FrancophonIA/ELRC3.0 huggingface dataset:
English: The hypotensive effects of dexmedetomidine may be of greater significance in those patients with preexisting hypotension (especially if not responsive to vasopressors), hypovolaemia, chronic hypotension or reduced functional reserve such as patients with severe ventricular dysfunction and the elderly and special care is warranted in these cases (see section 4.3).
Maltese: L-effetti ipotensivi ta' dexmedetomidine jistgħu jkunu ta' sinifikat akbar f'dawk il-pazjenti li diġà għandhom pressjoni baxxa (speċjalment jekk ma jirrispondux għal sustanzi li jikkawżaw tidjiq tal kanali tad-demm), ipovolemija, pressjoni baxxa kronika jew riserva funzjonali mnaqqsa bħal pazjenti b'disfunzjoni ventrikulari severa u l-anzjani u kura speċjali hija meħtieġa f'dawn il-każijiet (ara sezzjoni 4.3).
English: The mean percentage of unbound dexmedetomidine in plasma ranged from 8.5% in healthy subjects to 17.9% in subjects with severe hepatic impairment.
Maltese: Il-persentaġġ medju ta' dexmedetomidine mhux marbut filplażma jvarja minn 8.5% f'individwi f'saħħithom għal 17.9% f'individwi b'indeboliment epatiku sever.
English: Common (affects 1 to 10 users in 100) - chest pain or heart attack - fast heart rate - low or high blood sugar - nausea, vomiting or dry mouth - restlessness - high temperature - symptoms after stopping the medicine
Maltese: - sintomi wara li titwaqqaf il-mediċina Mhux komuni (jaffettwa persuna waħda sa 10 minn kull 1,000 li jużawh) - funzjoni tal-qalb imnaqqsa - nefħa fl-istonku
English: The pharmacokinetics of dexmedetomidine has been assessed following short term IV administration in healthy volunteers and long term infusion in ICU population.
Maltese: Il-farmakokinetika ta' dexmedetomidine kienet evalwata wara għoti IV fuq perjodu qasir lil voluntiera f'saħħithom u infużjoni fuq perjodu twil f'popolazzjoni fl-ICU.
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Maltese: Kull kunjett ta' 4 mL fih 400 mikrogramma ta' dexmedetomidine.
English: Dexmedetomidine normally does not cause deep sedation and patients may be easily roused.
Maltese: Dexmedetomidine normalment ma jikkawżax sedazzjoni fil-fond u l-pazjenti jistgħu jitqajmu faċilment.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The clinical significance is unknown.
Maltese: Is-sinifikat kliniku mhux magħruf.
English: Dexmedetomidine is metabolised in the liver and should be used with caution in patients with hepatic impairment.
Maltese: Dexmedetomidine huwa metabolizzat fil-fwied u għandu jintuża b'attenzjoni f'pazjenti b'indeboliment epatiku.
English: N
Maltese: Ċ.
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Maltese: Dexdor għandu jingħata minn professjonisti fil-kura tas-saħħa mħarrġa flimmaniġġar ta' pazjenti li jeħtieġu kura intensiva.
English: A risk to infants cannot be excluded.
Maltese: Ir-riskju għat-trabi tat-twelid mhux eskluż.
English: Delirium measured by the CAM-ICU scale was reduced in a study compared to midazolam and delirium-related adverse events were lower on dexmedetomidine compared to propofol.
Maltese: Delirju mkejjel bl-iskala CAM-ICU kien imnaqqas fi studju meta mqabbel ma' midazolam u avvenimenti avversi relatati ma' delirju kienu iktar baxxi b'dexmedetomidine meta mqabbel ma' propofol.
English: The major urinary metabolites are the two isomeric N-glucuronides, which together accounted for approximately 34% of the dose and N-methyl 3-hydroxymethyl dexmedetomidine O-glucuronide that accounted for 14.51% of the dose.
Maltese: 3-hydroxymethyl dexmedetomidine O-glucuronide li ammonta għal 14.51% tad-doża.
English: The most abundant circulating dexmedetomidine metabolites are two isomeric Nglucuronides.
Maltese: Il-metaboliti l-aktar abbundanti ta' dexmedetomidine fiċċirkolazzjoni huma ż-żewġ N-glucuronides isomeriċi.
