FrancophonIA/ELRC3.0 huggingface dataset:
English: The different quantities included may lead to the products having different viscosities, resulting in different rates of absorption of closantel from the injection site; however, this parameter is not considered to affect the elimination rate from the edible tissues, other than at the injection site itself.
Maltese: Ilkwantitajiet differenti inklużi jistgħu jwasslu għall-prodotti li jkollhom viskożitajiet differenti, li jirriżultaw f'rati differenti ta' assorbiment ta' closantel mis-sit tal-injezzjoni; madankollu, dan ilparametru mhuwiex ikkunsidrat li jaffettwa r-rata ta' eliminazzjoni mit-tessuti li jittieklu, minbarra fissit tal-injezzjoni nnifsu.
English: The Committee considered that, due to the slow and limited metabolism of closantel, the high protein binding and retention in plasma, and the long elimination time from tissues, the differences seen in the product formulations, which may lead to different rates of absorption from the injection site, should not influence the final rate of elimination from the edible tissues, other than at the injection site itself.
Maltese: Il-Kumitat ikkunsidra li, minħabba l-metaboliżmu bil-mod u limitat ta' closantel, l-irbit għoli ta' proteini u ż-żamma fil-plażma, u l-ħin tal-eliminazzjoni twil mit-tessuti, id-differenzi li dehru filformulazzjonijiet tal-prodott, li jistgħu jwasslu għal rati differenti ta' assorbiment minn sit tal-injezzjoni, m'għandux jinfluwenza r-rata finali ta' eliminazzjoni mit-tessuti li jittieklu, ħlief fis-sit tal-injezzjoni nnifsu.
English: The two products used in the studies include almost the same excipients, but in different quantities.
Maltese: Iż-żewġ prodotti użati fl-istudji jinkludu kważi l-istess eċċipjenti, iżda fi kwantitajiet differenti.
English: The study was conducted in 2016 with 20 treated animals (five mixed-sex groups of four animals) and a control group consisting of two untreated animals.
Maltese: L-istudju sar fl-2016 b'20 annimal ikkurat (ħames gruppi ta' erba' annimali-ta' sess imħallat) u grupp ta' kontroll magħmul minn żewġ annimali mhux ikkurati.
English: This mitigation measure was thoroughly evaluated and discussed by the CVMP, and determined to be unnecessary.
Maltese: Din il-miżura ta' mitigazzjoni ġiet evalwata u diskussa bir-reqqa mis-CVMP, u ġiet iddeterminata li mhijiex meħtieġa.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Maltese: Is-CVMP intalab jirrevedi d-data kollha disponibbli dwar it-tnaqqis tar-residwi għall-prodotti mediċinali veterinarji li fihom 50 mg closantel kull ml (bħala sustanza attiva waħda), ippreżentat bħala soluzzjoni għall-injezzjoni għall-użu taħt il-ġilda fin-nagħaġ u jirrakkomanda perjodi ta' rtirar għal-laħam u lġewwieni derivat minn nagħaġ ikkurati.
English: EU/1/00/140/001 Visudyne
Maltese: EU/1/00/140/001 Visudyne 15 mg Trab u solvent ghal soluzzjoni ghall-infużjoni
English: Pack size
Maltese: 1 kunjett
English: powder: 15 mg 1 vial
Maltese: Injezzjoni go vina Kunjett tal- ħġieġ Trab: 15 mg
English: 20 to 39
Maltese: 20 sa 39
English: • Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Maltese: • Peptostreptococcus species (inkluż P. micros, P anaerobius, P. magnus)
English: 10 to 19
Maltese: 10 sa 19
English: 5 to 10 days2
Maltese: 5 sa 10 ijiem2
English: Oral anticoagulants
Maltese: Antikoagulanti orali
English: 1, Avenue de la Gare, L-1611 Luxembourg
Maltese: L. S.A. 1, Avenue de la Gare L-1611, Luxembourg Il-Lussemburgu
English: Anaerobic micro-organisms:
Maltese: Mikro-organiżmi anerobiċi:
English: Gram-positive micro-organisms:
Maltese: Mikro-organiżmi Gram-negattivi:
English: Dose of Vaborem (meropenem/ vaborbactam)2
Maltese: (meropenem/ vaborbactam)2
English: Concomitant use with valproic acid/sodium valproate/valpromide
Maltese: Użu konkomitanti ma' valproic acid/sodium valproate/valpromide
