FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients prescribed 1 g every 8 hours as a 4-hour infusion, the dose should be similarly adjusted (moderate renal impairment: 500 mg every 8 hours; severe renal impairment: 500 mg every 12 hours).
Maltese: F'pazjenti li ngħataw riċetta għal 1 g kull 8 sigħat bħala infużjoni fuq tul ta' 4 sigħat, id-doża għandha tiġi aġġustata b'mod simili (indeboliment moderat tal-kliewi: 500 mg kull 8 sigħat; indeboliment sever tal-kliewi: 500 mg kull 12-il siegħa).
English: Prolonged use of Doribax should be
Maltese: Tużax Doribax:
English: Eleven percent had an APACHE II score of > 10, 9.5% had post-operative infections, 27% had single or multiple intra-abdominal abscesses and 4% had concurrent bacteraemia at baseline.
Maltese: Ħdax fil-mija kellhom punteġġ APACHE II ta' >10, 9.5% kellhom infezzjonijiet wara operazzjoni, 27% kellhom axxess intraaddominali wieħed jew aktar u 4% fl-istess ħin kellhom batteremija fil-linja bażi.
English: Description of the patient population treated in clinical studies In two clinical trials of patients with nosocomial pneumonia (N=979), 60% of the clinically-evaluable Doribax-treated patients had ventilator-associated pneumonia (VAP).
Maltese: Deskrizzjoni tal-popolazzjoni tal-pazjenti kkurati fi studji kliniċi F'żewġ provi kliniċi fuq pazjenti b'pulmonite li tittieħed minn ġo sptar (N=979), 60% tal-pazjenti li seta' jkollhom evalwazzjoni klinika, ikkurati b'Doribax, kellhom pulmonite assoċjata ma' ventilatur (VAP).
English: Each vial contains doripenem monohydrate equivalent to
Maltese: Kull kunjett fih doripenem monohydrate ekwivalenti għal
English: 500 mg every 8 hours
Maltese: 500 mg kull 8 sigħat siegħa
English: - Central nervous system disorders such as stroke or history of seizures.
Maltese: - Disturbi tas-sistema nervuża ċentrali bħal puplesija jew storja t'aċċessjonijiet.
English: Remove 55 ml of this solution from the infusion bag and discard.
Maltese: Neħħi 55 ml minn din is-soluzzjoni mill-borża tal-infużjoni u armiha.
English: The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg over 1 hour are approximately 23 g/ml and 36 µg.h/ml, respectively.
Maltese: Il-medja tas-Cmax u l-AUC0-∞ ta' doripenem f'individwi f'saħħithom fi studji wara l-għoti ta' 500 mg fuq perjodu ta' siegħa huma bejn wieħed u ieħor 23 µg/ml u 36 µg.h/ml, rispettivament.
English: Date of first authorisation: 25 July 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 25 Lulju 2008
English: In two clinical trials of patients with complicated urinary tract infections (N=1,179), 52% of microbiologically-evaluable Doribax-treated patients had complicated lower urinary tract infections and 48% had pyelonephritis, of which 16% were complicated.
Maltese: F'żewġ provi kliniċi fuq pazjenti b'infezzjonijiet kkumplikati fl-apparat tal-awrina (N=1,179), 52% ta' pazjenti kkurati b'Doribax li seta' jkollhom evalwazzjoni mikrobijoloġika kellhom infezzjonijiet ikkumplikati fil-parti t'isfel tal-apparat tal-awrina u 48% kellhom pajelonefrite li minnhom 16% kienu ikkumplikati.
English: Solution stored at room temperature
Maltese: Soluzzjoni maħżuna f'temperatura tal-kamra
English: Doripenem-M-1 had a slow elimination in the patient group and the half-life (and AUC) has not been satisfactorily determined.
Maltese: Doripenem-M-1 kellu eliminazzjoni bil-mod fil-grupp ta' pazjenti u l-half-life (u l-AUC) ma kienux determinate b'mod sodisfaċenti.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja għallMediċini: http://www.ema.europa.eu/.
English: Dosing recommendations for pathogens with MIC > 1 mg/l have not been established for continuous renal replacement therapy due to the potential for accumulation of doripenem and doripenem-M-1 metabolite (see sections 4.4 and 5.2).
