FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria
Maltese: VETERINARJU Methoxasol-T soluzjoni orali għall-ħnieżer u brojlerijiet Trimethoprim and sulfamethoxazole.
English: As to where Methoxasol-T is also authorised in Austria, Poland, Hungary, and Lithuania, these marketing authorisations have been included in the scope of the procedure.
Maltese: Għal imkejjen fejn Methoxasol-T huwa awtorizzat ukoll fl-Awstrija, il-Polonja, l-Ungerija, u l-Litwanja, dawn lawtorizzazzjonijiet għat-tqegħid fis-suq ġew inklużi fl-iskop tal-proċedura.
English: Pigs: Treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Maltese: Trattament u prevenzjoni ta' infezzjonijiet respiratorji kkawżati minn Actinobacillus pleuropneumoniae suxxettibbli għat-trimethoprim u s-sulfamethoxazole fejn il-marda instabet filmerħla.
English: To provide the dossier submitted upon application for a marketing authorisation, for each Member State mentioned above (including Germany) and, if applicable, for any other Member State or country of the European Economic Area (EEA): a. Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; b. Part IV Preclinical and clinical information.
Maltese: Parti I Sommarju tad-dossier, inkluż is-Sommarju tal-Karatteristiċi tal-Prodott, ir-rapporti ta' l esperti u l-kompożizzjoni kwantitattiva u kwalitattiva tal-prodott;
English: Methoxasol-T is intended for oral administration with drinking water: Pigs: 25 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 500 L drinking water, for 3-4 days.
Maltese: Il-ħnieżer: 25 mg/kg toqol tal-ġisem, li jikkorrispondi għal bejn wieħed u ieħor 1 litru tad-droga f'500 L ta' ilma tax-xorb, għal 3-4 ijiem.
English: No statistical approach was followed because both TMP and SMX concentrations in muscle, liver, kidney and fat + skin were below limit of quantification at the first sampling point 2 days after cessation of Methoxasol- T medication.
Maltese: L-ebda avviċinament statistiku ma kien segwit peress li kemm konċentrazzjonijiet ta' TMP u ta' SMX filmuskolu, fwied, kilwa u xaħam + ġilda ma kienu taħt limitu ta' kwantifikazzjoni fil-punt ta' l-ewwel teħid ta' kampjuni jumejn wara t-twaqqif ta' medikazzjoni Methoxasol- T. Għalhekk jidher li 5 ijiem huma aċċettabbli għal ħnieżer.
English: IMMEDIATE PACKAGING
Maltese: DAQS TAL-PAKKETT
English: To justify compliance of the dossier, as it exists in each Member State or EEA country, with respect to the requirements of Annex I of Directive 2001/82/EC, as amended.
Maltese: Biex jiġġustifika l-konformità tad-dossier, kif jeżisti f'kull Stat Membru jew pajjiż taż-ŻEE, firrigward tal-ħtiġijiet ta' l-Anness I tad-Direttiva 2001/82/KE, kif emendata.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concludes that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to the recommended changes to Summary of the Product Characteristics and product information.
Maltese: Għaldaqstant, l-użu tal-prodott għandu jkun ibbażat fuq kultura u sensittività ta' mikro-organiżmi minn każijiet morda fir-razzett jew minn esperjenza ta' qabel, riċenti fir-razzett.
English: • the conditions of use as proposed in the SPC preclude use in laying birds and restrict use of the product based on culture and sensitivity testing of micro-organisms from diseased farms.
Maltese: • il-kundizzjonijiet ta' l-użu kif proposti fl-SPC jipprekludu użu f'għasafar li jbidu u jillimitaw lużu tal-prodott abbażi ta' l-ittestjar ta' kultura u sensittività ta' mikro-organiżmi minn irziezet morda.
English: As for The Netherlands
Maltese: Bħal ta' l-Olanda
English: Content Pack size
Maltese: 1 pinna mimlija għal-lest
English: Route of administration
Maltese: għal-lest
English: 1 Source: DAL-MS-01.
Maltese: 1 Sors: DAL-MS-01.
