FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products containing clobutinol have been available since 1961 and are authorised in a number of EU Member States (see Annex I for the list of clobutinol containing medicinal products authorised in the EU).
Maltese: Il-prodotti mediċinali li fihom clobutinol ilhom disponibbli mill-1961 u huma awtorizzati f'għadd ta' Stati Membri ta' l-UE (ara l-Anness I għal-lista ta' prodotti mediċinali li fihom clobutinol awtorizzati fl-UE).
English: Clobutinol is a synthetic non-opioid cough suppressant.
Maltese: Clobutinol huwa sustanza sintetika mhux opioid li trażżan is-sogħla.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CLOBUTINOL (see Annex I)
Maltese: XJENTIFIKA TA' PRODOTTI MEDIĊINALI LI FIHOM CLOBUTINOL (ara Anness I)
English: To further investigate the torsadogenic potential of clobutinol a multiple rising dose study in healthy volunteers with doses exceeding the highest recommended therapeutic dose of 80 mg clobutinol t.i.d.
Maltese: Sabiex jiġi investigat aktar fid-dettall il-potenzjal torsadoġeniku ta' clobutinol, Boehringer Ingelheim wettqet studju ta' doża inkrimentali multipla f'voluntiera b'saħħithom b'dożi li qabżu l-ogħla doża terapewtika rakkomandata ta' 80 mg clobutinol t.i.d.
English: It was concluded that there is a potential risk of life-threatening arrhythmia under treatment with clobutinol.
Maltese: Ġie konkluż li hemm riskju potenzjali ta' arritmija ta' periklu għall-ħajja bi trattament bi clobutinol.
English: The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Maltese: Il-CHMP iddiskuta l-kwistjoni fil-laqgħa plenarja tiegħu ta' Settembru 2007 u l-proċedura skond lArtikolu 107(2) tad-Direttiva 2001/83/KE, kif emendat ġiet mibdija fil-laqgħa tal-CHMP ta' Settembru 2007.
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an opinion on 18 October 2007 recommending the revocation of the Marketing Authorisations for all clobutinol containing medicinal products in Annex I. The CHMP also recommended that temporary measures are needed in view of the potentially life-threatening risk associated with QT prolongation and therefore recommends to the European Commission that the marketing and the use of clobutinol containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Maltese: B'mod konformi mad-dispożizzjonijiet skond l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendat, il-Kumitat ta' l-Aġenzija dwar Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ħejja opinjoni fit-18 ta' Ottubru 2007 fejn irrakkomanda r-revoka ta' l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti mediċinali kollha li fihom clobutinol imsemmija fl-Anness I. Il-CHMP irrakkomanda wkoll li hemm bżonn ta' miżuri temporanji minħabba r-riskju li jista' jkun ta' periklu għall-ħajja assoċjat ma' titwil tal-QT u għalhekk irrakkomanda lill-Kummissjoni Ewropea sabiex ittqegħid fis-suq u l-użu ta' prodotti mediċinali li fihom clobutinol jiġi sospiż immedjatament fl-Istati Membri kollha konċernati ta' l-UE sakemm jiġu adottati l-miżuri finali.
English: The primary objective of the study was to investigate safety parameters with special emphasis on ECG (electrocaridiogram), tolerability and pharmacokinetics of clobutinol in healthy male and female volunteers following oral administration of a 80 mg single dose and of repeated rising doses of t.i.d.
Maltese: L-objettiv ewlieni ta' listudju kien li jiġu investigate l-parametri tas-sigurtà b'enfasi speċjali fuq l-ECG (elettrokardjogramma), it-tollerabilità u l-farmakokinetiċi ta' clobutinol f'voluntiera rġiel u nisa b'saħħithom wara l-għoti mill-ħalq ta' doża waħda ta' 80 mg u ta' dożi inkrimentali ripetuti ta' t.i.d. 80 mg (= doża terapewtika massima rakkomandata), 160 mg, 240 mg u 320 mg fuq 7 ijiem u doża finali fil-għodwa ta' jum 8 (= fuq tmint ijiem).
