FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Farmakokinetično/farmakodinamično (FK/FD) razmerje Podobno kot pri drugih betalaktamskih antibiotikih so v predkliničnih študijah razmerja FK/FD ertapenema ugotovili, da čas, ko plazemska koncentracija ertapenema presega MIK povzročitelja okužbe, najbolje sovpada z učinkovitostjo.
English: Ertapenem is highly bound to human plasma proteins.
Slovenian: Ertapenem se močno veže na človeške plazemske beljakovine.
English: Porphyromonas asaccharolytica*
Slovenian: Porphyromonas asaccharolytica* vrste Prevotella*
English: Prevention: • Prevention of surgical site infections in adults following surgery of the colon or rectum.
Slovenian: Preventiva: • preventiva pred okužbami na mestu posega v debelem črevesju ali danki pri odraslih.
English: • Changes in white blood cell count
Slovenian: • spremembe števila belih krvnih celic,
English: The plasma clearance (mL/min/kg) of ertapenem in patients 3 months to 12 years of age is approximately 2-fold higher as compared to that in adults.
Slovenian: Plazemski očistek (ml/min/kg) ertapenema pri bolnikih, starih od 3 mesece do 12 let, je približno dvakrat večji kot pri odraslih.
English: Uncommon: Increases in urine bacteria, urine white blood cells, urine epithelial cells, and urine red blood cells; urine yeast present Rare: Increase in urobilinogen
Slovenian: Občasni: povečanje števila bakterij v urinu, belih krvnih celic v urinu, epitelnih celic v urinu in rdečih krvnih celic v urinu, prisotnost glivic v urinu Redki: zvišanje urobilinogena
English: Compatibility of INVANZ with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated.
Slovenian: Zdravilo INVANZ je kompatibilno z intravenskimi raztopinami, ki vsebujejo heparin v obliki natrijeve soli ali kalijev klorid.
English: Following administration of a 1 g radiolabelled intravenous dose of ertapenem to healthy young adults (23 to 49 years of age), approximately 80 % is recovered in urine and 10 % in faeces.
Slovenian: Po intravenskem 1 g odmerku radioaktivno označenega ertapenema zdravim mladim odraslim (starim 23 do 49 let), se ga približno 80 % izloči v urinu in 10 % v blatu.
English: Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Slovenian: Enterokoki, vključno z Enterococcus faecalis in Enterococcus faecium Gram negativne aerobne bakterije: vrste Aeromonas vrste Acinetobacter
English: The major metabolite of ertapenem is the ring-opened derivative formed by dehydropeptidase-I-mediated hydrolysis of the beta-lactam ring.
Slovenian: Glavni presnovek ertapenema je derivat z odprtim obročem, ki nastane s hidrolizo betalaktamskega obroča z dehidropeptidazo I.
English: Prolonged use of ertapenem may result in overgrowth of non-susceptible organisms.
Slovenian: Ob dolgotrajnem zdravljenju z ertapenemom lahko pride do razrasta neobčutljivih organizmov.
English: When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
Slovenian: Ko je klinično indicirano, lahko v primeru kliničnega izboljšanja zdravilo zamenjamo z ustreznim peroralnim antibiotikom.
English: At the 15 mg/kg dose, the AUC value and plasma concentrations at the midpoint of the dosing interval in patients 3 months to 12 years of age were comparable to those in young healthy adults receiving a 1 g intravenous dose of ertapenem.
Slovenian: Pri odmerku 15 mg/kg so bile vrednost AUC in plazemske koncentracije na sredini dozirnega intervala pri bolnikih, starih od 3 mesece do 12 let, primerljive z vrednostmi pri mladih zdravih odraslih, ki so prejemali ertapenem v intravenskem 1-gramskem odmerku.
English: The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are:
Slovenian: Najpogostejši (pri več kot 1 od 100 bolnikov in manj kot 1 od 10 bolnikov) neželeni učinki so:
English: It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
Slovenian: Še posebej pomembno je, da zdravniku poveste, če imate bolezen ledvic in če se zdravite z dializo.
