FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral neuropathy resulted in discontinuation of one or more of the three medicinal products in 1% of patients in the ixazomib regimen compared to <1% of patients in the placebo regimen.
Maltese: Newropatija periferali rriżultat fit-twaqqif ta' waħda jew iżjed mit-tliet prodotti mediċinali f'1% tal-pazjenti fil-kors ta' ixazomib meta mqabbla ma' < 1% tal-pazjenti fil-kors tal-plaċebo korsijiet.
English: Hrvatska
Maltese: Stitikezza
English: EXP
Maltese: Avversa
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules ixazomib
Maltese: TAL-PRODOTT MEDIĊINALI NINLARO 2.3 mg kapsuli ibsin Ixazomib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1094/001
English: NINLARO 4 mg hard capsule: Light orange, size 3, marked “Takeda” on the cap and “4 mg” on the body with black ink.
Maltese: NINLARO 4 mg kapsuli ibsin Oranġjo ċar, ta' daqs 3, immarkati b'“Takeda” fuq l-għatu u “4 mg” fuq il-korp tal-kapsula bil-linka sewda.
English: NSMM-5001: The MAH should conduct a global, prospective, non-interventional, observational study in multiple myeloma patients and provide a report of descriptive data on 1,000 patients including 200 RRMM patients treated with ixazomib.
Maltese: L-MAH għandu jwettaq studju globali, prospettiv, mhux ta' intervent, u osservazzjonali, f'pazjenti b'majeloma multipla, u jipprovdi rapport ta' dejta deskrittiva dwar 1000 pazjent li jinkludu 200 pazjent RRMM kkurati b'ixazomib.
English: What NINLARO looks like and contents of the pack NINLARO 2.3 mg hard capsule: Light pink, size 4, marked “Takeda” on the cap and “2.3 mg” on the body with black ink.
Maltese: NINLARO 2.3 mg kapsula iebsa Roża ċar, ta' daqs 4, immarkati b'“Takeda” fuq l-għatu u “2.3 mg” fuq il-korp tal-kapsula bil-linka sewda.
English: Concomitant medicinal products, such as antiemetic, antiviral, and antihistamine medicinal products were given to patients at the physician's discretion as prophylaxis and/or management of symptoms.
Maltese: Prodotti mediċinali mogħtija fl-istess ħin, bħal prodotti mediċinali antiemetiċi, antivirali u antiistamini ngħataw lil pazjenti fid-diskrezzjoni tat-tabib bħala profilassi u/jew għall-ġestjoni tas-sintomi.
English: Common side effects may affect up to 1 in 10 people:
Maltese: Effetti sekondarji komuni li jistgħu jaffettwaw sa 1 minn kull 10 persuni:
English: • irregular heart rate (arrhythmia)
Maltese: • rata ta' taħbit tal-qalb irregolari (arritmija)
English: NAME OF THE MEDICINAL PRODUCT NINLARO 3 mg hard capsules ixazomib
Maltese: TAL-PRODOTT MEDIĊINALI NINLARO 3 mg kapsuli ibsin ixazomib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1094/002
English: C16019: In order to further investigate the efficacy the MAH should provide additional OS/PFS2 data when approximately 200 death events have occurred from the Phase 3, randomized, placebo-controlled, double-blind study of ixazomib in maintenance therapy in patients with multiple myeloma following SCT.
Maltese: Sabiex tiġi investigata b'mod addizzjonali l-effikaċja, l-MAH għandu jipprovdi data addizzjonali ta' OS/PFS2 meta jkunu seħħew madwar 200 avveniment ta' mewt mill-istudju ta' Fażi 3, li fih il-parteċipanti jintgħażlu b'mod każwali, ikkontrollat bil-plaċebo, double-blind, dwar terapija ta' manteniment b'ixazomib f'pazjenti b'majeloma multipli wara SCT.
English: Strong inducers may reduce the efficacy of ixazomib, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see sections 4.5 and 5.2).
Maltese: John's Wort (Hypericum perforatum), għandu jiġi evitat (ara sezzjonijiet 4.5 u 5.2).
English: Light pink, size 4 gelatin hard capsule, marked “Takeda” on the cap and “2.3 mg” on the body with black ink.
