FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pooled clinical studies (NP and complicated skin and soft tissue infection (cSSTI)), renal adverse reactions were reported more frequently in patients receiving telavancin compared with vancomycin (3.8% vs. 2.2%, respectively).
Maltese: Fl-istudji kliniċi ppuljati (NP u infezzjonijiet tal-ġilda u tat-tessut artab ikkumplikati (cSSTIcomplicated Skin and Soft Tissue Infections), reazzjonijiet avversi fil-kliewi ġew irrapportati iktar ta' spiss f'pazjenti li kienu qed jirċievu telavancin milli f'dawk li kienu qed jirċievu vancomycin (3.8% kontra 2.2% rispettivament).
English: A course of treatment usually lasts for 7 to 21 days.
Maltese: Kors ta' kura ġeneralment jieħu minn 7 ijiem sa 21 jum.
English: Vacuolisation of tubular epithelium was a common observation in animals treated with the telavancin medicinal product and with the vehicle (HP-β-CD).
Maltese: Il-vakwolizzazzjoni ta' epitilju tubulari kienet osservazzjoni komuni f'annimali kkurati bil-prodott mediċinali telavancin u bil-vettura (HP-β-CD).
English: At a dose of 10 mg/kg for 3 consecutive days to healthy volunteers subjected to bronchoalveolar lavage, the concentration ratio in pulmonary epithelial lining fluid/plasma ranged from 0.050 and 0.121 over a period of 4 to 24 hours after start of infusion.
Maltese: B'doża ta' 10 mg/kg għal 3 ijiem konsekuttivi lil voluntieri b'saħħithom li ġew suġġetti għal ħasil bronkoalveolari, il-proporzjon ta' konċentrazzjoni fil-fluwidu tar-riti epiteljali pulmonari/plażma kien ivarja minn 0.050 u 0.121 fuq perijodu ta' minn 4 sigħat sa 24 siegħa mill-bidu tal-infużjoni.
English: Telavancin exhibited linear pharmacokinetics at doses up to 15 mg/kg administered as a daily 60 minute intravenous infusion for 7 days in healthy volunteers.
Maltese: Telavancin wera farmakokinetiċi lineari f'dożi sa 15 mg/kg mogħtija bħala infużjoni minn ġol-vina f' 60 minuta kuljum għal 7 ijiem f'voluntieri b'saħħithom.
English: Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy.
Maltese: Ġew irrapportati reazzjonijiet ta' sensittività eċċessiva inkroċjata, inkluża anafilassi, f'pazjenti bi storja ta' allerġija għal vancomycin.
English: The final protocol for the PASS should be provided to the CHMP by 30 April 2014.
Maltese: Il-protokoll finali tal-PASS għandu jingħata lis-CHMP sat-30 ta' April 2014.
English: Furthermore, no evidence of hypercoagulability has been seen, as healthy subjects receiving telavancin have normal levels of D-dimer and fibrin degradation products.
Maltese: Barra minn hekk, ma dehret ebda evidenza ta' iperkoagulabilità, peress li individwi b'saħħithom li qed jirċievu telavancin għandhom livelli normali ta' prodotti D-Dimer u prodotti ta' degradazzjoni ta' fibrin.
English: Both studies consistently showed that the area under the curve (AUC) of telavancin, but not the maximum plasma concentration (Cmax) increases with decreasing renal function.
Maltese: Iż-żewġ studji wrew konsistentement li ż-żona ta' taħt il-kurvatura (AUC - Area Under the Curve) ta' telavancin, u mhux il-konċentrazzjoni massima filplażma (Cmax), tiżdied bi tnaqqis fil-funzjoni tal-kliewi.
English: The pharmacokinetics of telavancin have not been evaluated in severe hepatic impairment (Child-Pugh class C).
Maltese: Il-farmakokinetiċi ta' telavancin għadhom ma ġewx evalwati f'indeboliment sever tal-fwied (Child-Pugh klassi Ċ).
English: Since telavancin is primarily excreted unchanged by renal clearance and multiple CYP enzymes are able to metabolise telavancin, no relevant interactions are expected with inhibitors or inducers of the CYP450 system.
