FrancophonIA/ELRC3.0 huggingface dataset:
English: There was increased evidence of abortions at 500 mg/kg in a preliminary study in monkeys.
Maltese: Kien hemm aktar evidenza ta' aborti b'500 mg/kg fi studju preliminari fix-xadini.
English: The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2-5 years), 5.3 ml/min/kg (623 months) and 4.3 ml/min/kg (2-5 months).
Maltese: Il-medja tal-valuri tat-tneħħija ta' meropenem kienu 5.8 ml/min/kg (6-12-il sena), 6.2 ml/min/kg (2-5 snin), 5.3 ml/min/kg (6-23 xahar) u 4.3 ml/min/kg (2-5 xhur).
English: In individuals with normal renal function, rapid renal elimination will occur.
Maltese: F'individwi b'funzjoni renali normali, isseħħ eliminazzjoni renali rapida.
English: Cheshire SK10 2NA United Kingdom
Maltese: Cheshire SK10 2NA Ir-Renju Unit
English: The CHMP agreed with the updated harmonised wording proposed for the sections Pregnancy and Lactation in section 4.6, that was in line with the ‘Guideline on risk assessment of medicinal products on human reproduction and lactation (EMEA/CHMP/203927/2005, July 2008)'
Maltese: Is-CHMP qabel mal-kliem armonizzat aġġornat propost għas-sezzjonijiet Tqala u Treddigħ fissezzjoni 4.6, li kien konformi mal-'Linja gwida dwar il-valutazzjoni tar-riskju ta' prodotti mediċinali fuq ir-riproduzzjoni tal-bniedem u t-treddigħ (EMEA/CHMP/203927/2005, Lulju 2008)'
English: Content (concentration)
Maltese: (Konċentrat)
English: Common rash, pruritis
Maltese: Komuni raxx, ħakk
English: Furthermore, meropenem has not been formally evaluated in a clinical trial for VAP.
Maltese: Barra minn hekk, meropenem ma ġiex ivvalutat formalment fi prova klinika għal VAP.
English: Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60 %T>MIC for P. aeruginosa in 95 % of pre-term and 91 % of full term neonates.
Maltese: Simulazzjoni Monte Carlo ibbażata fuq popolazzjoni ta' mudell PK wriet li dożaġġ ta' 20 mg/kg kull 8 sigħat kisbet 60 %T>MIC għal P.aeruginosa f'95 % qabel it-termini u 91 % ta' trabi tat-twelid li temmew it-termini kollu.
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Maltese: Speċi li r-reżistenza akkwistata tista' tkun problema Erobiċi Gram-posittivi
English: "CANA" SA Pharmaceutical laboratories
Maltese: CANA Pharmaceutical Laboratories Societe Anonyme
English: The CHMP finally agreed the following indication:
Maltese: Finalment, is-CHMP qabel mal-indikazzjoni li ġejja:
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Maltese: Il-Ġermanja AstraZeneca GmbH Tinsdaler Weg 183
English: After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively.
Maltese: Wara infużjoni fuq 5 minuti il-vauri Cmax huma 52 u 112 µg/ml wara dożi ta' 500 u 1000 mg rispettivament.
English: Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6).
Maltese: Meropenem għandu jingħata permezz ta' infużjoni għal ġol-vina fuq madwar 15 sa 30 minuta (ara sezzjoni 6.2, 6.3 u 6.6).
English: In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml.
Maltese: Dożi ta' 500, 1000 u 2000 mg infużi fuq 30 minuta jagħtu medja ta' valuri ta' Cmax ta' madwar 23, 49 u 115 µg/ml rispettivament, li jikkorrispondu għal valuri ta' AUC ta' 39.3, 62.3 u 153 µg.h/ml.
English: • The injection may take about 5 minutes or between 15 and 30 minutes.
Maltese: • L-injezzjoni tista tieħu madwar 5 minuti jew bejn 15 u 30 minuta.
English: Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates.
