natgillin/translations-raw huggingface dataset:
When and how Dectova is given Dectova should be given as soon as possible, usually within 6 days of the symptoms of flu appearing.
Lijek Dectova treba primijeniti što je prije moguće, obično unutar 6 dana od pojave simptoma gripe.
Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL.
Dectova je bistra, bezbojna otopina za infuziju koja sadrži 200 mg zanamivira (u obliku hidrata) u
The most commonly reported adverse reactions considered possibly or probably related to Dectova are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).
Dectova su povišene vrijednosti alanin aminotransferaze (2%), povišene vrijednosti aspartat aminotransferaze (1%), hepatocelularno oštećenje (1%), proljev (1%) i osip (1%).
The clinical impact of substitutions associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may be strain-dependent.
Klinički utjecaj supstitucija povezanih sa smanjenom osjetljivošću na zanamivir i druge inhibitore neuraminidaze varijabilan je i mogao bi ovisiti o soju.
Treatment emergent resistance is rare with zanamivir (see section 5.1).
Kod liječenja zanamivirom rijetko se razvija rezistencija (vidjeti dio 5.1).
Dectova has not been studied in patients with end-stage renal disease.
Dectova se nije ispitivala u bolesnika u terminalnoj fazi bubrežne bolesti.
Serious skin or allergic reactions may occur after Dectova is given.
Ozbiljne kožne ili alergijske reakcije Nakon primjene lijeka Dectova mogu se javiti ozbiljne kožne ili alergijske reakcije.
Following twice-daily administration of zanamivir solution for infusion, pulmonary epithelial lining fluid concentrations were 60 - 65 % of the serum concentrations at the corresponding sampling time 12 hours after dosing.
Nakon primjene zanamivira u obliku otopine za infuziju dvaput na dan, njegove koncentracije u sekretu plućnog epitela iznosile su 60 - 65% koncentracija u serumu u odgovarajućem trenutku uzorkovanja 12 sati nakon primjene.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Pripremljeni se lijek ne smije čuvati dulje od 24 sata na temperaturi od 2°C do 8ºC, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity.
Ispitivanja učinaka na reprodukciju provedena na štakorima i kunićima ukazala su da zanamivir prolazi kroz posteljicu, ali nije bilo dokaza teratogenosti.
Dose N Cmax (g/mL)
Doza N Cmax (μg/ml)
Side effects where it is not known how likely they are to happen There isn't enough information to estimate how likely these side effects are:
Nema dovoljno informacija da bi se procijenilo koliko su vjerojatne sljedeće nuspojave:
Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate.
vjerojatnija u imunokompromitiranih bolesnika, važno je pratiti bolesnike zbog mogućeg razvoja rezistencije i razmotriti prelazak na neku drugu terapiju kad je to moguće.
A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg zanamivir twice daily intravenously in hospitalised patients (>16 years of age) with influenza.
Provedeno je dvostruko slijepo ispitivanje faze III radi ocjene djelotvornosti, antivirusne aktivnosti i sigurnosti zanamivira u intravenskoj dozi od 600 mg dvaput na dan u odnosu na oseltamivir u peroralnoj dozi od 75 mg dvaput na dan i zanamivir u intravenskoj dozi od 300 mg dvaput na dan u hospitaliziranih bolesnika (u dobi od > 16 godina) oboljelih od gripe.
Driving and using machines Dectova should not affect your ability to drive or use machines.
Dectova ne bi trebala utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
• clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study;
• kliničke i virološke aktivnosti zanamivira u usporedbi s placebom u ispitivanju izlaganja virusu gripe provedenom u ljudi
Dose proportionality was observed in zanamivir Cmax and AUC and no accumulation of zanamivir in serum was evident after repeated intravenous doses of up to 600 mg.
Opaženo je da su Cmax i AUC zanamivira bili proporcionalni dozi, a nakon ponovljene primjene intravenskih doza do 600 mg nije primijećena akumulacija zanamivira u serumu.