English: On 30 August 2007, the German Competent Authority (BfArM) issued a Rapid Alert informing the Members States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its decision to suspend the marketing authorisation of all clobutinol containing medicinal products in Germany on 31 August 2007 due to an increased risk of serious arrhythmia associated with clobutinol.
Maltese: Fit-30 ta' Awwissu 2007, l-Awtorità Kompetenti Ġermaniża (BfArM) ħarġet Twissija Rapida li biha infurmat lill-Istati Membri, lill-EMEA u lill-Kummissjoni Ewropea skond l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendat, dwar id-deċiżjoni tagħha li tissospendi l-awtorizzazzjoni għat-tqegħid fissuq tal-prodotti mediċinali kollha li fihom clobutinol fil-Ġermanja fil-31 ta' Awwissu 2007 minħabba riskju akbar ta' arritmija assoċjat ma' clobutinol.
English: Benefit/risk
Maltese: MILL-EMEA
English: The ICH E 14 limits of 20 ms are clearly exceeded even under therapy with the highest recommended and approved dose (240 mg).
Maltese: Il-limiti ICH E 14 ta' 20 ms jinqabżu b'mod ċar anki taħt terapija bl-ogħla doża rakkomandata u approvata (240 mg).
English: The decision of the German Competent Authority was based on newly available preliminary results from a clinical trial performed by Boehringer Ingelheim that have shown a prolongation of the QTc interval under treatment with clobutinol.
Maltese: Id-deċiżjoni ta' l-Awtorità Kompetenti Ġermaniża kienet ibbażata fuq riżultati preliminari disponibbli ġodda minn prova klinika mwettqa minn Boehringer Ingelheim li wrew titwil ta' l-intervall QTc bi trattament bi clobutinol.
English: 48 healthy volunteers (male and female) were planned to participate according to four sequential groups of twelve volunteers each.
Maltese: 48 voluntier b'saħħithom (irġiel u nisa) kienu ppjanati biex jipparteċipaw skond erba' gruppi sekwenzjali ta' 12-il volunteer kull wieħed.
English: The preliminary clinical trial results show a strong QT prolongation potential in healthy volunteers.
Maltese: Ir-riżultati tal-prova klinika preliminari juru potenzjal qawwi ta' titwil tal-QT f'voluntiera b'saħħithom.
English: The non-clinical study results indicate that clobutinol has a potential to prolong the QTc interval.
Maltese: Ir-riżultati ta' l-istudju mhux kliniku jindikaw li clobutinol għandu potenzjal li jtawwal l-intervall QTc.
English: • The Committee considered that clobutinol is approved for a condition which is not lifethreatening and for which alternative treatments are available, and the expected benefit is only symptomatic; furthermore the CHMP took into account that clobutinol could be available over the counter
Maltese: • Il-Kumitat qies li clobutinol huwa approvat għal kundizzjoni li mhijiex ta' periklu għall-ħajja u li għaliha jeżistu trattamenti alternattivi, u l-benefiċċju mistenni huwa biss sintomatiku; barra minn hekk il-CHMP ikkunsidra li clobutinol jista' jkun disponibbli mingħajr riċetta
English: Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for clobutinol is not considered favourable and recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I. The CHMP also recommended that temporary measures are needed in view of the potentially life-threatening risk associated with QT prolongation and therefore recommends to the European Commission that the marketing and the use of clobutinol containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Maltese: Wara li qies dawn l-elementi kollha, il-CHMP ikkonkluda li l-proporzjon tal-benefiċċju/riskju għal clobutinol mhux meqjus favorevoli u rrakkomanda r-revoka ta' l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti mediċinali msemmija fl-Anness I. Il-CHMP irrakkomanda wkoll li hemm bżonn ta' miżuri temporanji minħabba r-riskju potenzjalment ta' theddida għall-ħajja assoċjat ma' titwil talQT u għalhekk irrakkomanda lill-Kummissjoni Ewropea sabiex it-tqegħid fis-suq u l-użu ta' prodotti mediċinali li fihom clobutinol jiġi sospiż immedjatament fl-Istati Membri kollha konċernati ta' l-UE sakemm jiġu adottati l-miżuri finali.
