FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharm Res 2004; 21: 2064-71.
Maltese: Res 2004; 21: 2064-71.
English: • Infective endocarditis
Maltese: • Endokardite infettiva
English: Chemother 1997 ; 39: 789-96.
Maltese: J Antimicrob Chemother 1997 ; 39: 789-96.
English: • Bacteraemia/ Septicaemia / Sepsis
Maltese: • Batterimja/ Settiċemija / Sepsis
English: Yamada T , Nonaka T Yano T, Kubota T, Egashira N, Kawashiri T, Oishi R, Yamada T, Kawashiri T, Oishi R (2012).
Maltese: Il-MAH qabel ukoll mat-talba magħmula mis2 Yamada T , Nonaka T Yano T, Kubota T, Egashira N, Kawashiri T, Oishi R, Yamada T, Kawashiri T, Oishi R (2012).
English: The pharmacokinetics of teicoplanin for the treatment of Clostridium difficile was investigated in study DRC342-DLI073.
Maltese: Il-farmakokinetika ta' teicoplanin fil-kura ta' Clostridium difficile kienet investigata flistudju DRC342-DLI073.
English: • Urinary tract infections (UTI)
Maltese: • Infezzjonijiet fl-apparat urinarju (UTI)
English: Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Maltese: Uħud mis-sottokomponenti huma fil-fatt gruppi ta' qċaċet iżgħar, jiġifieri A2-1, A2-3, A2-5 u A3.
English: The microbiological spectrum of teicoplanin covers staphylococci including Staphylococcus aureus susceptible or resistant to methicillin, Streptococcus pneumoniae and other streptococci mainly including Streptococcus pyogenes, streptococci in the Viridans group and Enterococcus faecalis.
Maltese: L-ispettru mikrobijoloġiku ta' teicoplanin jkopri l-istafilokokki inkluż Staphylococcus aureus suxxettibbli jew reżistenti għal methicillin, Streptococcus pneumoniae u streptokokki oħra prinċipalment inkluż Streptococcus pyogenes, streptokokki fil-grupp ta' Viridans u Enterococcus faecalis.
English: Section 4.3 - Contraindications
Maltese: Sezzjoni 4.3 - Il-kontraindikazzjonijiet
English: The clinical and bacteriological efficacy of teicoplanin was shown in SSTIs (37.4% of all infection sites) in Study EG-87-42 (European Multicentre Study).
Maltese: L-effikaċja klinika u batterjoloġika ta' teicoplanin intweriet f'SSTIs (37.4% tas-siti kollha ta' infezzjoni) fl-Istudju EG-87-42 (Studju Multiċentriku Ewropew).
English: monograph for microbiological assay of antibiotics.
Maltese: Eur. għall-analiżi mikrobijoloġika ta' antibijotiċi.
English: Section 5.2 - Pharmacokinetic properties
Maltese: Sezzjoni 5.2 - It-tagħrif farmakokinetiku
English: For coagulase-negative staphylococci (CoNS), the resistance breakpoint is >4 mg/ml.
Maltese: Għal stafilokokki negattivi għall-koagulażi (CoNS), il-valur tal-limitu tar-reżistenza huwa ta' >4 mg/ml.
English: Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus with in-vitro bactericidal activity against aerobic and anaerobic gram-positive bacteria.
Maltese: Teicoplanin huwa antibijotiku glikopeptid prodott mill-fermentazzjoni ta' Actinoplanes teichomyceticus b'attività batteriċida in vitro kontra batterji erobiċi u anerobiċi gram-pożittivi.
English: Section 4.5- Interaction with other medicinal products and other forms of interaction The lack of interaction between teicoplanin and other antibiotics, antihypertensives, cardiotropic, antidiabetic agents and anaesthetic agents has been included in the proposed harmonised SmPC.
Maltese: Sezzjoni 4.5- L-interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni In-nuqqas ta' interazzjoni bejn teicoplanin u antibijotiċi oħra, mediċini kontra l-pressjoni għolja, aġenti kardjotropiċi u kontra d-dijabete u aġenti anestetiċi ġie inkluż fl-SmPC armonizzat propost.
English: The MAH has amended section 4.3 only including hypersensitivity to teicoplanin (or to any of the excipients).
Maltese: Il-MAH emenda s-sezzjoni 4.3 biss u inkluda sensittività eċċessiva għal teicoplanin (jew għal kwalunkwe wieħed mill-eċċipjenti).
