FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Fi studji dwar impetigo u f'żewġ studji dwar feriti miftuħa infettati sekondarjament (SIOW), rati ta' suċċessi kliniċi kienu għolja għal retapalumin f'pazjenti b' S. aureus reżistenti għal mupiroċina (100%: 11/11) jew S. aureus reżistenti għal aċidu fusidiku (96.7%: 29/30).
English: In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
Maltese: In vitro, retapamulin wera li kien substrat u impeditur ta' P-glycoprotein (Pgp).
English: Alternative therapy should be considered if there is no improvement or a worsening in the infected area after 2-3 days of treatment.
Maltese: Terapija alternattiva għandha tkun ikkunsidrata jekk ma jkunx hemm titjib jew ikun hemm deterjorament fiżżona infettata wara 2-3 ijiem ta' kura.
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment Retapamulin
Maltese: Ingwent Altargo 10 mg/g Retapamulin
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.
Maltese: 5 ng/ml fl-assenza ta' ketoconazole u < 17 ng/ml fil-preżenza ta' ketoconazole).
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.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku
English: ITTC- Intent to Treat Clinical Primary Efficacy Population; PPC -Per Protocol Clinical Primary Efficacy population; ITTB- Intent to Treat Bacteriological evaluable, Primary Efficacy Population; PPB - Per Protocol Bacteriologically evaluable, Primary Efficacy Population.
Maltese: ITTC- Popolazzjoni ta' Effikaċja Primarja Klinika Intenzjoni li Tikkura; PPC - Popolazzjoni ta' Effikaċja Primarja Klinika Skont il-Protokoll; ITTB- Popolazzjoni ta' Effikaċja Primarja Klinika Intenzjoni li Tikkura evalwabbli b'mod
English: Retapamulin is predominantly bacteriostatic against S. aureus and S. pyogenes.
Maltese: Retapalumin hu fil-biċċa l-kbira batterjostatiku kontra S. aureus u S. pyogenes.
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).
Maltese: Fil-popolazzjoni Intenzjoni li Tikkura evalwabbli b'mod Batterjoloġiku, ir-rata ta' suċċess kliniku ta' retapamulin (76.4%: 139/182) kienet superjuri b'mod statistiku g ħal dik ta' plaċebo (64.3%; 54/84).
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).
Maltese: Il-metaboliżmu ossidattiv in vitro ta' retapamulin f'mikorosomi tal-fwied fil-bniedem kien primarjament medjat b'CYP3A4 b'kontribuzzjonijiet żgħar minn CYP2C8 u CYP2D6 (ara sezzjoni 4.5).
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.
Maltese: Madankollu, l-ogħla esponiment sistemiku individwali fil-bniedem wara applikazzjoni topika ta' ingwent ta' 10 mg/g fuq 200 ċm2 ta' ġilda mibruxa (Cmax= 22 ng/ml; AUC(0-24) = 238 ng.h/ml) kien 660 darba inqas mill-IC50 ta' retapamulin għal inibizzjoni Pgp.
English: Exact CI is calculated using the F-distribution method.
Maltese: CI eżatt huwa kalkolat bl-użu tal-metodu ta' distribuzzjoni F.
English: The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ml).
Maltese: Il-maġġoranza tal kampjuni (89%) kienu taħt il-limitu t'isfel ta' kwantitazzjoni (0.5 ng/ml).
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).
Maltese: Erba' konċentrazzjonijiet ta' retapamulin fil-plażma (26.9, 80.3, 174.3, u 177.3 ng/ml) qabżu l-ogħla konċentrazzjoni osservata f'pazjenti b'età minn 2 sa 17-il sena (18.5 ng/ml).
English: Due to its distinct mode of action, target specific cross-resistance with other classes of antibacterial agents is rare.
Maltese: Minħabba l-mod distint ta' azzjoni tiegħu, target specific cross-resistance ma' klassijiet oħra ta' aġenti antibatteriċi hija rari.
English: Retapamulin is approximately 94% bound to human plasma proteins.
Maltese: Madwar 94% ta' retapamulin jeħel ma' proteini tal-plażma fil-bniedem.
English: • Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
Maltese: • Feriti infettati li jaqbżu l-10 ċm f'tul jew 100 ċm2 f'superfiċje totali.
English: Other medicines and Altargo
Maltese: Mediċini oħra u Altargo
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.
