FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reaction profile of tigecycline in these 58 subjects was generally consistent with that in adults, with the exception of nausea (48.3 %), vomiting (46.6 %) and elevated lipase in serum (6.9 %) which were seen at greater frequencies in children than in adults.
Croatian: Profil nuspojava tigeciklina u tih 58 ispitanika općenito je bio dosljedna profilu odraslih, uz mučninu (48,3 %), povraćanje (46,6 %) i povećane lipaze u serumu (6,9 %) kao iznimke koje su učestalije primijećene u djece nego u odraslih.
English: C-tigecycline, radioactivity was well distributed to most tissues, with the highest overall exposure observed in bone marrow, salivary glands, thyroid gland, spleen, and kidney.
Croatian: C-tigeciklina, radioaktivnost se dobro distribuirala u većinu tkiva, pri čemu je najveća ukupna ekspozicija opažena u koštanoj srži, žlijezdama slinovnicama, štitnjači, slezeni i bubrezima.
English: Single dose
Croatian: Jedna doza
English: Decreased susceptibility in both groups has been attributed to the overexpression of the non-specific AcrAB multi-drug efflux pump.
Croatian: Smanjena osjetljivost u obje se skupine pripisuje pretjeranoj ekspresiji nespecifične AcrAB efluks pumpe za više lijekova.
English: Do not use this medicine after the expiry date which is stated on the vial.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici.
English: The Tygacil solution should be yellow to orange in colour after dissolving; if it is not, the solution should be discarded.
Croatian: Otopina Tygacila nakon otapanja treba biti žute do narančaste boje; ukoliko to nije slučaj, otopinu treba baciti.
English: How to store Tygacil
Croatian: Kako primjenjivati Tygacil
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Croatian: Nositelj odobrenja Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgija
English: • Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4);
Croatian: • Komplicirane infekcije kože i mekih tkiva, isključujući infekcije dijabetičkog stopala (vidjeti dio 4.4);
English: There are no or limited amount of data from the use of tigecycline in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni tigeciklina u trudnica ograničeni.
English: Animal and human pharmacokinetic studies have demonstrated that tigecycline readily distributes to tissues.
Croatian: Farmakokinetička ispitivanja na životinjama i ljudima pokazale su da se tigeciklin brzo distribuira u tkiva.
English: Warfarin did not affect the pharmacokinetic profile of tigecycline.
Croatian: Varfarin nije utjecao na farmakokinetički profil tigeciklina.
English: • Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)
Croatian: • Bol u trbuhu, dispepsija (bol u želucu i probavne smetnje), anoreksija (gubitak apetita)
English: A limited number of patients were enrolled with co-morbid factors such as diabetes (25.8 %), peripheral vascular disease (10.4 %), intravenous substance abuse (4.0 %), and HIVpositive infection (1.2 %).
Croatian: Uključen je ograničen broj bolesnika s istovremeno prisutnim bolestima poput šećerne bolesti (25,80%), periferne vaskularne bolesti (10,4%), ovisnika o intravenskim tvarima (4,0 %) te HIV-pozitivnom infekcijom (1,2%).
English: The vial should be gently swirled until the medicine is dissolved.
Croatian: Bočicu treba nježno vrtjeti sve dok se lijek ne otopi.
English: For intravenous use after reconstitution and dilution.
Croatian: Za primjenu u venu nakon pripreme i razrjeđivanja.
English: No loading dose was administered in these studies.
Croatian: U ovim ispitivanjima nije primijenjena udarna doza.
English: No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega ili u bolesnika koji su na hemodijalizi (vidjeti dio 5.2).
English: Common side effects are (may affect up to 1 in 10 people):
Croatian: Česte nuspojave su (mogu se javiti u do 1 od 10 osoba):
English: As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes (see section 4.4).
Croatian: Kao što je poznato za tetraciklinsku skupinu antibiotika, i tigeciklin može prouzročiti trajna oštećenja zuba (promjena boje i oštećenje cakline), usporiti proces osifikacije kod fetusa koji su bili in utero izloženi tijekom druge polovice trudnoće, kao i u djece mlađe od osam godina uslijed nakupljanja u tkivima s velikom pregradnjom kalcija i stvaranja kompleksa kelata kalcija (vidjeti dio 4.4).
