FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncomplicated influenza in paediatric subjects aged 2-17 years The safety of peramivir was evaluated in a randomised, active-controlled study of 110 subjects with uncomplicated influenza who received open label treatment with a single dose of peramivir (600 mg for subjects 13 to 17 years of age and 12 mg/kg up to a maximum dose of 600 mg in subjects 2 to 12 years of age) or oral oseltamivir administered twice daily for 5 days.
Croatian: Nekomplicirana gripa u pedijatrijskih ispitanika u dobi od 2 do 17 godina Sigurnost peramivira ocijenjena je u randomiziranom, aktivno kontroliranom ispitivanju na 110 ispitanika s nekompliciranom gripom koji su podvrgnuti liječenju otvorenog tipa jednokratnom dozom peramivira (600 mg za ispitanike u dobi od 13 do 17 godina i 12 mg/kg do najveće doze od 600 mg u ispitanika u dobi od 2 do 12 godina) ili oralnom primjenom oseltamivira dvaput dnevno u razdoblju od pet dana.
English: 6.6 Special precautions for disposal and other handling Aseptic technique should be used during the preparation of Alpivab to prevent inadvertent microbial contamination.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek Alpivab potrebno je pripremiti primjenom aseptične metode kako bi se spriječilo nehotično mikrobiološko onečišćenje.
English: What Alpivab contains
Croatian: Što Alpivab sadrži
English: Children aged from 2 years and ≥50 kg body weight
Croatian: Djeca u dobi od dvije ili više godina i ≥50 kg tjelesne težine
English: Tell your doctor immediately if you experience abnormal behaviour after Alpivab is given.
Croatian: Odmah obavijestite svog liječnika ako primijetite neuobičajeno ponašanje nakon primjene lijeka Alpivab.
English: Treatment was given or commenced within 48 hours of onset of symptoms of influenza.
Croatian: Liječenje je primijenjeno ili započelo unutar 48 sati od pojavljivanja simptoma gripe.
English: Clinical trials in which single intravenous doses of peramivir were administered to patients with uncomplicated influenza included few subjects aged 65 and over (n=10).
Croatian: Kliničkim ispitivanjima u kojima su jednokratne intravenske doze peramivira primijenjene u bolesnika oboljelih od nekomplicirane gripe obuhvaćen je mali broj ispitanika u dobi od 65 godina i više (n = 10).
English: However, in an embryo-foetal development study in rats, in which dams received continuous infusions of peramivir from day 6-17 of gestation at doses of 50, 400 or 1000 mg/kg/day, dose related increases in the incidences of reduction of the renal papillae and dilatation of the ureters were observed.
Croatian: Međutim, u ispitivanju embrio-fetalnog razvoja na štakorima, u kojemu su ženke primale neprestane infuzije peramivira od 6. do 17. dana gestacije u dozama od 50, 400 ili 1000 mg/kg/dan, zabilježen je porast incidencije smanjenja bubrežne papile i dilatacije mokraćovoda povezan s dozom.
English: Inspect the Alpivab concentrate.
Croatian: 2. Provjerite koncentrat lijeka Alpivab.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Croatian: Učestalost se određuje prema sljedećim kategorijama: vrlo često (≥ 1/10), često (od ≥ 1/100 do < 1/10), manje često (od ≥ 1/1000 do < 1/100), rijetko (od ≥ 1/10 000 do < 1/1000), vrlo rijetko Tablica 3: Nuspojave u ispitivanjima peramivira za liječenje nekomplicirane gripe u odraslih Klasifikacija organskih sustava (SOC)
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
Croatian: • Ostali sastojci su natrijev klorid, voda za injekcije, kloridna kiselina (za prilagodbu pH vrijednosti), natrijev hidroksid (za prilagodbu pH vrijednosti).
English: The most important serious adverse reactions associated with peramivir in patients are anaphylaxis and skin reactions, including erythema multiforme and Stevens-Johnson Syndrome.
Croatian: Najvažnije ozbiljne nuspojave povezane s peramivirom u bolesnika jesu anafilaksa i kožne reakcije, uključujući multiformni eritem i Stevens-Johnsonov sindrom.
