FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no dose adjustment is considered to be necessary based on obesity alone.
Croatian: Međutim, smatra se da samo zbog pretilosti dozu ne treba prilagođavati.
English: The pharmacokinetics of daptomycin in paediatric subjects was evaluated in 3 single-dose pharmacokinetic studies.
Croatian: Farmakokinetika daptomicina u pedijatrijskih ispitanika bila je procijenjena u 3 farmakokinetička ispitivanja primjene jednokratne doze.
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Croatian: Farmakokinetika daptomicina u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) nije ispitivana.
English: Excretion of daptomycin into milk of lactating animals has not been studied.
Croatian: Izlučivanje daptomicina u mlijeko životinja za vrijeme laktacije nije ispitivano.
English: Animal studies showed that daptomycin is not absorbed to any significant extent after oral administration.
Croatian: Ispitivanja na životinjama pokazala su da se daptomicin nakon peroralne primjene ne apsorbira u značajnoj mjeri.
English: The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown.
Croatian: Nisu poznate interakcije daptomicina i tobramicina tijekom primjene daptomicina u odobrenoj dozi.
English: The efficacy of daptomycin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Croatian: Djelotvornost daptomicina u bolesnika s infekcijama umjetnih zalistaka ili s lijevostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus nije dokazana.
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Croatian: Važno: Prije propisivanja pročitati sažetak opisa svojstava lijeka.
English: Sodium hydroxide Citric acid
Croatian: natrijev hidroksid citratna kiselina
English: The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section
Croatian: Mogućnost dobivanja pogrešnih rezultata može se smanjiti tako da se uzorci za određivanje PV ili INR uzmu u vrijeme kada su koncentracije daptomicina u plazmi najniže (vidjeti dio 4.4).
English: Not known*: Acute generalised exanthematous pustulosis
Croatian: Akutna generalizirana egzantematozna pustuloza
English: Daptomycin should not be administered as a 2-minute injection to paediatric patients.
Croatian: Daptomicin se ne smije primijeniti kao 2-minutna injekcija pedijatrijskim bolesnicima.
English: If this applies to you, tell your doctor or nurse.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika ili medicinsku sestru.
English: Hospira UK Limited Horizon
Croatian: Hospira UK Ltd Horizon
English: There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes.
Croatian: Ne postoji kliničko iskustvo u bolesnika s primjenom daptomicina putem injekcije tijekom 2 minute.
English: In adults, daptomycin is given by intravenous infusion (see section 6.6) and administered over a 30-minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
Croatian: U odraslih se daptomicin daje intravenskom infuzijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 30 minuta ili intravenskom injekcijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 2 minute.
English: Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Croatian: Spol Nisu uočene klinički značajne razlike u farmakokinetici daptomicina s obzirom na spol.
English: In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient's pre-existing renal function (see section 4.5).
Croatian: Osim toga, tijekom istodobne primjene potencijalno nefrotoksičnih lijekova savjetuje se redovito praćenje bubrežne funkcije, bez obzira na prethodnu bubrežnu funkciju bolesnika (vidjeti također dio
English: Modified intent-to-treat Clinically evaluable Microbiologically evaluable (ME)
Croatian: Microbiologically evaluable, ME)
English: Studies of daptomycin with anticoagulants other than warfarin have not been conducted.
Croatian: Nisu provedena ispitivanja istodobne primjene daptomicina i drugih antikoagulansa osim varfarina.
English: Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Croatian: Daptomicin Hospira smije se rekonstituirati samo s otopinom natrijevog klorida 9 mg/ml (0,9%).
English: The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic impairment (Child-Pugh B classification of hepatic impairment) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/kg dose.
Croatian: Farmakokinetika daptomicina u ispitanika s umjerenim oštećenjem jetre (Child-Pugh stadij B oštećenja jetre), nakon primjene jednokratne doze od 4 mg/kg, nije se promijenila u usporedbi s onom u zdravih dobrovoljaca istog spola, dobi i tjelesne težine.