Maltese: Peress li telavancin huwa prinċipalment eliminat mingħajr tibdil permezz ta' tneħħija mill-kliewi u enzimi multipli ta' CYP kapaċi jimmetabolizzaw telavancin, mhux mistenni li jkun hemm effetti interattivi relevanti ma' impedituri jew sensitizzaturi tas-sistema tas-CYP450.
English: Ototoxicity
Maltese: Fertilità
English: Antibiotic-associated colitis and pseudomembranous colitis
Maltese: Kolite marbuta mal-antibijotiċi u kolite psewdomembranuża
English: S. aureus that exhibit high level resistance to glycopeptide antibacterial agents (GRSA) are not susceptible to telavancin.
Maltese: S. aureus li juru livell għoli ta' reżistenza għal antibatteriċi tat-tip glycopeptides (GRSA) mhumiex suxxettibbli għal telavancin.
English: Telavancin exerts concentration-dependent bactericidal activity against susceptible Gram-positive bacteria.
Maltese: Telavancin jeżerċita attività batteriċida dipendenti fuq il-konċentrazzjoni kontra batterja suxxettibbli pożittivi għal Gram.
English: Obese patients (defined as those with BMI > 30 kg/m2) should receive telavancin at the reduced dose of 7.5 mg/kg once every 24 hours (see section 5.2).
Maltese: Pazjenti obeżi (definiti bħala dawk b'BMI >30 kg/m2) għandhom jirċievu telavancin bid-doża mnaqqsa ta' 7.5 mg/kg darba kull 24 siegħa (ara sezzjoni 5.2).
English: Systemic macrophage hypertrophy and hyperplasia occurred in rats and dogs, in many organ systems that normally contain macrophages.
Maltese: Kien hemm ipertrofija ta' makrofaġi sistemika u iperplasja fil-firien u l-klieb, f'ħafna sistemi ta' organi li ġeneralment ikun fihom makrofaġi.
English: Effects on the kidney occurred after a minimum of 4 weeks of dosing and were a combination of renal tubular injury and tubular epithelial vacuolisation.
Maltese: Effetti fuq il-kliewi seħħew wara minimu ta' 4 ġimgħat ta' dożaġġ u kienu kombinazzjoni ta' ġrieħi tubulari tal-kliewi u vakwolizzazzjoni epitiljali tubulari.
English: Based on their pharmacokinetic properties, no interaction is expected with other beta-lactams, clindamycin, metronidazole, or
Maltese: Skont ilkaratteristiċi farmakokinetiċi tagħhom, mhux mistennija li jkun hemm interazzjoni ma' beta-lactams oħra, clindamycin, metronidazole, jew fluoroquinolones.
English: Exposure to telavancin increases with increase in BMI; for each 10-unit increase in BMI, it is estimated that plasma exposure will increase by up to 25%.
Maltese: L-espożizzjoni għal telavancin tiżdied b'żidiet fil-BMI; għal kull żieda ta' 10 unitajiet fil-BMI, huwa stmat li l-espożizzjoni tal-plasma tiżdied b'sa 25%.
English: Following administration of a single 10 mg/kg dose of telavancin, the pharmacokinetics of telavancin in subjects with moderate hepatic impairment (Child-Pugh class B) were similar to that observed in subjects with normal hepatic function.
Maltese: Wara l-għoti ta' doża waħda ta' 10 mg/kg telavancin, il-farmakokinetiċi ta' telavancin f'individwi b'indeboliment moderat tal-fwied (Child-Pugh klassi B) kienu simili għal dawk osservati f'individwi li kellhom funzjoni normali tal-fwied.
English: VIBATIV 750 mg powder for concentrate for solution for infusion Each vial contains 750 mg telavancin (as hydrochloride).
Maltese: VIBATIV 750 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 750 mg telavancin (bħala hydrochloride).
English: Cardiac disorders Uncommon:
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: • There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking medicinal products known to prolong the QT interval.
Maltese: • Hemm riskju ta' prolongazzjoni QTc, u Vibativ għandu jintuża b'kawtela fuq pazjenti li qed jieħdu prodotti mediċinali li huma magħrufin li jtawlu l-intervall ta' Q.
English: At a dose of 10 mg/kg, mean Vss averaged between 133 (SD 24) ml/kg after multiple dosing, corresponding to a value of approximately 10 l for a 75 kg person.