English: However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine or the concomitant anaesthetic, sedative, hypnotic or opioid may be required.
Maltese: Madankollu, minħabba l-interazzjonijiet farmakodinamiċi possibbli, meta jingħataw flimkien ma' dexmedetomidine, jista' jkun hemm bżonn ta' tnaqqis fid-dożaġġ ta' dexmedetomidine jew tal-anestetiku, sedattiv, ipnotiku jew opjojd mogħti fl-istess waqt.
English: 2 ml Type I glass ampoules
Maltese: 3 snin Wara d-dilwazzjoni
English: The mean body weight associated with these Vss and Cl estimates was 69 kg.
Maltese: Il-piż tal-ġisem medju assoċjat ma' dawn l-estimi ta' Vss u Cl kien ta' 69 kg.
English: Uncommon: Dyspnoea, apnoea
Maltese: Ipergliċemija, ipogliċemija
English: The most frequently reported adverse reactions with dexmedetomidine in procedural sedation are listed below (the protocols of phase III studies contained pre-defined thresholds for reporting changes in blood pressure, respiratory rate and heart rate as AEs).
Maltese: III kien fihom limiti definiti minn qabel għar rappurtar ta' bidliet fil-pressjoni tad-demm, rata respiratorja u rata tat-taħbit tal-qalb bħala AEs).
English: ICU sedation.
Maltese: U L-UŻU
English: It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings.
Maltese: Huwa għandu effett simpatolitiku permezz ta' tnaqqis tar-rilaxx ta' noradrenaline fittruf tan-nervituri tas-sistema nervuża awtonomika.
English: Children > 1 month post-natal, predominantly post-operative, have been evaluated for treatment up to 24 hours in the ICU and demonstrated a similar safety profile as in adults.
Maltese: Tfal ta' >1 xahar wara t-twelid, fil-biċċa l-kbira wara operazzjoni, kienu evalwati għal kura sa 24 siegħa fl-ICU u wrew profil ta' sigurtà simili għal dak fl-adulti.
English: The safety and efficacy of dexmedetomidine for sedation of non-intubated patients prior to and/or during surgical and diagnostic procedures was evaluated in two randomised, double-blind, placebocontrolled multicentre clinical trials.
Maltese: Sedazzjoni proċedurali/ta' meta l-pazjent ikun konxju Is-sigurtà u l-effikaċja ta' dexmedetomidine għas-sedazzjoni ta' pazjenti li ma jkunux diġà intubati qabel u/jew matul proċeduri kirurġiċi jew dijanjostiċi kienu evalwati f'żewġ provi kliniċi randomised, double blind, ikkontrollati bil-plaċebo u magħmula f'diversi ċentri.
English: NAME OF THE MEDICINAL PRODUCT Dexdor 100 micrograms/ml concentrate for solution for infusion
Maltese: Informazzjoni għall-utent Dexdor 100 mikrogramma/mL konċentrat għal soluzzjoni għall-infużjoni
English: Clinically significant hypotension or bradycardia should be treated as described in section 4.4.
Maltese: Pressjoni baxxa klinikament sinifikanti jew bradikardija għandhom jiġu kkurati kif deskritt f'sezzjoni 4.4.
English: Dexmedetomidine half life in children (1 months to 17 years) appears similar to that seen in adults, but in new-born infants (under 1 month) it appears higher.
Maltese: Il-half-life ta' dexmedetomidine fit-tfal (xahar sa 17-il sena) tidher simili għal dik osservata fl-adulti, iżda tidher li hija ogħla fi trabi tat-twelid (età inqas minn xahar).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dexmedetomidine, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal dexmedetomidine, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Body weightadjusted plasma clearance in new-born infants (under 1 month) appeared lower (0.9 l/h/kg) than in the older groups due to immaturity.
Maltese: It-tneħħija mill plażma aġġustata għall-piż tal-ġisem (età inqas minn xahar) dehret aktar baxxa (0.9 l/h/kg) milli filgruppi ta' età akbar minħabba immaturità.
English: In the case the required concentration is 8 micrograms/ml:
Maltese: F'każ li l-konċentrazzjoni meħtieġa hija ta' 8 mikrogrammi/mL:
English: Reduced fetal body weight was noted also in the rat fertility study at dose 18 µg/kg/day and was accompanied with delayed ossification at dose 54 µg/kg/day.