Maltese: Meropenem intwera li jippenetra f'ħafna fluwidi tal-ġisem u tessuti: inkluż il-pulmun, sekrezzjonijiet tal-bronki, bajl, fluwidu ċerebro-spinali, tessuti ġinekoloġiċi, ġilda, faxja, muskoli u tisfijiet tal-peritonew.
English: Complicated skin and skin structure infections (cSSSI)
Maltese: Infezzjonijiet ikkumplikati tal-ġilda u tal-istruttura tal-ġilda (complicated skin and skin structure infections - cSSSI)
English: There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg.
Maltese: Ma kienx hemm evidenza ta' potenzjal mutaġeniku f'batterija ta' test konvenzjonali u l-ebda evidenza ta' tossiċità fuq is-sistema riproduttiva inkluż potenzjal teratoġeniku fi studji fil-firien sa 750mg/kg u fix- xadini sa 360mg/kg.
English: 2745-663 Barcarena, Portugal
Maltese: Rua Humberto Madeira, n.º 7, Valejas 2745-663 Barcarena, IlPortugall
English: Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days.
Maltese: Tnaqqis tal-livelli fid-demm ta' valproic acid kienu rrapportati meta ingħata ma sustanzi ta' carbapenem lir-riżulta fi tnaqqis ta' 60-100% fil-livelli ta' valproic acid fi żmien jumejn.
English: • Sodium valproate (used to treat epilepsy).
Maltese: • Sodium valproate (jintuża biex jikkura l-epilessija).
English: Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6).
Maltese: Meropenem għandu jingħata bħala infużjoni għal ġol-vina fuq madwar 15 sa 30 minuta (ara sezzjoni .2, 6.3 u 6.6).
English: The signs may include a sudden onset of:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: Meropenem is generally well tolerated by the central nervous system.
Maltese: Meropenem b'mod ġenerali jiġi tollerat sew mis-sistema nervuża ċentrali.
English: There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Maltese: M'hemmx cross-resistance ibbażata fuq il-mira bejn meropenem u klassijiet oħra ta' sustanzi bħal quinolones, aminoglycosides, macrolides u tetracyclines.
English: A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l.
Maltese: Studju ta' 12-il pazjent li ngħataw meropenem 1000 mg kull 8 sigħat wara operazzjoni għal infezzjonijiet intra-addominali wrew Cmax u half-life li setgħu jitqabblu ma' dawk ta' individwi normali iżda b'volum ta' distribuzzjoni akbar 27 l.
English: • Complicated intra-abdominal infections
Maltese: • Infezzjonijiet intra-addominali ikkumplikati
English: Limited safety data are available to support the 2 g intravenous bolus or the corresponding paediatric 40 mg/kg bolus
Maltese: Dejta ta' sigurtà limitata hija disponibbli sabiex tappoġġja il-bolus ta' 2 g minn ġol-vini jew il-bolus pedjatriku korrispondenti ta' 40 mg/kg
English: Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours).
Maltese: Tqabbil wera farmakokinetika konsistenti bejn id-dożi u l-half-lives simili għal dawk osservati fl-adulti f'kollha ħlief għall-aktar individwi żgħar (<6 xhur t½ 1.6 sigħat).
English: Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Maltese: Ġew irrappurtati xi każijiet ta' aċċessjonijiet waqt il-kura b'carbapenems, inkluż meropenem (ara ssezzjoni 4.8).
English: AstraZeneca
Maltese: AstraZeneca AB
English: Slovak Republic AstraZeneca UK Ltd.
Maltese: Is-Slovakkja AstraZeneca UK Ltd.
English: 1, Place Renault 92844 RUEIL-MALMAISON Cédex
Maltese: AstraZeneca 1, Place Renault 92844
English: Hypersensitivity to any other carbapenem antibacterial agent.
Maltese: Sensittività eċċessiva għal kwalunkwe sustanza antibatterika carbapenem oħra.
English: 2719 EE, Zoetermeer, Netherlands
Maltese: AstraZeneca BV Louis Pasteurlaan 5 2719 EE, Zoetermeer, L-Olanda
English: Dainippon Sumitomo Pharma Co. Ltd. (Oita, Japan), was the originator and ACS Dobfar SpA (Milano / Italy) is an alternative manufacturer of both the intermediate HECA, and the pure sterile meropenem trihydrate.