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
Slovenian: Pogosti: zvišanje vrednosti ALT, AST, alkalne fosfataze Občasni: dvig celokupnega serumskega bilirubina, direktnega serumskega bilirubina, indirektnega serumskega bilirubina, serumskega kreatinina, serumske sečnine, serumske glukoze
English: - If you have any further questions, ask your doctor, nurse or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: What INVANZ looks like and contents of the pack INVANZ is a white to off-white, freeze-dried powder for concentrate for solution for infusion.
Slovenian: Izgled zdravila INVANZ in vsebina pakiranja Zdravilo INVANZ je bel do sivobel, liofiliziran prašek za koncentrat za raztopino za infundiranje.
English: For patients who received only INVANZ, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped:
Slovenian: Pri bolnikih, ki so prejemali samo zdravilo INVANZ, so med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja poročali o naslednjih neželenih učinkih:
English: Therefore, no dosage adjustment is recommended in patients with hepatic impairment.
Slovenian: Zato prilagoditve odmerjanja pri bolnikih z okvaro jeter ne priporočamo.
English: Uncommon: Sinus bradycardia Rare: Arrhythmia, tachycardia
Slovenian: Občasni: sinusna bradikardija Redki: aritmija, tahikardija
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.
Slovenian: Znižane koncentracije valprojske kisline lahko vodijo do nezadostnega nadzora nad napadi krčev, zato sočasne uporabe ertapenema in valprojske kisline/natrijevega valproata ne priporočamo.
English: Adults: To prevent surgical site infections following elective colorectal surgery, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
Slovenian: Odrasli: Priporočeni odmerek za preventivo pred okužbami na mestu kirurškega posega po elektivnem kirurškem posegu v kolorektalnem področju je 1 g v obliki enojnega intravenskega odmerka, ki mora biti zaključen znotraj 1 ure pred kirurško incizijo.
English: Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are:
Slovenian: Manj pogosti (pri več kot 1 od 1.000 bolnikov in manj kot 1 od 100 bolnikov) neželeni učinki so:
English: Intravenous use after reconstitution and dilution.
Slovenian: Za intravensko uporabo po pripravi koncentrata in redčenju.
English: • Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin
Slovenian: • naval vročine, visok krvni tlak, rdeč ali škrlaten, neprivzdignjen, za bucikino glavico velik izpuščaj pod kožo,
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.
Slovenian: Volumen porazdelitve (Vd) ertapenema pri odraslih je približno 8 litrov (0,11 litra/kg) ter približno 0,2 litra/kg pri otrocih, starih 3 mesece do 12 let, pri otrocih, starih 13 do 17 let, pa približno 0,16 litra/kg.
English: No data are available in children under 3 months of age.
Slovenian: Za otroke, mlajše od 3 mesecev, podatkov ni na voljo.
English: INVANZ is supplied in packs of 1 vial or 10 vials.
Slovenian: Zdravilo INVANZ je na voljo v škatlah z 1 ali 10 vialami.
English: • Gynaecological infections
Slovenian: • ginekološke okužbe,
English: frequency of acquired resistance > 50 % in some Member States.
Slovenian: pogostnost pridobljene odpornosti > 50 % v nekaterih državah članicah Na meticilin odporni stafilokoki (vključno z MRSA) so vedno odporni na betalaktame.
English: Infants and children (3 months to 12 years of age): The dose of INVANZ is 15 mg/kg given twice daily (not to exceed 1 g/day) by the intravenous route (see section 6.6).
Slovenian: Dojenčki in otroci (stari od 3 mesecev do 12 let): Odmerek zdravila INVANZ je 15 mg/kg dvakrat na dan (ne sme preseči 1 g/dan) intravensko (glejte poglavje 6.6).
English: Hepatic impairment No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Slovenian: Pri bolnikih z okvaro jetrne funkcije prilagoditve odmerka posebej ne priporočamo (glejte poglavje 5.2).
English: Average concentrations of ertapenem in urine exceed 984 micrograms/mL during the period 0 to 2 hours postdose and exceed 52 micrograms/mL during the period 12 to 24 hours post-administration.
Slovenian: Povprečne koncentracije ertapenema v urinu znašajo več kot 984 mikrogramov/ml v času 0 do 2 uri po odmerku in več kot 52 mikrogramov/ml v času 12 do 24 ur po odmerku.
English: Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity.
Slovenian: Pri zdravih odraslih prostovoljcih, ki so 8 dni prejemali 3-gramski dnevni odmerek ertapenema intravensko, ni prišlo do pomembne toksičnosti.
