FrancophonIA/ELRC3.0 huggingface dataset:
English: The information pack should contain the following:
Maltese: Il-pakkett ta' informazzjoni għandu jinkludi dan li ġej:
English: Pharmaceutical Form
Maltese: Għamla Farmaċew tika
English: Packaging Content (concentration)
Maltese: Vajrus attenwat talpanlewkopenja filqtates (PLI IV) millinqas 3.5 log 10
English: 100 % oxygen.
Maltese: 100 % ossiġenu.
English: Incompatibilities
Maltese: Inkompatibilitajie
English: F-54181 Heillecourt France
Maltese: F-54181 Heillecourt Franza
English: 54181 Heillecourt Cedex FRANCE
Maltese: 54181 Heillecourt Cedex FRANZA
English: Lot {Number}
Maltese: Tużax wara {Xagħar/Sena}.
English: It is involved in cellular metabolism and catabolism and permits production of energy in the form of adenosine triphosphate (ATP).
Maltese: Hu involut f'metaboliżmu u kataboliżmu ċellulari u jippermetti l-produzzjoni ta' enerġija fl-għamla ta' adenosine triphosphate (ATP).
English: 15 l cylinders filled at 200 bar, containing 3.2 m³ oxygen under a pressure of 1 bar at 15 ºC.
Maltese: Ċilindri ta' 15 l mimlija fi pressjoni ta' 200 bar, li fihom 3.2 m³ ossiġenu taħt pressjoni 1 bar f'temperatura ta' 15 ºC.
English: 50 l cylinders filled at 200 bar, containing 10.6 m³ oxygen under a pressure of 1 bar at 15 ºC.
Maltese: Ċilindri ta' 50 l mimlija fi pressjoni ta' 200 bar, li fihom 10.6 m³ ossiġenu taħt pressjoni ta' 1 bar f'temperatura ta' 15 ºC.
English: Manufacturer for the batch release: AIR LIQUIDE Santé FRANCE ZI Est, BP 34
Maltese: AIR LIQUIDE Santé FRANCE ZI Est, BP 34
English: The variation of the partial pressure of oxygen in the blood affects the cardiovascular system, the respiratory system, cellular metabolism, and the central nervous system.
Maltese: Il-varjazzjoni ta' pressjoni parzjali fid-demm jaffettwa s-sistema kardjo-vaskulari, is-sistema respiratorja, il-metaboliżmu ċellulari, is-sistema nervuża ċentrali.
English: The oxygen concentration can be reduced to 50 % by including 50 % nitrogen or approximately 60 % medical air.
Maltese: Il-konċentrazzjoni tista' titnaqqas sa 50 % billi tinkludi 50 % nitroġenu jew madwar 60 % arja medika.
English: Lot number
Maltese: Numru tal-lott
English: The first signs of oxygen toxicity include dyspnoea and cyanosis, but should only be suspected after at least 12 hours of 100 % oxygen administration or 18 hours of 80 % oxygen administration under normobaric conditions.
Maltese: L-ewwel sinjali ta' tossiċità ta' ossiġenu jinkludu dispnea u ċjanosi, imma għandhom jiġu suspettati biss wara ta' lanqas 12-il siegħa ta' għoti ta' 100 % ossiġenu jew 18-il siegħa ta' 80 % ossiġenu taħt kundizzjonijiet normobariċi.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu
English: Pack sizes
Maltese: TA' PRODOTT MHUX
English: Cylinders must be kept vertical.
Maltese: Iċ-ċilindri għandhom jinżammu vertikali.
English: Medicinal Oxygen Air Liquide Santé can be safely administered as a carrier gas for inhalation anaesthetics.
Maltese: Medicinal Oxygen Air Liquide Santé jista' jiġi amministrat b'mod sikur bħala gass portatur għat-teħid tan-nifs għal użu anestetiku.
English: 6.5 Nature and composition of immediate packaging 15 l and 50 l metal cylinders with pressure control valves (body and nozzle painted in white).
Maltese: Ċilindri tal-metall ta' 15 l u 50 l b'valvi li jirregolaw il-pressjoni (il-korp u ż-żenuna miżbugħin bl-abjad).
English: It is present in the plasma in the solution and is transported by erythrocytes in the form of oxyhaemoglobin.
Maltese: Huwa preżenti fil-plażma fis-soluzzjoni u jiġi trasportat b'eritroċiti f'għamla ta' oxyhaemoglobin.
