natgillin/translations-raw huggingface dataset:
Tell your doctor immediately if you experience serious skin or allergic reactions after Alpivab is given.
Odmah obavijestite svog liječnika ako primijetite ozbiljne reakcije na koži ili alergijske reakcije nakon primjene lijeka Alpivab.
In a clinical trial, no statistically significant clinical benefit could be demonstrated for peramivir over placebo in patients infected with the A/H1N1 virus containing the H275Y mutation.
U kliničkom se ispitivanju nije mogla dokazati ni jedna statistički značajna klinička korist peramivira u odnosu na placebo u bolesnika zaraženih virusom gripe tipa A/H1N1 koji sadržava mutaciju H275Y.
These events were reported primarily among paediatric patients and often had an abrupt onset and rapid resolution.
Ti su događaji zabilježeni ponajprije među pedijatrijskim bolesnicima te je često došlo do njihova naglog nastanka i brzog prestanka.
• increased level of urine ketone body
• povišena razina ketonskih tijela u mokraći
In simulations of a single dose of 600 mg, the predicted AUC in Asians (AUC0-24 88,800 ng•h/mL) was slightly higher as compared to Non-Asians (AUC0-24 77,200 ng•h/mL).
U simulacijama jednokratne doze od 600 mg predviđeni AUC u bolesnika Azijaca (AUC0-24 88 800 ng•h/ml) bio je nešto viši u odnosu na bolesnike koji nisu Azijci (AUC0-24 77 200 ng•h/ml).
%CV SD = Standard Deviation; CV = Coefficient of Variation
Srednja vrijednost (SD) Geometrijska srednja vrijednost % CV SD = standardna devijacija; CV = koeficijent varijacije
• acute kidney injury, reduced kidney function
• akutno oštećenje bubrega, smanjena funkcija bubrega
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
Live attenuated influenza vaccines should not be given until 48 hours after treatment with Alpivab.
Živa atenuirana cjepiva protiv gripe ne smiju se davati u razdoblju od 48 sati nakon liječenja lijekom Alpivab.
• Visually inspect the peramivir concentrate 10 mg/mL.
• Vizualno provjerite koncentrat peramivira od 10 mg/ml.
Elderly No dose adjustment is required based on age (see sections 4.4 and 5.2).
Nije potrebna prilagodba doze na osnovi dobi (vidjeti dijelove 4.4 i 5.2).
The primary endpoint, time to alleviation of symptoms, was defined as the number of hours from initiation of study drug until the start of the 24 hour period in which all seven symptoms of influenza (cough, sore throat, nasal congestion, headache, feverishness, myalgia and fatigue) were either absent or present at a level no greater than mild for at least 21.5 hours.
Primarna mjera ishoda, vrijeme potrebno za ublažavanje simptoma, definirana je kao broj sati od početka primjene ispitivanog lijeka do početka 24-satnog razdoblja u kojem je svih sedam simptoma gripe (kašalj, grlobolja, začepljenost nosa, glavobolja, grozničavost, mialgija i umor) izostalo ili bilo prisutno na razini ne većoj od blage najmanje 21,5 sati.
Table 2: Peramivir dose for adults and adolescents (from 13 years and 50 kg) based on absolute GFR Absolute Glomerular Filtration Rate (GFR)*
Tablica 2: Doza peramivira za odrasle i adolescente (s ≥13 godina i ≥50 kg) na temelju apsolutnog GFR-a Apsolutna brzina glomerularne filtracije (GFR)*
Live attenuated influenza vaccines are not recommended to be used until 48 hours following Alpivab administration due to a theoretical risk that peramivir could reduce the immunogenicity of the vaccine.
Ne preporučuje se primjena živih atenuiranih cjepiva protiv gripe prije isteka 48 sati nakon davanja lijeka Alpivab zbog teoretskog rizika da bi peramivir mogao smanjiti imunogenost cjepiva.
There is no preservative or antibacterial agent in the solution.
U otopini nema konzervansa ni antibakterijskih tvari.
Pharmacokinetics of peramivir in subjects 2 to 17 years of age (administered 12 mg/kg or 600 mg according to age and body weight) and in healthy adults (administered 600 mg) was similar (Table 5).
Farmakokinetika peramivira u ispitanika u dobi od 2 do 17 godina (koji su primili 12 mg/kg ili 600 mg u skladu s dobi i tjelesnom težinom) i u zdravih odraslih ispitanika (koji su primili 600 mg) bila je slična (tablica 5).