12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
12 mg/kg dvaput na dan, do maksimalne doze od 600 mg dvaput na dan
However, there is no information on placental transfer in humans.
nema informacija o prolasku kroz posteljicu u ljudi.
Zanamivir solution for infusion 600 mg
Zanamivir otopina za infuziju 600 mg
Zanamivir solution for infusion 300 mg
Zanamivir otopina za infuziju 300 mg
Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Poremećaji kože i potkožnog tkiva osip često urtikarija manje često multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza nepoznato
Each vial contains 3.08 mmol (70.8 mg) sodium.
Pomoćne tvari s poznatim učinkom Jedna bočica sadrži 3,08 mmol (70,8 mg) natrija.
The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to <18 years in the Phase II study.
Pedijatrijska populacija Profil nuspojava u pedijatrijskoj populaciji temelji se na 71 bolesniku u dobi od ≥ 6 mjeseci do
The pharmacokinetics of zanamivir in subjects 6 months to <18 years of age (administered standard dose of 12 mg/kg, 14 mg/kg or 600 mg according to age and body weight) and in adult subjects (administered standard dose of 600 mg) was similar (Table 7).
Farmakokinetika zanamivira bila je slična u ispitanika u dobi od 6 mjeseci do < 18 godina (koji su primali standardnu dozu od 12 mg/kg, 14 mg/kg ili 600 mg, u skladu s dobi i tjelesnom težinom) i odraslih ispitanika (koji su primali standardnu dozu od 600 mg) (Tablica 7).
Children Your doctor will decide on the correct dose of Dectova.
Liječnik će odrediti točnu dozu lijeka Dectova.
• The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2).
• Volumen lijeka Dectova i ukupan volumen za infuziju ovisit će o bolesnikovoj dobi, tjelesnoj težini i bubrežnoj funkciji (vidjeti dio 4.2).
Neuraminidase substitutions conferring reduced susceptibility to zanamivir have emerged during treatment with zanamivir in human viruses and those with zoonotic potential: E119D, E119G, I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
Supstitucije u neuraminidazi koje smanjuju osjetljivost na zanamivir javile su se tijekom primjene zanamivira za liječenje infekcija humanim virusima i virusima koji imaju zoonotički potencijal: E119D, E119G, I223R, R368G, G370D, N434S
Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion.
Preporučena doza je 600 mg dvaput na dan tijekom 5 - 10 dana, a primjenjuje se intravenskom infuzijom.
26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.
Prozirna bočica (staklo tipa I) volumena 26 ml s čepom (obložena klorbutilna guma), zaštitnim prstenom (aluminij) i plastičnom flip-off kapicom.
CLcr or CLCRRT (mL/min/1.73 m
CLcr ili CLCRRT (ml/min/1,73 m2)
There was no evidence of interaction with oral oseltamivir in a clinical study.
U kliničkom ispitivanju nisu pronađeni dokazi interakcije s peroralno primijenjenim oseltamivirom.
The 600 mg dose given intravenously best approximated epithelial lining fluid concentrations achieved by the approved 10 mg dose of zanamivir inhalation powder which demonstrated efficacy in large clinical studies in uncomplicated influenza.
Primjenom intravenske doze od 600 mg postignute su koncentracije u tekućini koja oblaže bronhalni epitel koje su bile najbliže onima zabilježenima nakon primjene odobrene doze zanamivira u obliku praška inhalata od 10 mg, za koju je u velikim kliničkim ispitivanjima dokazana djelotvornost kod nekomplicirane gripe.
• The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2 of the SmPC).
• Volumen lijeka Dectova i ukupan volumen za infuziju ovisit će o bolesnikovoj dobi, tjelesnoj težini i bubrežnoj funkciji (vidjeti dio 4.2 sažetka opisa svojstava lijeka).
How Dectova is given
Kako se Dectova primjenjuje
Following twice daily administration of 600 mg zanamivir solution for infusion, median trough zanamivir epithelial lining fluid concentrations ranged from 419 ng/mL to 584 ng/mL and were 47-66% of those in the initial bronchoalveolar sample following orally zanamivir inhalation powder 10 mg twice daily.
