FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Teysuno 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: Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil.
Maltese: Teysuno huwa mediċina li fih is-sustanzi attivi tegafur, gimeracil and oteracil.
English: This summary was last updated in 01-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2012.
English: It is available as capsules containing 15 mg tegafur with 4.35 mg gimeracil and 11.8 mg oteracil, and as capsules containing 20 mg tegafur with 5.8 mg gimeracil and 15.8 mg oteracil.
Maltese: Dan jiġi bħala kapsuli li fihom 15 mg tegafur ma' 4.35 mg gimeracil u 11.8 mg oteracil, u bħala kapsuli bojod li fihom 20 mg tegafur ma' 5.8 mg gimeracil u 15.
English: This is a summary of the European public assessment report (EPAR) for Teysuno.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Teysuno.
English: In the main study, Teysuno was compared with the anticancer medicine 5-FU given as an infusion in 1,053 adults with advanced gastric cancer.
Maltese: Fl-istudju prinċipali, Teysuno tqabbel mal-mediċina kontra l-kanċer 5-FU li ngħatat bħala infużjoni f'1,053 adult b' kanċer gastriku avvanzat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Teysuno on 14 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Teysuno fl-14 ta' Marzu 2011.
English: Why has Teysuno been approved?
Maltese: Għaliex ġie approvat Teysuno?
English: • patients with severe kidney problems requiring dialysis;
Maltese: • pazjenti bi problemi severi tal-kliewi li jeħtieġu d-dijaliżi;
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Maltese: Is-sustanza attiva f'Teysuno, tegafur, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer) li jkunu parti mill-grupp tal-‘antimetaboliti'.
English: Tegafur is a ‘prodrug' that is converted in the body to a chemical called 5-fluorouracil (5-FU).
Maltese: Tegafur huwa ‘prodroga' li fil-ġisem jinbidel f'kimika li tissejjaħ 5-fluorouracil (5-FU). 5-FU huwa simili għal piramidina, sustanza li tinsab fil-materjal ġenetiku taċ-ċelloli (DNA u RNA).
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Maltese: Iż-żewġ sustanzi attivi oħra f'Teysuno jippermettu lil tegafur sabiex ikun effettiv f'dożi aktar baxxi u b'inqas effetti sekondari: gimeracil billi jimpedixxi s-sintesi ta' 5-FU u oteracil billi jnaqqas l-attività ta' 5-FU fit-tessut normali, li mhuwiex affettwat minn kanċer fil-musrana.
English: What is the risk associated with Teysuno?
Maltese: X'inhu r-riskju assoċjat ma' Teysuno?
English: Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving 5-FU with cisplatin.
Maltese: Il-pazjenti li kienu qegħdin jirċievu Teysuno ma' ċisplatin għexu medja ta' 8.6 xhur meta mqabbla ma' 7.9 xhur għal pazjenti li kienu qed jirċievu 5-FU ma' ċisplatin.
English: • patients with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) as well as patients who, within the previous four weeks, have been treated with a medicine that inhibits this enzyme;
Maltese: • pazjenti li għandhom defiċjenza tal-enzima dihydropyrimidine dehydrogenase (DPD) kif ukoll pazjenti li, matul l-aħħar erba' ġimgħat, irċevew kura b'mediċina li timpedixxi din l-enzima;
English: The medicine can only be obtained with a prescription.
Maltese: Iż-żewġ mediċini ngħataw ma' ċisplatin.
English: In patients treated with Teysuno in combination with cisplatin, the most common severe side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts) and fatigue (tiredness).
Maltese: Fil-pazjenti li ħadu l-kura b'Teysuno f'kombinazzjoni ma' ċisplatin, l-effetti sekondarji severi l-aktar komuni (li dehru f'aktar minn pazjent 1 minn kull 10) kienu n-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola tad-demm bajda), anemija (għadd baxx taċ-ċelloli tad-demm ħomor) u għejja.
English: What is Teysuno?
Maltese: X'inhu Teysuno?
English: Teysuno is used to treat adults with advanced gastric (stomach) cancer.
Maltese: Teysuno jintuża fil-kura ta' adulti b'kanċer gastriku (tal-istonku) avvanzat. jintuża flimkien maċċisplatina (mediċina oħra kontra l-kanċer).
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Maltese: Fil-ġisem, 5-FU jissostitwixxi l-pirimidina u jinterferixxi mal-enzimi li jieħdu sehem fil-produzzjoni ta' DNA ġdid.