Maltese: (Oita, Ġappun), kien loriġinatur u ACS Dobfar SpA (Milan / Italja) huwa manifattur alternattiv kemm tal-HECA intermedju, kif ukoll tal-meropenem trihydrate sterili pur.
English: 10 or 20 mg/kg
Maltese: 10 jew 20 mg/kg
English: Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems.
Maltese: Reżistenza tal-batteri għall-meropenem tista tirriżulta minn (1) tnaqqis fil-permjabilità tal-membrana ta' barra ta' batteri Gram-negattivi (minħabba tnaqqis fil-produzzjoni ta' porins) (2) tnaqqis fl-affinità għal PBP's li huma mmirati (3) żieda fl-espressjoni ta' komponenti li jgħamlu parti mill-pompi li jimbuttawh 'l barra, u (4) produzzjoni ta' beta-lactamases li jkissru l-carbapenems.
English: 1 g/100 ml (not marketed)
Maltese: Użu għal ġol-vini 1 g/100 ml (not marketed)
English: A dose is usually given every 8 hours.
Maltese: Doża normalment tingħata kull 8 sigħat.
English: Broncho-pulmonary infections in cystic fibrosis
Maltese: Infezzjonijiet bronko-pulmonari fil-fibrożi ċistika
English: The CHMP therefore unanimously considered that there is no place for CLSI as soon as EUCAST breakpoints are available.
Maltese: Għaldaqstant, is-CHMP ikkunsidra b'mod unanimu li m'hemmx lok għal CLSI malli l-breakpoints tal-EUCAST ikunu disponibbli.
English: 1g/20 ml 5 mg / ml
Maltese: Użu għal ġol-vini 1g/20 ml 5 mg/ ml
English: 5 Non-species related breakpoints have been determined mainly from PK/PD data and are independent of the MIC distributions of specific species.
Maltese: Punti ta' fini li mhumiex relatati ma' l-ispeċi kienu determinati mid-dejta ta' PK/PD u huma indipendenti mid-distribuzzjoni ta' l-MIC għall-ispeċi speċifiċi.
English: Considering this, Section 4.4 was revised with amendments to the paragraphs on hypersensitivity and the gastro-intestinal system.
Maltese: Meta wieħed iqis dan, isSezzjoni 4.4 ġiet riveduta b'emendi għall-paragrafi dwar is-sensittività eċċessiva u s-sistema gastrointestinali.
English: Complicated intra-abdominal infections
Maltese: Infezzjonijiet intra-addominali ikkumplikati
English: Meronem 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Meronem 500 mg: Dan il-prodott mediċinali fih bejn wieħed u ieħor 2.0 mEq ta' sodium għal kull doża ta' 500 mg li għandha tkun meqjusa minn pazjenti fuq dieta kkontrollata ta' sodju.
English: • Probenecid (used to treat gout).
Maltese: • Probenecid (jintuża biex jikkura l-gotta)
English: Uncommon eosinophilia, thrombocytopenia, leucopenia, neutropenia
Maltese: Mhux magħruf tromboċitemija esinofilja, tromboċitopenja, lewkopenja, newtropenja agranuloċitożi, anemija imolitika
English: 500 mg/10 ml 5 mg / ml
Maltese: Użu għal ġol-vini 500 mg/10 ml 5 mg/ ml
English: LIST OF EXCIPIENTS Anhydrous sodium carbonate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Sodium carbonate anidrat.
English: Slovak Republic: Meronem 500mg i.v.
Maltese: Meronem 500mg i.v. Is-Slovenja: Meronem Spanja:
English: There were AUC increases of 2.4 fold in patients with moderate impairment (CrCL 33-74 ml/min), 5 fold in severe impairment (CrCL 4-23 ml/min) and 10 fold in haemodialysis patients (CrCL <2 ml/min) when compared to healthy subjects (CrCL >80 ml/min).