Maltese: Tnaqqis fil-piż tal-ġisem tal-fetu kien innutat ukoll fl-istudju dwar il-fertilità fil-firien b'doża ta' 18 µg/kg/kuljum u kien akkumpanjat minn ossifikazzjoni ttardjata b'doża ta' 54 µg/kg/kuljum.
English: - If you have any further questions, ask your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
Maltese: Sindrome ta' rtirar tal-mediċina, ipertermija
English: 2 ml glass ampoules 2, 5 or 10 ml glass vials
Maltese: Kontenituri ampulli tal-ħġieġ ta' 2 mL kunjetti tal-ħġieġ ta' 2, 5 jew 10 mL
English: Infusion time a, b
Maltese: Ħin talinfużjoni a,b
English: (see sections 4.2 and 5.2)
Maltese: (ara sezzjonijiet 4.2 u 5.2)
English: Anaerobes
Maltese: Anaerobi
English: Hypersensitivity to the active substance
Maltese: Sensittività eċċessiva għas-sustanza attiva
English: 250 mg doripenem.
Maltese: 250 mg ta' doripenem.
English: other than S. pneumoniae
Maltese: S. pneumoniae
English: Target attainment (MIC)
Maltese: Kisba immirata (MIC)
English: 500 mg doripenem.
Maltese: 500 mg ta' doripenem.
English: (see sections 4.2 and 5.1).
Maltese: (ara sezzjonijiet 4.2 u 5.1).
English: Not known: toxic epidermal necrolysis, Stevens-Johnson syndrome
Maltese: Mhux magħruf: nekrolisi epidermali tossika, sindromu ta' Stevens-Johnson
English: In vitro studies have determined that doripenem does not inhibit or induce the activities of CYP isoforms 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 or 3A4.
Maltese: Studji in vitro ddeterminaw li doripenem ma jimpedixxix jew jinduċi l-attivitajiet tal-isoformi CYP 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 jew 3A4.
English: Doribax is supplied in packs of 10 vials.
Maltese: Doribax jiġi f'pakketti ta' 10 kunjetti.
English: Staphylococcus aureus (methicillin susceptible strains only) Staphylococcus spp.
Maltese: Staphylococcus aureus (razez suxxettibbli għal methicillin biss) Staphylococcus spp.
English: sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni
English: Elderly patients ( 65 years of age)
Maltese: Pazjenti anzjani ( 65 sena)
English: Doribax contains the active substance doripenem.
Maltese: Doribax fih is-sustanza attiva doripenem.
English: CRRT: continuous renal replacement therapy; CVVH: continuous venovenous haemofiltration; CVVHDF: continuous venovenous haemodiafiltration; MIC: minimum inhibitory concentration
Maltese: CVVH: emofiltrazzjoni kontinwa venovenuża; CVVHDF: emo-dijafiltrazzjoni kontinwa venovenuża;
English: Common: pruritus, rash
Maltese: Komuni: ħakk, raxx
English: - The treatment course usually lasts 5 to 14 days.
Maltese: - Il-kors tat-trattament is-soltu jdum bejn 5 u 14-il ġurnata.
English: S  1 mg/l and R > 4 mg/l
Maltese: S 1 mg/l u R >4 mg/l
English: Common: phlebitis
Maltese: Komuni: flebite
English: Seizures have been reported during treatment with Doribax and antibiotics that work in a similar way to Doribax.
Maltese: Aċċessjonijiet ġew irrappurtati waqt kura b'Doribax u antibijotiċi li jaħdmu b'mod simili għal Doribax.
English: Doripenem is a synthetic carbapenem antibacterial agent.
Maltese: Mekkaniżmu ta' azzjoni Doripenem huwa sustanza anti-batterika carbapenem sintetika.
English: Doripenem AUC increased 49% in elderly adults relative to young adults.
Maltese: L-AUC ta' doripenem żdiedet 49% f'adulti anzjani meta mqabbla ma' adulti żgħażagħ.
English: Following a single 500 mg dose of Doribax, doripenem AUC increased 1.6-fold, 2.8-fold, and 5.1-fold in subjects with mild (CrCl 51-79 ml/min), moderate (CrCl 31-50 ml/min), and severe renal impairment (CrCl  30 ml/min), respectively, compared to age-matched healthy subjects with normal renal function (CrCl > 80 ml/min).
