FrancophonIA/ELRC3.0 huggingface dataset:
English: In summary, the CHMP harmonised the posology, for both adults and adolescents, and children over 50 kg body weight of 500 mg or 1 g (to be administered every 8 hours) and for children from 3 months (and under) to 11 years of age and up to 50 kg body weight a dose of 10 or 20 mg/kg (administered every 8 hours) for the following indications: Pneumonia , including community acquired pneumonia and nosocomial pneumonia Complicated urinary tract infections Complicated intra-abdominal infections Intra- and post-partum infections (for adults only) Complicated skin and skin tissue infections
Maltese: Fis-sommarju, is-CHMP armonizza l-pożoloġija, kemm għall-adulti kif ukoll għall-adolexxenti, u tfal b'piż tal-ġisem ta' aktar minn 50 kg ta' 500 mg jew 1 g (li tingħata kull 8 sigħat) u għal tfal minn 3 xhur (u iżgħar) sa' 11-il sena u b'piż tal-ġisem sa' 50 kg doża ta' 10 jew 20 mg/kg (li tingħata kull 8 sigħat) għall-indikazzjonijiet li ġejjin:
English: -- = Susceptibility testing not recommended as the species is a poor target for therapy with the medicinal product.
Maltese: -- = Testijiet tas-suxxettibilità mhux rakkomandati peress li l-ispeċi mhux soltu li tkun il-mira tat-terapija bil-prodott mediċinali.
English: 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25/1 mg/L.
Maltese: Anerobiċi Gram-pożittivi Anerobiċi Gram-negattivi Punti ta' fini mhux relatati ma' l-ispeċi5 1 Punti ta' fini ta' Meropenem għal Streptococcus pneumoniae u Haemophilus influenzae f'meninġite huma 0.25/1 mg/l 2 Razzez b'valuri MIC 'l fuq il-punt ta' fini S/I huma rari u għadhom ma ġewx irrappurtati.
English: The CHMP noted that the scope of this SPC harmonisation procedure covers two strengths (500 mg and 1g) of the unique IV pharmaceutical form.
Maltese: Is-CHMP innota li l-ambitu ta' din il-proċedura ta' armonizzazzjoni tal-SPC ikopri żewġ qawwiet (500 mg u 1 g) tal-għamla farmaċewtika
English: Anhydrous sodium carbonate.
Maltese: L-ingredjent l-ieħor huwa sodium carbonate anidrat.
English: Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function.
Maltese: Studji dwar il-farmakokinetika li saru f'pazjenti ma wrewx differenzi farmakokinetiċi sinifikanti meta mqabbla ma individwi b'saħħithom li kellhom finzjoni renali ekwivalenti.
English: Not known angioedema, anaphylaxis (see sections 4.3 and 4.4)
Maltese: Ma hemmx bżonn aġġustar fiddoża (ara sezzjoni 4.2)
English: 3 Susceptibility of staphylococci to meropenem is inferred from the methicillin susceptibility.
Maltese: 3 Is-suxxettibilità ta' stafilokokki għal meropenem hija mfassla fuq is-suxxettibilità għal methicillin. 4
English: Malta: Meronem IV
Maltese: Meronem IV Malta:
English: • Acute bacterial infection of the brain (meningitis)
Maltese: • Infezzjoni tal-batteri akuta tal-moħħ (meninġite)
English: Data from these studies showed that meropenem was effective in the treatment of bacterial meningitis, and similar in effectiveness to cefotaxime/ceftriaxone.
Maltese: Id-dejta minn dawn l-istudji wriet li meropenem kien effikaċi fil-kura ta' meninġite batterika, u simili fl-effikaċja għal cefotaxime/ceftriaxone.
English: The medicinal product is supplied in pack sizes of 1 or 10 vials.
Maltese: Il-prodott mediċinali jiġi f' daqsijiet tal-pakkett ta' 1 jew 10 kunjetti.
English: Section 6.1 - List of excipients
Maltese: Sezzjoni 6.1 - Lista ta' sustanzi mhux attivi
English: You may need urgent medical treatment.
