FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy young adults (25 to 45 years of age), the protein binding of ertapenem decreases, as plasma concentrations increase, from approximately 95 % bound at an approximate plasma concentration of < 50 micrograms/mL to approximately 92 % bound at an approximate plasma concentration of 155 micrograms/mL (average concentration achieved at the end of infusion following 1 g intravenously).
Maltese: F'adulti żagħżagħ f'saħħithom (25 sa 45 sena) l-irbit ta' ertapenem mal-proteina jonqos hekk kif jiżdiedu l-konċentrazzjonijiet fil-plażma, bejn wieħed u ieħor minn rabta ta' 95% meta jkun hemm konċentrazzjoni approssimattiva fil-plażma ta' < 50 mikrogrammi/mL sa rabta ta' bejn wieħed u ieħor 92% meta jkun hemm konċentrazzjoni approssimattiva fil-plażma ta' 155 mikrogrammi/mL (konċentrazzjoni medja fl-aħħar tal-infużjoni wara 1 g mogħtija fil-vina).
English: In a clinical study for the treatment of acute gynaecologic infections, in adults, 26 % of evaluable patients treated with ertapenem had severe disease (defined as temperature ≥ 39C and/or bacteraemia); ten patients had bacteraemia.
Maltese: Fi studju kliniku għall-kura ta' infezzjonijiet ġinekoloġiċi akuti, fl-adulti, 26% tal-pazjenti li setgħu jiġu evalwati u li ġew ikkurati b'ertapenem kellhom mard qawwi (definit bħala temperatura ≥ 39°C u/jew batterimja); għaxar pazjenti kellhom batterimja.
English: For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: elevations in ALT (4.6 %), AST (4.6 %), alkaline phosphatase (3.8 %) and platelet count
Maltese: F'pazjenti li ngħataw INVANZ biss, l-anomaliji tal-laboratorju l-iktar komuni li ġew irrappurtati, u rrati ta' inċidenza rispettivi tagħhom waqt it-terapija u fil-follow-up għal 14-il jum wara li twaqqfet ilkura kienu: Żidiet fl-ALT (4.6%), AST (4.6%), alkaline phosphatase (3.8%) u għadd tal-plejtlets
English: Common: Elevations in ALT and AST
Maltese: Komuni: Żidiet fl-ALT u AST
English: Each vial contains 1.0 g ertapenem.
Maltese: Kull kunjett fih 1.0 g ertapenem.
English: Excipient with known effect Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg).
Maltese: Kull doża ta' 1.0 g fiha madwar 6.0 mEq ta' sodium (madwar 137 mg).
English: Of evaluable patients treated with ertapenem in a clinical study for the treatment of intra-abdominal infections, in adults, 30 % had generalised peritonitis and 39 % had infections involving sites other than the appendix including the stomach, duodenum, small bowel, colon, and gallbladder; there were limited numbers of evaluable patients who were enrolled with APACHE II scores ≥ 15 and efficacy in these patients has not been established.
Maltese: Fi studju kliniku għall-kura ta' infezzjonijiet ġol-addome, fl-adulti, mill-pazjenti li setgħu jiġu evalwati u li ngħataw ertapenem, 30% kellhom peritonite mifruxa u 39% kellhom infezzjonijiet f'siti oħra barra l-appendiċi li kienu jinkludu l-istonku, id-duwodenu, il-musrana ż-żgħira, il-kolon, u l-marrara; kien hemm numru limitat ta' pazjenti li setgħu jiġu evalwati li ddaħħlu fl-istudju b'punteġġi APACHE II ta' ≥ 15 u l-effikaċja f'dawn il-pazjenti ma ġietx stabbilita.
English: • Diabetic foot infections of the skin and soft tissue (see section 4.4)
Maltese: • Infezzjonijiet dijabetiċi tal-ġilda u tat-tessut artab fis-saqajn, (ara sezzjoni 4.4)
English: Treatment
Maltese: Abort
English: • Altered mental status (including aggression)
Maltese: • Bidla fl-istat mentali (inkluż aggressjoni)
English: Uncommon: Anorexia Rare: Hypoglycaemia
Maltese: Mhux komuni: Anoreksja Rari:
English: This includes 9 patients in the ertapenem group (7 CAP and 2 IAI), 2 patients in the ceftriaxone group (2 CAP), and 1 patient with IAI in the ticarcillin/clavulanate group with secondary bacteraemia at entry into the study.
