FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat dose toxicity studies in dogs, minimal hepatic inflammation was observed after 14 days and 28 days of exposure to vaborbactam alone or combined meropenem/vaborbactam.
Maltese: Fi studji dwar effett tossiku minn dożi ripetuti fil-klieb, ġiet osservata infjammazzjoni fil-fwied minima wara 14-il jum u 28 jum ta' esponiment għal vaborbactam waħdu jew meropenem/vaborbactam kombinat.
English: Hepatic function should be closely monitored during treatment with meropenem/vaborbactam due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8).
Maltese: Monitoraġġ tal-funzjoni tal-fwied Il-funzjoni tal-fwied għandha tiġi mmonitorjata mill-qrib waqt kura b'meropenem/vaborbactam minħabba r-riskju ta' tossiċità epatika (disfunzjoni epatika b'kolestażi u ċitoliżi) (ara sezzjoni 4.8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains meropenem trihydrate equivalent to 1 g meropenem, and 1 g vaborbactam.
Maltese: Kull kunjett fih meropenem trihydrate ekwivalenti għal 1 g meropenem, u 1 g vaborbactam.
English: The plasma protein binding of meropenem is approximately 2%.
Maltese: It-twaħħil tal-proteina tal-plażma ta' meropenem huwa ta' madwar 2 %.
English: Vaborem contains 10.9 mmol (approximately 250 mg) of sodium per vial.
Maltese: 9 mmol (madwar 250 mg) ta' sodju għal kull kunjett.
English: A positive direct or indirect Coombs test may develop during treatment with meropenem/vaborbactam as seen with meropenem (see section 4.8).
Maltese: Jista' jiżviluppa test ta' Coombs pożittiv dirett jew indirett waqt kura b'meropenem/vaborbactam kif deher b'meropenem (ara sezzjoni 4.8).
English: What Vaborem is Vaborem is an antibiotic medicine that contains two active substances: meropenem and vaborbactam.
Maltese: Vaborem huwa mediċina antibijotika li fiha żewġ sustanzi attivi: meropenem u vaborbactam.
English: Clostridium difficile-associated diarrhoea has been reported with meropenem/vaborbactam.
Maltese: Ġiet irrappurtata dijarea assoċjata ma' Clostridium difficile b'meropenem/vaborbactam.
English: Limited post-marketing experience with meropenem alone indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
Maltese: Esperjenza limitata ta' wara t-tqegħid fis-suq b'meropenem waħdu tindika li jekk iseħħu reazzjonijiet avversi wara doża eċċessiva, dawn ikunu konsistenti mal-profil tar-reazzjonijiet avversi deskritt f'sezzjoni 4.8, ikunu ġeneralment ħfief fis-severità u jiġu riżolti mat-twaqqif jew tnaqqis fid-doża.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25° C.
English: • a medicine used to treat depression or anxiety called venlafaxine
Maltese: • mediċina li tintuża biex tikkura d-dipressjoni u l-ansjetà li jisimha venlafaxine
English: Vaborbactam does not inhibit class B enzymes (metallo-β-lactamases) or class D carbapenemases.
Maltese: Vaborbactam ma jinibixxix enzimi ta' klassi B (metallo-β-lattamażijiet) jew karbapenemażijiet ta' klassi D.
English: • A tingling feeling (pins and needles)
Maltese: • Sensazzjoni ta' tingiż (tnemnim)
English: • Swollen and red and irritated veins
Maltese: • Vini minfuħa u ħomor u irritati
English: The inhibitory spectrum of vaborbactam includes class A carbapenemases (such as KPC) and Class C carbapenemases.
Maltese: L-ispettru inibitorju ta' vaborbactam jinkludi karbapenemażijiet ta' klassi A (bħal KPC) u karbapenemażijiet ta' Klassi C.
English: Adverse reactions are classified according to frequency and System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza u s-Sistema tal
English: About 25% of the administered dose is eliminated as the inactive open ring form.
Maltese: Madwar 25 % tad-doża mogħtija jiġi eliminat bħala lforma ta' ċirku miftuħ inattiv.