English: Oxygen in concentration over 80 % (FiO2 0.8) should not exceed 18 hours.
Maltese: L-ossiġenu f'konċentrazzjoni ta' aktar minn 80 % (FiO2 0.8) m'għandux jingħata għal aktar minn 18-il siegħa.
English: Oxygenation can be assessed using pulse oximetry or arterial blood gas analysis.
Maltese: L-ossiġenazzjoni tista' tiġi assessjata permezz ta' oksimetru tal-polz jew analiżi ta' gass fid-demm arterjali.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/067/001
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/067/001
English: PHARMACEUTICAL FORM Inhalation gas.
Maltese: °C u materjali kombustibbli.
English: If you have been working in an oxygen-enriched atmosphere avoid smoking, open flames or other sources of ignition for at least 15 minutes.
Maltese: Jekk inti kont qed taħdem f'ambjent arrikkit bl-ossiġenu, evita t-tipjip, il-fjammi mhux mgħottija jew sorsi oħra ta' tqabbid għal ta' lanqas 15-il minuta.
English: Medicinal Oxygen Air Liquide Santé can be used during pregnancy and lactation.
Maltese: Medicinal Oxygen Air Liquide Santé jista' jintuża waqt it-tqala u t-treddiegħ.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Medicinal Oxygen Air Liquide Santé is an inhalation gas consisting of 100 % oxygen.
Maltese: U INGREDJENT(I) OĦRA Medicinal Oxygen Air Liquide Santé huwa gass għat-teħid tan-nifs li jikkonsisti minn 100 % ossiġenu.
English: Deprivation of oxygen, resulting in tissue hypoxia, results in a rapid deterioration of myocardial and central nervous activity.
Maltese: In-nuqqas ta' ossiġenu, li jirriżulta f'ipoksja tat-tessuti, iwassal għal deterjorament ta' malajr fl-attività mijokardjali u nervuża ċentrali.
English: Oxygen in concentration up to 100 % (FiO2 1.0) should not exceed 12 hours.
Maltese: Ossiġenu f'konċentrazzjoni sa 100 % (FiO2 1.0) m'għandux jingħata għal aktar minn it-12-il siegħa.
English: Pharmacotherapeutic group: Medical Gases, ATCvet code: QV03AN01.
Maltese: Gassijiet Mediċi, Kodiċi ATĊ veterinarja:
English: Medicinal Oxygen Air Liquide Santé has no known incompatibilities with other products likely to be administered concomitantly
Maltese: Medicinal Oxygen Air Liquide Santé mhux magħruf li għandu xi inkompatibilitajiet ma' prodotti oħra li jistgħu jingħataw fl-istess żmien
English: CONTRAINDICATIONS
Maltese: KUNTRADIZZJONIJIET
English: Cylinders should be protected from falling, from being hit, from sources of heat or ignition, from temperatures of more than 50 °C and from combustible materials.
Maltese: Iċ-ċilindri għandhom jiġu protetti milli jaqgħu, milli jintlaqtu, minn sorsi ta' sħana jew taqbid, minn temperaturi ta' aktar minn 50
English: Pregnancy and lactation Medicinal Oxygen Air Liquide Santé can be used during pregnancy and lactation.
Maltese: Tqala u treddiegħ Medicinal Oxygen Air Liquide Santé jista' jintuża waqt it-tqala u t-treddiegħ.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TA' L-AWTORIZZAZZJONI
English: In cases where oxygen toxicity is suspected, the fresh gas flow rate should be maintained, but the oxygen concentration of the inspired gas should be reduced to approximately 50 % or less if adequate oxygenation can be maintained.
Maltese: F'każijiet fejn tossiċità bl-ossiġenu hi suspettata, ir-rata ta' gass frisk għandha tibqa' tiġi mantenuta, imma l-konċentrazzjoni ta' l-ossiġenu tal-gass li jittieħed man-nifs għandha tiġi mnaqqsa b'madwar 50%, jew inqas jekk ossiġenazzjoni adegwata tista' tiġi mantenuta.
English: Cylinder valves and associated equipment must not be lubricated and must be kept entirely free from carbon-based oils and grease because otherwise there is a risk of spontaneous combustion and a violent explosion may occur.