Maltese: Dan jinkludi 9 pazjenti fil-grupp ta' ertapenem (7 CAP u 2 IAI), 2 pazjenti fil-grupp ta' ceftriaxone (2 CAP), u pazjent 1 b'IAI fil-grupp ta' ticarcillin/clavulanate li kellu batteremija sekondarja meta ddaħal fl-istudju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Intraabdominal Infections (IAI) 2 to 12 years
Maltese: Infezzjonijiet Intra-addominali (IAI)
English: In Escherichia coli, affinity is strongest to PBPs 2 and 3.
Maltese: F'Escherichia coli, ir-rabta hija l-iktar b'saħħitha ma' PBPs 2 u 3.
English: General properties
Maltese: Proprjetajiet ġenerali
English: Sodium bicarbonate (E500) Sodium hydroxide (E524) to adjust pH to 7.5
Maltese: Sodium hydroxide (E524) biex jaġġusta l-pH għal 7.5
English: Uncommon: Decreases in white blood cells, platelet count, segmented neutrophils, haemoglobin and haematocrit; increases in eosinophils, activated partial thromboplastin time, prothrombin time, segmented neutrophils, and white blood cells Rare: Decrease in lymphocytes; increases in band neutrophils, lymphocytes, metamyelocytes, monocytes, myelocytes; atypical lymphocytes
Maltese: Mhux komuni: Tnaqqis fiċ-ċelluli bojod tad-demm, għadd talplejtlets, newtrofili segmentati, emoglobina u ematokrit; żidiet fleosinofili, ħin tat-tromboplastin parzjali attivat, ħin tal-protrombin, newtrofili segmentati, u ċelluli bojod tad-demm
English: Methicillin-resistant staphylococci (including MRSA) are always resistant to beta-lactams.
Maltese: Staphylococci reżistenti għal methicillin (li jinkludu l-MRSA) huma dejjem reżistenti għall-beta-lactams.
English: Common: Diaper dermatitis Uncommon: Erythema, rash, petechiae
Maltese: Komuni: Dermatite tal-ħrieqi Mhux komuni: Eritema, raxx, petekje
English: The ratios (13 to 17 years/adults) for AUC, the end of infusion concentration and the concentration at the midpoint of the dosing interval were 0.99, 1.20, and 0.84, respectively.
Maltese: Il-proporzjonijiet (13 sa 17-il sena/adulti) għall-AUC, it-tmiem talkonċentrazzjoni tal-infużjoni u l-konċentrazzjoni f'nofs l-intervall tad-dożaġġ kienu ta' 0.99, 1.20, u 0.84, rispettivament.
English: AUCs of total ertapenem and of unbound ertapenem are increased in patients with moderate renal impairment (Clcr 31 to 59 mL/min/1.73 m2) approximately 1.5-fold and 1.8-fold, respectively, compared with healthy subjects.
Maltese: L-AUCs ta' ertapenem totali u ertapenem maħlul jiżdied f'pazjenti li għandhom indeboliment moderat tal-kliewi (Clcr 31 sa 59 mL/min/1.73 m2) bejn wieħed u ieħor 1.5 darbiet u 1.8 darbiet rispettivament, meta mqabbla ma' dak f'nies f'saħħithom.
English: • Viridans group streptococci: S ≤ 0.5 mg/L and R > 0.5 mg/L
Maltese: • Streptococci tal-grupp viridani: S ≤ 0.5 mg/L u R > 0.5 mg/L
English: • Dizziness, sleepiness, sleeplessness, confusion, seizure
Maltese: • Sturdament, ngħas, nuqqas ta' rqad, konfużjoni, puplesija
English: • altered mental status (including aggression, delirium, disorientation, mental status changes)
Maltese: • bidla fl-istat mentali (inkluż aggressjoni, delirju, disorjentament, tibdil fl-istat mentali)
English: Children (3 months to 12 years of age)
Maltese: Tfal (minn 3 xhur sa 12-il sena)
English: Rare: Neutropenia, thrombocytopenia
Maltese: Newtropenja, tromboċitopenja
English: Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) are:
Maltese: Effetti sekondarji rrappurtati rarament (iktar minn 1 f'kull 10,000 pazjent u inqas minn 1 minn kull 1,000 pazjent) huma:
English: • Agitation, anxiety, depression, tremor
Maltese: Aġitazzjoni, ansjetà, depressjoni
English: Laboratoire Merck Sharp & Dohme - Chibret (Mirabel), Route de Marsat.