English: Rare: Neutropenia, thrombocytopenia
Slovenian: Redki: nevtropenija, trombocitopenija
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).
Slovenian: Pri zdravih mladih odraslih (starih od 25 do 45 let) se vezava ertapenema zmanjšuje z naraščajočo plazemsko koncentracijo, in sicer od približno 95 % vezave pri plazemski koncentraciji približno < 50 mikrogramov/ml do približno 92 % vezave pri plazemski koncentraciji približno 155 mikrogramov/ml (povprečna koncentracija ob koncu intravenske infuzije 1-gramskega odmerka).
English: • Changes in liver function tests
Slovenian: • spremembe izvidov jetrne funkcije.
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.
Slovenian: Razmerje (od 13 do 17 let/odrasli) vrednosti AUC je znašalo 0,99, razmerje koncentracije ob koncu infuzije 1,20 ter razmerje koncentracije na sredini odmernega intervala 0,84.
English: The active ingredient of INVANZ is ertapenem 1 g.
Slovenian: Učinkovina je ertapenem 1 g.
English: Rare: Decreases in serum bicarbonate, serum creatinine, and serum potassium; increases in serum LDH, serum phosphorus, serum potassium
Slovenian: Redki: znižanje serumskega bikarbonata, serumskega kreatinina, serumske sečnine in serumskega kalija; zvišanje serumskega LDH, serumskega fosforja, serumskega kalija
English: Shake well to dissolve.
Slovenian: Dobro pretresite, da se vse raztopi.
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.
Slovenian: Pri zdravih mladih odraslih (starih 23 do 49 let) so po intravenski infuziji radioaktivno označenega 1-gramskega odmerka ertapenema večino radioaktivnosti odkrili v plazmi (94 %).
English: Clostridium species (excluding C. difficile)* Eubacterium species*
Slovenian: Anaerobne bakterije: vrste Clostridium (razen C. difficile)* vrste Eubacterium* vrste Fusobacterium* vrste Peptostreptococcus*
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)
Slovenian: Pogosti: izpuščaj, srbež Občasni: eritem, utrikarija Redki: dermatitis, luščenje Neznana: akutna generalizirana eksantemska pustuloza (AGEP), z zdravilom povezan izpuščaj z eozinofilijo in sistemskimi simptomi (sindrom DRESS)
English: Sodium bicarbonate (E500); sodium hydroxide (E524) to adjust pH to 7.5.
Slovenian: Natrijev hidrogenkarbonat (E500), natrijev hidroksid (E524) za uravnavo pH na 7,5.
English: There is relatively little experience with ertapenem in children less than two years of age.
Slovenian: Pri otrocih, mlajših od dveh let, je z ertapenemom relativno malo izkušenj.
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).
Slovenian: Zdravniku, medicinski sestri ali farmacevtu povejte, če jemljete zdravila, ki vsebujejo valprojsko kislino ali natrijev valproat (za zdravljenje epilepsije, bipolarne motnje, migrene ali shizofrenije), ker zdravilo INVANZ lahko vpliva na to, kako učinkujejo nekatera druga zdravila.
English: • Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting.
Slovenian: • alergija, slabo počutje, peritonitis v medenici, spremembe beločnice, omedlevica.
English: Antibiotic-associated colitis
Slovenian: Z antibiotikom povezan kolitis
English: Concentrations of ertapenem achieved in adult skin blister fluid at each sampling point on the third day of 1 g once daily intravenous doses showed a ratio of AUC in skin blister fluid: AUC in plasma of 0.61.
Slovenian: Koncentracije ertapenema v tekočini kožnih mehurjev pri odraslih so bile tretji dan intravenskega odmerjanja 1 g enkrat dnevno ob vsakokratnem vzorčenju sorazmerne AUC v plazmi, in sicer so znašale 0,61-kratnik plazemske AUC.
English: Children (3 months to 12 years of age)
Slovenian: Otroci (stari od 3 mesece do 12 let)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Common: Infused vein complication, phlebitis/thrombophlebitis Uncommon: Hypotension Rare: Haemorrhage, increased blood pressure
Slovenian: Pogosti: zapleti v zvezi z veno, v katero je bila nameščena infuzija, flebitis/tromboflebitis Občasni: hipotenzija Redki: krvavitev, zvišan krvni tlak
English: Solutions of INVANZ range from colourless to pale yellow.
