FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore caution is advised if retapamulin 10 mg/g ointment is administered to children in this age group who are also receiving CYP3A4 inhibitors, as further increase in systemic exposure to retapamulin may occur upon CYP3A4 inhibition.
Danish: Der skal derfor udvises forsigtighed, hvis retapamulin 10 mg/g salve administreres til børn i denne aldersgruppe, hvis de samtidig får CYP3A4-hæmmere, da der kan forekomme en yderligere stigning i den systemiske eksponering for retapamulin ved CYP3A4-hæmning.
English: A thin layer of ointment should be applied to the affected area twice daily for five days.
Danish: Et tyndt lag salve appliceres på det angrebne område 2 gange daglig i 5 dage.
English: In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as PantonValentine Leukocidin) should be considered.
Danish: I de tilfælde, hvor den manglende effekt af behandlingen er associeret med S. aureus, skal den behandlende læge tage den mulige tilstedeværelse af stammer med ekstra virulente faktorer (som f.eks. Panton-Valentine
English: In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1%
Danish: I kliniske studier, udført på 2.150 patienter i behandling med Altargo for overfladiske hudinfektioner, var den mest almindeligt rapporterede bivirkning irritation på applikationsstedet.
English: In a study conducted in healthy adult subjects, 10 mg/g retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days.
Danish: I et studie med raske voksne personer blev retapamulin 10 mg/g salve påført dagligt på ubeskadiget hud og på skadet hud under okklusion i op til 7 dage.
English: In the Intent to Treat Bacteriological evaluable population, the clinical success rate of retapamulin (76.4%: 139/182) was statistically superior to that of placebo (64.3%; 54/84).
Danish: Hos ‘Intent to Treat Bacteriological evaluable' populationen var den kliniske succesrate for retapamulin (76,4 %; 139/182) statistisk superior i forhold til placebo (64,3 %; 54/84).
English: However, retapamulin showed no advantage over placebo in subjects with SIOW due to S. pyogenes.
Danish: Retapamulin viste ingen fordele over for placebo hos forsøgspersoner med SIOW forårsaget af S. pyogenes.
English: While the S. aureus epidemiological cut off value for retapamulin is 0.5 µg/ml, the clinical significance of isolates with elevated retapamulin MICs is unknown due to the potential for high local concentrations (20,000 µg/ml) of retapamulin on the skin.
Danish: Mens den epidemiologiske cut-off-værdi for S. aureus er 0,5 µg/ml for retapamulin, kendes den kliniske relevans af isolater med forhøjede MICværdier for retapamulin ikke på grund af potentialet for høje lokale koncentrationer (20.000
English: Retapamulin is for cutaneous use only.
Danish: Retapamulin er kun til kutan anvendelse.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
Danish: In vitro er retapamulin vist at være substrat og hæmmer af P-glykoprotein (Pgp).
English: If you stop using Altargo
Danish: Hvis du holder op med at bruge Altargo
English: If you forget to use Altargo
Danish: Hvis du har glemt at bruge Altargo
English: There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin: AUC 238 ng.h/ml).
Danish: Der var ikke tegn på svækket fertilitet hos han- eller hunrotter efter oral administration af 50, 150 eller 450 mg/kg/dag, hvilket resulterede i en eksponeringsmargen på op til 5 gange den højeste, estimerede humane eksponering (kutan anvendelse på 200 cm2 skadet hud: AUC 238
English: Retapamulin MICs of 2-64 µg/ml have been reported for clinical isolates of S. aureus possessing either the efflux or cfr resistance mechanisms described above.
Danish: MIC-koncentrationer på 2-64 µg/ml for retapamulin er rapporteret for kliniske isolater af S. aureus, der enten havde efflux- eller cfr-hæmningsmekanismen beskrevet ovenfor.
English: Single plasma samples were obtained from 516 adult and paediatric patients who received topical treatment with retapamulin 10 mg/g ointment twice daily for 5 days for the treatment of secondarily infected traumatic lesions.
