FrancophonIA/ELRC3.0 huggingface dataset:
English: Oriprim vet oral powder (Finland) was excluded from the scope of this referral procedure based on the fact that its pharmaceutical form is different from Tribrissen Oral Paste for Horses.
Maltese: It-trab orali Oriprim vet (talFinlandja) ġie eskluż mill-ambitu ta' din il-proċedura ta' referenza abbażi tal-fatt li l-għamla farmaċewtika tagħha hija differenti minn dik ta' Tribrissen Oral Paste for Horses.
English: 25 mg sulfadiazine and 5 mg trimethoprim per kg BW per day, during max. 5 days
Maltese: 25 mg sulfadiazine u 5 mg trimethoprim għal kull kg piż tal-ġisem kuljum, għal massimu ta' 5 ijiem
English: Sulfadiazine 333 mg/g Trimethoprim 67 mg/g horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Maltese: Sulfadiazine 333 mg/g Trimethoprim 67 mg/g żwiemel Infezzjonijiet batteriċi, per eżempju feriti infettati, flapparat respiratorju, flapparat GI jew fis-sistema uroġenitali.
English: Treatment should be continued until 2 days after symptoms have resolved, up to a maximum of 5 days.
Maltese: It-trattament għandu jitkompla wara li jkunu għaddew jumejn mingħajr sintomi, sa massimu ta' 5 ijiem.
English: Each 45g syringe contains:
Maltese: Kull siringa ta' 45g fiha:
English: - Upper and lower respiratory tract infections, including strangles.
Maltese: - Infezzjonijiet fil-parti t'isfel jew ta' fuq ta' lapparat respiratorju, inkluża l-adenite tażżwiemel (strangles).
English: The product may be effective in alimentary tract infection such as diarrhoea; respiratory infections including pneumonia, pleurisy, strangles; wounds, septicaemia and general infections.
Maltese: Doża rrakkomandata infezzjonijiet fl-apparat alimentari inklużi dijarea; infezzjonijiet fl-apparat respiratorju inklużi pulmonite, plewrite, adenite taż-żwiemel (strangles); feriti, settiċemija u infezzjonijiet ġeneriċi.
English: − Gastro-intestinal infections: 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 application of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.
Maltese: − Infezzjonijiet gastrointestinali: 30 mg/kg kuljum fuq 2 applikazzjonijiet ta' 15 mg/kg piż tal-ġisem kuljum jew applikazzjoni 1 ta' 30 mg/kg kuljum, matul għallinqas 5 ijiem jew wara li jkunu għaddew jumejn mingħajr sintomi.
English: Sulfadiazine 333 mg Trimethoprim 67 mg horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Maltese: Sulfadiazine 333 mg Trimethoprim 67 mg żwiemel Infezzjonijiet batteriċi, per eżempju feriti infettati, flapparat respiratorju, flapparat GI jew fis-sistema uroġenitali.
English: 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
Maltese: 5 mg trimethoprim u 25 mg sulfadiazine għal kull kg ta' piż tal-ġisem kuljum għal massimu ta' 5 ijiem.
English: 30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37.5 g paste (one tube) per os to a 500 kg horse 12 times daily.
Maltese: 30 mg ta' komponenti attivi kombinati għal kull kg ta' piż tal-ġisem minn darba għal darbtejn kuljum, li jikkorrispondu għal 37.5 g pejst (tubu wieħed) mill-ħalq għal żiemel ta' 500 kg bejn darba u darbtejn kuljum.
English: To provide for each country of the European Economic Area (EEA) where the product is authorised from the dossier submitted: a. Part I Summary of the dossier, including the Summary of Product Characteristics (SPC), the expert reports and the quantitative and qualitative composition of the product; b. If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Maltese: Parti I, Sommarju tal-fajl, inklużi s-Sommarju tal-Karatteristiċi tal-Prodott (SPC), ir-rapporti ta' l-esperti u l-kompożizzjoni kwantitattiva u kwalitattiva tal-prodott; b. jekk ikun applikabbli, Parti IV, Tagħrif dwar l-Effikaċja, inkluż tagħrif dwar ilfarmakoċinetika, il-farmakodinamika u d-dejta dwar ir-reżistenza antimikrobika.