Nakon primjene zanamivira u obliku otopine za infuziju u dozi od 600 mg dvaput na dan, medijan najnižih koncentracija zanamivira u sekretu bronhalnog epitela kretao se u rasponu od 419 ng/ml do 584 ng/ml te je odgovarao 47 - 66% koncentracija izmjerenih u početnom bronhoalveolarnom uzorku nakon peroralne primjene zanamivira u obliku praška inhalata u dozi od 10 mg dvaput na dan.
• levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
• podataka o razinama zanamivira u sekretu koji oblaže bronhalni epitel i serumskim razinama zanamivira iz ispitivanja u kojem se provodila bronhoalveolarna lavaža
• The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
• Rukama nježno stisnite infuzijsku vrećicu nekoliko puta kako biste bili sigurni da se lijek dobro pomiješao s otopinom.
Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Preporučena doza je 600 mg dvaput na dan tijekom 5 - 10 dana.
Dectova 10 mg/mL solution for infusion
Dectova 10 mg/ml otopina za infuziju
6 months - <1 year mg/kg
6 mjeseci do < 1 godine mg/kg
Solution for infusion 200 mg/20 mL 1 vial
Otopina za infuziju 200 mg/20 ml
• Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
• Odredite volumen otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) koji će se upotrijebiti za infuziju.
Dectova contains sodium
Dectova sadrži natrij
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
It is supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off cap.
Dolazi u prozirnoj staklenoj bočici volumena 26 ml s gumenim čepom, aluminijskim zaštitnim prstenom i plastičnom flip-off kapicom.
Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known
Poremećaji imunološkog sustava orofaringealni edem edem lica anafilaktičke/anafilaktoidne reakcije nepoznato
Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
Odrasli i djeca (u dobi od 6 ili više godina i tjelesne težine od 50 kg ili više) kojima klirens kreatinina (engl. creatinine clearance, CLcr) ili klirens kontinuiranom bubrežnom nadomjesnom terapijom (engl. clearance by continual renal replacement therapy, CLCRRT) iznosi < 80 ml/min trebaju primiti početnu dozu od 600 mg, a zatim dvaput na dan dozu održavanja određenu u skladu s njihovom bubrežnom funkcijom (Tablica 2).
Uncommon side effects These may affect up to 1 in 100 people
Mogu se javiti u do 1 na 100 osoba
• Using a sterile needle and syringe, withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
• Koristeći sterilnu iglu i štrcaljku, izvucite odgovarajući volumen lijeka Dectova iz bočice/bočica i dodajte ga u infuzijsku vrećicu.
CLcr or CLCRRT (mL/min or mL/min/1.73m
CLcr ili CLCRRT (ml/min ili ml/min/1,73 m2)*
Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.
Zanamivir se izlučuje putem bubrega, pa se očekuje da se može ukloniti hemodijalizom.
Adults and children aged 6 months or more can be treated with Dectova.
Lijekom Dectova mogu se liječiti odrasli i djeca u dobi od 6 mjeseci ili više.
• very severe skin reactions such as: o a skin rash, which may blister, and looks like small targets (erythema multiforme) o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) o extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis).
o proširen osip praćen mjehurićima i ljuštenjem kože, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom) o opsežno ljuštenje kože na velikom dijelu tjelesne površine (toksična epidermalna nekroliza)
• The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for injection down to any concentration greater than or equal to 0.2 mg/mL.
• Doza se može infundirati u obliku u kojem dolazi ili razrijediti u otopini natrijeva klorida za injekciju od 9 mg/ml (0,9%) do bilo koje koncentracije od ≥ 0,2 mg/ml.
A double-blind, randomised study to examine the prophylactic antiviral activity and efficacy of repeat dose zanamivir 600 mg every 12 hours intravenously compared to placebo in healthy male volunteers against infection from inoculation with influenza A/Texas/91 (H1N1) virus was conducted.
12 sati u odnosu na placebo u sprječavanju infekcije u zdravih dobrovoljaca muškoga spola nakon inokulacije virusom gripe tipa A/Texas/91 (H1N1).