English: • Skin and soft tissue infections (SSTI)
Maltese: • Infezzjonijiet fil-ġilda u fit-tessuti rotob (SSTI)
English: It is a complex antibiotic, consisting of six closely related glycopeptide subcomponents (A2-1, A2-2, A2-3, A2-4 and A2-5 forming A2 group, and A3) as defined in the current European Pharmacopoeia (Ph.
Maltese: Huwa antibijotiku kumpless, magħmul minn sitt sottokomponenti glikopeptidi relatati mill-qrib (A2-1, A2-2, A2-3, A2-4 u A2-5 li jiffurmaw il-grupp A2, u A3) kif definit fil-monografiji attwali tal-Farmakopeja Ewropea (Ph. Eur.) għal teicoplanin.
English: Section 5.1 - Pharmacodynamic properties
Maltese: Sezzjoni 5.1 - Il-proprjetajiet farmakodinamiċi
English: The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%.
Maltese: Il-kura klinika u r-rata ta' titjib kienu ta' madwar 90% u rrata ta' suċċess batterjoloġika kienet ta' 76%.
English: In Study EG-87-42 (European Multicentre Study), the clinical and bacteriological efficacy of teicoplanin has been shown in UTI (8% of all infection sites).
Maltese: Fl-Istudju EG-87-42 (Studju Multiċentriku Ewropew), l-effikaċja klinika u batterjoloġika ta' teicoplanin intweriet fl-UTI (8% tas-siti kollha ta' infezzjoni).
English: In study EG-87-42, the clinical outcome for endocarditis was 83% (excluding patients considered as non-evaluable).
Maltese: Fl-istudju EG-87-42, ir-riżultat kliniku għall-endokardite kien ta' 83% (esklużi pazjenti meqjusa li ma jistgħux jiġu evalwati).
English: Overall, the undesirable effects listed in the CSP agreed during the PSUR work-sharing procedure number GR/H/PSUR/0001/001 have been included in section 4.8 of the proposed harmonised SmPC using the MedDRA Preferred Terms (PTs), and classified by System Organ Class (SOC).
Maltese: B'mod ġenerali, l-effetti mhux mixtieqa elenkati fis-CSP maqbula waqt il-Proċedura ta' qsim tax-xogħol tal-PSUR numru GR/H/PSUR/0001/001 ġew inklużi fis-sezzjoni 4.8 tal-SmPC armonizzat propost bl-użu tat-Termini Preferiti (PTs) MedDRA, u kklassifikati skont is-Sistema tal-Klassifika tal-Organi (SOC).
English: All the important safety information that has been included in the SmPC has been listed in order of importance: hypersensitivity reactions, infusion related reactions (Red Man Syndrome), severe bullous reactions (including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)), warning concerning the possible adverse reactions with the higher loading dose of 12mg/kg bid
Maltese: Linformazzjoni kollha importanti ta' sigurtà li ġiet inkluża fl-SmPC ġiet elenkata fl-ordni ta' importanza: reazzjonijiet ta' sensittività eċċessiva, reazzjonijiet relatati mal-infużjoni (Sindromu ta' Red Man), reazzjonijiet bullużi severi (inkluż is-Sindromu ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN )), twissija dwar ir-reazzjonijiet avversi possibbli bl-ogħla doża ta' tagħbija ta' 12mg/kg darbtejn kuljum (24mg/kg/kuljum), tromboċitopenija, nefrotossiċità, ototossiċità u superinfezzjoni.
English: The subcomponents are separated by HPLC according to their polarity.
Maltese: Is-sottokomponenti huma separati minn HPLC skont il-polarità tagħhom.
English: In all (pooled data), 72 episodes of infection were treated in 71 adult patients.
Maltese: B'kollox (tagħrif miġbur), 72 episodju ta' infezzjoni ġew ikkurati f'71 pazjent adult.
English: Section 4.9 - Overdose
Maltese: Sezzjoni 4.9 - Id-doża eċċessiva
English: • Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) There is evidence to suggest that teicoplanin is effective in this indication.
Maltese: • Peritonite assoċjata ma' dijalisi peritoneali ambulatorja kontinwa (CAPD)
English: Information on the active substance was submitted in an ASMF.
Maltese: Informazzjoni dwar is-sustanza attiva kienet sottomessa f'ASMF.
English: Indeed, in a Cochrane meta-analysis of randomised controlled trials (RCT) in adults and children with CAPD-associated peritonitis, although the primary response and relapse rates did not differ between intraperitoneal (IP) glycopeptide-based regimens compared to first generation cephalosporin regimens, glycopeptide regimens were more likely to achieve a complete cure, and primary treatment failure was less likely to occur with teicoplanin than vancomycin (Wiggins et al. 2008)1.