English: - urogenital infections caused by bèta-haemolytic streptococci; - wounds and abscesses by Streptococcus spp., Staphylococcus aureus.
Maltese: Trimethoprim 2 mg żwiemel - infezzjonijiet respiratorji kkawżati minn Streptococcus spp., Staphylococcus aureus; - infezzjonijiet gastrointestinali kkawżati minn E. coli; - infezzjonijiet uroġenitali kkawżati minn streptokokki beta emolitiċi; - feriti u axxessi minn Streptococcus spp., Staphylococcus aureus.
English: Sulfadiazine 33,34 g horses Tribrissen Oral Paste is indicated for the treatment of horses with bacterial infections caused by sensitive bacteria, including: - gastro-intestinal infections - infections of respiratory tracts - infections of urogenital tracts
Maltese: Sulfadiazine 33,34 g żwiemel b'infezzjonijiet batteriċi kkawżati minn batterji sensittivi, inkluż: - infezzjonijiet gastrointestinali - infezzjonijiet fl-apparati respiratorji - infezzjonijiet ta' l-apparati uroġenitali - infezzjonijiet f'feriti u ċellulite - salmonellożi - bħala trattament profilattiku għal infezzjonijiet wara operazzjoni.
English: The daily dose is 30 mg combined active ingredients per kg body weight the equivalent to the contents of one syringe for a 500 kg horse
Maltese: Id-doża ta' kuljum hija 30 mg ta' komponenti attivi kombinati għal kull kg ta' piż tal-ġisem ekwivalenti għall-kontenut ta' siringa waħda għal żiemel ta' 500 kg
English: − Infections of the genital tracts.
Maltese: − Infezzjonijiet ta' lapparati ġenetali.
English: - wound infections and cellulitis - salmonellosis - as profylacticum for postoperative infections paste for 50 kg body weight.
Maltese: Kull unità fuq l-iskala tal-planġer tipprovdi pejst biżżejjed għal 50 kg piż tal-ġisem.
English: Pivotal documents, including the SPC, should be presented in English.
Maltese: Dokumenti ewlenin, inkluż l-SPC, għandhom jiġu ppreżentati bl-Ingliż.
English: Trimethoprim 2.6g and Sulfadiazine 13.0g horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GItract, urogenital-tract and wound infections.
Maltese: Sulfadiazine 13.0g żwiemel Infezzjonijiet fiż-żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimetoprim + sulphonamide, eż. infezzjonijiet fil-passaġġi ta' l-arja, fl-apparat GI, flapparat uroġenitali u f'feriti infettati.
English: Therefore, it is not possible to recommend explicitly diseases or bacterial species for which the higher (2 X 30 mg/kg bw) or the lower dose (1 X 30 mg/kg bw) is appropriate.
Maltese: Għalhekk mhux possibbli li jiġu rakkomandati b'mod espliċitu mardiet u speċi batteriċi li għalihom ikunu xierqa d-doża l-għolja (2 X 30 mg/kg tal-piż tal-ġisem) u d-doża l-baxxa (1 X 30 mg/kg tal-piż tal-ġisem).
English: 30mg of combined active ingredients per kg bodyweight daily.
Maltese: 30 mg ta' komponenti attivi kombinati għal kull kg ta' piż tal-ġisem kuljum.
English: Indication salmonellosis has not been substantiated.
Maltese: L-indikazzjoni tas-salmonellożi ma ġietx sostanzjata.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, the CVMP concludes that there is no documented evidence from the field of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Maltese: Wara li ġew ikkunsidrati r-raġunijiet għar-riferiment u t-tweġibiet ipprovduti mid-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq, is-CVMP ikkonkluda li ma hemmx provi dokumentati mil-lat ta' problemi relatati man-nuqqas ta' effikaċja jew ta' tibdil fis-sitwazzjoni ta' reżistenza għall-patoġeni rilevanti li kienu jikkostitwixxu tħassib relatat ma' l-effikaċja jew ma' tibdil fis-sitwazzjoni ta' reżistenza għall-patoġeni rilevanti li jwasslu għal tħassib relatat mas-saħħa ta' l-annimali jew talbnedmin.
English: Taking into account the results of the clinical studies, pharmacokinetic properties of TMP/SDZ and practical aspects of twice daily dosing, once daily dosing of 30mg/kg bw should be recommended.