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta 'Novembru 2018
English: Stevens Johnson syndrome
Maltese: Sindrome ta' Stevens Johnson Eritema multiforme
English: • Enterobacter cloacae species complex
Maltese: • kumpless ta'Enterobacter cloacae species
English: Organisms
Maltese: Organi
English: Complicated urinary-tract infections, including pyelonephritis Gram-negative micro-organisms:
Maltese: Infezzjonijiet ikkumplikati fl-apparat tal-awrina, inkluż pijelonefrite Mikro-organiżmi Gram-negattivi:
English: Antiglobulin test (Coombs test) seroconversion
Maltese: Serokonverżjoni tat-test ta' antiglobulina (test ta' Coombs)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1334/001
Maltese: EU/1/18/1334/001
English: • Reconstitute 2 vials for the Vaborem 2 g/2 g dose • Reconstitute 1 vial for the Vaborem 1 g/1 g and Vaborem 0.5 g/0.5 g doses
Maltese: • Irrikostitwixxi 2 kunjetti għad-doża ta' Vaborem 2 g/2 g • Irrikostitwixxi kunjett 1 għad-dożi ta' Vaborem 1 g/1 g u Vaborem 0.5 g/0.5 g
English: A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0
Maltese: Menarini Pharma GmbH Tel: +43 1 879 95 85-0
English: • Peptoniphilus asaccharolyticus
Maltese: • Clostridium perfringens • Peptoniphilus asaccharolyticus
English: (≥1/1,000 to
Maltese: (≥1/1,000 sa
English: The most common adverse reactions that occurred among 322 patients from the pooled Phase 3 trials were headache (8.1%), diarrhoea (4.7%), infusion site phlebitis (2.2%) and nausea (2.2%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li seħħew fost 322 pazjent mill-provi miġbura ta' Fażi 3 kienu uġigħ ta' ras (8.1%), dijarea (4.7%), flebite fis-sit tal-infużjoni (2.2%) u nawsja (2.2%).
English: • of the lungs (pneumonia)
Maltese: • tal-pulmun (pulmonite)
English: Direct and indirect Coombs test positive
Maltese: Test Coombs dirett u indirett pożittiv
English: Vaborem is not chemically compatible with glucose-containing solutions.
Maltese: Vaborem mhuwiex kimikament kompatibbli ma' soluzzjonijiet li fihom glucose.
English: • medicines that weaken your body's immune system, such as tacrolimus, everolimus and cyclosporine
Maltese: • mediċini li jdgħajfu s-sistema immuni, bħal tacrolimus, everolimus u cyclosporine
English: 3 hours
Maltese: 3 sigħat
English: Minimum Inhibitory Concentrations (mg/l) Susceptible
Maltese: Konċentrazzjonijiet Minimi Inibitorji (mg/l)
English: • Sudden onset of a severe rash with bullseye-like spots or blistering or peeling skin, possibly with a high fever, joint pain, abnormal function of your liver, kidney or lung (these may be signs of more serious medical conditions called toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS))
Maltese: • Bidu f'daqqa ta' raxx sever b'tikek bħal bullseye jew infafet jew tqaxxir tal-ġilda, possibbilment b'deni għoli, uġigħ fil-ġogi, funzjoni anormali tal-fwied, il-kliewi jew il-pulmun tiegħek (dawn jistgħu jkunu sinajli ta' kondizzjonijiet mediċi aktar serji msejħa nekroliżi epidermali tossika, sindrome ta' Stevens-Johnson, eritema multiforme jew kondizzjoni magħrufa bħala reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS))
English: Alternatively, meropenem/vaborbactam should be discontinued (see section 4.5).
Maltese: Alternattivament, meropenem/vaborbactam għandu jitwaqqaf (ara sezzjoni 4.5).
English: Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH52
Maltese: Kategorija farmakoterapewtika: antibatteriċi għal użu sistemiku, karbapenemi, Kodiċi ATC:
English: Approximately 40-60% of a meropenem dose is excreted unchanged within 24 - 48 hours with a further 25% recovered as the microbiologically inactive hydrolysis product.
Maltese: Madwar 40-60% ta' doża ta' meropenem jiġi eliminat mhux mibdul fi żmien 24 - 48 siegħa b'25 % aktar irkuprat bħala l-prodott ta' idroliżi inattiv mikrobijoloġikament.