Maltese: Wara doża waħda ta' 500 mg Doribax, l-AUC ta' doripenem żdiedet 1.6 drabi, 2.8 drabi u 5.1 drabi aktar f'individwi b'indeboliment ħafif tal-kliewi (CrCl 51-79 ml/min), moderat (CrCl 31-50 ml/min), u sever (CrCl 30 ml/min), rispettivament, meta mqabbla ma' individwi f'saħħithom li huma ndaqs fletà b'funzjoni normali tal-kliewi (CrCl >80 ml/min).
English: The clinical cure rate at the end of treatment visit on day 10 was numerically lower for subjects in the doripenem arm of the primary microbiological intent-to-treat (MITT) (45.6% versus 56.8%; 95% CI: -26.3%; 3.8%) and co-primary microbiologically evaluable (ME) (49.1% [28/57] versus 66.1% [39/59]); 95% CI: -34.7%; 0.8%) analysis sets.
Maltese: 3%; 3.8%) u settijiet ta' analiżi ko-primarji mikrobijoloġikament evalwabbli (ME) (49.1% [28/57] kontra 66.1% [39/59]); 95% CI -34.7%; 0.8%).
English: dextrose 50 mg/ml (5%) solution for injection
Maltese: dextrose 50 mg/ml (5%) soluzzjoni għallinjezzjoni
English: Continuous renal replacement therapy
Maltese: Terapija ta' sostituzzjoni tal-kliewi kontinwa
English: Other sources of infection included colon perforation (20%), complicated cholecystitis (5%) and infections at other sites (14%).
Maltese: Sorsi oħra ta' infezzjoni kienu jinkludu titqib fil-kolon (20%), koleċistite kkumplikata (5%) u infezzjonijiet f'siti oħra (14%).
English: Luxembourg/Luxemburg JANSSEN-CILAG NV/SA Belgique/Belgien Tél/Tel: +32 14 64 94 11
Maltese: JANSSEN-CILAG NV/SA Tel/Tél: + 32 14 64 94 11
English: and Acinetobacter spp.
Maltese: Acinetobacter spp.
English: Adults (including people over 65 years of age) - The usual dose is 500 mg every eight hours.
Maltese: Adulti (inkluż persuni 'l fuq minn 65 sena) - Id-doża tas-soltu hija ta' 500 mg mogħtija kull tmien sigħat.
English: and Acinetobacter spp.).
Maltese: u Acinetobacter spp.).
English: Of these, 51% had generalised peritonitis at baseline.
Maltese: Minn dawn, 51% kellhom peritonite ġeneralizzata fil-linja bażi.
English: Solution stored in a refrigerator (2C-8C)
Maltese: Soluzzjoni maħżuna ġewwa friġġ (2 C-8 C)
English: Other medicines and Doribax
Maltese: Mediċini oħra u Doribax
English: The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Maltese: L-impatt tal-età fuq il-farmakokinetika ta' doripenem kien evalwat f'individwi nisa u rġiel anzjani f'saħħithom (66-84 sena).
English: Janssen Pharmaceutica NV
Maltese: Janssen Pharmaceutica NV Turnhoutseweg 30
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: 72 hours*
Maltese: 72 siegħa *
English: Adverse drug reactions that led to Doribax discontinuation were nausea (0.1%), diarrhoea (0.1%), pruritus (0.1%), vulvomycotic infection (0.1%), hepatic enzyme increased (0.2%) and rash (0.2%).
Maltese: Reazzjonijiet avversi tal-mediċina li wasslu biex ma titkompliex il-kura b'Doribax kienu tqalligħ (0.1%), dijarea (0.1%), ħakk (0.1%), infezzjoni bil-moffa fil-vulva (0.1%), żieda fl-enzimi tal-fwied (0.2%) u raxx (0.2%).
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH04.
Maltese: Antibatteriċi għal użu sistemiku, carbapenems, Kodiċi ATC:
English: Doribax was discontinued because of adverse drug reactions in 0.1% of patients overall.
Maltese: Doribax twaqqaf minħabba f'reazzjonijiet avversi tal-mediċina f'0.1% tat-total tal-pazjenti.