English: • patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
Maltese: • f'pazjenti li jbatu minn forom gravi ta' lewkopenija, newtropenija jew tromboċitopenija (livelli baxxi ta' ċelloli bojod jew ta' platelets fid-demm);
English: The CHMP decided that Teysuno's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Teysuno huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Teysuno been studied?
Maltese: Kif ġie studjat Teysuno?
English: How does Teysuno work?
Maltese: Għal xiex jintuża Teysuno?
English: The recommended dose for one cycle of treatment is 25 mg/m2 twice a day (in the morning and evening) for three weeks, followed by a one-week rest period.
Maltese: Id-doża rakkomandata għal ċiklu wieħed ta' kura hija ta' 25 mg/m2 darbtejn kuljum (filgħodu u filgħaxija) għal tliet ġimgħat, u hija segwita b'perjodu ta' mistrieħ ta' ġimgħa.
English: Teysuno should only be prescribed by a qualified doctor experienced in treating cancer patients with anticancer medicines.
Maltese: Teysuno għandu jingħata biss b'riċetta minn tabib ikkwalifikat b'esperjenza fil-kura ta' pazjenti bilkanċer b'mediċini kontra l-kanċer.
English: (periodontal 2008)
Maltese: (periodontali 2008)
English: Active substance:
Maltese: Sustanza attiva:
English: ATCvet code: QJ01DD91.
Maltese: Kodici ATĊ veterinarja: QJ01DD91.
English: Date of last renewal: 15/06/2011
Maltese: Data tal-aħħar tiġdid: 15/06/2011
English: (2003 survey)
Maltese: (servej 2003)
English: (e.g. S. xylosus, S. schleiferi, S. epidermidis) is 9.5 %.
Maltese: (e.g. S. xylosus, S. schleiferi, S. epidermidis) hija ta' 9.5 %.
English: Dog 29 ≤0.008
Maltese: Kelb 29 ≤0.008
English: 4.3 Contraindications
Maltese: 4.3 Kontra indikazzjonijiet
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2 °C - 8 °C ).
English: S.S. 156 Km 47,600 04100 Borgo San Michele Latina
Maltese: Haupt Pharma Latina S.r.l S.S. 156 Km 47,600 04100 Borgo San Michele Latina
English: were 2.3 %, 2.7 %, 3.1 % and 1.4 %, respectively.
Maltese: u Proteus spp. kienu ta' 2.3 %, 2.7 %, 3.1 % u 1.4 % rispettivament.
English: Bacterial Pathogen Origin
Maltese: Batterju patoġenu Oriġini
English: Elimination half-life is long - approximately 6.9 days.
Maltese: Il-half-life ta' eliminazzjoni huwa twil - bejn wieħed u ieħor 6.9 jiem.
English: Elimination half-life is long - approximately 5.5 days.
Maltese: Il-half-life ta' eliminazzjoni huwa twil - bejn wieħed u ieħor 5.5 jiem.
English: No. of Isolates cefovecin MIC (µg/ml)
Maltese: Iżolati cefovecin MIC (µg/ml)
English: EU/2/06/059/002 (5 ml)
Maltese: EU/2/06/059/001 (23 ml) EU/2/06/059/002 (5 ml)
English: EXP: {mm/yyyy}
Maltese: JIS: {xx/ssss}
English: (See also Section 4.5 ‘Special Precautions for Use'.)
Maltese: (Ara ukoll Sezzjoni 4.5 ‘Prekawzjonijiet Speċjali għall-Użu'.)
English: The percentage of cefovecin resistant isolates in E. coli, Prevotella oralis, Bacteroides spp.
Maltese: Il-persentaġġ ta' reżistenza għall-cefovecin f'iżolati ta' E. coli, Prevotella oralis, Bacteroides spp.
English: ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Dog Cat β haemolytic Streptococcus spp.
Maltese: Kelb Qattus β haemolytic Streptococcus spp.
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: MOD TA' AMMINISTRAZZJONI
English: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve
English: ITALY
Maltese: L-ITALJA
English: Pseudomonas spp., Enterococcus spp., and Bordetella bronchiseptica isolates are inherently resistant to cefovecin.
Maltese: Iżolati ta' Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica huma minnhom reżistenti għall-cefovecin.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Cefovecin is a third generation cephalosporin with a broad-spectrum of activity against Gram-positive and Gram-negative bacteria.
Maltese: Cefovecin huwa kefalosporin tat-tielet ġenerazzjoni b'attività wiesgħa kontra batterji Gram-positive u Gram-negative.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn
English: For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.
Maltese: Għat-trattament ta' axxessi u feriti tal-ġilda u tessuti rotob assoċjati ma' Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci u/jew Staphylococcus pseudintermedius.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2006
Maltese: Data tal-ewwel awtorizazzjoni: 19/06/2006
English: Plasma protein binding is high (96.0 % to 98.7 %) and the volume of distribution is low (0.1 l/kg).
