natgillin/translations-raw huggingface dataset:
Each vial contains 3.08 mmol (70.8 mg) sodium.
Ena viala vsebuje 3,08 mmol (70,8 mg) natrija.
There are limited data from the use of zanamivir in pregnant women.
Podatkov o uporabi zanamivirja pri nosečnicah je malo.
Common side effects These may affect up to 1 in 10 people
Pojavijo se lahko pri do 1 od 10 oseb
It is unknown whether zanamivir is excreted in human milk.
Ni znano, ali se zanamivir pri človeku izloča v materino mleko.
• Discard any unused portion of the vial.
• Morebitno neporabljeno vsebino viale zavrzite.
7 36.2 21 75.3 23 NA NA 1.84 19
7 36,2 21 75,3 23 NP
If you have any questions on the use of Dectova, ask the doctor or nurse who is giving it you.
Če imate dodatna vprašanja o uporabi zdravila Dectova, se posvetujte z zdravnikom ali medicinsko sestro, ki vam daje zdravilo.
Reduced susceptibility to zanamivir is associated with mutations that result in amino acid changes in the viral neuraminidase or viral hemagglutinin or both.
Zmanjšana občutljivost za zanamivir je povezana z mutacijami, ki povzročijo spremembe aminokislin v virusni nevraminidazi, virusnem hemaglutininu ali obeh.
Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test
Mediana razlika med zdravljenjema, dnevi (95 % IZ) Vrednost p iz Wilcoxonovega 2-stranskega testa vsote rangov
Other ingredients are sodium chloride and water for injections.
Drugi sestavini zdravila sta natrijev klorid in voda za injekcije.
This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial.
To zdravilo vsebuje 70,8 mg natrija (natrij je glavna sestavina kuhinjske soli) v eni viali.
T1/2 (h)
t1/2
In the population pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir.
V populacijski farmakokinetični analizi starost ni značilno vplivala na farmakokinetiko zanamivirja.
What Dectova is and what it is used for What you need to know before you are given Dectova How Dectova is given
Kaj je zdravilo Dectova in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Dectova Kako se daje zdravilo Dectova
The serum pharmacokinetics of zanamivir administered intravenously have been studied in healthy volunteers receiving single escalating doses from 1 to 1200 mg and repeated doses of 600 mg twice daily for 5 days.
Farmakokinetiko intravensko uporabljenega zanamivirja v serumu so raziskali pri zdravih prostovoljcih, ki so prejemali enkratne naraščajoče odmerke od 1 do 1200 mg in ponavljajoče se odmerke 600 mg dvakrat na dan 5 dni.
Results from a rat peri- and postnatal study showed no clinically meaningful impairment of offspring development.
Rezultati peri- in postnatalne študije pri podganah niso pokazali klinično pomembne okvare razvoja mladičev.
Common side effects that may show up in your blood tests: • increase in the level of liver enzymes (raised aminotransferases).
Pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi: • zvišanje jetrnih encimov (zvišane aminotransferaze).
Uncommon side effects These may affect up to 1 in 100 people
Pojavijo se lahko pri do 1 od 100 oseb
Other medicines and Dectova
Druga zdravila in zdravilo Dectova
Sudden changes in behaviour, hallucinations and fits
Nenadne spremembe vedenja, halucinacije in napadi krčev (konvulzije)
Hepatic impairment No dose modification is required (see section 5.2).
Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
How to prepare the infusion for intravenous administration:
Priprava infuzije za intravensko dajanje:
Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and promotes virus spread in the respiratory tract.
Zanamivir zavira nevraminidazo virusa influence, encim, ki sprošča virusne delce iz plazemske membrane okuženih celic in spodbuja širjenje virusa v dihalih.
The frequency of adverse reactions is based on the number of reports in the adult population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies.
Pogostnost neželenih učinkov temelji na številu poročil pri odrasli populaciji, ki je prejemala 600 mg zanamivirja dvakrat na dan intravensko v študijah II.
Hospitalised patients with influenza also have received 300 mg or 600 mg twice daily for 5 to 10 days.
Tudi hospitalizirani bolniki z gripo so prejemali 300 mg ali 600 mg dvakrat na dan od 5 do 10 dni.
As experience is limited, the use of Dectova in pregnancy should only be considered if the possible benefit to the patient is thought to outweigh any possible risk to the foetus.
Ker je izkušenj malo, je treba o uporabi zdravila Dectova med nosečnostjo razmišljati le, če možne koristi za bolnico domnevno odtehtajo vsa možna tveganja za plod.
The neuraminidase substitution Q136K (A/H1N1 and A/H3N2), confers high level resistance to zanamivir but is selected during adaptation to cell culture and not during treatment.