Maltese: Valvi taċ-ċilindri u tagħmir assoċjat m'għandhomx jiġu lubrikatu u għandhom jinżammu kompletament ħielsa minn żjut u griz ibbażżati fuq il-karbonju inkella jaf ikun hemm riskju ta' kombustjoni spontanea u jista' jkun hemm splużjoni vjolenti.
English: Do not lubricate.
Maltese: Mhux appklikabbli.
English: Intervention with oxygen therapy is essential for the resolution of adequate tissue oxygenation.
Maltese: Intervent b'terapija b'ossiġenu hija essenzjali għar-riżoluzzjoni ta' ossiġenazzjoni adegwata tat-tessuti.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Maltese: SID(/S-SIDIEN TA') L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs, cats and horses.
Maltese: VETERINARJU Medicinal Oxygen Air Liquide Santé 100 % gass għal teħid tan-nifs għal klieb, qtates u żwiemel.
English: Since even the smallest spark can cause violent ignition, electrical equipment capable of sparking should not be used in the vicinity of patients receiving oxygen.
Maltese: Filwaqt li l-ossiġenu mhuwiex infjammabbli, huwa jgħin ħafna l-kombustjoni u għalhekk m'għandhomx jiġu permessi fjammi mhux mgħottija qrib ir-reċipjent.
English: The animal must be monitored closely, preferably by means of a pulse oximeter, and the flow rate adapted during anaesthesia to meet their individual requirements.
Maltese: L-annimal għandu jiġi monitorat mill-qrib, preferibbilment permezz ta' oksimetru tal-polz, u r-rata ta' influss għandha tiġi adattata biex tissodisfa l-ħtiġijiet individwali tagħhom.
English: In-circuit oxygen meters can be used to measure the inspired oxygen fraction and depending on the individual animal, a level of 50 - 100 % of the veterinary medicinal product may be required.
Maltese: Miters ta' l-ossiġenu f'ċirkuwit jistgħu jintużaw biex ikejlu l-frazzjoni ta' l-ossiġenu li tittieħed man-nifs u skond l-annimal individwali, livell ta' 50 - 100 % tal-prodott mediċinali veterinarju jista' jkun meħtieġ.
English: Precautions to be taken by the person administering the veterinary medicinal product to animals Medicinal Oxygen Air Liquide Santé should only be used by persons who have been fully trained to use pressure regulators and associated equipment.
Maltese: Doża eċċessiva Minħabba l-pressjoni parzjali għolja ta' l-ossiġenu li jittieħed fl-annimali waqt l-amministrazzjoni tal-prodott mediċinali veterinarju, tossiċità dovuta għall-ossiġenu tista' tidher wara perijodi estiżi ta' żmien.
English: EXPIRY DATE
Maltese: PARIR SABIEX
English: Shelf-life of the veterinary medicinal product as packaged for sale:
Maltese: Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 % oxygen.
Maltese: OĦRA 100 % ossiġenu.
English: The precise fresh gas flow rate required by an animal during anaesthesia and recovery should be determined by a suitably experienced veterinarian, taking into consideration the bodyweight and health status of the animal and the anaesthetic equipment and agents being used.
Maltese: Dan il-prodott mediċinali veterinarju għandu jintuża biss minn persuni li huma mħarrġa sew fl-użu ta' regolaturi tal-pressjoni u tagħmir assoċjat.
English: Oxygen released at tissue level by oxyhaemoglobin is then used in mitochondria for the synthesis of ATP.
Maltese: L-ossiġenu hu element esssenzjali għal organiżmi ħajjin.
English: PACKAGE LEAFLET Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs, cats and horses.
Maltese: FIL-PAKKETT Medicinal Oxygen Air Liquide Santé 100 % gass għal teħid tan-nifs għal klieb, qtates u żwiemel.
English: Animals with pre-existing oxygen radical damage to the lung may have this damage exacerbated by oxygen therapy e.g. in the treatment of paraquat poisoning.
Maltese: Wara dawn ir-reazzjonijiet katalitiċi huwa jerġa' jidher fl-għamla ta' CO2 u H2O. Ossiġenu metabolizzat u ossiġenu mhux metabolizzat żejjed jiġu eliminati mill-ġisem meta tintefa' l-arja 'l barra.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ DWAR L-UŻU SIGUR U EFFETTIV D.
English: Full and empty cylinders should be stored separately.
Maltese: Ċilindri mimlijin u ċilindri vojta għandhom jiġu maħżuna separatament.
English: - and capsules, for oral administration.
