FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Patients were stratified at randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days).
Slovenian: Bolnike so ob randomizaciji stratificirali glede na čas od pojava simptomov do uvedbe zdravljenja (≤ 4 dni in 5 do 6 dni).
English: All patients must have their renal function assessed before and regularly during treatment.
Slovenian: Pri vseh bolnikih je treba ledvično funkcijo oceniti pred zdravljenjem in redno med zdravljenjem.
English: • seeing, hearing or feeling things which are not there
Slovenian: • prividi, prisluhi ali občutenje stvari, ki jih ni,
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP.
English: In adults with normal renal function, the elimination half-life is approximately 2-3 hours.
Slovenian: Pri odraslih z normalnim delovanjem ledvic je eliminacijski razpolovni čas približno 2-3 ure.
English: Serious skin or allergic reactions
Slovenian: Resne kožne ali alergijske reakcije
English: 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.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas ne sme presegati 24 ur na temperaturi od 2 °C do 8 °C, razen če sta priprava/razredčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: Overall, the safety profile in paediatric patients was similar to that observed in adults in the clinical studies.
Slovenian: Varnostni profil pri pediatričnih bolnikih je bil v splošnem podoben, kot so ga opazili v kliničnih študijah pri odraslih.
English: Dectova is used to treat severe flu (influenza virus infection).
Slovenian: Zdravilo Dectova se uporablja za zdravljenje hude gripe (okužbe z virusom influence).
English: • Calculate the required dose and volume of Dectova.
Slovenian: • Izračunajte potrebni odmerek in količino zdravila Dectova.
English: • If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room temperature before use.
Slovenian: • Če je vrečka za infundiranje shranjena v hladilniku, jo je treba pred uporabo vzeti iz hladilnika in ogreti na sobno temperaturo.
English: The plasma protein binding of zanamivir is very low (less than 10%).
Slovenian: Porazdelitev Vezava zanamivirja na beljakovine v plazmi je zelo majhna (manj kot 10 %).
English: Any unused solution should be discarded.
Slovenian: Vso neporabljeno raztopino je treba zavreči.
English: Q3 2025
Slovenian: 3. kvartal 2025
English: Table 7: Pharmacokinetic parameters in paediatric and adult subjects
Slovenian: Preglednica 7: Farmakokinetični parametri pri pediatričnih in odraslih preiskovancih
English: During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur.
Slovenian: Med zdravljenjem z zdravilom Dectova se lahko pojavijo spremembe vedenja, na primer zmedenost in neodzivnost.
English: In vitro activity
Slovenian: Aktivnost in vitro
English: Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) which can lead to loss of consciousness.
Slovenian: Nekaterim ljudem se lahko pojavijo halucinacije (prividi, prisluhi ali občutenje stvari, ki jih ni) ali napadi krčev (konvulzije), ki lahko povzročijo izgubo zavesti.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
English: The pharmacokinetics in elderly subjects was similar to young adult subjects.
Slovenian: Starejše osebe Farmakokinetika pri starejših osebah je bila podobna kot pri mladih odraslih.
English: Zanamivir is eliminated unchanged in urine by glomerular filtration.
Slovenian: Zanamivir se nespremenjen izloča v urinu z glomerularno filtracijo.
English: The safety and efficacy of Dectova in children aged under 6 months have not been established.
Slovenian: Varnost in učinkovitost zdravila Dectova pri otrocih do 6. meseca starosti nista ugotovljeni.
English: Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection.
Slovenian: Ni dokazano, da bi zdravilo Dectova zmanjšalo tveganje za bakterijske zaplete, povezane z okužbo z gripo.
English: Vials of Dectova are for single use only.
Slovenian: Viale zdravila Dectova so namenjene samo za enkratno uporabo.
English: Nervous system disorders convulsions depressed level of consciousness not known
Slovenian: Bolezni živčevja konvulzije deprimirana raven zavesti ni znano
English: The most important serious adverse reaction was hepatocellular injury, observed in two patients (<1%).
Slovenian: Najpomembnejši resni neželeni učinek je bila okvara jetrnih celic, ki je bila opažena pri dveh bolnikih (< 1%).
English: The amount you are given is based on your age, body weight, and the results of your blood tests (to check how well your kidneys are working).
Slovenian: Količina, ki jo boste dobili, je odvisna od vaše starosti, telesne teže in izvidov preiskav krvi (za preverjanje delovanja ledvic).
English: • The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
Slovenian: • je bolnikov virus influence znano ali domnevno odporen proti drugim zdravilom proti gripi razen zanamivirja in/ali
English: If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted.