English: Hospital-acquired pneumonia (HAP), including VAP
Maltese: Pulmonite li tittieħed mill-isptar (HAP), inkluż
English: Tremor Lethargy Dizziness Paraesthesia
Maltese: Rogħda Letarġija
English: Following dilution, the infusion should be completed within 4 hours when stored at 25° C, or within 22 hours when refrigerated at 2 - 8 °C.
Maltese: Wara d-dilwizzjoni, l-infużjoni għandha tkun lesta f'4 sigħat meta tinħażen f'temperatura ta' 25° C, jew fi 22 siegħa meta titpoġġa fi friġġ f'temperatura ta' 2 - 8 °C.
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate for solution for infusion meropenem/vaborbactam
Maltese: TAL-PRODOTT MEDIĊINALI Vaborem 1 g/1 g trab għal konċentrat għal soluzzjoni għall-infużjoni meropenem/vaborbactam
English: Pharmacokinetic studies with meropenem and vaborbactam in patients with renal impairment have shown that the plasma clearance of both meropenem and vaborbactam correlates with creatinine clearance.
Maltese: Studji farmakokinetiċi b'meropenem u vaborbactam f'pazjenti b'indeboliment tal-kliewi wrew li ttneħħija tal-plażma ta' kemm meropenem kif ukoll vaborbactam tikkorelata ma' tneħħija tal kreatinina.
English: • A positive result from a test called“Coombs”used to identify haemolytic anemia (see above) or reaction of your immune system to Vaborem
Maltese: • Riżultat pożittiv minn test imsejjaħ “Coombs” li jintuża biex jidentifikaw anemija emolitika (ara hawn fuq) jew reazzjoni tas-sistema immuni tiegħek għal Vaborem Rappurtar tal-effetti sekondarji
English: The final infusion concentration of meropenem and vaborbactam will be about 8 mg/ml each.
Maltese: Il-konċentrazzjoni tal-infużjoni finali ta' meropenem u vaborbactam ser tkun madwar 8 mg/ml kull wieħed.
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-fosfatażi
English: EXP
Maltese: VAP
English: The medicinal product is supplied in packs of 6 vials.
Maltese: Vaborem jiġi f'pakketti li fihom 6 kunjetti.
English: Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium may reduce plasma levels of valproic acid to concentrations below the therapeutic range as a result of this interaction, thus increasing the risk of breakthrough seizures.
Maltese: Rapporti tal-każijiet fil-letteratura urew li l-għoti flimkien ta' karbapenemi, inkluż meropenem, lil pazjenti li jirċievu valproic acid jew divalproex sodium jista' jnaqqas il-livelli fil-plażma ta' valproic acid għal konċentrazzjonijiet taħt il-medda terapewtika bħala riżultat ta' din l-interazzjoni, u b'hekk jiżdied ir-riskju ta' attakki ta' puplesija f'daqqa li jseħħu minkejja l-antikonvulsanti.
English: Eosinophilia
Maltese: Ipogliċemija
English: The chemical and physical in-use stability has been demonstrated for up to 4 hours at 25 °C or within 22 hours at 2 - 8 °C.
Maltese: °C jew fi żmien 22 siegħa f'2 - 8 °C.
English: Common: (may affect up to 1 in 10 people)
Maltese: Komuni: (jistgħu jaffettwaw sa 1 minn kull 10)
English: The mean non-renal clearance for meropenem was 4.8 L/h, which comprises both fecal elimination (~2% of the dose) and degradation due to hydrolysis.
Maltese: It-tneħħija medja mhux mill-kliewi għal meropenem hija 4.8 L/h, li tinkludi kemm eliminazzjoni mill-ippurgar (~2 % tad-doża) kif ukoll degradazzjoni minħabba idroliżi.
English: • you are allergic to other carbapenem antibiotics (the group to which meropenem belongs).
Maltese: • inti allerġiku għal antibijotiċi karbapenemi oħra (il-grupp li jappartjeni fih meropenem).
English: Data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA g) back to valproic acid, thus decreasing the serum concentrations of valproic acid.
