FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevertheless, despite the inadequate clinical data provided the critical interest of this drug should not be disregarded, especially in resistant Gram negative strains producing extended spectrum betalactamase.
Slovenian: Kljub nezadostnim priskrbljenim kliničnim podatkom se ne sme zanemariti ključnega interesa za to zdravilo, še posebej v primeru odpornih gramnegativnih sevov, ki tvorijo razširjeni spekter betalaktamaz.
English: • Changes in your blood.
Slovenian: • Spremembe krvi.
English: Not known toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme.
Slovenian: Neznano toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem.
English: The CHMP agreed that valproic acid should be avoided during treatment with Meronem.
Slovenian: CHMP se je strinjal, da se je treba med zdravljenjem z zdravilom Meronem izogibati valprojski kislini.
English: The MAH has undertaken to submit further data within the specified time frame specified in their letter of undertaking dated 23 July 2009.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je zavezal, da bo predložil nadaljnje podatke v danem časovnem okviru, ki je opredeljen v jamčevalnem pismu z dne 23. julija 2009.
English: It works by killing bacteria, which can cause serious infections.
Slovenian: Deluje tako, da uničuje bakterije, ki lahko povzročijo hude okužbe.
English: Haemophilus influenzae1 and Moraxella catarrhalis Neisseria meningitidis2,4
Slovenian: Haemophilus influenzae1 in Moraxella catarrhalis Neisseria meningitidis2,4
English: Allow the rubber stopper to dry.
Slovenian: Pustite, da se gumijasti zamašek posuši.
English: Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Slovenian: Peptostreptococcus species (vključno s P. micros, P anaerobius, P. magnus)
English: The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration.
Slovenian: Povprečna vezava meropenema na beljakovine v plazmi je bila približno 2 % in ni odvisna od koncentracije.
English: Data from this study showed that meropenem was highly effective in the treatment of bacterial gynaecological infections.
Slovenian: Podatki iz te študije so pokazali, da je zdravilo meropenem zelo učinkovito pri zdravljenju bakterijskih ginekoloških okužb.
English: Connect a new sterile needle to a new sterile syringe, without touching the ends.
Slovenian: Namestite novo sterilno iglo na novo sterilno brizgo, ne da bi se dotaknili njunih koncev.
English: Section 6.2 - Incompatibilities
Slovenian: Poglavje 6.2 - Inkompatibilnosti
English: Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems.
Slovenian: Odpornost bakterij proti meropenemu je lahko posledica: (1) manjše permeabilnosti zunanje membrane gramnegativnih bakterij (zaradi zmanjšanega nastajanja porinov), (2) manjše afinitete za ciljne PBP, (3) večje ekspresije komponent iztočne črpalke in (4) nastajanja beta-laktamaz, ki lahko hidrolizirajo karabapeneme.
English: There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals.
Slovenian: Pri mladih živalih niso ugotovili večje občutljivosti za meropenem v primerjavi z odraslimi.
English: 4 Meropenem breakpoints in Neisseria meningitidis relates to meningitis only.
Slovenian: 4 Mejne vrednosti pri Neisseria meningitidis se nanašajo samo na meningitis.
English: Gram-negative aerobes Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
Slovenian: Gramnegativni aerobi Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
English: If you notice any of the above, see a doctor straight away.
Slovenian: Če opazite kaj od naštetega, nemudoma pojdite k zdravniku.
English: Regarding the posology in elderly, the CHMP considered that being above 65 years of age does not per se constitute a problem for the drug administration, unless the clinical status and renal function of the patient are significantly altered.
Slovenian: Glede načina uporabe pri starejših osebah, je CHMP menil, da starost nad 65 let sama po sebi ne vpliva na dajanje zdravila, razen če nista klinično stanje in ledvična funkcija bolnika znatno spremenjena.
English: Gram-negative anaerobes Bacteroides caccae Bacteroides fragilis group Prevotella bivia Prevotella disiens
Slovenian: Gramnegativni anaerobi Bacteroides caccae Bacteroides fragilis skupina Prevotella bivia Prevotella disiens
English: Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6).
Slovenian: Meropenem se po navadi daje v intravenski infuziji, ki traja približno 15 do 30 minut (glejte poglavja 6.2, 6.3 in 6.6).
English: All of these studies (1 pivotal and 6 supportive) have been previously submitted in the original MAA.