Maltese: - u kapsuli, għal għoti orali.
English: • Treatment of peritoneal dialysis-associated peritonitis.
Maltese: • Kura ta' peritonite assoċjata mad-dijaliżi peritoneali.
English: The antibacterial activity of vancomycin is confined to Gram-positive microorganisms.
Maltese: L-attività antibatterika ta' vankomiċina hija limitata għal mikroorganiżmi Gram-pożittivi.
English: Vancomycin spectrum includes a wide range of pathogens including Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococus pneumoniae, Listeria monocytogenes and Clostridium difficile.
Maltese: L-ispettru ta' vankomiċina jinkludi medda wiesgħa ta' patoġeni inkluż Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococus pneumoniae, Listeria monocytogenes u Clostridium difficile.
English: 6 Joint guideline: https://www.britishinfection.org/files/5614/5674/2938/McGill_meningitis_guidelines_Final_published_proof.pdf 7 PD-related peritonitis https://ispd.org/ispd-guidelines/ guidelines on the management of PD-related peritonitis in adults from the International Society for Peritoneal Dialysis (ISPD) (Li PK et al., 2016 http://www.pdiconnect.com/content/36/5/481.full
Maltese: 6 Linja gwida konġunta: https://www.britishinfection.org/files/5614/5674/2938/McGill_meningitis_guidelines_Final_published_proof.pdf 7 Peritonite relatata ma' PD https://ispd.org/ispd-guidelines/ linji gwida dwar il-ġestjoni ta' peritonite relatata ma' PD fl-adulti mis-Soċjetà Internazzjonali għal Dijaliżi Peritoneali (ISPD) (Li PK et al., 2016 http://www.pdiconnect.com/content/36/5/481.full
English: 8 ISPD recommendations for paediatric patients (Warady BA et al., 2012) - https://ispd.org/media/pdf/Consensus__Change_20_.pdf 9https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/fulltext_treatment_guidance_ Clostridium_difficile_infection.pdf
Maltese: 8 Rakkomandazzjonijiet tal-ISPD għal pazjenti pedjatriċi (Warady BA et al., 2012) - https://ispd.org/media/pdf/Consensus__Change_20_.pdf 9https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/fulltext_treatment_guidance_ Clostridium_difficile_infection.
English: The CHMP noted the guidelines on the management of Peritoneal Dialysis-related peritonitis in adults from the International Society for Peritoneal Dialysis (ISPD) (Li PK et al., 20167), the ISPD recommendations for pediatric patients (Warady BA et al., 20128).
Maltese: Is-CHMP innota l-linji gwida dwar ilġestjoni ta' Peritonite relatata mad-Dijaliżi peritoneali fl-adulti mis-Soċjetà Internazzjonali għal Dijaliżi Peritoneali (ISPD, International Society for Peritoneal Dialysis) (Li PK et al., 20167), irrakkomandazzjonijiet tal-ISPD għal pazjenti pedjatriċi (Warady BA et al., 20128).
English: In addition, the CHMP reviewed the available evidence submitted within the referral procedure including several references to published literature and a meta-analysis of a total of 64 studies (32 for initial treatment and negative culture, 28 reporting treatment for Gram-positive and 24 reporting treatment for Gram-negative) and 21 randomized clinical trials (14 for initial treatment and negative culture, 8 reporting treatment for Gram-positive and 8 reporting treatment for Gram-negative), confirming the efficacy of vancomycin for the treatment of peritonitis in peritoneal dialysis.
Maltese: Barra minn hekk, is-CHMP irreveda l-evidenza disponibbli ppreżentata fil-proċedura ta' referenza inkluż diversi referenzi għal letteratura ppubblikata u metaanaliżi ta' total ta' 64 studju (32 għal kura inizjali u kultura negattiva, 28 li jirrappurtaw kura għal Gram-pożittiv u 24 li jirrappurtaw kura għal Gram-negattiv) u 21 prova klinika randomizzati (14 għal kura inizjali u kultura negattiva, 8 li jirrappurtaw kura għal Gram-pożittiv u 8 li jirrappurtaw kura għal Gram-negattiv), li tikkonferma l-effikaċja ta' vankomiċina għall-kura ta' peritonite f'dijaliżi peritoneali.