Maltese: Kapsula tal-ġelatina iebsa, ta' lewn roża ċar, ta' daqs 4, immarkata b'“Takeda” fuq l-għatu u “2.3 mg” fuq il-korp tal-kapsula bil-linka sewda.
English: Its active substance ixazomib works by blocking the action of proteasomes.
Maltese: Is-sustanza attiva tiegħu ixazomib jaħdem billi jimblokka l-azzjoni tal-proteasomes.
English: Second reduction to
Maltese: Ġimgħa 2
English: For additional information regarding lenalidomide and dexamethasone, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
Maltese: Għal aktar informazzjoni dwar lenalidomide u dexamethasone, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott (SKP) għal dawn il-prodotti mediċinali.
English: Thromboprophylaxis was recommended for all patients in both treatment groups according to the lenalidomide SmPC.
Maltese: Tromboprofilassi kienet rakkomandata għall-pazjenti kollha fiż-żewġ gruppi ta' trattament skont l-SmPC ta' lenalidomide.
English: Grade 3 adverse reactions were reported in 2% of patients in both regimens.
Maltese: Reazzjonijiet avversi ta' Grad 3 ġew irrappurtati fi 2% tal-pazjenti fiż-żewġ korsijiet.
English: Non-haematological toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) NINLARO 4 mg hard capsules
Maltese: Kull kapsula fiha 3 mg ta' ixazomib (bħala 4.3 mg ta' ixazomib citrate) NINLARO 4 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules
Maltese: Jekk ikollok effetti sekondarji, it-tabib tiegħek jista' jordnalek il-kapsuli NINLARO li fihom 3 mg jew 2.3 mg.
English: Prior to initiating a new cycle of therapy:
Maltese: Qabel tibda ċiklu ġdid ta' terapija:
English: • rapid death of cancer cells that may cause dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (tumour lysis syndrome)
Maltese: • il-mewt ta' malajr taċ-ċelluli tal-kanċer tista' tikkawża sturdament, tnaqqis fl-awrina, konfużjoni, rimettar, dardir, nefħa, qtugħ ta' nifs, jew disturbi fir-ritmu tat-taħbit tal-qalb (sindrome tal-lisi ta' tumur)
English: Thromboprophylaxis is recommended in patients being treated with ixazomib in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient's underlying risks and clinical status.
Maltese: It-tromboprofilassi hija rakkomandata f'pazjenti li jkunu qed jiġu ttrattati b'ixazomib flimkien ma' lenalidomide u dexamethasone, u għandha tkun ibbażata fuq evalwazzjoni tar-riskji sottostanti u l-istat kliniku tal-pazjent.
English: Polska Takeda Pharma sp. z o.o
Maltese: Takeda Pharma A/S
English: NINLARO 3 mg hard capsule: Light grey, size 4, marked “Takeda” on the cap and “3 mg” on the body with black ink.
Maltese: Kapsula tal-ġelatina iebsa, ta' lewn griża ċar, ta' daqs 4, immarkati b'“Takeda” fuq l-għatu u “3 mg” fuq il-korp tal-kapsula bil-linka sewda.
English: • lowered blood pressure (hypotension)
Maltese: • pressjoni tad-demm baxxa (ipotensjoni)
English: Hazard Ratio†
Maltese: Proporzjon ta' Periklu†
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC and resume ixazomib at its most recent dose.
Maltese: *Għal okkorrenzi addizzjonali, alterna l-modifika tad-dożi ta' lenalidomide u ixazomib.
English: When ixazomib is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives needs to be considered.
Maltese: Meta ixazomib jingħata flimkien ma' dexamethasone, li hu magħruf li huwa induttur minn dgħajjef sa moderat ta' CYP3A4, kif ukoll ta' enzimi u trasportaturi oħrajn, ir-riskju ta' tnaqqis fl-effikaċja ta' kontraċettivi orali għandu jiġi kkunsidrat.
English: Capsule shell Gelatin
Maltese: Qoxra tal-kapsula Ġelatina
English: A planned interim analysis for overall survival (OS) at a median follow up of 23 months was conducted with 35% of the required number of deaths for final OS analysis in the ITT population; there were 81 deaths in the ixazomib regimen and 90 deaths in the placebo regimen.
