FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 years.
Maltese: 6 sigħat).
English: EUCAST MIC breakpoints for imipenem to separate susceptible (S) pathogens from resistant (R) pathogens are as follows (v 1,1 2010-04-27):
Maltese: L-MIC breakpoints tal-EUCAST għal imipenem biex jinfirdu l-patoġeni suxxettibbli (S) minn dawk reżistenti (R) huma kif ġej (v 1,1 2010-04-27):
English: Common rash (e.g. exanthematous)
Maltese: Komuni raxx (eż. eksantematuż)
English: TIENAM belongs to a group of medicines called carbapenem antibiotics.
Maltese: IV jagħmel parti minn grupp ta' mediċini msejħa antibijotiċi carbapenem.
English: Gram-positive anaerobes:
Maltese: Anaerobi Gram-negattivi:
English: - The other ingredient is sodium bicarbonate.
Maltese: Is-sustanza l-oħra hija sodium bicarbonate.
English: Uncommon pancytopenia, neutropenia, leucopenia, thrombocytopenia, thrombocytosis
Maltese: Mhux komuni panċitopenija, newtropenija, lewkopenija, tromboċitopenija, tromboċitosi
English: The concomitant use of imipenem/cilastatin and valproic acid/sodium valproate is not recommended (see section 4.5).
Maltese: L-użu ta' imipenem/cilastatin flimkien ma' valproic acid/sodium valproate mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: TIENAM is to be reconstituted and further diluted (see section 6.2, 6.3 and 6.6) prior to administration.
Maltese: IV għandu jiġi rrikostitwit u mbagħad iddilwit aktar (ara sezzjonijiet 6.2, 6.3 u 6.6) qabel ma jingħata.
English: Finland: TIENAM
Maltese: Il-Finlandja: TIENAM
English: TIENAM 500 mg/500 mg contains 37.6 mg of sodium (1.6 mEq) which should be taken into consideration by patients on a controlled sodium diet.
Maltese: IV 500 mg/500 mg fih 37.6 mg ta' sodium (1.6 mEk) li għandu jitqies f'pazjenti fuq dieta b'livell ikkontrollat ta' sodium.
English: In studies of 178 paediatric patients ≥3 months of age, the reported adverse reactions were consistent with those reported for adults.
Maltese: Fi studji ta' 178 pazjent pedjatriku ta' ≥ 3 xhur, ir-reazzjonijiet avversi rrappurtati kienu konsistenti ma' dawk irrapurtati fl-adulti.
English: Species for which acquired resistance may be a problem: Gram-negative aerobes: Acinetobacter baumannii Pseudomonas aeruginosa
Maltese: Aerobi Gram-negattivi: Acinetobacter baumannii Pseudomonas aeruginosa
English: Others: Chlamydia spp.
Maltese: Oħrajn: Chlamydia spp.
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see section 6.2 and 6.3): 0.9% sodium chloride.
Maltese: Il-kontenut ta' kull kunjett għandu jiġi ttrasferit ġo 100 ml ta' soluzzjoni tal-infużjoni adattata (ara sezzjonijiet 6.2 u 6.3): 0.9% sodium chloride.
English: Following a single 250 mg/250 mg intravenous dose of TIENAM, the area under the curve (AUCs) for imipenem increased 1.1-fold, 1.9-fold, and 2.7-fold in subjects with mild (Creatinine Clearance (CrCL) 50-80 ml/min/1.73 m2), moderate (CrCL 30-<50 ml/min/1.73 m2), and severe (CrCL <30 ml/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function (CrCL >80 ml/min/1.73 m2), and AUCs for cilastatin increased 1.6-fold, 2.0-fold, and 6.2-fold in subjects with mild, moderate, and severe renal impairment, respectively, compared to subjects with normal renal function.
Maltese: IV minn ġol-vina, l-erja taħt il-kurva (AUCs) għal imipenem żdiedet 1.1 drabi aktar, 1.9 drabi aktar, u 2.7 drabi aktar f'individwi b'indeboliment tal-kliewi ħafif (Tneħħija tal-Kreatinina (CrCL) 50-80 ml/min/1.73 m2), moderat (CrCL 30-<50 ml/min/1.73 m2), u qawwi (CrCL <30 ml/min/1.73 m2), rispettivament, meta mqabbla ma' individwi b'funzjoni normali talkliewi (CrCL >80 ml/min/1.73 m2), u l-AUCs għal cilastatin żdiedu 1.6 drabi aktar, 2.0 drabi aktar, and 6.2 drabi aktar f'individwi b'indeboliment ħafif, moderat u qawwi tal-kliewi, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: TIENAM is given intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a does of >500 mg/500 mg.