Maltese: Rakkomandazzjonijiet tad-dożi għall-patoġeni b'MIC > 1 mg/l ma ġewx stabbiliti għat-terapija ta' rimpjazzament renali kontinwu minħabba li jista' jkun hemm akkumulu tal-metabolu doripenem-M-1 (ara sezzjonijiet 4.4 u 5.2).
English: Uncommon: hypersensitivity reactions (see section 4.4) Not known: anaphylaxis (see section 4.4)
Maltese: Mhux komuni: reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.4)
English: Overall, 54% of patients had a persistent complication, 9% had concurrent bacteraemia and 23% were infected with a levofloxacin
Maltese: B'kollox 54% tal-pazjenti kellhom kumplikazzjoni persistenti, 9% fl-istess ħin kellhom batteremija u 23% kienu infettati b'patoġenu tal-awrina reżistenti għal levofloxacin fil-linja bażi.
English: The usual treatment duration for patients with nosocomial pneumonia, including ventilator-associated pneumonia is 10 to 14 days and is often in the upper range for patients infected with non-fermenting gram-negative pathogens (such as Pseudomonas spp.
Maltese: It-tul ta' kura għal pazjenti bi pnewmonja nosokomjali, inkluż pnewmonja assoċjata mal-ventilatur issoltu huwa ta' bejn 10 t'ijiem u 14-il ġurnata u ta' spiss jinsab fil-firxa ta' fuq għal pazjenti infettati b'patoġeni li ma jiffermentawx u gram-negattivi (bħal Pseudomonas spp.
English: The most common adverse reactions were headache (10%), diarrhoea (9%) and nausea (8%).
Maltese: L-aktar reazzjonijiet avversi komuni kienu wġigħ ta' ras (10%), dijarea (9%) u tqalligħ (8%).
English: The overall 28-day all cause mortality rate was numerically higher for doripenem treated subjects in the MITT analysis set (21.5% versus 14.8%; 95% CI: -5.0%; 18.5%).The difference in clinical cure rate between doripenem versus imipenem/cilastatin was greater in patients with APACHE score > 15 (16/45 [36%] versus 23/46 [50%]) and in patients infected with Pseudomonas aeruginosa
Maltese: Id-differenza fir-rata klinika ta' fejqan bejn doripenem kontra imipenem/cilastatin kienet akbar f'pazjenti li kellhom il-punteġġ APACHE >15 (16/45 [36%] versus 23/46 [50%]) u f'pazjenti infettati b'Pseudomonas aeruginosa 7/17 [41%] versus 6/10 [60%]).
English: Based mainly on PK/PD considerations, a 4-hour infusion time may be more suitable to maximize the percentage time during the dosing interval that the plasma concentration of doripenem exceeds the minimum inhibitory concentration (%T > MIC), (see section 5.1).
Maltese: Ibbażat primarjament fuq konsiderazzjonijiet ta' PK/PD, perijodu ta' infużjoni ta' 4 sigħat jista' jkun aktar xieraq sabiex il-perċentwali talħin waqt l-intervall bejn id-dożi li l-konċentrazzjoni fil-plażma ta' doripenem taqbeż il-konċentrazzjoni inibitorja minima (%T > MIC) jilħaq il-massimu (ara sezzjoni 5.1).
English: JANSSEN-CILAG Polska Sp. z o.o.
Maltese: JANSSEN-CILAG s.r.o.
English: Very common: headache Uncommon: seizures (see section 4.4)
Maltese: Komuni ħafna: uġigħ ta' ras Mhux komuni: aċċessjonijiet (ara sezzjoni 4.4)
English: Common: nausea, diarrhoea Uncommon: C. difficile colitis (see section 4.4)
Maltese: Mhux magħruf: anafilassi (ara sezzjoni 4.4)
English: The study was stopped early based on the recommendation of an independent data monitoring committee.
Maltese: L-istudju twaqqaf qabel il-waqt fuq rakkomandazzjoni ta' kumitat ta' monitoraġġ tad-dejta indipendenti.
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to doripenem or not.
Maltese: L-informazzjoni li ġejja tagħti biss indikazzjoni approssimattiva talprobabbiltà ta' jekk il-mikroorgani¿mu hux se jkun suxxettibbli għal doripenem jew le.
English: In an interaction study, the serum concentrations of valproic acid were markedly reduced (AUC was reduced by 63%) following co-administration of doripenem and valproic acid.