English: Clin Microbiol Infect 2009; 15: 1067-1079
Maltese: European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect 2009; 15: 1067-1079
English: Vancomycin hydrochloride is defined as the hydrochloride salt of a mixture of related glycopeptides for which the characteristics are defined in the European Pharmacopeia 1058 monograph (currently under revision).
Maltese: Kloridrat tal-vankomiċina huwa definit bħala l-melħ kloridrat ta' taħlita ta' glikopeptidi relatati li lkaratteristiċi tagħha huma definiti fil-monograff European Pharmacopeia 1058 (bħalissa qiegħed jiġi rieżaminat).
English: Intravenous vancomycin is mainly used for the treatment of serious infections caused by microorganisms with mechanisms of resistance to beta-lactam antibiotics, in particular methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CoNS) and enterococci, the latter being often tolerant to β-lactam antibiotics.
Maltese: Vankomiċina mogħti ġol-vini jintuża prinċipalment għall-kura ta' infezzjonijiet serji kkawżati minn mikroorganiżmi b'mekkaniżmi ta' reżistenza għal antibijotiċi beta-lactam, b'mod partikolari Staphylococcus aureus reżistenti għall-metiċillina (MRSA, methicillin-resistant Staphylococcus aureus), staphylococci negattivi għall-koagulażi (CoNS, coagulase-negative staphylococci) u enterococci, dawn tal-aħħar normalment ikunu ta' spiss tolleranti għal antibijotiċi β-lactam.
English: - powder for solution for injection or infusion (500 mg and 1000 mg) used by intravenous administration.
Maltese: - trab għal soluzzjoni għall-injezzjoni jew infużjoni (500 mg jew 1000 mg) li jintuża permezz ta' għoti ġol-vini.
English: Vancomycin is also administered by the oral route for the treatment of Clostridium difficile-infection (CDI).
Maltese: Vankomiċina jingħata wkoll mir-rotta orali għall-kura ta' infezzjoni bi Clostridium difficile (CDI, Clostridium difficile-infection).
English: • Treatment of acute bacterial meningitis.
Maltese: • Kura ta' meninġite batterika akuta.
English: Furthermore, the role of selective intestinal decontamination is controversial.
Maltese: Barra minn hekk, ir-rwol ta' dekontaminazzjoni intestinali selettiva huwa kontroversjali.
English: • Concerning the “decontamination of the GI tract in immune-compromised patients when combined with an aminoglycoside”, the CHMP reviewed the available data submitted throughout this procedure.
Maltese: • Dwar id-”dekontaminazzjoni tal-apparat GI f'pazjenti b'immuni kompressi meta jingħata flimkien ma' aminoglikosidu”, is-CHMP irreveda d-data disponibbli ppreżentata matul din ilproċedura.
English: Finally, revisions were made to sections 5.1 and 5.2 to reflect current pharmacokinetic and pharmacodynamic data, and to sections 1 and 2 to reflect the amount of active substance in the finished product (based on the potency expressed in IU), and the dose and strength of vancomycin containing products (to be expressed in milligrams).
Maltese: Finalment, saru reviżjonijiet tas-sezzjonijiet 5.1 u 5.2 sabiex jirriflettu data farmakokinetika u farmakodinamika attwali, u tas-sezzjonijiet 1 u 2 sabiex jirriflettu l-ammont ta' sustanza attiva filprodott lest (abbażi tal-potenza espressa f'IU), u d-doża u l-qawwa ta' prodotti li fihom vankomiċina (li għandhom jiġu espressi f'milligrammi).
English: However, to ensure that the established therapeutic dose in terms of IU (potency) is maintained, and as indicated in the Question and Answer on expression/declaration of potency in quantitative and qualitative composition for vancomycin products (EMA/CHMP/QWP/667469/2015), the amount (mg) of active substance in the drug product should be adjusted to achieve the declared product strength in terms of IU.
Maltese: Madankollu, sabiex jiġi żgurat li ddoża terapewtika f'termini ta' IU (potenza) tinżamm, u kif indikat fil-Mistoqsija u t-Tweġiba dwar lespressjoni/id-dikjarazzjoni tal-potenza f'kompożizzjoni kwantitattiva u kwalitattiva għal prodotti vankomiċina (EMA/CHMP/QWP/667469/2015), l-ammont (mg) tas-sustanza attiva fil-prodott mediċinali għandu jiġi aġġustat sabiex tintlaħaq il-qawwa tal-prodott iddikjarata f'termini ta' IU.