English: Table 2 shows the recommended dose adjustments for patients with a CrCl ≤39 ml/min.
Maltese: Tabella 2 turi l-aġġustamenti fid-doża rakkomandati għal pazjenti b'CrCl ≤39 ml/min.
English: • Meropenem belongs to group of antibiotics called “carbapenems”.
Maltese: • Meropenem jappartjeni għal grupp ta' antibijotiċi msejħa “karbapenemi”.
English: • Vaborbactam is a “beta lactamase inhibitor”.
Maltese: • Vaborbactam huwa “inibitur ta' betalattamażi”.
English: The final volume is approximately 21.3 ml.
Maltese: Il-volum finali jkun ta' madwar 21.3 ml.
English: Vaborem is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Maltese: Vaborem huwa indikat għall-kura tal-infezzjonijiet li ġejjin f'adulti (ara sezzjonijiet 4.4 u 5.1):
English: The terminal half-life (t½) is 2.30 hours and 2.25 hours for meropenem and vaborbactam, respectively.
Maltese: In-nofs ħajja terminali (t½) hija 2.30 sigħat u 2.25 sigħat għal meropenem u vaborbactam,
English: Vaborbactam does not inhibit class D carbapenemases such as OXA-48 or class B metallo-β-lactamases such as NDM and VIM (see section 5.1).
Maltese: Vaborbactam ma jinibixxix karbapenemażijiet ta' Klassi D bħal OXA48 jew metallo-β-lattamażijiet bħal NDM u VIM (ara sezzjoni 5.1).
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Maltese: Il-frekwenzi huma definiti bħala: 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); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In vitro data suggest that vaborbactam may inhibit CYP2D6, and a risk for increased plasma concentrations of sensitive CYP2D6 substrates in vivo cannot be excluded.
Maltese: Dejta in vitro tissuġġerixxi li vaborbactam jista' jinibixxi CYP2D6, u riskju għal konċentrazzjonijiet miżjuda fil-plasma ta' substrati CYP2D6 sensittivi in vivo ma jistax jiġi eskluż.
English: Caution should be used when administering meropenem/vaborbactam concomitantly with medicinal products with a narrow therapeutic window that are predominantly metabolised by CYP450 enzymes (e.g. immunosuppressants such as tacrolimus, everolimus and cyclosporine, lovastatin, midazolam, sildenafil and warfarin) as conclusive data on whether meropenem or vaborbactam may be inhibitors or inducers of CYP450 enzymes is not yet available.
Maltese: Għandha tintuża l-kawtela meta meropenem/vaborbactam jingħata b'mod konkomitanti ma' prodotti mediċinali b'medda terapewtika dejqa li b'mod predominanti jiġu metabolizzati minn enzimi CYP450 (eż. immunosoppressanti bħal tacrolimus, everolimus and cyclosporine, lovastatin, midazolam, sildenafil u warfarin) minħabba li dejta konklussiva dwar jekk meropenem jew vaborbactam jistgħux ikunu inibituri jew indutturi ta' enzimi ta' CYP450, għadha mhux disponibbli.
English: Every 8 hours
Maltese: 8 sigħat
English: MENARINI HELLAS AE Τηλ: +30 210 8316111-13
Maltese: Τηλ: +30 210 8316111-13
English: Both meropenem and vaborbactam penetrate into human bronchial epithelial lining fluid (ELF) with concentrations around 65% and 79% of unbound plasma concentrations of meropenem and vaborbactam, respectively.
Maltese: Kemm meropenem kif ukoll vaborbactam jippenetraw fil-fluwidu tal-kisja epiteljali (ELF) bronkjali tal-bniedem b'konċentrazzjonijiet madwar 65 % u 79 % ta' konċentrazzjonijiet fil-plażma mhux imwaħħla ta' meropenem u vaborbactam, rispettivament.
English: Complicated intra-abdominal infections
Maltese: Limitazzjonijiet tad-dejta klinika Infezzjonijiet intraaddominali kkumplikati
English: Alanine aminotransferase increased
Maltese: Żieda fl-alanina aminotransferażi Żieda flaspartataminotransferażi
English: The recommended dose is 2 vials (a total of 2 g meropenem and 2 g vaborbactam), given every 8 hours.