Maltese: Ma kienx hemm sinjali ta' ġenotossiċita` meta evalwata in vitro għal tibdil ta' ġene u/jew effetti kromosomali fil-lymphoma cell assay fil-ġrieden, f'limfoċiti kkultivati periferali tad-demm uman, jew meta evalwati in vitro għal effetti kromosomali f'test mikronukleu fuq ġurdien.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 g, 10 g, 15 g TUBE
Maltese: TUBU TA' 5 g, 10 g, 15 g
English: n/N Success rate
Maltese: GĦAMLA KWALITATTIVA
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%
Maltese: Fi studji kliniċi li fihom 2150 pazjent b'infezzjoni superfiċjali fil-ġilda applikaw Altargo, l-aktar effett mhux mixtieq rappurtat kien irritazzjoni fil-post fejn jindilek, li affettwat madwar 1% tal-pazjenti.
English: Each gram contains 10 mg retapamulin (1% w/w)
Maltese: Kull gramma fiha 10 mg retapamulin (1% w/w)
English: However by the Follow-up visit this difference was less pronounced, (88.6% vs, 81% for retapamulin and placebo treated subjects respectively).
Maltese: (88.6% vs, 81% għal individwi kkurati b'retapamulin u bi plaċebo rispettivament).
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.
Maltese: It-teħid fl-istess ħin mill-ħalq ta' 200 mg ketoconazole darbtejn kuljum żied il-medja ta' AUC(0-24) u Cmax ta' retapamulin b'81% wara l-applikazzjoni topika ta' ingwent b'10 mg/g retapamulin fuq il-ġilda mibruxa ta' rġiel f'saħħithom.
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment
Maltese: Ingwent Altargo 10 mg/g
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.
Maltese: Il-feriti ta' individwi kkurati b'retapamulin fiequ aktar malajr sal-vista talAħħar tal-kura (jum 7-9), bi tnaqqis fil-daqs tal-feriti b'77.3% meta mqabbel ma' 43.5% g ħal individwi kkurati bi plaċebo.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for
Maltese: Antibijotiċi u kimoterapewtiċi għall-użu dermatoloġiku, Antibijotiċi għall
English: Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%: 8/8).
Maltese: Ftit MRSA ġew iżolati fi studji dwar impetigo u kollha kienu suċċessi kliniċi (100%: 8/8).
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.
Maltese: Kampjuni ta' plażma waħedhom ġew miksuba minn 516 adulti u pazjenti pedjatriċi li kienu ħadu trattament topiku b'ingwent ta' 10 mg/g retapamulin darbtejn kuljum għal 5 jiem għat-trattament ta' feriti trawmatiċi infettati sekondarjament.
English: Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.
Maltese: Il-frekwenza, tip u severità tar-reazzjonijiet avversi fil-popolazzjoni pedjatrika huma l-istess bħal fl-adulti.
English: 5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.
Maltese: Tubi ta' l-aluminju tal-5g, 10g u 15g b'tapp tal-plastik bil-kamin.
English: n/N Success Rate (%)
Maltese: suċċess (%)
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.
Maltese: (ara sezzjoni 5.2), mhux mistenni li l-għoti sistemiku fl-istess waqt ta' substrati ta' CYP3A4 twassal għal inibizzjoni ta' importanza klinika tal-metaboliżmu tagħhom minn retapamulin.
English: This might lead to side effects.
Maltese: Dan jista' jwassal għall-effetti sekondarji.
English: The reason for the reduced clinical efficacy observed in
Maltese: Effikaċja klinika u sigurtà
English: For S. aureus isolates with laboratorygenerated mutations in ribosomal protein L3, retapamulin MICs were 0.25-4 µg/ml.
Maltese: G ħall-iżolati ta' S. aureus b'mutazzjonijiet magħmula fil-laboratorju fil-proteina L3 tar-ribosoma, l- MICs ta' retapamulin kienu minn 0.25-4 µg/ml.
English: Re-evaluation of treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple
Maltese: Għalhekk il-plewromutilini jidher li jfixklu s sinteżi ta' proteini batteriċi b'mekkaniżmi multipli.
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).
Maltese: Madankollu, meta kienet aġġustata għall-karatteristiċi tal-ferita fil-linja bażi inkluż il-patoġenu, id-daqs u s severità tal-ferita, ir-rata ta' suċċess kliniku ta' retapamulin kienet superjuri għall-plaċebo għall-iskop finali ta' effikaċja primarja (p=0.0336).
English: MSSA
Maltese: Tqala
English: Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were measurable in 32% (16/50) of samples.
Maltese: Fost it-tfal b'età minn 9 xhur sa sentejn il-konċentrazzjonijiet ta' retapamulin fil-plażma setgħu jitkejlu f'32% (16/50) tal-kampjuni.
English: Carton of 12 sachets.
Maltese: Pakkett ta' 12-il qartas.
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline AB
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).
Maltese: ċi b'età minn sentejn 'l fuq l-esponiment sistemiku għal retapam ulin wara applikazzjoni topika ta' ingwent ta' 10 mg/g kien baxx (kon ċentrazzjoni massima fil -plażma ta' < 20 ng/mL).
English: No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of <2 µg/ml.