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva Laboratoire Merck Sharp & Dohme - Chibret (Mirabel), Route de Marsat.
English: AUCs of total ertapenem and of unbound ertapenem are increased in patients with severe renal impairment (Clcr 5 to 30 mL/min/1.73 m2) approximately 2.6-fold and 3.4-fold, respectively, compared with healthy subjects.
Maltese: L-AUCs ta' ertapenem totali u ertapenem maħlul jiżdiedu f'pazjenti li għandhom indeboliment qawwi tal-kliewi (Clcr 5 sa 30 mL/min/1.73 m2) bejn wieħed u ieħor 2.6 darbiet u 3.4 darbiet rispettivament, meta mqabbla ma' dawk f'nies f'saħħithom.
English: Not known: Altered mental status (including aggression, delirium, disorientation, mental status changes)
Maltese: Bidla fl-istat mentali (li tinkludi aggressjoni, delirju, disorjentament, tibdiliet flistat mentali)
English: The concomitant use of ertapenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Maltese: L-użu fl-istess ħin ta' ertapenem u ta' valproic acid/sodium valproate mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Renal and urinary disorders Rare: Renal insufficiency, acute renal insufficiency
Maltese: Insuffiċjenza renali, insuffiċjenza renali akuta
English: Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
Maltese: Qabel ma tinbeda t-terapija b'ertapenem, għandu jsir studju bir-reqqa dwar ir-reazzjonijiet ta' sensittività eċċessiva li seta' kien hemm qabel għal penicillins, cephalosporins, beta-lactams oħra u allerġeni oħra (ara sezzjoni 4.3).
English: Information from clinical studies
Maltese: Informazzjoni minn studji kliniċi
English: In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions.
Maltese: Fi studji kliniċi fl-adulti, meta ngħatat bi żball doża sa 3 g kuljum, dan ma wassalx għal reazzjonijiet avversi importanti.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: Following a single 1 g intravenous dose of ertapenem in adults, AUCs of total ertapenem (bound and unbound) and of unbound ertapenem are similar in patients with mild renal impairment (Clcr 60 to 90 mL/min/1.73 m2) compared with healthy subjects (ages 25 to 82 years).
Maltese: Wara doża waħdanija ta' ertapenem fil-vina fl-adulti, l-AUC ta' ertapenem totali (kemm marbut kif ukoll maħlul) u ta' ertapenem maħlul hija simili f'pazjenti b'indeboliment ħafif tal-kliewi (Clcr 60 sa 90 mL/min/1.73 m2) meta mqabbel ma' dak f'nies f'saħħithom (minn 25 sa 82 sena).
English: Prevention
Maltese: Prevenzjoni
English: Following the 20 mg/kg dose (up to a maximum dose of 1 g), the pharmacokinetic parameter values in patients 13 to 17 years of age were generally comparable to those in healthy young adults.
Maltese: Wara doża ta' 20 mg/kg (sa doża massima ta' 1 g), il-valuri tal-parametri farmakokinetiċi f'pazjenti li kellhom minn 13 sa 17-il sena kienu ġeneralment komparabbli ma' dawk f'adulti żgħar f'saħħithom.
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to ertapenem or not.
Maltese: L-informazzjoni li ġejja tagħti biss indikazzjoni approssimattiva tal-probabbiltà ta'jekk il-mikro-organiżmu hux suxxettibbli għal ertapenem jew le.
English: Common: Infused vein complication, phlebitis/thrombophlebitis Uncommon: Hypotension Rare: Haemorrhage, increased blood pressure
Maltese: Komuni: Kumplikazzjoni fil-vina tal-infużjoni, flebite/tromboflebite Mhux komuni: Pressjoni baxxa Rari:
English: • Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting.
Maltese: • Allerġija, ma tħossokx tajjeb, peritonite pelvika, bidliet fil-parti l-bajda tal-għajn, tintilef minn sensik.
