FrancophonIA/ELRC3.0 huggingface dataset:
English: Findings on the male reproductive organs were also observed in rats in the repeated dose toxicity studies for 14 days or 13 weeks at exposures more than 10- or 5-fold the clinical exposure based on AUC.
Croatian: Nalazi na reproduktivnim organima mužjaka također su opaženi u štakora u ispitivanjima toksičnosti ponovljenih doza tijekom 14 dana ili 13 tjedana pri izloženosti 10 ili 5 puta većoj od kliničke izloženosti na temelju AUC-a.
English: The area under the plasma concentration-time curve (AUC) divided by the minimum inhibitory concentration (MIC) of eravacycline has been shown to be the best predictor of efficacy in vitro, utilising human steady state exposures in a chemostat and confirmed in vivo in animal models of infection.
Croatian: Površina ispod krivulje koja označava koncentraciju u plazmi u vremenu (AUC) podijeljenu s minimalnom inhibitornom koncentracijom (MIK) eravaciklina pokazala se kao najbolji prediktor djelotvornosti in vitro, s pomoću izloženosti ljudi u stanju dinamičke ravnoteže u kemostatu, što je potvrđeno in vivo na životinjskim modelima infekcije.
English: Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia
Croatian: Poremećaji jetre i žuči povišena razina aspartat aminotransferaze (AST) povišena razina alanin aminotransferaze (ALT) hiperbilirubinemija
English: However, the resulting difference in exposure to eravacycline in terms of AUC does not warrant dose adjustments in the weight range studied.
Croatian: Međutim, rezultirajuća razlika u izloženosti eravaciklinu izražena u AUC ne opravdava prilagodbe doze u ispitanom rasponu tjelesne težine.
English: Table 3 Example calculations for weights ranging from 40 kg to 200 kg
Croatian: Tablica 3 Primjer izračuna za tjelesne težine od 40 kg do 200 kg
English: MIC Breakpoints (µg/mL) Susceptible (S ≤)
Croatian: Granične vrijednosti MIK-a (µg/ml) Osjetljivost (S ≤)
English: Carcinogenicity studies with eravacycline have not been conducted.
Croatian: Nisu provedena ispitivanja karcinogenosti s eravaciklinom.
English: Within the range of eravacycline multiple intravenous doses studied clinically, the pharmacokinetic parameters AUC and Cmax demonstrate linearity, but with increasing doses the increase in both AUC and Cmax are slightly less than dose-proportional.
Croatian: Unutar raspona klinički ispitanih višestrukih intravenskih doza eravaciklina, farmakokinetički parametri AUC i Cmax pokazuju linearnost, no pri povećanim su dozama povećanja vrijednosti AUC i Cmax nešto manje nego proporcionalna dozi.
English: It is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to treatment with eravacycline (see section 4.8).
Croatian: Važno je razmotriti tu dijagnozu u bolesnika u kojih se pojavi proljev tijekom ili nakon liječenja eravaciklinom (vidjeti dio 4.8).
English: Recommended infusion bag size
Croatian: Preporučena veličina vrećice za infuziju
English: Xerava is available in packs containing 1 vial or multipacks comprising 12 cartons, each containing 1 vial.
Croatian: Lijek Xerava dostupan je u pakiranjima od 1 bočice ili višestrukim pakiranjima koja sadrže 12 kutija, a svaka sadrži 1 bočicu.
English: A drug-drug interaction in vivo cannot be excluded and co-administration of eravacycline and other medicinal products that inhibit these transporters (examples of OATP1B1/3 inhibitors; atazanavir, cyclosporine, lopinavir, and saquinavir) may increase the eravacycline plasma concentration.
Croatian: Interakcije između lijekova in vivo nije moguće isključiti te istodobna primjena eravaciklina i drugih lijekova koji inhibiraju te prijenosnike (primjerice, inhibitori OATP1B1/3; atazanavir, ciklosporin, lopinavir i sakvinavir) može povećati koncentraciju eravaciklina u plazmi.
English: The mean pharmacokinetic parameters of eravacycline after single and multiple intravenous infusions (60 minutes) of 1 mg/ kg administered to healthy adults every 12 hours are presented in Table 2.
