FrancophonIA/ELRC3.0 huggingface dataset:
English: A course of treatment usually lasts from 5 to up to 14 days, depending on the type of infection you have and how you respond to treatment.
Slovenian: Zdravljenje po navadi traja od 5 do 14 dni, odvisno od vrste okužbe, ki jo imate, in vašega odziva na zdravilo.
English: It can kill many types of bacteria.
Slovenian: Uniči lahko številne vrste bakterij.
English: Overall, the safety profile in these 61 children was similar to that observed in the adult population with cIAI.
Slovenian: Na splošno je bil varnostni profil pri teh 61 otrocih podoben kot pri odrasli populaciji s cIAI.
English: This test looks for antibodies that fight against your red blood cells.
Slovenian: Ta preiskava ugotavlja protitelesa, ki delujejo proti vašim lastnim rdečim krvnim celicam.
English: 2 hours
Slovenian: 2 uri
English: Elderly patients (≥65 years)
Slovenian: Starejši (≥ 65 let)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8, vendar priporočil o odmerjanju ni mogoče dati.
English: The reconstituted vial should be used immediately.
Slovenian: Rekonstituirano vialo je treba uporabiti takoj.
English: This is because it is not known if the medicine is safe to use in these age groups.
Slovenian: Ni namreč znano, ali je uporaba tega zdravila v teh starostnih skupinah varna.
English: From a microbiological point of view, the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
English: Paediatric population Safety and efficacy in children and adolescents below 18 years of age have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost pri otrocih in mladostnikih do 18. leta starosti še nista ugotovljeni.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristjo in tveganjem zdravila.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo antibiotikov.
English: If this happens do not take medicines that stop or slow bowel movement.
Slovenian: Če se to zgodi, ne jemljite zdravil, ki ustavijo ali upočasnijo gibanje črevesa.
English: • severe allergic reaction (see Serious side effects, above)
Slovenian: • huda alergijska reakcija (glejte Resni neželeni učinki, zgoraj)
English: Do not use this medicine after the expiry date which is stated on the container.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku.
English: Zavicefta than you should)
Slovenian: Zavicefta, kot bi smeli).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Zavicefta should not be used in children and adolescents .
Slovenian: Zdravila Zavicefta se ne sme uporabljati pri otrocih in mladostnikih.
English: • swelling under the skin, particularly lips and around the eyes
Slovenian: • oteklost pod kožo, zlasti na ustnicah in okrog oči.
English: Duration of treatment
Slovenian: Trajanje zdravljenja
English: • infections caused by bacteria that other antibiotics may not be able to kill
Slovenian: • okužb z bakterijami, ki jih drugi antibiotiki morda ne morejo uničiti.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Clinical efficacy against specific pathogens
Slovenian: Klinična učinkovitost proti specifičnim patogenom
English: Other infections
Slovenian: Druge okužbe
English: The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Slovenian: Celotni čas med začetkom priprave in koncem priprave intravenske infuzije ne sme preseči 30 minut.
English: It is possible that this could cause anaemia (which may make you feel tired) and jaundice (yellowing of the skin and eyes)
Slovenian: Obstaja verjetnost, da to povzroči anemijo (zaradi katere lahko občutite utrujenost) in zlatenico (porumenelost kože in oči).
English: Very rare: (may affect up to 1 in 10,000 people) • swelling in a part of the kidney that causes a reduction in its normal working function
Slovenian: Zelo redki: (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • oteklost v delu ledvice, ki zmanjša njeno normalno delovanje
English: It is available in packs containing 10 vials.
Slovenian: Na voljo je v pakiranjih, ki vsebujejo 10 vial.
English: In some patients, the creatinine clearance estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection.
Slovenian: Nekaterim bolnikom se lahko očistek kreatinina, ocenjen iz serumskega kreatinina, hitro spremeni, zlasti zgodaj v poteku zdravljenja okužbe.
English: Store in the original package in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The safety assessment in children is based on the safety data from 1 trial in which 61 paediatric patients aged from 3 years to less than 18 years with cIAI received Zavicefta.
Slovenian: Ocena varnosti pri otrocih temelji na podatkih o varnosti iz 1 preskušanja, v katerem je 61 pediatričnih bolnikov s cIAI, starih od 3 let do manj kot 18 let, prejemalo zdravilo Zavicefta.
English: What is in this leaflet:
Slovenian: Kaj vsebuje navodilo:
English: shown in blood tests
Slovenian: pokaže se na preiskavah krvi
English: Limitations of the clinical data
Slovenian: Omejitve kliničnih podatkov
English: The maximum recommended daily dose of this medicinal product contains 444 mg sodium (found in table salt).
Slovenian: Največji priporočeni dnevni odmerek tega zdravila vsebuje 444 mg natrija (ki ga najdemo v kuhinjski soli).
English: Antibacterial activity in combination with other antibacterial agents
Slovenian: Protibakterijsko delovanje v kombinaciji z drugimi protibakterijskimi zdravili
English: From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če sta bila priprava in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.
Slovenian: Klinični pomen tega ni znan, a zaradi možnega antagonizma in vivo se je treba tej kombinaciji zdravil izogibati.
English: This may affect you being able to drive, use tools or machines.
Slovenian: To lahko neugodno vpliva na vašo sposobnost upravljanja vozil, orodij in strojev.
English: In case of hypersensitivity reactions, treatment with Zavicefta must be discontinued immediately and adequate emergency measures must be initiated.
Slovenian: V primeru preobčutljivostnih reakcij je treba zdravljenje z zdravilom Zavicefta nemudoma prekiniti in uvesti ustrezne nujne ukrepe.
English: • severe allergic reactions - signs include sudden swelling of your lips, face, throat or tongue, a severe rash or other severe skin reactions, difficulty swallowing or breathing.
Slovenian: • Hude alergijske reakcije - med znaki so nenadna oteklost ustnic, obraza, žrela ali jezika, hud izpuščaj ali druge hude kožne reakcije, težko požiranje ali težko dihanje.
English: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Slovenian: Prašek je treba pripraviti z vodo za injekcije, nastali koncentrat pa nato takoj razredčiti pred uporabo.
English: Not known: (frequency cannot be estimated from the available data)
Slovenian: Neznana pogostnost: (ni mogoče oceniti iz razpoložljivih podatkov)
English: Patients with CrCL 30 to 50 mL/min received a lower dose of Zavicefta than is currently recommended for patients in this sub-group.
Slovenian: Bolniki z ledvičnim očistkom (CrCL) 30 do 50 ml/min so prejeli nižji odmerek zdravila Zavicefta kot je trenutno priporočeno pri bolnikih v tej podskupini.
English: Adverse reactions are classified according to frequency and System Organ Class.
Slovenian: Neželeni učinki so razvrščeni po pogostnosti in organskem sistemu.
English: Unknown (cannot be estimated from the available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately.
Slovenian: Celotno količino (približno 12,0 ml) nastale raztopine takoj prenesite v infuzijsko vrečko.
English: • you have kidney problems - your doctor may give you a lower dose to make sure you don't get too much medicine.
Slovenian: • če imate težave z ledvicami - vam bo zdravnik lahko predpisal nižji odmerek zdravila, da bo prepričan, da ne prejmete prevelikega odmerka zdravila.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: The compatibility of Zavicefta with other medicines has not been established.
Slovenian: Kompatibilnost zdravila Zavicefta z drugimi zdravili ni ugotovljena.
English: Alternatively they are stable for up to 24 hours under refrigerated storage.
Slovenian: Do 24 ur so stabilne tudi, če so shranjene v hladilniku.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2 do 8 °C, razen če sta priprava in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: This could cause symptoms such as fits (see section If you use more
Slovenian: To bi lahko povzročilo simptome, kot so napadi, podobni epileptičnim (glejte poglavje Če ste uporabili večji odmerek zdravila
English: Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions:
Slovenian: Kategorije pogostnosti so oblikovane na podlagi neželenih učinkov in/ali potencialno klinično pomembnih laboratorijskih nepravilnosti ter so opredeljene po naslednjem dogovoru:
English: Zavicefta can also affect the results of some urine tests for sugar.
Slovenian: Zdravilo Zavicefta lahko vpliva tudi na rezultate nekaterih preiskav za sladkor v urinu.
English: Patients with limited treatment options
Slovenian: Bolniki z omejenimi možnostmi zdravljenja
English: Studies have shown that Zavicefta solutions for infusion are stable for up to 12 hours at room temperature.
Slovenian: Študije so pokazale, da so raztopine za infundiranje Zavicefta na sobni temperaturi stabilne do 12 ur.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: These show how well your kidneys are working.
Slovenian: kako dobro vam delujejo ledvice
English: If you have kidney problems your doctor may lower your dose.
Slovenian: Če imate težave z ledvicami, vam bo zdravnik morda zmanjšal odmerek.
English: Volume of diluent to be added (mL)
Slovenian: Količina vehikla, ki jo je treba dodati (ml)
English: Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Slovenian: Možne so resne preobčutljivostne reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
English: • you are allergic to ceftazidime, avibactam or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na ceftazidim, avibaktam ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Once removed from refrigeration to room temperature, the diluted product must be used within 12 hours.
Slovenian: Ko je razredčeno zdravilo enkrat vzeto iz hladilnika in dano na sobno temperaturo, ga je treba uporabiti v 12 urah.
English: Clinical efficacy and safety studies of Zavicefta have been conducted in cIAI, cUTI and HAP (including VAP).
Slovenian: Klinične študije učinkovitosti in varnosti zdravila Zavicefta so izvedli le pri cIAI, cUTI in HAP (vključno z VAP).
English: Medicinal products that inhibit peristalsis should not be given.
Slovenian: Zdravil, ki zavirajo peristaltiko, se ne sme uporabljati.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Contains sodium carbonate - see package leaflet for further details.
Slovenian: Vsebuje natrijev karbonat - za dodatne podrobnosti glejte navodilo za uporabo.
English: Ceftazidime/avibactam should only be used during pregnancy if the potential benefit outweighs the possible risk.
Slovenian: Kombinacijo ceftazidima in avibaktama se sme med nosečnostjo uporabiti le, če morebitne koristi pretehtajo možno tveganje.
English: Uncommon Very rare
Slovenian: Zelo redki Neznana pogostnost
English: This is equivalent to 22.2% of the adult recommended maximum daily dietary intake for sodium.
Slovenian: To ustreza 22,2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Other types of interaction
Slovenian: Druge vrste medsebojnih delovanj
English: Plasma exposure levels at maternal and foetal NOAEL (100 mg/kg/day) indicate moderate to low margins of safety.
Slovenian: Plazemska koncentracija ob NOAEL za mater in plod (100 mg/kg/dan) kaže zmerno do nizko mejo varnosti.
English: Mix gently to reconstitute and check to see that the contents have dissolved completely.
Slovenian: Za pripravo previdno premešajte in se prepričajte, ali se je celotna vsebina povsem raztopila.
English: It is given as a drip into a vein - this will take about 2 hours.
Slovenian: Zdravilo se daje kot infuzija v veno; infundiranje traja približno 2 uri.
English: In seven Phase 2 and Phase 3 clinical trials, 2024 adult patients were treated with Zavicefta.
Slovenian: V sedmih kliničnih preskušanjih 2. in 3. faze so z zdravilom Zavicefta zdravili 2024 odraslih bolnikov.
English: In patients with renal impairment, close monitoring of estimated creatinine clearance is advised.
Slovenian: Pri bolnikih z okvaro ledvic je priporočljivo natančno spremljati ocenjeni očistek kreatinina.
English: 5-10 days
Slovenian: 5-10 dni
English: Instructions for the reconstitution of Zavicefta vial are summarized below:
Slovenian: Navodila za pripravo viale zdravila Zavicefta so povzeta spodaj:
English: The most common adverse reactions occurring in ≥ 5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea.
Slovenian: Najpogostejši neželeni učinki, ki so se pojavili pri ≥ 5 % bolnikov, zdravljenih z zdravilom Zavicefta, so bili pozitiven direktni Coombsov test, navzea in driska.
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8°C, followed by up to 12 hours at not more than 25
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani do 24 ur pri temperaturi od 2 do 8 °C in nato do 12 ur pri največ 25°C.
English: A 100 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Slovenian: Za pripravo infuzije je mogoče uporabiti 100-ml infuzijsko vrečko glede na količino, ki jo potrebuje bolnik.
English: 7-14 days
Slovenian: 7-14 dni
English: In two studies in patients with cIAI, the most common diagnosis (approximately 42%) was appendiceal perforation or peri-appendiceal abscess.
Slovenian: V dveh študijah pri bolnikih s cIAI je bila najpogostejša diagnoza (približno 42 %) predrtje slepiča ali periapendikalni absces.
English: Hospital-acquired pneumonia, including VAP
Slovenian: Bolnišnična pljučnica, vključno z VAP
English: During a 4-hour haemodialysis period, 55% of the avibactam dose was removed.
Slovenian: Štiriurna hemodializa je odstranila 55 % odmerka avibaktama.
English: Zavicefta will be given to you by a doctor or a nurse.
Slovenian: Zdravilo Zavicefta vam bo dal zdravnik ali medicinska sestra.
English: Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent.
Slovenian: Pred začetkom zdravljenja je treba ugotoviti, ali ima bolnik anamnezo preobčutljivostne reakcije na ceftazidim, kakšen drug cefalosporin ali katero koli drugo vrsto betalaktamskih antibiotikov.
English: A decision must be made whether to discontinue breast feeding or to discontinue/abstain from ceftazidime/avibactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja s kombinacijo ceftazidima in avibaktama, upoštevaje korist dojenja za otroka in korist zdravljenja za žensko.
English: The medicinal product is supplied in packs of 10 vials.
Slovenian: Zdravilo je opremljeno v pakiranjih z 10 vialami.
English: Excipient with known effect: each vial contains 6.44 mmol of sodium (approximately 148 mg).
Slovenian: Pomožna snov z znanim učinkom: ena viala vsebuje 6,44 mmol natrija (približno 148 mg).
English: Animal studies with ceftazidime do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Slovenian: Študije ceftazidima na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: CrCL estimated using the Cockcroft-Gault formula
Slovenian: Očistek kreatinina ocenjen s Cockcroft-Gaultovo formulo.
English: 2 hours Guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress
Slovenian: Odvisno od tega, kako huda je okužba, od patogena/patogenov in od bolnikovega kliničnega in bakteriološkega napredka
English: How Zavicefta works Zavicefta works by killing certain types of bacteria, which can cause serious infections.
Slovenian: Kako deluje zdravilo Zavicefta Zdravilo Zavicefta deluje tako, da uniči določene vrste bakterij, ki lahko povzročijo hude okužbe.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zavicefta in one or more subsets of the paediatric population in the treatment of intra-abdominal infections, urinary tract infections, pneumonia and Gram-negative bacterial infections (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zavicefta za eno ali več podskupin pediatrične populacije za zdravljenje intraabdominalnih okužb, okužb sečil, pljučnice in okužb z gramnegativnimi bakterijami (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Anaerobes
Slovenian: • Anaerobi
English: In the rat, no adverse effects were observed on embryofetal development or fertility.
Slovenian: Pri podganah niso opažali neželenih učinkov na embrio-fetalni razvoj ali plodnost.
English: The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta.
Slovenian: Poročali so o naslednjih neželenih učinkih ceftazidima samega in/ali ugotovljenih v kliničnih preskušanjih 2. in 3. faze z zdravilom Zavicefta.
English: Prolonged use may result in the overgrowth of non-susceptible organisms (e.g. enterococci, fungi), which may require interruption of treatment or other appropriate measures.
Slovenian: Dolgotrajna uporaba lahko povzroči razrast neobčutljivih organizmov (npr. enterokokov, gliv); to lahko zahteva prekinitev zdravljenja ali druge ustrezne ukrepe.
English: If you have too much Zavicefta it could have an effect on the brain and cause fits or coma.
Slovenian: Če ste prejeli prevelik odmerek zdravila Zavicefta, bi lahko to imelo učinek na možgane in povzročilo napade, podobne epileptičnim ali komo.
English: • redness, pain or swelling where Zavicefta was given into a vein
Slovenian: • pordelost, bolečina ali oteklost na mestu, kjer ste zdravilo Zavicefta dobili v veno
English: Approximately 87% of patients had APACHE II scores of ≤ 10 and 4.0% had bacteraemia at baseline.
Slovenian: Približno 87 % bolnikov je imelo oceno APACHE II ≤ 10 in 4 % so imeli izhodiščno bakteriemijo.
English: The resulting solution should be administered over 120 minutes.
Slovenian: Nastalo raztopino je treba infundirati 120 minut.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja pripravljenega in razredčenega zdravila glejte poglavje 6.3.
English: Zavicefta is administered by intravenous infusion over 120 minutes in an infusion volume of 100 mL.
Slovenian: Zdravilo Zavicefta se daje v 120-minutni intravenski infuziji v infuzijskem volumnu 100 ml.
English: The total inuse stability from reconstitution to administration should not exceed 36 hours (24 hours at 2-8°C plus 12 hours room temperature).
Slovenian: Celotni čas od priprave do dajanja zdravila zaradi stabilnosti ne sme preseči 36 ur (24 ur na temperaturi od 2 do 8 °C in 12 ur na sobni temperaturi).
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Slovenian: Drugi neželeni učinki Zdravniku ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov:
English: Pharmacokinetic/pharmacodynamic relationship
Slovenian: Farmakokinetično/farmakodinamično razmerje
English: Death occurred in 2.1% (18/857) of patients who received Zavicefta and metronidazole and in 1.4% (12/863) of patients who received meropenem.
Slovenian: Smrt se je pojavila pri 2,1 % (18/857) bolnikih, ki so prejeli zdravilo Zavicefta in metronidazol in pri 1,4 % (12/863) bolnikih, ki so prejeli meropenem.
English: Probenecid (a potent OAT inhibitor) inhibits this uptake by 56% to 70% in vitro and, therefore, has the potential to alter the elimination of avibactam.
Slovenian: Probenecid (ki močno zavira OAT) in vitro zavre ta prevzem za 56 do 70 % in tako lahko spremeni izločanje avibaktama.