FrancophonIA/ELRC3.0 huggingface dataset:
English: Abacavir is metabolised by UDP-glucuronyltransferase (UGT) enzymes and alcohol dehydrogenase; co-administration of inducers or inhibitors of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Danish: Samtidig administration af UGT-enzym-induktorer eller -hæmmere eller af forbindelser, der elimineres via alkoholdehydrogenase, kan ændre eksponeringen over for abacavir.
English: The presence of M184V with K65R does give rise to crossresistance between abacavir, tenofovir, didanosine and lamivudine, and M184V with L74V gives rise to cross-resistance between abacavir, didanosine and lamivudine.
Danish: Tilstedeværelsen af M184V sammen med K65R giver mulighed for krydsresistens mellem abacavir, tenofovir, didanosin og lamivudin.
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunsuppression, højere Body Mass Index (BMI)).
English: The results are presented below:
Danish: Resultaterne er vist nedenfor:
English: 3 years.
Danish: 6.3 Opbevaringstid 3 år.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V,
Danish: Ydermere kan 69-indsættelseskomplekset eller Q151M-mutationen, sædvanligvis fundet i kombination med A62V, V751, F77L og F116Y, forårsage et højt niveau af resistens over for abacavir.
English: Common: anorexia Very rare: lactic acidosis
Danish: Almindelig: Appetitmangel Meget sjælden: Laktacidose
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).
Danish: Derfor frarådes samtidig brug af lamivudin og cladribin (se pkt.
English: Passage of HIV-1 (HXB2) in the presence of increasing 3TC concentrations results in high-level (>100 to >500-fold) lamivudine-resistant viruses and the RT M184I or V mutation is rapidly selected.
Danish: Hiv-1-resistens over for lamivudin involverer udviklingen af M1841- eller, hvad der er mere almindeligt, M184V-aminosyreændringer tæt ved den aktive del af viral RT. Tilførsel af hiv-1 (HXB2) under tilstedeværelse af øgede 3TC-koncentrationer resulterede i høje niveauer (> 100 til > 500 gange) af lamivudin-resistente vira, og RT M184I- eller V-mutation blev hurtigt selekteret.
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Danish: Læs oplysningerne under 'Andre bivirkninger ved kombinationsbehandling af hiv' under punkt 4 i denne indlægsseddel.
English: Musculoskeletal
Danish: Skeletmuskulatur
English: No Kivexa dosage adjustment necessary.
Danish: Dosisjustering af Kivexa ikke nødvendig.
English: • cladribine, used to treat hairy cell leukaemia
Danish: • cladribin (mod hårcelleleukæmi).
English: Phenobarbital/Lamivudine
Danish: Phenobarbital / lamivudin
English: An interim analysis from ACTG 5202 revealed that abacavir/lamivudine was associated with a statistically significantly higher risk of virological failure as compared to emtricitabine/tenofovir (defined as viral load >1000 copies/mL at or after 16 weeks and before 24 weeks or HIV-RNA level
Danish: En interimanalyse af data fra ACTG5202 afslørede, at abacavir/lamivudin var associeret med en statistisk signifikant højere risiko for virologisk svigt sammenlignet med emtricitabin/tenofovir (defineret som virusbyrde > 1.000 kopier/ml ved eller efter 16 uger og før 24 uger eller hiv-RNA-niveau > 200 kopier/ml ved eller efter 24 uger) hos patienter med en virusbyrde ≥ 100.000 kopier/ml ved screening (estimeret risikoratio: 2,33; 95 % CI: 1,46; 3,72; p=0,0003).
English: Do not take Kivexa Take special care with Kivexa
Danish: Vær ekstra forsigtig med at tage Kivexa
English: Tell your doctor.
Danish: Kontakt straks lægen.
English: Body system
Danish: Immunsystemet
English: Common: nausea, vomiting, diarrhoea
Danish: Almindelig: Kvalme, opkastning, mavesmerter ellerkramper, diarré
English: If the doctor thinks they may have been, you will then be told never again to take Kivexa, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen).
Danish: Hvis lægen mener, de kan være forårsaget af en overfølsomhedsreaktion, vil lægen råde dig til aldrig mere at tage Kivexa eller nogen anden medicin, som indeholder abacavir (f.eks. Trizivir, Triumeq eller Ziagen).