Maltese: Tabilħaqq, f'meta-analiżi ta' Cochrane ta' provi kkontrollati randomizzati (RCT) fl-adulti u fit-tfal b'peritonite assoċjata ma' CAPD, għalkemm ir-rispons primarju u r-rati ta' rikaduta ma kinux differenti bejn reġimens intraperitoneali (IP) ibbażati fuq glikopeptidi meta mqabbla ma' reġimens ta' kefalosporin tal-ewwel ġenerazzjoni, ir-reġimens tal-glikopeptidi kienu aktar probabbli li jiksbu fejqan komplet, u l-falliment tal-kura primarja kien inqas probabbli li jseħħ b'teicoplanin milli b'vancomycin (Wiggins et al. 2008)1.
English: The information on the measurement of teicoplanin trough serum concentrations by High Performance Liquid Chromatography (HPLC) and Fluorescence Polarization Immunoassay (FPIA) method was considered to be acceptable by the CHMP.
Maltese: L-informazzjoni dwar il-kejl ta' teicoplanin permezz tal-konċentrazzjonijiet minimi fis-serum permezz ta' Kromatografija Likwida ta' Prestazzjoni Għolja (HPLC) u l-metodu ta' Immunoassaġġ bi Fluworexxenza Polarizzata (FPIA) kien meqjus aċċettabbli mis-CHMP.
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of the Commission Implementing Regulation (EC) No 520/2012.
Maltese: III tar-Regolament ta' Implimentazzjoni tal-Kummissjoni (UE) Nru 520/2012.
English: The harmonised dossier was provided for the active substance (teicoplanin) and for products containing this substance: Targocid 100, 200 mg and 400 mg powder for solution for injection/infusion and Targocid 100, 200 mg and 400 mg powder and solvent for solution for injection/infusion.
Maltese: Targocid 100, 200 mg u 400 mg trab għal soluzzjoni għall-injezzjoni/infużjoni u Targocid 100, 200 mg u 400 mg trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni.
English: In line with the CHMP Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 rev 2), it was considered acceptable to further qualify the indications.
Maltese: F'konformità mal-Linja Gwida tas-CHPM dwar il-Valutazzjoni ta' Prodotti Mediċinali indikati għall-Kura ta' Infezzjonijiet Batteriċi (CPMP/EWP/558/95 rev 2), kien ikkunsidrat aċċettabbli li l-indikazzjonijiet ikomplu jiġu kkwalifikati.
English: A valid TSE certificate was provided for the active substance.
Maltese: Ċertifikat validu tat-TSE ġie pprovdut għas-sustanza attiva.
English: The CHMP concluded that teicoplanin should be indicated in complicated SSTIs i.e. severe cases, but not for the treatment of minor SSTIs in line with the British Society for Antimicrobial Chemotherapy (BSAC) guideline, which does not recommend systemic antibiotics for the treatment of minor SSTIs.
Maltese: Is-CHMP ikkonkluda li teicoplanin għandu jiġi indikat f'SSTIs ikkumplikati jiġifieri każijiet gravi, imma mhux għall-kura ta' SSTIs minuri f'konformità mal-linja gwida tas-Soċjetà Brittanika għal Kimoterapija Antimikrobjali (BSAC), li ma tirrakkomandax antibijotiċi sistemiċi għall-kura ta' SSTIs minuri.
English: However the available data suggest that teicoplanin administered IV or IM at dosages of 10 mg/kg every 12 hours for 1 to 5 doses (loading dosage), then 6 to 10 mg/kg once daily, is effective in the treatment of Gram-positive infections such as septicaemia, skin and soft tissue infections, bone and joint infections, lower respiratory tract infections, and in neutropenia and fever, in children.
Maltese: Madankollu d-dejta disponibbli tissuġġerixxi li teicoplanin mogħti ġol-vini jew fil-muskoli f'dożi ta' 10 mg/kg kull 12-il siegħa għal doża 1 sa 5 (doża ta' tagħbija), imbagħad ta' 6 sa 10 mg/kg darba kuljum, huwa effettiv fil-kura ta' infezzjonijiet Grampożittivi bħal settiċemija, infezzjonijiet fil-ġilda u fit-tessut artab, infezzjonijiet tal-għadam u tal-ġogi, infezzjonijiet fl-apparat respiratorju t'isfel, u fin-newtropenja u d-deni, fit-tfal.
