FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma protein binding of dalbavancin is 93 % and is not altered as a function of drug concentration, renal insufficiency, or hepatic insufficiency.
Maltese: It-twaħħil ta' dalbavancin mal-proteina fil-plażma huwa 93 % u ma jinbidilx bħala funzjoni tal-konċentrazzjoni tal-mediċina, insuffiċjenza renali, jew insuffiċjenza epatika.
English: In vivo PK/PD relationship of dalbavancin for S. aureus was investigated using a neutropenic model of animal infection that showed that net reduction in the log10 of colony-forming units (CFU) was greatest when larger doses were given less frequently.
Maltese: Ir-relazzjoni PK/PD in vivo ta' dalbavancin għal S. aureus ġiet investigata permezz ta' mudell newtropeniku ta' infezzjoni tal-annimali li wera li t-tnaqqis nett fil-log10 ta' unitajiet li jiffurmaw il-kolonji (CFUcolony-forming unit) kien l-akbar meta dożi akbar ingħataw b'mod inqas frekwenti.
English: The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati fil-provi kliniċi ta' Fażi 2/3 b'dalbavancin.
English: In Phase 2 / 3 clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg.
Maltese: Fi studji kliniċi ta' Fażi 2 / 3, 2,473 pazjent irċivew dalbavancin mogħti bħala infużjoni waħda ta' 1500 mg jew ta' 1000 mg segwita ġimgħa wara minn 500 mg.
English: Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Maltese: Żieda fl-esponiment għal substrati tat-trasportaturi li huma sensittivi għall-attività tat-trasportaturi inibita, bħal statins u digoxin, ma jistax tiġi eskluża jekk ikunu kombinati ma' dalbavancin.
English: The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, dose adjustment is not necessary based on age (see section 4.2).
Maltese: Il-farmakokinetika ta' dalbavancin ma nbidlitx b'mod sinifikanti mal-età; għalhekk, aġġustament fiddoża mhuwiex meħtieġ ibbażat fuq l-età (ara sezzjoni 4.2).
English: A total of 10 paediatric patients with ages 12 to 16 years who had resolving infections were given single doses of either dalbavancin 1,000 mg (body weight ≥ 60 kg) or dalbavancin 15 mg/kg (body weight < 60 kg).
Maltese: Total ta' 10 pazjenti pedjatriċi li kellhom minn 12 sa 16-il sena li kellhom infezzjonijiet li kienu qed ifiequ, ingħataw dożi waħidhom ta' dalbavancin 1000 mg (piż tal-ġisem ≥ 60 kg) jew dalbavancin
English: Potential for dalbavancin to affect the pharmacokinetics of other medicinal products.
Maltese: Potenzjal għal dalbavancin li jaffettwa l-farmakokinetika ta' prodotti mediċinali oħra.
English: Thus, the distributional half-life (t1/2β), which constitutes most of the clinically-relevant concentration-time profile, ranged from 5 to 7 days and is consistent with once-weekly dosing.
Maltese: (t1/2β), li tikkostitwixxi l-biċċa l-kbira tal-profil konċentrazzjoni-ħin klinikament rilevanti, varjat minn 5 sa 7 ijiem u hija konsistenti mad-dożaġġ ta' darba fil-ġimgħa.
English: No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A).
Maltese: L-ebda aġġustament fid-doża ta' dalbavancin mhuwa rakkomandat għal pazjenti b'indeboliment epatiku ħafif (Child-Pugh A).
English: Susceptibility testing breakpoints
Maltese: Breakpoints ta' ttestjar dwar is-suxxettibilità
English: The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
Maltese: 50 mg/ml (5 %) ta' glucose.
English: Xydalba will be given to you by a doctor or nurse.
Maltese: Xydalba se jingħatalek minn tabib jew infermier/a.
English: Dose adjustments are not required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 to 79 ml/min).
Maltese: Aġġustamenti fid-doża mhumiex meħtieġa għal pazjenti b'indeboliment renali ħafif jew moderat (tneħħija tal-kreatinina ≥ 30 sa 79 ml/min).
English: Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Maltese: Kull kunjett bit-trab fih dalbavancin hydrochloride ekwivalenti għal 500 mg ta' dalbavancin.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for ABSSSI that were susceptible to dalbavancin in vitro:
Maltese: L-effikaċja ntweriet fi studji kliniċi kontra l-patoġeni elenkati għal ABSSSI li kienu suxxettibbli għal dalbavancin in vitro:
English: The metabolic pathways responsible for producing these metabolites have not been identified; however, due to the relatively minor contribution of metabolism to the overall elimination of dalbavancin, drug-drug interactions via inhibition or induction of metabolism of dalbavancin are not anticipated.
