FrancophonIA/ELRC3.0 huggingface dataset:
English: In resistant isolates, resistance to other antibacterial agents of the carbapenem class was seen in some but not all isolates.
Croatian: Rezistencija na ostale antibiotike iz skupine karbapenema opažena je u nekih, ali ne i svih rezistentnih izolata.
English: The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem.
Croatian: Ukupan broj bolesnika liječenih ertapenemom u kliničkim studijama bio je veći od 2200, a od njih je više od 2150 primilo dozu od 1 g ertapenema.
English: Variations of colour within this range do not affect potency.
Croatian: Nijanse boje unutar ovog raspona ne utječu na djelotvornost lijeka.
English: No specific information is available on the treatment of overdose with ertapenem.
Croatian: Nisu dostupne specifične informacije o liječenju predoziranja ertapenemom.
English: Because of the potential for adverse reactions on the infant, mothers should not breast-feed their infants while receiving ertapenem.
Croatian: Zbog mogućih nuspojava u dojenčeta, majke ne bi trebale dojiti dok primaju ertapenem.
English: It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
Croatian: Osobito je važno da liječnik zna ako imate bolest bubrega i ako se liječite dijalizom.
English: Do not use INVANZ - if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections).
Croatian: Nemojte primjenjivati INVANZ - ako ste alergični na djelatnu tvar (ertapenem) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste alergični na antibiotike poput penicilina, cefalosporina ili karbapenema (koji se koriste za liječenje različitih infekcija).
English: INVANZ contains ertapenem which is an antibiotic of the beta-lactam group.
Croatian: INVANZ sadrži ertapenem, koji je antibiotik iz skupine beta-laktama.
English: Uncommon: Positive Clostridium difficile toxin
Croatian: Manje često: pozitivan nalaz toksina Clostridium difficile
English: Treatment was discontinued due to adverse reactions in 0.5 % of patients.
Croatian: Liječenje je zbog nuspojava prekinuto u 0,5% bolesnika.
English: Seizures occurred most commonly in elderly patients and those with pre-existing central nervous system (CNS) disorders (e.g. brain lesions or history of seizures) and/or compromised renal function.
Croatian: Napadaji su bili češći u starijih bolesnika i u bolesnika s postojećim poremećajima središnjeg živčanog sustava (npr. moždanim lezijama ili napadajima u anamnezi) i/ili kompromitiranom funkcijom bubrega.
English: Instructions of how to reconstitute and dilute INVANZ:
Croatian: Upute za rekonstituciju i razrjeđivanje lijeka INVANZ:
English: Not known: Muscular weakness
Croatian: Nepoznato: mišićna slabost
English: 15 mL Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal.
Croatian: Staklene bočice volumena 15 ml (staklo tip I) sa sivim čepom od butil gume i bijelom plastičnom kapicom na obojanom aluminijskom prstenu.
English: After reconstitution: Diluted solutions should be used immediately.
Croatian: Nakon rekonstitucije: Razrijeđena otopina se mora odmah primijeniti.
English: The mean plasma half-life in children 3 months to 12 years of age is approximately 2.5 hours.
Croatian: Prosječno poluvrijeme u plazmi u djece od 3 mjeseca do 12 godina života iznosi približno 2,5 sata.
English: In the absence of severe renal impairment, no dosage adjustment is necessary in elderly patients.
Croatian: Osim u slučaju teškog oštećenja funkcije bubrega, nije potrebna prilagodba doze u starijih bolesnika.
English: Concomitant use with valproic acid
Croatian: Istodobna primjena s valproatnom kiselinom
English: These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
Croatian: Vjerojatnije je da će te reakcije nastupiti u bolesnika koji u anamnezi imaju preosjetljivost na više alergena.
English: Diluted solutions (approximately 20 mg/mL ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2 to 8°C (in a refrigerator).
Croatian: Razrijeđene otopine (približno 20 mg/ml ertapenema) su fizikalno i kemijski stabilne tijekom 6 sati na sobnoj temperaturi (25°C), odnosno 24 sata na temperaturi od 2°C do 8°C (u hladnjaku).
