FrancophonIA/ELRC3.0 huggingface dataset:
English: Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein.
Maltese: Ruconest ġie studjat f'żewġ studji ewlenin li involvew total ta' 70 adult u adoloxxenti b'anġjoedema li tintiret ikkawżata minn livelli baxxi tal-proteina inibitur ta' esterase C1.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ruconest valida fl-Unjoni Ewropea kollha fit-28 ta' Ottubru 2010.
English: This is a summary of the European public assessment report (EPAR) for Ruconest.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ruconest.
English: The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and wor ks in the same way as the natural human protein.
Maltese: Is-sustanza attiva f'Ruconest, il-konestat alfa, hija kopja tal-proteina inibitur ta' esterase C1 u taħdem bl-istess mod kif taħdem il-proteina umana naturali.
English: Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours.
Maltese: Pazjenti li jirċievu Ruconest f'dożi ta' 50 unità/kg u 100 unità/kg beda jkollhom titjib wara siegħa u sagħtejn.
English: Why is Ruconest approved?
Maltese: Għaliex ġie approvat Ruconest?
English: Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.
Maltese: It-titjib tkejjel mill-pazjenti li kklassifikaw is-severità tas-sintomi tagħhom fuq skala minn 0 sa 100.
English: Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents.
Maltese: Ruconest huwa mediċina li tintuża biex jiġu kkurati attakki ta' anġjoedema li tintiret fl-adulti u ladoloxxenti.
English: The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache.
Maltese: L-effett sekondarju l-aktar komuni b'Ruconest (li deher f'bejn 1 u 10 pazjenti minn kull 100) huwa luġigħ ta' ras.
English: The company that markets Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Maltese: Il-kumpanija li timmanifattura Ruconest sejra tiżgura li l-professjonisti tal-kura tas-saħħa li huma mistennija jippreskrivu Ruconest jiġu pprovduti b'pakkett edukattiv li jkun fih informazzjoni dwar l-użu xieraq tal-mediċina u twissijiet dwar ir-riskju ta' allerġija.
English: The C1 esterase inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Maltese: Il-proteina tal-inibitur ta' esterase C1 hija meħtieġa biex jiġu kkontrollati s-sistemi ta' ‘komplement' jew ‘kuntatt', kollezzjonijiet ta' proteini fid-demm li jiġġieldu kontra l-infezzjoni u jikkawżaw infjammazzjoni.
English: What is the risk associated with Ruconest?
Maltese: X'inhu r-riskju assoċjat ma' Ruconest?
English: When an attack occurred, the patients were given Ruconest or placebo (a dummy treatment).
Maltese: Meta jkollhom attakk, ilpazjenti ngħataw Ruconest jew plaċebo (kura finta).
English: The CHMP decided that Ruconest's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ruconest huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What measures are being taken to ensure the safe and effective use of Ruconest?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ruconest?
English: What benefits of Ruconest have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Ruconest li ħarġu mill-istudji?
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Maltese: Il-pazjenti b'livelli baxxi ta' din il-proteina għandhom attività eċċessiva ta' dawn iżżewġ sistemi, li twassal għas-sintomi tal-anġjoedema.
English: Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema.
Maltese: Ruconest kien aktar effettiv mill-plaċebo biex itejjeb is-sintomi tal-pazjenti b'attakk ta' anġjoedema.
English: When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient's symptoms.
Maltese: Meta tingħata waqt attakk ta' anġjoedema, il-konestat alfa twaqqaf din l-attività eċċessiva, u tgħin biex ittaffi s-sintomi tal-pazjent.
English: Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Maltese: Ruconest jintuża f'pazjenti b'anġjoedema li tintiret li hija marbuta ma' livelli baxxi li jseħħu b'mod naturali ta' proteina msejħa ‘inibitur C1 esterase'.
English: A patient should not be given more than two injections within any 24-hour period.
Maltese: Pazjent m'għandux jingħata aktar minn żewġ injezzjonijiet fi żmien perjodu ta' 24 siegħa.
