FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical guidance recommends penems in cUTI without distinction of drugs regarding efficacy and safety.
Slovenian: Klinične smernice za zapletene okužbe sečil priporočajo uporabo penemov brez razlik med zdravili glede na učinkovitost in varnost.
English: Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60 %T>MIC for P. aeruginosa in 95 % of pre-term and 91 % of full term neonates.
Slovenian: Simulacija po metodi Monte Carlo na podlagi modela populacijske farmakokinetike je pokazala, da odmerna shema 20 mg/kg na 8 ur doseže 60 % t > MIC za P. aeruginosa pri 95 % nedonošenih in 91 % donošenih novorojenčkov.
English: The concomitant use of meropenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Slovenian: Sočasna uporaba meropenema in valprojske kisline oz. natrijevega valproata ni priporočljiva (glejte poglavje 4.5).
English: There are no or limited amount of data from the use of meropenem in pregnant women.
Slovenian: O uporabi meropenema pri nosečnicah podatkov ni ali jih je malo.
English: Due to the rapid onset and the extent of the decrease, co-administration of valproic acid with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4).
Slovenian: Zaradi hitrega pojava in obsega tega zmanjšanja velja, da sočasne uporabe valprojske kisline s karbapenemskimi zdravili ni mogoče obvladati in se ji je zato treba izogniti (glejte poglavje 4.4).
English: There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg.
Slovenian: Konvencionalna skupina testov ni pokazala znakov mutagenega potenciala in tudi ne znakov reproduktivnih toksičnih učinkov, vključno s teratogenim potencialom, v študijah na podganah do 750 mg/kg in pri opicah do 360 mg/kg.
English: Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2.
Slovenian: Pri bolnikih z okvaro ledvic obstaja možnost relativnega prevelikega odmerjanja, če odmerek ni prilagojen, kot je opisano v poglavju 4.2.
English: Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union.
Slovenian: V Evropski uniji so bili opisani lokalizirani skupki okužb z bakterijami, odpornimi proti karbapenemom.
English: Remove the needle and syringe from the vial and throw the empty vial away in a safe place.
Slovenian: Potegnite iglo in brizgo iz viale in zavrzite prazno vialo na varno mesto.
English: The clinical and bacteriological effectiveness of meropenem as monotherapy was similar to the combination treatment of clindamycin plus gentamicin.
Slovenian: Klinična in bakteriološka učinkovitost meropenema v obliki monoterapije je bila podobna kombiniranemu zdravljenju s klindamicinom in gentamicinom.
English: The CHMP agreed to the additional modifications in this section of the SPC, mentioning the effects on the kidney in mice, dogs and monkeys.
Slovenian: CHMP se je strinjal z dodatnimi spremembami tega poglavja v povzetku glavnih značilnosti zdravila z omembo učinkov na ledvice miši, psov in opic.
English: 2 Strains with MIC values above the S/I breakpoint are rare or not yet reported.
Slovenian: 2 Sevi z vrednostmi MIK nad mejno vrednostjo občutljivi/srednje občutljivi so redki ali še niso opisani.
English: AstraZeneca AB 151 85 Södertälje Sweden
Slovenian: AstraZeneca AB S-15185 Södertälje Švedska
English: Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem.
Slovenian: Uporaba pri bolnikih z boleznijo jeter: bolnikom z obstoječimi boleznimi jeter je treba med zdravljenjem z meropenemom kontrolirati delovanje jeter.
English: If you forget to use Meronem
Slovenian: Če ste pozabili uporabiti zdravilo Meronem
English: Take special care with Meronem Check with your doctor before using Meronem:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Meronem Pred uporabo zdravila Meronem se posvetujte z zdravnikom:
English: Although it is acknowledged that not all patients with community-acquired pneumonia (CAP) require treatment with a carbapenem the MAH argued that restriction of the indication to severe cases only is not required since severity is already implied by the route of administration of the product and other aspects of labelling.
Slovenian: Čeprav je potrjeno, da vsi bolniki z izvenbolnišnično pridobljeno pljučnico ne potrebujejo zdravljenja s karbapenemom, je imetnik dovoljenja za promet z zdravilom ugovarjal omejitvi indikacije samo na hude primere, ker je resnost upoštevana že pri poti uporabe zdravila in drugih vidikih označevanja.