English: Similar reactions have also occurred infrequently after restarting abacavir in patients who had only one of the key symptoms of hypersensitivity (see above) prior to stopping abacavir; and on very rare occasions have also been seen in patients who have restarted therapy with no preceding symptoms of a HSR (i.e., patients previously considered to be abacavir tolerant).
Danish: I meget sjældne tilfælde er overfølsomhedsreaktioner rapporteret hos patienter, der har genoptaget behandlingen, og som ikke havde haft nogen forudgående symptomer på en overfølsomhedsreaktion (f.eks. patienter, som tidligere ansås for at være abacavir-tolerante).
English: Readily available genotypic drug resistance interpretation algorithms and commercially available susceptibility tests have established clinical cut offs for reduced activity for abacavir and lamivudine as separate drug entities that predict susceptibility, partial susceptibility or resistance based upon either direct measurement of susceptibility or by calculation of the HIV-1 resistance phenotype from the viral genotype.
Danish: Disse forudsiger følsomhed, delvis følsomhed eller resistens baseret på enten direkte målinger af følsomheden eller ved beregning af fænotypen for hiv-1-resistens ud fra den virale genotype.
English: Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors may increase lamivudine exposure.
Danish: Aktiv renal udskillelse af lamivudin via urinen medieres af organisk kation transportører (OCT´er).
English: Rifampicin/Lamivudine
Danish: Rifampicin / lamivudin
English: If you know you have this gene, tell your doctor before you take Kivexa.
Danish: Hvis du ved, at du har genet HLA-B*5701, skal du fortælle det til lægen, før du begynder at tage Kivexa.
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.The results showed that there was a mean (90%CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Danish: Abacavirs farmakokinetik er blevet undersøgt hos patienter med let nedsat leverfunktion (Child-Pugh score 5-6), der fik en enkelt dosis på 600 mg; den mediane (intervel) AUC var 24,1 (10,4 - 54,8) mikrog·time/ml.
English: Genotypic SS in OBT
Danish: GSS i OBT Alle
English: Common: fever, lethargy, fatigue.
Danish: Almindelig: Feber, svær udmatning, træthed
English: NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine
Danish: LÆGEMIDLETS NAVN Kivexa 600 mg/300 mg filmovertrukne tabletter Abacavir/lamivudin
English: None M184V alone Any one NRTI mutation Any two NRTIassociated mutations 22
Danish: En NRTI-mutation 82 To NRTI-forbundne mutationer
English: Emtricitabine/Lamivudine
Danish: Emtricitabin/Lamivudin
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Ethanol/Lamivudine
Danish: Ethanol / lamivudin
English: Tell your doctor if you are being treated with any of these.
Danish: Tal med lægen, hvis du tager et eller flere af disse lægemidler.
English: Methadone/Lamivudine
Danish: Methadon / lamivudin
English: The clinical relevance of this finding has not been determined.
Danish: Den kliniske relevans af dette fund er ikke fastlagt.
English: The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Danish: Risikoen for at udvikle en overfølsomhedsreaktion over for abacavir er høj hos de patienter, der er bærer af HLA-B*5701-allel.
English: Appropriate use of abacavir and lamivudine can be guided using these currently recommended resistance algorithms.
Danish: Gældende resistens-algoritmer kan vejlede om hensigtsmæssig anvendelse af abacavir og lamivudin.
English: infection
Danish: Leversygdom
English: Retinoid compounds (e.g. isotretinoin)/Lamivudine No drug interaction studies
Danish: Retinoid-forbindelser (f.eks. isotretinoin) / lamivudin
English: Hypersensitivity case studies
Danish: Casestudier på overfølsomhed
English: • if you have a kidney problem
Danish: • hvis du har en nyresygdom.
English: Common: Arthralgia, muscle disorders
Danish: Almindelig: Artralgi, muskelforstyrrelser Sjælden: Rabdomyolyse
English: Phenytoin/Lamivudine
Danish: Phenytoin / lamivudin
English: - 88.3% with ABC/3TC vs 90.3% with TDF/FTC when taken with atazanavir/ritonovir as third drug, treatment difference -2.0% (95% CI -7.5%, 3.4%), - 87.4% with ABC/3TC vs 89.2% with TDF/FTC, when taken with efavirenz as third drug, treatment difference -1.8% (95% CI -7.5%, 3.9%).