Maltese: IV jingħata ġol-vina fuq perjodu ta' 20-30 minuta għal doża ta' ≤500 mg/500 mg jew fuq perjodu ta' 40-60 minuta għal doża ta' >500 mg/500 mg.
English: Patients with a creatinine clearance of ≤5 ml/min/1.73 m2
Maltese: Pazjenti bi tneħħija tal-kreatinina ta' ≤5 ml/min/1.73 m2
English: • Hypersensitivity to any other carbapenem antibacterial agent
Maltese: • Sensittività eċċessiva għal xi sustanza antibatterika carbapenem oħra
English: 500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 hours OR every 6 hours
Maltese: 500 mg/500 mg kull 6 sigħat JEW 1000 mg/1000 mg kull 8 sigħat JEW kull 6 sigħat
English: Commonly susceptible species: Gram-positive aerobes: Enterococcus faecalis Staphylococcus aureus (Methicillin-susceptible)*
Maltese: Enterococcus faecalis Staphylococcus aureus (suxxettibbli għall-Methicillin)*
English: All adverse reactions are listed under system organ class and frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1,000 sa <1/100), Rari (≥1/10,000 sa <1/1,000), Rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The mean peak plasma levels of cilastatin following the 250 mg/250 mg, 500 mg/500 mg, and 1000 mg/1000 mg doses were 22, 42, and 72 µg/ml respectively.
Maltese: L-ogħla livelli medji ta' cilastatin fil-plażma wara d-dożi ta' 250 mg/250 mg, 500 mg/500 mg, u 1000 mg/1000 mg kienu 22, 42, u 72 µg/ml rispettivament.
English: United Kingdom: Primaxin IV
Maltese: Tienam Ir-Renju Unit: Primaxin IV
English: Imipenem, also referred to as N-formimidoyl-thienamycin, is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya.
Maltese: Imipenem, imsejjaħ ukoll N-formimidoyl-thienamycin, huwa derivattiv semisintetiku ta' thienamycin, issustanza oriġinali magħmula mill-batterju filamentuż Streptomyces cattleya.
English: Paediatric (≥3 months of age)
Maltese: Pazjenti pedjatriċi (≥ 3 xhur)
English: • Skin peeling (toxic epidermal necrolysis)
Maltese: • Tqaxxir fil-ġilda (nekrolisi epidermali tossika)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: imipenem 500 mg and cilastatin 500 mg.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih: imipenem 500 mg u cilastatin 500 mg.
English: Very rare cyanosis, tachycardia, palpitations
Maltese: Rari ħafna ċjanożi, takikardija, palpitazzjonijiet
English: The maximum total daily dose should not exceed 4000 mg/4000 mg per day.
Maltese: Id-doża massima totali ta' kuljum m'għandiex taqbeż l-4000 mg/4000 mg kuljum.
English: Very rare gastro-enteritis
Maltese: Rari ħafna gastroenterite
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 qawwija (eż. reazzjoni anafilattika, reazzjoni qawwija fil-ġilda) għal kwalunkwe tip ieħor ta' sustanza antibatterika beta-lactam (eż. penicillins jew cephalosporins).
English: • Nausea, vomiting, diarrhoea.
Maltese: • Dardir, rimettar, dijarea.
English: In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons 5% glucose may be used instead.
Maltese: F'ċirkustanzi eċċezzjonali fejn, għal raġunijiet kliniċi, 0.9% sodium chloride ma jistax jintuża, jista' jintuża 5% glucose minfloku.
English: TIENAM is indicated for the treatment of the following infections in adults and children 1 year of age and above (see sections 4.4 and 5.1):
Maltese: IV huwa indikat għall-kura tal-infezzjonijiet li ġejjin fl-adulti u fi tfal ta' sena u akbar (ara sezzjonijiet 4.4 u 5.1):
English: • Decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins)
Maltese: • Tnaqqis fil-permeabilità tal-membrana ta' barra tal-batterji Gram-negattivi (minħabba tnaqqis fil-produzzjoni ta' porins).