Danish: En plasmaprøve blev indhentet fra hver af de 516 voksne og børn, der modtog kutan behandling med retapamulin 10 mg/g salve 2 gange daglig i 5 dage for behandling af sekundært inficerede traumatiske læsioner.
English: For S. aureus isolates with laboratorygenerated mutations in ribosomal protein L3, retapamulin MICs were 0.25-4 µg/ml.
Danish: MICkoncentrationer for retapamulin i S. aureus-isolater med laboratoriefremkaldte mutationer i ribosomal protein L3 var 0,25-4 µg/ml.
English: Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations)
Danish: Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road
English: Altargo is for adults and children aged nine months and older.
Danish: Altargo kan bruges til voksne og til børn over 9 måneder.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 oC
English: Exact CI is calculated using the F-distribution method.
Danish: Den præcise CI er beregnet ved brug af F-test.
English: There was no evidence of genotoxicity when evaluated in vitro for gene mutation and/or chromosomal effects in the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when evaluated in vivo for chromosomal effects in a rat micronucleus test.
Danish: Dette gælder både vurdering in vitro for genmutation og/eller kromosomal effekter i en muselymfomcelletest, i dyrkede humane perifere lymfocytter såvel som vurdering in vivo for kromosomale effekter i en mikronukleustest udført i rotter.
English: What you need to know before you use Altargo
Danish: Det skal du vide, før du begynder at bruge Altargo
English: Of the samples that had measurable concentrations 90% had retapamulin concentrations less than 2.5 ng/ml.
Danish: Af de prøver, hvor det var muligt at måle koncentrationen, havde 90 % en retapamulinkoncentration på under 2,5 ng/ml.
English: Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).
Danish: Pleuromutilin er isoleret ved fermentering af Clitopilus passeckerianus (tidligere Pleurotus passeckerianus).
English: Altargo contains butylated hydroxytoluene (E321) It may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous
Danish: Altargo indeholder butylhydroxytoluen (E321) Kan give lokalt hududslæt (f.eks. kontakteksem) og irritation af øjne og slimhinder.
English: Retapamulin is predominantly bacteriostatic against S. aureus and S. pyogenes.
Danish: Retapamulin er fortrinsvis bakteriostatisk mod S. aureus og S. pyogenes.
English: No clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data om eksponering over for retapamulin under graviditet.
English: Altargo should not be used on children who are less than nine months old.
Danish: Altargo må ikke anvendes til børn under 9 måneder.
English: In children aged from 2 months to 9 months plasma concentrations of retapamulin were measurable in 69% (20/29) of samples.
Danish: Hos børn i alderen 2 måneder til 9 måneder var plasmakoncentrationer af retapamulin målbare i 69 % (20/29) af prøverne.
English: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen af erhvervet resistens kan variere geografisk og med tiden hos udvalgte arter.
English: 0.5 g aluminium foil sachet.
Danish: 0,5 g brev af aluminiumsfolie.
English: If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.
Danish: Hvis du oplever en forværring af infektionen eller udvikler øget rødme, irritation eller andre tegn og symptomer på påsmøringsstedet.
English: n/N Success rate (%)
Danish: Forskel i succesrater (%)
English: A single retapamulin concentration (95.1 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml).
Danish: En enkelt retapamulinkoncentration (95,1 ng/ml) overskred den højeste observerede koncentration hos patienter i alderen 2-17 år (18,5 ng/ml).
English: Pruritus Erythema
Danish: Smerter Hudkløe Erytem
English: However, there were no systemic effects on juvenile rats with topical application of retapamulin ointment.
Danish: Der var derimod ingen systemisk effekt hos unge rotter efter påsmøring af retapamulinsalve.
English: However, the maximum individual systemic exposure in humans following topical application of 10 mg/g ointment on 200 cm2 of abraded skin (Cmax= 22 ng/ml; AUC(0-24) = 238 ng.h/ml) was 660-fold lower than the retapamulin IC50 for Pgp inhibition.