English: • the CHMP considered that vancomycin represent a crucial therapeutic option in the context of the treatment of serious infections (complicated skin and soft tissue infections, bone and joint infections, community acquired pneumonia, hospital acquired pneumonia including ventilatorassociated pneumonia, infective endocarditis, acute bacterial meningitis, bacteraemia that occurs in association with, or is suspected to be associated with, any of the above, perioperative antibacterial prophylaxis, peritoneal dialysis-associated peritonitis and treatment of Clostridium difficile infection) caused by Gram-positive pathogens, particularly those caused by MRSA,
Maltese: • is-CHMP ikkunsidra li vankomiċina jirrappreżenta għażla terapewtika kruċjali fil-kuntest talkura ta' infezzjonijet serji (infezzjonijiet ikkumplikati tat-tessuti tal-ġilda u tat-tessut artab, infezzjonijiet tal-għadam u tal-ġogi, pulmonite akkwiżita f'komunità, pulmonite akkwiżita fi sptar inkluż pulmonite assoċjata mal-ventilatur, endokardite infettiva, batteremija li ssir f'assoċjazzjoni ma', jew hija suspettata li hija assoċjata ma' kwalunkwe waħda minn ta' hawn fuq, profilassi antibatterika perioperatorja, peritonite assoċjata mad-dijaliżi peritoneali, u kura ta' infezzjoni bi Clostridium difficile) ikkawżata minn patoġeni Gram-pożittivi, b'mod partikolari dawk ikkawżati minn MRSA,
English: The following indications of vancomycin (oral route) for “treatment of staphylococcal enterocolitis” and “Decontamination of the gastrointestinal (GI) tract in immune-compromised patients when combined with an aminoglycoside” were not supported by the CHMP:
Maltese: L-indikazzjonijiet li ġejjin ta' vankomiċina (rotta orali) għall-“kura ta' staphylococcal enterocolitis” u “Dekontaminazzjoni tal-apparat gastrointestinali (GI) f'pazjenti b'immuni kompromessi meta jingħata flimkien ma' aminoglikosidu” ma ġewx appoġġjati mis-CHMP:
English: 1 ESCMID guidelines: https://www.escmid.org/escmid_publications/medical_guidelines/escmid_guidelines/ 2 ESCMID guideline https://www.escmid.org/fileadmin/src/media/PDFs/4ESCMID_Library/2Medical_Guidelines/ESCMID_Guidelines/Eu_Rec_Antimicrobal.pdf 3 IDSA guideline http://www.idsociety.org/Guidelines/Patient_Care/IDSA_Practice_Guidelines/Antimicrobial_Agent_Use/Vancomycin/Vancomycin/ 4 Bacterial meningitis:ESCMID guideline for bacterial meningitis: http://www.clinicalmicrobiologyandinfection.com/article/S1198743X(16)00020-3/abstract
Maltese: linja gwida tal-ESCMID għal meninġite batterika: http://www.clinicalmicrobiologyandinfection.com/article/S1198743X(16)00020-3/abstract
English: The active substance is obtained mainly by fermentation.
Maltese: Is-sustanza attiva tinkiseb prinċipalment permezz tal-fermentazzjoni.
English: • Treatment of: complicated skin and soft tissue infections, bone and joint infections, community acquired pneumonia, hospital acquired pneumonia including ventilator-associated pneumonia, infective endocarditis, bacteraemia that occurs in association with, or is suspected to be associated with any of the above (particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA)), perioperative antibacterial prophylaxis.
Maltese: • Kura ta': infezzjonijiet ikkumplikati tat-tessuti tal-ġilda u tat-tessut artab, infezzjonijiet talgħadam u tal-ġogi, pulmonite akkwiżita f'komunità, pulmonite akkwiżita fi sptar inkluż pulmonite assoċjata mal-ventilatur, endokardite infettiva, batteremija li sseħħ f'assoċjazzjoni ma', jew li hija suspettata li hija assoċjata ma' kwalunkwe waħda minn ta' hawn fuq (partikolarment dawk ikkawżati minn Staphylococcus aureus reżistenti għall-metiċillina (MRSA)), profilassi antibatterika perioperatorja.
English: Therefore, the CHMP discussed different alternative approaches to estimate the vancomycin exposure.
Maltese: Għalhekk, is-CHMP iddiskuta approċċi alternattivi differenti sabiex jiġi stmat l-esponiment ta' vankomiċina.