Substitucija nevraminidaze Q136K (A/H1N1 in A/H3N2) daje visoko stopnjo odpornosti proti zanamivirju,
• Use aseptic techniques throughout preparation of the dose.
• Med celotno pripravo odmerka morate uporabljati aseptičen postopek.
• serum zanamivir levels from patients with complicated influenza (see section 5.1).
• koncentracije zanamivirja v serumu pri bolnikih z zapleteno gripo (glejte poglavje 5.1).
Adverse reactions are listed by MedDRA system organ class.
Neželeni učinki so navedeni po organskih sistemih MedDRA.
Treatment emergent resistance is rare with zanamivir (see section 5.1).
Med zdravljenjem nastala odpornost je pri zanamivirju redka (glejte poglavje 5.1).
Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility.
Študije na živalih ne kažejo klinično pomembnih vplivov zanamivirja na plodnost samcev ali samic.
• the in vitro activity of zanamivir;
• aktivnosti zanamivirja in vitro,
 6 years to < 18 years
≥ 6 let do < 18 let
• 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.
• Vrečke za infundiranje lahko vsebujejo še dodaten presežek 0,9 % (9 mg/ml) raztopine natrijevega klorida za injekcije - tudi tega je mogoče odstraniti, če se to zdi potrebno.
Your doctor will decide how much Dectova is right for you.
Zdravnik bo določil, kolikšna količina zdravila Dectova je primerna za vas.
Zanamivir had a significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by the low infection rate (14% vs. 100% positive serology in placebo group, p <0.005), isolation of virus by viral culture (0% vs. 100% in placebo group, p <0.005), as well as reductions in fever (14% vs. 88% in placebo group, p <0.05), upper respiratory tract illness (0% versus 100% in placebo group, p<0.005) and total symptom scores (1 vs. 44 median score in placebo group, p<0.001).
A. To se je kazalo z nizko stopnjo okužbe (14 % v primerjavi s 100 % pozitivno serologijo v skupini s placebom, p < 0,005), izolacijo virusa v virusni kulturi (0 % proti 100 % v skupini s placebom, p < 0,005), pa tudi z zmanjšanjem zvišane telesne temperature (14 % v primerjavi s 88 % v skupini s placebom, p < 0,05), bolezni zgornjih dihal (0 % v primerjavi s 100 % v skupini s placebom, p < 0,005) in celotne ocene simptomov (1 v primerjavi z mediano oceno 44 v skupini s placebom, p < 0,001).
The efficacy of Dectova for the treatment of complicated influenza A or B virus infection in adults and children aged from 6 months has been inferred from:
O učinkovitosti zdravila Dectova za zdravljenje zapletenih okužb z virusi influence A ali B pri odraslih in otrocih od 6. meseca starosti naprej je mogoče sklepati na podlagi:
However, there is no information on placental transfer in humans.
Vendar pa pri človeku ni informacij o prehajanju skozi placento.
A number of neuraminidase amino acid substitutions that arise during oseltamivir or peramivir treatment result in reduced susceptibility to zanamivir.
Številne substitucije aminokislin v nevraminidazi, ki se pojavijo med zdravljenjem z oseltamivirjem ali peramivirjem, zmanjšajo občutljivost za zanamivir.
Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal function
Preglednica 1: Odmerna shema na podlagi telesne mase za dojenčke, otroke in mladostnike z normalnim delovanjem ledvic Razpon starosti
EU/1/18/1349/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1349/001
• 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.
• Odmerek je mogoče infundirati, kot je opremljen, ali ga razredčiti v 0,9 % (9 mg/ml) raztopini natrijevega klorida za injekcije na katero koli koncentracijo, večjo ali enako 0,2 mg/ml.
What Dectova looks like and contents of the pack
Izgled zdravila Dectova in vsebina pakiranja
Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected.
Zanamivir se ne presnavlja, zato ni pričakovati, da bi okvara jeter imela kakšen vpliv.
Dectova has not been studied in patients with end-stage renal disease.
Zdravilo Dectova ni raziskano pri bolnikih s končno odpovedjo ledvic.
Zanamivir is not a substrate, inhibitor or inducer of cytochrome P450 isoenzymes nor a substrate or inhibitor of renal and hepatic transporters at clinically relevant concentrations (see section 5.2).
Zanamivir v klinično pomembnih koncentracijah ni substrat, zaviralec ali induktor izoencimov citokroma P450 niti substrat ali zaviralec ledvičnih in jetrnih prenašalcev (glejte poglavje 5.2).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, with the exception of a rat embryofoetal development study (subcutaneous administration).
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in na razvoj ne kažejo posebnega tveganja za človeka, z izjemo študije embrio-fetalnega razvoja pri podganah (s subkutano uporabo).
Driving and using machines Dectova should not affect your ability to drive or use machines.