English: Although hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medicinal products, a possible contribution of tigecycline should be considered (see section 4.8).
Croatian: Iako se zatajenje jetre može javiti u bolesnika liječenih tigeciklinom zbog drugih osnovnih bolesti ili istovremene primjene drugih lijekova, potrebno je razmotriti mogući doprinos tigeciklina (vidjeti dio 4.8).
English: In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline treated patients has been observed as compared to the comparator treatment.
Croatian: U kliničkim ispitivanjima s kompliciranim infekcijama kože i mekih tkiva, kompliciranim intraabdominalnim infekcijama, infekcijama dijabetičkog stopala, bolničkom pneumonijom i ispitivanjima rezistentnih patogena, opažena je brojčano veća stopa smrtnosti među bolesnicima koji su primali tigeciklin u odnosu na one koji su primali usporedni lijek.
English: Tygacil is distributed in a ten vial tray pack.
Croatian: Tygacil se isporučuje u pakovanju od deset bočica.
English: These may be symptoms of acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting).
Croatian: To mogu biti simptomi akutnog pankreatitisa (upale gušterače koja može dovesti do snažne boli u abdomenu, mučnine i povraćanja).
English: Tigecycline is vulnerable to chromosomally-encoded multi-drug efflux pumps of Proteeae and Pseudomonas aeruginosa.
Croatian: Tigeciklin je osjetljiv na kromosomski kodirane efluks pumpe za više lijekova u Proteeae i Pseudomonas aeruginosa.
English: In an open-label, ascending multiple-dose study, 39 children aged 8 to 11 years with cIAI or cSSTI were administered tigecycline (0.75, 1, or 1.25 mg/kg).
Croatian: U otvorenom ispitivanju s više postupno rastućih doza, 39 djece u dobi od 8 do 11 godina s cIAI or cSSTI dobili su tigeciklin (0,75, 1 ili 1,25 mg/kg).
English: Tygacil should not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and because tigecycline may be associated with permanent teeth discolouration (see sections 4.2 and 4.8).
Croatian: Tygacil se ne smije primjenjivati kod djece mlađe od 8 godina zbog nedostatka podataka o sigurnosti i djelotvornosti u toj dobnoj skupini i zato što tigeciklin može biti povezan s trajnom promjenom boje zuba(vidjeti dijelove 4.2 i 4.8).
English: Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients (see section 4.4).
Croatian: Tigeciklin treba po mogućnosti primjenjivati u infuziji trajanja 60 minuta u pedijatrijskih bolesnika (vidjeti dio 4.4).
English: Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Croatian: Bolesnici koji su preosjetljivi na tetraciklinsku skupinu antibiotika mogu biti preosjetljivi i na tigeciklin.
English: The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Croatian: Pomoćne tvari su laktoza hidrat, kloridna kiselina i natrijev hidroksid.
English: • Jaundice (yellow coloration of the skin), inflammation of the liver
Croatian: • Žutica (žutilo kože), upala jetre
English: Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40 % and 23 %, and an increase in AUC by 68 % and 29 %, respectively.
Croatian: Istovremena primjena tigeciklina i varfarina (jednokratna doza od 25 mg) kod zdravih ispitanika dovela je do smanjenja klirensa R-varfarina za 40%, a S-varfarina za 23% te porasta AUC-a Rvarfarina za 68% odnosno S-varfarina za 29%.
English: Bolus intravenous administration of tigecycline has been associated with a histamine response in animal studies.
Croatian: Bolusna intravenska primjena tigeciklina u ispitivanjima na životinjama povezana je s histaminskomreakcijom.
English: The single-dose pharmacokinetic disposition of tigecycline was not altered in patients with mild hepatic impairment.
Croatian: Farmakokinetička raspoloživost tigeciklina nakon jednokratnog doziranja nije bila promijenjena u bolesnika s blagim oštećenjem jetre.
English: Uncommon side effects are (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave su (mogu se javiti u do 1 od 100 osoba):
English: Tygacil may cause side effects such as dizziness.
Croatian: Tygacil može uzrokovati nuspojave poput omaglice.
English: AST and ALT abnormalities in tigecycline-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy.
Croatian: Poremećaji AST-a i ALT-a u bolesnika koji su primali tigeciklin češće su zabilježeni u razdoblju nakon terapije za razliku od bolesnika koji su primali usporedni lijek kod kojih su bili češći za vrijeme terapije.