English: Uncommon oral and vaginal candidiasis
Slovenian: Občasni oralna in vaginalna kandidoza
English: Netherlands AstraZeneca BV at the Louis Pasteurlaan 5
Slovenian: Nizozemska AstraZeneca BV Louis Pasteurlaan 5
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Slovenian: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Postal 22876 Wedel Nemčija
English: Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius) Streptococcus pneumoniae
Slovenian: Streptococcus milleri skupina (S. anginosus, S. constellatus in S. intermedius) Streptococcus pneumoniae
English: If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meronem.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se pred uporabo zdravila Meronem posvetujte z zdravnikom ali medicinsko sestro.
English: Meropenem is detectable at very low concentrations in animal breast milk.
Slovenian: Meropenem je pri živalih v zelo majhni koncentraciji zaznaven v mleku.
English: Giving Meronem through a short cannula or venflon 1.
Slovenian: Dajanje zdravila Meronem po kratki kanili ali venflonu 1.
English: • Infections that you can catch during or after the delivery
Slovenian: • Okužbe, ki se lahko pojavijo med porodom ali po njem
English: For the AZ studies, complicated UTI was associated with structural and/or functional abnormalities such as prostatic hypertrophy, hydronephrosis, neurogenic bladder, vesicoureteric reflux, stricture, calculus, tumour, upper UTI or prolapse, indwelling urinary catheter, or concomitant urologic diagnostic or surgical procedure.
Slovenian: V študijah družbe AstraZeneca so zapletene okužbe sečil povezali s strukturnimi in/ali funkcionalnimi nepravilnostmi, kot so hipertrofija prostate, hidronefroza, nevrogeni sečni mehur, vezikouretralni refluks, striktura, kalkulus, tumor, okužba zgornjih sečil ali prolaps, stalni urinski kateter ali sočasni urološki diagnostični ali kirurški poseg.
English: Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis Streptococcus agalactiae (Group B)
Slovenian: Staphylococcus species (občutljiv za meticilin), vključno s Staphylococcus epidermidis Streptococcus agalactiae (skupina B)
English: Hypersensitivity to any other carbapenem antibacterial agent.
Slovenian: Preobčutljivost za katero koli drugo karbapenemsko protibakterijsko zdravilo.
English: The CHMP considered that there was no compulsory need for a specific statement on combination strategies in the SPC since the clinical practice is guided by official guidance, as referred to in section 4.1 of the SPC:
Slovenian: CHMP je menil, da posebna izjava o kombinacijskih strategijah v povzetku glavnih značilnosti zdravila ni potrebna, saj klinično prakso določajo uradne smernice, ki so navedene v poglavju 4.1 povzetka glavnih značilnosti zdravila:
English: Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
Slovenian: Upoštevajte naslednje nasvete: to bo pomagalo preprečiti pojav bakterij, ki lahko onemogočijo delovanje antibiotika.
English: What Meronem looks like and contents of the pack
Slovenian: Izgled zdravila Meronem in vsebina pakiranja
English: The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion.
Slovenian: Izmerjeni ledvični očistek in učinek probenecida kažeta, da je meropenem podvržen filtraciji in tubulni sekreciji.
English: Not known pain at the injection site
Slovenian: Neznano bolečina ne mestu injiciranja
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data but this is rare or very rare).
Slovenian: Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) pogosti (pojavijo se pri 1 do 10 od 100 bolnikov) občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov) redki (pojavijo se pri 1 do 10 od 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov) neznano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo, vendar je redka ali zelo redka).
English: 1, Place Renault 92844 RUEIL-MALMAISON Cédex
Slovenian: AstraZeneca 1, Place Renault 92844 RUEILMALMAISON Cédex Francija
English: Common transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.
Slovenian: Pogosti zvišanje transaminaz, zvišanje alkalne fosfataze, zvišanje laktat-dehidrogenaze v krvi.
English: Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.
Slovenian: Meropenem, namenjen za bolusno intravensko injiciranje, je treba pripraviti s sterilno vodo za injekcije.
English: • Probenecid (used to treat gout).