Croatian: Srednje vrijednosti farmakokinetičkih parametara eravaciklina nakon jednokratne intravenske infuzije i nakon višestrukih intravenskih infuzija (60 minuta) od 1 mg/kg danih zdravim odraslim osobama svakih 12 sati navedene su u Tablici 2.
English: Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako tijekom ili nakon liječenja na mjestu infuzije primijetite bilo što od sljedećeg: crvenilo kože, osip, upalu, bol ili osjetljivost.
English: In vitro, eravacycline and its metabolites are not inhibitors or inducers of CYP enzymes or transport proteins (see section 5.2).
Croatian: Eravaciklin i njegovi metaboliti nisu in vitro inhibitori ni induktori CYP enzima ni proteina prijenosnika (vidjeti dio 5.2).
English: Therefore, such patients should be monitored for adverse reactions (see Section 4.8), particularly if these patients are obese and/or are also being treated with strong CYP3A inhibitors where the exposure may be further increased (see sections 4.5 and 5.2).
Croatian: Stoga je takve bolesnike potrebno pratiti radi otkrivanja eventualnih nuspojava (vidjeti dio 4.8), posebice ako su ti bolesnici pretili i/ili se također liječe jakim inhibitorima CYP3A pa izloženost može biti dodatno povećana (vidjeti dijelove 4.5 i 5.2).
English: Infusion site reactions can be mitigated by reducing the eravacycline infusion concentration or the infusion rate.
Croatian: Reakcije na mjestu infuzije moguće je ublažiti smanjenjem koncentracije infuzije ili brzine infuzije eravaciklina.
English: Animal studies indicate that eravacycline crosses the placenta and is found in foetal plasma.
Croatian: Ispitivanja na životinjama pokazuju da eravaciklin prolazi kroz posteljicu te ga je moguće pronaći u plazmi fetusa.
English: • Inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
Croatian: • upala i bol prouzročeni krvnim ugrušcima ne mjestu injekcije (tromboflebitis)
English: Eravacycline (and metabolites) is excreted in the milk of lactating rats.
Croatian: Eravaciklin (i njegovi metaboliti) izlučuju se u mlijeko ženki štakora.
English: Potential for other medicinal products to affect the pharmacokinetics of eravacycline
Croatian: Mogućnost drugih lijekova da utječu na farmakokinetiku eravaciklina
English: Xerava is used to treat adults with a complicated infection in the abdomen.
Croatian: Xerava se upotrebljava za liječenje odraslih s kompliciranim infekcijama u trbušnoj šupljini.
English: Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.
Croatian: Vaš liječnik može povećati dozu (1,5 mg/kg svakih 12 sati) ako uzimate druge lijekove, uključujući rifampicin, fenobarbital, karbamazepin, fenitoin ili gospinu travu.
English: Serious and occasionally fatal hypersensitivity reactions are possible and have been reported with other tetracycline class antibiotics (see section 4.3).
Croatian: Moguće su ozbiljne i povremeno smrtonosne reakcije preosjetljivosti te su prijavljene s drugim antibioticima tetraciklinske skupine (vidjeti dio 4.3).
English: Eravacycline did affect mating and fertility in male rats at clinically relevant exposures (see section 5.3).
Croatian: Eravaciklin je utjecao na parenje i plodnost u mužjaka štakora pri klinički relevantnim izloženostima (vidjeti dio 5.3).
English: Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6).
Croatian: Xerava se ne smije upotrebljavati u djece mlađe od osam godina zbog promjene boje zuba (vidjeti dijelove 4.4 i 4.6).
English: In clinical trials in cIAI, there were no immunocompromised patients, and the majority of patients (80%) had APACHE II scores <10 at baseline; 5.4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis.
Croatian: U kliničkim ispitivanjima kompliciranih intraabdominalnih infekcija nije bilo imunokompromitiranih bolesnika te je većina bolesnika (80 %) imala početnu vrijednost bodova prema APACHE II sustavu <10; 5,4 % bolesnika imalo je istodobnu bakterijemiju na početku ispitivanja; 34 % bolesnika imalo je kompliciranu upalu crvuljka.
English: Other bacterial resistance mechanisms that could potentially affect eravacycline are associated with upregulated, non-specific intrinsic multidrug-resistant (MDR) efflux.