English: Monte Carlo simulations supported the use of 500 mg 4-hour infusions every 8 hours in subjects with normal renal function for target pathogens with doripenem MICs  4 mg/l.
Maltese: Simulazzjonijiet Monte Carlo appoġġjaw l-użu ta' infużjonijiet ta' 500 mg fuq 4 sigħat kull 8 sigħat f'individwi b'funzjoni normali tal-kliewi għall-patoġeni fil-mira b'MICs 4 mg/l ta' doripenem.
English: Doripenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-positive and gram-negative bacteria, with the exception of relatively rare carbapenem hydrolysing beta-lactamases.
Maltese: Doripenem huwa stabbli għal idrolisi millmaġġoranza ta' beta-lactamases, inklużi penicillinases u cephalosporinases li jipproduċuhom batterji gram-pożittivi u gram-negattivi, bl-eċċezzjoni tal-beta-lactamases relattivament rari li jidrolizzaw ilcarbapenems.
English: Hypersensitivity to any other carbapenem antibacterial agent Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
Maltese: Sensittività eċċessiva għal kwalunkwe sustanza antibatterjali carbapenem oħra Sensittività eċċessiva severa (eż. reazzjoni anafilattika, reazzjoni severa fil-ġilda) għal kull tip ieħor ta' sustanza antibatterjali beta-lactam (eż. penicillins jew cephalosporins).
English: The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg and 1 g over 4 hours are approximately 8 µg/ml and 17 µg/ml, and 34 µg.h/ml and 68 µg.h/ml, respectively.
Maltese: Il-medja tasCmax u l-AUC0-∞ ta' doripenem f'individwi f'saħħithom fi studji wara l-għoti ta' 500 mg u 1 g fuq perjodu ta' erba' sigħat huma bejn wieħed u ieħor 8 µg/ml u 17 µg/ml, u 34 µg.h/ml u 68 µg.h/ml, rispettivament.
English: Each vial contains doripenem monohydrate equivalent to 250 mg doripenem.
Maltese: Kull kunjett fih doripenem monohydrate ekwivalenti għal 250 mg doripenem.
English: In patients with moderate renal impairment (CrCl ≥ 30 to  50 ml/min), the dose of doripenem should be 250 mg every 8 hours (see section 6.6).
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi (CrCl ≥ 30 sa  50 ml/min), id-doża ta' doripenem għandha tkun ta' 250 mg kull 8 sigħat (ara sezzjoni 6.6).
English: Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Not known (cannot be
Maltese: Komuni ħafna (≥1/10); Komuni (≥1/100 sa <1/10); Mhux komuni (≥1/1,000 sa <1/100); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: What Doribax contains - The active substance is doripenem.
Maltese: X'fih Doribax - Is-sustanza attiva hija doripenem.
English: Each vial contains 250 mg doripenem (as monohydrate).
Maltese: Kull kunjett fih 250 mg doripenem (bħala monohydrate).
English: Therefore, close safety monitoring is advised.
Maltese: Għalhekk, huwa konsiljat li jkun hemm monitoraġġ mil-qrib tas-sigurtà.
English: Additive activity or weak synergy with amikacin and levofloxacin has been seen for Pseudomonas aeruginosa and for gram-positive bacteria with daptomycin, linezolid, levofloxacin, and
Maltese: Attività addizzjonali jew sinerġija dgħajfa b'amikacin u levofloxacin intweriet għal Pseudomonas aeruginosa u għal batterji gram-pożittivi b'daptomycin, linezolid, levofloxacin, u vancomycin.
English: Doripenem undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
Maltese: Doripenem jgħaddi minn ftit jew l-ebda metaboliżmu medjat miċ-Ċitokroma P450 (CYP450).
English: Each vial contains doripenem monohydrate equivalent to 500 mg doripenem.
Maltese: Kull kunjett fih doripenem monohydrate ekwivalenti għal 500 mg doripenem.
English: In two clinical trials of patients with complicated intra-abdominal infections (N=962) the most common anatomical site of infection in microbiologically-evaluable Doribax-treated patients was the appendix (62%).
Maltese: F'żewġ provi kliniċi fuq pazjenti b'infezzjonijiet intraaddominali kkumplikati (N=962) l-aktar sit anatomiku komuni ta' infezzjoni f'pazjenti kkurati b'Doribax li seta' jkollhom evalwazzjoni mikrobijoloġika kien l-appendiċi (62%).