Maltese: minħabba l-kontribut relattivament minuri tal-metaboliżmu għall-eliminazzjoni ġenerali ta' dalbavancin, interazzjonijiet bejn mediċina u oħra permezz ta' inibizzjoni jew induzzjoni tal metaboliżmu ta' dalbavancin, mhumiex antiċipati.
English: Angelini Pharma Magyarország Kft Dayka Gábor u. 3., 214-215. számú iroda H-1118 Budapest
Maltese: Angelini Pharma Magyarország Kft Dayka Gábor u.
English: In Phase 3 studies, patients have been administered single doses of up to 1,500 mg.
Maltese: Fi studji ta' Fażi 3, il-pazjenti ngħataw dożi singoli sa 1500 mg.
English: Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Maltese: Xydalba 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni dalbavancin
English: ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ
Maltese: ΠΑΡΑΓΩΓΗΣ &
English: Dalbavancin was not mutagenic or clastogenic in a battery of in vitro and in vivo genotoxicity tests.
Maltese: Dalbavancin ma kienx mutaġeniku jew klastoġeniku f'sensiela ta' testijiet ġenotossiċi in vitro u in vivo.
English: Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk.
Maltese: Reazzjonijiet avversi tal-klassi Ototossiċità ġiet assoċjata mal-użu ta' glikopeptidi (vancomycin u teicoplanin); pazjenti li jkunu qed jirċievu terapija konkomitanti ma' prodott mediċinal ototossika, bħal aminoglycoside, jistgħu jkunu f'riskju akbar.
English: All Gram-negative bacteria are inherently resistant to dalbavancin.
Maltese: Mekkaniżmu ta' reżistenza Il-batterji Gram negattivi kollha huma intrinsikament reżistenti għal dalbavancin.
English: These may be signs of an infection of the bowel.
Maltese: Dawn jistgħu jkunu sinjali ta' infezzjoni tal-imsaren.
English: The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Maltese: Il-kompatibilità tal-konċentrat rikostitwit ta' Xydalba kienet stabbilita biss ma' soluzzjoni għall-infużjoni ta' 50 mg/ml (5 %) ta' glucose.
English: In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1).
Maltese: F'infezzjonijiet imħallta li fihom batterji Gram negattivi huma ssuspettati, il-pazjenti għandhom jiġu ttrattati wkoll b'sustanza(i) antibatterjali xierqa kontra l-batterji Gram negattivi (ara sezzjoni 5.1).
English: Common - may affect up to 1 in 10 people: Headache
Maltese: Komuni - jistgħu jaffettwaw sa 1 minn 10 persuni:
English: Rash
Maltese: Rimi
English: For dosing instructions in subjects with renal impairment refer to section 4.2.
Maltese: Għal istruzzjonijiet dwar id-dożaġġ f'individwi b'indeboliment renali irreferi għal sezzjoni 4.2.
English: General disorders and administration site conditions infusion-related reactions
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata reazzjonijiet relatati mal-infużjoni
English: Clinical drug-drug interaction studies with dalbavancin have not been conducted.
Maltese: Studji kliniċi dwar interazzjonijiet bejn mediċina u oħra b'dalbavancin ma sarux.
English: In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Maltese: Fil-provi maġġuri ta' ABSSSI, it-tipi ta' infezzjonijiet ittrattati kienu ristretti għal ċellulite/erysipelas, axxessi u infezzjonijiet tal-feriti biss.
English: Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion.
Maltese: Xydalba kienet stabbilita biss ma' soluzzjoni għall-infużjoni ta' 50 mg/ml (5 %) ta' glucose.
English: Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions.
Maltese: Xydalba għandu jingħata permezz ta' infużjoni ġol-vini, bl-użu ta' ħin totali ta' 30 minuta ta' infużjoni biex jiġi mminimizzat ir-riskju ta' reazzjonijiet relatati mal-infużjoni.
English: Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin.
Maltese: Dalbavancin ma jiġix metabolizzat mill-enzimi ta' CYP in vitro, u għalhekk, indutturi jew inibituri ta' CYP mogħtija miegħu mhumiex probabbli li jinfluwenzaw il-farmakokinetika ta' dalbavancin.
English: Sími: +41 848 00 79 70 medinfo@correvio.com
Maltese: +41 848 00 79 70 medinfo@correvio.com
English: • Cough
Maltese: • Sturdament
English: Cross-resistance between dalbavancin and other classes of antibiotics was not seen in in vitro studies.