Slovenian: • Probenecid (uporablja se za zdravljenje protina).
English: Regarding the dosage schedule for adults with impaired renal function, the MAH stated that dose adjustments of the upper limit from 1 g to 2 g had not been studied but are widely used in clinical practice.
Slovenian: O urniku odmerjanja za odrasle s poslabšano ledvično funkcijo, je imetnik dovoljenja za promet z zdravilom navedel, da prilagajanje zgornje meje odmerka iz 1 g na 2 g ni bilo raziskano, vendar se v klinični praksi pogosto uporablja.
English: Wipe the end of the short cannula or venflon with an alcohol wipe and allow it to dry.
Slovenian: Obrišite konec kratke kanile ali venflona z alkoholnim zložencem in pustite, da se posuši.
English: The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.
Slovenian: Čas od začetka priprave do konca intravenskega injiciranja ali infundiranja ne sme biti daljši od ene ure.
English: However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s).
Slovenian: Vendar so lahko bakterije odporne proti več kot eni skupini protimikrobnih zdravil, če zadevni mehanizem vključuje nepermeabilnost in/ali iztočno črpalko/črpalke.
English: It was added to aid in the dissolution of the bulk drug by increasing the pH of the solution above the pKa value of the carboxyl group of meropenem.
Slovenian: Sestavina se doda za pomoč pri raztapljanju zdravila, kar se doseže s povečanjem pH raztopine nad vrednost pKa karboksilne skupine meropenema.
English: Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered.
Slovenian: V poštev pride prenehanje zdravljenja z meropenemom in uporaba specifičnega zdravljenja, usmerjenega proti Clostridium difficile.
English: The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2-5 years), 5.3 ml/min/kg (623 months) and 4.3 ml/min/kg (2-5 months).
Slovenian: Povprečne vrednosti očistka kreatinina so bile 5,8 ml/min/kg (6-12 let), 6,2 ml/min/kg (2-5 let), 5,3 ml/min/kg (6-23 mesecev) in 4,3 ml/min/kg (2-5 mesecev).
English: Please note: If your prescribed dose of Meronem is more than 1g, you will need to use more than 1 vial of Meronem.
Slovenian: 40 ml Opomba: Če je vaš predpisani odmerek zdravila Meronem več kot 1 g, boste morali uporabiti več kot 1 vialo zdravila Meronem.
English: Data from these studies showed that meropenem was effective in the treatment of bacterial meningitis, and similar in effectiveness to cefotaxime/ceftriaxone.
Slovenian: Podatki iz teh študij so pokazali, da je bil meropenem učinkovit pri zdravljenju bakterijskega meningitisa in da je po učinkovitosti podoben cefotaksimu/ceftriaksonu.
English: When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur.
Slovenian: Če osebe z normalnim delovanjem ledvic dobijo več odmerkov na 8 ur, ne pride do kopičenja meropenema.
English: Check the vial and the expiry date.
Slovenian: Preverite vialo in rok uporabnosti.
English: 5 Non-species related breakpoints have been determined mainly from PK/PD data and are independent of the MIC distributions of specific species.
Slovenian: 5 Mejni vrednosti, ki nista vezani na vrsto, sta bili določeni predvsem iz podatkov o farmakokinetiki/farmakodinamiki in nista odvisni od porazdelitve MIC za posamezno vrsto.
English: Since the original MAA application, 5 further clinical studies have been conducted in approximately 650 patients (data regarding numbers of patients treated with meropenem are not available).
Slovenian: Od izvirne vloge za dovoljenje za promet z zdravilom so izvedli pet nadaljnjih kliničnih študij pri približno 650 bolnikih (podatki o številu bolnikov, zdravljenih z meropenemom, niso na voljo).
English: The CHMP proposed to retain the information on convulsions and hepatic reactions as such statement warrants the attention of prescribers on the need for careful use of meropenem, taking into account both adverse events.
Slovenian: CHMP je predlagal, da se informacije o konvulzijah in jetrnih reakcijah ohranijo, ker taka navedba zagotavlja, da bodo zdravstveni delavci, ki predpisujejo zdravilo, opozorjeni na potrebo po previdni uporabi meropenema in bodo upoštevale oba neželena učinka.