Slovenian: Vse te študije (ena glavna in šest podpornih) so bile že predložene v izvirni vlogi za odobritev dovoljenja za promet z zdravilom.
English: The MAH's recommendation for administration over 15 to 30 minutes is based on dosage recommendations used in the efficacy studies conducted to support the registration of meropenem.
Slovenian: Priporočilo imetnika dovoljenja za promet z zdravilom glede dajanja, ki traja dlje od 15 do 30 minut, temelji na priporočilih o odmerku, ki se uporabljajo v študijah učinkovitosti v podporo registraciji meropenema.
English: The adequacy of meropenem to treat acute bacterial meningitis in adults is based upon the evaluation in adults referred to above, plus an extrapolation of efficacy from the much larger group of children with meningitis also evaluated.
Slovenian: Primernost meropenema za zdravljenje akutnega bakterijskega meningitisa pri odraslih temelji na ovrednotenju pri odraslih, ki je omenjeno zgoraj, z dodatkom ekstrapolacije učinkovitosti iz veliko večje skupine otrok z meningitisom, ki so jo ravno tako ovrednotili.
English: Based on the Quality data submitted, the CHMP agreed that this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: CHMP se je na osnovi predloženih podatkov o kakovosti strinjal, da se to zdravilo ne sme mešati z drugimi zdravili z izjemo tistih, ki so omenjena v poglavju 6.6.
English: The CHMP noted that the scope of this SPC harmonisation procedure covers two strengths (500 mg and 1g) of the unique IV pharmaceutical form.
Slovenian: CHMP je ugotovil, da obseg tega postopka uskladitve povzetkov glavnih značilnosti zdravila zajema dve jakosti (500 mg in 1 g) edinstvene intravenske farmacevtske oblike.
English: The CHMP agreed that there should be an “immediate use” of reconstituted solutions, especially since very rapid degradation of Glucose 5% occurs.
Slovenian: CHMP se je strinjal, da je treba rekonstituirane raztopine uporabiti takoj, zlasti zaradi zelo hitrega razkrajanja 5-odstotne glukoze.
English: Improvement in lung function following an acute pulmonary exacerbation in CF is important to the quality of life and survival of the patient since lung function is the best predictor of mortality.
Slovenian: Izboljšanje pljučne funkcije po akutni pljučni eksacerbaciji pri cistični fibrozi je pomembno za kakovost življenja in preživetje bolnika, ker je pljučna funkcija najboljši napovedni kazalnik umrljivosti.
English: Therefore, section 6.3 of the SPC states that reconstituted solutions are to be used within 1 hour (this covers the preparation of the reconstituted solution and the duration of intravenous injection or infusion of the reconstituted solution).
Slovenian: Zaradi tega poglavje 6.3 povzetka glavnih značilnosti zdravila navaja, da je treba rekonstituirane raztopine uporabiti v 1 uri (to zajema pripravo rekonstituirane raztopine in trajanje intranvenskega injiciranja ali infundiranja rekonstituirane raztopine).
English: -- = Susceptibility testing not recommended as the species is a poor target for therapy with the medicinal product.
Slovenian: -- = Testiranje občutljivosti ni priporočljivo, ker je ta vrsta slabo primerna za zdravljenje s tem zdravilom.
English: The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
Slovenian: Edini presnovek meropenema je imel v študijah na živalih podoben profil toksičnih učinkov.
English: What Meronem is and what it is used for Before you use Meronem How to use Meronem Possible side effects
Slovenian: Kaj je zdravilo Meronem in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Meronem Kako uporabljati zdravilo Meronem Možni neželeni učinki
English: Nausea and changes in tests of liver function are among the commonest risks and these findings were reversible on discontinuation.
Slovenian: Slabost in spremembe v testih funkcije jeter so med najpogostejšimi tveganji, po prekinitvi uporabe zdravila pa so reverzibilni.
English: See leaflet for information.
Slovenian: Za informacije glejte navodilo.
English: Gram-negative aerobes Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa
Slovenian: Gramnegativni aerobi Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa
English: Inherently resistant organisms Gram-negative aerobes Stenotrophomonas maltophilia Legionella species
Slovenian: Inherentno odporni organizmi Gramnegativni aerobi Stenotrophomonas maltophilia Legionella species
English: The medicinal product is supplied in pack sizes of 1 or 10 vials.