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/kg (up to a maximum dose of 1 g) dose in patients 3 to 23 months of age were 103.8 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 13.5 micrograms/mL at 6 hour postdose, and 2.5 micrograms/mL at 12 hour postdose.
Maltese: Konċentrazzjonijiet medji tal-plażma ta' ertapenem wara doża waħda ta' infużjoni ġol-vini ta' 30 minuta ta' 15 mg/kg (sa doża massima ta' 1 g) f'pazjenti li kellhom minn 3 sa 23 xahar kienu ta' 103.8 mikrogrammi/mL (Cmax) 30 minuta wara d-doża (tmiem tal-infużjoni), 13.5 mikrogrammi/mL 6 sigħat wara d-doża, u 2.5 mikrogrammi/mL 12-il siegħa wara d-doża.
English: Seizures have been reported during clinical investigation in adult patients treated with ertapenem (1 g once a day) during therapy or in the 14-day follow-up period.
Maltese: Puplesiji kienu rrappurtati matul l-investigazzjoni klinika f'pazjenti adulti kkurati b'ertapenem (1 g darba kuljum) matul it-terapija jew fil-perjodu ta' 14-il jum ta' wara .
English: INVANZ 1 g powder for concentrate for solution for infusion ertapenem
Maltese: INVANZ 1 g trab għal konċentrat għal soluzzjoni għall-infużjoni ertapenem
English: The major metabolite of ertapenem is the ring-opened derivative formed by dehydropeptidase-I-mediated hydrolysis of the beta-lactam ring.
Maltese: L-ikbar metabolit ta' ertapenem huwa derivattiv b'ċirku miftuħ iffurmat bl-idrolisi permezz ta' dehydropeptidase-I taċ-ċirku beta-lactam.
English: - Central nervous system disorders, such as localised tremors, or seizures.
Maltese: - Mard tas-sistema nervuża ċentrali, bħal rogħda lokalizzata, jew puplesiji.
English: Of the 80 % recovered in urine, approximately 38 % is excreted as unchanged ertapenem and approximately 37 % as the ring-opened metabolite.
Maltese: Mit-80% misjub fl-awrina, bejn wieħed u ieħor 38% jitneħħa bħala ertapenem mhux mibdul u bejn wieħed u ieħor 37% bħala l-metabolit b'ċirku miftuħ.
English: In healthy young adults (23 to 49 years of age), after intravenous infusion of radiolabelled 1 g ertapenem, the plasma radioactivity consists predominantly (94 %) of ertapenem.
Maltese: F'adulti żagħżagħ f'saħħithom (23 sa 49 sena), wara l-influżjoni fil-vina ta' 1g ta' ertapenem radjutikkettat, ir-radjoattività fil-plażma tikkonsisti kważi għalkollox (94%) f'ertapenem.
English: Ertapenem
Maltese: Tqala
English: INVANZ 1 g powder for concentrate for solution for infusion Ertapenem
Maltese: INVANZ 1 g trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The volume of distribution (Vdss) of ertapenem in adults is approximately 8 litres (0.11 litre/kg) and approximately 0.2 litre/kg in paediatric patients 3 months to 12 years of age and approximately 0.16 litre/kg in paediatric patients 13 to 17 years of age.
Maltese: Il-volum ta' distribuzzjoni (Vdss) ta' ertapenem fl-adulti huwa ta' bejn wieħed u ieħor 8 litri (0.11 litru/kg) u ta' madwar 0.2 litru/kg f'pazjenti pedjatriċi li għandhom minn 3 xhur sa 12-il sena, u madwar 0.16 litru/kg kg f'pazjenti pedjatriċi li għandhom minn 13 sa 17-il sena.
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of ertapenem exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in pre-clinical PK/PD studies.
Maltese: Relazzjoni Farmakokinetika/Farmakodinamika (PK/PD) Bħal mediċini oħrajn beta-lactam kontra l-mikrobi, il-ħin li l-konċentrazzjoni tal-plażma ta' ertapenem jaqbeż il-MIC tal-organiżmu li qed jinfetta, intwera li jikkorrelata l-aħjar mal-effikaċja PK/PD fi studji pre-kliniċi.