Danish: Den maksimale systemiske eksponering i mennesker efter kutan anvendelse af 10 mg/g salve på 200 cm2 skadet hud (Cmax = 22 ng/ml; AUC(0-24) = 238 ng · h/ml) var dog 660 gange lavere end retapamulins IC50 for Pgp-hæmning.
English: Systemic exposure following topical application of retapamulin through intact skin was very low.
Danish: Den systemiske eksponering efter kutan anvendelse af retapamulin på ubeskadiget hud var meget lille.
English: Retapamulin concentrations were measurable in 46% (36/79) of samples (range 0.52 to 177.3 ng/ml) but the majority of these samples (27/36; 75%) contained < 5.0 ng/ml.
Danish: Retapamulinkoncentrationer var målbare i 46 % (36/79) af prøverne (interval 0,52 til 177,3 ng/ml), men størstedelen af disse prøver (27/36; 75 %) indeholdt
English: No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Danish: In vitro blev der ikke observeret forskelle i aktiviteten af retapamulin mod S. aureus, uanset om isolaterne var methicillin-følsomme eller
English: Butylated hydroxytoluene (E321)
Danish: Hvid blød paraffin Butylhydroxytoluen (E321)
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Sensibilisering eller alvorlig lokal irritation
English: Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were measurable in 32% (16/50) of samples.
Danish: Hos børnene i alderen 9 måneder til 2 år var plasmakoncentrationerne af retapamulin målbare i 32 % (16/50) af prøverne.
English: Four plasma retapamulin concentrations (26.9, 80.3, 174.3, and 177.3 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml).
Danish: Fire plasmakoncentrationer af retapamulin (26,9; 80,3; 174,3 og 177,3 ng/ml) overskred den højeste observerede koncentration hos patienter i alderen 2-17 år (18,5 ng/ml).
English: Do not use in the eyes or on mucous membranes.
Danish: Må ikke bruges ved øjne eller på slimhinder.
English: GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131
Danish: GlaxoSmithKline Malta (Malta) Limited Tel: + 356 21 238131
English: Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20 ng/mL).
Danish: Den systemiske eksponering over for retapamulin har været lav efter kutan anvendelse af retapamulin 10 mg/g salve hos voksne og børn i alderen 2 år og ældre (maksimal plasmakoncentration < 20 ng/ml).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment
Danish: LÆGEMIDLETS NAVN Altargo 10 mg/g salve.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 g, 10 g, 15 g TUBE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED 5 g, 10 g, 15 g TUBE
English: Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Retapamulinsalve indeholder butylhydroxytoluen, som kan give lokalt hududslæt (f.eks. kontakteksem) eller irritation af øjne og slimhinder.
English: It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of ointment, or in an aluminium foil sachet containing 0.5 g of ointment.
Danish: Aluminiumstube med plastikskruelåg indeholdende 5 g, 10 g eller 15 g salve, eller brev af aluminiumsfolie indeholdende 0,5 g salve.
English: Therefore it is not expected that clinically important increases in plasma concentrations of retapamulin will occur in patients aged 2 years and older who are also receiving CYP3A4 inhibitors.
Danish: Der forventes derfor ingen klinisk relevant stigning i plasmakoncentrationer af retapamulin hos patienter i alderen 2 år og ældre, som også får
English: If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort.
Danish: Hvis salven ved et uheld kommer i berøring med disse områder, skal de vaskes grundigt med vand.
English: The study failed to meet the primary end point which was the clinical success rate at follow-up (day 12 - 14) for subjects in the Intent to Treat Clinical
Danish: Det primære endepunkt for studiet var klinisk succesrate ved opfølgning (dag 12-14) for forsøgspersoner i 'Intent to Treat' populationen (se tabel nedenfor).