Maltese: Id-doża rakkomandata hija ta' 2 kunjetti (total ta' 2 g meropenem u 2 g vaborbactam), mogħtija kull 8 sigħat.
English: In one additional patient, a serious adverse reaction of infusion related reaction was reported (0.3%).
Maltese: F'pazjent addizzjonali wieħed, ġiet irrappurtata reazzjoni avversa severa ta' reazzjoni relatata mal-infużjoni (0.3%).
English: Serious and occasionally fatal hypersensitivity reactions have been reported with meropenem and/or meropenem/vaborbactam (see sections 4.3 and 4.8).
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva serji u xi drabi fatali b'meropenem u/jew meropenem/vaborbactam (ara sezzjonijiet 4.3 u 4.8).
English: • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
Maltese: • Pulmonite li tittieħed mill-isptar (HAP), inkluż pulmonite assoċjata mal-ventilatur (VAP).
English: Pseudomonas aeruginosa
Maltese: Enterobacteriaceae Pseudomonas aeruginosa
English: Approximately 75 to 95% of vaborbactam is excreted unchanged in the urine over a 24 - 48 hour period.
Maltese: Madwar 75 sa 95 % ta' vaborbactam jiġi eliminat mhux mibdul fl-awrina għal perjodu ta' 2448 siegħa.
English: After reconstitution, 1 ml of the solution contains 50 mg meropenem and 50 mg vaborbactam (see section
Maltese: Wara r-rikostituzzjoni, 1 ml tas-soluzzjoni fih 50 mg meropenem u 50 mg vaborbactam (ara sezzjoni 6.6).
English: Vaborbactam has no antibacterial activity.
Maltese: Vaborbactam m'għandu l-ebda attività antibatterika.
English: The steady-state volumes of distribution of meropenem and vaborbactam in patients were 20.2 L and 18.6 L, respectively, following doses of 2 g meropenem/2 g vaborbactam infused over 3 hours every 8 hours, indicating that both compounds distribute into a volume of distribution consistent with the extracellular fluid compartment.
Maltese: 18.6 L, rispettivament, wara dożi ta' 2 g meropenem/2 g vaborbactam li ġew infużi għal 3 sigħat kull 8 sigħat, li jindikaw li ż-żewġ komposti jiddistribwixxu f'volum ta' distribuzzjoni konsistenti malkompartiment tal-fluwidu ekstraċellulari.
English: Meropenem alone is not known to interact with active transport systems.
Maltese: Meropenem waħdu mhuwiex magħruf li jinteraġixxi ma' sistemi ta' trasport attivi.
English: Meropenem is a substrate of OAT1 and OAT3 and as such, probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem.
Maltese: Meropenem huwa substrat ta' OAT1 u OAT3 u, probenecid jikkompeti ma' meropenem għal sekrezzjoni tubulari attiva u b'hekk jinibixxi l-eliminazzjoni mill-kliewi ta' meropenem.
English: The Cmax and AUC of meropenem and vaborbactam are linear across the dose range studied (1 g to 2 g for meropenem and 0.25 g to 2 g for vaborbactam) when administered as a single 3-hour intravenous infusion.
Maltese: Linearità/nuqqas ta' linearità Is-Cmax u l-AUC ta' meropenem u vaborbactam huma lineari fil-medda tad-doża studjata (1 g sa 2 g għal meropenem u 0.25 g sa 2 g għal vaborbactam) meta jingħata bħala infużjoni waħda ġol-vini ta' 3 sigħat.
English: Hypersensitivity to any carbapenem antibacterial agent.
Maltese: Sensittività eċċessiva għal kwalunkwe aġent antibatteriku karbapenemiku.
English: In vitro studies demonstrated no antagonism between meropenem/vaborbactam and levofloxacin, tigecycline, polymyxin, amikacin, vancomycin, azithromycin, daptomycin or linezolid.
Maltese: polymyxin, amikacin, vancomycin, azithromycin, daptomycin jew linezolid.
English: Patients taking CYP2D6 substrates with narrow therapeutic index (e.g. dextromethorphan, desipramine, venlafaxine, and metoprolol) should be monitored for signs of toxicity.
Maltese: Il-pazjenti li jieħdu substrati ta' CYP2D6 b'indiċi terapewtiku dejjaq (eż. dextromethorphan, desipramine, venlafaxine, u metoprolol) għandhom jiġu mmonitorjati għal sinjali ta' tossiċità.