Dectova 10 mg/mL solution for infusion zanamivir
Dectova 10 mg/ml otopina za infuziju zanamivir
NA 2.49 118
14 0,305 ND 2,49 118
This substitution has no effect on zanamivir; therefore, viruses with the H275Y substitution retain full susceptibility to zanamivir.
virusi sa supstitucijom H275Y zadržavaju punu osjetljivost na zanamivir.
Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.
Tijekom primjene zanamivira u bolesnika s gripom, osobito djece i adolescenata, prijavljeni su neuropsihijatrijski događaji, uključujući epileptičke napadaje, delirij, halucinacije i neuobičajeno ponašanje.
Also contains sodium chloride, water for injections
POPIS POMOĆNIH TVARI Također sadrži natrijev klorid i vodu za injekcije
• Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection included - this can also be removed if considered necessary.
• Infuzijske vrećice mogu sadržavati više od deklarirane količine otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) - taj se dodatni volumen također može izbaciti, ako se ocijeni da je potrebno.
Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Poremećaji jetre i žuči povišene vrijednosti alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST)
Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Djeca i adolescenti (u dobi od 6 godina do manje od 18 godina i tjelesne težine manje od 50 kg) te dojenčad i mala djeca (u dobi od 6 mjeseci do manje od 6 godina) kojima klirens kreatinina (CLcr) ili klirens kontinuiranom bubrežnom nadomjesnom terapijom (CLCRRT) iznosi < 80 ml/min trebaju primiti početnu dozu, a zatim odgovarajuću dozu održavanja dvaput na dan kako je prikazano u
Preparation of Dectova
Priprema lijeka Dectova
Begin maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
*CLcr ili CLCRRT izražen u ml/min za adolescente u dobi od 13 do manje od 18 godina, odnosno u ml/min/1,73 m2 za djecu u dobi od 6 godina do manje od 13 godina.
Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously must be reduced in patients with renal impairment (see section 4.2).
Oštećenje funkcije bubrega Budući da se zanamivir eliminira bubrežnim klirensom, u bolesnika s oštećenjem bubrežne funkcije doza lijeka Dectova mora se smanjiti kod intravenske primjene (vidjeti dio 4.2).
Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL).
Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata) u 20 ml otopine (10 mg/ml).
Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions' in section 4).
Simptomi mogu uključivati oticanje kože ili grla, otežano disanje, kožni osip praćen mjehurićima ili ljuštenje kože
Each mL of Dectova contains 10 mg of zanamivir (as hydrate).
Jedan ml lijeka Dectova sadrži 10 mg zanamivira (u obliku hidrata).
The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric patients between 6 months and <6 years and 12 mg/kg for those between 6 years and <18 years of age were similar to those seen in adults who received 600 mg twice daily intravenously.
Farmakokinetika zanamivira nakon intravenske primjene doze od 14 mg/kg dvaput na dan u pedijatrijskih bolesnika u dobi od 6 mjeseci do < 6 godina te u dozi od 12 mg/kg u bolesnika u dobi od
A Phase I, open-label study to evaluate serum and lower respiratory pharmacokinetics following administration of intravenous and inhaled zanamivir to healthy adult subjects utilising bronchoalveolar lavage fluid was conducted.
Ispitivanje uz bronhoalveolarnu lavažu Provedeno je otvoreno ispitivanje faze I u kojem su se uz pomoć tekućine za bronhoalveolarnu lavažu ocjenjivali farmakokinetički parametri u serumu i donjim dišnim putovima nakon intravenske i inhalacijske primjene zanamivira zdravim odraslim ispitanicima.
Table 2: Initial and maintenance dose regimens for adults and children (6 years and over with a body weight of 50 kg or above) with renal impairment
Tablica 2: Početna doza i doza održavanja za odrasle i djecu (u dobi od 6 ili više godina i tjelesne težine od 50 kg ili više) s oštećenjem bubrežne funkcije
In order to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection, the MAH should submit the results of a prospective observational study in patients with complicated influenza infection.