English: • Diabetic foot infections of the skin and soft tissue (see section 4.4)
Croatian: • infekcija kože i mekih tkiva kod dijabetičkog stopala (vidjeti dio 4.4)
English: Localised clusters of infections due to carbapenem-resistant organisms have been reported in the European Union.
Croatian: U Europskoj uniji prijavljeno je lokalizirano grupiranje infekcija uzrokovanih organizmima rezistentnima na karbapeneme.
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).
Croatian: Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate lijekove koji se zovu valproatna kiselina ili natrijev valproat (koriste se za liječenje epilepsije, bipolarnog poremećaja, migrene ili shizofrenije).
English: The prescribers are informed that local MIC breakpoints, if available, should be consulted.
Croatian: Upućuju se propisivači da usporede i lokalne vrijednosti MIK-a, ako su dostupne.
English: Considerations for use in particular populations
Croatian: Napomene za primjenu u određenim populacijama
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.
Croatian: Snižene koncentracije valproatne kiseline mogu dovesti do neadekvatne kontrole napadaja; stoga se istodobna primjena ertapenema i valproatne kiseline/natrijevog valproata ne preporučuje te je potrebno razmotriti primjenu zamjenskog antibiotika ili antikonvulziva.
English: There have also been reports of changes in some laboratory blood tests.
Croatian: Prijavljene su i promjene u rezultatima nekih laboratorijskih pretraga krvi.
English: Certain side effects, such as dizziness and sleepiness, have been reported with INVANZ, which may affect some patients' ability to drive or operate machinery.
Croatian: Kod primjene lijeka INVANZ prijavljene su neke nuspojave, poput omaglice i pospanosti, koje u nekih bolesnika mogu utjecati na sposobnost vožnje ili rukovanja strojevima.
English: • Hypersensitivity to any other carbapenem antibacterial agent
Croatian: • Preosjetljivost na bilo koji drugi antibiotik iz skupine karbapenema
English: Therefore, ertapenem should not be used in these patients (see section 5.2.).
Croatian: Stoga se tim bolesnicima ne treba davati ertapenem (vidjeti dio 5.2).
English: INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Croatian: INVANZ je u odraslih indiciran za profilaksu infekcije operativnog područja nakon elektivnog kolorektalnog kirurškog zahvata (vidjeti dio 4.4).
English: Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity.
Croatian: Intravenska primjena ertapenema u dozi od 3 g na dan tijekom 8 dana u zdravih odraslih dobrovoljaca nije izazvala značajnu toksičnost.
English: Discontinuation of therapy with INVANZ and the administration of specific treatment for Clostridium difficile should be considered.
Croatian: Treba razmotriti prekid liječenja lijekom INVANZ te primjenu specifičnog liječenja za Clostridium difficile.
English: • Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site)
Croatian: • tegobe s venom u koju se daje lijek (uključujući upalu, stvaranje kvržice, oticanje na mjestu injiciranja ili istjecanje tekućine u okolno tkivo i kožu)
English: Rare: Genital bleeding
Croatian: Rijetko: genitalno krvarenje
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).
Croatian: Prije započinjanja terapije ertapenemom potrebno je prikupiti detaljne podatke o prethodnim reakcijama preosjetljivosti na peniciline, cefalosporine, ostale beta-laktame i druge alergene (vidjeti dio 4.3).
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Treba uzeti u obzir službene preporuke u vezi primjerene primjene antimikrobnih lijekova.
English: Ertapenem can be removed to some extent by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
Croatian: Ertapenem se u određenoj mjeri može ukloniti hemodijalizom (vidjeti dio 5.2), no nema podataka o primjeni hemodijalize za liječenje predoziranja.