Danish: - 88,3 % i ABC/3TC-gruppen versus 90,3 % i TDF/FTC-gruppen; begge grupper blev samtidig behandlet med atazanavir/ritonavir som tredje lægemiddel.
English: ABC BID +3TC+EFV (n=386)
Danish: ABC to/dag +3TC+EFV (n=386)
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 observeret som en del af en overfølsomhedsreaktion over for abacavir er beskrevet i detaljer i pkt.
English: Other common symptoms are:
Danish: Andre symptomer:
English: Management of ABC HSR reaction
Danish: Håndtering af ABC-overfølsomhedsreaktion
English: EPZ104057 (HEAT study) was a randomised, double-blind, placebo-matched, 96 week, multi-centre study with the primary objective of evaluating the relative efficacy of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir /emtricitabine (TDF/FTC, 300mg/200mg), each given once-daily in combination with lopinavir/ritonavir (LPV/r, 800mg/200mg) in HIV-infected, therapy-naive adults.
Danish: Dette studie havde som primært formål at evaluere den relative effekt af abacavir/lamivudin (ABC/3TC, 600 mg/300 mg) og tenofovir/emtricitabin (TDF/FTC, 300 mg/200 mg), begge administreret en gang daglig i kombination med lopinavir/ritonavir (LPV/r, 800 mg/200 mg) hos hiv-inficerede, behandlingsnaive voksne.
English: ABC QD +3TC+EFV (n=384)
Danish: ABC en/dag +3TC+EFV (n=384)
English: A comparison of a regimen including once daily versus twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Danish: Indenfor rammerne af et randomiseret, kontrolleret multicenterstudie med hiv-inficerede pædiatriske patienter blev der foretaget en sammenligning af dosering 1 gang daglig versus 2 gange daglig af abacavir og lamivudin.
English: Week 4 (n = 166)
Danish: (N=386)
English: Didanosine/Lamivudine
Danish: Didanosin / lamivudin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 600 mg abacavir (som sulfat) og 300 mg lamivudin
English: Cimetidine/Lamivudine
Danish: Cimetidin / lamivudin
English: The signs and symptoms of this HSR are listed below.
Danish: Tegn og symptomer på denne overfølsomhedsreaktion er anført nedenfor.
English: The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
Danish: Aktive stoffer: Hver Kivexa filmovertrukken tablet indeholder 600 mg abacavir (som sulfat) og 300 mg lamivudin.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY
Danish: Kontakt STRAKS din læge i tilfælde af symptomer, der tyder på overfølsomhedsreaktioner
English: Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Danish: I reproduktionstoksicitetsundersøgelser blev der observeret embryo- og føtal-toksicitet hos rotter, men ikke hos kaniner.
English: Number of Subjects Number of Virological Failures Number of OnTherapy Genotypes
Danish: Antal virologiske svigt
English: There are conflicting data in some comparative studies with Kivexa i.e. HEAT, ACTG5202 and ASSERT:
Danish: Der er modstridende data i nogle sammenlignende studier med Kivexa (HEAT, ACTG5202 og ASSERT): EPZ104057 (HEAT-studiet) var et randomiseret, dobbeltblindet, placebokontrolleret multicenter-studie, der forløb over 96 uger.
English: • nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Danish: Andre almindelige symptomer: • kvalme, opkastning, diarré, mavesmerter, udtalt træthed.
English: Ranitidine/Lamivudine
Danish: Ranitidin / lamivudin
English: • Clinical Description of abacavir HSR
Danish: • Klinisk beskrivelse af overfølsomhedsreaktion over for abacavir
English: Response by Baseline HIV-1 RNA ≥100,000 c/mL
Danish: Respons ved baseline-hiv-1RNA < 100.000 kopier/ml Respons ved baseline-hiv-1RNA ≥ 100.000 kopier/ml
English: Abacavir hypersensitivity
Danish: Overfølsomhed over for abacavir
English: Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
Danish: I meget sjældne tilfælde er disse overfølsomhedsreaktioner opstået hos personer, der genoptog behandling med abacavir, og som ikke havde nogen symptomer på overfølsomhed, før de stoppede med at tage medicinen.