English: Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.
Croatian: Virusi gripe tipa A/H1N1 koji sadržavaju mutaciju H275Y imaju smanjenu osjetljivost na peramivir i oseltamivir.
English: Nervous system disorders hypoaesthesia, paraesthesia
Croatian: Poremećaji živčanog sustava hipoestezija, parestezija
English: Peramivir was not mutagenic or clastogenic in a battery of in-vitro and in-vivo assays.
Croatian: Peramivir nije pokazao ni mutageno ni klastogeno djelovanje u nizu in vitro i in vivo testova.
English: Crossresistance between peramivir and each of oseltamivir and zanamivir may also occur.
Croatian: Može doći i do unakrsne rezistencije između peramivira, oseltamivira i zanamivira.
English: In a study in subjects with various degrees of renal impairment and subjects with normal renal function, a single 2 mg/kg IV dose of peramivir was administered.
Croatian: U ispitivanju na ispitanicima s različitim stupnjevima oštećenja bubrega i ispitanicima s normalnom funkcijom bubrega primijenjena je jednokratna intravenska doza peramivira od 2 mg/kg.
English: Neuraminidase inhibition occurred at very low peramivir concentrations in-vitro, with median inhibitory concentration 50% (IC50) values of 0.13 nanomolar (nM) to 0.99 nM against influenza A and B strains.
Croatian: Do inhibicije neuraminidaze došlo je pri vrlo niskim koncentracijama peramivira in vitro, s medijanom vrijednosti inhibitorne koncentracije 50 % (IC50) od 0,13 nanomola (nM) do 0,99 nM za sojeve gripe tipa
English: The elimination half-life of peramivir following IV administration to healthy subjects of 600 mg as a single dose is approximately 20 hours.
Croatian: Poluvijek eliminacije peramivira nakon intravenske primjene na zdravim ispitanicima u jednokratnoj dozi od 600 mg iznosi približno 20 sati.
English: Blood and lymphatic system disorders neutrophil count decreased
Croatian: Poremećaji krvi i limfnog sustava smanjen broj neutrofila
English: How to store Alpivab
Croatian: Kako čuvati Alpivab
English: There are no or limited amount of data (less than 300 pregnancies outcomes) from the use of peramivir in pregnant women.
Croatian: Ne postoje podaci o primjeni peramivira u trudnica ili je njihova količina ograničena (manje od 300 ishoda trudnoće).
English: Metabolism and nutrition disorders blood lactate dehydrogenase increased decreased appetite, blood albumin decreased, blood chloride increased, blood glucose decreased, blood lactate dehydrogenase decreased, blood potassium increased, blood sodium increased, blood uric acid increased, protein total increased
Croatian: Poremećaji metabolizma i prehrane povišena razina laktatdehidrogenaze u krvi smanjen apetit, smanjena razina albumina u krvi, povišena razina klorida u krvi, smanjena razina glukoze u krvi, smanjena razina laktat-dehidrogenaze u krvi, povišena razina kalija u krvi, povišena razina natrija u krvi, povišena razina mokraćne kiseline u krvi, povećanje ukupne količine proteina
English: In a clinical trial in which 245 subjects were infected at baseline with influenza A/H1N1 containing the H275Y mutation, the median baseline IC50 values for peramivir, oseltamivir and zanamivir were 51.0 nM, 487.6 nM and 0.95 nM, respectively.
Croatian: U kliničkom ispitivanju u kojemu je 245 ispitanika na početku liječenja bilo zaraženo virusom gripe tipa A/H1N1 koji sadržava mutaciju H275Y, medijan početne vrijednosti IC50 za peramivir iznosio je 51,0 nM, za oseltamivir 487,6 nM i za zanamivir 0,95 nM.
English: Skin and subcutaneous tissue disorders dermatitis, drug eruption, eczema, urticaria erythema multiforme dermatitis exfoliative*, Stevens-Johnson syndrome*
Croatian: Poremećaji kože i potkožnog tkiva dermatitis, erupcija uzrokovana lijekom, ekcem, urtikarija multiformn i eritem eksfolijativni dermatitis*, StevensJohnsonov sindrom*
English: In adults and adolescents (from 13 years and 50 kg) with chronic renal impairment maintained on haemodialysis, peramivir should be administered after dialysis at a dose adjusted for renal function (Table 2).