Maltese: Jista jkollok bżonn trattament mediku urġenti.
English: MERREM 500 mg Powder and solvent for solution for infusion
Maltese: MERREM 500 mg polvere e solvente per soluzione per infusione
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjonijiet ma prodotti mediċinali oħra u forom oħra ta' interazzjonijiet
English: Data from this and a further study, of 122 patients (of whom 70 received meropenem in combination with tobramycin), conducted since the first registration show that meropenem is effective in the treatment of LRTI in patients with CF, and similar in effectiveness to ceftazidime alone or in combination with tobramycin.
Maltese: Id-dejta minn dan l-istudju u minn ieħor, ta' 122 pazjent (li 70 minnhom irċevew meropenem flimkien ma' tobramycin), li sar mill-ewwel reġistrazzjoni juru li meropenem huwa effikaċi fil-kura ta' LRTI f'pazjenti b'CF, u jixbaħ fl-effikaċja lil ceftazidime waħdu jew flimkien ma' tobramycin.
English: The safety of Meronem in CF derived from trials, national and international named patient/compassionate use data and comparative studies between meropenem and tobramycin or ceftazidim was also discussed.
Maltese: Ġiet diskussa wkoll is-sigurtà ta' Meronem fis-CF li ħarġet mill-provi, mid-dejta ta' pazjenti msemmija/użu b'kompassjoni nazzjonali u internazzjonali u minn studji komparattivi bejn meropenem u tobramycin jew ceftazidim.
English: • Infections of the mouth or the vagina that are caused by a fungus (thrush).
Maltese: • Infezzjonijiet fil-ħalq u fil-vaġina ikkawżati bil-fungu (thrush).
English: • Broncho-pulmonary infections in cystic fibrosis
Maltese: • Infezzjonijiet bronko-pulmonarji f'fibrożi b'ċesti
English: Czech Republic AstraZeneca UK Ltd.
Maltese: Il-Litwanja AstraZeneca UK Ltd.
English: United Kingdom: Meronem IV
Maltese: Ir-Renju Unit: Meronem IV
English: Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem.
Maltese: Probenecid jikkompeti ma' meropenem għas-sekkrezzjoni attiva mit-tubi irqaq u għalhekk iwaqqaf leskressjoni renali ta' meropenem bir-riżultat li l-half-life u l-konċentrazzjoni fil-plażma ta' meropenem jiżdiedu.
English: Giving Meronem through a port or central line 1.
Maltese: Tagħti Meronem minn ġewwa port jew linja ċentrali
English: Based on the Quality data submitted, the CHMP concluded that meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection and that for intravenous infusion, meropenem vials may be directly constituted with 0.9 % sodium chloride or 5 % glucose solutions for infusion.
Maltese: Abbażi tad-dejta sottomessa dwar il-Kwalità, is-CHMP, ikkonkluda li meropenem għall-użu ta' injezzjoni bolus minn ġol-vini għandu jkun ikkostitwit b'ilma sterili għall-injezzjoni u li għal infużjoni minn ġol-vini, il-kunjetti ta' meropenem jistgħu jiġu kkostitwiti direttament b'0.9 % sodium chloride jew b'5 % soluzzjonijiet ta' glukożju għall-infużjoni.
English: EXP
Maltese: Is-CHMP
English: The MAH provided an overview of the pathogens relevant to LRTI, including MIC summary data for the common LRTI pathogens isolated.
Maltese: Il-MAH elenka wkoll il-patoġeni rilevanti għal IAI, inkluż dejta fil-qosor tal-MIC għall-patoġeni komuni tal-IAI iżolati mill-istudji kliniċi.
English: The clinical programme submitted at the time of the original MAA application described 6 clinical studies in approximately 950 patients with SSSIs, of which approximately 470 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva 6 studji kliniċi f'madwar 950 pazjent b'SSSIs, li madwar 470 minnhom kienu kkurati b'meropenem.
English: No specific medicinal product interaction studies other than probenecid were conducted.
Maltese: Ma sarux studji dwar interazzjonijiet ma prodotti mediċinali speċifiċi ħlief dak ta' probenecid.