English: Based on the Monte Carlo simulations conducted by Yamada et al2 the MAH has proposed a loading dose of 6mg/kg bid for 3 administrations for most infections, and 12mg/kg bid for 3 to 5 administrations for bone and joint infections and infective endocarditis.
Maltese: Abbażi tas-simulazzjonijiet Monte Carlo mmexxija minn Yamada et al2 il-MAH ippropona doża ta' tagħbija ta' 6mg/kg darbtejn kuljum għal 3 għotjiet għal ħafna mill-infezzjonijiet, u ta' 12mg/kg darbtejn kuljum għal 3 sa 5 għotjiet għall-infezzjonijiet tal-għadam u tal-ġogi u għall-endokardite infettiva.
English: Treatment of infections caused by Gram-positive microorganisms The following infections caused by Gram-positive microorganisms were discussed by the CHMP:
Maltese: L-infezzjonijiet li ġejjin ikkawżati minn mikrorganiżmi Gram-pożittivi kienu diskussi mis-CHMP:
English: • The Committee reviewed the available data on submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the SmPC.
Maltese: • Il-Kumitat irreveda d-dejta disponibbli sottomessa mill-MAH mill-istudji kliniċi eżistenti, id-dejta ta' farmakoviġilanza u l-letteratura ppubblikata li jiġġustifikaw l-armonizzazzjoni proposta talSmPC.
English: The proposed harmonised SmPC reflecting the changes was considered to be acceptable by the CHMP.
Maltese: L-SmPC armonizzat propost li jirrifletti t-tibdil kien meqjus aċċettabbli mis-CHMP.
English: The preclinical safety data reported support these proposed amendments and are provided within the expert report on the toxicological and pharmacological documentation.
Maltese: Id-dejta dwar is-sigurtà preklinika rrappurtata tappoġġa dawn l-emendi proposti u hija pprovduta fir-rapport espert dwar id-dokumentazzjoni tossikoloġika u farmakoloġika.
English: There were also a few cases of endocarditis, respiratory tract infections and urinary tract infections.
Maltese: Kien hemm ukoll ftit każijiet ta' endokardite, infezzjonijiet fl-apparat respiratorju u infezzjonijiet fl-apparat urinarju.
English: monograph.
Maltese: IV.
English: The clinical studies included two open-label non-comparative therapeutic studies; the European Multicentre Study (EG-87-42) and the US Open Multicentre Study (N-86-04) and a review of the comparative studies conducted with teicoplanin (EG-87-35).
Maltese: L-istudji kliniċi kienu jinkludu żewġ studji terapewtiċi mhux komparattivi b'tikketta miftuħa; l-Istudju Multiċentriku Ewropew (EG-87-42) u l-Istudju Multiċentriku Miftuħ tal-Istati Uniti (N-86-04) u reviżjoni tal-istudji komparattivi li saru b'teicoplanin (EG-87-35).
English: Although no PK-PD modelling has been done, the proposed posology for children is based on Monte Carlo simulations conducted by Lucas et al in 2004 3and Reed in 19974, which was considered to be acceptable by the CHMP.
Maltese: Għalkemm ma sar l-ebda mmudellar tal-PK-PD, il-pożoloġija proposta għat-tfal hija bbażata fuq issimulazzjonijiet Monte Carlo li saru minn Lucas et al fl-2004 3u Reed fl-19974, li kienet ikkunsidrata aċċettabbli mis-CHMP.
English: Section 4.4 - Special warnings and precautions for use The wording of the core safety profile (CSP), currently approved in the context of the PSUR worksharing procedure number GR/H/PSUR/0001/001, was proposed by the MAH for the harmonised SmPC.
Maltese: Sezzjoni 4.4 - It-twissijiet speċjali u l-prekawzjonijiet għall-użu Il-kliem tal-profil tas-sigurtà ewlenija (CSP), attwalment approvat fil-kuntest tal-proċedura ta' qsim tax-xogħol tal-PSUR numru GR/H/PSUR/0001/001, kien propost mill-MAH għall-SmPC armonizzat.
English: This information has been proposed by the MAH in the harmonised SmPC and was considered to be acceptable by the CHMP.
Maltese: Din linformazzjoni ġiet proposta mill-MAH fl-SmPC armonizzat u kienet meqjusa aċċettabbli mis-CHMP.
English: The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland.