Croatian: U odraslih i adolescenata (s ≥13 godina i ≥50 kg) s kroničnim oštećenjem funkcije bubrega koji se podvrgavaju hemodijalizi peramivir treba primjenjivati nakon dijalize u dozi prilagođenoj funkciji bubrega (tablica 2).
English: This medicinal product contains 212.4 mg sodium per 3 vials, equivalent to 10.6% of the World Health Organization (WHO) recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 212,4 mg natrija u tri bočice, što odgovara 10,6 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: Alpivab should be administered as a single intravenous dose within 48 hours of the onset of symptoms of influenza.
Croatian: Alpivab je potrebno primijeniti kao jednokratnu intravensku dozu unutar 48 sati od početka pojavljivanja simptoma gripe.
English: Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with peramivir (see section 4.8).
Croatian: Pri primjeni peramivira prijavljene su anafilaktičke reakcije i ozbiljne kožne reakcije (uključujući multiformni eritem, toksičnu epidermalnu nekrolizu i Stevens-Johnsonov sindrom) (vidjeti dio 4.8).
English: Immune system disorders anaphylactic reaction*, anaphylactic shock*
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija*, anafilaktički šok*
English: Each mL of concentrate contains 0.154 millimole (mmol) sodium, which is 3.54 mg of sodium.
Croatian: Jedan mililitar koncentrata sadrži 0,154 milimola (mmol) natrija, što odgovara količini od 3,54 mg natrija.
English: Acute renal necrosis was found in rabbits at doses ≥ 200 mg/kg with a clear no observed adverse effect level (NOAEL) established in multiple studies at 100 mg/kg/day.
Croatian: Akutna nekroza bubrega utvrđena je u kunića pri dozama ≥ 200 mg/kg, s jasnom razinom pri kojoj nije primijećen štetan učinak (engl. no observed adverse effect level, NOAEL) utvrđenom na 100 mg/kg/dan u više ispitivanja.
English: Study treatment was started within 48 hours of onset of symptoms.
Croatian: Ispitivano liječenje započelo je unutar 48 sati od pojavljivanja simptoma.
English: 13 years - <18
Croatian: 13 godina - <18
English: In paediatric subjects (age 2 to 17 years) with uncomplicated influenza enrolled in a clinical trial, the safety profile of peramivir was similar to that reported in adults.
Croatian: Sigurnosni profil peramivira u pedijatrijskih ispitanika (u dobi od 2 do 17 godina) s nekompliciranom gripom koji su sudjelovali u kliničkom ispitivanju bio je sličan sigurnosnom profilu zabilježenom u odraslih.
English: Each 20 mL vial contains 200 mg peramivir.
Croatian: Jedna bočica od 20 ml sadrži 200 mg peramivira.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of concentrate contains 200 mg peramivir.
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 20 ml koncentrata sadrži 200 mg peramivira.
English: Exposure (AUC0-12) to peramivir following a single dose was approximately 33 % higher in elderly subjects compared to young adults (61,334 vs. 46,200 ng•hr/mL, respectively).
Croatian: Izloženost (AUC0-12) peramiviru nakon jednokratne doze bila je približno 33 % veća u starijih ispitanika (61 334 ng•hr/ml) u odnosu na mlađe punoljetnike (46 200 ng•hr/ml).
English: • Children aged from 2 years weighing less than 50 kg receive 12 mg per kg body weight.
Croatian: • Djeca u dobi od 2 ili više godina i tjelesne težine manje od 50 kg primaju 12 mg po kg tjelesne težine.
English: Available information on influenza drug susceptibility should be taken into account when deciding whether to use peramivir (see section 5.1).
Croatian: Pri odlučivanju o primjeni peramivira potrebno je uzeti u obzir dostupne informacije o osjetljivosti na lijekove za gripu (vidjeti dio 5.1).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 3 vials
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 3 bočice
English: It is first diluted and then given into a vein by infusion (drip), over 15 to 30 minutes.