Maltese: Reżistenza inkroċjata bejn dalbavancin u klassijiet oħrajn ta' antibijotiċi ma dehritx fl-istudji in vitro.
English: Genital itching (females)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Nervous system disorders headache dysgeusia, dizziness
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras tibdil fis-sens tat-togħma, sturdament
English: Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis
Maltese: Infezzjonijiet u infestazzjonijiet infezzjoni mikotika vulvovaġinali, infezzjoni fil-passaġġ urinarju, infezzjoni fungali, kolite kkawżata mnn
English: Hydroxy-dalbavancin and mannosyl aglycone show significantly less antibacterial activity compared to dalbavancin.
Maltese: Hydroxy-dalbavancin u mannosyl aglycone juru inqas attività antibatterjali b'mod sinifikanti meta mqabbla ma' dalbavancin.
English: Bactericidal activity against staphylococci in vitro is time-dependent at serum concentrations of dalbavancin similar to those obtained at the recommended dose in humans.
Maltese: L-attività batteriċidjali kontra stafilokokki in vitro hija dipendenti fuq il-ħin f'konċentrazzjonijiet ta' dalbavancin fis-serum simili għal dawk miksuba bid-doża rakkomandata fil-bnedmin.
English: Elderly
Maltese: Angelini
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash
Maltese: • Sogħla • Uġigħ ta' żaqq u skonfort, indiġestjoni, stitikezza
English: Other medicines and Xydalba
Maltese: Kif taħżen Xydalba
English: The marketing authorisation holder (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 updates of the RMP.
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 sussegwenti maqbul tal-RMP.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Each pack contains 1 vial.
Maltese: Kull pakkett fih kunjett wieħed.
English: Tél/Tel: +32 (0)28 08 86 20 medinfo@correvio.com
Maltese: +32 (0)28 08 86 20 medinfo@correvio.com
English: In Phase 1 studies, healthy volunteers have been administered single doses of up to 1,500 mg, and cumulative doses up to 4,500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
Maltese: Fi studji ta' Fażi 1, voluntiera f'saħħithom ingħataw dożi waħidhom ta' sa 1500 mg fuq perjodu ta' sa 8 ġimgħat, bla ebda sinjali ta' tossiċità jew riżultati tal-laboratorju li kkawżaw tħassib kliniku.
English: Date of first authorisation: 19 February 2015 Date of latest authorisation:
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Frar 2015
English: How to store Xydalba
Maltese: X'fih Xydalba
English: If you suffer from chronic kidney problems, your doctor may decide to reduce your dose.
Maltese: Jekk tbati minn problemi kroniċi tal-kliewi, it-tabib tiegħek jista' jiddeċiedi li jnaqqaslek id-doża.
English: The mean AUC for subjects with creatinine clearance < 30 ml/min was approximately 2 - fold higher.
Maltese: medju għal individwi bi tneħħija tal-kreatinina ta' < 30 ml/min kien madwar darbtejn ogħla.
English: constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting
Maltese: Disturbi gastro-intestinali tqalligħ, dijarea stitikezza, uġigħ addominali, dispepsja,
English: Dalbavancin MICs are higher for vancomycin-intermediate staphylococci (VISA) than for fully vancomycin susceptible strains.
Maltese: L-MICs ta' dalbavancin huma ogħla għal staphylococci li huma intermedji għal vancomycin (VISAvancomycin-intermediate staphylococci) milli għal razez kompletament suxxettibbli għal vancomycin.
English: Package leaflet: Information for the patient Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Maltese: Informazzjoni għall-pazjent Xydalba 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni dalbavancin
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Maltese: L-użu ta' antibijotiċi jista' jiffavorixxi t-tkabbir żejjed ta' mikroorganiżmi li ma jkunux suxxettibli.
English: Studies in animals have shown reduced fertility (see section 5.3).
Maltese: Fertilità Studji fl-annimali wrew fertilità mnaqqsa (ara sezzjoni 5.3). Ir-riskju potenzjali għall-bnedmin mhuwiex magħruf.
English: The volume of distribution at steady state was similar to the volume of extracellular fluid.
Maltese: Il-volum tad distribuzzjoni fl-istat fiss kien simili għall-volum ta' fluwidu ekstraċellulari.
English: • Abnormal liver function test
Maltese: • Bidliet f'testijiet tad-demm oħra
English: Reproductive toxicity studies in rats and rabbits showed no evidence of a teratogenic effect.