Maltese: Dejta minn studji in vitro u f'annimali tissuġġerixxi li l-karbapenemi jistgħu jinibixxu l-idroliżi tal-metabolit glukoronid ta'
English: • Staphylococcus aureus (methicillin susceptible isolates only)
Maltese: • Staphylococcus aureus (iżolati suxxettibbli għall-metiċillina biss) • Staphylococcus epidermidis (iżolati suxxettibbli għall-metiċillina biss)
English: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Maltese: Reazzjoni għallmediċina b'esinofilja u sintomi sistemiċi
English: Seizures have been reported during treatment with meropenem alone, especially in patients treated with anticonvulsants (see section 4.4).
Maltese: Jekk ikun meħtieġ l-għoti ta' Vaborem, għandha tiġi kkunsidrata terapija antikonvulsanti supplimentali (ara sezzjoni 4.5).
English: Gram-negative micro-organisms: • Citrobacter freundii
Maltese: • Citrobacter freundii
English: The final infusion concentration of meropenem and vaborbactam will be 2 mg/ml each.
Maltese: Ilkonċentrazzjoni tal-infużjoni finali ta' meropenem u vaborbactam ser tkun madwar 2 mg/ml kull wieħed.
English: The safety and efficacy of meropenem/vaborbactam in children and adolescents younger than 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' meropenem/vaborbactam fit-tfal u fl-adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Phlebitis Vascular pain
Maltese: Uġigħ vaskulari
English: • Headache
Maltese: • Uġigħ
English: Pain
Maltese: UŻU
English: Resistant
Maltese: Ipotensjoni
English: NAME OF THE MEDICINAL PRODUCT Vaborem 1 g/1 g powder for concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Vaborem 1 g/1 g trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: To prepare the Vaborem 0.5 g/0.5 g dose for intravenous infusion: Immediately after reconstitution of one vial,10.5 ml of the reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Maltese: Immedjatament wara r rikostituzzjoni ta' kunjett wieħed, 10.5 ml tal-kontenut tal-kunjett rikostitwit għandu jinġibed minn kunjett u jiżdied lura fil-250 ml borża tal-infużjoni ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (salina normali).
English: Less than 10
Maltese: Inqas minn 10
English: Pharmacokinetic data from a population pharmacokinetic analysis showed a reduction in plasma clearance of meropenem/vaborbactam that correlates with age-associated reduction in creatinine clearance.
Maltese: Anzjani Dejta farmakokinetika minn analiżi tal-farmakokinetika tal-popolazzjoni wriet tnaqqis fit-tneħħija tal plażma ta' meropenem/vaborbactam li tikkorelata ma' tnaqqis assoċjat mal-età fit-tneħħija tal kreatinina.
English: Seizures
Maltese: Parasteżija
English: Vaborbactam is a non-beta-lactam inhibitor of class A and class C serine beta-lactamases, including Klebsiella pneumoniae carbapenemase, KPC.
Maltese: Kien hemm bosta raporti ta' żidiet fl-effetti antikoagulanti ta' aġenti antikoagulanti mogħtija mill-ħalq, inkluż warfarin fil-pazjenti, li qed jirċievu aġenti antibatteriċi b'mod konkomitanti.
English: How to store Vaborem
Maltese: Doża ta' Vaborem
English: • Increase in the amount of enzymes produced by your liver called alanine aminotransferase or aspartate aminotransferase - shown in blood tests
Maltese: • Żieda fl-ammont ta' enzimi prodotti mill-fwied tiegħek imsejħa alanina aminotransferażi jew aspartataminotransferażi - li tidher fit-testijiet tad-demm
English: Recommended intravenous dose for patients with a creatinine clearance (CrCl) ≥40 ml/min1
Maltese: Pożoloġija Tabella 1 turi d-doża ġol-vini rakkomandata għal pazjenti bi tneħħija tal-kreatinina (CrCl) ≥40 ml/min
English: Mechanisms of resistance in Gram-negative bacteria that are known to affect meropenem/vaborbactam include organisms that produce metallo-β-lactamases or oxacillinases with carbapenemase activity.
Maltese: Mekkaniżmi ta' reżistenza f'batterji Gram-negattivi li huma magħrufa li jaffettwaw meropenem/vaborbactam jinkludu organiżmi li jipproduċu metallo-β-lattamażijiet jew ossaċillinażijiet b'attività karbapenemażika.