Croatian: Drugi bakterijski mehanizmi rezistencije koji bi potencijalno mogli utjecati na eravaciklin povezani su s povećanom razinom ekspresije za nespecifični, intrizični efluks multiple rezistencije na antibiotike.
English: The observations included degeneration of the seminiferous tubules, oligospermia, and cellular debris in the epididymides, spermatid retention in the seminiferous tubules, increase of spermatid head retention in Sertoli cells, and vacuolation of Sertoli cells and decreased sperm counts.
Croatian: Opažanja su uključivala degeneraciju sjemenih kanalića, oligospermiju i stanične ostatke u epididimisu, zadržavanje spermatida u sjemenim kanalićima, povećan broj zadržavanja glava spermatida u Sertolijevim stanicama te vakuolizaciju Sertolijevih stanica i smanjen broj spermatozoida.
English: 10mL Type I glass vial with chlorobutyl rubber stopper and aluminium cap.
Croatian: Staklena bočica od 10 ml, staklo tipa I, s čepom od klorobutilne gume i aluminijskim poklopcem.
English: The powder for concentrate for solution for infusion (powder for concentrate) will be reconstituted in the vial with 5 mL of water for injections.
Croatian: Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat) rekonstituira se u bočici s 5 ml vode za injekcije.
English: Xerava is a pale yellow to dark yellow cake in a 10mL glass vial.
Croatian: Lijek Xerava blijedožuti je do tamnožuti kolačić u staklenoj bočici od 10 ml.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnoga tkiva osip hiperhidroza
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xerava in one or more subsets of the paediatric population in cIAI (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Xerava u jednoj ili više podskupina pedijatrijske populacije u liječenju kompliciranih intraabdominalnih infekcija (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: No adverse effects on mating or fertility were observed in female rats.
Croatian: Nisu opažene nuspojave povezane s parenjem ili plodnošću u ženki štakora.
English: - The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Croatian: - Ostali sastojci su manitol (E421), kloridna kiselina (za prilagodbu pH vrijednosti) i natrijev hidroksid (za prilagodbu pH vrijednosti).
English: Concomitant use of strong CYP3A4 inducers
Croatian: Istodobna primjena jakih induktora CYP3A4
English: Xerava will be given to you by a doctor or nurse.
Croatian: Lijek Xerava dat će Vam liječnik ili medicinska sestra.
English: Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions.
Croatian: Eravaciklin se primjenjuje intravenskom infuzijom tijekom približno jednog sata kako bi se rizik od reakcija na mjestu infuzije sveo na najmanju moguću mjeru.
English: Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline.
Croatian: Druge nuspojave prijavljene su s drugim tetraciklinskim antibioticima, uključujući minociklin i doksiciklin.
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 72 hours at refrigerated conditions (2-8°C) .
Croatian: Kemijska i fizikalna stabilnost u primjeni nakon razrjeđivanja u vrećicama za infuziju dokazana je nakon 72 sata na temperaturama hladnjaka (2-8°C) .
English: The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.
Croatian: Preporučena doza za odrasle temelji se na tjelesnoj težini te iznosi 1 mg/kg svakih 12 sati.
English: The in vitro binding of eravacycline to human plasma proteins increases with increasing concentrations, with 79%, 86% and 90% (bound) at 0.1, 1 and10 µg/mL, respectively.
Croatian: In vitro vezanje eravaciklina za proteine u ljudskoj plazmi povećava se s višim koncentracijama, pri čemu vezanje iznosi 79 %, 86 % odnosno 90 % pri 0,1 µg/ml, 1 µg/ml odnosno 10 µg/ml.
English: However, patients receiving strong CYP3A inhibitors (for example ritonavir, itraconazole, clarithromycin) with a combination of factors that may increase the exposure, such as severe hepatic impairment and/or obesity should be monitored for adverse reactions (see sections 4.4 and 4.8).
Croatian: Međutim, bolesnike koji primaju jake inhibitore CYP3A (na primjer ritonavir, itrakonazol, klaritromicin) uz kombinaciju čimbenika koji mogu povećati izloženost, kao što je teško oštećenje funkcije jetre i/ili pretilost, potrebno je pratiti radi otkrivanja eventualnih nuspojava (vidjeti dijelove 4.4 i 4.8).