English: ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ Aχαίας 4 & Τροιζηνίας GR-14564 Νέα Κηφισιά
Maltese: ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ Aχαίας 4 & Τροιζηνίας GR-14564 Νέα Κηφισιά
English: Co. Louth, A91 P9KD, Ireland
Maltese: Louth, A91 P9KD, L-Irlanda
English: Tabulated list of adverse reactions (Table 1)
Maltese: Lista tabulata ta' reazzjonijiet avversi (Tabella 1)
English: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Maltese: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, L-Irlanda
English: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Maltese: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA
English: Angelini S.p.A Viale Amelia 70
Maltese: S.p.A Viale Amelia 70
English: Day 1: 411 (86)
Maltese: Jum 1: 411 (86)
English: Day 1: 281 (52)
Maltese: Jum 1: 281 (52)
English: Day 8: 141 (26)
Maltese: Jum 8: 141 (26)
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk,
Maltese: Almac Pharma Services (L-Irlanda) Limited Finnabair Industrial Estate, Dundalk,
English: AUC0-Day14
Maltese: AUC0-Jum14
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S.
Maltese: • Il-grupp ta' Streptococcus anginosus (li jinkludi S. anginosus, S. intermedius, u S.
English: • The active substance is dalbavancin.
Maltese: • Is-sustanza attiva hi dalbavancin.
English: Patients up to 93 years of age have been included in clinical studies.
Maltese: Pazjenti sa 93 sena ġew inklużi fl-istudji kliniċi.
English: In in vitro studies, no antagonism has been observed between dalbavancin and other commonly used antibiotics (i.e. cefepime, ceftazidime, ceftriaxone, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam and trimethoprim/sulfamethoxazole), when tested against 12 species of Gram-negative pathogens (see section 4.5).
Maltese: Fi studji in vitro, l-ebda antagoniżmu ma ġie osservat bejn dalbavancin u antibijotiċi oħra użati komunement (i.e. cefepime, ceftazidime, ceftriaxone, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam u trimethoprim/sulfamethoxazole), meta ġie ttestjat kontra 12il speċi ta' patoġeni Gram negattivi (ara sezzjoni 4.5).
English: The mean terminal elimination half-life (t1/2) was 372 (range 333 to 405) hours.
Maltese: Il medja tal-half-life tal-eliminazzjoni terminali (t1/2) kienet 372 (medda 333 sa 405) sigħat.
English: : Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
Maltese: Suxxettibbli ≤ 0.125 mg/l; Reżistenti > 0.125 mg/l,
English: Antibacterial activity against other relevant pathogens
Maltese: Attività antibatterjali kontra patoġeni rilevanti oħra
English: Koprska ulica 108 A SI-1000 Ljubljana Tel: +386 1 544 65 79 info@angelini.si
Maltese: Angelini Pharma d.o.o. Koprska ulica 108 A SI-1000 Ljubljana Tel: +386 1 544 65 79 info@angelini.si
English: • Beta-haemolytic streptococci of Groups A, B, C, G: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
Maltese: • Streptokokki betaemolitiċi ta' Gruppi A, B, Ċ, G: Suxxettibbli ≤ 0.125 mg/l; Reżistenti > 0.125 mg/l,
English: Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Maltese: Xydalba hu indikat għall-kura ta' infezzjonijiet batterjali akuti tal-ġilda u infezzjonijiet fl-istruttura talġilda (ABSSSI - acute bacterial skin and skin structure infections) fl-adulti (ara sezzjonijiet 4.4 u 5.1).
English: Psychiatric disorders insomnia
Maltese: Disturbi psikjatriċi insomnja
English: The metabolites hydroxy-dalbavancin and mannosyl aglycone have been detected in urine (< 25 % of administered dose).
Maltese: Il-metaboliti hydroxydalbavancin u mannosyl aglycone ġew osservati fl-awrina (< 25 % tad-doża mogħtija).
English: • Viridans group streptococci (Streptococcus anginosus group only): Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l.