Maltese: Studji dwar it-tossiċità riproduttiva fil-firien u l-fniek ma wrew ebda evidenza ta' effett teratoġeniku.
English: After reconstitution each ml contains 20 mg dalbavancin.
Maltese: Wara r-rikostituzzjoni kull ml fih 20 mg ta' dalbavancin.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: il-kundizzjonijiet u l-ħinijiet tal-ħażna waqt u qabel l-użu huma r-responsabbiltà ta' min ikun qed jużah u normalment ma jkunux aktar minn 24 siegħa f'temperatura bejn 2°C sa 8°C, ħlief jekk irrikostituzzjoni/dilwizzjoni ikunu saru f'kundizzjonjiet asettiċi kkontrollati u vvalidati.
English: In dogs only, infusion reactions characterised by skin swelling and/or redness (not associated with the injection site), mucosal pallor, salivation, vomiting, sedation, and modest declines in blood pressure and increases in heart rate were observed in a dose-dependent manner.
Maltese: Fil-klieb biss, reazzjonijiet għall-infużjoni kkaratterizzati minn nefħa u/jew ħmura tal-ġilda (mhux assoċjat mas-sit tal-injezzjoni), sfurija mukożali, salivazzjoni, rimettar, sedazzjoni, u tnaqqis modest fil-pressjoni tad-demm u żidiet fir-rata tal-qalb, kienu osservati b'mod dipendenti mid doża.
English: • Abdominal pain (stomach ache) and/or watery diarrhoea.
Maltese: • Diffikultà biex tieħu n-nifs (bronkospażmu)
English: Xydalba 500 mg powder for concentrate for solution for infusion
Maltese: Xydalba 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Other side effects reported with Xydalba are listed below.
Maltese: Effetti sekondarji oħra li ġew irrappurtati b'Xydalba huma elenkati hawn taħt.
English: and Enterococcus spp.
Maltese: u Enterococcus spp. hija medjata minn VanA,
English: • Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing.
Maltese: • Nefħa f'daqqa ta' xufftejk, wiċċek, gerżuma jew ilsien; raxx sever; ħakk; tagħfis fil gerżuma; tnaqqis fil-pressjoni tad-demm; diffikultà biex tibla u/jew diffikultà biex tieħu n-nifs.
English: Respiratory, thoracic and mediastinal disorders cough bronchospasm
Maltese: toraċiċi u medjastinali sogħla bronkospażmu
English: Estimated pharmacokinetic parameters of dalbavancin following the two-dose regimen and the single-dose regimen, respectively, are shown in Table 2 below.
Maltese: Il-parametri farmakokinetiċi stmati ta' dalbavancin wara l-kors ta' żewġ dożi u l-kors ta' doża waħda, rispettivament, qed jintwerew f'Tabella 2 hawn taħt.
English: What Xydalba looks like and contents of the pack
Maltese: Id-dehra ta' Xydalba u l-kontenut tal-pakkett
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: In rats, at exposures approximately 3 times above clinical exposure, there was reduced fertility and an increased incidence of embryo-lethality, reductions in foetal weight and skeletal ossification and increased neonatal mortality.
Maltese: Fil-firien, f'esponimenti ta' madwar 3 darbiet ogħla mill-esponiment kliniku, kien hemm tnaqqis filfertilità u żieda fl-inċidenza ta' embrijoletalità, tnaqqis fil-piż tal-feti u ossifikazzjoni skeletrika u żieda fil-mortalità tal-frieħ li kienu għadhom kemm twieldu.
English: The pharmacokinetics of dalbavancin have been characterised in healthy subjects, patients, and special populations.
Maltese: Il-farmakokinetika ta' dalbavancin kienet ikkaratterizzata f'individwi f'saħħithom, pazjenti, u popolazzjonijiet speċjali.
English: Based on in vitro studies the activity of dalbavancin is not affected by other classes of vancomycin resistance genes.
Maltese: Ibbażat fuq studji in vitro, l-attività ta' dalbavancin ma tiġix affettwat minn klassijiet oħrajn ta' ġeni reżistenti għal vancomycin.
English: Lorenzo Pharma OÜ
Maltese: lewkopenija, newtropenija
English: • Inflammation and swelling of surface veins, flushing
Maltese: • Infezzjonijiet vaġinali, infezzjonijiet fungali, infezzjoni fungali fil-ħalq
English: EXP
Maltese: L-AUC
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8).