Croatian: Prvo se razrjeđuje, a zatim se infuzijom (dripom) daje u venu u trajanju od 15 do 30 minuta.
English: It is provided in a clear glass vial with a coated rubber stopper, aluminium overseal and flip-off cap.
Croatian: Nalazi se u prozirnoj staklenoj bočici s obloženim gumenim čepom, aluminijskim pokrovom i „flip-off“zatvaračem.
English: Gastrointestinal disorders nausea, vomiting abdominal pain upper, abdominal discomfort, gastritis
Croatian: Poremećaji probavnog sustava mučnina, povraćanje bol u gornjem dijelu abdomena, nelagoda u abdomenu, gastritis
English: • blood test showing increased levels of alanine aminotransferase, aspartate aminotransferase
Croatian: • povišena razina alanin aminotransferaze i aspartat aminotransferaze na pretragama krvi
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Peramivir is cleared by renal excretion and can be cleared by haemodialysis.
Croatian: Peramivir se uklanja bubrežnim izlučivanjem i može se ukloniti hemodijalizom.
English: Cardiac disorders electrocardiogram QT prolonged
Croatian: Srčani poremećaji produljeni QT interval na elektrokardiogramu
English: Dilute the required dose of Alpivab concentrate in sodium chloride 9 mg/mL (0.9 %) or 4.5 mg/mL (0.45 %) solution for infusion, 5 % dextrose or Ringer lactate solution to a volume of 100 mL.
Croatian: 5. Potrebnu dozu koncentrata lijeka Alpivab razrijedite otopinom natrijeva klorida od 9 mg/ml (0,9 %) ili 4,5 mg/ml (0,45 %) za infuziju, 5-postotnom otopinom dekstroze ili otopinom Ringerova laktata do volumena od 100 ml.
English: Mean (SD) Geometric Mean %CV
Croatian: Srednja vrijednost (SD) Geometrijska srednja vrijednost % CV
English: Hepatobiliary disorders increased gammaglutamyltransferase liver disorder*, alanine aminotransferase increased*, aspartate aminotransferase increased*
Croatian: Poremećaji jetre i žuči povišena razina gamaglutamiltransferaze poremećaj rada jetre*, povišena razina alanin aminotransferaze *, povišena razina aspartat aminotransferaze
English: Alpivab 200 mg concentrate for solution for infusion peramivir
Croatian: Alpivab 200 mg koncentrat za otopinu za infuziju peramivir
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju
English: Among the 93 subjects enrolled in the peramivir dose group, 43% were infected with influenza A virus (subtypes H1 and H3; 54 % and 46 %, respectively) and 27% with influenza B virus.
Croatian: Od 93 ispitanika u skupini koja je liječena dozom peramivira, 43 % je bilo zaraženo virusom gripe tip A (podtip H1 54 % i podtip H3 46 %), a 27 % virusom gripe tip B.
English: Use aseptic technique during the preparation of Alpivab to prevent microbial contamination.
Croatian: Alpivab pripremite primjenom aseptične metode kako bi se spriječilo mikrobiološko onečišćenje.
English: Reduced renal function
Croatian: Smanjena funkcija bubrega
English: Peramivir is not significantly metabolised in humans.
Croatian: Ne dolazi do značajne metabolizacije peramivira u ljudi.
English: Efficacy (time to resolution of fever; time to resolution of influenza symptoms, viral shedding, virus susceptibility) was a secondary endpoint.
Croatian: Sekundarna mjera ishoda bila je djelotvornost (vrijeme do prestanka vrućice, vrijeme do prestanka simptoma gripe, izlučivanje virusa, osjetljivost virusa).
English: NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Alpivab 200 mg koncentrat za otopinu za infuziju
English: Among the 97 subjects enrolled in the peramivir 600 mg dose group, 99 % were infected with influenza A virus (subtypes H1 and H3; 71 % and 26 %, respectively) and 1 % with influenza B virus.
Croatian: Od 97 ispitanika u skupini koja je liječena dozom peramivira od 600 mg, 99 % je bilo zaraženo virusom gripe tip A (podtip H1 71 % i podtip H3 26 %), a 1 % virusom gripe tip B.