Maltese: • Grupp viridans ta' streptokokki (grupp ta' Streptococcus anginosus biss): Suxxettibbli ≤ 0.125 mg/l; Reżistenti > 0.125 mg/l.
English: Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Maltese: verapamil, quinidine, itraconazole, clarithromycin u cyclosporine.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Maltese: Ilkategoriji ta' frekwenza huma derivati skont il-konvenzjonijiet li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000).
English: Angelini Pharmaceuticals România SRL Str. Dr. Carol Davila, Nr. 9, Sector 5
Maltese: Dr. Carol Davila, Nr. 9, Sector 5
English: Systemic exposures to dalbavancin are dose proportional following single doses over a range of 140 to 1120 mg, indicating linear pharmacokinetics of dalbavancin.
Maltese: Esponimenti sistemiċi għal dalbavancin huma proporzjonali għad-doża wara dożi waħidhom fuq medda ta' 140 sa 1120 mg, li tindika farmakokinetika lineari ta' dalbavancin.
English: Following a single dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11 %, 35 %, and 47 % in subjects with mild (CLCR 50 - 79 ml/min), moderate (CLCR 30 - 49 ml/min), and severe (CLCR < 30 ml/min) renal impairment, respectively, compared to subjects with normal renal function.
Maltese: Wara doża waħda ta' 500 mg jew 1000 mg ta' dalbavancin, it-tneħħija medja mill-plażma (CLT) tnaqqset bi 11 %, 35 %, u 47 % f'individwi b'indeboliment renali ħafif (CLCR 50 - 79 ml/min), moderat (CLCR 30 - 49 ml/min), u sever (CLCR < 30 ml/min), rispettivament, meta mqabbla ma' individwi b'funzjoni renali normali.
English: Mean (SD) dalbavancin pharmacokinetic parameters using population PK analysis1 Parameter
Maltese: Medja (SD) tal-parametri farmakokinetiċi ta' dalbavancin bl-użu ta' analiżi PK tal-popolazzjoni1
English: • The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only).
Maltese: • Is-sustanzi l-oħra huma mannitol (E421), lactose monohydrate, hydrochloric acid u/jew sodium hydroxide (għal aġġustament tal-pH biss).
English: 2 1,000 mg on Day 1 + 500 mg on Day 8; Study DUR001-303 subjects with evaluable PK sample.
Maltese: 2 1000 mg f'Jum 1 + 500 mg f'Jum 8; Studju DUR001-303 individwi b'kampjun PK li jista' jiġi evalwat.
English: Resistance to dalbavancin in Staphylococcus spp.
Maltese: Ir-reżistenza għal dalbavancin fi Staphylococcus spp.
English: Apparent terminal t½ was similar for dalbavancin doses of 1,000 mg and 15 mg/kg, with mean values of 227 and 202 hours, respectively.
Maltese: It-t½ terminali apparenti kienet simili għal dożi ta' dalbavancin ta' 1000 mg u 15 mg/kg, b'valuri medji ta' 227 u 202 sigħat, rispettivament.
English: Clostridioides (formerly Clostridium) difficile-associated diarrhoea
Maltese: Clostridioides (qabel kien Clostridium) difficile, kandidjasi orali
English: Vascular disorders flushing, phlebitis
Maltese: Disturbi vaskulari fwawar, flebite
English: The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function.
Maltese: Il-farmakokinetika ta' dalbavancin ġiet evalwata fi 28 individwu bi gradi varji ta' indeboliment renali u fi 15-il individwu tal-kontroll imqabbla b'funzjoni renali normali.
English: Mean plasma exposures for dalbavancin, based on AUCinf (17,495 µg•h/ml and 16,248 µg •h/ml) and Cmax (212 µg/ml and 191 µg/ml) were similar when administered as 1,000 mg to paediatric subjects (12-16 years) weighing > 60 kg (61.9 - 105.2 kg) or as 15 mg/kg to paediatric subjects weighing < 60 kg (47.9-58.9 kg).