English: Based on the discussed data, the MAH concluded that the safety profile reported in the population of patients with CF is similar to that reported overall and that meropenem is well tolerated.
Maltese: Abbażi tad-dejta diskussa, il-MAH ikkonkluda li l-profil ta' sigurtà rrappurtat fil-popolazzjoni ta' pazjenti b'CF huwa simili għal dak irrappurtat globalment u li meropenem huwa ttollerat sew.
English: Nervous system disorders
Maltese: Disturbi fil-kliewi ufis-sistema urinarja
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studju fl-annimali ma indikawx, b'mod dirett jew indirett, effetti ħżiena fir-rigward ta' tossiċita ripproduttiva (ara sezzjoni 5.3).
English: Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg.
Maltese: Effetti dehru fi studji ta' tossiċita akuta fl-annimali b'dożi li jaqbżu 1000mg/kg.
English: From a conceptual perspective, combinations of antibacterials from different classes may cover unsuspected pathogens, improve coverage for antibiotic-resistant pathogens like P. aeruginosa, prevent or reduce antibiotic resistance and achieve better clinical and bacteriological outcomes.
Maltese: Minn perspettiva kunċettwali, il-kombinazzjoni ta' antibatteriċi minn klassijiet differenti tista' tkopri patoġeni mhux issuspettati, ittejjeb il-kopertura għal patoġeni reżistenti għall-antibijotiċi bħal P. aeruginosa, tipprevjeni jew tnaqqas ir-reżistenza antibijotika u tikseb riżultati kliniċi u batterjoloġiċi aqwa.
English: • Sore veins where Meronem is injected.
Maltese: • Vini maħsusa fejn Meronem jiġi injettat.
English: To date, 7 AstraZeneca (AZ) sponsored studies have been conducted in UTIs.
Maltese: S'issa, saru 7 studji sponsorjati minn AstraZeneca (AZ) fil-UTIs.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih
English: For the indication acute bacterial meningitis the CHMP agreed with the MAH proposal concerning the dosage regimen including exclusively higher doses of 2 g to be administered every 8 hours for both adults and adolescents, and children over 50 kg body weight.
Maltese: Għall-indikazzjoni meninġite batterika akuta, is-CHMP qabel mal-proposta tal-MAH rigward reġim ta' dożar li jinkludi esklussivament dożi ogħla ta' 2 g li għandhom jingħataw kull 8 sigħat kemm għall-adulti u għall-adolexxenti, u tfal b'piż tal-ġisem ta' aktar minn 50 kg.
English: Since the original MAA application, 5 further clinical studies have been conducted in approximately 650 patients (data regarding numbers of patients treated with meropenem are not available).
Maltese: Millapplikazzjoni oriġinali tal-MAA, saru 5 studji kliniċi oħrajn f'madwar 650 pazjent (id-dejta rigward lgħadd ta' pazjenti kkurati b'meropenem mhix disponibbli).
English: Ireland: Meronem IV
Maltese: Meronem L-Irlanda: Meronem IV L-Italja:
English: See leaflet for information.
Maltese: Ara l-fuljett għall-informazzjoni.
English: Belgium: Meronem IV
Maltese: Meronem IV
English: The appropriateness of carbapenems including meropenem in UTI is supported by the clinical studies and the clinical experience.
Maltese: L-adegwatezza ta' carbapenems inkluż meropenem fil-UTI hija appoġġjata mill-istudji kliniċi u millesperjenza klinika.
English: Adverse reactions listed in the table with a frequency of “not known” were not observed in the 2,367 patients who were included in pre-authorisation clinical studies with intravenous and intramuscular meropenem but have been reported during the post-marketing period.
Maltese: Reazzjonijiet avversi elenkati fit-tabella bi frekwenza “mhux magħrufa” ma dehrux fl-2,367 pazjent li kienu inklużi fl-istudji kliniċi ta' qabel l-awtorizazzjoni b'meropenem ġol-vina u ġol-muskolu iżda kienu rapportati fil-perijodu ta' wara tqegħid fis-suq.