English: Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Croatian: Daptomicin se nije pokazao mutagenim ni klastogenim pomoću kompleta testova za ispitivanje genotoksičnosti in vivo i in vitro.
English: Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
Croatian: U kliničkim ispitivanjima u bolesnika primjenjivana je infuzija daptomicina tijekom najmanje 30 minuta.
English: What Daptomycin Hospira is and what it is used for What you need to know before you are given Daptomycin Hospira How Daptomycin Hospira is given Possible side effects
Croatian: Što je Daptomicin Hospira i za što se koristi Što morate znati prije nego počnete primati Daptomicin Hospira
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Daptomycin Hospira susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Croatian: Nositelj odobrenja osigurat će da svi laboratoriji za koje se očekuje da će izvoditi testove osjetljivosti na lijek Daptomicin Hospira dobiju: - sažetak opisa svojstava lijeka, - letak za laboratorije vezano uz testiranje osjetljivosti.
English: (Body Mass Index of >40 kg/m 2).
Croatian: veća u ekstremno pretilih ispitanika (indeks tjelesne mase > 40 kg/m 2).
English: Uncommon: Supraventricular tachycardia, extrasystole
Croatian: Supraventrikularna tahikardija, ekstrasistole
English: Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30-minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance (CL) decreased and systemic exposure (AUC) increased as renal function (creatinine clearance) decreased.
Croatian: Nakon primjene jednokratne intravenske doze daptomicina od 4 mg/kg ili 6 mg/kg tijekom 30 minuta odraslim ispitanicima s različitim stupnjevima oštećenja bubrega, ukupni se klirens daptomicina (CL) smanjivao, a sistemska izloženost (AUC) se povećavala kako se pogoršavala funkcija bubrega (smanjivao se klirens kreatinina).
English: Using a new syringe, insert the needle into the inverted vial.
Croatian: Koristeći novu štrcaljku umetnuti iglu u preokrenutu bočicu.
English: - That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
Croatian: Kod testiranja osjetljivosti na daptomicin potrebna je prisutnost kalcija u mediju za testiranje i preporučuju se metode ispitivanja kod kojih je koncentracija kalcija u mediju stalna.
English: - Adult and paediatric (1 to 17 years of age) patients withStaphylococcus aureus bacteraemia (SAB).
Croatian: - Odrasli i pedijatrijski bolesnici (u dobi od 1 do 17 godina) sa Staphylococcus aureus bakterijemijom (SAB).
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.
Croatian: Rekonstituirana i razrijeđena otopina se zatim treba primijeniti putem intravenske infuzije tijekom 30 ili 60 minuta.
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2).
Croatian: U pedijatrijskih bolesnika mlađih od 7 godina koji primaju dozu od 9-12 mg/kg, daptomicin treba primijeniti tijekom 60 minuta (vidjeti dijelove 4.2 i 5.2).
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Croatian: Uočene razlike su najvjerojatnije posljedica fiziološkog smanjenja bubrežne funkcije u starijoj populaciji.
English: Not known*: Eosinophilic pneumonia 1**, cough
Croatian: Eozinofilna pneumonija 1**, kašalj
English: Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Croatian: Razine kreatin fosfokinaze (CPK) moraju se mjeriti na početku i u redovitim razmacima (barem svakog tjedna) tijekom liječenja (vidjeti dio 4.4).
English: If CDAD is suspected or confirmed, daptomycin may need to be discontinued and appropriate treatment instituted as clinically indicated.
Croatian: Ako se posumnja ili potvrdi proljev povezan s bakterijom Clostridium difficile, možda će biti potrebno prekinuti liječenje daptomicinom te uvesti odgovarajuće klinički indicirano liječenje.
English: - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Croatian: - Odrasli i pedijatrijski bolesnici (u dobi od 1 do 17 godina) bolesnici s kompliciranim infekcijama kože i mekih tkiva.
English: In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes.