English: ACS Dobfar, S.p.A. Nucleo Industriale S. Atto (loc. S. Nicolo' a Tordino) 64100 Teramo (TE) Italy
Maltese: Nicolo' a Tordino) 64100 Teramo (TE) L-Italja
English: Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Maltese: Infezzjonijiet minħabba organiżmi Gram-negattivi aerobiċi f'pazjenti b'għażliet ta' kura limitati
English: 1 As calculated using the Cockcroft-Gault formula
Maltese: Kif ikkalkulat permezz tal-formula ta' Cockcroft-Gault
English: The use of Vaborem to treat patients with infections due to bacterial organisms who have limited treatment options is based on pharmacokinetic/pharmacodynamic analyses for meropenem/vaborbactam and on limited data from a randomised clinical trial in which 32 patients were treated with Vaborem and 15 patients were treated with best available therapy for infections caused by carbapenem-resistant organisms (see section 5.1).
Maltese: L-użu ta' Vaborem biex jikkura pazjenti b'infezzjonijiet minħabba organiżmi batteriċi li għandhom għażliet ta' kura limitati huwa bbażat fuq analiżijiet farmakokinetiċi/farmakodinamiċi għal meropenem/vaborbactam u fuq dejta limitata minn prova klinika randomised li fiha 32 pazjent ġew ikkurati b'Vaborem u 15-il pazjent ġew ikkurati bl-aħjar terapija disponibbli għal infezzjonijiet ikkawżati minn organiżmi reżistenti għal carbapenem (ara sezzjoni 5.1).
English: 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) should be withdrawn from a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection for each vial and reconstituted with the appropriate number of vials of meropenem/vaborbactam for the corresponding Vaborem dosage:
Maltese: 20 ml ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (salina normali) għandha tinġibed minn 250 ml borża tal-infużjoni ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għallinjezzjoni għal kull kunjett u tiġi rikostitwita bin-numru xieraq ta' kunjetti ta' meropenem/vaborbactam għad-dożaġġ korrispondenti ta' Vaborem:
English: Uncommon: (may affect up to 1 in 100 people)
Maltese: Mhux komuni: (jistgħu jaffettwaw sa 1 minn kull 100)
English: For vaborbactam, the PK-PD index associated with antimicrobial activity is the ratio of free vaborbactam plasma AUC: meropenem/vaborbactam MIC.
Maltese: Għal vaborbactam, l-indiċi PK-PD assoċjat mal-attività antimikrobika huwa l-proporzjon ta' AUC fil-plażma ta' vaborbactam liberu:
English: Simultaneous administration of antibacterial agents with warfarin may augment its anticoagulant effects.
Maltese: L-għoti simultanju ta' aġenti antibatteriċi ma' warfarin jista' jżid l-effetti antikoagulanti tiegħu.
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate meropenem/vaborbactam
Maltese: TAL-PRODOTT MEDIĊINALI Vaborem 1 g/1 g trab għal konċentrat meropenem/vaborbactam
English: Meropenem does not have activity against methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) or vancomycin-resistant Enterococci (VRE).
Maltese: Meropenem m'għandux attività kontra Staphylococcus aureus reżistenti għall-metiċillina (MRSA) u
English: Pruritus Rash Urticaria
Maltese: Dijarea Nawsja Rimettar
English: Recommended intravenous doses for patients with a CrCl ≤39 ml/min1
Maltese: Tabella 2: Dożi ġol-vini rakkomandati għal pazjenti b'CrCl ≤39 ml/min1 CrCl (ml/min)
English: Sodium carbonate
Maltese: Karbonat tas-sodju
English: The plasma protein binding of vaborbactam is approximately 33%.
Maltese: It-twaħħil tal-proteina talplażma ta' vaborbactam huwa ta' madwar 33 %.
English: In subjects with end stage renal disease (ESRD) administered 1 g meropenem and 1 g vaborbactam, the mean total recovery in dialysate following a haemodialysis session was 38% and 53% for meropenem and vaborbactam, respectively.
Maltese: F'individwi b'marda tal-kliewi fl-aħħar stadju (ESRD) li jingħataw 1 g meropenem u 1 g vaborbactam, l-irkupru medju totali fid dijaliżat wara sessjoni ta' emodijaliżi kien 38 % u 53 % għal meropenem u vaborbactam,
English: Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1).