English: Mode of action TIENAM consists of two components: imipenem and cilastatin sodium in a 1:1 ratio by weight.
Maltese: IV jikkonsisti f'żewġ komponenti: imipenem u cilastatin sodium fi proporzjon ta' 1:1 skont il-piż.
English: 1 Proteus and Morganella species are considered poor targets for imipenem.
Maltese: 1 L-ispeċi Proteus u Morganella huma kkunsidrati miri dgħajfa għal imipenem.
English: Pack sizes of 1, 10 or 25 vials.
Maltese: Il-prodott mediċinali jiġi f'pakketti ta' kunjett 1, 10 kunjetti u 25 kunjett.
English: Total daily dose for patients with normal renal function (mg/day)
Maltese: Doża totali kuljum għal pazjenti b'funzjoni normali tal-kliewi (mg/kuljum)
English: Before initiating therapy with TIENAM, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
Maltese: IV, wieħed għandu jistaqsi bir-reqqa dwar reazzjonijiet ta' sensittività eċċessiva għal carbapenems, penicillins, cephalosporins, beta-lactams oħra u allerġeni oħra, fil-passat (ara sezzjoni 4.3).
English: Common increases in serum transaminases, increases in serum alkaline phosphatase
Maltese: Komuni żidiet fit-transaminases tas-serum, żidiet flalkaline phosphatase tas-serum
English: The average clearance (CL) and volume of distribution (Vdss) for imipenem were approximately 45% higher in paediatric patients (3 months to 14 years) as compared to adults.
Maltese: It-tneħħija medja (CL) u l-volum ta' distribuzzjoni (Vdss) għal imipenem kienu madwar 45% ogħla f'pazjenti pedjatriċi (3 xhur sa 14-il sena) meta mqabbla mal-adulti.
English: Inherently resistant species: Gram positive aerobes: Enterococcus faecium Gram negative aerobes: Some strains of Burkholderia cepacia (formerly Pseudomonas cepacia) Legionella spp.
Maltese: Xi razez ta' Burkholderia cepacia (li qabel kienet Pseudomonas cepacia) Legionella spp.
English: Similarly, the most frequently reported local adverse reactions were phlebitis/thrombophlebitis (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4%) and vein induration (0.2%).
Maltese: B'mod jixxiebah, l-aktar reazzjonijiet avversi lokali rrappurtati b'mod frekwenti kienu flebite/tromboflebite (3.1%), uġigħ fis-sit tal-injezzjoni (0.7%), eritema fis-sit talinjezzjoni (0.4%) u ebusija fil-vina (0.2%).
English: Very rare flushing
Maltese: Rari agranuloċitosi
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01D H51
Maltese: Antibatteriċi għal użu sistemiku, carbapenems, Kodiċi ATC:
English: Uncommon psychic disturbances including hallucinations and confusional states
Maltese: Mhux komuni disturbi psikiki li jinkludu alluċinazzjonijiet u stati ta' konfużjoni
English: • Infection affecting the lungs (pneumonia)
Maltese: • Infezzjoni li taffettwa l-pulmuni (pulmonite)
English: Studies in pregnant monkeys have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'xadini tqal urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Each vial contains sodium bicarbonate equivalent to approximately 1.6 mEq of sodium (approximately 37.6 mg).
Maltese: Kull kunjett fih sodium bicarbonate ekwivalenti għal madwar 1.6 mEk ta' sodium (madwar 37.6 mg).
English: • Tremors and uncontrolled twitching of muscles
Maltese: • Tregħid u ċaqliq bla kontroll tal-muskoli
English: There is no target-based cross-resistance between imipenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Maltese: M'hemmx reżistenza inkroċjata bbażata fuq is-sit fil-mira bejn imipenem u sustanzi oħra tal-klassijiet ta' quinolone, aminoglycoside, macrolide u tetracycline.
English:  body weight is < 70 kg.
Maltese:  l-piż tal-ġisem jkun < 70 kg.
English: • Dizziness, sleepiness
Maltese: Jekk tieqaf tuża PRIMAXIN
English: The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of imipenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered (see section 4.4).