English: Seizures
Maltese: Infużjoni
English: 113.2 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 12.8 micrograms/mL at 6 hour postdose, and 3.0 micrograms/mL at 12 hour postdose.
Maltese: 9 mikrogrammi/mL (Cmax) 30 minuta wara d-doża (tmiem tal-infużjoni), u 6.2 mikrogrammi/mL 12-il siegħa wara d-doża.
English: In vitro studies indicate that ertapenem does not inhibit P-glycoprotein-mediated transport of digoxin or vinblastine and that ertapenem is not a substrate for P-glycoprotein-mediated transport.
Maltese: Studji in vitro jindikaw li ertapenem ma jfixkilx il-ġarr ta' digoxin jew vinblastine permezz tal-Pglycoprotein, u li ertapenem mhux sottostrat għall-ġarr permezz tal-P-glycoprotein.
English: Uncommon: Sinus bradycardia Rare: Arrhythmia, tachycardia
Maltese: Mhux komuni: Bradikardija tassinus
English: Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
Maltese: Mhux mistenni li jkun hemm interazzjonijiet ta' prodotti mediċinali kkawżati minn inibizzjoni fittneħħija permezz tal-P-glycoprotein jew permezz tas-CYP (ara sezzjoni 5.2.)
English: • Changes in liver function tests
Maltese: • Tibdiliet f'xi testijiet tad-demm tal-laboratorju
English: Others:
Maltese: Komuni:
English: Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported.
Maltese: Minn meta l-mediċina tpoġġiet fuq is-suq, ġew irrappurtati reazzjonijiet allerġiċi qawwija (anafilassi), sindromi ta' sensittività eċċessiva (reazzjonijiet allerġiċi inkluż raxx, deni, testijiet tad-demm mhux normali).
English: Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection
Maltese: Pulmonite, mikożi fil-ġilda, infezzjoni fil-ferita wara operazzjoni, infezzjoni fil-passaġġ tal-awrina
English: There have also been reports of changes in some laboratory blood tests.
Maltese: Kien hemm ukoll rapporti ta' bidliet f'xi testijiet tad-demm tal-laboratorju.
English: For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0 %), and elevations in ALT (2.9 %) and AST (2.8 %).
Maltese: Għall-pazjenti li ngħataw INVANZ biss, l-anomaliji tal-laboratorju l-iktar komuni li ġew irrappurtati u r-rati ta' inċidenza rispettivi matul it-terapija u matul l-14-il jum ta' follow-up wara li twaqqfet il-kura kienu: tnaqqis fl-għadd tan-newtrofili (3.0%), u żidiet fl-ALT (2.9%) u fl-AST (2.8%).
English: Uncommon: Oral candidiasis, candidiasis, fungal infection, pseudomembranous enterocolitis, vaginitis
Maltese: Mhux komuni: Kandidjasi tal-ħalq, kandidjasi, infezzjoni bil-moffa, enterokolite psewdomembranuża, vaġinite
English: Resistance can also arise via the acquisition of beta-lactamases with significant carbapenem-hydrolysing activity (e.g. IMP and VIM metallo-beta-lactamases or KPC types), though these are rare.
Maltese: Ir-reżistenza tista' wkoll tinħoloq permezz tal-akkwist ta' beta-lactamases b'attività sinifikanti carbapenem hydrolysing (eż. IMP u VIM metallo-beta-lactamases jew tipi ta' KPC), għalkemm dawn huma rari.
English: • Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation
Maltese: • Infjammazzjoni tal-ġilda, infezzjoni fungali tal-ġilda, ġilda titqaxxar, infezzjoni tal-ferita wara operazzjoni
English: Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution.
Maltese: Ittrasferixxi l-kontenut tal-kunjett tal-1 g ta' INVANZ fil-kunjett tal-50 mL ta' 9 mg/mL (0.9%) f'soluzzjoni ta' sodium chloride.
English: Klebsiella oxytoca
Maltese: L-ispeċi Rickettsia
English: Common: Diarrhoea Uncommon: Faeces discoloured, melaena
Maltese: Komuni: Dijarea Mhux komuni: Tibdil fil-kulur tal-ippurgar, melaena
English: A clinically significant interaction due to ertapenem displacing another medicinal product or another medicinal product displacing ertapenem is unlikely.