Maltese: L-ebda żvilupp ta' reżistenza ma ġie osservat waqt trattament b'retapamulin fil-programm ta' studju kliniku u l-iżolati kliniċi kollha kienu mfixkla minn konċentrazzjonijiet ta' <2µg/ml ta' retapamulin.
English: Application site reactions
Maltese: Reazzjonijiet fis-sit talapplikazzjoni
English: 5.2 Pharmacokinetic properties
Maltese: Kategorija farmakoterapewtika:
English: In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4.
Maltese: Fil-mikrosomi tal-fwied fil-bniedem, retapamulin intwera li huwa impeditur qawwi ta' CYP3A4.
English: In children aged from 2 months to 9 months plasma concentrations of retapamulin were measurable in 69% (20/29) of samples.
Maltese: xhur il-konċentrazzjonijiet ta' retapamulin fil-plażma setgħu jitkejlu f'69% (20/29) tal-kampjuni.
English: Altargo is for adults and children aged nine months and older.
Maltese: Altargo qiegħed għal adulti u tfal ta' 9 xhur jew akbar.
English: A single retapamulin concentration (95.1 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml).
Maltese: 1 ng/ml) qabżet l-ogħla konċentrazzjoni osservata f'pazjenti b'età minn 2 sa 17-il sena (18.5 ng/ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 0.5 g SACHET
Maltese: KARTUNA GĦAL QRATAS TA' 0.5 g
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.
Maltese: Konċentrazzjonijiet ta' retapamulin setgħu jitkejlu f'46% (36/79) tal-kampjuni (firxa 0.52 sa 177.3 ng/ml)
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kaxxa wara ‘EXP'.
English: In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Maltese: Fi studji mifruxa fuq 14-il ġurnata (50, 150 jew 450 mg/kg) dwar tossiċita` orali fi ġrieden kien hemm evidenza ta' tibdiliet adattivi fil-fwied u fit-tirojde.
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):
Maltese: Effetti sekondarji oħra (frekwenza mhux magħrufa, ma tistax tittieħed stima mid-dejta disponibbli):
English: One involves mutations in ribosomal protein L3, the second is a non-specific efflux mechanism (ABC transporter vgaAv).
Maltese: Wieħed jinvolvi tibdil fil-proteina L3 tar-ribosoma, it-tieni huwa mekkaniżmu effluss mhux speċifiku (ABC transporter vgaAv).
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.
Maltese: Il-valur ġeometriku medju Cmax fi plażma wara applikazzjoni fuq 200 ċm2 ta' ġilda mibruxa kien ta' 9.75 ng/ml fl-ewwel ġurnata u 8.79 ng/ml fis-seba'
English: However, see section 4.4 and below regarding clinical efficacy against MRSA.
Maltese: Madankollu, ara sezzjoni 4.4 u hawn taħt dwar effikaċja klinika kontra
English: Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
Maltese: F'adulti ġew osservati esponimenti sistemiċi żgħar ħafna, għalhekk l-esponiment fi trabi mreddgħa aktarx ikun negliġibbli.
English: Carcinogenesis, mutagenesis, reproductive toxicity Long-term studies in animals to evaluate carcinogenic potential have not been conducted with
Maltese: Karċinoġenesi, mutaġenesi, tossiċità riproduttiva
English: Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.
Maltese: Infezzjonijiet li jistgħu jiġu ttrattati jinkludu impetigo (li tikkawża qoxra niexfa fuq partijiet infettati), qtugħ, brix u feriti
English: There was no treatment-related effect on embryofetal development.
Maltese: Ma kien hemm ebda effett relatat mat-trattament fuq l iżvilupp embrijo-fetali.
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.
Maltese: Suxxettibiltà għal pleuromutilins tista' wkoll tiġi affettwata permezz ta' Cfr rRNA methyltransferase, li jagħti cross-resistance għall-phenicols, il-lincosamides u l-istreptogramin A fl-istaphylococci.
English: Each gram of ointment contains 10 milligrams of - The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
Maltese: - Is-sustanzi l-oħra huma paraffin ħafif u abjad u butylated hydroxytoluene (E321), priservattiv.
English: See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Maltese: Ara s-sezzjonijiet 4.4 u 5.1 għal tagħrif importanti dwar l-attivita` klinika ta' retapamulin kontra tipi
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.
Maltese: Għalhekk attenzjoni hija rrakkomandata jekk ingwent ta' 10 mg/g retapamulin jingħata lil tfal f'dan il-grupp ta' età li qed jirċievu wkoll inibituri ta' CYP3A4, għax ma' l-inibizzjoni ta' CYP3A4 jista' jkun hemm żjieda akbar fl-esponiment sistemiku għal retapamulin.