Maltese: B'doża ta' 10 mg/kg, il-medja ta' Vss kienet bejn 133 (SD 24) ml/kg wara dożi multipli, li tikkorrispondi għal valur ta' madwar 10 l għal persuna ta' 75 kg.
English: Patients with severe renal impairment, i.e. creatinine clearance (CrCl) <30 ml/min, including patients undergoing haemodialysis (see section 4.4).
Maltese: Pazjenti b'indeboliment sever tal-kliewi, jiġifieri bi tneħħija ta' kreatinina (CrCl) inqas minn 30 ml/min, inklużi pazjenti li jkunu fuq emodijalisi (ara s-sezzjoni 4.4).
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Maltese: L-użu ta' antibijotiċi jista' jinkoraġġixxi l-iżvilupp iżżejjed ta' mikroorganiżmi mhux suxxettibbli.
English: The mean (SD) maximum telavancin concentration (Cmax) amounts to 108 (26) µg/ml at steady state at a once daily dose of 10 mg/kg infused over a period of 1 h (tmax) and then falls to a trough value of 8.55 (2.84) µg/ml (C24h ).
Maltese: Bħala medja (SD), il-konċentrazzjoni massima ta' telavancin (Cmax) tammonta għal 108 (26) µg/ml fi stadju fiss b'doża waħda kuljum ta' 10 mg/kg li tiġi infuża fuq perijodu ta' siegħa (tmax) u li mbagħad tinżel għal-livell l-aktar baxx ta' 8.55 (2.84) µg/ml (C24h).
English: The most commonly reported related adverse reactions (occurring in >1% of patients) were: fungal infection, insomnia, dysgeusia, headache, dizziness, nausea, constipation, diarrhoea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, renal failure acute, blood creatinine increased, urine abnormality (foamy urine), fatigue and chills.
Maltese: L-aktar reazzjonijiet avversi relatati rrapportati (li seħħew f'iktar minn 1% tal-pazjenti) kienu: infezzjonijiet fungali, nuqqas ta' rqad, tibdil fit-togħma, uġigħ ta' ras, sturdament, dardir, stitikezza, , dijarea, remettar, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase , ħakk, raxx, falliment akut tal-kliewi, żieda tal-kreatinina fid-demm, awrina anormali (awrina bil-fowm), għeja u
English: It was demonstrated in a clinical study with intravenous midazolam that multiple doses of telavancin had no effect on the pharmacokinetics of midazolam, which is a sensitive substrate for CYP3A4.
Maltese: Fi studju kliniku b'midazolam li ngħata mill-vina ntwera li dożi multipli ta' telavancin ma kellhom ebda effett fuq il-farmakokinetiċi ta' midazolam, li huwa sottostrat sensittiv għal CYP3A4.
English: VIBATIV can only be used when other antibiotics are not suitable.
Maltese: VIBATIV jista' jintuża biss meta antibijotiċi oħra ma jkunux adegwati.
English: Final results of the study and the re-evaluation of the benefit/risk ratio for Vibativ should be provided to CHMP no later than 31 December 2017.
Maltese: Ir-riżultati finali tal-istudju u l-evalwazzjoni mill-ġdid tal-proporzjon ta' benefiċċji meta mqabbla mar-riskji ta' Vibativ għandhom jingħataw lis-CHMP mhux iktar tard mill-31 ta' Diċembru 2017.
English: Vacuolisation was not associated with renal function impairment, but was not reversible after 4 weeks of recovery.
Maltese: Il-vakwolizzazzjoni ma kinetx marbuta ma' indeboliment fil-funzjoni tal-kliewi, imma ma kinetx riversibbli wara 4 ġimgħat ta' rkupru.
English: deafness
Maltese: truxija
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including telavancin (see section 4.8), and may range in severity from mild to life-threatening.
Maltese: Kolite marbuta mal-antibijotiċi u kolite psewdomembranuża ġew irrapportati ma' kważi s-sustanzi antibatteriċi kollha, inkluż telavancin (ara s-sezzjoni 4.8), b'firxa fis-severità minn ħafif sa ta' periklu għal ħajja.
English: In healthy young adults, after infusion of radiolabeled telavancin, approximately 76% of the administered dose was recovered from urine and less than 1% of the dose was recovered from faeces (collected for up to 9 days), based on total radioactivity.