Maltese: Il-medja tal-esponimenti tal-plażma għal dalbavancin, ibbażata fuq AUCinf (17,495 µg•h/ml u 16,248 µg•h/ml) u Cmax (212 µg/ml u 191 µg/ml) kienu simili meta mogħti bħala 1000 mg lil individwi pedjatriċi (12-16-il sena) li jiżnu > 60 kg (61.9 - 105.
English: Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA04.
Maltese: Kategorija farmakoterapewtika: antibatterjali għal użu sistemiku, antibatterjali glikopeptidi, Kodiċi ATC:
English: Dalbavancin is a bactericidal lipoglycopeptide.
Maltese: Mekkaniżmu ta' azzjoni Dalbavancin huwa lipoglycopeptide batteriċida.
English: Adverse reactions are classified according to System Organ Class and frequency.
Maltese: Ir reazzjonijiet avversi huma kklassifikati skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza.
English: Blood and lymphatic system disorders anaemia, thrombocytosis, eosinophilia, leucopenia, neutropenia
Maltese: Disturbi tad-demm u tassistema limfatika anemija, tromboċitożi, eosinofilija,
English: LV-1010 Riga Tel: + 371 6721 1124
Maltese: Riga Tel: + 371 6721 1124
English: Dalbavancin toxicity profile in juvenile rats was consistent with that previously observed in adult rats at the same dose (mg/kg /day) levels.
Maltese: Il-profil ta' tossiċità ta' dalbavancin f'firien ġuvenili kien konsistenti ma' dak osservat preċedentement f'firien adulti fl-istess livelli ta' doża (mg/kg /jum).
English: Angelini Farmacèutica S.A. C. Osi, 7
Maltese: Angelini Farmacèutica S.A. C.
English: Following administration of a single 1,000 mg dose in healthy subjects, an average of 19 % to 33 % of the administered dalbavancin dose was excreted in urine as dalbavancin and 8 % to 12 % as the metabolite hydroxy-dalbavancin.
Maltese: Eliminazzjoni Wara l-għoti ta' doża waħda ta' 1000 mg f'individwi f'saħħithom, medja ta' 19 % sa 33 % tad-doża mogħtija ta' dalbavancin ġiet eliminata fl-awrina bħala dalbavancin, u 8 % sa 12 % bħala l-metabolit hydroxy-dalbavancin.
English: 3 1,500 mg; Study DUR001-303 subjects with evaluable PK sample.
Maltese: 3 1500 mg; Studju DUR001-303 individwi b'kampjun PK li jista' jiġi evalwat.
English: Xydalba contains sodium
Maltese: Xydalba fih is-sodium
English: This has been reported as a side effect with a similar medicine.
Maltese: Dan ġie rrappurtat bħala effett sekondarju b'mediċina simili.
English: The pharmacokinetics of dalbavancin were evaluated in 17 subjects with mild, moderate, or severe hepatic impairment and compared to 9 matched healthy subjects with normal hepatic function.
Maltese: Il-farmakokinetika ta' dalbavancin ġiet evalwata fi 17-il individwu b'indeboliment epatiku ħafif, moderat jew sever u pparagunata ma' 9 individwi mqabbla b'funzjoni epatika normali.
English: For example: 25 ml of the concentrate contains 500 mg dalbavancin.
Maltese: Pereżempju: 25 ml tal konċentrat fih 500 mg ta' dalbavancin.
English: • Staphylococcus spp.
Maltese: • Staphylococcius spp.:
English: • Group G streptococci
Maltese: • Grupp ta' G streptokokki
English: Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.
Maltese: Xydalba fih is-sustanza attiva dalbavancin, li hija antibijotiku tal-grupp glikopeptid.
English: Sodium hydroxide and/or hydrochloric acid (for pH adjustment)
Maltese: Sodium hydroxide u/jew hydrochloric acid (għal aġġustament tal-pH)
English: The reconstitution time may be up to 5 minutes.
Maltese: Il-ħin tar rikostituzzjoni jista' jkun sa 5 minuti.