Maltese: Analiżi interim ippjanata għas-sopravivenza globali (OS) fil-follow-up medjan ta' 23 xahar twettqet b'35% tan-numru meħtieġ ta' mwiet għal analiżi finali tal-OS fil-popolazzjoni bl-intenzjoni li tiġi kkurata; kien hemm 81 mewt fil-kors ta' ixazomib u 90 mewt fil-kors tal-plaċebo.
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) NINLARO 3 mg hard capsules
Maltese: Kull kapsula fiha 2.3 mg ta' ixazomib (bħala 3.3 mg ta' ixazomib citrate) NINLARO 3 mg kapsuli ibsin
English: At this analysis, estimated median PFS was 20 months in the ixazomib regimen and 15.9 months in the placebo regimen (HR=0.82 [95% CI (0.67, 1.0)]) in the ITT population.
Maltese: 82 [95% CI (0.67, 1.0)]) fil-popolazzjoni ITT.
English: Musculoskeletal and connective tissue disorders Back pain
Maltese: Sindromu ta' enċefalopatija posterjuri riversibbli
English: • If Grade 2 or 3 rash occurs again, withhold ixazomib and lenalidomide until rash recovers to ≤ Grade 1.
Maltese: • Jekk jerġa' jseħħ raxx ta' Grad 2 jew 3, tkomplix tieħu ixazomib u lenalidomide sakemm ir-raxx jinżel għal ≤ Grad 1.
English: Rash occurred in 18% of patients in the ixazomib regimen compared to 10% of patients in the placebo regimen.
Maltese: Raxx seħħ fi 18% ta' pazjenti fil-kors ta' ixazomib meta mqabbla ma' 10% ta' pazjenti fil-kors tal-plaċebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1094/003
English: • Withhold ixazomib.
Maltese: Żomm dan il-fuljett.
English: Table 4: Progression free survival and response Results in multiple myeloma patients treated with ixazomib or placebo in combination with lenalidomide and dexamethasone (intent-to-treat population)
Maltese: Għal prodotti mediċinali oħrajn mogħtija fl-istess ħin li jistgħu jkunu meħtieġa, irreferi għas-SKP kurrenti ta' lenalidomide u dexamethasone.
English: Metabolism by multiple CYP enzymes and non-CYP proteins is expected to be the major clearance mechanism for ixazomib.
Maltese: Il-metaboliżmu minn enzimi multipli ta' CYP u proteini mhux ta' CYP huwa mistenni li jkun l-akbar mekkaniżmu ta' tneħħija għal ixazomib.
English: Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients given the ixazomib, lenalidomide and dexamethasone combination.
Maltese: Pnewmonja fungali u virali li kellhom riżultat fatali kienu rrappurtati rarament f'pazjenti mogħtija ixazomib, lenalidomide u dexamethasone flimkien.
English: Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 24% in patients in the ixazomib regimen and 15% of patients in the placebo regimen.
Maltese: Disturbi fl-għajnejn ġew irrappurtati b'bosta termini ppreferuti differenti, iżda kollox ma' kollox, il-frekwenza kienet ta' 24% f'pazjenti fil-kors ta' ixazomib, u ta' 15% tal-pazjenti fil-kors tal-plaċebo.
English: Light orange, size 3 gelatin hard capsule, marked “Takeda” on the cap and “4 mg” on the body with black ink.
Maltese: Kapsula tal-ġelatina iebsa, ta' lewn oranġjo ċar, ta' daqs 3, immarkata b'“Takeda” fuq l-għatu u “4 mg” fuq il-korp tal-kapsula bil-linka sewda.
English: NINLARO, lenalidomide and dexamethasone are taken in 4-week treatment cycles.
Maltese: NINLARO meħud ma' Lenalidomide u Dexamethasone Ħu l-mediċina
English: • lowered white blood cells called neutrophils (neutropenia) that may increase the risk of infection
Maltese: • għadd baxx ta' ċelluli bojod tad-demm imsejħa newtrofili (newtropenja) li jista' jżid ir-riskju ta'
English: NINLARO is used to treat adults with multiple myeloma.