English: In individuals with normal renal function, rapid renal elimination will occur.
Maltese: F'indivdwi b'funzjoni talkliewi normali, ser isseħħ eliminazzjoni mill-kliewi rapida.
English: The final infusion concentration of meropenem and vaborbactam will be about 4 mg/ml each.
Maltese: Ilkonċentrazzjoni tal-infużjoni finali ta' meropenem u vaborbactam ser tkun madwar 4 mg/ml kull wieħed.
English: • Fungal infections, including those of the vagina or mouth
Maltese: • Infezzjonijiet fungali, inkluż dawk tal-vaġina jew ħalq
English: The use of Vaborem to treat patients with complicated intra-abdominal infections is based on experience with meropenem alone and pharmacokinetic-pharmacodynamic analyses of meropenem/vaborbactam.
Maltese: L-użu ta' Vaborem biex jikkura pazjenti b'infezzjonijiet intraaddominali kkumplikati huwa bbażat fuq esperjenza b'meropenem waħdu u analiżijiet farmakokinetiċi farmakodinamiċi ta'
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to meropenem/vaborbactam in vitro.
Maltese: L-effikaċja ntweriet fi studji kliniċi kontra l-patoġeni li ġejjin li kienu suxxettibbli għal meropenem/vaborbactam in vitro.
English: Meropenem and vaborbactam are removed by haemodialysis (see section 5.2).
Maltese: Studji f'annimali li saru b'meropenem u vaborbactam ma jurux effetti ħżiena fuq il-fertilità (ara 5.3).
English: • The following reactions may develop, alone or in combination, where Vaborem is given into a vein: reddened skin (erythema); hot, tender and swollen vein around the needle (phlebitis); a blood clot in the vein where the needle was put through your skin (infusion site thrombosis)
Maltese: • Ir-reazzjonijiet li ġejjin jistgħu jiżviluppaw, waħidhom jew flimkien, meta Vaborem jingħata ġo vina: ġilda li ssir ħamra (eritema); vina taħraq, sensittiva u minfuħa madwar il-labra (flebite); koagulazzjoni tad-demm ġol-vina fejn tiddaħħal il-labra ġol-ġilda (trombożi tas-sit talinfużjoni)
English: Resistance
Maltese: Inkontinenza
English: Susceptibility testing break points
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: For susceptibility testing purposes, the concentration of vaborbactam is fixed at 8 mg/l.
Maltese: 1Għal skopijiet ta' ttestjar ta' suxxetibbiltà, il-konċentrazzjoni ta' vaborbactam hija fissa għal 8 mg/l.
English: • a medicine used to treat seizures or given prior to a surgery or certain examinations inside your body such as a colonoscopy, called midazolam
Maltese: • mediċina li tintuża biex tikkura aċċessjonijiet jew tingħata qabel kirurġija jew ċerti eżaminazzjonjiet fil-ġisem bħal kolonoskopija, li jisimha midazolam
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: Manufacturer ACS Dobfar, S.p.A. Nucleo Industriale S. Atto (loc. S. Nicolo' a Tordino) 64100 Teramo (TE) Italy
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to meropenem/vaborbactam.
Maltese: Pazjenti li għandhom storja ta' sensittività eċċessiva għal karbapenemi, peniċillini jew aġenti antibatteriċi betalattamiċi oħra jistgħu wkoll jkunu sensittivi ħafna għal meropenem/vaborbactam.
English: • Reaction that occurs during or shortly after Vaborem is given that presents as a malaise (generally feeling unwell) possibly with any of the following: reduced blood pressure, nausea, vomiting, abdominal cramps, fever, flushing, rapid heart beats or difficulty to breathe, headache
Maltese: • Reazzjoni li sseħħ waqt jew ftit wara li jingħata Vaborem li tidher bħala telqa (tħossok ġeneralment ħażin) possibbilment b'xi waħda minn li ġejjin: tnaqqis fil-pressjoni tad-demm, dardir, rimettar, uġigħ addominali, deni, fwawar, taħbit tal-qalb mgħaġġel jew diffikultà biex tieħu nifs, uġigħ ta' ras
English: There is no dose adjustment necessary (see section 4.2).