English: Meronem and associated names (see Annex I) 1 g Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
Maltese: Meronem u ismijiet assoċjati (ara Anness I) 1 g Kull kunjett fih meropenem trihydrate, ekwivalenti għal 1.0 g meropenem anidrat.
English: Although other drugs do have activity against P. aeruginosa, specialists prefer to have a choice of agents to overcome issues of temporary reductions in susceptibility (i.e. antibiotic cycling), allergy or other intolerances.
Maltese: Għalkemm mediċini oħrajn għandhom attività kontra P. aeruginosa, l-ispeċjalisti jippreferu li jkollhom għażla ta' sustanzi sabiex jegħlbu kwistjonijiet ta' tnaqqis temporanju fis-suxxettibilità (jiġifieri ċiklar antibijotiku), allerġiji u intolleranzi oħrajn.
English: • Infection affecting the lungs (pneumonia)
Maltese: • Infezzjoni li taffetwa il-pulmuni (pnewmonja)
English: 500 mg/10 ml
Maltese: Użu għal ġol-vini 500 mg/10 ml
English: Take special care with Meronem Check with your doctor before using Meronem:
Maltese: QABEL MA' TUŻA MERONEM 'għandekx tuża Meronem:
English: The clinical programme submitted at the time of the original MAA application described 5 clinical studies in approximately 1150 patients with IAI, of which approximately 580 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva 5 studji kliniċi f'madwar 1150 pazjent b'IAI, li madwar 580 minnhom kienu kkurati b'meropenem.
English: Paediatrics
Maltese: Pedjatriċi
English: The MAH has undertaken to submit further data within the specified time frame specified in their letter of undertaking dated 23 July 2009.
Maltese: Il-MAH aċċetta li jissottometti dejta ulterjuri fil-limitu ta' żmien speċifikat fl-ittra ta' impenn tiegħu datata t-23 ta' Lulju 2009.
English: The CHMP agreed with the following information added by the MAH in section 4.3 of the SPC on hypersensitivity to any other carbapenem antibacterial agent and severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (eg penicillins or cephalosporins).
Maltese: Is-CHMP qabel mal-informazzjoni li ġejja miżjuda mill-MAH fis-sezzjoni 4.3 tal-SPC dwar issensittività eċċessiva għal kwalunkwe sustanza antibatterika carbapenem oħra u sensittività eċċessiva severa (eż. reazzjoni anafilattika, reazzjoni severa fil-ġilda) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż peniċillini jew cephalosporins).
English: Uncommon urticaria
Maltese: Ir-Repubblika Ċeka
English: Complicated urinary tract infections
Maltese: Infezzjonijiet ikkumplikati tal-apparat urinarju
English: The clinical programme submitted at the time of the original MAA application described 1 clinical study in 40 patients, of which 27 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva studju kliniku wieħed f'40 pazjent, li 27 minnhom kienu kkurati b'meropenem.
English: The CHMP noted that the proposed indication in complicated IAIs is in accordance with the clinical documentation and the clinical experience gained in this field.
Maltese: Is-CHMP innota li l-indikazzjoni proposta f'IAIs ikkumplikati hija konformi mad-dokumentazzjoni klinika u mal-esperjenza klinika miksuba f'dan il-qasam.
English: Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8).
Maltese: Għalhekk huwa mportanti li tkun konsidrata din id-dijanjożi f'pazjenti li taqbadhom dijarea waqt jew wara li jingħata meropenem (ara sezzjoni 4.8).
English: The clinical programme submitted at the time of the original MAA application described 6 clinical studies in approximately 1200 patients, of which approximately 650 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva 6 studji kliniċi f'madwar 1200 pazjent, li minnhom madwar 650 kienu kkurati b'meropenem.
English: Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite.
Maltese: L-Antibijotiċi jintużaw sabiex ifejqu infezzjonijiet ikkawżati mill-batteri.
English: A positive direct or indirect Coombs test may develop during treatment with meropenem.
Maltese: Test ta' Coombs pożittiv dirett jew indirett jista' jiżviluppa waqt kura b'meropenem.