Maltese: Fi studju dwar interazzjonijiet, il-konċentrazzjonijiet ta' valproic acid fis-serum tnaqqsu b'mod notevoli (l-AUC tnaqqas b'63%) wara li doripenem u valproic acid ingħataw flimkien.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Maltese: Breakpoints fil-konċentrazzjoni impeditorja minima (MIC) stabbiliti mill-Kumitat Ewropew dwar Ittestjar ta' Suxxettibilità Kontra l-Mikrobi (EUCAST) huma kif ġej:
English: (methicillin susceptible strains only)
Maltese: (razez suxxettibbli għal methicillin biss) Streptococcus pneumoniae
English: In 3,142 adult patients (1,817 of which received Doribax) evaluated for safety in phase II and phase III clinical trials, adverse reactions due to Doribax 500 mg every 8 hours occurred at a rate of 32%.
Maltese: Fi 3,142 pazjenti adulti (li minnhom 1,817 irċivew Doribax) li kienu evalwati għas-sigurtà fi provi kliniċi ta' fażi
English: Close safety monitoring is advised for patients on continuous renal replacement therapy, due to limited clinical data and an expected increased exposure to doripenem-M-1 metabolite (see section 4.4).
Maltese: Monitoraġġ mil-qrib għas-sigurtà huwa konsiljat għall-pazjenti fuq terapija ta' rimpjazzament renali kontinwa, minħabba dejta limitata u żieda mistennija fl-esponiment għallmetabolit doripenem-M-1 (ara sezzjoni 4.4).
English: If the doripenem dose is increased beyond the recommended dose for continuous renal replacement therapy, the systemic exposure of the doripenem-M-1 metabolite is even further increased.
Maltese: Jekk id-doża ta' doripenem tiżdied aktar mid-doża rakkomandata għal terapija ta' rimpjazzament renali kontinwu, l-esponiment sistemiku tal-metabolu doripenem-M-1 terġa tiżdied aktar.
English: Of these, 50% had late-onset VAP (defined as that occurring after five days of mechanical ventilation), 54% had an APACHE (Acute Physiology And Chronic Health Evaluation) II score > 15 and 32% received concomitant aminoglycosides (76% for more than 3 days).
Maltese: Minn dawn, 50% kellhom VAP li seħħet tard (definita bħala dik li tiġri wara ħamest ijiem fuq apparat ta' ventilazzjoni mekkanika), 54% kellhom punteġġ APACHE (Evalwazzjoni ta' Fiżjoloġija Akuta U Saħħa Kronika)
English: OUTER CARTON
Maltese: Suxxettibiltà
English: Preparation of 250 mg dose of solution for infusion using the 250 mg vial Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 250 mg vial and shake it to form a suspension.
Maltese: Il-preparazzjoni ta' soluzzjoni ta' doża ta' 250 mg għall-infuzjoni bl-użu tal-kunjett ta' 250 mg Żid 10 ml ta' ilma sterili għall-injezzjonijiet jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għall-injezzjoni fil-kunjett ta' 250 mg u ħawdu biex tifforma suspensjoni.
English: Decreases in valproic acid levels have also been reported when co-administered with other carbapenem agents, achieving a 60-100% decrease in valproic acid levels in about two days.
Maltese: Każijiet ta' tnaqqis fil-livelli ta' valproic acid ġew irrappurtati wkoll b'għoti flimkien ma' sustanzi carbapenem oħrajn, li wasslu għal tnaqqis ta' bejn 60-100% fil-livelli ta' valproic acid f'jumejn, bejn wieħed u ieħor.
English: filiāle Latvijā
Maltese: Latvija
English: Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): ● Nosocomial pneumonia (including ventilator-associated pneumonia)
Maltese: Doribax huwa indikat għall-kura tal-infezzjonijiet li ġejjin fl-adulti (ara sezzjonijiet 4.4 u 5.1):
English: S  1 mg/l and R > 1 mg/l S  1 mg/l and R > 1 mg/l “inappropriate target” S  1 mg/l and R > 1 mg/l IE (insufficient evidence) S  1 mg/l and R > 1 mg/l
Maltese: IE (evidenza insuffiċjenti) S 1 mg/l u R >1 mg/l
English: The pharmacokinetics of doripenem are linear over a dose range of 500 mg to 2 g when intravenously infused over 1 hour and 500 mg to 1 g when intravenously infused over 4 hours.