Maltese: Meta wieħed iqis ir-riżultati ta' l-istudji kliniċi, il-karatteristiċi farmakoċinetiċi ta' TMP/SDZ u laspetti prattiċi ta' dożi ta' darbtejn kuljum, għandha tiġi rakkomandata doża ta' 30 mg/kg tal-piż talġisem darba kuljum.
English: On 12 July 2007 CVMP sent a list of questions to all marketing authorisation holders.
Maltese: Fit-12 ta' Lulju ta' l-2007 s-CVMP bagħat lista ta' mistoqsijiet lil dawk li għandhom l-awtorizzazzjoni għat-tqegħid fis-suq.
English: However, horses are treated individually and considered of relatively little importance as food producing species.
Maltese: Madankollu, iż-żwiemel huma ttrattati individwalment u kkunsidrati ta' importanza relattivament żgħira bħala speċi talproduzzjoni alimentari.
English: The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days.
Maltese: It-trattament għandu jitkompla sa 5 ijiem jew sa jumejn wara li s-sintomi jkunu għaddew, sa massimu ta' 5 ijiem.
English: Each syringe provides a daily dose for a 500 kg horse.
Maltese: Kull siringa tipprovdi doża ta' kuljum għal żiemel ta' 500 kg.
English: CVMP received SPCs, a master reference dossier on residues and withdrawal periods, residue studies, efficacy data and periodic safety update reports, an expert statement on the efficacy including reference papers, pharmacokinetic data, antimicrobial resistance information and MIC/resistance data.
Maltese: Is-CVMP irċieva SPCs, dokument ta' referenza ewlieni fuq ir-residwi u fuq il-perjodi ta' tneħħija, studji dwar ir-residwi u rapporti perjodiċi ta' aġġornamenti dwar is-sigurtà, stqarrija minn esperti fuq leffikaċja inklużi dokumenti ta' referenza, dejta farmakoċinetika, tagħrif dwar ir-reżistenza għallantimikrobiċi u dejta dwar l-MIC / ir-reżistenza.
English: Each division on the dial-a-dose plunger provides sufficient product to treat 50 kg of bodyweight.
Maltese: Kull diviżjoni fuq il-planġer tattip 'dial-a-dose' tipprovdi prodott suffiċjenti biex jiġu ttrattati 50 kg tal-piż talġisem.
English: Ireland VPA
Maltese: Ir-Renju Unit
English: Treatment should be
Maltese: Għat-trattament ta'
English: Trimethoprim 5.78%w/w Sulfadiazine 28.89% w/w horses Treatment of bacterial infections in horses caused by sensitive microorganisms including:
Maltese: Trimethoprim 5.78%piż/piż Sulfadiazine 28.89% w/w żwiemel Trattament ta' infezzjonijiet batteriċi fi żwiemel ikkawżati minn mikrorganiżmi sensittivi fosthom: Escherichia coli, Staphylococcus spp., Streptococcus spp.
English: At most, it indicates that a daily dose of 2 X 30 mg/kg may be necessary when pathogens involved in the disease are less susceptible to TMP/SDZ.
Maltese: L-iktar l-iktar tindika li jista' jkun hemm bżonn doża ta' kuljum ta' 2 X 30 mg/kg meta l-patoġeni involuti jkunu inqas suxxetibbli għal TMP/SDZ.
English: It is noted that a daily dose of 2 X 15 mg/kg bw is recommended in several SPCs.
Maltese: Huwa nnotat li doża ta' kuljum ta' 2 X 15 mg/kg tal-piż tal-ġisem hi rrakkomandata f'ħafna SPCs.
English: In conclusion, considering the reasons and recommendations mentioned above, the dose of 1 X 30 mg/kg bw per day to be administered over a maximum period of 5 days has been substantiated.
Maltese: Finalment, meta wieħed iqis ir-raġunijiet u r-rakkomandazzjonijiet imsemmija hawn fuq, ġiet sostanzjata d-doża ta' 1 X 30 mg/kg tal-piż tal-ġisem kuljum amministrata matul perjodu massimu ta' ħamest ijiem.