Resistance
Otpornost
The pharmacokinetics of peramivir was evaluated in 20 elderly subjects (>65 years of age) following a single 4 mg/kg IV dose of peramivir.
Farmakokinetika peramivira ocijenjena je na 20 starijih bolesnika (>65 godina) nakon jednokratne intravenske doze peramivira od 4 mg/kg.
No human data on the effect of peramivir on fertility are available.
Nisu dostupni podaci o učincima peramivira na plodnost u ljudi.
The pharmacokinetics of peramivir has been evaluated in a study in paediatric subjects 2 to 17 years of age with uncomplicated influenza.
Farmakokinetika peramivira ocijenjena je u ispitivanju na pedijatrijskim ispitanicima u dobi od 2 do 17 godina oboljelima od nekomplicirane gripe.
Pack size of 3 single-use vials.
Pakiranje od 3 bočice za jednokratnu uporabu.
Available pharmacodynamic/toxicological data in animals have shown excretion of peramivir in milk (see section 5.3).
Dostupni farmakodinamički/toksikološki podaci pokazali su da se u životinja peramivir izlučuje u mlijeko (vidjeti dio 5.3).
In clinical trials, H275Y was the only resistance-associated treatment-emergent mutation in the neuraminidase gene that occurred in virus obtained from more than one peramivir-treated subject (in 9 of 481[1.9 %] infected with the A/H1N1 influenza virus).
U kliničkim je ispitivanjima mutacija H275Y bila jedina mutacija nastala tijekom liječenja povezana s otpornošću u genu neuraminidaze koja se pojavila u virusu dobivenom od više od jednog ispitanika liječenog peramivirom (u 9 od 481 [1,9 %] zaraženih virusom gripe tipa A/H1N1).
No clinically relevant alterations to peramivir pharmacokinetics are expected in patients with hepatic impairment based on the route of peramivir elimination.
Ne očekuju se klinički bitne promjene u farmakokinetici peramivira u bolesnika s oštećenjem jetre na temelju načina eliminacije peramivira.
The pharmacokinetics of peramivir following a 600 mg intramuscular (IM) injection was similar in males and females with AUC0-∞ of 76,600 ng•hr/mL and 101,000 ng•hr/mL, respectively, and Cmax of 27,760 ng/mL and 34,710 ng/mL, respectively.
Farmakokinetika peramivira nakon intramuskularne (i.m.) injekcije od 600 mg bila je slična u muškaraca i žena s AUC0-∞ od 76 600 ng•hr/ml i 101 000 ng•hr/ml te Cmax od 27 760 ng/ml i 34 710 ng/ml.
Uncommon, may affect up to 1 in 100 people
Manje često, mogu se pojaviti u do 1 na 100 osoba
• Add the measured volume of peramivir concentrate into the infusion container.
• Izmjerenu količinu koncentrata peramivira dodajte u spremnik infuzije.
Unknown
Rijetko Nepoznato
Psychiatric disorders insomnia abnormal behaviour*, delirium*
Psihijatrijski poremećaji nesanica neuobičajeno ponašanje*, delirij*
The ITTI population included 84 subjects with influenza confirmed by PCR.
Populacija ITTI obuhvaćala je 84 ispitanika oboljela od gripe potvrđene lančanom reakcijom polimeraze.
Common adverse reactions not reported in adults were injection site rash, pyrexia, tympanic membrane hyperaemia, psychomotor hyperactivity, and pruritus.
Česte nuspojave koje nisu zabilježene u odraslih bile su osip na mjestu injiciranja, pireksija, hiperemija timpanske membrane, psihomotorna hiperaktivnost i pruritus.
The elderly subjects enrolled were aged 65 to 79 years, with a mean age of 70.1 years, with creatinine clearance (Cockcroft-Gault calculation) CrClcg ranging from 82.8 mL/min to 197.9 mL/min.
Stariji ispitanici obuhvaćeni ispitivanjem bili su u dobi od 65 do 79 godina, srednje vrijednosti dobi od 70,1 godina, s vrijednosti klirensa kreatinina (CockcroftGaultova formula) CrClcg u rasponu od 82,8 ml/min do 197,9 ml/min.
Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin.
Simptomi mogu uključivati oticanje kože ili grla, otežano disanje, osip u obliku mjehurića ili ljuštenje kože.
There is no experience of acute overdose with peramivir in humans.