Maltese: Il-farmakokinetika ta' doripenem hi lineari fuq medda ta' doża ta' bejn 500 mg u 2 g meta mogħti b'infużjoni ġol-vini fuq perjodu ta' siegħa u bejn 500 mg u 1 g meta mogħti b'infużjoni ġol-vini fuq perjodu ta' 4 sigħat.
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
Maltese: Reazzjonijiet ta' sensittività eċċessiva serji u akuti (anafilattiċi) jeħtieġu kura ta' emerġenza immedjata.
English: Monte Carlo simulations using pathogen susceptibility results from completed phase III trials and population PK data indicated that the %T>MIC target of 35% was achieved in greater than 90% of patients with nosocomial pneumonia, complicated urinary tract infections and complicated intra-abdominal infections, for all degrees of renal function.
Maltese: III kompluti u dejta PK tal-poplazzjoni indikaw li l-mira %T>MIC ta' 35% inkisbet f'aktar minn 90% tal-pazjenti b'pulmonite li tittieħed minn ġo sptar, infezzjonijiet ikkumplikati intraaddominali u infezzjonijiet ikkumplikati fl-apparat tal-awrina, għal gradi kollha ta' funzjoni tal-kliewi.
English: Doripenem single dose pharmacokinetics after a 4-hour infusion in adults with cystic fibrosis are consistent with those in adults without cystic fibrosis.
Maltese: Il-farmakokinetika b'doża waħda ta' doripenem wara infużjoni ta' 4 sigħat f'adulti b'fibrosi ċistika hija konsistenti ma' dik f'adulti mingħajr fibrosi ċistika.
English: - Serious skin reactions, with a widespread rash with peeling skin and blisters in the mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson syndrome).
Maltese: - Reazzjonijiet serji tal-ġilda, b'raxx imferrexx fejn il-ġilda titqaxxar u b'infatet fil-ħalq, fl għajnejn u fil-parti ġenitali (nekrolisi epidermali tossiku jew sindromu ta' Stevens-Johnson).
English: The lowered valproic acid levels can lead to inadequate seizure control.
Maltese: Il-livelli iktar baxxi ta' valproic acid jistgħu jwasslu għallkontroll inadegwat ta' aċċessjonijiet.
English: Based on in vitro studies it is not expected that doripenem will inhibit or induce the activities of CYP450.
Maltese: Fuq bażi ta' studji in vitro mhuwiex mistenni li doripenem jimpedixxi jew jinduċi l-attivitajiet ta' CYP450.
English: Doribax can be removed by continuous renal replacement therapy or haemodialysis (see section 5.2).
Maltese: Doribax jista' jitneħħa permezz ta' terapija ta' rimpjazzament kontinwu jew dijalisi tad-demm (ara sezzjoni 5.2).
English: In seriously ill patients or those with an impaired immune response, a 4-hour infusion time may be more suitable when the MIC of doripenem for the known or suspected pathogen(s) has been shown or is expected to be > 0.5 mg/l, in order to reach a target attainment of 50% T>MIC in at least 95% of the patients (see section 4.2).
Maltese: F'pazjenti morda serjament jew dawk b'indeboliment fir-rispons immuni, ħin ta' infużjoni ta' 4 sigħat jista' jkun aktar xieraq meta lMIC ta' doripenem għall-patoġenu(i) magħruf(a) jew issuspettat(i) intweriet jew hija mistennija li tkun > 0.5 mg/l, sabiex tintlaħaq il-mira ta' kisba ta' 50% T>MIC f'mill-anqas 95% tal-pazjenti (ara sezzjoni 4.2).
English: Intravenous injection of doripenem had no adverse effects on general fertility of treated male and female rats or on postnatal development and reproductive performance of the offspring at doses as high as 1 g/kg/day (based on AUC, at least equal to the exposure to humans at the dose of 500 mg administered every 8 hours).
Maltese: Injezzjoni fil-vina ta' doripenem ma kelliex effetti avversi fuq il-fertilità ġenerali ta' firien rġiel u nisa trattati jew fuq żvilupp ta' wara t-twelid u prestazzjoni riproduttiva tal-wild f'dożi għoljin daqs 1 g/kg/jum (abbażi tal-AUC, tal-anqas ugwali għall-espożizzjoni għall-bniedem fid-doża ta' 500 mg li tingħata kull 8 sigħat).