English: GENTAMICINA 6% BRAUN USO VETERINARIO
Maltese: ĠENTAMIĊINAA 6% BRAUN USO VETERINARIO
English: 43206 Tarragona Spain
Maltese: 43206 Tarragona Spanja
English: C/ Prudenci Bertrana, 5 Polígono Industrial Agro-Reus Reus
Maltese: S.L.U. C/ Prudenci Bertrana, 5 Polígono Industrial Agro-Reus Reus
English: Spain B.BRAUN VETCARE, S.A. Crta.
Maltese: Spanja B.BRAUN VETCARE, S.A. Crta.
English: 1 VICH GL 43: Guideline on target animal safety for veterinary pharmaceutical products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004361.pdf
Maltese: 1 VICH GL 43: Guideline on target animal safety for veterinary pharmaceutical products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004361.pdf amministrazzjoni approvati fiż-żwiemel adulti u fil-moħor, b'mod partikolari fir-rigward ta' nefrotossiċità kkawżata minn ġentamiċina.
English: Spain Industrial Veterinaria, S.A. Esmeralda, 19
Maltese: Industrial Veterinaria, S.A. Esmeralda, 19
English: Spain SUPER´S DIANA, S.L Ctra.
Maltese: Spanja SUPER´S DIANA, S.L Ctra.
English: Spain CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona) Spain
Maltese: Spanja CENAVISA Camí Pedra Estela s/n 43205 Reus
English: Over 50 different enzymes have been identified.
Maltese: Ġew identifikati 'l fuq minn 50 enzima differenti.
English: Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona
Maltese: Spanja FATRO IBERICA, S.L. Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona Spanja
English: IAPSA PORTUGUESA PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq 1700-073 Lisboa Portugal
Maltese: IAPSA PORTUGUESA PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq
English: Lithuania Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer the Netherlands
Maltese: Il-Litwanja Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer
English: Spain LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
Maltese: Spanja LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
English: Belgium EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Maltese: Il-Belġju EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Il-Belġju
English: The reference product is Gentaject 10% solution for injection for horses which has been authorised in Ireland since 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
Maltese: Il-prodott ta' referenza huwa Gentaject 10% taħlita likwida għall-injezzjoni għaż-żwiemel li ilu awtorizzat fl-Irlanda mill-1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
English: ATCvet code: QJ01GB03
Maltese: QJ01GB03
English: Spain LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
Maltese: LIFE SCIENCE, S.A. C/ Venus, 26
English: Spain Laboratorios e Industrias IVEN, S.A
Maltese: Spanja Laboratorios e Industrias IVEN, S.A
English: Austria Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
Maltese: L-Awstrija Vana GmbH Wolfgang Schmälzl Gasse 6 1020
English: Spain LABORATORIOS SYVA, S.A.U.
Maltese: Spanja LABORATORIOS SYVA, S.
English: Spain Laboratorios e Industrias IVEN, S.A.
Maltese: Spanja Laboratorios e Industrias IVEN, S.A.
English: Germany CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Maltese: Handelsgesellschaft mbH Ostlandring 13
English: Lithuania LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
Maltese: Párroco Pablo Díez, 49-57 24010, León
English: Latvia Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Maltese: Il-Latvja Huvepharma AD 33 James Boucher Blvd.
English: Ozzano Emilia (Bologna) Italy
Maltese: Via Emilia 285 Ozzano Emilia (Bologna) L-Italja
English: N-Acetyltransferases (AAC) - catalyses acetyl CoA-dependent acetylation of an amino group
Maltese: N-Acetyltransferases (AAC) - jikkatalizza l-aċetilazzjoni dipendenti fuq l-acetyl CoA ta' grupp amminiku 2.
English: Croatia Krka - Farma d.o.o.
Maltese: Il-Kroazja Krka - Farma d.o.o. Radnička cesta 48 10000
English: An application for the product Genta Equine 10% solution for injection for horses, containing gentamicin as the active substance was submitted to Denmark as a concerned Member State in a mutual recognition procedure (MRP) under the legal basis of Article 13(1) of Directive 2001/82/EC, i.e. a generic application.