English: What Kivexa is and what it is used for What you need to know before you take Kivexa How to take Kivexa
Danish: Det skal du vide, før du begynder at tage Kivexa Sådan skal du tage Kivexa Bivirkninger
English: ABC QD + 3TC QD + EFV QD (N=384) Number of Baseline Mutations1
Danish: ABC 2 x dgl.+ 3TC 1 x dgl.
English: The proportion of treatment-experienced patients in the CAL30001 study with HIVRNA <50 copies/mL at Week 48 by genotypic sensitivity score in optimized background therapy (OBT) are tabulated The impact of major IAS-USA defined mutations to abacavir or lamivudine and multi-NRTI resistance associated mutations to the number of baseline mutations on response was also evaluated.
Danish: Tabellen viser andelen af behandlingserfarne patienter i CAL30001-studiet med hiv-RNA < 50 kopier/ml ved uge 48 opdelt efter genotypisk sensitivitetsscore ved optimeret baggrundsbehandling (OBT).
English: Similar proportions of patients in the once-daily and twice-daily abacavir arms of CAL30001 had GSS scores of <2 or ≥2 and successfully suppressed to <50 copies/mL by Week 48.
Danish: 2 eller  2 og suppression til < 50 kopier/ml ved uge 48 var sammenlignelige i de 2 behandlingsarme, abacavir én gang daglig og abacavir 2 gange daglig.
English: Liver disease
Danish: • åndenød.
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine .There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues: these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Danish: Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i variende grad, hvilket er mest udtalt for stavudin, didanosin og zidovudin.
English: (estimated hazard ratio: 2.33, 95% CI: 1.46, 3.72, p=0.0003).
Danish: Behandlingsforskel -1,8 % (95 % CI: -7,5 %; 3,9
English: Not applicable.
Danish: Oral anvendelse.
English: Liver/pancreas
Danish: Lever/bugspytkirtel
English: Do not stop taking Kivexa unless your doctor advises you to do so.
Danish: Du må kun stoppe din behandling med Kivexa efter aftale med lægen.
English: This should take approximately 30 minutes.
Danish: Dette burde vare ca. 30 minutter.
English: Date of first authorisation: 6 March 2009 Date of latest renewal: 20 February 2019
Danish: Dato for første markedsføringstilladelse: 6. marts 2009 Dato for seneste fornyelse: 20. februar 2019
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt, som din læge har fortalt dig.
English: You should take your temperature as you may have a fever.
Danish: Du bør tage din temperatur, da du kan have feber.
English: This is done by your doctor or a nurse, who will also monitor you during that time.
Danish: Dette gøres af lægen eller en sygeplejerske, som også overvåger dig under behandlingen.
English: It is especially important to tell your doctor if you are taking medicines containing any of the following active substances:
Danish: Det er særlig vigtigt at fortælle det til din læge, hvis du bruger medicin, der indeholder en eller flere af følgende aktive stoffer:
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler for bortskaffelse.
English: During this time the liposomes are formed spontaneously (figure 2).
Danish: I løbet af denne tid dannes liposomerne spontant (figur 2).
English: Embryotoxic effects were observed only at maternal toxic levels.
Danish: Embryotoksiske virkninger blev kun observeret på maternelle toksiske niveauer.
English: Adults > 30 years
Danish: Voksne > 30 år
English: Check with your doctor if you are not sure.
Danish: Spørg din læge, hvis du ikke er sikker.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes øjeblikkeligt.
English: In the event of an overdose, it is recommended that appropriate supportive treatment be initiated.
Danish: I tilfælde af en overdosis anbefales det, at passende understøttende behandling igangsættes.
English: Paediatric population < 2 years
Danish: Pædeatrisk population < 2 år
English: However, no specific subset analyses for efficacy are available in patients < 18 years of age and ≥ 18 years of age.
Danish: Der er dog ikke nogen specifikke analyser af undergrupper til rådighed angående virkning hos patienter på < 18 år og ≥ 18 år.
English: These data indicate that neither total nor free mifamurtide accumulated during the treatment period.
Danish: Disse data tyder på, at hverken total eller fri mifamurtid akkumulerede i behandlingsperioden.
English: Adverse reactions are classified according to system organ class and frequency.