Croatian: U odraslih bolesnika, ta doza se daje izravno u krvotok (u venu) ili u obliku infuzije koja traje oko 30 minuta ili u obliku injekcije koja traje oko 2 minute.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Daptomycin Hospira are provided with: - Summary of Product Characteristics - Dosage card
Croatian: Nositelj odobrenja osigurat će da svi liječnici za koje se očekuje da će propisivati/primjenjivati lijek Daptomicin Hospira dobiju sljedeće: - sažetak opisa svojstava lijeka, - karticu za doziranje.
English: For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 hours at 2°C-8°C).
Croatian: Za 2-minutnu intravensku injekciju, vrijeme čuvanja rekonstituirane otopine u bočici (vidjeti dio 6.6) pri 25°C ne smije prelaziti 12 sati (ili 48 sati pri 2°C - 8°C).
English: The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed 12 hours (24 hours if refrigerated).
Croatian: Ukupno vrijeme čuvanja (rekonstituirane otopine u bočici i razrijeđene otopine u infuzijskoj vrećici) pri 25°C ne smije prelaziti 12 sati (ili 24 sata u hladnjaku).
English: - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
Croatian: - Odrasli bolesnici s desnostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus.
English: Your doctor will make sure you have a blood test and will advise whether or not to continue with Daptomycin Hospira.
Croatian: Vaš liječnik će se pobrinuti da obavite krvne pretrage i odrediti trebate li nastaviti primati lijek Daptomicin
English: 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Daptomycin Hospira for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Croatian: 12 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 60 minuta cSSTI = komplicirane infekcije kože i mekih tkiva; SAB = bakterijemija uzrokovana bakterijom S. aureus; (1) Minimalno trajanje liječenja lijekom Daptomycin Hospira za SAB u pedijatrijskih bolesnika treba biti sukladno opaženom riziku od komplikacija u pojedinog bolesnika.
English: On the second day after administration of a 6 mg/kg dose to HD and CAPD adult patients the daptomycin AUC was approximately 1.3-fold higher than that observed after a second 6 mg/kg dose in adult patients with normal renal function.
Croatian: Drugog dana nakon primjene doze od 6 mg/kg odraslim bolesnicima na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi AUC daptomicina bio je približno 1,3 puta veći u odnosu na AUC opažen nakon primjene druge doze od 6 mg/kg odraslim bolesnicima s normalnom funkcijom bubrega.
English: The safety and efficacy of daptomycin in children and adolescents aged below 18 years with RIE due to Staphylococcus aureus have not been established.
Croatian: Sigurnost i djelotvornost daptomicina u djece i adolescenata mlađih od 18 godina s desnostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus nisu ustanovljene.
English: Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes.
Croatian: Pedijatrijski bolesnici u dobi od 7 do 17 godina moraju primiti daptomicin u infuziji tijekom 30 minuta.
English: Uncommon: Dyspepsia, glossitis
Croatian: Dispepsija, glositis
English: Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion,
Croatian: Temeljeno na rezultatima tih ispitivanja, oba načina primjene daptomicina, 2-minutna intravenska injekcija i 30-minutna intravenska infuzija, imali su sličan sigurnosni profil i profil podnošljivosti.
English: 12-17 years (N=13)
Croatian: 12-17 godina (N=13)
English: Adults - cSSTI without concurrent SAB: daptomycin 4mg/kg is administered once every 24hours for 7-14 days or until the infection is resolved (see section 5.1).
Croatian: Odrasli - Komplicirane infekcije kože i mekih tkiva bez istodobne bakterijemije izazvane bakterijom Staphylococcus aureus: 4 mg/kg daptomicina primjenjuje se jedanput svaka 24 sata tijekom 714 dana ili dok infekcija ne prođe (vidjeti dio 5.1).
English: It may be necessary for your doctor to monitor your blood clotting times.
Croatian: Možda će biti potrebno da liječnik prati
English: On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
Croatian: Na temelju zabilježenih nuspojava, nije vjerojatno da bi daptomicin utjecao na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Unlike in adults, daptomycin should not be administered by injection over a 2-minute period in paediatric patients.