English: • The Committee concluded that the QT/QTc prolongation is clearly dose dependent and that the ICH E14 limits of 20 ms are clearly exceeded even under therapy with the highest recommended and approved dose (240 mg)
Maltese: • Il-Kumitat ikkonkluda li t-titwil tal-QT/QTc huwa dipendenti b'mod ċar fuq id-doża u li l-limiti ICH E14 ta' 20 ms jiġu maqbuża b'mod ċar anki taħt terapija bl-ogħla doża rakkomandata u approvata (240 mg)
English: At the same time as the decision of the BfArM to suspend all clobutinol containing medicinal products in Germany, Boehringer Ingelheim decided to withdraw voluntarily its clobutinol containing medicinal products worldwide from the market.
Maltese: Simultanjament mad-deċiżjoni tal-BfArM li jissospendi l-prodotti mediċinali kollha li fihom clobutinol fil-Ġermanja, Boehringer Ingelheim iddeċidiet li tirtira volontarjament mis-suq madwar iddinja kollha l-prodotti mediċinali tagħha li fihom clobutinol
English: The study was prematurely discontinued on day 2 in the third group (720 mg dose group).
Maltese: L-istudju ġie mwaqqaf qabel il-waqt fit-tieni jum fit-tielet grupp (il-grupp b'doża ta' 720 mg).
English: They are available as generic or branded medicines, mostly marketed by Boehringer Ingelheim under the trade name Silomat.
Maltese: Huma disponibbli bħala mediċini ġeneriċi jew irreġistrati, ikkummerċjati prinċipalment minn Boehringer Ingelheim taħt l-isem kummerċjali Silomat.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: Potentially life-threatening torsades de pointes may be caused by QT prolongation.
Maltese: Benefiċċju/riskju Torsades de pointes potenzjalment ta' theddida għall-ħajja jistgħu jkunu kkawżati minn titwil tal-QT.
English: Clobutinol is a non-opioid cough suppressant and the expected benefit is symptomatic.
Maltese: Clobutinol huwa sustanza mhux tal-loppju li trażżan is-sogħla u l-benefiċċju mistenni huwa sintomatiku.
English: EU/1/01/178/001 Targretin
Maltese: EU/1/01/178/001
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Għamla farmaċewtika
English: The full EPAR for Edarbi 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: Edarbi 40 and 80 mg was also more effective than ramipril (10 mg).
Maltese: Edarbi 40 u 80 mg kien ukoll aktar effettiv mir-ramipril (10 mg).
English: This is a summary of the European public assessment report (EPAR) for Edarbi.
Maltese: Dan huwa sommarju tar-Rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Edarbi.
English: Three studies investigated the effects of Edarbi in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Maltese: Tliet studji investigaw l-effetti ta' Edarbi meħud ma' mediċini anti-ipertensivi oħra (klortalidonu, amlodipina, u idroklorotijażide).
English: In the two studies with Edarbi taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Edarbi 40 mg and a fall of about 14.5 mmHg on Edarbi 80 mg after 6 weeks.
Maltese: Fiż-żewġ studji fuq Edarbi meħud waħdu apparagun ma' plaċebo, il-pazjenti kellhom tnaqqis medju fil-pressjoni sistolika tad-demm ta' madwar 13.5 mmHg b'Edarbi 40 mg u tnaqqis ta' madwar 14.5 mmHg b'Edarbi 80 mg wara 6 ġimgħat.
English: This summary was last updated in 10-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2013.
English: Edarbi on its own was more effective than placebo.
Maltese: Edarbi waħdu kien aktar effettiv minn plaċebo.
English: When Edarbi alone was compared with other medicines, 80 mg of Edarbi was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Maltese: Meta Edarbi waħdu tqabbel ma' mediċini oħra, 80 mg ta' Edarbi kien aktar effettiv fit-tnaqqis talpressjoni tad-demm milli l-ogħla doża approvata tal-valsartan (320 mg) u tal-olmesartan medoxomil (40 mg).