English: Musculoskeletal and connective tissue disorders arthralgia, blood creatine phosphokinase increased
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija, povišena razina kreatin fosfokinaze u krvi
English: • liver disorder
Croatian: • poremećaj rada jetre
English: • Once a diluted peramivir solution has been prepared, administer immediately or store in a refrigerator (2 °C to 8 °C) for up to 24 hours.
Croatian: • Nakon što je razrijeđena otopina peramivira pripremljena, odmah je primijenite ili je čuvajte u hladnjaku (od 2 °C do 8 °C) najdulje 24 sata.
English: Alpivab is administered via intravenous infusion for 15 to 30 minutes.
Croatian: Alpivab se primjenjuje intravenskom infuzijom u trajanju od 15 do 30 minuta.
English: 2 years - <7 years
Croatian: 2 godine - <7 godina
English: Discard any unused diluted solution of Alpivab after 24 hours.
Croatian: 8. Neiskorištenu razrijeđenu otopinu lijeka Alpivab bacite nakon 24 sata.
English: If refrigerated, allow the diluted peramivir solution to reach room temperature, then administer immediately.
Croatian: Ako ste razrijeđenu otopinu peramivira čuvali u hladnjaku, ostavite je da dosegne sobnu temperaturu, a zatim odmah primijenite.
English: Clear glass vial (Type I) with a coated bromobutyl-rubber stopper, aluminium overseal and flip-off cap.
Croatian: Prozirna staklena bočica (tip I) s obloženim čepom od bromobutilne gume, aluminijskim pokrovom i „flip-off“ zatvaračem.
English: 7 years - <13 years
Croatian: 7 godina - <13 godina
English: If refrigerated, allow the diluted Alpivab solution to reach room temperature, then administer immediately.
Croatian: Ako ste razrijeđenu otopinu lijeka Alpivab čuvali u hladnjaku, ostavite je da dosegne sobnu temperaturu, a zatim odmah primijenite.
English: Peramivir had no effects on mating or fertility in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama peramivir nije imao učinak na parenje ili plodnost (vidjeti dio 5.3).
English: Recommended single dose 600 mg
Croatian: Preporučena jednokratna doza 600 mg od 30 do 49
English: The potential for interactions of peramivir with other medicines is low, based on the known elimination pathway of peramivir.
Croatian: Na temelju poznatog eliminacijskog puta peramivira, mogućnost interakcije peramivira s drugim lijekovima niska je.
English: 1 mL concentrate for solution for infusion contains 10 mg peramivir (anhydrous base).
Croatian: 1 ml koncentrata za otopinu za infuziju sadrži 10 mg peramivira (bezvodna osnova).
English: Mean peak concentrations of peramivir were approximately 10 % higher in elderly subjects following administration of a single dose when compared to young adults (22,647 vs. 20,490 ng/mL, respectively).
Croatian: Srednje vrijednosti vršnih koncentracija peramivira nakon primjene jednokratne doze bile su približno 10 % više u starijih ispitanika (22 647 ng/ml) u odnosu na mlađe punoljetnike (20 490 ng/ml).
English: Add the measured volume of Alpivab concentrate into the infusion container.
Croatian: 4. Izmjerenu količinu koncentrata lijeka Alpivab dodajte u spremnik infuzije.
English: How Alpivab is given
Croatian: Kako se Alpivab primjenjuje
English: 2 years - <18 years
Croatian: 2 godine - <18 godina
English: • abnormal sensation such as prickling, tingling and itchiness
Croatian: • neuobičajen osjećaj peckanja, svrbeža i trnaca
English: If a patient receives 600 mg peramivir the required volume of Alpivab concentrate is 60 mL (3 vials of 20 mL each).
Croatian: Ako bolesnik prima 600 mg peramivira, potrebna količina koncentrata lijeka Alpivab iznosi 60 ml (3 bočice, od kojih svaka sadrži 20 ml).