English: • Changes in liver function tests
Croatian: • promjene u rezultatima testova funkcije jetre
English: EU/1/02/216/001 1 vial EU/1/02/216/002 10 vials
Croatian: EU/1/02/216/001 1 bočica EU/1/02/216/002 10 bočica
English: Methicillin-susceptible-staphylococci (including Staphylococcus aureus)* Streptococcus agalactiae*
Croatian: Stafilokoki osjetljivi na meticilin (uključujući Staphylococcus aureus)* Streptococcus agalactiae*
English: Preparation for intravenous administration: INVANZ must be reconstituted and then diluted prior to administration.
Croatian: Priprema za intravensku primjenu: INVANZ se prije primjene mora rekonstituirati, a zatim razrijediti.
English: Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Croatian: Enterokoki uključujući Enterococcus faecalis i Enterococcus faecium
English: An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
Croatian: Dodatnih 476 bolesnika primilo je ertapenem u jednokratnoj dozi od 1 g prije operacije, u kliničkoj studiji profilakse infekcije operativnog područja nakon kolorektalnog kirurškog zahvata.
English: Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported.
Croatian: Nakon što je lijek stavljen na tržište prijavljene su teške alergijske reakcije (anafilaksa) i sindromi preosjetljivosti (alergijske reakcije uključujući osip, vrućicu, odstupanja od normalnih nalaza krvnih pretraga).
English: However, in the event of an overdose, treatment with INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.
Croatian: Ipak, u slučaju predoziranja potrebno je prekinuti liječenje lijekom INVANZ i primijeniti opće suportivno liječenje sve dok se lijek ne eliminira putem bubrega.
English: However, micro-organisms may exhibit resistance to more than one class of antibacterial agents when the mechanism is, or includes, impermeability to some compounds and/or an efflux pump.
Croatian: Međutim, mikroorganizmi mogu biti rezistentni na više od jedne skupine antibiotika ako mehanizam rezistencije obuhvaća nepropusnost za neke spojeve i/ili efluks pumpu.
English: Patients should be informed that dizziness and somnolence have been reported with INVANZ (see section 4.8).
Croatian: Bolesnike treba obavijestiti da su pri primjeni lijeka INVANZ prijavljene omaglica i somnolencija (vidjeti dio 4.8).
English: Diluted solutions should be used immediately.
Croatian: Razrijeđena otopina se mora odmah primijeniti.
English: Children and adolescents (3 months to 17 years of age) Experience with INVANZ is limited in children less than two years of age.
Croatian: Djeca i adolescenti (u dobi od 3 mjeseca do 17 godina) Iskustvo s primjenom lijeka INVANZ u djece mlađe od 2 godine je ograničeno.
English: Excipient with known effect Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg).
Croatian: Pomoćna tvar s poznatim učinkom Jedna doza od 1,0 g sadrži približno 6,0 mEq natrija (približno 137 mg).
English: The change in binding was < 12 % at peak plasma ertapenem concentration following a 1 g dose.
Croatian: Promjena u vezivanju bila je < 12% pri vršnoj koncentraciji ertapenema u plazmi nakon doze od 1 g.
English: The concomitant use of ertapenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena ertapenema i valproatne kiseline/natrijevog valproata (vidjeti dio 4.5).
English: Common: Elevations in ALT and AST
Croatian: Često: povišene vrijednosti ALT-a i AST-a
English: INVANZ may be used for the treatment of infections in adult patients with mild to moderate renal impairment.
Croatian: INVANZ se može primjenjivati u liječenju infekcija u odraslih bolesnika s blagim do umjerenim oštećenjem bubrega.
English: Uncommon: Headache Not known: Hallucinations
Croatian: Manje često: glavobolja Nepoznato: halucinacije
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.
Croatian: U kliničkim studijama pedijatrijske populacije primjena jednokratne intravenske (i.v.) doze od 40 mg/kg, do najviše 2 g, nije dovela do toksičnosti.
English: In patients whose creatinine clearance is  30 mL/min/1.73 m2, no dosage adjustment is necessary.
Croatian: U bolesnika u kojih klirens kreatinina iznosi > 30 ml/min/1,73 m2 nije potrebna prilagodba doze.