Kako bi se ocijenila klinička učinkovitost liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s kompliciranom gripom, nositelj odobrenja treba dostaviti rezultate prospektivnog opservacijskog ispitivanja u bolesnika s kompliciranom gripom.
Begin twice daily maintenance dosing 48 hours after the initial dose
Doza održavanja dvaput na dan počinje se primjenjivati 48 sati nakon početne doze
Common side effects that may show up in your blood tests: • increase in the level of liver enzymes (raised aminotransferases).
• povišene vrijednosti jetrenih enzima (povišene razine aminotransferaza)
Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:
A ili B u odraslih i pedijatrijskih bolesnika (u dobi od ≥ 6 mjeseci):
Begin maintenance dosing 12 hours after the initial dose
Doza održavanja počinje se primjenjivati 12 sati nakon početne doze
• rash.
• osip
How to store Dectova
Kako čuvati lijek Dectova
There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Usporedbe terapija u cjelokupnoj IPP populaciji i dvama unaprijed specificiranim podskupinama nisu pokazale značajne razlike s obzirom na TTCR
Cmin (g/mL)
(μg/ml)
Your doctor will decide how much Dectova is right for you.
Liječnik će odrediti dozu lijeka Dectova primjerenu za Vas.
Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays.
U testovima inhibicije neuraminidaze opažena je križna rezistencija između zanamivira i oseltamivira ili peramivira.
A prospective observational study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection
Prospektivno opservacijsko ispitivanje s ciljem ocjenjivanja kliničke učinkovitosti liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s kompliciranom gripom.
A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection
Retrospektivno opservacijsko ispitivanje pregledom zdravstvenih kartona s ciljem ocjenjivanja kliničke učinkovitosti liječenja otopinom zanamivira za infuziju od 10 mg/ml u kohorti bolesnika s kompliciranom gripom liječenih u jedinicama intenzivnog liječenja.
Begin maintenance dosing 24 hours after the initial dose
Doza održavanja počinje se primjenjivati 24 sata nakon početne doze
In order to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in ICU-treated influenza patients, the MAH should submit the results of an observational chart review effectiveness study of IV zanamivir in ICU-treated influenza patients.
Kako bi se ocijenila klinička učinkovitost liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s gripom liječenih u jedinicama intenzivnog liječenja, nositelj odobrenja treba dostaviti rezultate opservacijskog ispitivanja učinkovitosti provedenog pregledom zdravstvenih kartona bolesnika s gripom liječenih intravenskom formulacijom zanamivira u jedinicama intenzivnog liječenja.
Begin twice daily maintenance dosing 12 hours after the initial dose
Doza održavanja dvaput na dan počinje se primjenjivati 12 sati nakon početne doze
Table 4: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight of 42.8 kg or above) with renal impairment
Tablica 4: Početna doza i doza održavanja za dojenčad i malu djecu (u dobi od 6 mjeseci do manje od 6 godina i tjelesne težine od 42,8 kg ili više) s oštećenjem bubrežne funkcije
7 36.2 21 75.3 23 NA NA 1.84 19
23 ND ND 1,84 19
Begin twice daily maintenance dosing 24 hours after the initial dose
Doza održavanja dvaput na dan počinje se primjenjivati 24 sata nakon početne doze
The potential for interactions with other medicines is low, based on the known elimination pathway of zanamivir.
S obzirom na poznati put eliminacije zanamivira, potencijal za interakcije s drugim lijekovima je nizak.
Age Group
Dobna skupina
Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata) u 20 ml otopine.
Each mL of solution contains 10 mg of zanamivir (as hydrate).
Jedan ml otopine sadrži 10 mg zanamivira (u obliku hidrata).
years mg/kg
1 do < 2 godine mg/kg
12 mg/kg 8 mg/kg twice daily
12 mg/kg 8 mg/kg dvaput na dan
• Discard any unused portion of the vial.
• Bacite sav neupotrijebljen lijek koji je preostao u bočici.
Each vial contains 200 mg of zanamivir (as hydrate).
Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata).