FrancophonIA/ELRC3.0 huggingface dataset:
English: Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%: 8/8).
Danish: Kun få MRSA blev isoleret ved studier med impetigo og alle var kliniske succeser (100 %: 8/8).
English: Apply the ointment as soon as you remember, and apply the next dose at the usual time.
Danish: Påsmør salven, så snart du kommer i tanke om det. Påsmør den næste dosis til sædvanlig tid.
English: België/Belgique/Belgien
Danish: Belgique/Belgien
English: In vitro, three mechanisms have been identified which reduce susceptibility to retapamulin.
Danish: In vitro er der identificeret tre mekanismer, hvorved følsomheden for retapamulin reduceres.
English: Read all of this leaflet carefully before you start using this medicine because it contains
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: The following convention has been used for the classification of frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available
Danish: Meget almindelig (> 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Carefully wipe off the extra ointment.
Danish: Tør forsigtigt den overskydende salve af.
English: If you accidentally use Altargo inside your nose you could have a nose bleed.
Danish: Hvis du ved et uheld kommer til at bruge Altargo på slimhinden i næsen, kan du få næseblod.
English: Retapamulin should not be used to treat abscesses.
Danish: Retapamulin bør ikke anvendes til behandling af abscesser.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Altargo is not expected to affect your ability to drive or use machines.
Danish: Altargo forventes ikke at påvirke evnen til at føre motorkøretøj eller arbejde med maskiner.
English: If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments.
Danish: Ved mistanke om en super-infektion med en ikke-følsom mikroorganisme, skal behandling foretages ud fra en klinisk og en mikrobiologisk vurdering.
English: The following side effects have occurred on the skin where Altargo has been applied: Common side effects (may affect up to 1 in 10 people):
Danish: Følgende bivirkninger er set på huden, hvor Altargo er blevet påført: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine
Danish: Voksne (18-65 år), unge (12-17 år), spædbørn og børn (9 måneder - 11 år)
English: This non-target specific efflux mechanism has also been demonstrated to reduce the in vitro activity of streptogramin A.
Danish: Det er også vist, at denne nonspecifikke efflux mekanisme reducerer in vitro-aktiviteten af streptogramin A.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for
English: If there is no improvement in your infection after two to three days of treatment contact your doctor.
Danish: Hvis der ikke ses forbedringer af infektionen efter 2-3 dages behandling, skal du kontakte lægen.
English: • Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.
Danish: • Inficerede læsioner over 10 cm i længden eller med et totalt overfladeareal > 100 cm2.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt
English: Carton of 12 sachets.
Danish: Pakning med 12 breve.
English: If the patient is a child less than two years old it is especially important that you tell your doctor about any other medicines that the child is being given, including medicines bought without a prescription.
Danish: Hvis patienten er et barn under 2 år, er det særlig vigtigt, at du fortæller det til lægen, hvis barnet får anden medicin.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Altargo ointment contains an antibiotic called retapamulin, which is used on the skin.
Danish: Altargo salve indeholder et antibiotika, kaldet retapamulin, som bruges på huden.
English: Your doctor will decide if Altargo can be used for a child aged less than 2 years old who is taking other medicines.
Danish: Det er op til lægen at afgøre, om Altargo kan anvendes til et barn under 2 år, som får anden medicin.
English: However by the Follow-up visit this difference was less pronounced, (88.6% vs, 81% for retapamulin and placebo treated subjects respectively).
Danish: Ved opfølgningsbesøg var denne forskel dog mindre udtalt (88,6 % vs 81 % for forsøgspersoner behandlet med henholdsvis retapamulin og placebo).
English: Elderly (aged 65 and older)
Danish: Ældre (over 65 år)
English: In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the
Danish: I tilfælde af sensibilisering eller alvorlig lokal irritation ved brug af retapamulinsalve skal behandlingen afbrydes, salven vaskes omhyggelig af og passende alternativ behandling af
English: Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
Danish: Retapamulin blev givet ved kontinuerlig intravenøs infusion til drægtige kaniner fra dag 7 til dag 19 af drægtighedsperioden.
English: 4.7 Effects on ability to drive and use machines Altargo has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Altargo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene
English: - The active substance is retapamulin.
Danish: - Aktivt stof: Retapamulin.
English: The area treated may be covered with sterile bandage or gauze dressing.
Danish: Det behandlede område kan dækkes af en steril bandage eller gazeforbinding.
English: Currently available data are described in section 5.2, but no recommendation on a
Danish: 5.2, men der kan ikke gives nogen anbefalinger
English: Abscesses
Danish: Abscesser
English: However, see section 4.4 and below regarding clinical efficacy against MRSA.
Danish: 4.4 og nedenstående med hensyn til den kliniske effekt mod MRSA.
English: Due to its distinct mode of action, target specific cross-resistance with other classes of antibacterial agents is rare.
Danish: På grund af retapamulins særlige virkningsmekanisme er specifik krydsresistens med andre klasser af antibakterielle midler sjælden.
English: See section 5.2 regarding plasma concentrations of retapamulin observed in patients in different age groups.
Danish: 5.2 vedrørende plasmakoncentrationer af retapamulin, som blev observeret hos patienter i forskellige aldersgrupper.
English: Lesions of subjects treated with retapamulin healed more quickly by the End of therapy visit (day 7-9), with a reduction in size of the lesions by 77.3% compared to 43.5% for placebo treated subjects.
Danish: Læsioner hos forsøgspersoner behandlet med retapamulin var helet hurtigere ved det afsluttende behandlingsbesøg (dag 7-9) med en reduktion i størrelse af læsioner på 77,3 % sammenlignet med 43,5 % for forsøgspersoner behandlet med placebo.
English: After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
Danish: Efter du har påført salven, kan du dække det behandlede område med en steril bandage eller forbinding, medmindre lægen har fortalt dig, at du ikke må dække området til.
English: No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.
Danish: Ingen studier har evalueret effekten af retapamulin på den præ-/postnatale udvikling.
English: However, in the two studies that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%).
Danish: De to studier, der omfattede patienter med SIOW, viste dog en utilstrækkelig effekt af retapamulin ved infektioner forårsaget af MRSA (75,7 %).
English: Prolonged use and overgrowth of non-susceptible micro-organisms Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.
Danish: Anvendelse over længere tid og vækst af ikke-følsomme mikroorganismer Anvendelse af retapamulin over længere tid kan medføre vækst af ikke-følsomme mikroorganismer, inklusive svampe.
English: Short term treatment of the following superficial skin infections in adults, adolescents, infants and children (aged from nine months) (see section 5.1):
Danish: Korttidsbehandling af følgende overfladiske hudinfektioner hos voksne, unge, børn og spædbørn (fra 9 måneder) (se pkt.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for
Danish: Farmakoterapeutisk klassifikation: Antibiotica og chemotherapeutica til dermatologisk brug, Antibiotica til udvortes brug.
English: Talk to your doctor or pharmacist before using Altargo.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Altargo.
English: The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may have been influenced by the presence of a particular MRSA clone.
Danish: Årsagen til den mindre kliniske effekt mod MRSA ved SIOW er ukendt, men kan muligvis skyldes tilstedeværelsen af en speciel MRSA-klon.
English: One involves mutations in ribosomal protein L3, the second is a non-specific efflux mechanism (ABC transporter vgaAv).
Danish: Den ene mekanisme skyldes en mutation i det ribosomale protein L3, mens den anden er en non-specifik efflux-mekanisme (ABC transporter vgaAv).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the
Danish: En beslutning om at fortsætte/stoppe amningen eller fortsætte/stoppe behandlingen med Altargo bør træffes, idet der tages højde for fordelene ved amningen for barnet i forhold til de terapeutiske fordele for moderen ved behandlingen med Altargo.
English: There was no treatment-related effect on embryofetal development.
Danish: Der var ingen behandlingsrelateret effekt på embryoets/fostrets udvikling.
English: Susceptibility to pleuromutilins can also be affected by the Cfr rRNA methyltransferase, which confers cross-resistance to phenicols, lincosamides and streptogramin A in staphylococci.
Danish: Følsomhed for pleuromutiliner kan også påvirkes af Cfr rRNA metyltransferase, der kan give krydsresistens over for phenicoler, lincosamider og streptogramin A hos stafylokokker.
English: Single plasma samples were obtained approximately 4-8 hours after the first application on days 3 or 4 from patients aged from 2 months to 2 years with impetigo or with secondarily infected traumatic lesions or dermatoses (note that retapamulin is not indicated for use in secondarily infected dermatoses).
Danish: Der blev indhentet enkelte plasmaprøver ca. 4-8 timer efter den første påsmøring på dag 3 og 4 fra patienter i alderen 2 måneder til 2 år med impetigo eller med sekundært inficerede traumatiske læsioner eller dermatoser (bemærk, at retapamulin ikke er indiceret til sekundært inficerede dermatoser).
English: Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
Danish: Hos voksne er der set en minimal systemisk eksponering, hvorfor eksponering af barnet ved amning forventes at være ubetydelig.
English: Altargo is used to treat bacterial infections affecting small areas of skin.