English: Common thrombocythaemia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Consequently taking into account the microbiological activity of meropenem, the current microbiological context, the clinical practice, the medical need of penems in some situations, and the fact that meropenem is intended only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered the indication “acute bacterial meningitis” to be acceptable.
Maltese: B'konsegwenza ta' dan, meta wieħed jikkunsidra l-attività mikrobijoloġika ta' meropenem, il-kuntest mikrobijoloġiku attwali, il-prattika klinika, il-ħtieġa medika ta' penems f'ċerti sitwazzjonijiet, u l-fatt li meropenem huwa maħsub biss għal infezzjonijiet batteriċi severi suspettati li huma dovuti jew tabilħaqq dovuti għal patoġeni reżistenti għal beta-lactams oħrajn u suxxettibbli għal meropenem, is-CHMP ikkunsidra li lindikazzjoni “meninġite batterika akuta” hija aċċettabbli.
English: For all indications no dose adjustment was considered to be necessary in hepatically impaired patients and in the elderly with normal renal function or creatinine clearance values above 50ml/min, for all indications.
Maltese: Għall-indikazzjonijiet kollha ma nħassitx il-ħtieġa ta' aġġustament tad-doża f'pazjenti b'indeboliment epatiku u fl-anzjani b'funzjoni renali normali jew b'valuri ta' tneħħija tal-kreatinina ogħla minn 50 ml/min, għall-indikazzjonijiet kollha.
English: Acute bacterial meningitis
Maltese: Meninġite batterika akuta
English: The CHMP considered that although the level of demonstration was more limited in adults than in children, meropenem is an adequate option for also treating adult cases of acute meningitis.
Maltese: Ma kienx hemm evidenza ta' żieda fis-sensittività għal meropenem f'annimali ta' età iżgħar meta mqabbla ma' annimali adulti.
English: The clinical programme submitted at the time of the original MAA application describes 4 clinical studies in approximately 220 patients with meningitis infections, of which approximately 120 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva 4 studji kliniċi f'madwar 220 pazjent b'infezzjonijiet tal-meninġite, li minnhom madwar 120 kienu kkurati b'meropenem.
English: Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes.
Maltese: ent, dożi ta' meropenem sa 20 mg/kg jistgħu jingħataw bħala olus ġol-vina fuq madwar 5 minuti.
English: Children who weigh over 50 kg will be given an adult dose.
Maltese: Tfal li jiżnu aktar minn 50 kg jingħataw iddoża ta' l-adulti
English: Connect a new sterile needle to a new sterile syringe, without touching the ends.
Maltese: Iġbed l'ammont irrakkomandat ta' 'ilma għall-injezzjoni',sterili, fis-siringa.
English: The clinical programme submitted at the time of the original MAA application described 2 clinical studies in approximately 470 patients, of which approximately 230 were treated with meropenem.
Maltese: Il-programm kliniku sottomess fiż-żmien tal-applikazzjoni oriġinali tal-MAA iddeskriva 2 studji kliniċi f'madwar 470 pazjent, li minnhom madwar 230 kienu kkurati b'meropenem.
English: Norway: Meronem
Maltese: Meronem Ċipru: MERONEM
English: 500 mg/20ml
Maltese: Użu għal ġol-vini 500 mg/20ml
English: Uncommon paraesthesiae
Maltese: Mhux komuni paraesteżiji
English: 500 mg/20 ml
Maltese: Użu għal ġol-vini 500 mg/20 ml
English: 1g /30ml
Maltese: Użu għal ġol-vini 1g /30ml
English: Consequently, taking into account the knowledge of the pharmacological class of -penems, the current microbiological context, the clinical practice and the clinical recommendations, the medical need of penems in some situations, and considering that meropenem should be used only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to meropenem, the CHMP considered that the following meropenem wording of the SPC therapeutic indication was acceptable:
Maltese: B'konsegwenza ta' dan, meta wieħed jikkunsidra l-attività mikrobijoloġika ta' -penems, il-kuntest mikrobijoloġiku attwali, il-prattika klinika, il-ħtieġa medika ta' penems f'ċerti sitwazzjonijiet, u l-fatt li meropenem huwa maħsub biss f'infezzjonijiet batteriċi severi suspettati li huma dovuti jew tabilħaqq dovuti għal patoġeni reżistenti għal betalactams oħrajn u suxxettibbli għal meropenem, is-CHMP ikkunsidra li l-indikazzjoni li ġejja hija aċċettabbli:
English: In this leaflet:
Maltese: L-Isvezzja:
English: Event
Maltese: TIKKETTA
English: The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration.