Slovenian: Zdravilo je opremljeno v pakiranjih z 1 ali 10 vialami.
English: The symptoms include frequent infections, high temperature and sore throat.
Slovenian: Med simptomi so lahko pogoste okužbe, visoka telesna temperatura in vnetje žrela.
English: The CHMP considered that although the level of demonstration was more limited in adults than in children, meropenem is an adequate option for also treating adult cases of acute meningitis.
Slovenian: CHMP je menil, da je meropenem, čeprav je raven dokazovanja pri odraslih bolj omejena kot pri otrocih, primerna možnost tudi za zdravljenje primerov akutnega meningitisa pri odraslih.
English: Adverse reactions listed in the table with a frequency of “not known” were not observed in the 2,367 patients who were included in pre-authorisation clinical studies with intravenous and intramuscular meropenem but have been reported during the post-marketing period.
Slovenian: Neželenih učinkov, ki so v preglednici navedeni s pogostnostjo "neznano", niso opazili med 2.367 bolniki, vključenimi v klinične študije intravensko in intramuskularno uporabljenega meropenema pred izdajo dovoljenja za promet, temveč so jih zabeležili v postmarketinškem obdobju.
English: You will usually receive a dose every 8 hours.
Slovenian: Po navadi boste odmerek dobivali na 8 ur.
English: Therefore, as this reaction is considered relevant for the carbapenem class and as a wording has been mentioned in Section 4.4 of the SPC of other carbapenems, the CHMP agreed on the following statement in Section 4.4 of the Meronem SPC:
Slovenian: Ker ta reakcija velja za pomembno za razred karbapenemov in ker je omenjena v poglavju 4.4. povzetkov glavnih značilnosti zdravila za druge karbapeneme, se je CHMP strinjal z naslednjo izjavo v poglavju 4.4. povzetka glavnih značilnosti za zdravilo Meronem:
English: A population model developed from data in 79 patients with intra-abdominal infection or pneumonia, showed a dependence of the central volume on weight and the clearance on creatinine clearance and age.
Slovenian: Populacijski model, razvit na podlagi podatkov 79 bolnikov z intraabdominalnimi okužbami ali pljučnico, je pokazal odvisnost centralnega volumna od telesne mase in očistka od očistka kreatinina in starosti.
English: The CHMP noted that the proposed indication in complicated IAIs is in accordance with the clinical documentation and the clinical experience gained in this field.
Slovenian: CHMP je ugotovil, da je predlagana indikacija za zapletene intraabdominalne okužbe skladna s klinično dokumentacijo in kliničnimi izkušnjami, pridobljenimi na tem področju.
English: The solution should be shaken before use.
Slovenian: Raztopino je treba pred uporabo pretresti.
English: Finally, the “Species for which acquired resistance may be a problem” and the “Inherently resistant organisms” were revised.
Slovenian: Na koncu sta bili pregledani in popravljeni navedbi „Vrste, pri katerih lahko pridobljena odpornost pomeni težavo“ in „Naravno odporni organizmi“.
English: Dainippon Sumitomo Pharma Co. Ltd. (Oita, Japan), was the originator and ACS Dobfar SpA (Milano / Italy) is an alternative manufacturer of both the intermediate HECA, and the pure sterile meropenem trihydrate.
Slovenian: Družba Dainippon Sumitomo Pharma Co. Ltd. (Oita, Japonska) je originator, družba ACS Dobfar SpA (Milano, Italija) pa alternativni izdelovalec intermediata HECA in tudi čistega sterilnega meropenem trihidrata.
English: How to store Meronem Further information
Slovenian: Shranjevanje zdravila Meronem Dodatne informacije
English: Sections of the SPC pertaining to the quality aspects of the dossier, in particular sections 6.3 and 6.4 were also harmonised.
Slovenian: Usklajena so bili tudi poglavja povzetka glavnih značilnosti zdravila, ki se nanašajo na kakovostne vidike dokumentacije, še posebej poglavji 6.3 in 6.4.
English: Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher that in anuric patients.
Slovenian: Meropenem se odstrani s hemodializo in očistek med hemodializo je približno 4-krat večji kot pri anuričnih bolnikih.
English: The MAH submitted a harmonisation of Module 3.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil uskladitev 3. modula.
English: From a conceptual perspective, combinations of antibacterials from different classes may cover unsuspected pathogens, improve coverage for antibiotic-resistant pathogens like P. aeruginosa, prevent or reduce antibiotic resistance and achieve better clinical and bacteriological outcomes.
Slovenian: Iz idejnega vidika lahko kombinacije protibakterijskih zdravil iz različnih razredov zajamejo nepričakovane povzročitelje bolezni in večje število patogenov, odpornih na antibiotike, kot je P. aeruginosa, preprečujejo ali zmanjšajo antibiotično odpornost ter dosežejo boljše klinične in bakteriološke izide.
English: Faecal elimination represents only approximately 2% of the dose.
Slovenian: V blatu se izloči le približno 2 % odmerka.
English: Rare convulsions (see section 4.4)
Slovenian: Redki konvulzije (glejte poglavje 4.4)
English: Important information about some of the ingredients of Meronem Meronem contains sodium.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Meronem Zdravilo Meronem vsebuje natrij.
English: Recent susceptibility data for European isolates from various surveillance programmes and in light of clinical data, AstraZeneca propose that P. aeruginosa and Burkholderia cepacia will be listed under species that may be resistant to meropenem.
Slovenian: Družba AstraZeneca zaradi zadnjih podatkov o občutljivosti evropskih izolatov iz različnih programov nadzorovanja in zaradi kliničnih podatkov predlaga, da se bakteriji P. aeruginosa and Burkholderia cepacia navede med vrstami, ki so morda odporne na meropenem.
English: Therefore, the CHMP considered it more appropriate to group these sub-indications under general terms and therefore agreed the following indication:
Slovenian: Zaradi tega je CHMP menil, da je te podindikacije bolj primerno uvrstiti med splošne pogoje, tako da se je strinjal z naslednjo indikacijo:
English: The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours.
Slovenian: Farmakokinetika meropenema pri novorojenčkih, ki so potrebovali antiinfekcijsko zdravljenje, je pokazala večji očistek pri novorojenčkih z večjo kronološko ali gestacijsko starostjo; v celoti je bil povprečni razpolovni čas 2,9 ure.
English: Finally, with regards to the potential interaction with anticoagulants, the CHMP maintains its position that oral anticoagulants effects may be augmented when used concomitantly with antibiotics
Slovenian: CHMP je nazadnje glede na morebitno medsebojno delovanje z antikoagulanti ohranil svoje stališče, da se lahko učinki peroralnih antikoagulantov povečajo s sočasno uporabo antibiotikov.
English: European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below.
Slovenian: Spodaj so prikazane klinične mejne vrednosti za testiranje MIK po EUCAST (European Committee on Antimicrobial Susceptibility Testing).
English: These studies recruited patients with LRTI, which was appropriate at that time.
Slovenian: V te študije so vključili bolnike z okužbo spodnjih dihalnih poti, kar je bilo takrat primerno.
English: It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving meropenem.
Slovenian: Pomembno je, da zdravniku poveste, če ste noseči ali nameravate dojiti, preden dobite meropenem.
English: • The dose for adults is usually between 500 mg (milligrams) and 2 g (gram).
Slovenian: • Odmerek za odrasle je po navadi od 500 mg (miligramov) do 2 g (grama).
English: Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function.
Slovenian: Farmakokinetične študije pri bolnikih niso pokazale bistvenih farmakokinetičnih razlik v primerjavi z zdravimi osebami z enakim delovanjem ledvic.
English: No specific medicinal product interaction studies other than probenecid were conducted.
Slovenian: Specifične študije medsebojnega delovanja z drugimi zdravili razen probenecida niso bile izvedene.
English: Meronem contains sodium.
Slovenian: Meronem vsebuje natrij.
English: • If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem
Slovenian: • če ste alergični (preobčutljivi) na druge antibiotike, npr. peniciline, cefalosporine ali karbapeneme, ker ste lahko v tem primeru alergični tudi na meropenem.
English: The CHMP therefore unanimously considered that there is no place for CLSI as soon as EUCAST breakpoints are available.
Slovenian: CHMP je zato enoglasno menil, da se prelomne točke CLSI prenehajo uporabljati, takoj ko bodo na voljo prelomne točke EUCAST.
English: In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: V spodnji preglednici so vsi neželeni učinki navedeni po organskem sistemu in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: If your doctor decides to stop your treatment, dispose of any unused Meronem in an appropriate way.
Slovenian: Če se zdravnik odloči za prenehanje vašega zdravljenja, morate neuporabljeno zdravilo Meronem ustrezno zavreči.
English: AstraZeneca UK Ltd. Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
Slovenian: AstraZeneca UK Ltd. Alderley Park Macclesfield Cheshire SK10 4TF Velika Britanija
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in ostale oblike interakcij
English: Other possible side effects of unknown frequency
Slovenian: Drugi možni neželeni učinki, katerih pogostnost je neznana
English: • Your doctor or nurse will normally give Meronem to you.
Slovenian: • Običajno vam bo zdravilo Meronem dal zdravnik ali medicinska sestra.
English: Based on the Quality data submitted, the CHMP revised the text in this section and stated that the medicinal product is supplied in pack sizes of 1 or 10 vials and that not all pack sizes may be marketed.
Slovenian: Na temelju predloženih podatkov o kakovosti je CHMP pregledal besedilo tega poglavja in izjavil, da je zdravilo dostavljeno v velikostih pakiranja od 1 do 10 vial in ni nujno, da so v prometu vsa navedena pakiranja.
English: Giving the injection You can either give this medicine through a short cannula or venflon, or through a port or central line.
Slovenian: Injiciranje Zdravilo lahko daste po kratki kanili ali venflonu ali skozi nastavek ali centralni kanal.
English: • Sodium valproate (used to treat epilepsy).
Slovenian: • Natrijev valproat (uporablja se za zdravljenje epilepsije).
English: It was noted that this indication was claimed for adults and children, but no paediatric posology recommendation were proposed by the MAH, however, this is accepted given the claimed gynaecological infections.
Slovenian: Opazili so, da se je indikacija nanašala na odrasle in otroke, vendar imetnik dovoljenja za promet z zdravilom ni podal nobenih priporočil za pediatrično odmerjanje, kar pa so vseeno sprejeli zaradi navedenih ginekoloških infekcij.
English: No data is available, but it is not expected that Meronem will affect the ability to drive or use machines.
Slovenian: Za zdravilo Meronem ni podatkov, vendar se ne pričakuje, da bo vplivalo na sposobnost vožnje in upravljanje strojev.
English: In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %).
Slovenian: Analiza 4.872 bolnikov s 5.026 terapevtskimi izpostavljenostmi meropenemu je pokazala, da so bili v povezavi z meropenemom najpogosteje opisani neželeni učinki driska (2,3 %), izpuščaj (1,4 %), navzea/bruhanje (1,4 %) in vnetje na mestu injiciranja (1,1 %).
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Slovenian: Vrste, pri katerih je lahko problem pridobljena odpornost Grampozitivni aerobi
English: Data from this and a further study, of 122 patients (of whom 70 received meropenem in combination with tobramycin), conducted since the first registration show that meropenem is effective in the treatment of LRTI in patients with CF, and similar in effectiveness to ceftazidime alone or in combination with tobramycin.
Slovenian: Podatki iz te in iz dodatne študije pri 122 bolnikih (od katerih jih je 70 prejemalo meropenem v kombinaciji s tobramicinom), ki so jo izvedli od prve registracije zdravila, kažejo, da je meropenem učinkovit pri zdravljenju okužbe spodnjih dihalnih poti pri bolnikih s cistično fibrozo in da ima podobno učinkovitost kot cefazidim v obliki monoterapije ali v kombinaciji s tobramicinom.
English: Streptococcus groups A, B, C, G Streptococcus pneumoniae1 Other streptococci Enterococcus
Slovenian: Streptokoki skupine A, B, C, G Streptococcus pneumoniae1 Drugi streptokoki Enterococcus
English: Although other drugs do have activity against P. aeruginosa, specialists prefer to have a choice of agents to overcome issues of temporary reductions in susceptibility (i.e. antibiotic cycling), allergy or other intolerances.
Slovenian: Čeprav obstajajo druga zdravila, ki so aktivna proti bakteriji P. aeruginosa, imajo specialisti na voljo raje več zdravil, s katerimi premagujejo težave zaradi začasnega zmanjšanja občutljivosti (tj. kolobarjenje z antibiotiki), alergij ali drugih intoleranc.