English: The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li seħħew f'≥ 1 % tal-pazjenti kkurati b'dalbavancin kienu dardir (2.4 %), dijarea (1.9 %) u wġigħ ta' ras
English: Hepatic impairment
Maltese: Infezzjonijiet Imħallta
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Maltese: Il-breakpoints ta' konċentrazzjoni inibitorja minima (MIC - minimum inhibitory concentration) determinati mill-Kumitat Ewropew dwar l-Ittestjar ta' Suxxettibbilità Antimikrobjali (EUCASTEuropean Committee on Antimicrobial Susceptibility Testing) huma kif ġejjin:
English: The mean AUC was unchanged in subjects with mild hepatic impairment compared to subjects with normal hepatic function; however, the mean AUC decreased by 28 % and 31 %, respectively, in subjects with moderate and severe hepatic impairment.
Maltese: L-AUC medja ma nbidlitx f'individwi b'indeboliment epatiku ħafif meta mqabbla ma' individwi b'funzjoni epatika normali; madankollu, l-AUC medja naqset bi 28 % u 31 %, rispettivament, f'individwi b'indeboliment epatiku moderat u sever.
English: Lactose monohydrate Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Rapid intravenous infusions of glycopeptide antibacterial agents can cause reactions that resemble “Red-Man Syndrome”, including flushing of the upper body, urticaria, pruritus, and/or rash.
Maltese: sustanzi antibatteriċi glikopeptidi jistgħu jikkawżaw reazzjonijiet li jixbhu “Red-Man Syndrome”, inkluż fwawar fin-naħa ta' fuq tal-ġisem, urtikarja, ħakk, u/jew raxx.
English: Reproductive system and breast disorders vulvovaginal pruritus
Maltese: Disturbi fis-sistema riproduttiva u fis-sider ħakk vulvovaġinali
English: Metabolism and nutrition disorders decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni tnaqqis fl-aptit
English: Rare aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl transferase increased,
Maltese: Investigazzjonijiet żieda f'lactate dehydrogenase fid-demm, żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda fl aċidu uriku fid-demm, test tal-funzjoni tal-fwied b'riżultat anormali, żieda fit transaminases, żieda f'alkaline phosphatase fid-demm, żieda fl-għadd tal-plejtlits, żieda fit-temperatura tal ġisem, żieda fl-enzimi epatiċi, żieda f'gamma glutamyl transferase
English: Koidu str. 20-19
Maltese: Lorenzo Pharma OÜ Koidu str. 20-19
English: Potential for other medicinal products to affect the pharmacokinetics of dalbavancin.
Maltese: Potenzjal għal prodotti mediċinali oħra li jaffettwaw il-farmakokinetika ta' dalbavancin.
English: The pharmacokinetics of dalbavancin are best described using a three-compartment model (α and β distributional phases followed by a terminal elimination phase).
Maltese: Ilfarmakokinetika ta' dalbavancin hi l-aħjar deskritta permezz ta' mudell bi tliet kompartimenti (fażijiet distributtivi α u β segwiti minn fażi ta' eliminazzjoni terminali).
English: Dose-dependent toxicity included serum chemistry and histological evidence of renal and hepatic injury, reduced red blood cell parameters and injection site irritation.
Maltese: Tossiċità dipendenti mid-doża inkludiet kimika fis-serum u evidenza istoloġika ta' ħsara renali u epatika, tnaqqis fil-parametri taċ-ċelluli tad-demm ħomor u irritazzjoni fissit tal-injezzjoni.
English: Patients with chronic kidney problems
Maltese: Pazjenti bi problemi kroniċi fil-kliewi
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The experience with dalbavancin in elderly is limited: 276 patients ≥ 75 years of age were included in the Phase 2/3 clinical studies, of which 173 received dalbavancin.
Maltese: L-esperjenza b'dalbavancin fl-anzjani hija limitata: 276 pazjent li kellhom ≥ 75 sena kienu inklużi fl-istudji kliniċi ta' Fażi 2/3, li minnhom 173
English: • If you are allergic to other antibiotics such as vancomycin or teicoplanin.
Maltese: • Jekk inti allerġiku għal antibijotiċi oħra bħal vancomycin jew teicoplanin.
English: Metabolites have not been observed in significant amounts in human plasma.