Maltese: Prodott, sezzjoni 4.2).
English: Mechanisms of bacterial resistance that could decrease the antibacterial activity of meropenem/vaborbactam include porin mutations affecting outer membrane permeability and overexpression of efflux pumps.
Maltese: Attività antibatterika flimkien ma' aġenti antibatteriċi oħra Studji in vitro ma wrew l-ebda antagoniżmu bejn meropenem/vaborbactam u levofloxacin, tigecycline,
English: Vaborem will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Maltese: Vaborem ser jingħatalek minn tabib jew infermier, għalhekk mhuwiex probabbli li ser tingħata d-doża l-ħażina.
English: Complicated UTI (cUTI), including pyelonephritis
Maltese: inkluż pijelonefrite
English: Frequency of adverse reactions by system organ class
Maltese: Tabella 3: Frekwenza ta' reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi Sistema tal
English: To prepare the Vaborem 0.5 g/0.5 g for intravenous infusion: Immediately after reconstitution of one vial, 10.5 ml of the reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Maltese: 10.5 ml tal-kontenut tal-kunjett rikostitwit għandu jinġibed mill-kunjett u jiżdied lura fil-250 ml borża tal-infużjoni ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (salina normali).
English: Vaborem will be given to you by a doctor or nurse by infusion (a drip) into a vein, lasting 3 hours.
Maltese: Vaborem ser jingħatalek minn tabib jew infermier permezz ta' infużjoni (dripp) ġo vina, li ddum 3 sigħat.
English: Infusion site thrombosis
Maltese: Lewkopenja Newtropenja Esinofilja
English: Clinical efficacy has not been established against the following pathogens that are relevant to the approved indications although in vitro studies suggest that they would be susceptible to meropenem and/or meropenem/vaborbactam in the absence of acquired mechanisms of resistance.
Maltese: L-effikaċja klinika ma ġietx stabbilita kontra l-patoġeni li ġejjin li huma relevanti għallindikazzjonijiet approvati għalkemm studji in vitro jissuġġerixxu li sejrin ikunu suxxettibbli għal meropenem u/jew meropenem/vaborbactam fin-nuqqas ta' mekkaniżmi akkwiżiti ta' reżistenza.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet.
Maltese: Il-prodott mediċinali jiġi fornut f'pakketti ta' 6 kunjetti.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of meropenem/vaborbactam in pregnant women.
Maltese: Għall-meropenem/vaborbactam m'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu fin-nisa tqal.
English: To prepare the Vaborem 2 g/2 g dose for intravenous infusion: Immediately after reconstitution of two vials, the entire reconstituted vial contents should be withdrawn from each of the two vials and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Maltese: Immedjatament wara r-rikostituzzjoni ta' kunjett wieħed, il-kontenut tal-kunjett rikostitwit kollu għandu jinġibed minn kunjett u jiżdied lura fil-250 ml borża tal-infużjoni ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (salina normali).
English: Before initiating therapy with Vaborem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Maltese: Qabel tinbeda terapija b'Vaborem, għandha ssir domanda b'attenzjoni dwar reazzjonijiet ta' sensittività eċċessiva preċedenti għal antibijotiċi betalattamiċi.
English: Blood bilirubin increased
Maltese: Żieda fil bilirubina fiddemm
English: No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża (ara sezzjoni 4.2).
English: The concentration time profiles are similar for ELF and plasma.
Maltese: Il-profili taż-żmien tal-konċentrazzjoni huma simili għal ELF u plażma.
English: Interference with laboratory testing: see section 4.4.
Maltese: Interferenza ma' testijiet fil-laboratorju: ara sezzjoni 4.4.
English: Calle 8, N° 703 (esquina 5) Parque Industrial Pilar - (1629) Provincia de Buenos Aires Argentina
Maltese: Sanofi Pasteur SA Calle 8, N° 703 (esquina 5) Parque Industrial Pilar - (1629) Provincia de Buenos Aires Argentina
English: Irritability
Maltese: - irritabilità
English: DTaP-IPV-HB-Hib
Maltese: DTaP-IPV-HB-Hib IM
English: For adsorbent: see section 2.