Maltese: Il-medja tat-twaħħil mal-proteini tal-plażma ta' meropenem kien madwar 2 % u kien indipendenti mill-konċentrazzjoni.
English: Finland: Meronem
Maltese: Meronem Il-Finlandja: Meronem Franza:
English: AstraZeneca AS Hoffsveien 70 B/Postboks 200 Vinderen 0319 OSLO Norway
Maltese: In-Norveġja AstraZeneca AS Hoffsveien 70
English: MIC summary data for the common gynaecological pathogens isolated from the clinical study presented in the original MAA are presented
Maltese: It-tabella li jmiss ta' patoġeni elenkati hija meħuda minn esperjenza klinika u linji gwida terapewtiċi
English: Slovenia
Maltese: Is-Slovakkja:
English: Children over 50 kg body weight, The adult dose should be administered.
Maltese: Tfal li jiżnu 'l fuq minn 50kg Għandha tintuża d-doża ta' l-adulti.
English: Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Maltese: Kull kunjett fih meropenem trihydrate ekwivalenti għal 500mg meropenem anidrat
English: Nevertheless, despite the inadequate clinical data provided the critical interest of this drug should not be disregarded, especially in resistant Gram negative strains producing extended spectrum betalactamase.
Maltese: Madankollu, minkejja d-dejta klinika mhux adegwata pprovduta, l-interess kliniku ta' din il-mediċina m'għandux jiġi injorat, b'mod speċjali f'razez reżistenti Gram negattivi li jipproduċu extended spectrum beta-lactamase.
English: AstraZeneca Kft. H-2045 Törökbálint Park u. 3.
Maltese: Total ta' 484 avveniment ġew identifikati f'273 każ, li nġabru fil-qosor u ġew diskussi mill-MAH.
English: It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent.
Maltese: Huwa rakkomandat li l-INR ikun moniterat frekwentament waqt u ftit wara li jingħataw l-antibijotiċi ma sustanza orali kontra il-koagulazzjoni fid-demm.
English: Haemodialysis will remove Meronem and its metabolite.
Maltese: L-emodijaliżi tneħħi Meronem u l-metabolit tiegħu.
English: Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg).
Maltese: Kull kunjett ta' 1g fih 208mg sodium carbonate li jsarraf bejn wieħed u ieħor għal 4.0mEq ta' sodium (bejn wieħed u ieħor 90mg)
English: 1g/30 ml
Maltese: Użu għal ġol-vini 1g/30 ml
English: • If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem
Maltese: • Jekk inti allerġiku (tbati minn sensittivita' eċċessiva) għal xi antibijotiċi oħra bħal peniċillins, cephalosporins, jew carbapenems għax tista tkun allerġiku wkoll għal meropenem.
English: 1g/20 ml
Maltese: Użu għal ġol-vini 1g/20 ml
English: The full EPAR for M-M-RVaxPro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: They should be re-vaccinated at between 12 and 15 months.
Maltese: Għandhom jitlaqqmu mill-ġdid bejn 12 u 15-il xahar.
English: Other information about M-M-RVaxPro
Maltese: Informazzjoni oħra dwar M-M-RVaxPro
English: In a study of 1,279 children, M-M-RVaxPro triggered the same level of immune response as a comparator vaccine, with more than 98% of vaccinated patients having sufficient levels of antibodies against the three viruses.
Maltese: Fi studju fuq 1,279 tifel u tifla, M-M-RVaxPro attiva l-istess livell ta' rispons immunitarju bħal vaċċin komparatur, b' aktar minn 98% tal-pazjenti mlaqqma jkollhom livelli suffiċjenti ta' antikorpi kontra ttliet virusis.