English: In clinical trials in cSSTI, the most common type of infection in tigecycline treated-patients was cellulitis (58.6 %), followed by major abscesses (24.9 %).
Croatian: U kliničkim ispitivanjima s cSSTI-ovima (engl. complicated skin and soft tissue infections), najčešći oblik infekcije u bolesnika koji su liječeni tigeciklinom bio je celulitis (58,6) , a potom slijede veliki apscesi (24,9).
English: In all Phase 3 and 4 (cSSTI and cIAI) studies, death occurred in 2.4 % (54/2216) of patients receiving tigecycline and 1.7% (37/2206) of patients receiving active comparators.
Croatian: U svim ispitivanjima faze 3 i 4 (kompliciranih infekcija kože i mekih tkiva i kompliciranih intraabdominalnih infekcija), smrt je nastupila u 2,4% (54/2216) bolesnika koji su primali tigeciklin i 1,7% (37/2206) bolesnika koji su primali aktivne usporedne lijekove.
English: 5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals.
Croatian: Bočice od prozirnog stakla tipa 1 od 5 ml, sa sivim čepovima od butil gume i aluminijskim kapicama.
English: Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see section 6.2)
Croatian: Infuzijska otopina koja se primjenjuje treba biti kompatibilna s tigeciklinom i drugim lijekovima koji se daju u zajedničkoj liniji (vidjeti dio 6.2)
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline.
Croatian: Istovremena primjena P-gp inhibitora (npr. ketokonazol ili ciklosporin) ili P-gp induktori (npr. rifampicin) mogu djelovati na farmakokinetiku tigeciklina.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
Croatian: Stoga je ovu dijagnozu nužno uzeti u obzir u bolesnika koji se javljaju zbog proljeva tijekom ili neposredno nakon primjene bilo kojeg antibakterijskog lijeka (vidjeti dio 4.8).
English: Investigations elevated amylase in serum, increased blood urea nitrogen (BUN)
Croatian: Pretrage povećana razina amilaze u serumu, povećana razina dušika u krvi (BUN)
English: Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Croatian: Tigeciklin može biti povezan s trajnom promjenom boje zuba kod ljudi, ukoliko se primjenjuje u razdoblju razvoja zuba (vidjeti dio 4.8).
English: Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle), tigecycline should be used immediately.
Croatian: Nakon pripreme i razrjeđivanja u vrećici ili drugom prikladnom spremniku za infuziju (npr. staklenoj boci), tigeciklin treba odmah primijeniti.
English: Gastrointestinal disorders nausea, vomiting, diarrhoea abdominal pain, dyspepsia, anorexia acute pancreatitis (see section 4.4)
Croatian: Poremećaji probavnog sustava mučnina, povraćanje, proljev bol u trbuhu, dispepsija, anoreksija akutni pankreatitis (vidjeti dio 4.4)
English: For single use only, any unused solution should be discarded.
Croatian: Isključivo za jednokratnu primjenu; neupotrjebljena otopina mora se baciti.
English: • Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson
Croatian: • Kožni osip, koji može dovesti do izrazitog stvaranja mjehurića i ljuštenja kože (StevensJohnsonov sindrom).
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline (see section 5.2).
Croatian: Istovremena primjena P-gp inhibitora (npr. ketokonazola ili ciklosporina) ili P-gp induktora (npr. rifampicin) mogu imati utjecaj na farmakokinetički učinak tigeciklina (vidjeti dio 5.2).
English: This prevents incorporation of amino acid residues into elongating peptide chains.
Croatian: Na taj se način sprječava ugradnja ostataka aminokiselina u peptidne lance koji se produljuju.
English: Powder for solution for infusion 10 vials
Croatian: Prašak za otopinu za infuziju 10 bočica
English: Tetracycline class antibiotics
Croatian: Tetraciklinski antibiotici
English: • Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
Croatian: • Akutni pankreatitis (upala gušterače koja može rezultirati jakim bolom u trbuhu, mučninom, i povraćanjem)
English: Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with cIAI secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
Croatian: Nužan je oprez prilikom primjene kombinacije antibiotika u svim slučajevima u kojima se tigeciklin daje teškim bolesnicima s cIAI-ovima, koje su posljedica klinički verificirane perforacije crijeva ili bolesnicima s početnom sepsom ili septičkim šokom (vidjeti dio 4.8).