Maltese: Id-doża ta' tagħbija ta' 12mg/kg darbtejn kuljum hija konformi ma' dik attwalment rakkomandata fl-SmPCs fi Franza u fil-Finlandja.
English: The general format proposed by the MAH is in accordance with the EU guideline on the SmPC and therefore considered to be acceptable by the CHMP.
Maltese: Il-format ġenerali propost mill-MAH huwa konformi mal-linja gwida tal-UE dwar l-SmPC u għalhekk meqjus aċċettabbli mis-CHMP.
English: The antibacterial spectrum has been updated in accordance with the CHMP Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CHMP/EWP/588/95 rev 2).
Maltese: Indikati għall-Kura ta' Infezzjonijiet Batteriċi tas-CHMP (CHMP/EWP/588/95 rev 2).
English: It can be concluded that batch results prove good consistency of the manufacturing process.
Maltese: Jista' jiġi konkluż li r-riżultati tallott juru konsistenza tajba tal-proċess ta' manifattura.
English: Risk minimisation activities
Maltese: L-attivitajiet għall-minimizzazzjoni tar-riskji
English: Regarding interactions with teicoplanin, it is known that due to the potential for increased adverse effects, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, amphotericin B, ciclosporin, and furosemide.
Maltese: Fir-rigward ta' interazzjonijiet b'teicoplanin, huwa magħruf li minħabba l-potenzjal għal żieda fl-effetti avversi, teicoplanin għandu jingħata b'kawtela f'pazjenti li qed jirċievu mediċini nefrotossiċi jew ototossiċi fl-istess ħin, bħal aminoglycosides, amphotericin B, ciclosporin, u furosemide.
English: The finished product dossier was updated to include compatibility studies with various types of diluents, PVC bags and syringes, together with in-use stability data.
Maltese: Il-dossier tal-prodott lest kien aġġornat biex jinkludi studji ta' kompatibilità ma' tipi differenti ta' dilwenti, boroż tal-PVC u siringi, flimkien ma' dejta dwar l-istabbiltà waqt l-użu.
English: In the current version of EUCAST MIC breakpoints, the resistance breakpoint for Staphylococcus aureus has been reduced to >2 mg/ml to avoid reporting of glycopeptide intermediate resistant Staphylococcus aureus (GISA) isolates, as serious infections with GISA isolates are not treatable with increased doses of vancomycin or teicoplanin.
Maltese: Fil-verżjoni attwali tal-valuri tal-limitu tal-MIC tal-EUCAST, il-valur tal-limitu tar-reżistenza għal Staphylococcus aureus ġie mnaqqas għal >2 mg/ml biex jiġi evitat ir-rapportar ta' iżolati ta' glycopeptide intermediate resistant Staphylococcus aureus (GISA), peress li infezzjonijiet serji b'iżolati ta' GISA ma jistgħux jiġu kkurati b'żidiet fid-dożi ta' vancomycin jew teicoplanin.
English: Section 4.2 - Posology and method of administration Posology
Maltese: Sezzjoni 4.2 - Il-pożoloġija u l-metodu ta' kif għandu jingħata Il-pożoloġija
English: Section 4.8 - Undesirable effects
Maltese: Sezzjoni 4.8 - L-effetti mhux mixtieqa
English: The product information was therefore updated to declare the qualitative and quantitative details of the active substance in terms of mass and IU: each vial contains 200mg (or 400) mg teicoplanin equivalent to 200,000 IU (or 400,000 IU).
Maltese: L-informazzjoni dwar il-prodott għalhekk ġiet aġġornata biex tiddikjara d-dettalji kwalitattivi u kwantitattivi tas sustanza attiva f'termini ta' massa u ta' IU: kull kunjett fih 200 mg (jew 400) mg ta' teicoplaninekwivalenti għal 200,000
English: Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4.
Maltese: Targocid ma jingħatax permezz tar-rotta intraventrikulari u huwa msemmi bħala twissija speċjali fis-sezzjoni 4.4.
English: Section 4.1 - Therapeutic Indications
Maltese: Sezzjoni 4.1 - L-indikazzjonijiet terapewtiċi
English: Measurement of serum concentration
Maltese: Il-kejl tal-konċentrazzjoni fis-serum
English: Risk management plan (RMP)
Maltese: Il-pjan għall-ġestjoni tar-riskju (RMP)
English: However a few cases of endocarditis were included in the open-label studies (EG-87-42 and N-86-04) conducted in support of the initial marketing authorisation.