English: 1 g contain: Sulfadiazine 288.3 mg horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI
Maltese: Sulfadiazine 288.3 mg Trimethoprim 58.0 mg żwiemel Infezzjonijiet fiż-żwiemel ikkawżati minn mikrorganiżmi sensittivi għal trimetoprim + sulphonamide, eż. infezzjonijiet fil-passaġġi ta' l-arja, fl-apparati GI, flapparat uroġenitali u f'feriti infettati.
English: − Serious acute infections outside of the intestinal tracts (respiratory-urinal tracts): first an injection of Tribrissen 48% or Duoprim, followed by a daily administration of Tribrissen Oral Paste at 30mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 administrations of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.
Maltese: − Infezzjonijiet akuti gravi barra mill-apparati intestinali (apparati respiratorji-urinarji): lewwel injezzjoni ta' Tribrissen 48% jew Duoprim, segwita minn amministrazzjoni ta'
English: The
Maltese: kg.
English: The clinical studies presented for the treatment of salmonellosis, applying a daily dose of 2 X 30 mg/kg bw to be administered over 10 days are exceedingly poor (few animals, poor results).
Maltese: L-istudji kliniċi ppreżentati għat-trattament tas-salmonellożi, b'applikazzjoni ta' doża ta' 2 X 30 mg/kg tal-piż tal-ġisem amministrata matul għaxart ijiem huma batuti ħafna (ftit annimali, riżultati insuffiċjenti).
English: It is noted that there are no reports (PSURs) on lack of efficacy or developing resistance following use of TMP/SDZ in horses.
Maltese: Ġie nnutat li ma hemmx rapporti (PSUR) dwar in-nuqqas ta' effikaċja jew liżvilupp ta' reżistenza wara l-użu ta' TMP/SDZ fiż-żwiemel.
English: (See section 6.4.)
Maltese: (Ara sezzjoni 5.2.).
English: EU/1/02/216/001 EU/1/02/216/002
Maltese: EU/1/02/216/002
English: The active ingredient of INVANZ is ertapenem 1 g.
Maltese: Is-sustanza ativa ta' INVANZ hi ertapenem 1g.
English: Ceftriaxone n/m % n/m %
Maltese: Ertapenem Ceftriaxone n/m % n/m %
English: Infuse over a period of 30 minutes.
Maltese: L-infużjoni għandha ddum 30 minuta.
English: Investigations Chemistry
Maltese: Investigazzjonijiet Kimika
English: F-63963 Clermont-Ferrand Cedex 9, France.
Maltese: F-63963 Clermont-Ferrand Cedex 9, Franza.
English: Microbiological susceptibility
Maltese: Suxxettibilità mikrobijoloġika
English: EU/1/02/216/001 1 vial EU/1/02/216/002 10 vials
Maltese: EU/1/02/216/001 kunjett 1 EU/1/02/216/002 10 kunjetti
English: Gram-negative aerobes:
Maltese: Erobi Gram-negattivi:
English: • Intra-abdominal infections
Maltese: • Infezzjonijiet intra-addominali
English: The overall safety profile is comparable to that in adult patients.
Maltese: Il-profil tas-sigurtà totali hu komparabbli ma' dak f'pazjenti adulti.
English: Lactobacillus species
Maltese: L-ispeċi Lactobacillus
English: • abnormal movements
Maltese: • movimenti mhux normali
English: Superinfection
Maltese: INFECTOPHARM
English: * Activity has been satisfactorily demonstrated in clinical studies.
Maltese: * L-attività intweriet b'mod sodisfaċenti fi studji kliniċi. †
English: Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Maltese: Corynebacterium jeikeium Enterococci inkluż Enterococcus faecalis u Enterococcus faecium
English: In vitro studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the six major CYP isoforms: 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4.
Maltese: Studji in vitro tal-mikrosomi tal-fwied tal-bniedem jindikaw li ertapenem ma jfixkilx il-metaboliżmu li jseħħ permezz tas-sitt isoforms CYP prinċipali: 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: Date of first authorisation: 18 April 2002 Date of latest renewal: 22 December 2011
Maltese: Data tal-aħħar tiġdid: 22 ta' Diċembru 2011
English: Uncommon: Positive Clostridium difficile toxin
Maltese: Mhux komuni: Pożittiv għat tossina tal-Clostridium difficile
English: The total number of patients treated with ertapenem in clinical studies was 384.
Maltese: In-numru totali ta' pazjenti kkurati b'ertapenem fi studji kliniċi kien ta' 384.