English: Children (3 months to 12 years of age)
Croatian: Djeca (u dobi od 3 mjeseca do 12 godina)
English: The recommended dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) given once a day.
Croatian: Preporučena doza lijeka INVANZ za odrasle i adolescente u dobi od 13 godina ili starije je 1 gram (g) jedanput na dan.
English: Paediatric population (3 months to 17 years of age):
Croatian: Pedijatrijska populacija (3 mjeseca do 17 godina):
English: • Low blood pressure, slow heart rate
Croatian: • nizak krvni tlak, usporeno kucanje srca
English: • Agitation, anxiety, depression, tremor
Croatian: • uznemirenost, anksioznost, depresija, drhtanje
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.
Croatian: Nakon primjene doze od 20 mg/kg (do maksimalne doze od 1 g), vrijednosti farmakokinetičkih parametara u bolesnika u dobi od 13 do 17 godina uglavnom su bili slične onima u zdravih mlađih odraslih osoba.
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.
Croatian: Rezistencija također može proizaći iz stjecanja beta-laktamaza koje snažno hidroliziraju karbapeneme (npr. metalo-beta-laktamaze tipa IMP i VIM ili karbapenemaze tipa KPC), premda su one rijetke.
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.
Croatian: Tijekom kliničkih ispitivanja u odraslih bolesnika liječenih ertapenemom (1 g jedanput na dan) napadaji su prijavljeni za vrijeme liječenja ili u 14-dnevnom razdoblju praćenja.
English: INVANZ should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.
Croatian: INVANZ se ne smije koristiti tijekom trudnoće osim u slučaju da liječnik smatra da moguća korist od liječenja opravdava mogući rizik za plod.
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.
Croatian: Ertapenem je vrlo stabilan na hidrolizu većinom enzima iz skupine beta-laktamaza, uključujući penicilinaze, cefalosporinaze i betalaktamaze proširenog spektra, ali ne i metalo-beta-laktamaze.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedene studije o učincima lijeka na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Altered mental status (including aggression)
Croatian: • promijenjeno psihičko stanje (uključujući agresivnost)
English: Methicillin-resistant staphylococci (including MRSA) are always resistant to beta-lactams.
Croatian: Stafilokoki rezistentni na meticilin (uključujući MRSA) uvijek su rezistentni na beta-laktame.
English: INVANZ will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.
Croatian: INVANZ će uvijek pripremiti liječnik ili drugi zdravstveni radnik i primijenit će Vam ga intravenski (u venu).
English: • Intra-abdominal infections
Croatian: • intraabdominalnih infekcija
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).
Croatian: Odrasli i adolescenti (13 do 17 godina): Doza lijeka INVANZ je 1 gram (g) jedanput na dan, primijenjeno intravenskim putem (vidjeti dio 6.6).
English: Similar observations have been made in the post-marketing environment.
Croatian: Slična su bila zapažanja i nakon stavljanja lijeka u promet.
English: The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
Croatian: Drugi sastojci su: natrijev hidrogenkarbonat (E500) i natrijev hidroksid (E524).
English: Gender The plasma concentrations of ertapenem are comparable in men and women.
Croatian: Spol Koncentracije ertapenema u plazmi u žena usporedive su s onima u muškaraca.
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 %.
Croatian: In vivo je probenecid (500 mg svakih 6 sati) smanjio vezanu frakciju ertapenema u plazmi na kraju infuzije u ispitanika kojima je primijenjena jednokratna intravenska doza ertapenema od 1 g sa približno 91% na približno 87%.
English: If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
Croatian: Ako se brinete da ste možda propustili primiti dozu lijeka, odmah se javite svom liječniku ili drugom zdravstvenom radniku.
English: • Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation
Croatian: • upala kože, gljivična infekcija kože, ljuštenje kože, infekcija rane nakon operacije
English: • Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or cephalosporins).