Slovenian: Če se med infundiranjem zdravila Dectova pojavi kakršna koli preobčutljivostna reakcija, je treba infundiranje takoj končati in uvesti ustrezno zdravljenje.
English: Elderly No dose adjustment is required based on age.
Slovenian: Prilagoditev odmerka glede na starost ni potrebna.
English: Resistance selection during zanamivir treatment is rare.
Slovenian: Selekcija odpornosti med zdravljenjem z zanamivirjem je redka.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Dectova in one or more subsets of the paediatric population in the treatment and prevention of influenza (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Dectova za eno ali več podskupin pediatrične populacije za zdravljenje in preprečevanje gripe (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • being less alert or not responding to loud sounds or being shaken
Slovenian: • zmanjšana pozornost ali neodzivnost na glasne zvoke ali tresenje
English: Serious skin and allergic reactions may occur with Dectova, but there isn't enough information to estimate how likely they are.
Slovenian: Med uporabo zdravila Dectova se lahko pojavijo resne kožne in alergijske reakcije, vendar ni na voljo dovolj podatkov za oceno, kako verjetne so.
English: Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions' in section 4).
Slovenian: Med simptomi so lahko otekanje kože ali žrela, težko dihanje, izpuščaj z mehurji ali lupljenje kože (glejte tudi "Resne kožne ali alergijske reakcije" v poglavju 4).
English: The volume of distribution of zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water.
Slovenian: Volumen porazdelitve zanamivirja pri odraslih je približno 16 litrov; to je približno enako volumnu zunajcelične vode.
English: Pharmacokinetic studies in Thai, Chinese and Japanese healthy subjects did not identify any clinically relevant differences in the pharmacokinetics of zanamivir in these populations compared with Caucasians.
Slovenian: Farmakokinetične študije pri zdravih tajskih, kitajskih in japonskih preiskovancih niso pokazale klinično pomembnih razlik v farmakokinetiki zanamivirja v teh populacijah v primerjavi z belci.
English: The primary endpoint was time to clinical response (TTCR); clinical response was defined as a composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and systolic blood pressure) or hospital discharge.
Slovenian: Primarni opazovani dogodek je bil čas do kliničnega odziva (TTCR - time to clinical response); klinični odziv je bil opredeljen kot sestavljeni dogodek stabilizacije vitalnih znakov (temperatura, saturacija s kisikom, respiratorno stanje, srčna frekvenca in sistolični krvni tlak) ali odpust iz bolnišnice.
English: 6 months - <1 year mg/kg
Slovenian: mesecev - < 1 leto mg/kg
English: • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
Slovenian: • druga protivirusna zdravila za zdravljenje influence (vključno z zanamivirjem za inhaliranje) za konkretnega bolnika niso primerna.
English: This substitution has no effect on zanamivir; therefore, viruses with the H275Y substitution retain full susceptibility to zanamivir.
Slovenian: Ta substitucija ne vpliva na zanamivir, zato ostanejo virusi s substitucijo H275Y v polni meri občutljivi na zanamivir.
English: The clinical impact of reduced susceptibility in these viruses is unknown, and the effects of specific substitutions on virus susceptibility to zanamivir may be strain-dependent.
Slovenian: Klinični vpliv zmanjšane občutljivosti pri teh virusih ni znan in učinki specifičnih substitucij na občutljivost virusa za zanamivir so lahko odvisni od seva.
English: • severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
Slovenian: • hude alergijske reakcije, vključno s srbečim izpuščajem, otekanjem obraza, žrela ali jezika, težave z dihanjem, omotica in bruhanje.
English: The H275Y substitution is the most common neuraminidase resistance substitution and is associated with reduced susceptibility to peramivir and oseltamivir.
Slovenian: Substitucija H275Y je najpogostejša substitucija odpornosti proti nevraminidazi in je povezana z manjšo občutljivostjo za peramivir in oseltamivir.
English: In the rat embryofoetal study, there was an increase in the incidence rates of a variety of minor skeletal and visceral alterations, most of which remained within the background rates of the historical occurrence in the strain studied.
Slovenian: V embrio-fetalni študiji pri podganah so ugotovili povečanje incidenčnih deležev različnih manjših skeletnih in visceralnih sprememb, toda večina jih je ostala v okviru izhodiščnih deležev pojavljanja pri proučevanem sevu v preteklosti.
English: 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:
Slovenian: Neželeni učinki, katerih verjetnost ni znana Za oceno tega, kako verjetni so naslednji neželeni učinki, ni dovolj podatkov:
English: A doctor or nurse will give you Dectova as an infusion (drip) into a vein.
Slovenian: Zdravnik ali medicinska sestra vam bo dal zdravilo Dectova v infuziji (kapalni) v veno.