English: In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/kg/day
Danish: Et embryotoksicitetsstudie af rotter viste udviklingstoksicitet (nedsat fosterkropsvægt og forsinket skeletal ossifikation) og maternal toksicitet efter orale doser på ≥ 150 mg/kg/dag (svarende til ≥ 3 gange den estimerede humane eksponering (se ovenstående)).
English: Retapamulin elimination in humans has not been investigated.
Danish: Elimination Retapamulins elimination er ikke undersøgt hos mennesker.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use in the eyes or on mucous membranes
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Må ikke bruges ved øjne eller på slimhinder
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 g, 10 g 15 g TUBE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 5 g, 10 g, 15 g TUBE
English: The reason for the reduced clinical efficacy observed in
Danish: Årsagen til den reducerede virkning, der blev observeret hos disse patienter, er ukendt.
English: Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin antibacterial agents that interact with the ribosome.
Danish: Retapamulin hæmmer selektivt bakteriernes proteinsyntese ved at interagere med et specifikt site på 50S-delen af det bakterielle ribosom.
English: Clinical Response at Follow-up (day 12-14), by Analysis population Difference in success rates (%)
Danish: Klinisk respons ved opfølgning (dag 12-14), efter analysepopulation Retapamulin
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Danish: I tilfælde, hvor den lokale prævalens af resistens tyder på, at produktets virkning ved nogle typer af infektioner er tvivlsom, bør den behandlende læge søge ekspertrådgivning.
English: Application site reactions
Danish: Kontaktdermatitis Reaktioner på applikationsstedet
English: Alternative therapy should be considered if there is no improvement or a worsening in the infected area after 2-3 days of treatment.
Danish: Hvis der ikke ses forbedringer, eller hvis infektionen forværres efter 2-3 dages behandling, bør alternativ behandling overvejes.
English: Retapamulin should not be used to treat infections known or thought likely to be due to MRSA.
Danish: Retapamulin bør ikke bruges i behandlingen af infektioner forårsaget af MRSA.
English: Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy adult males.
Danish: Ved samtidig administration af oral ketoconazol 200 mg 2 gange daglig og retapamulin 10 mg/g salve på skadet hud blev retapamulins gennemsnitlige AUC(0-24) og Cmax øget med 81 % hos voksne, raske mænd.
English: Retapamulin is not recommended for use in children aged less than 9 months.
Danish: Retapamulin bør ikke anvendes til børn under 9 måneder.
English: The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ml on day 1 and 8.79 ng/ml on day 7, and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ml.
Danish: Den geometriske middelværdi for Cmax i plasma efter administration på 200 cm2 skadet hud var 9,75 ng/ml på dag 1 og 8,79 ng/ml på dag 7.
English: Clinical Success Rates at Follow up for SIOW patients with S. aureus Phenotype/PFGE type
Danish: Klinisk succesrate ved opfølgning af SIOW-patienter med S. aureus Cephalexin præcis CI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 0.5 g SACHET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED 0,5 g BREV
English: Methicillin-resistant Staphylococcus aureus (MRSA) Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
Danish: Methicillin-resistent Staphylococcus Aureus (MRSA) Retapamulin bør ikke anvendes til behandling af infektioner forårsaget af MRSA (se pkt.
English: The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients
Danish: Den maksimale målte plasmakoncentration af retapamulin var 10,7 ng/ml hos voksne og 18,5 ng/ml hos børn (i alderen 2-17 år).
English: See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Danish: Vigtig information om retapamulins kliniske aktivitet mod forskellige typer af Staphylococcus aureus er anført under pkt.
English: Each gram of ointment contains 10 milligrams of - The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
Danish: - Øvrige indholdsstoffer: Hvid blød paraffin og butylhydroxytoluen (E321), et
English: MSSA
Danish: oC.
English: Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated
Danish: Der bør gives symptomatisk behandling ved tegn og symptomer på overdosering efter kutan anvendelse, eller hvis retapamulin salve indtages ved et uheld.