Croatian: • Teška preosjetljivost (npr. anafilaktička reakcija, teška kožna reakcija) na bilo koji drugu vrstu beta-laktamskih antibiotika (npr. peniciline ili cefalosporine).
English: Due to the limited extent of hepatic metabolism of ertapenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
Croatian: S obzirom na ograničenu metabolizaciju ertapenema u jetri ne očekuje se da bi poremećaj funkcije jetre utjecao na njegovu farmakokinetiku.
English: It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with INVANZ.
Croatian: Važno je da obavijestite liječnika ako dobijete proljev prije, za vrijeme ili nakon liječenja lijekom INVANZ.
English: Adverse reactions (i.e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20.8 % of patients treated with ertapenem.
Croatian: Nuspojave (tj. one reakcije čiju je povezanost s lijekom ispitivač smatrao mogućom, vjerojatnom ili sigurnom) bile su prijavljene u približno 20,8% bolesnika liječenih ertapenemom.
English: The proportion of patients with a favourable clinical response assessment at posttreatment visit in the clinical MITT population is shown below:
Croatian: Udio bolesnika s povoljnim kliničkim odgovorom na kontrolnom pregledu nakon liječenja, iz prilagođene kliničke populacije predviđene za liječenje, prikazan je u sljedećoj tablici:
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.
Croatian: U kliničkom ispitivanju liječenja intraabdominalnih infekcija u odraslih, 30% bolesnika liječenih ertapenemom koje je bilo moguće ocijeniti imalo je generalizirani peritonitis, a 39% infekciju drugih organa osim crvuljka, uključujući želudac, dvanaesnik, tanko crijevo, debelo crijevo i žučni mjehur; broj bolesnika obuhvaćenih procjenom koji su pri uključivanju u ispitivanje imali rezultat ≥ 15 prema bodovnom sustavu APACHE II bio je ograničen pa nije utvrđena djelotvornost u tih bolesnika.
English: Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
Croatian: Interakcije uzrokovane inhibicijom klirensa lijekova iz organizma posredovanim P-glikoproteinom ili CYP enzimima nisu vjerojatne (vidjeti dio 5.2).
English: Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection
Croatian: Rijetko: pneumonija, dermatomikoza, postoperativna infekcija rane, infekcija mokraćnih puteva
English: Do not take any medicine to treat diarrhoea without first checking with your doctor.
Croatian: Nemojte uzimati nikakav lijek protiv proljeva prije nego što se posavjetujete sa svojim liječnikom.
English: The major metabolite of ertapenem is the ring-opened derivative formed by dehydropeptidase-I-mediated hydrolysis of the beta-lactam ring.
Croatian: Glavni metabolit ertapenema je derivat otvorenog prstena nastao hidrolizom betalaktamskog prstena posredovanom dehidropeptidazom-I.
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to ertapenem or not.
Croatian: Niže navedeni podaci predstavljaju samo približne smjernice o vjerojatnoj osjetljivosti pojedinih mikroorganizama na ertapenem.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
Croatian: Stoga je važno ovu dijagnozu uzeti u obzir kod bolesnika kod kojih se nakon primjene antibiotika pojavi proljev.
English: The recommended dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g/day).
Croatian: Preporučena doza za djecu u dobi od 3 mjeseca do 12 godina je 15 mg/kg dvaput na dan (ne više od 1 g na dan).
English: The total number of patients treated with ertapenem in clinical studies was 384.
Croatian: U kliničkim ispitivanjima ertapenemom su liječena ukupno 384 bolesnika.
English: Not known: Anaphylaxis including anaphylactoid reactions
Croatian: Nepoznato: anafilaksa uključujući anafilaktoidne reakcije
English: However, ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus.
Croatian: Međutim, ertapenem se ne bi trebao uzimati u trudnoći osim u slučaju da moguća korist od liječenja nadilazi mogući rizik za plod.
English: • altered mental status (including aggression, delirium, disorientation, mental status changes)
Croatian: • promjene psihičkog stanja (uključujući agresivnost, delirij, dezorijentiranost, promijenjeno psihičko stanje)