Croatian: Za razliku od odraslih, daptomicin se ne smije primijeniti kao 2-minutna injekcija pedijatrijskim bolesnicima.
English: Daptomycin pharmacokinetics in patients in this study are summarised in Table 2.
Croatian: Farmakokinetika daptomicina u bolesnika u ovom ispitivanju sažeto je prikazana u Tablici
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes as directed in section 4.2.
Croatian: Rekonstituirana i razrijeđena otopina zatim se treba primijeniti putem intravenske infuzije tijekom 30 ili 60 minuta, kao što je navedeno u dijelu 4.2.
English: After a single 6 mg/kg dose of daptomycin, the clearance and elimination half-life of daptomycin in children 13-24 months of age were similar to children 2-6 years of age who received a single 4-10 mg/kg dose.
Croatian: Nakon jednokratne doze daptomicina od 6 mg/kg, klirens i poluvijek eliminacije daptomicina u djece u dobi od 13 do 24 mjeseca bili su slični onima u djece u dobi od 2 do 6 godina koja su primila jednokratnu dozu od 4-10 mg/kg.
English: Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/or following administration for prolonged periods.
Croatian: Izolirani su sojevi sa smanjenom osjetljivošću na daptomicin, posebno pri liječenju bolesnika s infekcijama koje je teško liječiti i/ili nakon produljene primjene.
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes.
Croatian: U pedijatrijskih bolesnika mlađih od 7 godina koji primaju dozu od 9-12 mg/kg, daptomicin treba primijeniti tijekom 60 minuta.
English: In paediatric patients aged 1 to 6 years, Daptomycin Hospira is given by intravenous infusion over a 60-minute period (see section 6.6).
Croatian: U pedijatrijskih bolesnika u dobi od 1 do 6 godina daptomycin Hospira se primjenjuje intravenskom infuzijom tijekom razdoblja od 60 minuta (vidjeti dio 6.6).
English: The dosage regimen for daptomycin in paediatric patients with renal impairment has not been established.
Croatian: Režim doziranja daptomicina u pedijatrijskih bolesnika s oštećenjem funkcije bubrega nije ustanovljen.
English: Daptomycin Hospira given as 2-minute intravenous injection (adult patients only)
Croatian: Primjena lijeka Daptomicin Hospira kao intravenske injekcije tijekom 2 minute (samo odrasli bolesnici)
English: After a single 4 mg/kg dose of daptomycin, total clearance normalised by weight and elimination half-life of daptomycin in adolescents (12-17 years of age) with Gram-positive infection were similar to adults.
Croatian: Nakon jednokratne doze daptomicina od 4 mg/kg, ukupni klirens normaliziran prema tjelesnoj težini i poluvijek eliminacije daptomicina u adolescenata (u dobi od 12-17 godina) s Gram-pozitivnom infekcijom bili su slični onima u odraslih.
English: Therefore, it is recommended that: - Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients.
Croatian: Stoga se preporučuje: - U svih bolesnika treba određivati CPK u plazmi prije početka terapije i u pravilnim vremenskim razmacima tijekom terapije (najmanje jedanput tjedno).
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDBAC-11-02) with bacteraemia caused by Staphylococcus aureus.
Croatian: Sigurnost i djelotvornost daptomicina bile su procijenjene u pedijatrijskih bolesnika u dobi od 1 do 17 godina (ispitivanje DAP-PEDBAC-11-02) s bakterijemijom izazvanom bakterijom Staphylococcus aureus.
English: Clinical data on the use of daptomycin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Croatian: Desnostrani infektivni endokarditis izazvan bakterijom Staphylococcus aureus Klinički podaci o primjeni daptomicina u liječenju desnostranog infektivnog endokarditisa izazvanog bakterijom Staphylococcus aureus ograničeni su na 19 odrslih bolesnika (vidjeti "Informacije iz kliničkih ispitivanja" u dijelu 5.1).
English: Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C-8°C.
Croatian: Utvrđena stabilnost razrijeđene otopine u infuzijskoj vrećici iznosi 12 sati pri 25°C ili 24 sata ako se čuva u hladnjaku pri 2°C - 8°C.