Danish: Altargo bruges til behandling af bakterielle infektioner på små hudområder.
English: See package leaflet for further information
Danish: Se indlægssedlen for yderligere information
English: However, when adjusted for baseline wound characteristics including pathogen, wound size and severity, the clinical success rate of retapamulin was superior to placebo for the primary efficacy endpoint (p=0.0336).
Danish: Hvis der blev justeret for baseline-sårkarakteristika, herunder patogen, sårstørrelse og sværhedsgrad, var den kliniske succesrate for retapamulin bedre end for placebo for det primære effektendepunkt (p=0,0336).
English: The safety and efficacy of retapamulin ointment in infants less than nine months of age has not been established.
Danish: Sikkerhed og virkning af retapamulinsalve hos spædbørn under 9 måneder er ikke klarlagt.
English: No pharmacokinetic data are available in patients with renal or hepatic impairment.
Danish: Ingen farmakokinetiske data er tilgængelig for patienter med nedsat nyre- eller leverfunktion.
English: In studies in impetigo and in two studies of secondarily infected open wounds (SIOW), clinical success rates were high for retapamulin in patients with mupirocin-resistant S. aureus (100%: 11/11) or fusidic acid-resistant S. aureus (96.7%: 29/30).
Danish: I studier med impetigo og i to studier med sekundært åbne, inficerede sår (SIOW), var den kliniske succesrate høj for retapamulin hos patienter med mupirocin-resistente S. aureus (100 %: 11/11) eller fusidinsyre-resistente S. aureus (96,7 % 29/30).
English: Carcinogenesis, mutagenesis, reproductive toxicity Long-term studies in animals to evaluate carcinogenic potential have not been conducted with
Danish: Karcinogenicitet, mutagenicitet, reproduktionstoksicitet Der er ikke foretaget langtidsstudier med retapamulin hos dyr for at vurdere den potentielle
English: Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.
Danish: Hyppighed, type og alvorlighedsgrad for bivirkninger i den pædiatriske population er den
English: Altargo is for use on the skin only.
Danish: Altargo må kun bruges til påsmøring på huden.
English: This difference was primarily due to the higher success rate observed in retapamulin-treated subjects with infections caused by S. aureus in comparison to placebo treated subjects (see Table below).
Danish: Denne forskel skyldtes primært den højere succesrate, der blev observeret hos forsøgspersoner med infektioner forårsaget af S. aureus, der blev behandlet med retapamulin sammenlignet med forsøgspersoner behandlet med placebo (se tabel nedenfor).
English: The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ml).
Danish: Størstedelen af prøverne (89 %) lå under kvantiseringsgrænsen (0,5 ng/ml).
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There are no data on the effects of retapamulin on human fertility.
Danish: Der er ingen data hvad angår retapamulins virkning på fertiliteten hos mennesker.
English: By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, partially block P-site interactions, and prevent normal formation of active 50S ribosomal subunits.
Danish: Ved at binde til dette site hæmmer pleuromutilin peptidyl transfer, blokerer delvist P-site-interaktioner og forhindrer den normale funktion af ribosomets aktive 50S-del.
English: A thin layer of ointment is usually put on the infected skin twice a day for five days.
Danish: Et tyndt lag salve påføres sædvanligvis den inficerede hud 2 gange daglig i 5 dage.
English: Severe skin reactions or allergies (frequency not known) If you develop a severe skin reaction or an allergy: (e.g. severe itching or severe rash, swelling of the
Danish: Tilstande, som du skal være opmærksom på Alvorlige hudreaktioner eller allergier (hyppigheden ikke kendt) Hvis du udvikler en alvorlig hudreaktion eller en allergi (f.eks. alvorlig kløe, alvorligt udslæt, hævelse af ansigtet, læberne eller tungen):
English: Data indicate that the binding site involves ribosomal protein L3 and is in the region of the ribosomal P site and peptidyl transferase centre.
Danish: Data indikerer, at bindingen sker til det ribosomale protein L3, og at bindingsstedet er i området af ribosomets P-site og peptidyl transferasecenter.
English: • Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
Danish: • Impetigo-læsioner > 10 i antal og med et totalt overfladeareal på mere end 100 cm2.
English: In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis.
Danish: Hos aber, der blev doseret oralt (50, 150, 450 mg/kg) i 14 dage var der dosisrelaterede
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 oC
English: In children aged from 9 months to 2 years it is possible that higher plasma concentrations may occasionally occur during treatment with retapamulin 10 mg/g ointment compared to older children and adults.
Danish: Hos børn i alderen 9 måneder til 2 år er det muligt, at der i nogle tilfælde kan forekomme højere plasmakoncentrationer under behandling med retapamulin 10 mg/g salve sammenlignet med ældre børn og voksne.