Zdravilo Dectova ne bi smelo vplivati na vašo sposobnost upravljanja vozil ali strojev.
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).
Zanamivir se izloči skozi ledvice, zato je treba bolnikom z okvaro ledvic odmerek intravensko uporabljenega zdravila Dectova zmanjšati (glejte poglavje 4.2).
Annual reports to be submitted
Predaja letnih poročil
Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1).
Mladostniki, otroci in dojenčki morajo od 5 do 10 dni prejemati odmerno shemo na podlagi telesne mase
Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with zanamivir (see section 4.8).
Resne preobčutljivostne reakcije Med uporabo zanamivirja so bile opisane anafilaktične reakcije in resne kožne reakcije (vključno z multiformnim eritemom, toksično epidermalno nekrolizo in Stevens-Johnsonovim sindromom) (glejte poglavje 4.8).
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.
Po uporabi raztopine zanamivirja za infundiranje dvakrat na dan je bila koncentracija v tekočini sluzničnega epitelija v pljučih od 60 do 65 % koncentracije v serumu ob ustreznem času vzorčenja 12 ur po uporabi.
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.
Intravensko uporabljani odmerek 600 mg se je najbolje približal koncentraciji v tekočini epitelijske sluznice, doseženi z odobrenim 10-mg odmerkom zanamivirja v prašku za inhaliranje, katerega učinkovitost je bila dokazana v velikih kliničnih študijah pri nezapleteni gripi.
Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Bolezni kože in podkožja izpuščaj pogosti urtikarija občasni multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza ni znano
The clinical impact of substitutions associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may be strain-dependent.
Klinični vpliv substitucij, povezanih z manjšo občutljivostjo za zanamivir in druge zaviralce nevraminidaze, je variabilen in je lahko odvisen od seva.
This medicinal product contains 70.8 mg sodium per vial, equivalent to 3.54% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Zdravilo vsebuje 70,8 mg natrija na vialo; to ustreza 3,54 % največjega dnevnega vnosa natrija (2 g) za odrasle po priporočilu SZO.
• levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
• koncentracije zanamivirja v tekočini bronhoepitelijske sluznice in v serumu v študiji bronhoalveolarne lavaže,
When and how Dectova is given Dectova should be given as soon as possible, usually within 6 days of the symptoms of flu appearing.
Zdravilo Dectova je treba dati čim prej, po navadi v 6 dneh od pojava simptomov gripe.
Zanamivir solution for infusion 600 mg
Zanamivir raztopina za infundiranje 600 mg
The study did not meet its pre-specified primary objective of demonstrating superiority of 600 mg zanamivir to oral oseltamivir or to 300 mg zanamivir in TTCR.
Študija ni dosegla vnaprej določenega primarnega cilja, dokaza superiornosti 600 mg zanamivirja pred peroralnim oseltamivirjem ali 300 mg zanamivirja, kar zadeva čas do kliničnega odziva.
Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity.
Študije o sposobnosti razmnoževanja pri podganah in kuncih so pokazale, da zanamivir prehaja skozi placento; znakov teratogenosti ni bilo.
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:
4.1 Terapevtske indikacije Zdravilo Dectova je indicirano za zdravljenje zapletenih in potencialno življenjsko ogrožajočih okužb z virusom influence A ali B pri odraslih in pediatričnih bolnikih (starih ≥ 6 mesecev), če:
Marketing Authorisation Holder GlaxoSmithKline Trading Services Limited 12 Riverwalk
Imetnik dovoljenja za promet z zdravilom GlaxoSmithKline Trading Services Limited Riverwalk 12
THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Zanamivir solution for infusion 300 mg
Zanamivir raztopina za infundiranje 300 mg
GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italy
GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italija
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Like all medicines, Dectova can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Dectova neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Cmax in AUC zanamivirja sta kazala sorazmernost odmerku in po ponavljajočih se intravenskih odmerkih do 600 mg se zanamivir ni kopičil v serumu.
Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Bolezni jeter, žolčnika in žolčevodov povišana raven alanin-aminotransferaze (ALT) in/ali aspartat-aminotransferaze (AST) okvara jetrnih celic pogosti zvišanje alkalne fosfataze občasni
The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to <18 years in the Phase II study.
faze pri 71 bolnikih, starih ≥ 6 mesecev do < 18 let.
GM %CV GM %CV GM Range
(h) GS % KV GS % KV GS Razpon GS % KV
Neuraminidase inhibition occurred at very low zanamivir concentrations in vitro, with median inhibitory (IC50) values of 0.33 nM to 5.77 nM against influenza A and B strains respectively.
Zavrtje nevraminidaze se je in vitro pojavilo pri zelo nizkih koncentracijah zanamivirja; mediana inhibicijska koncentracija (IC50) je bila 0,33 nM proti sevu influence A in 5,77 nM proti sevu influence B. Odpornost
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.