Maltese: Il-livelli mnaqqsa ta' valproic acid jistgħu jwasslu għal kontroll mhux adegwat tal-aċċessjonijiet; għalhekk, l-użu ta' imipenem flimkien ma' valproic acid/sodium valproate mhuwiex irrakkomandat u għandhom jiġu kkunsidrati terapiji antibatteriċi jew antikonvulsanti alternattivi oħra (ara sezzjoni 4.4).
English: Clinical data are insufficient to recommend dosing for paediatric patients with renal impairment (serum creatinine > 2 mg/dl).
Maltese: Dejta klinika mhijiex biżżejjed biex jiġi rrakkomandat għoti ta' dożi lil pazjenti pedjatriċi b'indeboliment tal-kliewi (kreatinina fis-serum  2 mg/dl).
English: Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications (see section 4.1).
Maltese: Lużu konkomitanti ta' aminoglycoside jista' jkun indikat meta infezzjonijiet bi Pseudomonas aeruginosa jkunu ssuspettati jew ippruvati li huma involuti fl-indikazzjonijiet approvati (ara sezzjoni 4.1).
English: Common thrombophlebitis
Maltese: Komuni tromboflebite
English: Distribution The binding of imipenem to human serum proteins is approximately 20%.
Maltese: Distribuzzjoni L-irbit ta' imipenem mal-proteini tas-serum tal-bniedem huwa ta' madwar 20%.
English: Greece: Primaxin
Maltese: Meningite PRIMAXIN
English: Each dose of 500 mg/500 mg should be given by intravenous infusion over 20 to 30 minutes.
Maltese: Kull doża ta' 500 mg/500 mg għandha tingħata permezz ta' infużjoni ġol-vina fuq perjodu ta' bejn 20 u 30 minuta.
English: Peak plasma levels of cilastatin, following a 20 minute intravenous infusion of TIENAM, ranged from 21 to 26 μg/ml for the 250 mg/250 mg dose, from 21 to 55 μg/ml for the 500 mg/500 mg dose and from 56 to 88 μg/ml for the 1000 mg/1000 mg dose.
Maltese: IV fuq perjodu ta' 20 minuta ġolvina, kienu fuq medda ta' 21 sa 26 μg/ml għad-doża ta' 250 mg/250 mg, bejn 21 u 55 μg/ml għad-doża ta' 500 mg/500 mg u bejn 56 u 88 μg/ml għad-doża ta' 1000 mg/1000 mg.
English: Slovak Republic: TIENAM i.v.
Maltese: Ir-Repubblika Ċeka: Tienam i.v.
English: For patients with normal renal function (creatinine clearance of >70 ml/min/1.73 m2), the recommended dose regimens are:
Maltese: Għal pazjenti b'funzjoni tal-kliewi normali (tneħħija tal-kreatinina ta' >70 ml/min/1.73 m2), l-iskedi talgħoti tad-dożi rrakkomandati huma:
English: A reduction in dose is necessary when:  creatinine clearance is ≤ 70 ml/min/l.73 m2 (see Table 1) or
Maltese: Tnaqqis fid-doża huwa meħtieġ meta:  t-tneħħija tal-kreatinina tkun ≤ 70 ml/min/l.73 m2 (ara Tabella 1) jew
English: At the higher dose, the exposure following administration of 25/25 mg/kg imipenem/cilastatin to children was 9% higher as compared to the exposure in adults receiving a 1000 mg/1000 mg dose.
Maltese: B'doża għola, l-esponiment wara għoti ta' 25/25 mg/kg ta' imipenem/cilastatin lit-tfal kien ta' 9% ogħla meta mqabbel mal-esponiment fl-adulti li kienu qed jirċievu doża ta' 1000 mg/1000 mg.
English: Symptoms of overdose that can occur are consistent with the adverse reaction profile; these may include seizures, confusion, tremors, nausea, vomiting, hypotension, bradycardia.
Maltese: Sintomi ta' doża eċċessiva li jistgħu jseħħu huma konsistenti mal-profil ta' reazzjonijiet avversi; dawn jistgħu jinkludu aċċessjonijiet, konfużjoni, tregħid, nawsja, rimettar, pressjoni baxxa, bradikardija.
English: • Streptococcus A, B, C, G: The beta-lactam susceptibility of beta-haemolytic streptococcus groups A,
Maltese: Wieħed jasal għas-suxxettibiltà tal-gruppi A, B, C u G tal-istreptococcus beta-emolitiku għall-beta-lactam mis-suxxettibiltà għall-penicillin.