English: Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults.
Croatian: Tigeciklin primijenjen u zdravih odraslih ispitanika u preporučenoj dozi nije utjecao na brzinu ili opseg apsorpcije ili klirens digoksina (0,5 mg, te potom 0,25 mg dnevno).
English: • Pruritus (itching), rash
Croatian: • Pruritus (svrbež), osip
English: This in vitro information is consistent with the lack of effect of tigecycline on digoxin clearance noted in the in vivo drug interaction study described above (see section 4.5).
Croatian: Ta in vitro informacija koja je konzistentna sa smanjenjem učinka tigeciklina na klirens digoksina, zabilježenog u in vivo studiji interakcije opisana je u tekstu gore (vidjeti dio 4.5).
English: Tygacil should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 5.1).
Croatian: Tygacil se ne smije primjenjivati u djece ispod 8 godina starosti zbog promjene boje zubi (vidjeti dijelove 4.4 i 5.1).
English: If a focus of infection other than cSSTI or cIAI is identified after initiation of tigecycline therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Croatian: Ako se ustanovi žarište infekcije različito od komplicirane infekcije kože i mekih tkiva ili komplicirane intraabdominalne infekcije nakon uvođenja liječenja tigeciklinom, potrebno je razmotriti uvođenje alternativnog antibakterijskog liječenja koje se pokazalo djelotvorno u liječenju specifičnog tipa prisutne infekcije (ili više njih).
English: Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
Croatian: Adolescenti u dobi od 12 do <18 godina: 50 mg tigeciklina svakih 12 sati tijekom 5 do 14 dana.
English: Nervous system disorders dizziness
Croatian: Poremećaji živčanog sustava omaglica
English: Skin and subcutaneous tissue disorders pruritus, rash severe skin reactions, including Stevens-Johnson Syndrome
Croatian: Teške kožne reakcije, uključujući Stevens-Johnson sindrom
English: Tigecycline should be administered intravenously through a dedicated line or through a Y-site.
Croatian: Tigeciklin se mora primjenjivati intravenski kroz zasebnu liniju ili Y-liniju.
English: The target AUC0-12h in adults after the recommended dose of 100 mg loading and 50 mg every 12 hours, was approximately 2500 ng•h/mL.
Croatian: Ciljni AUC0-12h u odraslih nakon preporučene udarne doze od 100 mg te potom 50 mg svakih 12 sati iznosio je približno 2500 ng•h/ml.
English: • Vein irritations from the injection, including pain, inflammation, swelling and clotting
Croatian: • Nadraženost vene na mjestu injekcije, uključujući bol, upalu, oteklinu i ugruške
English: Renal clearance is approximately 13 % of total clearance.
Croatian: Bubrežni klirens iznosi otprilike 13% ukupnog klirensa.
English: (Cyprus Branch), Τηλ: +357 22 817690
Croatian: Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch), Τηλ: +357 22 817690
English: The safety of tigecycline was also investigated in an open-label, ascending multi-dose PK study in 58 children aged 8 to 11 years with cSSTI (n=15), cIAI (n=24) or community-acquired pneumonia (n=19).
Croatian: Sigurnost tigeciklina također je ispitivana u otvorenom farmakokinetičkom ispitivanju s više postupno rastućih doza u 58 djece u dobi od 8 do 11 godina s kompliciranim infekcijama kože i mekih tkiva (n=15), kompliciranim intraabdominalnim infekcijama (n=24) ili upalom pluća zadobivenom u socijalnim kontaktima (n=19).
English: Justification for not including Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za ne navođenje Braillea
English: Cross-resistance between tigecycline and minocycline-resistant isolates among the Enterobacteriaceae due to multi-drug resistance (MDR) efflux pumps has been shown.
Croatian: Pokazalo se da kod Enterobacteriaceae postoji križna rezistencija u izolata rezistentnih na tigeciklin i minociklin zbog efluks-pumpi rezistencije na više lijekova (MDR; od engl. multi-drug resistance).
English: The recommended dose in adolescents aged 12 to <18 years is 50 mg given every 12 hours.
Croatian: Preporučena doza u adolescenata u dobi od 12 do <18 godina je 50 mg koja se daje svakih 12 sati.