Maltese: L-applikazzjoni għall-prodott Genta Equine 10% taħlita likwida għall-injezzjoni għaż-żwiemel, li fih ġentamiċina bħala s-sustanza attiva ġiet ippreżentata lid-Danimarka bħala Stat Membru kkonċernat fi proċedura ta' rikonoxximent reċiproku (MRP) skont il-bażi legali tal-Artikolu 13(1) tadDirettiva 2001/82/KE, jiġifieri applikazzjoni ġenerika.
English: Gentamicin is best considered as a narrow-spectrum Gram-negative bactericidal antimicrobial (e.g. E. coli, Proteus, Pseudomonas).
Maltese: Ġentamiċina jista' jitqies l-aħjar bħala antimikrobiku bi spettru dejjaq kontra batterji Gram-negattivi (eż. E. coli, Proteus, Pseudomonas).
English: Slovakia Fatro S.p.A.
Maltese: FATRO S.p.A.
English: Gentamicin is deactivated in the presence of inflammatory debris, low oxygen environments and low pH. Gentamicin is eliminated unchanged by the kidney via glomerular filtration, including 85-95% of the dose.
Maltese: Ġentamiċina jiġi eliminat mhux mibdul mill-kliewi permezz ta' filtrazzjoni glomerulari, inkluż 85-95% tad-doża.
English: 31303 Burgdorf Germany
Maltese: 31303 Burgdorf Il-Ġermanja
English: Spain MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
Maltese: A.U Poligono Industrial El Segre, Parcela 409-410 25191 Lérida Spanja
English: GENTAMICINA GANADEXIL Gentamicin (as gentamicin sulphate)
Maltese: ĠENTAMIĊINAA GANADEXIL Gentamicin (as gentamicin sulphate)
English: Vijenac A. Cesarca 16
Maltese: Il-Kroazja PROPHARMA VET d.o.o. Vijenac A. Cesarca 16 31000
English: Spain POLICHEM S.L.U.
Maltese: Spanja POLICHEM
English: There are several mechanisms by which various strains of bacteria have developed resistance against aminoglycosides like gentamicin.
Maltese: Hemm diversi mekkaniżmi li permezz tagħhom diversi razez ta' batterji żviluppaw resistenza kontra aminoglikosidi bħal ġentamiċina.
English: Do not use in known cases of renal dysfunction.
Maltese: Tużax f'każijiet magħrufa ta' disfunzjoni renali.
English: All other dosing regimens appear to be approved based on expert reports, scientific publications and PK/PD characteristics.
Maltese: L-iskemi l-oħra kollha ta' dożaġġ jidhru li ġew approvati abbażi ta' rapporti ta' esperti, pubblikazzjonijiet xjentifiċi u karatteristiċi PK/PD.
English: Gentamicin is a narrow-spectrum Gram-negative bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas.
Maltese: Ġentamiċina huwa antimikrobiku bi spettru dejjaq kontra batterji Gramnegattivi, mingħajr effetti fuq il-batterji anaerobe u l-mikoplasmi.
English: Particular caution should be taken when administering gentamicin with other potential nephrotoxic medicinal products (containing e.g. NSAIDs, furosemide, and other aminoglycosides).
Maltese: Għandha tingħata attenzjoni partikolari meta ġentamiċina jingħata ma' prodotti mediċinali nefrotossiċi potenzjali oħra (eż. li fihom NSAIDs, furosemide, u aminoglikosidi oħra).
English: The approved dosing regimens vary widely, ranging between doses of 2-10 mg/kg bw at intervals of 8-24 hours over 3-5 days.
Maltese: L-iskemi ta' dożaġġ approvati jvarjaw ħafna, b'firxa ta' dożi bejn 2-10 mg/kg tal-piż tal-ġisem f'intervalli ta' 8-24 siegħa fuq 3-5 ijiem.
English: This monitoring includes assessing relevant kidney parameters in blood (e.g. creatinine and urea) and urinalysis (e.g. gamma glutamyl transferase/creatinine ratio).
