir ikke et substrat for OATP1B1, OATP1B3, OCT1, OCT2, OAT1, MATE1, MATE2-K, MRP2 eller MRP4.
English: Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
Danish: Dolutegravir ↔ AUC ↓ 4 % Cmax ↔ 0 %
English: Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Etravirin ↔ (induktion af UGT1A1og CYP3A-enzymer)
English: AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Danish: Dolutegravir ↓ AUC ↓ 25 % Cmax ↓ 12 % Cτ ↓ 36 %
English: Darunavir+ritonavir+etravirine/ Dolutegravir ↓
Danish: Darunavir + ritonavir + etravirin/dolutegravir
English: Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Danish: Andre tegn og symptomer som er observeret ved overfølsomhedsreaktioner er beskrevet i detaljer i pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg abacavir (as sulfate), 300 mg lamivudine.
Danish: Hver filmovertrukken tablet indeholder: 50 mg dolutegravir (som natrium), 600 mg abacavir (som sulfat), 300 mg lamivudin.
English: Darunavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Darunavir ↔ Ritonavir ↔ (induktion af UGT1A1og CYP3A-enzymer)
English: Methadone dosage adjustment likely not needed in majority of patients; occasionally methadone re-titration may be required.
Danish: Retitrering af methadon kan være nødvendig i enkelte tilfælde.
English: Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Tipranavir ↔ Ritonavir ↔ (induktion af UGT1A1og CYP3A-enzymer)
English: Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Danish: Fosamprenavir ↔ Ritonavir ↔ (induktion af UGT1A1og CYP3A-enzymer)
English: If you take more Triumeq than you should
Danish: Hvis du har taget for meget Triumeq
English: rash, pruritus, alopecia1
Danish: Udslæt, kløe, hårtab1
English: Dolutegravir hypersensitivity
Danish: Overfølsomhed over for dolutegravir
English: Rare acute hepatic failure1
Danish: Akut leversvigt1
English: lactic acidosis1
Danish: Laktacidose1
English: immune reconstitution syndrome (see section 4.4) Metabolism and nutrition disorders: Common:
Danish: Metabolisme og ernæring: Almindelig:
English: Miscellaneous
Danish: Sorbitol
English: CPK elevations, ALT/AST elevations
Danish: Forhøjet niveau af kreatinkinase (CK), forhøjet niveau af ALAT/ASAT
English: Miscellaneous Alcohol
Danish: Alkohol
English: If you take too many tablets of Triumeq, contact your doctor or pharmacist for advice.
Danish: Kontakt lægen eller apoteket, hvis du har taget mere Triumeq, end lægen har foreskrevet.
English: Hypersensitivity reactions
Danish: Klinisk beskrivelse af overfølsomhedsreaktioner
English: In vitro, abacavir did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrates no or weak inhibition of OATP1B1, OAT1B3, OCT1, OCT2, BCRP and P-gp or
Danish: In vitro hæmmede eller inducerede abacavir ikke CYP-enzymer (såsom CYP3A4, CYP2C9 eller CYP2D6) og udviser ingen eller kun svag hæmning af OATP1B1, OAT1B3, OCT1, OCT2, BCRP og P-gp eller MATE2-K. Abacavir forventes derfor ikke at påvirke plasmakoncentrationerne af lægemiddelstoffer, som er substrater for disse enzymer eller transportører.
English: Virologic Failure Reasons Data in window not below 50 c/mL threshold Discontinued for lack of efficacy Discontinued for other reason while not below threshold No Virologic Data
Danish: Data i vinduet ikke under grænsen på 50 kopier/ml
English: This summary was last updated in October 2013.
Danish: Dette sammendrag blev sidst ajourført i oktober 2013.
English: This protects the pigs against the disease.
Danish: Dette beskytter grisene mod denne sygdom.
English: These clinical signs normally resolve without treatment.
Danish: Disse kliniske symptomer forsvinder normalt uden behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn PCV on 24 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suvaxyn PCV den 24. juli 2009.
English: The safety of the vaccine has been addressed in both laboratory and field conditions: a temporary increase in body temperature (up to 1.7°C) is very common during the first 24 hours after vaccination.
Danish: Vaccinens sikkerhed er blevet undersøgt under både laboratorie- og feltbetingelser: En midlertidig stigning i kropstemperatur (op til 1,7 °C) er meget almindelig inden for de første 24 timer efter vaccinationen.
English: Severe anaphylactic (allergic) reactions are uncommon but may be lethal.
Danish: Alvorlige anafylaktisk (allergiske) reaktioner er usædvanlige, men kan være dødelige.
English: Exceptionally, in some herds a large proportion of animals may react after vaccination.
Danish: Undtagelsesvist kan en stor del af besætningen reagere efter vaccinationen.
English: The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Danish: Det hævede område er sædvanligvis mindre end 5 cm i diameter, men i nogle tilfælde kan hævelsen være større.
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Danish: Vaccinen indeholder også “adjuvanser” for at forstærke immunresponsen.
English: Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
Danish: Porcint circovirus rekombinant virus (cpcv) 1-2, inaktiverede
English: The effectiveness of Suvaxyn PCV has been studied in laboratory and field studies in a large number of pigs.
Danish: Virkningen af Suvaxyn PCV er blevet undersøgt i laboratorie- og feltundersøgelser hos et stort antal svin.