English: Bacteroides fragilis and species in the B. fragilis Group* Inherently resistant organisms:
Maltese: Bacteroides fragilis u speċi fil-Grupp B. fragilis*
English: 2 to 12 years 13 to 17 years
Maltese: 3 sa 23 xhur 2 sa 12-il sena 13 sa 17-il sena
English: Each vial contains: 1.0 g ertapenem (as sodium).
Maltese: Kull kunjett fih: 1.0 g ta' ertapenem (bħala sodium).
English: Adverse reactions (i.e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20 % of patients treated with ertapenem.
Maltese: Reazzjonijiet avversi (i.e. dawk li huma kkunsidrati millinvestigatur li huma possibbilment, probabbilment, jew definittivament marbuta mal-prodott mediċinali) kienu rrappurtati f'madwar 20% tal-pazjenti li ħadu ertapenem.
English: Paediatric population (3 months to 17 years of age):
Maltese: Popolazzjoni pedjatrika (minn 3 xhur sa 17-il sena):
English: The mechanism of action of ertapenem differs from that of other classes of antibiotics, such as quinolones, aminoglycosides, macrolides and tetracyclines.
Maltese: Il-mekkaniżmu tal-azzjoni ta' ertapenem hu differenti minn dak ta' klassijiet oħra ta' antibijotiċi, bħal quinolones, aminoglycosides, macrolides u tetracyclines.
English: Adult and adolescents (13 to 17 years of age)
Maltese: Adulti u adolexxenti (minn 13 sa 17-il sena)
English: Methicillin-susceptible-staphylococci (including Staphylococcus aureus)* Streptococcus agalactiae*
Maltese: Staphylococci suxxettibbli għal methicillin (inkluż Staphylococcus aureus)*
English: INVANZ contains ertapenem which is an antibiotic of the beta-lactam group.
Maltese: INVANZ fih ertapenem li huwa antibijotiku tal-grupp beta-lactam.
English: INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Maltese: INVANZ hu indikat għall-użu fl-adulti għall-profilassi ta' infezzjoni fis-sit kirurġiku wara operazzjoni elettiva tal-kolon u r-rektum (ara sezzjoni 4.4).
English: Treatment was discontinued due to adverse reactions in 0.5 % of patients.
Maltese: Il-kura twaqqfet minħabba reazzjonijiet f'0.5% tal-pazjenti.
English: The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
Maltese: Is-sustanzi l-oħra huma: sodium bicarbonate (E500) and sodium hydroxide (E524).
English: (NB: Susceptibility of staphylococci to ertapenem is inferred from methicillin susceptibility and susceptibility of group A, B, C,& G streptococci is inferred from benzylpenicillin susceptibility)
Maltese: Is-suxxettibilità ta' staphylococci għal ertapenem hija kundizzjonali fuq suxxettibbiltà għal methicillin u suxxettibbiltà tal-grupp ta' streptococci A, B, C u G hija konkluża missuxxettibbiltà għal benzylpenicillin)
English: Common: Rash, pruritus Uncommon: Erythema, urticaria Rare: Dermatitis, desquamation Not known: Acute Generalised Exanthematous Pustulosis (AGEP), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Maltese: Pustulożi Esantematika Ġeneralizzata Akuta (AGEP, Acute Generalised Exanthematous Pustulosis), Raxx ikkawżat mill-Mediċina b'Eosinofilja u Sintomi Sistemiċi (sindrome DRESS)
English: • Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or cephalosporins).
Maltese: • Sensittività eċċessiva serja (eż. reazzjoni anafilattika, reazzjoni serja fil-ġilda) għal xi tip ieħor ta' mediċina antibatterika beta-lactam (eż. penicillins jew cephalosporins).
English: Sodium bicarbonate (E500); sodium hydroxide (E524) to adjust pH to 7.5.
Maltese: TA' EĊĊIPJENTI Sodium bicarbonate (E500), sodium hydroxide (E524) biex jaġġusta l-pH għal 7.5.
English: Intravenous administration: INVANZ should be infused over a period of 30 minutes.
Maltese: INVANZ għandu jiġi infuż fuq perijodu ta' 30 minuta.
English: Adults and adolescents (13 to 17 years of age): The dose of INVANZ is 1 gram (g) given once a day by the intravenous route (see section 6.6).
Maltese: Adulti u adolexxenti (13 sa 17-il sena): Id-doża ta' INVANZ hi ta' 1 gramma (g) mogħtija fil-vina darba kuljum (ara sezzjoni 6.6).
English: Methicillin-resistant staphylococci and enterococci are resistant to ertapenem, owing to PBP target insensitivity; P. aeruginosa and other non-fermentative bacteria are generally resistant, probably owing to limited penetration and to active efflux.
Maltese: Staphylococci reżistenti għal methicillin u enterococci huma reżistenti għal ertapenem, minħabba li huma insensittivi fil-mira għal PBP; P. aeruginosa u batterji oħrajn li mhumiex fermentattivi huma ġeneralment reżistenti, probabbilment minħabba penetrazzjoni limitata u effluss attiv.
English: • Hypersensitivity to any other carbapenem antibacterial agent
Maltese: • Sensittività eċċessiva għal xi mediċina antibatterika ta' carbapenem oħra
English: Ertapenem is effectively stable to hydrolysis by most classes of betalactamases, including penicillinases, cephalosporinases and extended spectrum beta-lactamases, but not metallo-beta-lactamases.
Maltese: Ertapenem hu effettivament stabbli għall-idrolisi mill-biċċa l-kbira tal-klassijiet ta' beta-lactamases, li jinkludu penicillinases, cephalosporinases u extended spectrum beta-lactamases, iżda mhux metallo-beta-lactamases.
English: 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: Rari (≥ 1/ 10,000 sa < 1/1000);
English: Compatibility of INVANZ with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated.
Maltese: Intweriet il-kompatibilità ta' INVANZ ma' soluzzjonijiet li jingħataw fil-vina li fihom sodium talheparin u potassium chloride.
English: Do not freeze solutions of INVANZ.
Maltese: Tiffriżax soluzzjonijiet ta' INVANZ.
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH03
Maltese: Antibatteriċi għal użu sistemiku, carbapenems, Kodiċi ATC:
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: INVANZ contains sodium
Maltese: INVANZ fih is-sodium
English: Common: Elevations in ALT, AST, alkaline phosphatase Uncommon: Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose
Maltese: Komuni: Żidiet fl-ALT, AST, alkaline phosphatase Mhux komuni: Żidiet fil- bilirubin totali fis-serum, bilirubin dirett tas-serum, bilirubin indirett tasserum, krejatinina tas-serum, urea tas-serum, glukosju tas-serum Rari: tnaqqis fil-bikarbonat tasserum, krejatinina tas-serum, u potassju tas-serum; żidiet fil-LDH tas-serum, fosfru tas-serum, potassju tas-serum
English: Moraxella catarrhalis*
Maltese: • M. catarrhalis:
English: INFECTOPHARM Arzneimittel und Consilium GmbH Tel. +49 (0)6252 / 95-7000 kontakt@infectopharm.com
Maltese: +49 (0)6252 / 95-7000 kontakt@infectopharm.com
English: Resistance is uncommon in Enterobacteriaceae and ertapenem is generally active against those with extended-spectrum beta-lactamases (ESBLs).
Maltese: Ir-reżistenza mhix komuni f'Enterobacteriaceae u ertapenem ġeneralment huwa attiv kontra dawk blextended-spectrum beta-lactamases (ESBLs).
English: Anaerobes:
Maltese: • Enterobacterales:
English: In vivo, probenecid (500 mg every 6 hours) decreased the bound fraction of ertapenem in plasma at the end of infusion in subjects administered a single 1 g intravenous dose from approximately 91 % to approximately 87 %.
Maltese: In vivo, probenecid (500 mg kull 6 sigħat) naqqas il-parti marbuta ta' ertapenem fil-plażma flaħħar tal-infużjoni f'pazjenti li ngħataw doża waħda ta' 1 g fil-vina, minn bejn wieħed u ieħor 91% sa bejn wieħed u ieħor 87%.
English: In paediatric clinical studies, a single intravenous (IV) dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
Maltese: Fi studji kliniċi pedjatriċi, doża ewlenija fil-vini (IV) ta' 40 mg/kg sa massimu ta' 2 g ma rriżultatx f'tossiċità.
English: Concomitant use with valproic acid
Maltese: Użu flimkien ma' valproic acid