Maltese: Dan il-monitoraġġ jinkludi valutazzjoni tal-parametri rilevanti tal-kliewi fid-demm (eż ilkreatinina u l-urea) u analiżi tal-awrina (eż. il-proporzjon tal-gamma glutamyl transferase/kreatinina).
English: Spain LABORATORIOS MAYMO, S.A.
Maltese: Spanja LABORATORIOS MAYMO, S.A. Via Augusta, 302
English: Whereas:
Maltese: Tqala:
English: The CVMP also considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive when the posology for adult horses (with appropriate warnings and advice on dosing) is changed to: “Single dose of 6.6 mg/kg bw given intravenously once daily for 3-5 consecutive days.
Maltese: Is-CVMP qies ukoll li l-bilanċ tal-benefiċċju-riskju għal prodotti mediċinali veterinarji injettabbli li fihom ġentamiċina għaż-żwiemel huwa pożittiv meta l-pożoloġija għaż-żwiemel adulti (bi twissijiet adegwati u parir dwar id-dożaġġ) titbiddel għal: “Doża unika ta' 6.6 mg/kg tal-piż tal-ġisem li tingħata ġol-vina darba kuljum għal 3-5 ijiem konsekuttivi.
English: PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE
Maltese: PURMICINA 40 MG/ML SOLUCIÓN
English: Applicant/Marketing Authorisation Holder
Maltese: Applikant/Detentur talAwtorizzazzjoni għattqegħid fis-Suq
English: There are three types of aminoglycoside modifying enzymes:
Maltese: Hemm tliet tipi ta' enżimi li jimmodifikaw l-aminoglikosidi: 1.
English: Vanapere tee 14, Pringi 74001 Viimsi
Maltese: L-Estonja Interchemie werken "De Adelaar" Eesti BĦALA Vanapere tee 14, Pringi 74001 Viimsi Harjumaa L-Estonja
English: Lithuania Bela-pharm GmbH & Co.KG Lohner Str. 19
Maltese: Il-Litwanja Bela-pharm GmbH & Co.KG Lohner Str. 19 49377 Vechta
English: Referral procedures on the basis of Article 35 of Directive 2001/82/EC require a clearly formulated question referred to the Committee.
Maltese: Proċeduri ta' riferiment abbażi tal-Artikolu 35 tad-Direttiva 2001/82/KE jeħtieġu mistoqsija fformulata b'mod ċar li tiġi rriferita lill-Kumitat.
English: PHARMACOLOGICAL PROPERTIES
Maltese: Franklin Pharmaceuticals
English: Their rate of killing increases as the gentamicin concentration increases above the minimum concentration (MIC) for a given Gram-negative pathogen, with optimal maximum serum concentration (Cmax) to MIC ratio of 8
Maltese: Ir-rata tal-qtil tagħhom tiżdied hekk kif il-konċentrazzjoni ta' ġentamiċina tiżdied 'il fuq mill-konċentrazzjoni minima (MIC) għal patoġenu Gram-negattiv partikulari, bi proporzjon ottimali bejn il-konċentrazzjoni massima fis-serum (Cmax) u l-MIC ta' 8-10.
English: Horses:
Maltese: Billi:
English: Based on all available evidence, the CVMP considered that a single daily dose of 6.6 mg gentamicin/kg bw, administered intravenously, would provide an efficacious dose, taking into account the desired PK/PD characteristics for a concentration-dependent antibiotic, i.e. optimal maximum serum concentration (Cmax) to MIC ratio of 8-10, and assuming a bacterial MIC ≤2 µg/ml.
Maltese: Abbażi tal-evidenza kollha disponibbli, is-CVMP qies li doża waħda kuljum ta' 6.6 mg ta' ġentamiċina/kg tal-piż tal-ġisem, li tingħata ġol-vina, għandha tipprovdi doża effikaċi, meta wieħed iqis il-karatteristiċi PK/PD mixtieqa għal antibijotiku li jiddependi fuq il-konċentrazzjoni, jiġifieri proporzjon ottimali bejn il-konċentrazzjoni massima fis-serum (Cmax) u l-MIC ta' 8-10, u jekk wieħed jassumi MIC batterjali ta' ≤2 µg/ml.