English: In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4.
Danish: Det er påvist, at retapamulin er en stærk hæmmer af CYP3A4 i humane levermikrosomer.
English: Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial medicinal product.
Danish: Retapamulinsalve bør ikke anvendes under graviditet, medmindre en kutan, antibakteriel behandling er klart nødvendig.
English: No treatment-related effects on male or female fertility have been shown in animal studies (see section 5.3).
Danish: Dyreforsøg har ikke vist behandlingsrelaterede virkninger på den mandlige eller den kvindelige fertilitet
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 0.5 g SACHET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 0,5 g BREV
English: 5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.
Danish: Aluminiumstube med plastikskruelåg indeholdende 5 g, 10 g eller 15 g. Pakning med 1 tube.
English: What Altargo looks like and contents of the pack Altargo is a smooth, off-white ointment.
Danish: Altargo er en jævn, let gullig salve.
English: 5.2 Pharmacokinetic properties
Danish: 5.3 Prækliniske sikkerhedsdata
English: However, since plasma concentrations of retapamulin during topical application have been low (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4 substrates will result in clinically important inhibition of their metabolism by retapamulin.
Danish: 5.2), forventes det dog ikke, at samtidig systemisk administration af CYP3A4-substrater resulterer i, at retapamulin hæmmer CYP3A4-substraternes metabolisme i en klinisk relevant grad.
English: 4.2 Posology and method of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Epistaxis has been reported with use of Altargo on nasal mucosa.
Danish: Epistaxis er blevet rapporteret ved anvendelse af
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and fetal/postnatal development (see section 5.3).
Danish: Resultaterne af disse forsøg er utilstrækkelige til at kunne foretage en vurdering af effekten på fostrets udvikling, fødslen og den postnatale udvikling (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment Retapamulin
Danish: Altargo 10 mg/g salve
English: DATE OF REVISION OF THE TEXT
Danish: LÆGEMIDLETS NAVN
English: Any remaining ointment at the end of treatment should be discarded.
Danish: Hvis der ved behandlingsophør er mere salve tilbage i tuben, skal det destrueres.
English: Uncommon side effects (may affect up to 1 in 100 people): - pain, itching, redness or rash (contact dermatitis) Other side effects (frequency not known, cannot be estimated from the available data):
Danish: Andre bivirkninger (hyppigheden af disse er ikke kendt):
English: Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects with S. aureus and S. pyogenes
Danish: Kliniske succesrater ved opfølgning for ‘Intent to Treat Bacteriological Evaluable' SIOW-forsøgspersoner med S. aureus og S. pyogenes Placebo n/N Succesrate (%) 95 % præcis CI n/N Succesrate (%)
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller
English: Pathogen
Danish: Placebo
English: Re-evaluation of treatment
Danish: Toksicitet efter gentagne doser
English: There were no treatment
Danish: Der var ingen tegn på genotoksicitet.
English: GlaxoSmithKline Pharmaceuticals s.a./n.v.
Danish: GlaxoSmithKline - Produtos Farmacêuticos, Lda
English: If you use more Altargo than you should
Danish: Hvis du har brugt for meget Altargo
English: S. pyogenes
Danish: ITTC PPC
English: − early recognition and intervention may improve outcome
Danish: − tidlig påvisning og intervention kan forbedre udfaldet
English: Date of first authorisation: 27th June 2006 Date of latest renewal: 18th April 2016
Danish: Dato for første markedsføringstilladelse: 27. juni 2006 Dato for seneste fornyelse: 18. april 2016
English: The predicted time to steady-state was approximately 36 weeks.
Danish: Den forventede tid til steady state var cirka 36 uger.
English: Prophylactic steroid treatment is currently not recommended.
Danish: Profylaktisk steroidbehandling anbefales ikke for nuværende.
English: Effects on laboratory tests
Danish: Virkninger på laboratorieprøver