Maltese: Indeboliment renali irriżulta fl-AUC fil-plażma aktar ogħli u half-life itwal għal meropenem.Kien hemm żidiet fl-AUC ta' 2.4-il darba f'pazjenti b'indeboliment renali moderat (CrCL 33-74 ml/min), 5 darbiet f'indeboliment qawwi (CrCL 4-23 ml/min) u 10 darbiet f'pazjenti fuq l-emodijaliżi (CrCL<2ml/min) meta mqabbla ma' individwi b'saħħithom (CrCL >80 ml/min).
English: Do not store above 30°C
Maltese: Taħżinx f'aktar minn 30°C
English: Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes.
Maltese: Alternattivament, dożi sa 1 g jistgħu jingħataw bħala injezzjoni bolus għal ġol-vina fuq madwar 5 minuti.
English: The clinical and bacteriological effectiveness of meropenem as monotherapy was similar to the combination treatment of clindamycin plus gentamicin.
Maltese: L-effikaċja klinika u batterjoloġika ta' meropenem bħala monoterapija kienet simili għat-trattament ikkombinat ta' clindamycin flimkien ma' gentamicin.
English: Not known toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme.
Maltese: Mhux magħruf nekroliżi tossika tal-ġilda sindrome ta' Stevens-Johnson eritema multiforme
English: For intravenous infusion meropenem vials may be directly constituted with 0.9 % sodium chloride or 5% glucose solutions for infusion.
Maltese: Għal infużjoni għal ġol-vina l-kunjetti ta' Meronem jistgħu jiġu rikostitiwiti direttament b' 0.9% sodium chloride jew 5% glucose soluzzjonijiet għall-infużjoni.
English: For the AZ studies, complicated UTI was associated with structural and/or functional abnormalities such as prostatic hypertrophy, hydronephrosis, neurogenic bladder, vesicoureteric reflux, stricture, calculus, tumour, upper UTI or prolapse, indwelling urinary catheter, or concomitant urologic diagnostic or surgical procedure.
Maltese: Għall-istudji tal-AZ, l-UTI ikkumplikata kienet assoċjata ma' anormalitajiet strutturali u/jew funzjonali bħal ipertrofija prostatika, idronefrożi, bużżieqa tal-awrina newroġenika, vesicoureteric reflux, restrizzjoni, ġebla, tumur, UTI ta' fuq jew prolass, katiter urinarju fil-bużżieqa tal-awrina, jew dijanjostika uroloġika konkomittanti jew intervent kirurġiku.
English: The CHMP adopted a harmonised text for this section.
Maltese: Is-CHMP adotta kliem armonizzat għal din is-sezzjoni.
English: Rare convulsions (see section 4.4)
Maltese: Rari konvulżjonijiet (ara sezzjoni
English: The information presented reflects that currently approved for Dainippon Sumitomo Pharma and for ACS Dobfar SpA, and includes additional information and the changes that have taken place up to date.
Maltese: L-informazzjoni ppreżentata tirrifletti dik approvata fil-preżent għal Dainippon Sumitomo Pharma u għal ACS Dobfar SpA, u tinkludi informazzjoni addizzjonali u l-bidliet li saru sal-lum.
English: meropenem
Maltese: Ċipru
English: 500 mg
Maltese: Meronem 500 mg.
English: Czech Republic: MERONEM
Maltese: Ir-Rpubblika Ċeka: MERONEM
English: The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs.
Maltese: Id-doża normali hi bejn 10 mg u 40 mg ta' Meronem għal kull kilogram (kg) illi jiżen it-tifel/tifla.
English: Meronem 1.0 g: This medicinal product contains approximately 4.0 mEq of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Meronem 1.0 g: Dan il-prodott mediċinali fih bejn wieħed u ieħor 4.0 mEq ta' sodium għal kull doża ta' 1.0 g li għandha tkun meqjusa minn pazjenti fuq dieta kkontrollata ta' sodju.