English: Ozzano Emília Bologna
Maltese: Via Emilia 285 Ozzano Emília Bologna L-Italja
English: Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats
Maltese: Bovini (għoġġiela sa 250 kg), porċini (ħnieżer li jkunu qed jitreddgħu), ekwini mhux maħsuba għallkonsum millbniedem, klieb u qtates
English: There are insufficient data available to support the currently approved indications.
Maltese: M'hemmx biżżejjed data disponibbli b'appoġġ tal-indikazzjonijiet attwalment approvati.
English: Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19
Maltese: Bela-pharm GmbH & Co.KG Lohner Str. 19 49377 Vechta
English: Radnička cesta 48
Maltese: Lenaartseweg 48 2320
English: Use only based on the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u tar-riskju millveterinarju responsabbli.
English: VETERSAN GENTAMICINA Gentamicin (as gentamicin sulphate)
Maltese: Gentamicin (as gentamicin sulphate)
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Maltese: • is-CVMP qies li l-bilanċ ġenerali tal-benefiċċju-riskju huwa pożittiv għall-prodotti mediċinali veterinarji (ara anness I), soġġett għall-emendi fl-informazzjoni dwar il-prodott; is-CVMP irrakkomanda varjazzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali veterinarji li fihom ġentamiċina ippreżentati bħala taħlita ta' likwidi għall-injezzjoni biex jingħataw liż-żwiemel, sabiex jiġu emendati s-sommarji tal-karatteristiċi tal-prodott, it-tikketta u lfuljetti ta' tagħrif kif stabbilit fl-Anness
English: GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE
Maltese: GENTAVALL 40 MG/ML SOLUCIÓN
English: The scope of referral procedures is limited to evaluation of quality, safety and efficacy of veterinary medicinal products.
Maltese: is-sigurtà u l-effikaċja ta' prodotti mediċinali veterinarji.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi li fuqhom għandu jintuża lprodott, l-applikanti/detenturi tal-awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: Where blood monitoring is available, target peak plasma gentamicin concentrations should be approximately 16-20 µg/ml.
Maltese: Fejn ikun monitoraġġ tad-demm disponibbli, il-konċentrazzjonijiet massimi fil-mira ta' ġentamiċina fil-plasma għandhom ikunu ta' madwar 16-20 µg/ml.
English: In addition, there are only limited choices available for the treatment of Gram-negative infections in horses, and clinical experience has shown that gentamicin is effective in adult horses at a single daily dose of 6.6 mg/kg bw (intravenously) over 3-5 days.
Maltese: Barra minn hekk, hemm biss għażliet ta' kura limitati disponibbli għall-kura ta' infezzjonijiet Gramnegattivi fiż-żwiemel, u l-esperjenza klinika wriet li ġentamiċina huwa effettiv fiż-żwiemel adulti f'doża unika kuljum ta' 6.6 mg/kg tal-piż tal-ġisem (ġol-vina) fuq 3-5 ijiem.
English: Therefore, on 14 February 2014, Denmark presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC, for all veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Maltese: Għalhekk, fl-14 ta' Frar 2014, skont l-Artikolu 35 tad-Direttiva 2001/82/KE d-Danimarka ppreżentat notifika ta' riferiment lill-Aġenzija Ewropea għall-Mediċini (‘l-Aġenzija'), għall-prodotti mediċinali veterinarji kollha li fihom ġentamiċina ppreżentati bħala taħlita ta' likwidi għall-injezzjoni biex jingħataw liż-żwiemel.
English: Latvia CP - Pharma Handelsges.
Maltese: CP-Pharma
English: Gentamicin sulphate is bactericidal in action by irreversibly binding to 30S ribosomal subunits, and acts through two different mechanisms.
Maltese: Is-sulfat ta Ġentamiċina jaġixxi bħala batteriċida billi jeħel b'mod irriversibbli mas-sottounitajiet ribosomali 30S, u jaġixxi permezz ta' żewġ mekkaniżmi differenti.