Maltese: NINLARO jintuża biex jittratta adulti b' majeloma multipla.
English: Ixazomib should be taken at approximately the same time on days 1, 8, and 15 of each treatment cycle at least 1 hour before or at least 2 hours after food (see section 5.2).
Maltese: Ixazomib għandu jittieħed madwar l-istess ħin f'jiem 1, 8 u 15 ta' kull ċiklu ta' trattament mill-inqas siegħa qabel jew mill-inqas sagħtejn wara l-ikel (ara t-taqsima 5.2).
English: Administration with a high-fat meal decreased ixazomib AUC by 28% compared with administration after an overnight fast (see section 4.2).
Maltese: L-għoti ma' ikla b'kontenut għoli ta' xaħam naqqas l-AUC ta' ixazomib bi 28% meta mqabbel mal-għoti wara sawm matul il-lejl (ara sezzjoni 4.2).
English: Transporter-based interactions
Maltese: Interazzjonijiet ibbażati fuq it-trasportaturi
English: • low platelet counts (thrombocytopenia) which may increase the risk of nose bleeds and you may easily bruise
Maltese: • għadd baxx ta' plejtlits (tromboċitopenija) li jista' jżid ir-riskju li tinfaraġ u li titbenġel faċilment
English: How to store NINLARO
Maltese: Għalxiex jintuża NINLARO
English: For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of lenalidomide or a proteasome inhibitor.
Maltese: Għall-iskopijiet ta' dan l-istudju, mard refrattorju kien imfisser bħala progressjoni tal-marda bit-trattament jew progressjoni fi żmien 60 jum wara l-aħħar doża ta' lenalidomide bħala impeditur ta' proteasome.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Maltese: U KONTENUT Kapsula iebsa
English: = intake of medicinal product
Maltese:  = teħid tal-prodott mediċinali
English: Ixazomib is 99% bound to plasma proteins and distributes into red blood cells with a blood-to-plasma AUC ratio of 10.
Maltese: Ixazomib huwa 99% imwaħħal mal-proteini tal-plażma u jiġi ddistribwit fiċ-ċelluli ħomor tad-demm bi proporzjon ta' AUC ta' demm għall-plażma ta' 10.
English: • nausea, vomiting and diarrhoea
Maltese: • dardir, remettar u dijarea
English: Fertility studies have not been conducted with ixazomib (see section 5.3).
Maltese: Ma twettaq l-ebda studju dwar il-fertilità b'ixazomib (ara sezzjoni 5.3).
English: Log-rank test P-value: Hazard ratio (95% CI): Median:
Maltese: Studju dwar l-effikaċja wara l-awtorizzazzjoni (PAES):
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: carbamazepine, phenytoin, rifampicin and St. John's wort (Hypericum perforatum).
Maltese: B'mod partikolari, kellem lit-tabib, l-ispiżjar jew l-infermier tiegħek jekk qed tieħu kwalunkwe mill-mediċini li ġejjin: carbamazepine, phenytoin, rifampicin u St.
English: The recommended starting dose of ixazomib is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.
Maltese: Id-doża rakkomandata tal-bidu ta' ixazomib hija 4 mg mogħtija oralment darba fil-ġimgħa f'Jiem 1, 8, u 15 ta' ċiklu ta' trattament ta' 28 jum.
English: Consider adding G-CSF as per clinical guidelines.
Maltese: Ikkunsidra żżid G-CSF skont il-linji gwida kliniċi.
English: The majority of target organ findings demonstrated partial to full recovery following discontinuation of treatment, with the exception of neuronal findings in the lumbar dorsal root ganglion and dorsal column.
Maltese: Il-maġġoranza tas-sejbiet fl-organi fil-mira wrew irkupru minn parzjali sa sħiħ wara t-twaqqif tat-trattament, bl-eċċezzjoni tas-sejbiet newronali fil-gangliju tal-għerq dorsali lumbari u l-ispina dorsali.
English: Ixazomib is for oral use.
Maltese: Ixazomib hu għal użu orali.
English: Twenty five percent of patients had a creatinine clearance of < 60 mL/min.