Maltese: Għalhekk, huwa importanti li wieħed jikkunsidra din id-dijanjosi f'pazjenti li jkollhom dijarea waqt jew wara l-kura b'dalbavancin (ara sezzjoni 4.8).
English: Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Riżultati minn studju in vitro ta' screening tar-riċettur ma jindikawx interazzjoni probabbli ma' miri terapewtiċi oħra jew potenzjal ta' interazzjonijiet farmakodinamiċi klinikament rilevanti
English: Approximately 20 % of the administered dose was excreted in faeces.
Maltese: Madwar 20 % tad-doża mogħtija ġiet eliminata fl-ippurgar.
English: Methicillin resistance has no impact on dalbavancin activity.
Maltese: Reżistenza għal methicillin m'għandha l-ebda impatt fuq l-attività ta' dalbavancin.
English: The clinical significance of the decrease in mean plasma CLT, and the associated increase in AUC0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with severe renal impairment has not been established.
Maltese: Billi tirrapporta l effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din ilmediċina.
English: Dalbavancin Plasma Concentrations versus time in a typical ABSSSI patient (simulation using population pharmacokinetic model) for both the single and the two-dose regimens.
Maltese: Il-Konċentrazzjonijiet ta' Dalbavancin fil-Plażma kontra ż-żmien f'pazjent tipiku b'ABSSSI (simulazzjoni li tuża mudell farmakokinetiku tal-popolazzjoni) kemm għall-kors ta' doża waħda kif ukoll għall-kors ta' żewġ dożi.
English: • If you have or have had kidney problems.
Maltese: • Jekk għandek jew kellek problemi fil-kliewi.
English: Subgroups:
Maltese: Sottogruppi:
English: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy /
Maltese: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy / Alemanha / Nemčija / Nemecko,
English: Date of latest renewal: 21 November 2016
Maltese: Data tal-aħħar tiġdid: 21 ta' Novembru 2016
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/740/001
Maltese: EU/1/11/740/001
English: Email: ameluz@biofrontera.com
Maltese: E-mail: ameluz@biofrontera.com
English: Moderate/ severe
Maltese: Moderata/severa
English: See also section 6.6.
Maltese: Ara wkoll sezzjoni 6.6.
English: Sodium benzoate (E211) Purified water
Maltese: Sodium benzoate (E211) Ilma ppurifikat
English: • Porphyria.
Maltese: • Porfirja.
English: Tube
Maltese: TUBU
English: N MAL Mean + SD (%)
Maltese: N MAL Medja + SD (%)
English: 51377 Leverkusen Germany
Maltese: 51377 Leverkusen
English: Actinic keratosis lesion severity was graded according to the scale described by Olsen et al., 1991 (J Am Acad Dermatol 1991; 24: 738-743):
Maltese: Is-severità tal-leżjoni b'keratosi aktinika kienet iggradata skont l-iskala deskritta minn Olsen et al., 1991 (J Am Acad Dermatol 1991; 24: 738-743):
English: Clinical description of severity grading
Maltese: Deskrizzjoni klinika tal-gradazzjoni tas-severità
English: Lower 97.5% Confidence Limit
Maltese: Limitu ta' Kunfidenza talInqas 97.5%
English: Do not use Ameluz:
Maltese: Tużax Ameluz:
English: Number of treatments
Maltese: Numru ta' trattamenti
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku.
English: Alemanha / Nemčija / Nemecko, Tél / Tel: / Teл.
Maltese: Tél / Tel: / Teл.
English: Ameluz (78.2%) was significantly more effective than MAL (64.2%, [97.5%- confidence interval: 5.9; ∞]) and placebo (17.1%, [95%confidence interval: 51.2; 71.0]).
Maltese: Ameluz (78.2%) kien ferm aktar effettiv meta mqabbel mal-MAL (64.2%, [97.5%-intervall ta' fiduċja: 5.9; ∞]) u plaċebo (17.1%, [95%-intervall ta' fiduċja: 51.2; 71.0]).
English: One gram gel contains 2.4 mg sodium benzoate (E211), 3 mg soybean phosphatidylcholine, and 10 mg propylene glycol.
Maltese: Gramma ġel fiha 2.4 mg sodium benzoate (E211), 3 mg soybean phosphatidylcholine, u 10 mg propylene glycol.
English: 2 g gel
Maltese: 2 g ġel
English: • temporary memory loss1
Maltese: • telf temporanju tal-memorja1
English: Ameluz 78 mg/g gel 5-aminolaevulinic acid
Maltese: Ameluz 78 mg/g ġel 5-aminolaevulinic acid