English: The CVMP Antimicrobials Working Party (AWP) and Efficacy Working Party (EWP) were consulted on several aspects of a safe dosing regimen of gentamicin in horses.
Maltese: Il-Grupp ta' Ħidma dwar l-Antimikrobiċi (AWP) u l-Grupp ta' Ħidma dwar l-Effikaċja (EWP) tas-CVMP ġew ikkonsultati dwar diversi aspetti ta' skema sigura ta' dożaġġ ta' ġentamiċina fiż-żwiemel.
English: Single dose of 6.6 mg/kg body weight given intravenously once daily for 3-5 consecutive days.
Maltese: Doża waħda ta' 6.6 mg/kg tal-piż tal-ġisem li tingħata ġol-vina darba kuljum għal 3-5 ijiem konsekuttivi.
English: Currently injectable veterinary medicinal products containing gentamicin for use in horses are authorised in the EU for the treatment of a variety of indications, including broad ones such as infections of the respiratory tract, gastrointestinal, and genito-urinary tract, caused by various target pathogens.
Maltese: Attwalment prodotti mediċinali veterinarji injettabbli li fihom ġentamiċina għall-użu fiż-żwiemel huma awtorizzati fl-UE għall-kura ta' varjetà ta' indikazzjonijiet, fosthom indikazzjonijiet wiesa' bħal infezzjonijiet tal-passaġġ respiratorju, tal-passaġġ gastrointestinali, u ġenito-urinarju, ikkawżati minn diversi patoġeni fil-mira.
English: Iceland Franklin Pharmaceuticals Ltd. Athboy Road
Maltese: L-Islanda Franklin Pharmaceuticals
English: Pregnancy:
Maltese: Żwiemel:
English: The lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gram-negative bacteria susceptible to gentamicin.” This indication is consistent with the distribution pattern of gentamicin, which is primarily in the extracellular fluid.
Maltese: In-nuqqas ta' data u l-evidenza xjentifika limitata tappoġġja biss indikazzjoni limitata, jiġifieri “Għall-kura ta' infezzjonijiet tal-passaġġ respiratorju t'isfel fiż-żwiemel ikkawżati minn batterji aerobiċi Gram-negattivi suxxettibbli għal ġentamiċina.
English: The CVMP recommended a dosing regimen for adult horses of 6.6 mg/kg once daily for 3-5 days, accompanied by strong warnings in the product literature about the lack of target animal safety data.
Maltese: Is-CVMP irrakkomanda skema ta' dożaġġ għal żwiemel adulti ta' 6.6 mg/kg darba kuljum għal 3-5 ijiem, akkumpanjata bi twissijiet qawwija fil-letteratura dwar il-prodott dwar in-nuqqas ta' data dwar issigurtà tal-annimali fil-mira.
English: Pharmacotherapeutic group: Antibacterials for systemic use, gentamicin.
Maltese: Antibatteriċi għall-użu sistemiku, ġentamiċina.
English: Enzymatic modification is the most common type of aminoglycoside resistance.
Maltese: Il-modifika enżimatika hija l-aktar tip ta' reżistenza komuni kontra laminoglikosidi.
English: Over-use of gentamicin products might result in an increased risk of the theoretical concept of adaptive resistance.
Maltese: L-użu eċċessiv ta' prodotti ta' ġentamiċina jista' jwassal għal żieda fir-riskju tal-kunċett teoretiku ta' reżistenza adattiva.
English: The CVMP considered that this dose was supported by clinical experiences, taking into account that a single daily administration would reduce the risk of nephrotoxicity in adult horses (compared to more frequent daily administrations) and also the risk of the theoretical concept of adaptive resistance.
Maltese: Is-CVMP qies li din id-doża ġiet appoġġjata minn esperjenzi kliniċi, b'kont meħud li amministrazzjoni unika kuljum għandha tnaqqas ir-riskju ta' nefrotossiċità fiż-żwiemel adulti (meta mqabbla ma' għotjiet aktar frekwenti kuljum) u anke r-riskju tal-kunċett teoretiku ta' reżistenza adattiva.