English: The active substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Edarbi, l-azilsartan medoxomil, hija ‘antagonista tar-riċettur ta' angjotensina II', li jfisser li timblokka l-azzjoni ta' ormon fil-ġisem magħruf bħala angjotensina II. L-anġjotensina
English: The CHMP concluded that Edarbi belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Maltese: Is-CHMP ikkonkluda li Edarbi jagħmel parti minn klassi stabbilita ta' mediċini fil-kura tal-ipertensjoni u li r-riskji tiegħu huma simili għal mediċini oħrajn ta' din il-klassi.
English: Why has Edarbi been approved?
Maltese: Għaliex ġie approvat Edarbi?
English: Edarbi is a medicine that contains the active substance azilsartan medoxomil.
Maltese: Edarbi huwa mediċina li fiha s-sustanza attiva azilsartan medoxomil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edarbi on 07 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Edarbi valida fl-Unjoni Ewropea kollha fis-7 ta' Diċembru 2011.
English: This compares with a fall of 0.3 to 1.4 mmHg in the patients taking placebo.
Maltese: Dan meta mqabbel ma' tnaqqis ta' 0.3 sa 1.4 mmHg fil-pazjenti li kienu qegħdin jieħdu l-plaċebo.
English: A risk management plan has been developed to ensure that Edarbi is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Edarbi jintuża bl-aktar mod sigur possibbli.
English: Side effects with Edarbi are generally mild or moderate, with the most common side effect being dizziness.
Maltese: L-effetti sekondarji b'Edarbi huma ġeneralment ħfief jew moderati, u l-effett sekondarju l-aktar komuni huwa l-isturdament.
English: The patients in the combination studies had moderate to severe hypertension.
Maltese: Il-pazjenti fl-istudji ta' kombinazzjoni kellhom ipertensjoni minn moderata sa severa.
English: What is Edarbi?
Maltese: Kif jintuża Edarbi?
English: What is the risk associated with Edarbi?
Maltese: Għal xiex jintuża Edarbi?
English: What measures are being taken to ensure the safe and effective use of Edarbi?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Edarbi?
English: Edarbi is used in adults who have essential hypertension (high blood pressure).
Maltese: Edarbi jintuża fl-adulti li jkollhom ipertensjoni (pressjoni tad-demm għolja) essenzjali.
English: Five studies investigated the effects of Edarbi taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Maltese: Ħames studji investigaw l-effetti ta' Edarbi meħud waħdu, u qabbluh ma' plaċebo (kura finta) jew ma' mediċini anti-ipertensivi oħra (ramipril, valsartan u olmesartan medoxomil).
English: This allows the blood pressure to fall towards normal, thus reducing the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni tad-demm, u b'hekk jitnaqqsu r-riskji assoċjati mal-pressjoni għolja tad-demm, fosthom il-puplesija.
English: Edarbi is taken by mouth and the usual recommended dose is 40 mg once a day.
Maltese: Edarbi jittieħed mill-ħalq u d-doża normalment irrakkomandata hija 40 mg darba kuljum.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 80 mg, or another medicine for hypertension, such as chlortalidone or hydrochlorothiazide, can be added.
Maltese: Jekk ilpressjoni tad-demm ma tkunx ikkontrollata biżżejjed, id-doża tista' tiżdied għal 80 mg, jew tista' tiżdied mediċina oħra kontra l-ipertensjoni, bħall-klortalidonu jew l-idroklorotijażide.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edarbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: L-istudji wrew ukoll li Edarbi, meta jittieħed flimkien ma' mediċini oħra, jista' jipproduċi tnaqqis addizzjonali fil-pressjoni tad-demm apparagun ma' meta dawn il-mediċini jittieħdu mingħajr Edarbi.
English: How has Edarbi been studied?
Maltese: Kif ġie studjat Edarbi?