Maltese: F'adulti żgħar b'saħħithom, wara l-infużjoni ta' telavancin radjutikkettat, madwar 76 % tad-doża mogħtija kienet irkuprata mill-awrina u inqas minn 1% tad-doża kienet irkuprata fl-ippurgar (miġbura sa 9 ijiem wara), skont ir-radjuattività totali.
English: Reconstitution time is not more than 5 minutes for the vial containing 250 mg.
Maltese: Il-ħin ta' rikostituzzjoni mhux aktar minn 5 minuti għall-kunjett li fih 250 mg.
English: Ex vivo platelet aggregation Chromogenic factor Xa assay Functional (chromogenic) factor X assay Bleeding time
Maltese: Aggregazzjoni ta' plejtlits ex vivo Assaġġ għal fattur kromoġeniku Xa Assaġġ għal fattur funzjonali (kromoġeniku) X
English: The nosocomial pneumonia (NP) studies excluded known or suspected pulmonary disease like granulomatous diseases, lung cancer, or other malignancy metastatic to the lungs; cystic fibrosis or active tuberculosis; Legionella pneumophila pneumonia; meningitis, endocarditis, or osteomyelitis; refractory shock defined as supine systolic blood pressure <90 mm Hg for >2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents.
Maltese: L-istudji dwar il-nosocomial pneumonia (NP) kienu jeskludu mard pulmonari magħruf jew issuspettat bħal mard granulomatosi, kanċer tal-pulmun, jew malinni metastatiċi oħra tal-pulmun; fibrosi ċistika jew tuberkolosi attiva; pnewmonja minn Legionella pneumophila; meningite, endokardite, jew osteomajlite; xokk refrattorju mfisser bħala pressjoni tad-demm sistolika supina <90 mm Hg għal >2 sigħat b'evidenza ta' ipoperfużjoni jew il-ħtieġa ta' sustanzi simpatomimetiċi ta' doża għolja.
English: Severe
Maltese: JIS
English: Reconstitution time is not more than 10 minutes for the vial containing 750 mg.
Maltese: Il-ħin ta' rikostituzzjoni mhux aktar minn 10 minuti għall-kunjett li fih 750 mg.
English: A dose adjustment should be made in obese patients with BMI > 30 kg/m2 (see section 4.2).
Maltese: F'pazjenti obeżi b'BMI >30 kg/m2 għandu jsir aġġustament tad-doża (ara sezzjoni 4.2).
English: a ESRD= End-stage renal disease maintained on haemodialysis b Baseline mean creatinine clearance as calculated by Cockcroft-Gault equation
Maltese: CL (ml/h/kg) a ESRD= Mard tal-kliewi tal-aħħar fażi miżmum b'emodijalisi bIl-medja tal-linja bażi ta' tneħħija ta' kreatinina kif ikkalkulat bl-ekwazzjoni ta' Cockcroft-Gault
English: Body mass index (BMI) at baseline was found to influence telavancin pharmacokinetics in the population pharmacokinetic analysis in healthy (without infection) adult subjects.
Maltese: L-indiċi tal-massa tal-ġisem (Body mass index, BMI) fil-linja bażi nstab li jinfluwenza lfarmakokinetika ta' telavancin fl-analiżi farmakokinetika tal-popolazzjoni f'individwi adulti b'saħħithom (mingħajr infezzjoni).
English: Telavancin is mainly excreted unchanged accounting for approximately 82% of the total amount recovered over 48 hours in urine.
Maltese: Telavancin huwa eliminat prinċipalment mhux mibdul u dan jgħodd għal madwar 82 % tal-ammont totali ta' awrina rkuprat fuq 48 siegħa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION VIBATIV 250 mg powder for concentrate for solution for infusion Each vial contains 250 mg telavancin (as hydrochloride).
Maltese: VIBATIV 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 250 mg telavancin (bħala hydrochloride).
English: Telavancin is a low clearance active substance with a mean (SD) CL of 13.1 (2.0) ml/hr/kg in subjects with normal renal function, corresponding to a total CL of approximately 1 l/hr in a 75 kg subject.
Maltese: Televancin huwa sustanza attiva bi tneħħija baxxa b'medja (SD) ta' CL 13.1 (SD 2.0) ml/kg/siegħa f'pazjenti b'funzjoni renali normali li tikkorrispondi għal valur ta' madwar 1 l/siegħa għal persuna ta' 75 kg. Flimkien ma' Vss żgħir, dan
English: The use in patients with acute renal failure or creatinine clearance (CrCl) <30 ml/min including patients undergoing haemodialysis is contraindicated (see section 4.3).