Nema iskustava akutnog predoziranja peramivirom u ljudi.
Following intravenous administration of a single dose of peramivir 600 mg over 30 minutes, Cmax was reached at the end of infusion.
Nakon intravenske primjene jednokratne doze 600 mg peramivira tijekom 30 minuta, vrijednost Cmax dosegnuta je na kraju infuzije.
This medicine contains 212.4 mg sodium (main component of cooking/table salt) in each dose consisting of 3 vials.
Ovaj lijek sadrži 212,4 mg natrija (glavni sastojak kuhinjske soli) u pojedinačnoj dozi koja se sastoji od triju bočica.
A randomised, multicentre, double-blind trial conducted in Japan evaluated a single intravenous administration of peramivir 300 mg or 600 mg, or placebo administered over 30 minutes in subjects 20 to 64 years of age with uncomplicated influenza.
Randomiziranim, multicentričnim, dvostruko slijepim ispitivanjem provedenim u Japanu ocjenjivala se jednokratna intravenska primjena peramivira od 300 mg ili 600 mg ili placeba, s trajanjem primjene od 30 minuta u ispitanika u dobi od 20 do 64 godine s nekompliciranom gripom.
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.
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.
6.6 Special precautions for disposal and other handling Aseptic technique should be used during the preparation of Alpivab to prevent inadvertent microbial contamination.
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.
What Alpivab contains
Što Alpivab sadrži
Children aged from 2 years and ≥50 kg body weight
Djeca u dobi od dvije ili više godina i ≥50 kg tjelesne težine
Tell your doctor immediately if you experience abnormal behaviour after Alpivab is given.
Odmah obavijestite svog liječnika ako primijetite neuobičajeno ponašanje nakon primjene lijeka Alpivab.
Treatment was given or commenced within 48 hours of onset of symptoms of influenza.
Liječenje je primijenjeno ili započelo unutar 48 sati od pojavljivanja simptoma gripe.
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).
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).
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.
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.
Inspect the Alpivab concentrate.
2. Provjerite koncentrat lijeka Alpivab.
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).
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)
• The other ingredients are sodium chloride, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
• Ostali sastojci su natrijev klorid, voda za injekcije, kloridna kiselina (za prilagodbu pH vrijednosti), natrijev hidroksid (za prilagodbu pH vrijednosti).
The most important serious adverse reactions associated with peramivir in patients are anaphylaxis and skin reactions, including erythema multiforme and Stevens-Johnson Syndrome.
Najvažnije ozbiljne nuspojave povezane s peramivirom u bolesnika jesu anafilaksa i kožne reakcije, uključujući multiformni eritem i Stevens-Johnsonov sindrom.
Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.
Virusi gripe tipa A/H1N1 koji sadržavaju mutaciju H275Y imaju smanjenu osjetljivost na peramivir i oseltamivir.
Nervous system disorders hypoaesthesia, paraesthesia
Poremećaji živčanog sustava hipoestezija, parestezija
Peramivir was not mutagenic or clastogenic in a battery of in-vitro and in-vivo assays.
Peramivir nije pokazao ni mutageno ni klastogeno djelovanje u nizu in vitro i in vivo testova.
Crossresistance between peramivir and each of oseltamivir and zanamivir may also occur.
Može doći i do unakrsne rezistencije između peramivira, oseltamivira i zanamivira.
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.
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.
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.
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
The elimination half-life of peramivir following IV administration to healthy subjects of 600 mg as a single dose is approximately 20 hours.
Poluvijek eliminacije peramivira nakon intravenske primjene na zdravim ispitanicima u jednokratnoj dozi od 600 mg iznosi približno 20 sati.
Blood and lymphatic system disorders neutrophil count decreased
Poremećaji krvi i limfnog sustava smanjen broj neutrofila
How to store Alpivab
Kako čuvati Alpivab
There are no or limited amount of data (less than 300 pregnancies outcomes) from the use of peramivir in pregnant women.
Ne postoje podaci o primjeni peramivira u trudnica ili je njihova količina ograničena (manje od 300 ishoda trudnoće).
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
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
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.
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.
Skin and subcutaneous tissue disorders dermatitis, drug eruption, eczema, urticaria erythema multiforme dermatitis exfoliative*, Stevens-Johnson syndrome*
Poremećaji kože i potkožnog tkiva dermatitis, erupcija uzrokovana lijekom, ekcem, urtikarija multiformn i eritem eksfolijativni dermatitis*, StevensJohnsonov sindrom*
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).