English: Your doctor will decide if this
Danish: Lægen vil vurdere, om denne behandling er den rette for dig.
English: Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day corresponding to ≥ 8 times the estimated human exposure (see above).
Danish: Maternal toksicitet blev vist ved dosering ≥ 7,2 mg/kg/dag svarende til ≥ 8 gange den estimerede humane eksponering (se ovenstående).
English: In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Danish: I 14 dages (50, 150, 450 mg/kg) orale toksicitetsstudier af rotter var der tegn på adaptive leverog thyroidforandringer.
English: Keep using Altargo for as long as your doctor advises.
Danish: Du skal fortsætte med at bruge Altargo lige så længe, som lægen har foreskrevet.
English: Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.
Danish: Du må ikke påsmøre andre salver, cremer eller lotion på det område, du behandler med Altargo, medmindre lægen har fortalt dig andet.
English: Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple
Danish: Det lader derfor til, at pleuromutilin hæmmer bakteriernes proteinsyntese via forskellige mekanismer.
English: Nevertheless, the highest plasma concentrations recorded were low (< 10.5 ng/ml in the absence of ketoconazole and < 17 ng/ml in the presence of ketoconazole.
Danish: Ikke desto mindre var de højeste registrerede plasmakoncentrationer lave (< 10,5 ng/ml ved fravær af ketoconazol og < 17 ng/ml ved tilstedeværelse af
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg retapamulin (1% w/w).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver gram salve indeholder 10 mg retapamulin (1 % w/w).
English: Each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321).
Danish: Hver gram salve indeholder op til 20 µg butylhydroxytoluen (E321).
English: This plasma concentration was observed in a child with a secondary infected dermatosis, for which retapamulin is not indicated
Danish: Denne plasmakoncentration blev observeret hos et barn med sekundært inficeret dermatose, hvortil
English: The excretion of retapamulin in milk has not been studied in animals.
Danish: Udskillelsen af retapamulin i modermælken er ikke undersøgt hos dyr.
English: The in vitro oxidative metabolism of retapamulin in human liver microsomes was primarily mediated by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).
Danish: Den in vitro oxidative metabolisme af retapamulin i humane levermikrosomer er primært medieret af CYP3A4 og kun i mindre grad af CYP2C8 og CYP2D6 (se pkt.
English: A multicentre, randomised, double-blind, study compared the efficacy of retapamulin ointment to placebo ointment for the treatment of SIOW.
Danish: Et randomiseret, dobbeltblindt multicenter-studie sammenlignede effekten af retapamulinsalve ved behandling af SIOW med placebosalve.
English: Apply to the affected area as directed by your doctor.
Danish: Påføres på det angrebne område som beskrevet af lægen.
English: Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.
Danish: Infektioner, der kan behandles, er børnesår (der forårsager skorpedannende sår på de inficerede områder), rifter, hudafskrabninger og sammensyede sår.
English: Sampling occurred pre-dose for adult subjects on days 3 or 4, and between 0-12 hours after the last application for paediatric subjects on days 3 or 4.
Danish: Prøverne blev taget før administration hos voksne på dag 3 eller 4 og mellem 0-12 timer efter sidste påsmøring hos børn på dag 3 eller 4.
English: The effect of concurrent application of retapamulin and other topical medicinal products to the same area of skin has not been studied, and is not recommended.
Danish: Effekten ved samtidig administration af retapamulin og andre lægemidler til kutan anvendelse, på samme hudområde, er ikke undersøgt og kan ikke anbefales.
English: n/N Success rate
Danish: n/N Succesrate
English: If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for retapamulin eller et af de øvrige indholdsstoffer i Altargo (angivet
English: Other medicines and Altargo
Danish: Brug af anden medicin sammen med Altargo
English: It is unknown whether retapamulin is excreted in human breast milk.
Danish: Det er uvist, om retapamulin udskilles i human mælk.
English: Due to the very low systemic exposures, tissue distribution of retapamulin has not been investigated in humans.
Danish: På grund af den meget lave systemiske eksponering er der ikke lavet undersøgelser på retapamulins vævsfordeling hos mennesker.
English: $: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%)
Danish: Den præcise CI er beregnet ved brug af F-test. $: Responsraten for MRSA på grund af PVL+MRSA var 8/13 (62 %).
English: $ In vitro, retapamulin was equally active against methicillin-susceptible and methicillin-resistant strains of S. aureus.
Danish: $ In vitro var retapamulin lige aktiv mod methicillin-følsomme og methicillin-resistente stammer af S. aureus.