Maltese: L-użu għal pazjenti b'falliment akut tal-kliewi jew dawk bi tneħħija ta' kreatinina (CrCl) inqas minn 30 ml/min, inklużi pazjenti li jkunu fuq emodijalisi huwa kontraindikat (ara s-sezzjoni 4.3).
English: Both effects were reversible following an 8 week recovery period.
Maltese: Iż-żewġ effetti kienu riversibbli wara perijodu ta' rkupru ta' 8 ġimgħat.
English: This dose is given as an infusion (drip into a vein) over a period of about 60 minutes.
Maltese: Din id-doża tingħata bħala infużjoni (bid-dripp fil-vina) fuq perijodu ta' madwar 60 minuta.
English: 10 mg/kg every 24 hours 7.5 mg/kg every 24 hours *As calculated using the Cockcroft-Gault formula
Maltese: 7.5 mg/kg kull 24 siegħa *Kif ikkalkulat skont il-formola ta' Cockcroft-Gault
English: Microalbumin assays based on immunoassay utilizing nephelometric (turbidity) detection are not affected and can be used to monitor urinary protein excretion during telavancin treatment.
Maltese: Assaġġi b'microalbumin ibbażati fuq immunoassaġġi msejsa fuq intraċċar nefelometriku (turbidità) ma kinux affettwati u jistgħu jintużaw sabiex jimmonitorjaw l-eliminazzjoni ta' proteina fl-awrina waqt il-kura b'telavancin.
English: Rapid intravenous infusions of antimicrobial agents of the class of glycopeptides have been associated with red man syndrome-like reactions, including flushing of the upper body, urticaria, pruritus or rash (see section 4.8).
Maltese: Infużjonijiet ġol-vina ta' malajr ta' sustanzi antimikrobijali tal-klassi ta' glycopeptides ġew assoċjati ma' reazzjonijiet bħal tas-sindromu tar-raġel aħmar, li jinkludu fwawar fuq in-naħa ta' fuq tal-ġisem, urtikarja, ħakk u raxx (ara s-sezzjoni 4.8).
English: The telavancin medicinal product, which contains the excipient hydroxypropylbetadex (HP-β-CD), induced adverse effects in animal studies at plasma concentrations that were in the same range as clinical exposure levels and with possible relevance to clinical use.
Maltese: Il-prodott mediċinali ta' telavancin, li fih is-sustanza mhix attiva ta' hydroxypropylbetadex (HP-β-CD), wassal għal effetti avversi fi studji fuq l-annimali f'konċentrazzjonijiet fil-plażma li kienu fl-istess firxa bħal-livelli ta' espożizzjoni klinika u possibilment rilevanti għall-użu kliniku.
English: Changes in AUC only become clinically relevant in patients with moderate and severe renal impairment.
Maltese: Bidliet fl-AUC isiru biss klinikament rilevanti f'pazjenti b'indeboliment tal-kliewi moderat u sever.
English: In a second study, 6 weeks of dosing was associated with sloughed testicular germ cells in the epididymis, indicative of testicular injury, and effects upon sperm quality and quantity were observed.
Maltese: Fit-tieni studju, lgħoti ta' doża wara 6 ġimgħat kien assoċjat ma' ċelluli ġerminali testikulari tal-epididimi mqaxxra, li hu indikattiv ta' ġerħa testikulari, u dehru effetti fuq il-kwalità u l-kwantità tal-isperma.
English: Telavancin inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II, which prevents polymerisation of the precursor into peptidoglycan and subsequent cross-linking events.
Maltese: Telavancin jimpedixxi l-bijosintesi tal-ħajt ċellulari billi jintrabat ma' prekursuri ta' peptidoglycan fil-fażi tardiva, li jinkludi lipid II, li jimpedixxi l-polimerizzazzjoni tal-prekursur fi peptidoglycan u każijiet sussegwenti ta' inkroċjar.