English: Distribution The binding of cilastatin to human serum proteins is approximately 40%.
Maltese: Distribuzzjoni L-irbit ta' cilastatin mal-proteini tas-serum tal-bniedem huwa ta' madwar 40%.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rrikostitwit, ara sezzjoni 6.3. 6.5
English: For paediatric patients ≥1 year of age, the recommended dose is 15/15 or 25/25 mg/kg/dose administered every 6 hours.
Maltese: Għal pazjenti pedjatriċi ta' età ≥ 1 sena, id-doża rrakkomandata hija ta' 15/15 jew 25/25 mg/kg/doża mogħtija kull 6 sigħat.
English: The AUC for imipenem following administration of 15/15 mg/kg per body weight of imipenem/cilastatin to paediatric patients was approximately 30% higher than the exposure in adults receiving a 500 mg/500 mg dose.
Maltese: L-AUC ta' imipenem wara għoti ta' 15/15 mg/kg piż tal-ġisem ta' imipenem/cilastatin lill-pazjenti pedjatriċi kienet madwar 30% ogħla millesponiment fl-adulti li kienu qed jirċievu doża ta' 500 mg/500 mg.
English: Approximately 10% was found as the Nacetyl metabolite, which has inhibitory activity against dehydropeptidase comparable to that of cilastatin.
Maltese: Madwar 10% instab bħala l-metabolit N-acetyl, li għandu attività impeditorja kontra d-dehydropeptidase kumparabbli ma' dik ta' cilastatin.
English: A teratology study in pregnant cynomolgus monkeys given imipenem-cilastatin sodium at doses of 40/40 mg/kg/day (bolus intravenous injection) resulted in maternal toxicity including emesis, inappetence, body weight loss, diarrhoea, abortion, and death in some cases.
Maltese: Studju ta' teratoloġija f'xadini cynomolgus tqal li ngħataw imipenem-cilastatin sodium f'dożi ta' 40/40 mg/kg/kuljum (bħala injezzjoni f'daqqa ġol-vina) wassal għal tossiċità fl-omm li kienet tinkludi rimettar, nuqqas t'aptit, telf ta' piż tal-ġisem, dijarea, abort, u f'xi każijiet mewt.
English: • Imipenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-positive and gram-negative bacteria, with the exception of relatively rare carbapenem hydrolysing beta-lactamases.
Maltese: • Imipenem huwa stabbli għal idrolisi mill-biċċa l-kbira ta' beta-lactamases, li jinkludu lpenicillinases u s-cephalosporinases li jipproduċuhom il-batterji gram-pożittivi u gramnegattivi, bl-eċċezzjoni tal-beta-lactamases li jidrolizzaw il-carbapenem u li huma relattivament rari.
English: Powder for solution for infusion 1 vial
Maltese: Trab għal soluzzjoni għall-infużjoni Kunjett 1
English: What TIENAM contains - The active substances are imipenem and cilastatin.
Maltese: Is-sustanzi attivi huma imipenem u cilastatin.
English: • Disturbances in taste
Maltese: Disturbi vaskulari
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti sekondarji li jista' jkun hemm li huma elenkati hawn taħt hija ddefinita bl-użu talkonvenzjoni li ġejja:
English: The usual dose of TIENAM for adults and adolescents is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours.
Maltese: IV għall-adulti u l-adoloxxenti hija ta' 500 mg/500 mg kull 6 sighat jew 1,000 mg/1,000 mg kull 6 jew kull 8 sigħat.
English: When doses of imipenem-cilastatin sodium (approximately 100/100 mg/kg/day or approximately 3 times the usual recommended daily human intravenous dose) were administered to pregnant cynomolgus monkeys at an intravenous infusion rate which mimics human clinical use, there was minimal maternal intolerance (occasional emesis), no maternal deaths, no evidence of teratogenicity, but an increase in embryonic loss relative to control groups (see section 4.6).
Maltese: Meta dożi ta' imipenemcilastatin sodium (madwar 100/100 mg/kg/kuljum jew madwar 3 darbiet aktar mid-doża fil-vina li soltu tkun irrakkomandatafil-bnedmin) ingħataw lil xadini cynomolgus tqal b'rata ta' infużjoni li timita l-użu kliniku fil-bnedmin, kien hemm intolleranza minima fl-omm (rimettar kultant), ma kien hemm l-ebda mwiet tal-omm, l-ebda evideza ta' teratoġeniċità, iżda kien hemm żieda fit-telf tal-embriji meta mqabbla mal-gruppi ta' kontroll (ara sezzjoni 4.6).