English: Resistance in immunocompromised patients
Slovenian: Odpornost pri imunsko oslabelih bolnikih
English: • The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
Slovenian: • Vrečko za infundiranje je treba obzirno stiskati z rokami, da se vsebina dobro premeša.
English: 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%).
Slovenian: Najpogosteje poročani neželeni učinki, ki so morda ali verjetno povezani z zdravilom Dectova, so povišana raven alanin-aminotransferaze (2 %), povišana raven aspartat-aminotransferaze (1 %), okvara jetrnih celic (1 %), driska (1 %) in izpuščaj (1 %).
English: Psychiatric disorders abnormal behaviour hallucinations delirium not known
Slovenian: Psihiatrične motnje nenormalno vedenje halucinacije delirij ni znano
English: Dectova should not be administered simultaneously with other intravenous medicinal products or prepared in solutions containing glucose or other electrolytes (see section 6.6).
Slovenian: Zdravila Dectova se ne sme uporabljati sočasno z drugimi intravenskimi zdravili, prav tako se ga ne sme pripravljati v raztopinah, ki vsebujejo glukozo ali elektrolite (glejte poglavje 6.6).
English: Human challenge study
Slovenian: Provokacijska študija pri človeku
English: • clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study;
Slovenian: • klinične in virološke aktivnosti zanamivirja v primerjavi s placebom v provokacijski študiji gripe pri človeku,
English: In vitro studies indicate that zanamivir is not an inhibitor or substrate of Breast Cancer Resistant Protein (BCRP), P-glycoprotein, Multidrug And Toxin Extrusion protein (MATE)1, MATE2-K, Organic Anion Transporter (OAT)1, OAT3, Organic Anion Transporting Polypeptide (OATP)1B1, OATP1B3 and Organic Cation Transporter (OCT)2 transporters, nor is it an inhibitor of cytochrome P450 (CYP) enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4.
Slovenian: Študije in vitro kažejo, da zanamivir ni zaviralec ali substrat BCRP (Breast Cancer Resistant Protein), P-glikoproteina, prenašalcev MATE (Multidrug And Toxin Extrusion protein)1, MATE2-K, OAT (Organic Anion Transporter)1, OAT3, OATP (Organic Anion Transporting Polypeptide)1B1, OATP1B3 ali OCT (Organic Cation Transporter)2 , niti ni zaviralec encimov citokroma P450 (CYP) CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ali 3A4.
English: Dectova is administered by intravenous infusion over 30 minutes.
Slovenian: Intravenska uporaba Zdravilo Dectova se daje v 30-minutni intravenski infuziji.
English: As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the child.
Slovenian: Ker je izkušenj malo, je treba o uporabi zanamivirja pri doječih ženskah razmišljati le, če možne koristi za mater domnevno odtehtajo vsa možna tveganja za otroka.
English: It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.
Slovenian: Če ste dobili večji odmerek zdravila Dectova, kot bi smeli Ni verjetno, da bi dobili preveč zdravila, toda če menite, da ste dobili preveč zdravila Dectova, o tem nemudoma obvestite zdravnika ali medicinsko sestro.
English: For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.
Slovenian: Bolniki na intermitentni hemodializi ali intermitentni peritonealni dializi morajo odmerek dobiti po dokončanem dializiranju.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA
English: Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Specifičnega antidota za zdravljenje prevelikega odmerjanja tega zdravila ni. Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe, vključno z nadziranjem vitalnih znakov in opazovanjem bolnikovega kliničnega stanja.
English: In rats, zanamivir has been shown to be secreted in low amounts into milk.
Slovenian: Pri podganah je dokazano, da se zanamivir v majhni količini izloča v mleko.
English: Each vial contains 3.08 mmol (70.8 mg) sodium.
Slovenian: Ena viala vsebuje 3,08 mmol (70,8 mg) natrija.
English: There are limited data from the use of zanamivir in pregnant women.
Slovenian: Podatkov o uporabi zanamivirja pri nosečnicah je malo.
English: Common side effects These may affect up to 1 in 10 people
Slovenian: Pojavijo se lahko pri do 1 od 10 oseb
English: It is unknown whether zanamivir is excreted in human milk.
Slovenian: Ni znano, ali se zanamivir pri človeku izloča v materino mleko.
English: • Discard any unused portion of the vial.
Slovenian: • Morebitno neporabljeno vsebino viale zavrzite.
English: 7 36.2 21 75.3 23 NA NA 1.84 19
Slovenian: 7 36,2 21 75,3 23 NP
English: If you have any questions on the use of Dectova, ask the doctor or nurse who is giving it you.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Dectova, se posvetujte z zdravnikom ali medicinsko sestro, ki vam daje zdravilo.