Maltese: Abbinar ma' proteini fil-plażma huwa għoli (96.0 % sa 98.7 %) u l-volum ta' distribizzjoni huwa baxx (0.1 l/kg).
English: When applying a proposed microbiological breakpoint of S ≤ 2 µg/ml, no resistance to cefovecin was detected in Pasteurella multocida, Fusobacterium spp.
Maltese: Meta jiġi applikat breakpoint mikrobijoloġiku propost ta' S ≤ 2 µg/ml, ma kien hemm l-ebda reżistenza f'iżolati ta' Pasteurella multocida u Fusobacterium spp u Porphyromonas spp.
English: Dog 272 ≤0.008
Maltese: Kelb 272 ≤0.
English: Anaerobic bacteria such as Bacteroides spp.
Maltese: Mikrobi anerobiċi bħal Bacteroides spp.
English: S.S. 156 Km 47,600
Maltese: Haupt Pharma Latina S.r.l S.S. 156 Km 47,600
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injection
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: 852 mg cefovecin (as sodium salt)
Maltese: 852 mg cefovecin (f'forma ta' sodju)
English: PACKAGE SIZE 10 ml (after reconstitution) 4 ml (after reconstitution)
Maltese: DAQS TAL-PAKKETT 10 ml (wara rikostituzzjoni) 4 ml (wara rikostituzzjoni)
English: At ten and fourteen days after administration, urine concentrations were 1.3 µg/ml and 0.7 µg/ml, respectively.
Maltese: Fl-10 jum u fl-14-il jum wara l-amministrazzjoni, il-konċentrazzjoni fl-urina kienet ta' 1.3 μg/ml u ta' 0.7 μg/ml, rispettivament.
English: Resistance to cephalosporins results from enzymatic inactivation (β-lactamase production), from reduced permeability by porin mutations or change in efflux, or by selection of low-affinity penicillin-binding proteins.
Maltese: permjebilità imnaqqsa permezz ta' porin mutations jew bdil fl-efflux, jew b'selezzjoni ta' low-affinity penicillin-binding proteins.
English: 13 mg/ml benzyl alcohol 4.45 ml water for injections
Maltese: 13.00 mg/ml benzyl alcohol 4.45 ml ilma għall-injezzjonijiet
English: ADVERSE REACTIONS
Maltese: RESPONSABBLI
English: In-vitro activity against these pathogens as well as against other skin and urinary tract pathogens collected during a European (Denmark, France, Germany, Italy and United Kingdom) MIC survey (1999 - 2000)
Maltese: L-attività in-vitro kontra dawn il-patoġeni kif ukoll kontra patoġeni oħra tal-ġilda u tas-sistema urinarja miġbura waqt stħarriġ Ewropew (Danimarka, Franza, Ġermanja, Italja u r-Renju Unit) dwar il-MIC (1999 - 2000) u waqt studji Ewropej (Franza, Ġermanja, Spanja u r-Renju Unit) fuq leffiċenza u s-sigurtà klinika (2001 - 2003) jidhru hawn taħt.
English: Pharmacotherapeutic group: Antibacterials for systemic use (cephalosporins).
Maltese: Antibijotiċi għal użu sistemiku (kefalosporini).
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Tagħrif farmakokinetiku
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 340 mg cefovecin
Maltese: 340 mg cefovecin
English: Plasma protein binding is high (more than 99 %) and the volume of distribution is low (0.09 l/kg).
Maltese: proteini fil-plażma huwa għoli (aktar minn 99 %) u l-volum ta' distribizzjoni huwa baxx (0.09 l/kg).
English: For the treatment of urinary tract infections associated with Escherichia coli and/or Proteus spp.
Maltese: Għat-trattament ta' infezzjonijiet tal-apparat urinarju assoċjati ma' Escherichia coli u/jew Proteus spp.
English: When applying a proposed microbiological breakpoint of I ≤ 4 µg/ml, cefovecin resistance in S. pseudintermedius and beta-haemolytic Streptococci isolates was less than 0.02 % and 3.4 % in Prevotella intermedia isolates.
Maltese: pseudintermedius u beta-haemolytic Streptococci kienet ta' anqas minn 0.02 % u 3.4 % f'iżolati ta'
English: Peak concentrations in tissue cage fluid of 31.9 μg/ml were measured 2 days after administration.
Maltese: L-ogħla konċentrazzjoni ta' 31.9 μg/ml fit-tissue cage fluid ġiet imkejla jumejn wara l-amministrazzjoni.