English: Each vial contains: imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih: imipenem monohydrate ekwivalenti għal 500 mg imipenem anhydrate u cilastatin sodium ekwivalenti għal 500 mg cilastatin
English: 2 The breakpoints for Pseudomonas relate to high dose frequent therapy (1g every 6 hours).
Maltese: 2 Il-breakpoints għal Pseudomonas huma assoċjati ma' terapija frekwenti b'doża għolja (1 g kull
English: Rare acute renal failure, oligurial/anuria, polyuria, urine discoloration (harmless and should not be confused with haematuria) The role of TIENAM in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.
Maltese: Rari insuffiċjenza akuta tal-kliewi, oligurja/anurja, poliurja, bidla fil-kulur tal-awrina (mhu xejn u wieħed m'għandux jitfixklu ma' ematurja) Huwa diffiċli biex tistma r-rwol ta' PRIMAXIN
English: The medicinal product is supplied in packs of 1 vial, 10 vials and 25 vials.
Maltese: Id-daqsijet tal-pakkett huma ta' kunjett wieħed, 10 kunjetti jew 25 kunjett.
English: • Fungal infection (candidiasis)
Maltese: • Infezzjoni bil-moffa (kandidjasi)
English: Reconstitution:
Maltese: ATTENZJONI:
English: Imipenem-cilastatin sodium is haemodialyzable.
Maltese: Imipenemcilastatin sodium jitneħħa permezz tal-emodijalisi.
English: Each vial contains imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin.
Maltese: Kull kunjett fih imipenem monohydrate ekwivalenti għal 500 mg ta' imipenem anhydrate u cilastatin sodium ekwivalenti għal 500 mg ta' cilastatin.
English: Children
Maltese: Malta:
English: Very rare pruritus vulvae
Maltese: Rari ħafna ħakk fil-vulva
English: Individual urinary recoveries ranged from 5 to 40%, with an average recovery of 15-20% in several studies.
Maltese: Irkupru individwali mill-awrina kien fuq medda ta' bejn 5 u 40%, b'irkupru medju ta' 15-20% f'diversi studji.
English: Very rare haemorrhagic colitis, abdominal pain, heartburn, glossitis, tongue papilla hypertrophy, increased salivation
Maltese: Rari ħafna kolite emorraġika, uġigħ fl-addome, ħruq ta' stonku, glossite, ipertrofija tal-papilla tal-ilsien, żieda fil-bżieq
English: • Neisseria gonorrhoeae: There is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with imipenem.
Maltese: M'hemmx evidenza biżżejjed li Neisseria gonorrhoeae hija mira tajba għal terapija b'imipenem.
English: Following a single 250 mg/250 mg intravenous dose of TIENAM given 24 hours after haemodialysis, AUCs for imipenem and cilastatin were 3.7-fold and 16.4-fold higher, respectively, as compared to subjects with normal renal function.
Maltese: IV mogħtija minn ġol-vina 24 siegħa wara l-emodijalisi, l-AUCs għal imipenem u cilastatin kienu 3.7 drabi aktar u 16.4 drabi aktar, rispettivament, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of imipenem/cilastatin (see section 4.8).
Maltese: Huwa imporatanti li tiġi kkunsidrata din id-dijanjosi f'pazjenti li jiżviluppaw dijarea waqt jew wara l-użu ta' imipenem/cilastatin (ara sezzjoni 4.8).
English: Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates imipenem.
Maltese: Cilastatin sodium huwa impeditur kompetittiv, riversibbli u speċifiku ta' dehydropeptidase-I, l-enzima filkliewi li timmetabolizza imipenem u twaqqfu milli jaħdem.
English: Estonia: TIENAM I.V.
Maltese: CONET Spanja: TIENAM I.V.
English: • rare: affects 1 to 10 users in 10,000
Maltese: • rari: jaffettwaw minn persuna waħda sa 10 persuni minn kull 10,000 li jużawh
English: Very rare chest discomfort, asthenia/weakness
Maltese: Rari ħafna skonfort fis-sider, astenja/dgħufija