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark
Maltese: 2620 Albertslund Id-Danimarka
English: Meronem 500 mg 674 mg powder in a 20 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap Meronem 1 g 1348 mg powder in a 30 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap)
Maltese: 1348 mg trab f'kunjett ta' 30 ml tal-ħġieġ Tip 1 bl-għatu (griż ta' gomma halobutilic b'kappa ta' laluminium).
English: Severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).
Maltese: Sensittività eċċessiva severa (eż. reazzjoni anafilattika, reazzjoni severa fil-ġilda) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż peniċillini jew cephalosporins).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Meropenem trihydrate equivalent to 500 mg anhydrous meropenem Meropenem trihydrate equivalent to 1 g anhydrous meropenem
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih meropenem trihydrate ekwivalenti għal 500mg meropenem anidrat
English: • Acute bacterial meningitis
Maltese: • Meninġite tal-batteri akuta
English: They have no effect against infections caused by viruses.
Maltese: M'għandhomx effett kontra infezzjonijiet tal-virus.
English: The IV LD50 of meropenem in rodents is greater that 2000 mg/kg.
Maltese: Il-LD50 meta meropenem jingħata IV fl-annimali hija akbar minn 2000 mg/kg.
English: Due to the rapid onset and the extent of the decrease, co-administration of valproic acid with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4).
Maltese: Minħabba lbidu qalil u l-ammont ta' tnaqqis, li jingħata valproic acid ma sustanzi ta' carbapenem, mhux ikkunsidrat addattat u għalhekk għandu jiġi evitat (ara sezzjoni 4.4).
English: The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
Maltese: L-uniku metabolu ta' meropenem kellu profil ta' tossiċità baxxa simili fi studji fuq annimali.
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7
Maltese: L-Awstrija AstraZeneca Österreich GmbH,
English: Injection
Maltese: Infezzjoni
English: Meropenem is mentioned as a recommended drug in therapeutic guidelines and the indication “Intra-abdominal infections” is approved in all 29 European countries.
Maltese: Meropenem jissemma' bħala mediċina rrakkomandata f'linji gwida terapewtiċi u l-indikazzjoni “Infezzjonijiet intra-addominali kkumplikati” hija approvata fid-29 pajjiż Ewropew kollha.
English: Recent susceptibility data for European isolates from various surveillance programmes and in light of clinical data, AstraZeneca propose that P. aeruginosa and Burkholderia cepacia will be listed under species that may be resistant to meropenem.
Maltese: Dejta reċenti ta' suxxettibilità għal iżolati Ewropej minn diversi programmi ta' sorveljanza u fid-dawl ta' dejta klinika, AstraZeneca jipproponi li P. aeruginosa u Burkholderia cepacia jkunu elenkati taħt lispeċi li jistgħu jkunu reżistenti għal meropenem.
English: Uncommon thrombophlebitis
Maltese: Mhux komuni tromboflebite
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih meropenem trihydrate ekwivalenti għal 500mg meropenem anidrat.
English: Consequently the CLSI paragraph was deleted and only EUCAST information was specified for this harmonised EU SPC.
Maltese: B'konsegwenza ta' dan il-paragrafu dwar is-CLSI tħassar u ġiet speċifikata biss l-informazzjoni EUCAST għal dan l-SPC armonizzat talUE.
English: Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
Maltese: Esperjenza limitata ta' wara t-tqegħid fis-suq tindika li reazzjonijiet avversi li jseħħu wara doża eċċessiva, huma konsisitenti mal-profil tar-reazzjonijiet avversi deskritti f'sezzjoni 4.8, ikunu b'mod ġenerali ħfief u jgħaddu meta titwaqqaf jew titnaqqas iddoża.
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Maltese: Il-Bulgarija AstraZeneca UK Limited 600 Capability Green Luton
English: Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Maltese: Meropenem jeżerċita l-attivita batteriċida billi jinibixxi s-sinteżi tas-cell wall ta' batteri Gram-pożittivi u Gram-negattivi billi jeħel mal-miri tal-proteini li jeħlu mal-peniċillina (PBPs).