English: STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TAL-MRLs
English: For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β-haemolytic Streptococci, Escherichia coli and/or Pasteurella multocida.
Maltese: Għat-trattament ta' infezzjonijiet tal-ġilda u tessuti rotob inkluż pyoderma, feriti u axxessi assoċjati ma' Staphylococcus pseudintermedius, β-haemolytic Streptococci, Escherichia coli u/jew Pasteurella multocida.
English: Fourteen days after administration, the mean cefovecin concentration in plasma was 5.6 μg/ml.
Maltese: Erbatax-il ġurnata wara l-amministrazzjoni, il-konċentrazzjoni medja ta' cefovecin fil-plażma kienet ta' 5.6 μg/ml.
English: For the treatment of urinary tract infections associated with Escherichia coli.
Maltese: Ghat-trattament ta' infezzjonijiet tal-apparat urinarju assoċjati ma' Escherichia coli.
English: At fourteen days after administration, urine concentrations were 2.9 μg/ml.
Maltese: Fl-14-il jum wara lamministrazzjoni, il-konċentrazzjoni fl-urina kienet ta' 2.9 μg/ml.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Each vial contains 852 mg cefovecin.
Maltese: Kull kunjett fih 852 mg cefovecin
English: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Maltese: Injezzjoni waħda taħt il-ġilda ta' 8 mg/kg piż (1 ml għal kull 10 kg piż).
English: Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamine, corticosteroids, and airway management, as clinically indicated.
Maltese: Reazzjonijiet ipersensittivi akuti serji jistgħu jeħtieġu trattament b'epinefrina u miżuri oħra ta' emerġenza, li jinkludu ossiġinu, fluwidi intravenużi, anti-istamina intravenuża, kortikosterojdi, u mmaniġjar tal-kanali tan-nifs, skond kif indikat klinikalment.
English: BATCH NUMBER
Maltese: NUMRU/I
English: Diluent:
Maltese: Klieb:
English: The percentage of cefovecin resistant isolates in coagulase negative Staphylococci spp.
Maltese: Il persentaġġ ta' reżistenza għall-cefovecin f'iżolati ta' coagulase negative Staphylococcus spp.
English: In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections.
Maltese: Barra minn hekk, cefovecin juri attività in-vitro kontra Escherichia coli li hija assoċjata ma' infezzjonijiet tas-sistema urinarja fil-klieb u l-qtates.
English: CLINICAL PARTICULARS
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: Bacteroides spp.
Maltese: Qattus Bacteroides spp.
English: 1 Lowest concentration, which completely inhibits visible growth of at least 50 % of isolates 2 Lowest concentration, which completely inhibits visible growth of at least 90 % of isolates 3 Some of these pathogens (e.g. S. aureus) exhibited natural in vitro resistance to cefovecin 4 The clinical significance of these in vitro data has not been demonstrated.
Maltese: 3 Ftit minn dawn il-patoġeni (e.g. S. aureus) juru reżistenza naturali in vitro kontra cefovecin 4 Is-sinifikat kliniku ta' dawn id-data in vitro ma ġiex muri.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dogs and cats: 8 mg cefovecin/kg body weight (1 ml/10 kg body weight).
Maltese: U METODU TA' AMMINISTRAZZJONI Klieb u qtates: 8 mg/kg piż (1 ml għal kull 10 kg piż).
English: 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol
Maltese: 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216)
English: Cefovecin exhibits in-vitro activity against Staphylococcus pseudintermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Maltese: Cefovecin juri attività in-vitro kontra Staphylococcus pseudintermedius u Pasteurella multocida li huma assoċjati ma' infezzjonijiet tal-ġilda tal-klieb u l-qtates.
English: In dogs, when cefovecin was administered as a single subcutaneous dose of 8 mg/kg bodyweight, absorption was rapid and extensive; peak plasma concentration at 6 hours was 120 µg/ml and bioavailability approximately 99 %.
Maltese: Meta cefovecin ġie amministrat fil-klieb f'doża waħda ta' 8 mg/kg piż taħt il-ġilda, kien hemm assorbiment malajr u b'mod wiesgħa; l-ogħla konċentrazzjoni fil-plażma wara 6 sigħat kienet ta' 120 µg/ml u l-bioavilibilità kienet bejn wieħed u ieħor ta' 99 %.
English: Porphyromonas gingivalis and Prevotella intermedia collected from canine periodontal disease were also shown to be susceptible.
Maltese: Prophyromonas gingivalis u Prevotella intermedia miġbura minn mard periodontali tal-klieb dehru li jirrispondu ukoll.