English: Coagulation tests affected by telavancin
Maltese: Indeboliment tal-kliewi
English: nausea constipation, diarrhoea, vomiting abdominal pain, dry mouth, dyspepsia, flatulence, hypoaesthesia alanine aminotransferase increased, aspartate aminotransferase erythema, face oedema, hyperhidrosis, urticaria Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramp, myalgia renal failure acute, blood creatinine increased, foamy urine (lower blood urea increased, dysuria, haematuria, microalbuminuria, oliguria, pollakiuria, renal impairment, urine odour abnormal General disorders and administration site conditions asthenia, infusion site reactions, malaise, non-cardiac chest pain, peripheral oedema, pain, pyrexia, Red Man syndrome international normalised ratio increased * Based on post-marketing reports.
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda eritema, edema tal-wiċċ, iperidrosi, urtikarja Disturbi muskolu skeletriċi u tat-tessut konnettiv artralġja, uġigħ fid-dahar, bugħawwieġ, uġigħ fil-muskolu falliment akut tal-kliewi, żieda tal-kreatinina fid-demm, awrina bilurea ogħla fid-demm, dajsurja, ematurja, mikroalbuminurja, oligurja, pollakiurja, indeboliment tal-kliewi, riħa mhix normali ta'
English: The potential risk for humans
Maltese: Irriskju potenzjali għall-bniedem għadu mhux magħruf.
English: Activated partial thromboplastin time
Maltese: Il-ħin ta' tromboplastin parzjalment attivat
English: VIBATIV 250 mg powder for concentrate for solution for infusion The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 17 ml).
Maltese: Preparat tal-konċentrat rikostitwit (kunjett ta' VIBATIV 250 mg) Il-kontenut tal-kunjett li jikkonsisti minn 250 mg telavancin għandu jiġi rikostitwit b'15 ml soluzzjoni ta' dextrose 50 mg/ml (5%) għall-injezzjoni, jew ilma għall-injezzjonijiet jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni sabiex tikseb konċentrazzjoni ta' madwar 15 mg/ml (volum totali ta' madwar 17 ml).
English: VIBATIV 750 mg powder for concentrate for solution for infusion The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of
Maltese: VIBATIV 750 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Il-kontenut tal-kunjett li jikkonsisti minn 750 mg telavancin għandu jiġi rikostitwit b'45 ml soluzzjoni ta' dextrose 50 mg/ml (5%) għall-injezzjoni, jew ilma għall-injezzjonijiet jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni sabiex tikseb konċentrazzjoni ta' madwar 15 mg/ml (volum
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il
English: clostridium colitis, urinary tract infection anaemia, leukopenia, thrombocythaemia, thrombocytopenia, eosinophil count increased, neutrophil count increased decreased appetite, hyperglycaemia, hyperkalaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia agitation, anxiety, confusional state, depression ageusia, migraine, paraesthesia, parosmia, somnolence, tremor
Maltese: kolite ta' clostridium, infezzjoni fil-passaġġ tal-awrina Disturbi tad-demm u tas-sistema limfatika anaemija, lewkopenija, tromboċitemija, tromboċiopenija, żieda flgħadd ta' esinofili, żieda fl-għadd ta' newtrofili tnaqqis fl-aptit, ipergliċemija, iperkalemija, ipogliċemija,
English: Analysis of patient population pharmacokinetic data did not show a relevant effect of age on pharmacokinetics.
Maltese: L-analiżi ta' tagħrif farmakokinetiku ta' popolazzjoni ta' pazjenti ma wrietx effett rilevanti ta' età fuq il-farmakokinetiċi.
English: dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain
Maltese: L-istudji fuq l-annimali wrew tossiċità riproduttiva
English: After 13 weeks of treatment, reversible seminiferous tubular degeneration was observed in the testis of rats.
Maltese: Wara 13-il ġimgħa ta' kura, deġenerazzjoni tubulari seminiferuża riversibbli kienet osservata fittestikoli tal-firien.
English: The effect of renal impairment on the pharmacokinetics of telavancin has been evaluated in 2 clinical pharmacology studies in healthy subjects with normal renal function and subjects with mild to severe renal impairment.
Maltese: L-effett tal-indeboliment tal-kliewi fuq il-farmakokinetċi ta' telavancin ġie evalwat f'2 studji talfarmakoloġija klinika f'individwi b'saħħithom b'funzjoni normali tal-kliewi u f'individwi b'indeboliment tal-kliewi minn ħafif sa sever.