Maltese: Għal adsorbent: ara sezzjoni 2.
English: Tel. aus dem Ausland: +49 69 305 21 130
Maltese: aus dem Ausland: +49 69 305 21 130
English: • Poliovirus (Inactivated) Types 1/2/3
Maltese: • Poljovirus (Inattivat) Tipi 1/2/3
English: • Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin 25/25 µg
Maltese: Tossojdi ta' Pertussi/ Emaglutinin Filamentuż 25/25 µg
English: 12 µg conjugated to Tetanus protein
Maltese: 12 µg konjugat għal proteina tat-Tetnu
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Bar code 2D jġorru l-identifikatur uniku inklużi.
English: Months N=249** N=204† N=178†† N=177 to
Maltese: Xhur N=249** N=204† N=178†† N=177 to
English: Saccharose
Maltese: Sakkarosju
English: 25 micrograms
Maltese: 25 mikrogramma
English: 22-36 micrograms
Maltese: 22-36 mikrogramma
English: Additional injections (booster)
Maltese: Injezzjonijiet addizzjonali (buster)
English: Pyrexia (body temperature ≥ 38.0°C)
Maltese: Deni (temperatura tal-ġisem ≥ 38.0°C)
English: • Haemophilus influenzae type b polysaccharide
Maltese: • Haemophilus influenzae polysaccharide tip b
English: * Adverse reactions from spontaneous reporting.
Maltese: * Reazzjonijiet avversi min rappurtar spontanju
English: Potential side effects
Maltese: Effetti sekondarji potenzjali
English: With hepatitis B
Maltese: epatite B.
English: Booster vaccination:
Maltese: Vaċċinazzjoni buster:
English: Hexacima is available in pack containing 10 vials.
Maltese: Hexacima huwa disponibbli f'pakkett li fih 10 fjali.
English: LLOQ value for anti-PT and anti-FHA is 2 EU/ml
Maltese: Il-valur LLOQ għal anti-PT u anti-FHA huwa ta' 2 EU/ml
English: vakcín sanofi-aventis, s.r.o.
Maltese: Sanofi Pasteur divize. vakcín sanofi-aventis, s.r.o.
English: Potassium dihydrogen phosphate
Maltese: Disodium hydrogen phosphate Potassium dihydrogen phosphate Trometamol
English: Sanofi Aventis Latvia SIA Vakcīnu nodaļa
Maltese: Latvia SIA Vakcīnu nodaļa
English: Date of latest renewal: 08 January 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' April 2013 Data tal-aħħar tiġdid: 08 ta' Jannar 2018
English: b- Tabulated list of adverse reactions
Maltese: b- Reazzjonijiet avversi elenkati f'tabella
English: 10 vials (0.5 ml)
Maltese: 10 kunjetti (0.5ml)
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU -DEJTA TINQARA MILL-BNIEDEM PC:
English: Efficacy and effectiveness in protecting against pertussis
Maltese: Effikaċja u effettività fil-protezzjoni kontra pertussis
English: Booster vaccination at 11-12 months of age after a two doses primary course
Maltese: Tilqim buster fi 11-12-il xahar ta 'età wara kors primarju ta żewġ dożi
English: Sanofi Pasteur
Maltese: Sanofi Pasteur SA
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexacima in children over 24 months of age has not been studied in clinical trials.
Maltese: Vaċċini, vaċċini batterjali u virali kombinati, Kodiċi ATC: J07CA09 L-immunoġeniċità ta Hexacima fi tfal aktar minn 24 xahar ta 'età ma ġiex studjat fi provi kliniċi.
English: Anaphylactic reaction*
Maltese: Reazzjoni anafilattiku*
English: Persistence of immune response
Maltese: Persistenza tar-rispons immuni
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu un nutrizzjoni
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+)
Maltese: 1 Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al3+)
English: The safety of Hexacima in children over 24 months of age has not been studied in clinical trials.
Maltese: Is-sigurtà ta Hexacima fi tfal aktar minn 24 xahar ta 'età ma ġiex studjat fi provi kliniċi.