Maltese: Il-metaboliti ma ġewx osservati f'ammonti sinifikanti fil-plażma umana.
English: Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin.
Maltese: Dalbavancin jeħel b'mod riversibbli mal-proteini tal-plażma tal-bniedem, primarjament mal-albumina.
English: The interaction potential of dalbavancin on medicinal products metabolised by CYP enzymes is expected to be low since it is neither an inhibitor nor an inducer of CYP enzymes in vitro.
Maltese: Il-potenzjal ta' interazzjoni ta' dalbavancin fuq prodotti mediċinali metabolizzati minn enzimi ta' CYP hu mistenni li jkun baxx peress li mhuwiex la inibitur u lanqas induttur ta' enzimi ta' CYP in vitro.
English: Interactions with other antibacterial agents
Maltese: Interazzjonijiet ma' sustanzi antibatteriċi oħra
English: Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
Maltese: • Żieda fil-livelli fid-demm ta' gamma-glutamyl transferase (enzima prodotta mill-fwied u minn tessut ieħor tal-ġisem)
English: The reconstituted concentrate in the vial contains 20 mg/ml dalbavancin.
Maltese: Il-konċentrat rikostitwit fil-kunjett fih 20 mg/ml ta' dalbavancin.
English: Recommended dose and duration of treatment for adults The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).
Maltese: Id-doża rakkomandata ta' dalbavancin f'pazjenti adulti b'ABSSSI hija ta' 1500 mg mogħtija bħala infużjoni waħda ta' 1500 mg jew bħala 1000 mg segwita ġimgħa wara minn 500 mg (ara sezzjonijiet 5.1 u 5.2).
English: The safety profile of dalbavancin in the subjects aged between 12 and 16 years in this study was consistent with the safety profile observed in adults treated with dalbavancin.
Maltese: Il-profil tas-sigurtà ta' dalbavancin f'individwi li kellhom bejn 12 u 16-il sena f'dan l-istudju kien konsistenti mal-profil tassigurtà osservat fl-adulti kkurati b'dalbavancin.
English: There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
Maltese: M'hemm l-ebda esperjenza b'dalbavancin fit-trattament ta' pazjenti severament immunokompromessi.
English: There are no data on dalbavancin as an inhibitor of CYP2C8.
Maltese: M'hemm l-ebda dejta dwar dalbavancin bħala inibitur ta' CYP2C8.
English: Xydalba vials are for single-use only.
Maltese: Xydalba hu biex jintuża darba biss.
English: In patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2).
Maltese: F'pazjenti b'indeboliment renali kroniku li t-tneħħija tal-kreatinina tagħhom hija ta' < 30 ml/min u li ma jkunux qed jirċievu emodijalisi skedat regolarment, id-doża rakkomandata titnaqqas għal 1000 mg mogħtija bħala infużjoni waħda jew 750 mg segwita ġimgħa wara minn 375 mg (ara sezzjoni 5.2).
English: Dalbavancin pharmacokinetics in subjects with end-stage renal disease receiving regularly scheduled renal dialysis (3 times/week) were similar to those observed in subjects with mild to moderate renal impairment, and less than 6 % of an administered dose is removed after 3 hours of haemodialysis.
Maltese: Il-farmakokinetika ta' dalbavancin f'persuni b'mard renali fl-aħħar stadju li jkunu qed jirċievu dijalisi tal-kliewi skedata regolarment (3 darbiet/ġimgħa) kienet simili għal dik osservata f'individwi b'indeboliment renali minn ħafif sa moderat, u inqas minn 6 % tad-doża mogħtija titneħħa wara 3 sigħat ta' emodijalisi.
English: Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.
Maltese: Kunjett tal-ħġieġ ta' tip I li jintuża darba biss, ta' 48 ml, b'tapp elastomeriku u siġill aħdar flip off.
English: Each vial contains dalbavancin hydrochloride equivalent to 500 mg dalbavancin.
Maltese: Kull kunjett fih dalbavancin hydrochloride ekwivalenti għal 500 mg ta' dalbavancin.