Slovenian: Raztopina zdravila INVANZ je brezbarvna do bledo rumena.
English: Do not use solvents or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
Slovenian: Za pripravo ali uporabo ertapenema ne uporabljajte topil ali infuzijskih raztopin, ki vsebujejo glukozo.
English: Rare: Abortion
Slovenian: Redki: splav
English: • Changes in some laboratory blood tests
Slovenian: • spremembe nekaterih laboratorijskih izvidov krvi.
English: Plasma concentrations at the midpoint of the dosing interval following a single 15 mg/kg intravenous dose of ertapenem in patients 3 months to 12 years of age are comparable to plasma concentrations at the midpoint of the dosing interval following a 1 g once daily intravenous dose in adults (see Plasma concentrations).
Slovenian: Plazemske koncentracije na sredini odmernega intervala po enem intravenskem odmerku ertapenema 15 mg/kg so pri bolnikih, starih od 3 mesece do 12 let, primerljive s plazemskimi koncentracijami na sredini odmernega intervala po odmerku 1 g enkrat dnevno pri odraslih (glej Plazemske koncentracije).
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.
Slovenian: Med odraslimi bolniki, ki jih je bilo mogoče oceniti in ki so se zdravili z ertapenemom, jih je v klinični študiji zdravljenja okužb v trebušni votlini 30 % imelo generalizirani peritonitis in 39 % okužbe drugih organov razen slepiča, vključno z želodcem, dvanajstnikom, tankim črevesom, kolonom in žolčnikom.
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).
Slovenian: Plazemske koncentracije po 1-gramskem in 2-gramskem intravenskem odmerku ertapenema so pri zdravih starejših osebah (≥ 65 let) nekoliko višje (približno 39 % pri 1 g in 22 % pri 2 g) kot pri mlajših odraslih (< 65 let).
English: Lactobacillus species
Slovenian: Anaerobne bakterije: vrste Lactobacillus
English: Rare: Cholecystitis, jaundice, liver disorder
Slovenian: Redki: holecistitis, zlatenica, motnje v delovanju jeter
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).
Slovenian: Po enkratnem 1-gramskem odmerku ertapenema sta vrednosti AUC celokupnega ertapenema (vezanega in nevezanega) ter nevezanega ertapenema pri odraslih bolnikih z blago okvaro ledvic (Clcr 60 to 90 ml/min/1,73 m2) podobni kot pri zdravih posameznikih (starih 25 do 82 let).
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.
Slovenian: odmerku 40 mg/kg do največ 2 g ni prišlo do toksičnega učinka.
English: To provide an estimate of the pharmacokinetic data if all patients in this age group were to receive a 1 g dose, the pharmacokinetic data were calculated adjusting for a 1 g dose, assuming linearity.
Slovenian: Da bi ocenili farmakokinetične podatke, kakršne bi dobili, če bi vsi bolniki v tej skupini prejeli odmerek 1 g, so farmakokinetične podatke ob predpostavki linearnosti s preračunom prilagodili za odmerek 1 g. Primerjava rezultatov kaže, da odmerek 1 g ertapenema enkrat dnevno pri bolnikih, starih 13 do 17 let, doseže farmakokinetični profil, podoben tistemu pri odraslih.
English: It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.
Slovenian: Pomembno je, da preden dobite zdravilo INVANZ, zdravniku poveste, če ste noseči ali nameravate zanositi.
English: If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
Slovenian: Če vas skrbi, da je bil odmerek zdravila INVANZ izpuščen, se takoj pogovorite z zdravnikom ali z drugim zdravstvenim delavcem.
English: The pharmacokinetics of ertapenem in patients with hepatic impairment have not been established.
Slovenian: Farmakokinetike ertapenema pri bolnikih z okvaro jeter niso preučili.
English: • Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds,
Slovenian: • zamašen nos, kašelj, krvavitev iz nosu, pljučnica, nenavadni zvoki pri dihanju, piskanje,
English: Due to the limited extent of hepatic metabolism of ertapenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
Slovenian: Ker jetra nimajo pomembne vloge v presnovi ertapenema, ne pričakujemo, da bi okvara jeter vplivala na farmakokinetiko ertapenema.