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).
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.
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.
Alpivab should be administered as a single intravenous dose within 48 hours of the onset of symptoms of influenza.
Alpivab je potrebno primijeniti kao jednokratnu intravensku dozu unutar 48 sati od početka pojavljivanja simptoma gripe.
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).
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).
Immune system disorders anaphylactic reaction*, anaphylactic shock*
Poremećaji imunološkog sustava anafilaktička reakcija*, anafilaktički šok*
Each mL of concentrate contains 0.154 millimole (mmol) sodium, which is 3.54 mg of sodium.
Jedan mililitar koncentrata sadrži 0,154 milimola (mmol) natrija, što odgovara količini od 3,54 mg natrija.
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.
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.
Study treatment was started within 48 hours of onset of symptoms.
Ispitivano liječenje započelo je unutar 48 sati od pojavljivanja simptoma.
13 years - <18
13 godina - <18
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.
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.
Each 20 mL vial contains 200 mg peramivir.
Jedna bočica od 20 ml sadrži 200 mg peramivira.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of concentrate contains 200 mg peramivir.
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 20 ml koncentrata sadrži 200 mg peramivira.
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).
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).
• Children aged from 2 years weighing less than 50 kg receive 12 mg per kg body weight.
• Djeca u dobi od 2 ili više godina i tjelesne težine manje od 50 kg primaju 12 mg po kg tjelesne težine.
Available information on influenza drug susceptibility should be taken into account when deciding whether to use peramivir (see section 5.1).
Pri odlučivanju o primjeni peramivira potrebno je uzeti u obzir dostupne informacije o osjetljivosti na lijekove za gripu (vidjeti dio 5.1).
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 3 vials
4. FARMACEUTSKI OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 3 bočice
It is first diluted and then given into a vein by infusion (drip), over 15 to 30 minutes.
Prvo se razrjeđuje, a zatim se infuzijom (dripom) daje u venu u trajanju od 15 do 30 minuta.
It is provided in a clear glass vial with a coated rubber stopper, aluminium overseal and flip-off cap.
Nalazi se u prozirnoj staklenoj bočici s obloženim gumenim čepom, aluminijskim pokrovom i „flip-off“zatvaračem.
Gastrointestinal disorders nausea, vomiting abdominal pain upper, abdominal discomfort, gastritis
Poremećaji probavnog sustava mučnina, povraćanje bol u gornjem dijelu abdomena, nelagoda u abdomenu, gastritis
• blood test showing increased levels of alanine aminotransferase, aspartate aminotransferase
• povišena razina alanin aminotransferaze i aspartat aminotransferaze na pretragama krvi
Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenjem jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
Peramivir is cleared by renal excretion and can be cleared by haemodialysis.
Peramivir se uklanja bubrežnim izlučivanjem i može se ukloniti hemodijalizom.
Cardiac disorders electrocardiogram QT prolonged
Srčani poremećaji produljeni QT interval na elektrokardiogramu
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.
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.
Mean (SD) Geometric Mean %CV
Srednja vrijednost (SD) Geometrijska srednja vrijednost % CV
Hepatobiliary disorders increased gammaglutamyltransferase liver disorder*, alanine aminotransferase increased*, aspartate aminotransferase increased*
Poremećaji jetre i žuči povišena razina gamaglutamiltransferaze poremećaj rada jetre*, povišena razina alanin aminotransferaze *, povišena razina aspartat aminotransferaze
Alpivab 200 mg concentrate for solution for infusion peramivir
Alpivab 200 mg koncentrat za otopinu za infuziju peramivir
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
4. FARMACEUTSKI OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju
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.
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.
Use aseptic technique during the preparation of Alpivab to prevent microbial contamination.
Alpivab pripremite primjenom aseptične metode kako bi se spriječilo mikrobiološko onečišćenje.
Reduced renal function
Smanjena funkcija bubrega
Peramivir is not significantly metabolised in humans.
Ne dolazi do značajne metabolizacije peramivira u ljudi.
Efficacy (time to resolution of fever; time to resolution of influenza symptoms, viral shedding, virus susceptibility) was a secondary endpoint.
Sekundarna mjera ishoda bila je djelotvornost (vrijeme do prestanka vrućice, vrijeme do prestanka simptoma gripe, izlučivanje virusa, osjetljivost virusa).
NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion
NAZIV LIJEKA Alpivab 200 mg koncentrat za otopinu za infuziju