Pri zdravih moških prostovoljcih so izvedli dvojno slepo, randomizirano študijo za proučitev profilaktičnega protivirusnega delovanja in učinkovitosti ponavljajočih se odmerkov 600 mg zanamivirja na 12 ur intravensko v primerjavi s placebom proti okužbi zaradi inokulacije z virusom influence A/Texas/91
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.
Študija bronhoalveolarne lavaže Izvedli so odprto študijo I. faze za ovrednotenje farmakokinetike v serumu in spodnjih dihalih po uporabi intravenskega in vdihanega zanamivirja pri zdravih odraslih; uporabljena je bila tekočina iz bronhoalveolarne lavaže.
There is limited experience of overdose from administration of Dectova.
Izkušenj s prevelikim odmerjanjem zdravila Dectova je malo.
Children Your doctor will decide on the correct dose of Dectova.
Zdravnik bo določil pravilni odmerek zdravila 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.
Vzdrževalno odmerjanje začnite 48 ur po začetnem odmerku *CLcr ali CLCRRT enote so v ml/min za mladostnike od 13. do manj kot 18. leta ali v ml/min/1,73m2 za otroke od 6. do manj kot 13. leta.
Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1).
Zdravljenje z zdravilom Dectova je treba začeti čim prej in običajno v 6 dneh po pojavu simptomov gripe
Serious skin or allergic reactions may occur after Dectova is given.
Po uporabi zdravila Dectova se lahko pojavijo resne kožne ali alergijske reakcije.
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.
Otroci in mladostniki (od 6. do manj kot 18. leta in s telesno maso manj kot 50 kg) ter dojenčki in otroci (od 6. meseca do manj kot 6. leta) z očistkom kreatinina (CLcr) ali očistkom ob stalnem ledvičnem nadomestnem zdravljenju (CLCRRT) < 80 ml/min morajo prejeti začetni odmerek, ki mu sledijo ustrezni vzdrževalni odmerki dvakrat na dan, kot je prikazano v preglednicah 3, 4 in 5.
Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.
Zanamivir se izloča skozi ledvice in pričakovati je, da se odstrani s hemodializo.
CLcr or CLCRRT (mL/min/1.73 m
CLcr ali CLCRRT (ml/min/1,73 m2)
Dectova 10 mg/mL solution for infusion zanamivir
Dectova 10 mg/ml raztopina za infundiranje zanamivir
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 zanamivirja je bila pri preiskovancih, starih od 6 mesecev do < 18 let (ki so prejemali standardni odmerek 12 mg/kg, 14 mg/kg ali 600 mg glede na starost in telesno maso) in pri odraslih preiskovancih (ki so prejemali standardni odmerek 600 mg) podobna (preglednica 7).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
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 zanamivirja pri pediatričnih bolnikih, starih od 6 mesecev do < 6 let med uporabo intravenskih odmerkov 14 mg/kg dvakrat na dan in starih od 6 let do < 18 let med uporabo 12 mg/kg, je bila podobna kot pri odraslih, ki so prejemali 600 mg dvakrat na dan intravensko.
years mg/kg
leti mg/kg
12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
12 mg/kg dvakrat na dan do največjega odmerka 600 mg dvakrat na dan
These symptoms also occur in people with flu who are not being given Dectova.
Toda ti simptomi se lahko pojavijo tudi pri osebah z gripo, ki ne prejemajo zdravila Dectova, zato ni znano, ali je zdravilo Dectova imelo kakšno vlogo pri njihovem nastanku.
years mg/kg years mg/kg years mg years mg %CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available
% KV = odstotni koeficient variacije, GS = geometrična sredina, NP = ni podatka
Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Priporočeni odmerek je 600 mg dvakrat na dan od 5 do 10 dni.
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).
I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
Preparation of Dectova
Priprava zdravila Dectova
There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Čas do kliničnega odziva se v primerjavah zdravljenj ni značilno razlikoval ne v celotni populaciji, pozitivni za gripo, ne v vnaprej določenih podskupinah (preglednica 6).
Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known
Bolezni imunskega sistema orofaringealni edem edem obraza anafilaktične/anafilaktoidne reakcije ni znano
Dectova has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Dectova nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Solution for infusion A clear, colourless solution for infusion.
FARMACEVTSKA OBLIKA Raztopina za infundiranje Bistra, brezbarvna raztopina za infundiranje.
• fits (seizures)
• napadi krčev (konvulzije),
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.
Selekcija odpornih virusov influence je bolj verjetna po zdravljenju s protivirusnimi zdravili pri imunsko oslabelih bolnikih; to velja tudi za zdravilo Dectova.