English: Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis
Croatian: Trombocitemija, eozinofilija, povećanje internacionalnog normaliziranog omjera (INR), leukocitoza
English: In all populations the clinical success rates were comparable between the daptomycin and SOC treatment arms, supporting the primary efficacy analysis in the ITT population.
Croatian: U svim populacijama stope kliničkog uspjeha bile su usporedive između skupina liječenih daptomicinom i skupina liječenih standardom skrbi, što podupire primarnu analizu djelotvornosti u populaciji s namjerom liječenja.
English: In paediatric patients aged 7 to 17 years, Daptomycin Hospira is given by intravenous infusion over a 30-minute period (see section 6.6).
Croatian: U pedijatrijskih bolesnika u dobi od 7 do 17 godina Daptomycin Hospira se primjenjuje se intravenskom infuzijom tijekom razdoblja od 30 minuta (vidjeti dio 6.6).
English: Reconstituted solutions of Daptomycin Hospira range in colour from yellow to light brown.
Croatian: Boja rekonstituirane otopine lijeka Daptomicin Hospira u rasponu je od žute do svijetlo smeđe.
English: Indicationfor use Creatinine clearance Dose recommendation
Croatian: Indikacija za primjenu Klirens kreatinina
English: Indication cSSTI without SAB
Croatian: Indikacija cSSTI bez SAB-a cSSTI udružen sa SAB-om
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion
Croatian: Primjena lijeka Daptomicin Hospira kao intravenske infuzije tijekom 30 ili 60 minuta
English: If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin 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 je žarište infekcije utvrđeno nakon početka terapije daptomicinom, a ne radi se o kompliciranoj infekciji kože i mekih tkiva niti o desnostranom infektivnom endokarditisu, potrebno je razmotriti uvođenje alternativne antibakterijske terapije koja je dokazano djelotvorna u liječenju određene vrste prisutne infekcije ili infekcija.
English: For the 30-minute intravenous infusion, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C must not exceed 12 hours (or 24 at 2°C-8°C).
Croatian: Za 30-minutnu intravensku infuziju ukupno vrijeme čuvanja (rekonstituirane otopine u bočici i razrijeđene otopine u infuzijskoj vrećici; vidjeti dio 6.6) pri 25°C ne smije prelaziti 12 sati (ili 24 sata pri 2°C - 8°C).
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Croatian: Miozitis, povišen mioglobin, slabost mišića, bol u mišićima, artralgija, povišena razina laktat dehidrogenaze u serumu (LDH), grčevi u mišićima
English: No clinical data on pregnancies are available for daptomycin.
Croatian: Nisu dostupni klinički podaci o primjeni daptomicina u trudnoći.
English: Daptomycin is administered intravenously in 0.9% sodium chloride (see section 6.6).
Croatian: Daptomicin se primjenjuje intravenski u 0,9% otopini natrijevog klorida (vidjeti dio 6.6).
English: The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Croatian: Aztreonam nije značajno promijenio farmakokinetiku daptomicina.
English: Enterococcal infections
Croatian: Infekcije izazvane enterokokima
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 1 BOČICU
English: How to store Daptomycin Hospira
Croatian: Kako čuvati Daptomicin Hospira
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Croatian: KUTIJA ZA 5 BOČICA
English: Not known*: Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling, anaphylaxis**, infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
Croatian: Preosjetljivost**, koja se očitovala kao izolirana spontana izvješća koja su uključivala, ali nisu bila ograničena na angioedem, osip uzrokovan lijekom uz eozinofiliju i sistemske simptome (DRESS), plućnu eozinofiliju, vezikulobulozni osip koji je zahvatio sluznice i osjećaj orofaringealnog oticanja, anafilaksija**, reakcije na infuziju, uključujući sljedeće simptome: tahikardiju, piskanje, vrućicu, tresavicu, sistemsku pojavu crvenila uz osjećaj vrućine, vrtoglavicu, sinkopu i metalni okus u ustima