Danish: Bivirkninger klassificeres ud fra systemorganklasse og hyppighed.
English: Supportive measures should be based on institutional guidelines and the clinical symptoms observed.
Danish: Understøttende behandling bør baseres på institutionelle retningslinjer og de observerede kliniske symptomer.
English: A frequency of ‘not known (cannot be estimated from available data)' is considered appropriate.
Danish: Hyppigheden "ikke kendt (kan ikke estimeres ud fra forhåndenværende data)" anses for at være passende.
English: Do not use this medicine if you notice any visible signs of deterioration.
Danish: Brug ikke lægemidlet, hvis du ser synlige tegn på nedbrydning.
English: It is not recommended to give this medicine to children below the age of 2 years because information on how safe and how well this medicine works is not available for this age group.
Danish: Det er ikke anbefalet at give dette lægemiddel til børn under 2 år, da der ikke er tilgængelige oplysninger om sikkerheden og virkningen af dette lægemiddel i den aldersgruppe.
English: Dose and duration of treatment
Danish: Dosis og behandlingsvarighed
English: You should not stop treatment with MEPACT before finishing the course of treatment without discussing with your doctor first.
Danish: Du bør ikke stoppe behandlingen med MEPACT, før du har afsluttet behandlingsforløbet, uden at drøfte det med lægen først.
English: A fever with a low white blood cell count (neutropenia) may be a sign of serious infection.
Danish: Feber med et lavt antal hvide blodlegemer (neutropeni) kan være et tegn på alvorlig infektion.
English: It stimulates your immune system to help your body kill tumour cells.
Danish: Det stimulerer dit immunsystem og hjælper dermed din krop med at dræbe svulstceller.
English: The second episode involved multiple grand mal seizures over the course of days.
Danish: Den anden episode involverede gentagende grand mal anfald over flere dage.
English: Based on the prevalence of the disease, children and young adults were studied in the pivotal trial.
Danish: På basis af sygdommens prævalens blev børn og unge voksne undersøgt i det pivotale studie.
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, inden du bruger dette lægemiddel.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), not known (cannot be estimated from the available data).
Danish: Hyppighedsgrupperingerne defineres i henhold til følgende konvention: meget almindelig (> 1/10), almindelig (> 1/100 til < 1/10), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The safety and efficacy of mifamurtide in children aged 0 to 2 years have not been established.
Danish: Mifamurtids sikkerhed og virkning for børn mellem 0 og 2 år er ikke klarlagt.
English: Therefore, there are not sufficient data to recommend the use of MEPACT in patients > 30 years of age.
Danish: Derfor foreligger der ikke tilstrækkelig dokumentation for, at MEPACT kan anbefales til patienter på > 30 år.
English: It may be difficult to distinguish allergic reactions from exaggerated inflammatory responses, but patients should be monitored for signs of allergic reactions.
Danish: Det kan være vanskeligt at skelne allergiske reaktioner fra forøgede inflammatoriske responser, men patienterne bør overvåges for tegn på allergiske reaktioner.
English: Materials required but not provided
Danish: Nødvendige materialer, som ikke leveres
English: The PIL should be updated accordingly.
Danish: Indlægssedlen bør opdateres i overensstemmelse hermed.
English: From a microbiological point of view, immediate use is recommended.
Danish: Fra et mikrobiologisk synspunkt anbefales øjeblikkelig anvendelse.
English: The liposomes were phagocytosed by cells of the reticuloendothelial system.
Danish: Liposomerne blev fagocyteret af celler i det reticulo-endotele system.
English: MEPACT has not been tested in pregnant women.
Danish: MEPACT er ikke blevet undersøgt til gravide kvinder.
English: It is not necessary to interrupt your schedule of MEPACT if your chemotherapy is delayed; you should complete 36 weeks (9 months) of treatment with MEPACT without an interruption.
Danish: Det er ikke nødvendigt at afbryde behandlingen med MEPACT, hvis din kemoterapi udsættes; du skal gennemføre 36 ugers (9 måneders) behandling med MEPACT uden afbrydelse.
English: Chemical and physical stability has been demonstrated for 6 hours up to 25 ºC.
Danish: Den kemiske og fysiske stabilitet er blevet påvist for 6 timer ved op til 25 °C.