English: A. LABELLING
Maltese: MANIFATTURA
English: Active substance: 340 mg cefovecin (as sodium salt)
Maltese: 340 mg cefovecin (f'forma ta' sodju)
English: Dog4 Cat4
Maltese: Kelb4 Qattus4
English: As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues associated with Porphyromonas spp.
Maltese: infezzjonijiet serji tal-ħanek u tessuti periodontali assoċjati ma' Porphyromonas spp.
English: SPECIAL WARNING(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Reconstitution yields either 4 ml or 10 ml of solution for injection respectively.
Maltese: Rikostituzzjoni tagħti 4 ml jew 10 ml ta' soluzzjoni għall-injezzjoni rispettivament.
English: Discard date:
Maltese: DATA TA' SKADENZA JIS:
English: Excipients:
Maltese: Jiskadi:
English: Do not use in cases of hypersensitivity to cephalosporin or penicillin antibiotics.
Maltese: Tużax f'każijiet ta' ipersensittività għal antibijotiċi tat-tip kefalosporini jew penicillini.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin
Maltese: Convenia 80 mg/ml trab u solvent għas-soluzzjoni għall-injezzjoni fi klieb u qtates.
English: INDICATION(S) For certain skin, soft tissue, urinary tract and severe periodontal infections.
Maltese: Għal xi infezzjonijiet tal-ġilda, infezzjonijiet tal-apparat urinarju u infezzjonijiet periodontali serji.
English: Periodontal isolates were collected during a European (France and Belgium) clinical efficacy and safety field study (2008).
Maltese: Iżolati periodontali kienu miġbura waqt studju Ewropew (Franza u Belġju) fuq l-effiċenza u s-sigurtà klinika (2008).
English: In cats, when cefovecin was administered as a single subcutaneous dose of 8 mg/kg bodyweight, absorption was rapid and extensive; peak plasma concentration at 2 hours was 141 µg/ml and bioavailability approximately 99 %.
Maltese: Meta cefovecin ġie amministrat fil-qtates f'doża waħda ta' 8 mg/kg piż taħt il-ġilda, kien hemm assorbiment malajr u b'mod wiesgħa; l-ogħla konċentrazzjoni fil-plażma wara sagħtejn kienet ta' 141 µg/ml u l-bioavilibilità kienet bejn wieħed u ieħor ta' 99 %.
English: Cats:
Maltese: Qtates:
English: Dog Cat Pasteurella multocida Dog Cat
Maltese: IL-KLIEM " GĦALL-KURA TAL-ANNIMALI BISS”
English: Type I glass vial of either 10 ml or 19 ml with chlorobutyl rubber stopper sealed with an aluminium flipoff seal.
Maltese: Kunjett tal-ħġieġ ta' Tip 1 ta' 10 ml jew 19 ml b'tapp tal-chlorobutyl rubber b'siġill tal-aluminju flipoff.
English: Cat
Maltese: IEĦOR
English: Manufacturer responsible for batch release: Haupt Pharma Latina S.r.l.
Maltese: Prodott mediċinali veterinarju li jingħata bir-riċetta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 23 ml vial of lyophilised powder contains: Active substance:
Maltese: Kull kunjett ta' 5 ml trab lajofiliżżat fih Sustanza attiva:
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: To reconstitute, withdraw of the required volume of the supplied diluent from its vial (for 23 ml vial containing 852 mg of lyophilised powder reconstitute using 10 ml of diluent, or for 5 ml vial containing 340 mg of lyophilised powder reconstitute using 4 ml of diluent) and add to the vial containing the lyophilised powder.
Maltese: Biex tirrikostitwixxi, iġbed il-volum li hemm bżonn mid-dilwent fornut mill-kunjett tiegħu (għall kunjett ta' 23 ml li fih 852 mg trab lajofiliżżat irrikostitwixxi b'10 ml ta' dilwent, jew għall-kunjett ta' 5 ml li fih 340 mg trab lajofiliżżat irrikostitwixxi b'4 ml ta' dilwent) u żid fil-kunjett li fih it-trab lajofiliżżat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Convenia.
Maltese: VETERINARJU Dilwent għal Convenia.
English: QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol in water for injections.
Maltese: OĦRA 13 mg/ml benzyl alcohol f'ilma għall-injezzjonijiet.
English: BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT
English: Fourteen days after administration the mean cefovecin concentration in plasma was 18 µg/ml.
Maltese: Erbatax-il ġurnata wara lamministrazzjoni, il-konċentrazzjoni medja ta' cefovecin fil-plażma kienet ta' 18 μg/ml.