English: Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates.
Slovenian: Dokazano je, da meropenem dobro prodira v različne telesne tekočine in tkiva, med drugim v pljuča, bronhialne izločke, žolč, cerebrospinalno tekočino, ginekološka tkiva, kožo, fascijo, mišice in peritonealni eksudat.
English: Remove any air in the syringe by gently pushing the plunger until all the air has gone.
Slovenian: Odstranite morebitni zrak v brizgi tako, da rahlo potiskate bat, dokler ne iztisnete vsega zraka.
English: The MAH commits to carrying out a number of quality-related steps pertaining to the Drug Substance and the Drug Product and to submit the data listed in the Letter of Undertaking within the specified timeframe.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvedel številne ukrepe, povezane s kakovostjo učinkovine in zdravila, in da bo v predvidenem roku predložil podatke, navedene v pismu o prevzeti obveznosti.
English: The IV LD50 of meropenem in rodents is greater that 2000 mg/kg.
Slovenian: Intravenski LD50 meropenema pri glodalcih je večji od 2000 mg/kg.
English: Like all medicines, Meronem can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Meronem neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Put the needle of the syringe through the centre of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meronem.
Slovenian: Zabodite iglo brizge skozi srednji del sivega gumijastega zamaška in vbrizgajte priporočeno količino vode za injekcije v vialo ali viale zdravila Meronem.
English: A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l.
Slovenian: Študija, v kateri je 12 bolnikov po operaciji dobivalo 1000 mg meropenema na 8 ur zaradi intraabdominalnih okužb, je pokazala primerljivo Cmax in razpolovni čas kot pri normalnih preiskovancih, a večji volumen porazdelitve (27 l).
English: The CHMP considered that the clinical documentation submitted by the MAH did not greatly contribute to the assessment as the studies include a mix of wide cutaneous infections without a robust documentation on severe cellulitis, not completely relevant considering the interest of penems.
Slovenian: CHMP je menil, da klinična dokumentacija, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ni veliko prispevala k ovrednotenju, saj študije vključujejo mešanico številnih kožnih okužb brez tehtne dokumentacije o hudem celulitisu, ki niso zelo relevantne za peneme.
English: • Meronem will be given to you as an injection or infusion into a large vein.
Slovenian: • Zdravilo Meronem boste dobili z injekcijo ali infuzijo v eno od velikih ven.
English: Dose in elderly patients
Slovenian: Odmerek pri starejših bolnikih
English: The following table of pathogens listed is derived from clinical experience and therapeutic guidelines.
Slovenian: Naslednja preglednica navedenih patogenov je pripravljena na podlagi kliničnih izkušenj in terapevtskih smernic.
English: Consequently the CHMP agreed that the wording of the therapeutic indication was appropriate as follows:
Slovenian: CHMP se je zato strinjal, da je za besedilo terapevtske indikacije primerna naslednja oblika:
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija: Optinem
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: The CHMP considered that it would be artificial to put emphasis on some sub-gynaecological infections as the level of demonstration was limited overall for gynaecological infections and especially when scrutinizing specific sub-indications such as episiotomy, endometritis.
Slovenian: Odbor CHMP je menil, da bi bilo napačno poudarjati določene podzvrsti ginekoloških okužb, saj je raven dokazovanja pri ginekoloških okužbah na splošno omejena, kar še posebej velja za primer temeljitega preiskovanja določenih podindikacij, kot sta epiziotomija in endometritis.
English: The CHMP agreed that intentional overdosing of Meronem is unlikely, although unintentional overdosing could occur, particularly in patients with renal impairment.
Slovenian: CHMP se je strinjal, da je namerno preveliko odmerjanje zdravila Meronem malo verjetno, čeprav lahko pride do nenamernega prevelikega odmerjanja še posebej pri bolnikih s poslabšanim delovanjem ledvic.
English: In individuals with normal renal function, rapid renal elimination will occur.
Slovenian: Pri posameznikih z normalno ledvično funkcijo poteka izločanje hitro prek ledvic.
English: Renal impairment results in higher plasma AUC and longer half-life for meropenem.