English: The amount of doripenem and doripenem-M-1 removed during a 12-hour CVVH session was approximately 28% and 10% of the dose, respectively; and during a 12-hour CVVHDF session was approximately 21% and 8% of the dose, respectively.
Maltese: L-ammont ta' doripenem u doripenem-M-1 imneħħija waqt sessjoni CVVH fuq 12-il siegħa kienet madwar 28% u 10% tad-doża, rispettivament; u waqt sessjoni ta' 12-il siegħa b'CVVHDF kienet 21% u 8% tad-doża, rispettivament.
English: Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of doripenem exceeds the minimum inhibitory concentration (%T>MIC) of the infecting organism has been shown to best correlate with efficacy in pre-clinical pharmacokinetic/pharmacodynamic (PK/PD) studies.
Maltese: Bħal sustanzi oħra beta-lactam kontra l-mikrobi, il-ħin li l-konċentrazzjoni ta' doripenem fil-plażma taqbeż il-minimum inhibitory concentration (%T>MIC) tal-organiżmu infettiv intweriet li taqbel laktar mal-effikaċja ta' qabel l-istudji farmakokinetiċi u farmakodinamiċi (PK/PD) kliniċi.
English: In vitro doripenem showed little potential to antagonise or be antagonised by other antibacterial agents.
Maltese: In vitro doripenem wera ftit potenzjal li jantagonizza jew jiġi antagonizzat minn sustanzi antibatteriċi oħra.
English: Dosing recommendations for patients on continuous renal replacement therapy were developed to achieve doripenem systemic exposures similar to subjects with normal renal function who receive doripenem 500 mg as a 1-hour infusion, to maintain doripenem concentrations above a minimum inhibitory concentration of 1 mg/l for at least 35% of the dosing interval, and to maintain doripenem and doripenem-M-1 metabolite exposures below those observed with a 1-hour infusion of 1 g doripenem every 8 hours in healthy subjects.
Maltese: Rakkomandazzjonijiet dwar id-dożi għall-pazjenti fuq terapija ta' rimpjazzament renali kontinwa kienu żviluppati sabiex jinkisbu esponimenti simili għall-dawk f'individwi b'funzjoni renali normali li jirċievu doripenem 500 mg b'infużjoni fuq perijodu ta' siegħa, sabiex jinżammu l-konċentrazzjonijiet ta' doripenem il' fuq mill-konċentrazzjoni minima inibitorja ta' 1 mg/ml għal mill-anqas 35% talintervall bejn id-dożi, u biex jinżammu esponimenti ta' doripenem u doripenem-M-1 taħt dawk osservati b'infużjoni fuq perijodu ta' siegħa ta' 1 g doripenem kull 8 sigħat f'individwi b'saħħithom.
English: Each vial contains 500 mg doripenem (as monohydrate).
Maltese: Kull kunjett fih 500mg doripenem (bħala monohydrate).
English: Symptoms of overdose may include rash.
Maltese: Sintomi ta' doża eċċessiva jistgħu jinkludu r-raxx.
English: In healthy young adults given a single 500 mg dose of Doribax, 71% and 15% of the dose was recovered in urine as unchanged active substance and ring-opened metabolite, respectively.
Maltese: F'adulti żgħażagħ f'saħħithom li ngħataw doża waħda ta' 500 mg ta' Doribax, 71% u 15% tad-doża ġiet irkuprata mill-awrina bħala sustanza attiva mhux mibdula u metabolit ċirku miftuħ rispettivament.
English: In patients with severe renal impairment (CrCl < 30 ml/min), the dose of doripenem should be 250 mg every 12 hours (see section 6.6).
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (CrCl <30 ml/min), id-doża ta' doripenem għandha tkun ta' 250 mg kull 12-il siegħa (ara sezzjoni 6.6).
English: Staphylococci inferred from the methicillin breakpoint S  1 mg/l and R > 4 mg/l
Maltese: Staphylococci inferita mill-breakpoint ta' methicillin
English: The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Maltese: Il-medja tal-irbit ta' doripenem mal-proteini tal-plażma kienet bejn wieħed u ieħor 8.1% u hija indipendenti mill-konċentrazzjonijiet fil-plażma.