English: Doribax 250 mg powder for infusion doripenem
Maltese: Doribax 250 mg trab għall-infużjoni doripenem
English: Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of 1 or 4 hours.
Maltese: Doribax għandu jiġi rikostitwit imbagħad iddilwit aktar (ara sezzjoni 6.6) qabel ma jingħata permezz ta' infużjoni ġol-vina fuq perjodu ta' 1 jew 4 sigħat.
English: Complicated UTI, including pyelonephritis
Maltese: - Żomm dan il-fuljett.
English: Doribax 500 mg powder for infusion doripenem
Maltese: Doribax 500 mg trab għall-infużjoni doripenem
English: United Kingdom JANSSEN-CILAG Ltd. Tel: +44 1494 567 444
Maltese: Deutschland JANSSEN-CILAG GmbH Tel: +49 2137 955 955
English: Before therapy with Doribax is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics.
Maltese: Qabel ma tinbeda kura b'Doribax, għandu jsir studju bir-reqqa dwar storja medika fil-passat ta' reazzjonijiet ta' sensittività eċċessiva għal sustanzi attivi oħra f'din ilklassi jew għal antibijotiċi beta-lactam.
English: Janssen-Cilag International NV
Maltese: JANSSEN-CILAG B.V.
English: NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
Maltese: Sommarju tal-profil tas-sigurtà
English: There is no accumulation of doripenem following multiple intravenous infusions of either 500 mg or 1 g administered every 8 hours for 7 to 10 days in subjects with normal renal function.
Maltese: M'hemmx akkumulazzjoni ta' doripenem wara infużjonijiet multipli jew ta' 500 mg jew ta' 1 g doripenem mogħtija kull 8 sigħat għal bejn 7 u 10 ijiem f'persuni b'funzjoni tal-kliewi normali.
English: Frequency Infusion time 500 mg or 1 g* every 8 hours 1 or 4 hours**
Maltese: 500 mg jew 1 g*
English: Infusion solution
Maltese: Mhux applikabbli
English: Species resistant to other carbapenems do generally express co-resistance to doripenem.
Maltese: Speċi reżistenti għal carbapenems oħrajn ġeneralment jesprimu koreżistenza għal doripenem.
English: Bacterial resistance mechanisms that effect doripenem include active substance inactivation by carbapenem-hydrolysing enzymes, mutant or acquired PBPs, decreased outer membrane permeability and active efflux.
Maltese: Mekkaniżmi ta' reżistenza tal-batterji li jaffettwaw doripenem jinkludu l-inattivazzjoni tas-sustanza attiva permezz ta' enzimi li jidrolizzaw il-carbapenem, PBP's mutanti jew akkwiżiti, tnaqqis filpermeabilità tal-membrana ta' barra u effluss attiv.
English: Preparation of 500 mg dose of solution for infusion using the 500 mg vial Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 500 mg vial and shake it to form a suspension.
Maltese: Il-preparazzjoni ta' soluzzjoni ta' doża ta' 500 mg għall-infuzjoni bl-użu tal-kunjett ta' 500 mg Żid 10 ml ta' ilma sterili għall-injezzjonijiet jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għall-injezzjoni fil-kunjett ta' 500 mg u ħawdu biex tifforma suspensjoni.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving beta-lactam antibiotics.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (anafilattiċi) serji u xi kultant fatali ġraw f'pazjenti li kienu qed jirċievu antibijotiċi beta-lactam.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2C-8C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-kundizzjonijiet u l-ħinijiet tal-ħażna waqt l-użu huma r-responsabbiltà ta' min qed jużah u normalment ma jkunux aktar minn 24 siegħa f'temperatura bejn 2 C-8 C, sakemm irrikostituzzjoni/dilwizzjoni ma tkunx saret f'kundizzjonjiet asettiċi kkontrollati u vvalidati.
English: A study of 233 patients with late-onset VAP failed to demonstrate the non-inferiority of an investigational 7-day course of doripenem (1 g every 8 hours as a 4 hour infusion) compared to a 10-day course of imipenem/cilastatin (1 g every 8 hours as a 1 hour infusion).
Maltese: Studju ta' 233 pazjent li kellhom pnewmonja assoċjata mal-ventilatur li beda tard naqas milli juri nnuqqas ta' inferjorità ta' kors investigattiv ta' doripenem ta' 7 ijiem (gramma kull 8 sigħat, bħala infużjoni ta' 4 sigħat) meta mqabbel ma' kors ta' imipenem/cilastatin ta' 10 ijiem (gramma kull 8 sigħat, bħala infużjoni ta' siegħa).