Slovenian: Okvara ledvic povzroči večjo plazemsko AUC in daljši razpolovni čas meropenema.
English: • Shortness of breath, wheezing or trouble breathing.
Slovenian: • Kratke sape, piskajočega dihanja ali težkega dihanja.
English: Although the bacteriology of nosocomial pneumonia and ventilator-associated pneumonia (VAP) are similar, the severity of the general condition of the patients and treatment outcome are sufficiently different to consider that efficacy in VAP cannot be extrapolated from efficacy in nosocomial pneumonia.
Slovenian: Čeprav sta bakteriologija bolnišnično pridobljene pljučnice in bakteriologija z ventilatorji povezane pljučnice podobni, sta resnost splošnega stanja bolnikov in izid zdravljenja dovolj različna, da učinkovitosti pri pljučnici, povezani z ventilatorji, ni mogoče ekstrapolirati iz učinkovitosti pri bolnišnično pridobljeni pljučnici.
English: Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem.
Slovenian: Bolniki z anamnezo preobčutljivosti za karbapeneme, peniciline ali druge betalaktamske antibiotike so lahko preobčutljivi tudi na meropenem.
English: If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Meronem, kot bi smeli Če pomotoma uporabite odmerek, večji od predpisanega, se takoj posvetujte s svojim zdravnikom ali najbližjo bolnišnico.
English: Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8).
Slovenian: Med zdravljenjem z meropenemom je treba natančno kontrolirati delovanje jeter, ker obstaja tveganje toksičnih učinkov na jetra (disfunkcija jeter s holestazo in citolizo) (glejte poglavje 4.8).
English: Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability.
Slovenian: Koncentracija meropenema v cerebrospinalni tekočini je pri otrocih z meningitisom približno 20 % sočasne koncentracije v plazmi, vendar je interindividualna variabilnost občutna.
English: There is no dose adjustment necessary (see section 4.2).
Slovenian: Prilagoditev odmerka ni potrebna (glejte poglavje 4.2).
English: The CHMP considered that the information submitted by the MAH was insufficient and not convincing enough to allow the deletion of the monitoring of the treatment due to hepatic toxicity.
Slovenian: CHMP je menil, da informacije, ki jih je predložil imetnik dovoljenja za promet z zdravilom, niso zadostne in niso dovolj prepričljive, da bi omogočile odpravo spremljanja zdravljenja zaradi jetrne toksičnosti.
English: For the indications above, the CHMP, considering the safety profile of the drug, was of the view that dosing beyond 1g in IV bolus in adults and 20 mg/kg IV bolus in children should not be exceeded.
Slovenian: Za zgoraj naštete indikacije je CHMP ob upoštevanju varnostnega profila zdravila menil, da se ne sme preseči odmerjanja, ki znaša 1 g za intravenski bolus pri odraslih in 20 mg/kg za intravenski bolus pri otrocih.
English: The safety profile is based primarily on monotherapy clinical trials and the numbers of post marketing reports of adverse events of patients receiving bi-therapy are small, therefore it would not be possible to extrapolate from these.
Slovenian: Varnostni profil temelji zlasti na kliničnih preskušanjih monoterapije, število poročil po začetku trženja zdravila o neželenih učinkih pri bolnikih, ki so deležni zdravljenja z dvema zdraviloma, pa je majhno, zato teh podatkov ne bi bilo mogoče uporabiti.
English: • Acute bacterial infection of the brain (meningitis)
Slovenian: • Akutna bakterijska okužba možganov (meningitis)
English: Meropenem is generally well tolerated by the central nervous system.
Slovenian: Osrednje živčevje meropenem praviloma dobro prenaša.
English: Based on the Quality data submitted, the CHMP concluded that meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection and that for intravenous infusion, meropenem vials may be directly constituted with 0.9 % sodium chloride or 5 % glucose solutions for infusion.
Slovenian: Na temelju predloženih podatkov o kakovosti je CHMP zaključil, da je treba meropenem za bolusne intravenske injekcije konstituirati s sterilno vodo za injekcije in da se lahko viale meropenema za intravensko infuzijo konstituirajo neposredno z 0,9-odstotno raztopino natrijevega klorida ali 5odstotno raztopino glukoze za infundiranje.