English: After further dilution 1 mL contains 0.3 mg eravacycline.
Croatian: Nakon dodatnog razrjeđivanja 1 ml sadrži 0,3 mg eravaciklina.
English: In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5).
Croatian: U bolesnika koji istodobno primaju jake induktore CYP3A4 preporučeni režim doziranja iznosi 1,5 mg/kg eravaciklina svakih 12 sati tijekom 4 do 14 dana (vidjeti dijelove 4.4 i 4.5).
English: As for other tetracycline class antibiotics, eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses exposed in utero during the 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes (see sections 4.4 and 5.3).
Croatian: Kao i drugi antibiotici tetraciklinske skupine, eravaciklin može inducirati trajna oštećenja zuba (promjenu boje i oštećenja cakline) te odgoditi procese okoštavanja u fetusa izloženih in utero tijekom 2. i 3. tromjesečja trudnoće zbog nakupljanja u tkivima s visokom pregradnjom kalcija i oblikovanja kelatnog kompleksa s kalcijem (vidjeti dijelove 4.4 i 5.3).
English: Doses more than 2- or 4-fold higher than the clinical exposure (based on AUC) were associated with maternal toxicity (clinical observations and reduced body weight gain and food consumption), and reduced foetal body weights and delays in skeletal ossification in both species and abortion in the rabbit.
Croatian: Dvostruko ili četverostruko veće doze od kliničke izloženosti (na temelju AUC-a) bile su povezane s toksičnosti majke (klinička opažanja i smanjeno dobivanje na tjelesnoj težini te konzumacija hrane), smanjenom tjelesnom težinom fetusa i odgodama u okoštavanju u obje vrste te s pobačajima u kunića.
English: If pancreatitis is suspected, eravacycline should be discontinued.
Croatian: Ako se sumnja na pankreatitis, potrebno je prekinuti liječenje eravaciklinom.
English: Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1).
Croatian: Lijek Xerava indiciran je za liječenje kompliciranih intraabdominalnih infekcija (engl. complicated intra-abdominal infections, cIAI) u odraslih (vidjeti dijelove 4.4 i 5.1).
English: Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.
Croatian: Obavijestite svojeg liječnika ako imate problema s jetrom ili prekomjernu tjelesnu težinu, posebice ako već uzimate itrakonazol (za liječenje gljivičnih infekcija), ritonavir ( za liječenje virusnih infekcija) ili klaritromicin (antibiotik) jer će Vas u tom slučaju liječnik pratiti kako bi otkrio eventualne nuspojave.
English: Gently invert the bag to mix the solution.
Croatian: Pažljivo preokrenite vrećicu kako biste promiješali otopinu.
English: There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems.
Croatian: Ne postoji ciljno utemeljena križna rezistencija između eravaciklina i antibiotika drugih skupina kao što su kinoloni, penicilini, cefalosporini i karbapenemi.
English: • Breathing difficulties
Croatian: • poteškoće s disanjem
English: Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
Croatian: Produljena primjena može dovesti do pretjeranog rasta otpornih mikroorganizama, uključujući gljivice.
English: In clinical trials, the most common adverse reactions in patients with cIAI treated with eravacycline (n=576) were nausea (3.0%), vomiting, infusion site phlebitis (each 1.9%), phlebitis (1.4%), infusion site thrombosis (0.9%), diarrhoea (0.7%), vessel puncture site erythema (0.5%), hyperhidrosis, thrombophlebitis, infusion site hypoaesthesia, and headache (each 0.3%), which were generally mild or moderate in severity.
Croatian: U kliničkim su ispitivanjima najčešće nuspojave u bolesnika s kompliciranom intraabdominalnom infekcijom liječenih eravaciklinom (n = 576) bile mučnina (3,0 %), povraćanje, flebitis na mjestu infuzije (svaka 1,9 %), flebitis (1,4 %), tromboza na mjestu infuzije (0,9 %), proljev (0,7 %), eritem na mjestu uboda u krvnu žilu (0,5 %), hiperhidroza, tromboflebitis, hipoestezija na mjestu infuzije i glavobolja (svaka 0,3 %), koje su općenito bile blage do umjerene težine.
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Croatian: Suprotno tomu, nakon prekida može biti potrebno najmanje dva tjedna kako bi se indukcija CYP3A4 smanjila.