English: ‘Essential' means that the hypertension has no obvious cause.
Maltese: ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti.
English: Streptococcus groups A, B, C and G
Maltese: Streptococcus gruppi A, B, C and G
English: IV dose
Maltese: IV doża
English: Treatment of Clostridium difficile infection (CDI):
Maltese: Trattament ta' infezzjoni Clostridium difficile (CDI):
English: Vertigo, tinnitus, dizziness
Maltese: Vertigo, tinnitus, stordament
English: Susceptibility testing breakpoints
Maltese: Suxxettibilità fit-testjar tal-breakpoints
English: 10 to 21 days
Maltese: 10 sa 21 jum
English: Intraperitoneal administration
Maltese: Amministrazzjoni intraperitonali
English: Coagulase-negative staphylococci1 ≤ 4 mg/L
Maltese: Coagulase-negattiv staphylococci1 ≤ 4 mg/L
English: Infective endocarditis
Maltese: Endocarditis infettiv
English: Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.
Maltese: Neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia riversibbli.
English: For information about the preparation of the solution, please see section 6.6.
Maltese: Għal informazzjoni dwar il-preparament tas-soluzzjoni, jekk jogħġbok ara ara sezzjoni 6.6.
English: System organ class Frequency
Maltese: Sistema tal-klassifika tal-organi Frekwenza
English: 7 to 14 days
Maltese: 7 sa 14-il jum
English: Linerarity/non-linearity
Maltese: Linearità/mhux lineari
English: Gram positive aerobic species Erysipelothrix rhusiopathiae, Heterofermentative Lactobacillus, Leuconostoc spp
Maltese: Speċi arobiċi pożittivi Gram Erysipelothrix rhusiopathiae, Heterofermentative Lactobacillus, Leuconostoc spp
English: Intermittent haemodialysis Peritoneal dialysis
Maltese: Haemodialysis intermittenti Dijaliżi peritonali
English: Summary of the Safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: Oral administration
Maltese: Amministrazzjoni orali
English: Potential for Systemic Absorption
Maltese: Potenzjal għall-assorbiment sistemiku
English: Capsules
Maltese: Kapsuli orali
English: Anaerobic species Clostridium innocuum
Maltese: Speċi anarobiċi Clostridium innocuum
English: Tabulated List of Adverse reactions
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: Interstitial nephritis, acute renal failure.
Maltese: Nefrite interstizjali, insuffiċjenza renali akuta.
English: PMA (weeks) Dose (mg/kg) Interval of administration (h)
Maltese: Doża (mg/kg) Intervall ta ' lamministrazzjoni (h)
English: Immune system disorders: Rare
Maltese: Disturbi marbuta mas- sistema immuni: Rari
English: It is usually given every 6 hours.
Maltese: Huwa normalment mogħtija kull 6 sigħat.
English: Severe bullous reactions
Maltese: Reazzjonijiet severe bullożi
English: Biliary excretion is insignificant (less than 5% of a dose).
Maltese: L-eskrezzjoni biljari hija insinifikanti (inqas minn 5% ta' doża).
English: Vancomycin is administered intravenously for the treatment of systemic infections.
Maltese: Vankomiċin huwa amministrat intravinuża għat-trattament ta ' infezzjonijiet sistematiċi.
English: Intermittent therapy: the recommended dose is 15-30 mg/kg in the long-dwell, every 5-7 days.
Maltese: Terapija intermittenti: id-doża rrakkomandata hija 15-30 mg/kg fil-long-dwell, kull 5-7 tijiem.
English: Synergism
Maltese: Sinerġiżmu
English: In the case of patients with normal renal function, intravenous infusion of multiple doses of 1g vancomycin (15 mg/kg) for 60 minutes produces approximate average plasma concentrations of 50-60 mg/L, 20-25 mg/L and 5-10 mg/L, immediately, 2 hours and 11 hours after completing the infusion, respectively.