English: • Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
Croatian: • Porast amilaze, enzima koji se nalazi u žlijezdama slinovnicama i gušterači, porast dušika iz ureje u krvi (BUN)
English: It is unknown whether tigecycline/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se tigeciklin i njegovi metaboliti u majčino mlijeko u ljudi.
English: In repeated dose toxicity studies in rats and dogs, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone marrow hypocellularity, and adverse renal and gastrointestinal effects have been seen with tigecycline at exposures of 8 and 10 times the human daily dose based on AUC in rats and dogs, respectively.
Croatian: U ispitivanjima toksičnosti nakon višekratnog doziranja u štakora i pasa opaženi su limfoidna deplecija/atrofija limfnih čvorova, slezene i timusa, smanjeni broj eritrocita, retikulocita, leukocita i trombocita, povezani s hipocelularnošću koštane srži, kao i štetni učinci na bubrege i gastrointestinalni trakt, u slučaju izloženosti tigeciklinu u dozama koje su bile 8 odnosno 10 puta veće od dnevne doze kod ljudi, na temelju AUC kod štakora odnosno pasa.
English: Tigecycline may have adverse reactions similar to tetracycline class antibiotics.
Croatian: Tigeciklin može imati slične nuspojave slične tetraciklinskoj skupini antibiotika.
English: Tigecycline is not removed in significant quantities by haemodialysis.
Croatian: Hemodijalizom se ne uklanjaju značajne količine tigeciklina.
English: Tigecycline did not affect mating or fertility in rats at exposures up to 4.7 times the human daily dose based on AUC.
Croatian: Tigeciklin nije utjecao na parenje ni plodnost štakora pri izloženosti dozama do 4,7 puta većima od dnevne doze za ljude na temelju AUC-a.
English: In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.
Croatian: U kliničkim ispitivanjima provedenima na bolesnicima s kompliciranom intraabdominalnom infekcijom, poremećeno zacjeljivanje kirurških rana povezano je sa superinfekcijom.
English: Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Croatian: Takve reakcije uključuju fotosenzibilnost, pseudotumor velikog mozga, pankreatitis te antianabolički učinak koji dovodi do porasta dušika iz ureje u krvi (BUN), azotemije, acidoze i hiperfosfatemije (vidjeti dio 4.8).
English: • Pneumonia
Croatian: • Upala pluća
English: • If you are suffering from diarrhoea before you are given Tygacil.
Croatian: • Ako imate proljev prije primanja Tygacila.
English: Therefore, no dosage adjustment is necessary when tigecycline is administered with digoxin.
Croatian: Stoga nije potrebna prilagodba doze u slučaju istovremene primjene tigeciklina i digoksina.
English: Underlying diseases
Croatian: Osnovne bolesti
English: The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Croatian: Preporučena doza za odrasle osobe jest početna doza od 100 mg, nakon čega slijedi 50 mg svakih 12 sati tijekom 5 do 14 dana.
English: Hepatobiliary disorders elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia jaundice, liver injury, mostly cholestatic hepatic failure
Croatian: Poremećaji jetre i žuči povišena razina aspartat aminotransferaze (AST) u serumu, povišena alanin aminotransferaza (ALT) u serumu, hiperbilirubinemija žutica, ozljeda jetre, uglavnom kolestatska zatajenje jetre (vidjeti dio 4.4)
English: Cases of liver injury with a predominantly cholestatic pattern have been reported in patients receiving tigecycline treatment, including some cases of hepatic failure with a fatal outcome.
Croatian: U bolesnika koji su liječeni tigeciklinom prijavljeni su slučajevi oštećenja jetre pretežno kolestatskog tipa, uključujući neke slučajeve zatajenja jetre sa smrtnim ishodom.
English: Adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose.
Croatian: Doza u odraslih bolesnika treba se smanjiti na 25 mg svakih 12 sati nakon udarne doze od 100 mg.
English: Viridans group streptococci
Croatian: Skupina viridans streptokoka
English: In female rats, there were no compound-related effects on ovaries or oestrus cycles at exposures up to 4.7 times the human daily dose based on AUC.
Croatian: U ženki štakora nije bilo s djelatnom tvari povezanih učinaka na jajnike niti spolne cikluse pri izloženosti dozama do 4,7 puta većima od dnevne doze za ljude na temelju AUC-a.