Maltese: Ħamsa u għoxrin fil-mija tal-pazjenti kellhom tneħħija tal-krejatinina ta' < 60 mL/min.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Maltese: Thalidomide hu sustanza attiva teratoġena umana magħrufa li tikkawża difetti tat-twelid severi u li huma ta' theddida għall-ħajja.
English: note 3
Maltese: nota 3
English: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid
Maltese: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid Spanja
English: Streptococcus pyogenes (Group A)
Maltese: Streptococcus pyogenes (Grupp A)
English: Section 6.2 - Incompatibilities
Maltese: Sezzjoni 6.2 - Inkompatibilitajiet
English: Gram-negative anaerobes Bacteroides caccae Bacteroides fragilis group Prevotella bivia Prevotella disiens
Maltese: Anerobiċi Gram-negattivi Bacteroides caccae Bacteroides fragilis grupp Prevotella bivia Prevotella disiens
English: Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Maltese: Peptostreptococcus species (inklużi P.micros, P.anaerobius, P.magnus)
English: Gram-negative aerobes Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa
Maltese: Erobiċi Gram-negattivi Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa
English: Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius) Streptococcus pneumoniae
Maltese: Streptococcus milleri grupp (S. anginosus, S. constellatus, u S. intermedius) Streptococcus pneumoniae
English: Gram-negative aerobes Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
Maltese: Erobiċi Gram-negattivi Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria gonorrhoeae Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
English: Streptococcus groups A, B, C, G Streptococcus pneumoniae1 Other streptococci Enterococcus
Maltese: Streptococcus gruppi A, B, C, G Streptococcus pneumoniae1 Streptokokki oħrajn Enterococcus
English: AstraZeneca UK Limited 15 Stanhope Gate London W1K 1LN United Kingdom
Maltese: AstraZeneca UK Limited 15 Stanhope Gate London WLK 1LN
English: Creatinine clearance (ml/min)
Maltese: krejatinina (ml/min)
English: Resistant (R) (mg/l)
Maltese: Reżistenti (R) (mg/l)
English: EUCAST clinical MIC breakpoints for meropenem (2009-06-05, v 3.1) Organism
Maltese: Punti ta' fini kliniċi ta' l-MIC għal meropenem skond EUCAST (2009-06-05, v 3.1)
English: Do not store above 30°C.
Maltese: Taħżinx f'aktar minn 30°C.
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Maltese: Relazzjoni farmakokinetika/ Farmakodinamika (PK/PD)
English: Belgium NV AstraZeneca SA Rue Egide Van Ophemstraat 110 1180 Brussel
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
English: 500 mgTrockenstechampullen
Maltese: Optinem i.v. 500 mgTrockenstechampullen
English: Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis Streptococcus agalactiae (Group B)
Maltese: Staphylococcus aureus (razzez suxxettibli għal methicillin biss) £ Staphylococcus species (razzez suxxettibli għal methicillin biss) inkluża Staphylococcus epidermidis Streptococcus agalactiae (Grupp B)
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophemstraat 110 1180 Brussel
Maltese: Il-Lussemburgu NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel,
English: BATCH NUMBER Lot
Maltese: NUMRU TAL- LOT Lot
English: Susceptible (S) (mg/l)
Maltese: Suxxettibli (S) (mg/l)
English: Gram-positive anaerobes
Maltese: Anerobiċi Gram-positivi
English: 1 gTrockenstechampullen
Maltese: Optinem i.v. 1 gTrockenstechampullen
English: • The dose for adults is usually between 500 mg (milligrams) and 2 g (gram).
Maltese: • Id-doża normali għall-adulti hi bejn 500mg (milligrammi) jew 2 g (grammi).
English: Alternative therapies were also discussed.
Maltese: Ġew diskussi wkoll terapiji alternattivi.
English: Complicated urinary tract infections (cUTI)
Maltese: Infezzjonijiet ikkumplikati tal-apparat urinarju (complicated urinary tract infections - cUTI)
English: 500 mg or 1 g
Maltese: 500 mg jew 1 g
English: Other micro-organisms Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetii Mycoplasma pneumoniae
Maltese: Mikro-organiżmi oħra Chlamydophilia pneumoniae Chlamydophilia psittaci Coxiella burnetii Mycoplasma pneumoniae
English: Meropenem is a member of the beta-lactam family of antibacterials and belongs to the class of carbapenems and is a broad-spectrum of in vitro antibacterial activity against Gram positive and Gram negative, aerobic and anaerobic pathogens, including extended-spectrum beta-lactamase (ESBL) and AMpC chromosomal beta-lactamase producing Enterobacteriaceae.