Maltese: Madankollu ftit każijiet ta' endokardite kienu inklużi fl-istudji b'tikketta miftuħa (EG-87-42 u N-86-04) imwettqa b'appoġġ għallawtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: As is the current practice in some member states, the maintenance dose of 6-12mg/kg od depending on the type of infection was maintained: 6mg/kg od for complicated skin, soft tissue and urinary tract infections and pneumonia and 12mg/kg od for bone and joint infections and endocarditis.
Maltese: Bħalma hija l-prattika attwali f'xi Stati Membri, inżammet id-doża ta' manteniment ta' 6-12mg/kg darba kuljum skont it-tip ta' infezzjoni: 6mg/kg darba kuljum għall-infezzjonijiet ikkumplikati tal-ġilda, tat-tessut artab u tal-apparat urinarju u pnewmonja u ta' 12mg/kg darba kuljum għall-infezzjonijiet tal-għadam u tal-ġogi u għall-endokardite.
English: In the four published studies of the initial dossier, the teicoplanin dose regimens across studies ranged from 6 mg/kg unit dose to a loading dose of 10 mg/kg every 12 hours for 3 doses followed by 10 mg/kg daily maintenance dose.
Maltese: Fl-erba' studji ppubblikati tad-dossier inizjali, ir-reġimens tad-doża ta' teicoplanin fl-istudji kienu jvarjaw minn doża unika ta' 6 mg/kg għal doża ta' tagħbija ta' 10 mg/kg kull 12-il siegħa għal 3 dożi segwit minn doża ta' manteniment ta' 10 mg/kg kuljum.
English: Regarding Enterococcus spp., the resistance breakpoint for teicoplanin has been reduced to >2 mg/ml to avoid erroneous reporting of isolates with Van-A-mediated resistance.
Maltese: Fir-rigward ta' Enterococcus spp., il-valur tal-limitu tar-reżistenza għal teicoplanin ġie mnaqqas għal >2 mg/ml biex jiġi evitat ir-rapportar żbaljat ta' iżolati b'reżistenza medjata b'Van-A.
English: The strengths of teicoplanin finished product are conventionally declared and prescribed in terms of mass (e.g. 200 mg and 400 mg), but given the variability of the active substance, it is the potency of the finished product, as determined by microbiological assay and declared in IU (e.g. 200,000 IU or 400,000 IU), that determines the quantitative amount of active substance in the finished product.
Maltese: Il-qawwiet tal-prodott lest teicoplanin ġew iddikjarati b'mod konvenzjonali u preskritti f'termini ta' massa (eż. 200 mg u 400 mg), iżda minħabba l-varjabbiltà tas-sustanza attiva, hija l-qawwa talprodott lest, kif determinata mill-analiżi mikrobijoloġika u ddikjarata fl-IU (eż. 200,000
English: In keeping with the adult studies, the clinical cure was > 80%.
Maltese: F'konformità mal-istudji fuq l-adulti, il-kura klinika kienet ta' > 80%.
English: The results from these three studies showed that teicoplanin achieves an overall clinical and bacteriological response rate of nearly 90% in culture and toxin positive patients.
Maltese: Ir-riżultati minn dawn it-tliet studji wrew li teicoplanin jikseb rata globali ta' rispons kliniku u batterjoloġiku ta' kważi 90% f'kultura u fuq pazjenti pożittivi għal tossini.
English: Treatment of Clostridium difficile infection-associated diarrhoea and colitis In the clinical development program of teicoplanin, three open, non-controlled studies were conducted with teicoplanin IV formulation administered orally for antibiotic-associated diarrhea (AAD) and 1 Wiggins KJ, Cochrane Collaboration review and meta-analysis 2008.
Maltese: Il-kura ta' dijarea u kolite assoċjati mal-infezzjoni b'Clostridium difficile Fil-programm ta' żvilupp kliniku ta' teicoplanin, saru tliet studji miftuħa u mhux ikkontrollati bilformulazzjoni IV ta' teicoplanin mogħtija mill-ħalq għal dijarea assoċjata mal-antibijotiċi (AAD) u kolite psewdomembranuża (PMC) ikkawżata minn C. difficile.
English: Recent time-kill studies confirm that in vitro bactericidal activity of teicoplanin is optimally tested according to CLSI guidelines, with tolerance defined at 24 hours.
Maltese: Studji riċenti time-kill jikkonfermaw li l-attività batteriċida in vitro ta' teicoplanin tiġi ttestjata bl-aħjar mod skont il-linji gwida tas-CLSI, b'tolleranza definita f'24 siegħa.