English: Reduced susceptibility to zanamivir is associated with mutations that result in amino acid changes in the viral neuraminidase or viral hemagglutinin or both.
Slovenian: Zmanjšana občutljivost za zanamivir je povezana z mutacijami, ki povzročijo spremembe aminokislin v virusni nevraminidazi, virusnem hemaglutininu ali obeh.
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test
Slovenian: Mediana razlika med zdravljenjema, dnevi (95 % IZ) Vrednost p iz Wilcoxonovega 2-stranskega testa vsote rangov
English: Other ingredients are sodium chloride and water for injections.
Slovenian: Drugi sestavini zdravila sta natrijev klorid in voda za injekcije.
English: This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial.
Slovenian: To zdravilo vsebuje 70,8 mg natrija (natrij je glavna sestavina kuhinjske soli) v eni viali.
English: T1/2 (h)
Slovenian: t1/2
English: AUC(0-) (g.h/mL)
Slovenian: AUC(0-∞) (µg.h/ml)
English: In the population pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir.
Slovenian: V populacijski farmakokinetični analizi starost ni značilno vplivala na farmakokinetiko zanamivirja.
English: What Dectova is and what it is used for What you need to know before you are given Dectova How Dectova is given
Slovenian: Kaj je zdravilo Dectova in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Dectova Kako se daje zdravilo Dectova
English: 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.
Slovenian: 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.
English: Results from a rat peri- and postnatal study showed no clinically meaningful impairment of offspring development.
Slovenian: Rezultati peri- in postnatalne študije pri podganah niso pokazali klinično pomembne okvare razvoja mladičev.
English: Common side effects that may show up in your blood tests: • increase in the level of liver enzymes (raised aminotransferases).
Slovenian: Pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi: • zvišanje jetrnih encimov (zvišane aminotransferaze).
English: 50 to <80
Slovenian: 50 do < 80
English: Uncommon side effects These may affect up to 1 in 100 people
Slovenian: Pojavijo se lahko pri do 1 od 100 oseb
English: Other medicines and Dectova
Slovenian: Druga zdravila in zdravilo Dectova
English: Sudden changes in behaviour, hallucinations and fits
Slovenian: Nenadne spremembe vedenja, halucinacije in napadi krčev (konvulzije)
English: Hepatic impairment No dose modification is required (see section 5.2).
Slovenian: Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: How to prepare the infusion for intravenous administration:
Slovenian: Priprava infuzije za intravensko dajanje:
English: 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.
Slovenian: Zanamivir zavira nevraminidazo virusa influence, encim, ki sprošča virusne delce iz plazemske membrane okuženih celic in spodbuja širjenje virusa v dihalih.
English: 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.
Slovenian: Pogostnost neželenih učinkov temelji na številu poročil pri odrasli populaciji, ki je prejemala 600 mg zanamivirja dvakrat na dan intravensko v študijah II.
English: Hospitalised patients with influenza also have received 300 mg or 600 mg twice daily for 5 to 10 days.
Slovenian: Tudi hospitalizirani bolniki z gripo so prejemali 300 mg ali 600 mg dvakrat na dan od 5 do 10 dni.
English: 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.
Slovenian: 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.
English: 15 to <30
Slovenian: 15 do < 30
English: 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.
Slovenian: Substitucija nevraminidaze Q136K (A/H1N1 in A/H3N2) daje visoko stopnjo odpornosti proti zanamivirju,
English: • Use aseptic techniques throughout preparation of the dose.
Slovenian: • Med celotno pripravo odmerka morate uporabljati aseptičen postopek.
English: • serum zanamivir levels from patients with complicated influenza (see section 5.1).
Slovenian: • koncentracije zanamivirja v serumu pri bolnikih z zapleteno gripo (glejte poglavje 5.1).
English: Adverse reactions are listed by MedDRA system organ class.
Slovenian: Neželeni učinki so navedeni po organskih sistemih MedDRA.
English: Treatment emergent resistance is rare with zanamivir (see section 5.1).
Slovenian: Med zdravljenjem nastala odpornost je pri zanamivirju redka (glejte poglavje 5.1).
English: Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility.
Slovenian: Študije na živalih ne kažejo klinično pomembnih vplivov zanamivirja na plodnost samcev ali samic.
English: • the in vitro activity of zanamivir;
Slovenian: • aktivnosti zanamivirja in vitro,
English:  6 years to < 18 years
Slovenian: ≥ 6 let do < 18 let
English: • 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.
Slovenian: • 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.
English: Your doctor will decide how much Dectova is right for you.
Slovenian: Zdravnik bo določil, kolikšna količina zdravila Dectova je primerna za vas.