Maltese: Meropenem huwa membru tal-familja ta' antibatteriċi beta-lactams u jappartjeni għall-klassi ta' carbapenems u huwa spettru wiesgħa ta' attività antibatterika in vitro kontra patoġeni ajrobiċi u anajrobiċi Gram pożittivi u Gram negattivi, inkluż extended-spectrum beta-lactamase (ESBL) u Enterobacteriaceae AMpC kromosomali li jipproduċu l-beta-lactamase.
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy
Maltese: Palazzo Volta Via Francesco Sforza 20080
English: Haemophilus influenzae1 and Moraxella catarrhalis Neisseria meningitidis2,4
Maltese: Haemophilus influenzae1 u Moraxella catarrhalis
English: Studies 3591IL/0065 and 3591IL/0022 included only paediatric patients but studies 3591IL/0020 and 3591IL/0021 included both paediatric and adult patients.
Maltese: L-istudji 3591IL/0065 u 3591IL/0022 kienu jinkludu pazjenti pedjatriċi biss iżda l-istudji 3591IL/0020 u 3591IL/0021 kienu jinkludu kemm pazjenti pedjatriċi kif ukoll adulti.
English: Table 1 System Organ Class
Maltese: Klassi ta' L-Organu tasSistema
English: Inherently resistant organisms Gram-negative aerobes Stenotrophomonas maltophilia Legionella species
Maltese: Stenotrophomonas maltophilia Legionella species
English: 14122 Iraklio Attikis Greece
Maltese: GR-141 22 Iraklion Attikis, Il-Greċja
English: Meronem contains sodium.
Maltese: Meropenem fih sodium.
English: AstraZeneca AB 151 85 Södertälje Sweden
Maltese: S-15185 Södertälje L-Isvezja
English: In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Fit-tabella ta' taħt ir-reazzjonijiet avversi kollha huma elenkati skont il-klassi ta' l-organu tas-sistema u l-frekwenza: komuni ħafna (>1/10); komuni (>1/100 sa <1/10); mhux komuni (>1/1,000 sa <1/100); rari (>1/10,000 sa <1/1,000); rari ħafna (< 1/10,000) u mhux magħruf ( ma' jistax jiġi stmat minn dejta disponibbli
English: The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %).
Maltese: L-aktar avvenimenti avversi komuni relatati mal-laboratorju li kienu rapportati b'meropenem kienu trombo-ċitożi (1.6%) u żieda flenzimi epatiċi (1.5-4.3%)
English: AstraZeneca UK Ltd. Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
Maltese: Alderley Park Macclesfield Cheshire SK10 4TF
English: Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02
Maltese: Kategorija farmakoterapewtika: antibatteriċi għall-użu sistemiku, carbapenems, Kodiċi ATC:
English: Broncho-pulmonary infections in cystic fibrosis (CF)
Maltese: Infezzjonijiet bronko-pulmonari fil-fibrożi ċistika (CF)
English: For single use only.
Maltese: IV unika.
English: In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %).
Maltese: Wara li ġew ikkunsidrati 4,872 pazjent b'5,026 esponiment għall-kura b'meropenem, reazzjonijiet avversi, relatati ma meropenem, li l-aktar ġew rapportati kienu dijarea (2.3%), raxx (1.4%), dardir/rimettar (1.4%) u infjammazzjoni fil-post tal-injezzjoni (1.1%).
English: Meronem 500 mg: anhydrous sodium carbonate Meronem 1 g: anhydrous sodium carbonate
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi Meronem 500 mg: sodium carbonate anidrat Meronem 1 g: sodium carbonate anidrat
English: Meronem belongs to a group of medicines called carbapenem antibiotics.
Maltese: Meronem jippartjeni lil grupp ta' mediċini li jissejħu antibijotiċi carbapenem.
English: Pack sizes of 1 or 10 vials.
Maltese: Daqsijiet tal-pakkett 1 jew 10 kunjetti.