Maltese: Mhux probabbli li jkun hemm interazzjoni klinikament sinifikanti minħabba li ertapenem jieħu post prodott mediċinali ieħor jew prodott mediċinali ieħor jieħu post ertapenem.
English: The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of ertapenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.
Maltese: Il-livelli aktar baxxi ta' valproic acid jistgħu jwasslu għal kontroll mhux adegwat ta' attakki ta' puplesija; għaldaqstant, l-użu fl-istess ħin ta' ertapenem u ta' valproic acid/sodium valproate mhuwiex rakkomandat u għandhom jiġu kkunsidrati terapiji antibatteriċi u anti-konvulżivi alternattivi.
English: Plasma concentrations following a 1 g and 2 g intravenous dose of ertapenem are slightly higher (approximately 39 % and 22 %, respectively) in healthy elderly adults (≥ 65 years) relative to young adults ( 65 years).
Maltese: Il-konċentrazzjonijiet ta' ertapenem fil-plażma wara doża fil-vina ta' 1 g u 2 g huma ftit ogħla (bejn wieħed u ieħor 39% u 22% rispettivament) f'adulti anzjani f'saħħithom ( ≥ 65 sena) meta mqabbla ma' adulti żagħżagħ ( < 65 sena).
English: • Vaginal discharge and irritation
Maltese: • Tnixxija mill-vaġina u irritazzjoni fil-vaġina
English: : 80000 673 (+357 22866700) cyprus_info@merck.com
Maltese: Merck Sharp & Dohme Cyprus Limited Τηλ.: 80000 673 (+357 22866700) cyprus_info@merck.com
English: For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution and discard.
Maltese: Għal doża ta' 1 g, iġbed 10 mL minn kunjett tal-50 mL ta' 9 mg/mL (0.9%) f'soluzzjoni ta' sodium chloride u armi.
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 20 mg/kg (up to a maximum dose of 1 g) dose in patients 13 to 17 years of age were 170.4 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 7.0 micrograms/mL at 12 hour postdose, and 1.1 microgram/mL at 24 hour postdose.
Maltese: 4 mikrogrammi/mL (Cmax) 30 minuta wara d-doża (tmiem tal-infużjoni), 7.0 mikrogrammi/mL 12 sigħat wara d-doża, u 1.1 mikrogrammi/mL 24 siegħa wara d-doża.
English: While antibiotics including INVANZ kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Maltese: Filwaqt li antibijotiċi, inkluż INVANZ joqtlu ċerti batterji, batterji oħra u moffa jistgħu jkomplu jikbru b'mod aktar minn dak normali.
English: Instructions for use:
Maltese: Prevenzjoni:
English: Tell your doctor, nurse or pharmacist if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia).
Maltese: Għid lit-tabib, lill-infermier jew lill-ispiżjar tiegħek jekk qed tieħu mediċini li jisimhom valproic acid jew sodium valproate (użati biex jikkuraw l-epilessija, disturbi bipolari, emigranji, jew skizofrenija).
English: Pseudomonas aeruginosa
Maltese: • alluċinazzjonijiet
English: No data are available in children under 3 months of age.
Maltese: M'hemmx dejta disponibbli għal tfal b'età inqas minn 3 xhur.
English: For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8 %), infused vein complication (4.5 %) and nausea (2.8 %).
Maltese: F'pazjenti li ngħataw INVANZ biss, ir-reazzjonijiet avversi l-iktar komuni li ġew irrappurtati waqt itterapija u fil-follow-up għal 14-il jum wara li twaqqfet il-kura kienu: dijarea (4.8%), kumplikazzjonijiet fil-vina li fiha saret l-infużjoni (4.5%) u dardir (2.8%).
English: • Diaper rash
Maltese: • tbajja' fuq is-snien
English: Similar observations have been made in the post-marketing environment.
Maltese: Osservazzjonijiet simili saru fl-ambjent ta' wara t-tqegħid fis-suq.
English: The change in binding was < 12 % at peak plasma ertapenem concentration following a 1 g dose.
Maltese: Il-bidla fl-irbit kienet < 12% fl-ogħla konċentrazzjonijiet ta' ertapenem fil-plażma wara doża ta' 1 g.