English: Name and address of the manufacturer(s) responsible for batch release Patheon Italia S.p.A.
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Patheon Italia S.p.A.
English: Eravacycline is metabolised primarily by CYP3A4- and FMO-mediated oxidation of the pyrrolidine ring to TP-6208, and by chemical epimerisation at C-4 to TP-498.
Croatian: Eravaciklin se metabolizira prvenstveno putem oksidacije pirolidinskog prstena posredovane CYP3A4 i FMO do TP-6208 te kemijskom epimerizacijom na C-4 do TP-498.
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava.
Croatian: Hitno potražite liječničku pomoć ako posumnjate da imate anafilaktičku reakciju dok primate lijek Xerava.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah, osim u slučaju kada način otvaranja/rekonstitucije/razrjeđivanja isključuje rizik od mikrobiološke kontaminacije.
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life-threatening.
Croatian: Kolitis povezan s antibioticima i pseudomembranozni kolitis prijavljeni su prilikom primjene gotovo svih antibiotika i prema težini mogu biti blagi do opasni po život.
English: Additional measures to reduce the occurrence and severity of infusion site reactions include decreasing the eravacycline infusion rate and/or concentration.
Croatian: Dodatne mjere za smanjenje pojave i težine reakcija na mjestu infuzije uključuju smanjenje brzine protoka i/ili koncentracije infuzije eravaciklina.
English: There are limited data on the use of eravacycline in pregnant women.
Croatian: Podaci o primjeni eravaciklina u trudnica su ograničeni.
English: Eravacycline and its metabolites are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 in vitro.
Croatian: Eravaciklin i njegovi metaboliti nisu inhibitori CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4 in vitro.
English: Antibiotic class adverse reactions include pseudomembranous colitis, and overgrowth of nonsusceptible organisms, including fungi (see section 4.4).
Croatian: Nuspojave skupine antibiotika uključuju pseudomembranozni kolitis i pretjeran rast otpornih organizama, uključujući gljivice (vidjeti dio 4.4).
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age.
Croatian: U populacijskoj farmakokinetičkoj analizi eravaciklina nisu opažene klinički značajne razlike u farmakokinetici eravaciklina s obzirom na dob.
English: Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.
Croatian: Nuspojave tetraciklinske skupine uključuju fotoosjetljivost, pseudotumor cerebri i antianaboličko djelovanje koji dovode do povišene razine ureje u krvi, azotemije, acidoze i hiperfosfatemije.
English: It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
Croatian: Lijek će se primijeniti kapanjem izravno u venu (intravenski) tijekom približno jednog sata.
English: Xerava will be given to you in hospital by a doctor or nurse.
Croatian: Lijek Xerava dat će Vam liječnik ili medicinska sestra u bolnici.
English: Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:
Croatian: Obratite se svojem liječniku ili medicinskoj sestri prije nego što primite lijek Xerava ako ste zabrinuti zbog bilo čega navedenog u nastavku:
English: • Inflammation of a vein causing pain and swelling (phlebitis)
Croatian: • upala vene koja uzrokuje bol i oticanje (flebitis)
English: Keep the vial in the inner carton in order to protect from light.
Croatian: Bočicu čuvati u unutarnjoj kutiji radi zaštite od svjetlosti.
English: No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega ili u bolesnika koji su na hemodijalizi.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John's Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako uzimate, ako ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove, uključujući rifampicin i klaritromicin (antibiotike), fenobarbital, karbamazepin i fenitoin (za liječenje epilepsije), gospinu travu (biljni pripravak za liječenje depresije i tjeskobe), itrakonazol (za liječenje gljivičnih infekcija), ritonavir, atazanavir, lopinavir i sakvinavir (za liječenje virusnih infekcija) te ciklosporin (za supresiju imunosnog sustava).
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:
Croatian: Hitno potražite liječničku pomoć ako sumnjate da imate anafilaktičku reakciju ili ako nastupi bilo koji simptom naveden u nastavku dok primate lijek Xerava:
English: mannitol (E421), sodium hydroxide, hydrochloric acid
Croatian: POPIS POMOĆNIH TVARI manitol (E421), natrijev hidroksid, kloridna kiselina