English: Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če se ga dobi brez recepta.
English: INVANZ contains ertapenem which is an antibiotic of the beta-lactam group.
Slovenian: Zdravilo INVANZ vsebuje ertapenem, ki spada v skupino betalaktamskih antibiotikov.
English: • Skin redness
Slovenian: • pordela koža,
English: Sodium bicarbonate (E500) Sodium hydroxide (E524) to adjust pH to 7.5
Slovenian: 6.1 Seznam pomožnih snovi natrijev hidrogenkarbonat (E500) natrijev hidroksid (E524) za uravnavo pH na 7,5
English: This is because you may have a condition known as colitis (an inflammation of the bowel).
Slovenian: Lahko da imate kolitis (vnetje debelega črevesa).
English: Because of the potential for adverse reactions on the infant, mothers should not breast-feed their infants while receiving ertapenem.
Slovenian: Zaradi možnih neželenih učinkov pri dojenčku matere med zdravljenjem z ertapenemom ne smejo dojiti.
English: There are inadequate data on the safety and efficacy of ertapenem in patients with advanced renal impairment and patients who require haemodialysis to support a dose recommendation.
Slovenian: Podatkov o varnosti in učinkovitosti ertapenema pri bolnikih z napredovalo okvaro ledvic in pri bolnikih, ki potrebujejo hemodializo, nimamo dovolj, da bi lahko izdelali priporočilo za odmerjanje.
English: Uncommon: Hot flush, hypertension
Slovenian: Občasni: navali vročine, hipertenzija
English: Efficacy of ertapenem in the treatment of diabetic foot infections with concurrent osteomyelitis has not been established.
Slovenian: Učinkovitost ertapenema pri zdravljenju okužb diabetične noge ob sočasnem osteomielitisu ni bila dokazana.
English: Common: Headache Uncommon: Dizziness, somnolence, taste perversion, seizure (see section 4.4) Rare: Tremor, syncope Not known: Hallucinations, depressed level of consciousness, dyskinesia, myoclonus, gait disturbance
Slovenian: Pogosti: glavobol Občasni: omotica, zaspanost, spremenjen okus, epileptični napad (glejte poglavje 4.4) Redki: tremor, sinkopa Neznana: halucinacije, zmanjšana stopnja zavesti, diskinezija, mioklonus, motnja hoje
English: • Decrease in white blood cells, decrease in blood platelet count
Slovenian: • zmanjšanje števila belih krvnih celic, zmanjšanje števila trombocitov,
English: The efficacy of INVANZ in the treatment of community acquired pneumonia due to penicillin-resistant Streptococcus pneumoniae has not been established.
Slovenian: Učinkovitost zdravila INVANZ pri zdravljenju zunajbolnišnične pljučnice, ki jo povzroča na penicilin odporna bakterija Streptococcus pneumoniae, ni bila dokazana.
English: Adults and adolescents (13 to 17 years of age)
Slovenian: Odrasli in mladostniki (stari od 13 do 17 let)
English: 2 to 12 years 13 to 17 years
Slovenian: 2 do 12 let
English: Children and adolescents (3 months to 17 years of age):
Slovenian: Otroci in mladostniki (stari od 3 mesece do 17 let):
English: Do not freeze solutions of INVANZ.
Slovenian: Raztopine zdravila INVANZ ne zamrzujte.
English: Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) are:
Slovenian: Redko (pri več kot 1 od 10.000 bolnikov in manj kot 1 od 1.000 bolnikov) poročani neželeni učinki:
English: The reconstituted solution should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation.
Slovenian: Koncentrat je treba takoj po pripravi razredčiti v raztopini natrijevega klorida 9 mg/ml (0,9 %).
English: AUCs of total ertapenem and of unbound ertapenem are increased in patients who require haemodialysis approximately 2.9-fold and 6.0-fold, respectively, between dialysis sessions, compared with healthy subjects.
Slovenian: Vrednost AUC celokupnega ertapenema je pri bolnikih, ki potrebujejo hemodializo, med posameznimi dializami v primerjavi z zdravimi posamezniki povečana za 2,9-krat, vrednost AUC nevezanega ertapenema pa za 6,0-krat.