English: Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Maltese: L-ingwent retapamulin fih butylated hydroxytoluene, li jista' jikkawża reazzjoni lokali fil-ġilda (e.g. dermatite mill-kuntatt), jew irritazzjoni fl-għajnejn u fil-membrani mukużi.
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.
Maltese: Kampjuni ttieħdu qabel id-doża minn suġġetti adulti f'jum 3 u 4, u bejn 0-12-il siegħa wara l-aħħar applikazzjoni minn suġġetti pedjatriċi fit-tielet jew ir-raba' jum.
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.
Maltese: Jinbiegħ f'tubu ta' l-aluminju b'tapp tal-plastik, li jkun fih 5 grammi, 10 grammi jew 15-il gramma ingwent, jew f'qartas ta' l-aluminju li jkun fih 0.5g t'ingwent.
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.
Maltese: Fi tfal b'età minn 9 xhur sa sentejn huwa possibbli li xi kultant jista' jkun hemm kon ċentrazzjonijiet ogħla fil-plażma waqt kura b'ingwent ta' 10 mg/g retapamulin meta mqabbla ma' tfal akbar u ma' adulti.
English: The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients
Maltese: 7 ng/ml fl-adulti u 18.5 ng/ml f'pazjenti pedjatriċi (età minn 2 sa 17-il sena).
English: This non-target specific efflux mechanism has also been demonstrated to reduce the in vitro activity of streptogramin A.
Maltese: Dan il-mekkaniżmu effluss mhux speċifiku wera wkoll li jnaqqas l-attivita` in vitro ta' streptogramin A.
English: Pruritus Erythema
Maltese: TAGĦRIF
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.
Maltese: is-sinifikat kliniku tal-iżolati b'MICs ta' retapamulin għoljin m'huwiex magħruf minħabba li jista' jkun hemm konċentrazzjonijiet lokali kbar (20,000 µg/ml) ta' retapamulin fuq il-ġilda.
English: In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
Maltese: F'pazjenti ta' inqas minn 18-il sena is-superfiċje totali m'għandux ikun aktar minn 2% tas-superfiċje totali tal-ġisem.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Maltese: Taħżinx f'temperatura'l fuq minn 25°Ċ.
English: Pathogen
Maltese: Tfal
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.
Maltese: Użu fit-tul u tkabbir eċċessiv ta' mikro-organiżmi mhux suxxettibbli Użu fit-tul ta' retapamulin jista' jirriżulta fi tkabbir e ċċessiv ta' mikro-organiżmi mhux suxxettibbli, inkluż moffa.
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.
Maltese: Billi jeħlu ma' dan is-sit, plewromutilini jimpedixxi ttrasferiment ta' peptidyl, u hekk jimblukkaw parzjalment interazzjonijiet fis-sit P, u ma jħallux ilformazzjoni normali ta' sub-unitajiet attivi tar-ribosoma 50S.
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
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament
English: Skin and subcutaneous tissue disorders
Maltese: Ipersensittivita' li tinkludi anġjoedema
English: $ In vitro, retapamulin was equally active against methicillin-susceptible and methicillin-resistant strains of S. aureus.
Maltese: In vitro, retapamulin kien attiv l-istess kontra razez ta' S. aureus suxxettibbli u reżistenti għal metiċillina.
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.
Maltese: Informazzjoni miġbura tindika li s-sit li jwaħħal jinvolvi proteini L3 tar-ribosoma u li qiegħed fir-reġjun tas sit P tar-ribosoma u ċ-ċentru tal- peptidyl transferase.
English: Retapamulin elimination in humans has not been investigated.
Maltese: L-eliminazzjoni ta' retapamulin mill-bniedem ma ġietx investigata.
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
Maltese: Rispons kliniku meta l-individwi Ġew Segwiti (jum 12-14), permezz ta' popolazzjoni ta' Analiżi
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
Maltese: Fi studju dwar embrijotossiċita` fil-ġrieden, tossiċita` ta' l-iżvilupp (tnaqqis fil-pis tal-fetu u dewmien fl ossifikazzjoni skeltrali) ġiet osservata b'dożi orali ta' ≥ 150 mg/kg/kuljum li jikkorrispondu għal ≥ 3 darbiet aktar mill-ogħla esponiment stmat tal-bniedem (ara hawn fuq).
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.
Maltese: Retapamulin selettivament jimpedixxi is-sinteżi tal-proteini batteriċi billi jaħdem f'sit uniku fis-subunita` 50S tar-ribosoma batterika li hija distinta mis-siti li jwaħħlu ta' aġenti oħra antibatteriċi mhux plewromutilini
English: Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects with S. aureus and S. pyogenes
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni
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.
Maltese: MRSA f'SIOW mhijiex ċara u setgħet ġiet influwenzata millpreżenza ta' klonu partikolari ta' MRSA.