Maltese: Vaborem huwa indikat ukoll għall-kura ta' infezzjonijiet minħabba organiżmi batteriċi f'pazjenti adulti b'għażliet ta' kura limitati (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, cephalosporins or monobactams).
Maltese: Sensittività eċċessiva severa (eż. reazzjoni anafilattika, reazzjoni severa tal-ġilda) għal kwalunkwe tip ieħor ta' aġent antibatteriku betalattamiku (eż. peniċillini, ċefalosporini jew monobattamiċi). 4.4
English: Each vial contains 10.9 mmol of sodium (approximately 250 mg).
Maltese: 9 mmol ta' sodju (madwar 250 mg).
English: thoracic and mediastinal disorders Gastrointestinal disorders
Maltese: Disturbi gastrointestinali
English: Hepatic impairment
Maltese: Infezzjoni ġdida
English: Spectrum of activity of meropenem/vaborbactam
Maltese: Spettru ta' attività ta' meropenem/vaborbactam
English: Thrombocythaemia Leucopenia Neutropenia
Maltese: Trombożi fis-sit tal-infużjoni
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is sistema riproduttiva (ara 5.3).
English: Agranulocytosis Haemolytic anaemia
Maltese: Anemija emolitika
English: CrCl (ml/min)1
Maltese: (CrCl) ≥40 ml/min1 Tip ta' infezzjoni
English: Seizures have been reported during treatment with meropenem (see section 4.8).
Maltese: Ġew irrappurtati attakki ta' puplesija b'meropenem (ara sezzjoni 4.8).
English: Each vial contains 1 g meropenem (as meropenem trihydrate) and 1 g vaborbactam.
Maltese: Kull kunjett fih 1 g meropenem (bħala meropenem trihydrate) u 1 g vaborbactam.
English: Controlled sodium diet
Maltese: Dieta b'sodju kkontrollat
English: Clostridium difficile-associated diarrhoea
Maltese: Kolite bi Clostridium difficile
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia The use of Vaborem to treat patients with hospital-acquired pneumonia, including ventilator-associated pneumonia, is based on experience with meropenem alone and pharmacokinetic-pharmacodynamic analyses for meropenem/vaborbactam.
Maltese: Pulmonite li tittieħed mill-isptar, inkluż pulmonite assoċjata mal-ventilatur L-użu ta' Vaborem biex jikkura pazjenti b'pulmonite li tittieħed mill-isptar, inkluż pulmonite assoċjata mal-ventilatur, huwa bbażat fuq esperjenza b'meropenem waħdu u analiżijiet farmakokinetiċi farmakodinamiċi ta' meropenem/vaborbactam.
English: • Complicated urinary tract infection (cUTI), including pyelonephritis
Maltese: • Infezzjoni kkumplikata fl-apparat tal-awrina (cUTI), inkluż pijelonefrite • Infezzjoni kkumplikata intraaddominali (cIAI)
English: Severe adverse reactions were observed in two patients (0.6 %), one infusion related reaction and one blood alkaline phosphatase increased respectively.
Maltese: Ġew osservati reazzjonijiet avversi severi f'żewġ pazjenti (0.6%), reazzjoni waħda relatata malinfużjoni u waħda żieda fil-fosfatażi alkalina fid-demm rispettivament.
English: It may be due to bacteria called Clostridium difficile.
Maltese: Dijarea assoċjata ma' Clostridium difficile
English: Patients with known seizure disorders should continue anticonvulsant therapy.
Maltese: Pazjenti b'disturbi ta' attakk ta' puplesija magħrufa għandhom ikomplu terapija antikonvulsanti.
English: • of the stomach and gut (intra-abdominal infections)
Maltese: • tal-istonku u tal-imsaren (infezzjonijiet intraaddominali)
English: New infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: Respiratory,
Maltese: Batteremija,
English: 50 ml clear glass vial (Type 1) closed with a rubber (bromobutyl) stopper and aluminium overseal with flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett ta' ħġieġ ċar (Tip 1) ta' 50 ml magħluq b'tapp tal-gomma (bromobutyl) u siġill tal-aluminju b'għatu tat-tip flip-off.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 g meropenem/1 g vaborbactam LIST OF EXCIPIENTS Sodium carbonate
Maltese: ATTIVA(I) 1 g meropenem/1 g vaborbactam