English: For broncho-pulmonary infections in cystic fibrosis the CHMP agreed with the MAH proposal for the dosage regimen including the posology 2g/8h in adults and adolescents and children over 50 kg body weight, and 40 mg/kg q8h in children from 3 months (and under) to 11 years of age and up to 50 kg body weight, as higher doses are specifically requested in the treatment of infections due to Acinetobacter or P. aeruginosa.
Maltese: Għall-infezzjonijiet bronko-pulmonari fil-fibrożi ċistika, is-CHMP qabel mal-proposta tal-MAH għal reġim ta' dożar li jinkludi l-pożoloġija 2g/8 sigħat fl-adulti u fl-adolexxenti u tfal b'piż tal-ġisem ta' aktar minn 50 kg, u 40 mg/kg q8sigħat fi tfal minn 3 xhur (u iżgħar) sa 11-il sena u b'piż tal-ġisem sa 50 kg, minħabba li dożi ogħla huma meħtieġa b'mod speċjali fil-kura ta' infezzjonijiet ikkawżati minn Acinetobacter jew P. aeruginosa.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Il-ġustifkazzjoni sabiex ma jiġix inkluż il-braille ġiet aċċettata
English: After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion.
Maltese: Wara għotja mgħaġġla (5 minuti jew anqas) il-farmakokinteika tkun biesponenzjali iżda tkun ferm anqas evidenti wara infużjoni ta' 30 minuta.
English: PHARMACEUTICAL PARTICULARS
Maltese: Farmaċewtika
English: MERREM 250 mg Powder and solvent for solution for infusion
Maltese: MERREM 250 mg polvere e solvente per soluzione per infusione
English: It inhibits bacterial wall synthesis like other beta-lactam antibiotics, but is resistant to degradation by beta-lactamases or cephalosporinases.
Maltese: Jinibixxi s-sinteżi ta' ħajt batteriku bħal antibijotiċi beta-lactam oħrajn, iżda huwa reżistenti għad-degradazzjoni minn betalactamases jew cephalosporinases.
English: 250 mg/5 ml (not marketed)
Maltese: 500 mg/2 ml (mhux fis-suq)
English: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
Maltese: Kull kunjett fih meropenem trihydrate ekwivalenti għal 1 g meropenem anidrat.
English: The CHMP considered that meropenem has a relatively low acute toxicity, even though effects on the kidney were seen in mice at 2200 mg/kg, dogs at 2000 mg/kg and monkeys at 500mg/kg.
Maltese: Is-CHMP ikkunsidra li meropenem għandu tossiċità akuta relattivament baxxa, anki jekk dehru effetti fuq il-kliewi fil-ġrieden b'2200 mg/kg, fil-klieb b'2000 mg/kg u fix-xadini b'500 mg/kg.
English: The pharmacokinetics in infants and children with infection at doses of 10, 20 and 40 mg/kg showed Cmax values approximating to those in adults following 500, 1000 and 2000 mg doses, respectively.
Maltese: Il-farmakokinetika fi tfal żgħar u tfal b'infezzjoni b'dożi ta' 10, 20 u 40 mg/kg urew valuri ta' Cmax li jqarrbu għal dawk fl-adulti wara dożi ta' 500, 1000 u 2000 mg rispettivament.
English: Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study.
Maltese: Evidenza istoloġika ta' ħsara fit-tubi rqaq tal-kliewi dehret biss fi ġrieden u klieb meta ngħataw dożi ta' 2000 mg/kg u aktar wara li ingħata darba u aktar u fix-xadini b'500mg/kg fi studju ta' 7-tijiem.
English: The amount of liquid that you need is shown in the table below: Dose of Meronem Amount of ‘Water for Injections' needed for dilution 500 mg (milligrams) 10 ml (milliliters) 1 g (gram)
Maltese: Doża ta' Meronem Ammont ta' ‘Ilma għallinjezzjoni' meħtieġa għaddiluzzjoni 500 mg (milligrammi) 10 ml (millilitri) 1 g (gramma)