English: In patients with mild renal impairment (i.e. creatinine clearance (CrCl) is > 50 to  80 ml/min), no dose adjustment is necessary.
Maltese: F'pazjenti b'indeboliment ħafif tal-kliewi (i.e. tneħħija tal-krejatinina (CrCl) hija > 50 sa  80 ml/min), l-ebda aġġustament tad-doża mhuwa meħtieġ.
English: Due to limited clinical data and an expected increased exposure to doripenem and its metabolite (doripenem-M-1), Doribax should be used with caution in patients with severe renal impairment (see
Maltese: Minħabba dejta klinika limitata u żieda mistennija fl-esponiment għal doripenem u l-metabolit tiegħu (doripenem-M-1), Doribax għandu jintuża b'attenzjoni f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: The safety profile in approximately 500 patients who received Doribax 1 g every 8 hours as a 4-hour infusion in phase I, II and III clinical trials, was consistent with the safety profile for patients receiving
Maltese: Il-profil tas-sigurtà f'madwar 500 pazjent li rċevew Doribax 1 g darba kull 8 sigħat bħala infużjoni ta' 4 sigħat fi provi kliniċi ta' fażi 1, II u III, kienu konsistenti mal-profil tas-sigurtà għal pazjenti li rċevew 500 mg kull 8 sigħat.
English: Common: hepatic enzyme increased
Maltese: Infezzjonijiet u infestazzjonjiet
English: JANSSEN-CILAG B.V. Tel: +31 13 583 73 73
Maltese: JANSSEN-CILAG, S.A. Tel: +34 91 722 81 00
English: AUC of the microbiologically inactive ring-opened metabolite (doripenem-M-1) is expected to be considerably increased in patients with severe renal impairment compared with healthy subjects.
Maltese: L-AUC tal-metabolit ċirku miftuħ li huwa mikrobijoloġikament inattiv (doripenem-M-1) hija mistennija li tiżdied b'mod konsiderevoli f'pazjenti b'indeboliment sever tal-kliewi meta mqabbla ma' individwi b'saħħithom.
English: Therefore, no CYP450-related drug interactions are to be expected (see section 5.2).
Maltese: Għalhekk, mhuma mistennija l-ebda interazzjonijiet ma' mediċini relatati ma' CYP450 (ara sezzjoni 5.2).
English: White to slightly yellowish off-white crystalline powder
Maltese: Mill-aspett mikrobijoloġiku, il-prodott għandu jintuża immedjatament.
English: The exposure to the metabolite doripenem-M-1 in patients on continuous renal replacement therapy may be increased to levels where no in vivo safety data are presently available.
Maltese: L-esponiment għall-metabolit deropenem-M-1 f'pazjenti fuq terapija ta' rimpjazzament renali kontinwa tista' tiżdied għal-livelli fejn bħalissa għad m'hemmx dejta ta' sigurtà disponibbli.
English: For doripenem, limited clinical data on exposed pregnancies are available.
Maltese: Għal doripenem, huwa disponibbli tagħrif kliniku limitat dwar tqaliet esposti.
English: Pneumonitis with inhalational use
Maltese: Infezzjonijiet intraaddominali kkumplikati
English: Tell your doctor if you are taking: - valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines or
Maltese: Għid lit-tabib tiegħek jekk tkun qed tieħu: - valproic acid jew sodium valproate (jintuża biex jikkura l-epilessija, disturb bipolari,
English: Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 50 ml or 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Maltese: Iġbed is-suspensjoni permezz ta' siringa u labra u żidha fil-borża tal-infużjoni li jew ikun fiha 50 mg jew 100 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għall-injezzjoni jew inkella soluzzjoni ta' dextrose 50 mg/ml (5%) għall-injezzjoni u ħallat biex tinħall kompletament.
English: What Doribax looks like and contents of the pack Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial.
Maltese: Kif jidher Doribax u l-kontenut tal-pakkett Doribax huwa trab kristallin abjad sa abjad jagħti ftit fl-isfar f'kunjett tal-ħġieġ.
English: Therefore, doripenem should not be administered by this route.
Maltese: L-użu fit-tul ta' Doribax għandu jiġi evitat.