English: • blood tests showing decreased levels of albumin, glucose, lactate dehydrogenase
Croatian: • smanjena razina albumina, glukoze i laktat dehidrogenaze na pretragama krvi
English: Renal and urinary disorders blood urea increased, blood present in urine, urobilin present in urine, blood creatinine increased, urine ketone body increased acute kidney injury*, renal impairment*
Croatian: Poremećaji bubrega i mokraćnog sustava povišena razina ureje u krvi, prisutnost krvi u mokraći, prisutnost urobilina u mokraći, povišena razina kreatinina u krvi, povišena razina ketonskih tijela u mokraći akutno oštećenje bubrega*, oštećenje funkcije bubrega*
English: Alpivab contains sodium
Croatian: Alpivab sadrži natrij
English: • Children aged from 2 years weighing 50 kg or more receive 600 mg (3 Alpivab vials).
Croatian: • Djeca u dobi od 2 ili više godina i tjelesne težine od 50 kg ili više primaju 600 mg (3 bočice
English: The pharmacokinetics of peramivir in subjects with hepatic impairment has not been studied.
Croatian: Nije ispitana farmakokinetika peramivira u ispitanika s oštećenjem jetre.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: natrijev klorid voda za injekcije natrijev hidroksid (za prilagodbu pH vrijednosti) kloridna kiselina (za prilagodbu pH vrijednosti)
English: • nausea (feeling sick), vomiting
Croatian: • mučnina, povraćanje
English: In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of Alpivab concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Croatian: Za dozu peramivira od 300 mg potrebno je 30 ml (1½ bočice) koncentrata lijeka Alpivab, a za dozu od 200 mg, samo 20 ml (1 bočica).
English: Once a diluted Alpivab solution has been prepared, administer immediately or store in a refrigerator (2 °C to 8 °C) for up to 24 hours.
Croatian: 7. Nakon što je razrijeđena otopina lijeka Alpivab pripremljena, odmah je primijenite ili je čuvajte u hladnjaku (2 °C do 8 °C) najdulje 24 sata.
English: In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of peramivir concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Croatian: Za dozu peramivira od 300 mg potrebno je 30 ml (1½ bočice) koncentrata peramivira, a za dozu od 200 mg samo 20 ml (1 bočica).
English: • sleeplessness
Croatian: • nesanica
English: • blood tests showing increased levels of lactate dehydrogenase
Croatian: • povišena razina laktat dehidrogenaze na pretragama krvi
English: Geometric Mean %CV
Croatian: % CV
English: Cross resistance
Croatian: Unakrsna rezistencija
English: Once diluted, administer the prepared Alpivab solution immediately; otherwise, store in a refrigerator (2 °C - 8 °C) for up to 24 hours.
Croatian: Nakon razrjeđivanja, pripremljenu otopinu Alpivaba odmah primijenite ili je čuvajte u hladnjaku (2 °C - 8 °C) najdulje 24 sata.
English: Eye disorders vision blurred
Croatian: Poremećaji oka zamućen vid
English: General disorders and administration site conditions chest discomfort, fatigue *These events reported from post-authorization use occurred with different dosage and dosing schedule to that described in the SmPC.
Croatian: *Nuspojave zabilježene pri primjeni nakon davanja odobrenja koje su se javile pri dozama i rasporedu doziranja različitima od doza i rasporeda opisanih u sažetku opisa svojstava lijeka.
English: • Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
Croatian: • Primijenite razrijeđenu otopinu intravenskom infuzijom u trajanju od 15 do 30 minuta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL concentrate contains 10 mg peramivir (anhydrous basis).
Croatian: 1 ml koncentrata sadrži 10 mg peramivira (bezvodna osnova).
English: Delirium, hallucinations and abnormal behaviour have been reported in patients with influenza who were receiving peramivir.
Croatian: U bolesnika oboljelih od gripe koji su primili peramivir prijavljeni su delirij, halucinacije i neuobičajeno ponašanje.
English: • urobilin presented in the urine
Croatian: • prisutnost urobilina u mokraći
English: • If a patient receives 600 mg peramivir the required volume of peramivir concentrate is 60 mL
Croatian: • Ako bolesnik prima 600 mg peramivira, potrebna količina koncentrata peramivira iznosi 60 ml (3 bočice, od kojih svaka sadrži 20 ml).