Maltese: Fil-każ ta ' pazjenti b'funzjoni renali normali, infużjoni ta ' dożi multipli ta ' 1 g vankomiċin (15 mg/kg) għal 60 minuta jipproduċi konċentrazzjonijiet plasma medja approssimattiva ta ' 50-60 mg/L, 20-25 mg/L u 5-10 mg/L, immedjatament, sagħtejn u 11-il siegħa wara li jitlesti l-infużjoni, rispettivament.
English: Stevens-Johnson syndrome (SJS) has been reported with the use of vancomycin (see section 4.8).
Maltese: Is-sindromu Stevens-Johnson (SJS) ġie rrapurtat bl-użu tal-vankomiċin (ara sezzjoni 4.8).
English: - Necrotizing
Maltese: -Nekrotizant
English: The reactions abate when administration is stopped, generally between 20 minutes and 2 hours.
Maltese: Ir-reazzjonijiet jitnaqqsu meta l-amministrazzjoni titwaqqaf, ġeneralment bejn 20 minuta u sagħtejn wara.
English: Vancomycin is active against gram-positive bacteria, such as staphylococci, streptococci, enterococci, pneumococci, and clostridia.
Maltese: Vankomiċin hija attiva kontra l-bakterja Gram-pożittivi, bħalma huma l-istafilokoċċi, streptococci, enterokoċċi, pneumococci, u clostridia.
English: Intravenous administration
Maltese: Reżistenti inerenti
English: Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin.
Maltese: Kull kunjett fih 500 mg vancomycin idrokloridju ekwivalenti għal 500,000 IU vancomycin.
English: 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), not known (cannot be estimated from the available data).
Maltese: 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), mhux magħruf (ma tistax tiġi stmata mid-data disponibbli).
English: It is usually given every 8 to 12 hours.
Maltese: Huwa normalment jingħata kull 8 sa 12-il siegħa.
English: At serum concentrations of vancomycin of 10 mg/l to 100 mg/l, the binding of the drug to plasma proteins is approximately 30-55%, measured by ultra-filtration.
Maltese: F'konċentrazzjonijiet tasserum tal-vankomiċin ta' 10 mg/l għal 100 mg/l, l-irbit tad-droga mall-proteini tal-plażma huwa bejn wieħed u ieħor 30-55%, imkejjel bl-ultra-filtrazzjoni.
English: Each vial contains 1000 mg contains vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin.
Maltese: Kull kunjett fih 1000 mg hydrochloride vankomiċin ekwivalenti għall-vankomiċin 1,000,000 IU.
English: Trough values of 15-20 mg/l are usually recommended by clinical laboratories to better cover susceptible-classified pathogens with MIC ≥1 mg/L (see sections 4.4 and 5.1).
Maltese: L-inqas valuri talkoncentrazzjoni ta' 15-20 mg/l huma normalment rrakkomandati mill-laboratorji kliniċi sabiex ikopru aħjar patoġeni mhux klassifikati suxxettibbli ma MIC ≥1 mg/L (ara sezzjonijiet 4.4 u 5.1).
English: [For parenteral formulations authorised for oral use:] Oral administration
Maltese: [For parenteral formulations authorised for UŻU ORALI:] Amministrazzjoni mill-ħalq
English: [For parenteral formulations authorised for intraperitoneal use:] Intraperitoneal administration
Maltese: [Għal formulazzjonijiet parenterali awtorizzati għall-użu peritonew:] Amministrazzjoni intraperitonjali
English: Men: [Weight (kg) x 140 - age (years)]/ 72 x serum creatinine (mg/dl) Women: 0.85 x value calculated by the above formula.
Maltese: [Piż (kg) x 140 - età (snin)]/72 x kreatinin tas-serum (mg/dl)
English: Vancomycin will be given into your vein for at least 60 minutes.
Maltese: Il-Vancomycin se jingħata fil-vina tiegħek għal mill-inqas 60 minuta.
English: Adults and adolescents aged 12 to less than 18 years old
Maltese: Adulti u adolexxenti b'età ta' 12-il sena sa inqas minn 18-il sena [Din is-sezzjoni għandha tinqara kif ġej:]