natgillin/translations-raw huggingface dataset:
Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Razpoložljive informacije o varnosti oseltamivirja za zdravljenje gripe pri dojenčkih, mlajših od enega leta, iz prospektivnih in retrospektivnih opazovalnih študij (ki vključujejo skupaj več kot 2.400 dojenčkov tega starostnega razreda), podatkovne baze epidemioloških raziskav in poročil pridobljenih v obdobju trženja kažejo, da je varnostni profil pri dojenčkih mlajših od enega leta podoben znanemu varnostnemu profilu pri otrocih starih eno leto in več.
Recommended dose for prevention
Priporočeni odmerek za preprečevanje
• Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
• Zdravilo Ebilfumin se uporablja pri odraslih, mladostnikih, otrocih in dojenčkih (vključno z donošenimi novorojenčki) za zdravljenje gripe (influence).
For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture.
Za pripravo doma se mora posebej priložiti odmernik za odvzem pravilnega volumna vode in za odmerjanje mešanice zdravila Ebilfumin-voda.
Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of oseltamivir, described in section 4.8 Undesirable effects.
Neželeni dogodki, o katerih so poročali po prevelikem odmerjanju, so bili po naravi in pogostnosti podobni tistim, ki so jih opazili pri terapevtskih odmerkih zdravila Ebilfumin, opisanih v poglavju 4.8 Neželeni učinki.
With a suitable stirring device, stir for 2 minutes.
S primerno mešalno napravo mešamo 2 minuti.
During treatment with Ebilfumin, tell a doctor immediately:
Med zdravljenjem z zdravilom Ebilfumin morate nemudoma povedati svojemu zdravniku:
Draw up the correct amount of liquid mixture from the first bowl.
Povlecite pravilno količino suspenzije iz prve posode.
Open the stated amount of Ebilfumin capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Odprite ustrezno količino kapsul zdravila Ebilfumin in dajte vsebino vsake kapsule direktno v čašo z vodo in konzervansom.
In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
V izjemnih primerih (npr. pojav virusa, proti kateremu cepivo ne učinkuje, ali pri pandemiji) ga lahko pri posameznikih, starih eno leto ali več, uporabimo kot sezonsko preventivo.
Add the water to the powder in the bowl.
Vodo nato dodajte prašku v posodi.
Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small amounts of suspension.
Suspenzijo, pripravljeno v lekarni, opremite z graduirano brizgo za peroralno dajanje, namenjeno za merjenje majhnih količin suspenzije.
Oseltamivir given orally inhibits influenza A and B virus replication and pathogenicity in vivo in animal models of influenza infection at antiviral exposures similar to that achieved in man with 75 mg twice daily.
Peroralno zaužiti oseltamivir zavira razmnoževanje virusa influence A in B ter patogenezo v živalskih modelih okužbe z gripo in vivo pri izpostavljenosti protivirusnemu zdravilu, ki je podobna tisti, ki jo dosežemo pri ljudeh z odmerkom 75 mg dvakrat na dan.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Considering this information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, where there are clear potential benefits to breastfeeding mothers.
Upoštevajoč to informacijo, patogenost krožečega seva virusa gripe in osnovno zdravstveno stanje doječe ženske, lahko o uporabi oseltamivirja razmislimo, kadar obstajajo jasne pričakovane koristi za doječe matere.
These cases include fatal fulminant hepatitis/hepatic failure.
Ti primeri vključujejo fulminantni hepatitis s smrtnim izidom/odpoved jeter.
The protection against influenza lasts only as long as oseltamivir is administered.
Zaščita proti gripi traja samo, dokler jemljemo zdravilo Ebilfumin.
The NNT in this study was 25 (95 % CI 23 - 62).
NNT v tej študiji je bil 25 (95-% interval zaupanja 23 - 62).
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 neuraminidases.
Virusi, odporni na oseltamivir, ki so jih izolirali iz bolnikov, zdravljenih z oseltamivirjem in laboratorijski sevi virusa gripe, odporni na oseltamivir, so imeli mutacije v N1 in N2 nevraminidazah.
Simulation of once daily dosing of 3mg/kg in infants <1 year shows an exposure in the same range or higher than for once daily dosing of 75 mg in adults.
Simulacija enkrat dnevnega odmerjanja 3 mg/kg pri dojenčkih, mlajših od 1 leta, kaže na izpostavljenost v enakem ali večjem obsegu kot pri enkrat dnevnem odmerjanju 75 mg pri odraslih.
Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Zdravilo Ebilfumin ne vpliva na učinkovitost cepiva proti gripi, torej vam zdravnik lahko predpiše oboje.
Oseltamivir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Zdravilo Ebilfumin uporabimo za zdravljenje ali preprečevanje gripe le, kadar zanesljivi epidemiološki podatki kažejo na prisotnost virusa influence v okolici.
However,
Kakor koli,
Ebilfumin has no effect on your ability to drive or use machines.
Zdravilo Ebilfumin nima vpliva na vašo sposobnost vožnje in upravljanja strojev.
Oseltamivir resistance
Odpornost na oseltamivir
Ebilfumin 30 mg, 45 mg and 75 mg capsules are available for infants and children 1 year of age or older
Kapsule zdravila Ebilfumin 30 mg, 45 mg in 75 mg so na voljo za dojenčke in otroke stare 1 leto ali več.
To make a 30 mg or a 60 mg dose, you need:
Za pripravo 30 mg ali 60 mg odmerka, potrebujete:
Most of the patients with oseltamivir-resistant virus were infected with influenza type A and had prolonged viral shedding.
Večina bolnikov z virusom, odpornim na oseltamivir, je bila okužena z virusom gripe tipa A in je imela podaljšano izločanje virusa.
If you forget to take Ebilfumin
Če pozabite vzeti zdravilo Ebilfumin
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Farmakokinetične lastnosti oseltamivirja, kot sta majhna vezava na beljakovine in presnova, ki je neodvisna od sistema CYP450 in glukoronidaznih sistemov (glejte poglavje 5.2), nakazujejo, da klinično pomembna medsebojna delovanja z drugimi zdravili na osnovi omenjenih mehanizmov, niso verjetna.
Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Največje koncentracije oseltamivir karboksilata v plazmi se pri večini ljudi zmanjšajo z razpolovno dobo od 6 do 10 ur.
A large amount of data on oseltamivir exposure of pregnant women from post-marketing reports and observational studies (more than 1000 exposed outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.
Večje število podatkov o uporabi oseltamivirja pri nosečnicah iz poročil po prihodu zdravila na trg in opazovalnih študij (več kot 1000 izpostavljenih nosečnosti v prvem trimesečju) ne kaže na njegovo malformacijsko toksičnost ali feto/neonatalno toksičnost.
These patients were randomized to be treated, within 96 hours of symptoms onset, with standard dose (73 patients) or double dose (78 patients) of oseltamivir, for a duration of 10 days.
Ti bolniki so bili randomizirani na zdravljenje v 96 urah po pojavu simptomov z običajnim odmerkom (73 bolnikov) ali dvojnim odmerkom (78 bolnikov) oseltamivirja, v trajanju 10 dni.
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.
Če ste noseči, menite, da bi lahko bili noseči ali če načrtujete zanositev, o tem obvestite zdravnika, ki bo odločil, ali lahko prejmete zdravilo Ebilfumin ali ne.
Creatinine clearance
Očistek kreatinina
The NNT in this study was 28 (95 % CI 24 - 50).
NNT v tej študiji je bil 28 (95-% interval zaupanja 24 - 50).
Stop taking Ebilfumin and contact a doctor or pharmacist immediately.
Prenehajte jemati zdravilo Ebilfumin in takoj obvestite zdravnika ali farmacevta.
Open a second capsule for a 60 mg dose.
Za pripravo 60 mg odmerka odprite tudi drugo kapsulo.
In patients with influenza who were receiving oseltamivir, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes.
Pri bolnikih z gripo, ki so prejemali zdravilo Ebilfumin, so po prihodu zdravila na trg poročali o konvulzijah in deliriju (vključno s simptomi kot so spremenjena raven zavesti, zmedenost, nenavadno vedenje, prividi, halucinacije, agitacija, aksioznost, more), ki je v zelo redkih primerih vodil do samopoškodbe ali smrti.
The recommended dose is based on the patient's body weight.
Priporočen odmerek je odvisen od telesne mase bolnika.
The safety profile of oseltamivir observed in this study was consistent with that observed in previous clinical trials where oseltamivir was administered for treatment of influenza in nonimmunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac co-morbidities]).
Varnostni profil oseltamivirja v tej študiji se je skladal z ugotovljenim v predhodnih kliničnih preskušanjih, pri katerih so oseltamivir uporabljali za zdravljenje gripe pri imunsko neogroženih bolnikih (sicer zdravi bolniki ali “ogroženi” bolniki [npr. tisti z respiratornimi in/ali srčnimi soobolenji)].
Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects.
Gripa je povezana s neželenimi izidi za nosečnost in plod; obstaja tveganje za večje prirojene malformacije, vključno s prirojenimi srčnimi napakami.
Before you take Ebilfumin, make sure the prescribing doctor knows
Preden boste vzeli zdravilo Ebilfumin, se prepričajte, da zdravnik ve:
The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established.
Učinkovitost oseltamivirja pri zdravljenju ali pri preprečevanju gripe pri imunsko ogroženih bolnikih ni zanesljivo dokazana.
A pooled population pharmacokinetic analysis indicates that the Ebilfumin dosage regimen described in Section 4.2 Posology and method of administration results in lower exposure (30% on average across all trimesters) to the active metabolite in pregnant women compared to non-pregnant women.
Populacijska farmakokinetična analiza združenih podatkov kaže, da režim odmerjanja zdravila Ebilfumin, opisan v poglavju 4.2 Odmerjanje in način uporabe, vodi v manjšo izpostavljenost aktivnemu presnovku (30 % v povprečju v vseh trimesečjih) pri nosečnicah v primerjavi z ženskami, ki niso noseče.
The study included solid organ transplant [SOT] patients, haematopoietic stem cell transplant [HSCT] patients, HIV positive patients with a CD4+ cell count <500 cells/mm3, patients on systemic immunosuppressive therapy, and those with haematological malignancy.
Študija je vključila bolnike s presajenimi parenhimskimi organi, bolnike s presajenimi krvotvornimi matičnimi celicami, HIVpozitivne bolnike s številom celic CD4+ < 500 celic/mm3, bolnike, ki so prejemali sistemsko imunosupresivno zdravljenje, in bolnike s hematološkimi malignostmi.
Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate.
Večina absorbiranega oseltamivirja (> 90 %) se izloči s pretvorbo v oseltamivir karboksilat.
Ebilfumin is indicated in adults and children including full-term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Zdravilo Ebilfumin je indicirano pri odraslih in otrocih, vključno z donošenimi novorojenčki,ki imajo simptome, značilne za gripo, ko je virus influence prisoten v okolici.
The total volume required is determined by the weight of the patient according to the recommendation in the table below.
Celokupni volumen, ki je potreben, je določen s telesno maso bolnika, v skladu s priporočili v spodnji preglednici.
Reports of overdoses with oseltamivir have been received from clinical trials and during postmarketing experience.
Poročila o prevelikem odmerjanju z zdravilom Ebilfumin so bila prejeta iz kliničnih preskušanj in po prihodu zdravila na trg.
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
• Stevens-Johnson sindrom in toksična epidermalna nekroliza: zapletena, možno življenjsko ogrožajoča alergijska reakcija, hudo vnetje vrhnjice in možno tudi notranjih plasti kože, na začetku z zvišano telesno temperaturo, vnetim grlom in utrujenostjo, kožnimi izpuščaji, ki preidejo v mehurje, luščenjem večjih površin kože, možnimi težavami z dihanjem in nizkim krvnim tlakom;
Recommended dose for treatment
Priporočeni odmerek za zdravljenje
Body weight*
Telesna masa*
90 ml or 100 ml*
90 ml ali 100 ml*
No data allowing a dose recommendation for premature children (< 36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje, za nedonošene otroke (< 36 tednov postkoncepcijske starosti) trenutno niso na voljo.
30 mg every second day
30 mg vsak drugi dan
Storage of the pharmacy compounded suspension Shelf life of 3 weeks when stored below 25 °C.
Shranjevanje suspenzije, pripravljene v lekarni Rok uporabe je 3 tedne, če se zdravilo shranjuje pri temperaturi do 25 °C.
In both cases, the correct volumes should preferably be marked on the syringes.
V obeh primerih mora biti po možnosti pravilen volumen označen na brizgi.
Insufficient data are available for infants who have a postconceptual age of less than 36 weeks.
Na voljo ni dovolj podatkov za dojenčke s postkoncepcijsko starostjo manj kot 36 tednov.
The safety profile reported in subjects who received the recommended dose of oseltamivir for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Varnostni profil, katerega so poročali pri osebah, ki so prejele priporočeni odmerek zdravila Ebilfumin za preprečevanje (75 mg enkrat na dan do 6 tednov) je kakovostno podoben tistemu, ki so ga opazili v študijah zdravljenja, kljub dolgotrajnemu odmerjanju v študijah preprečevanja.
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy compounded 6 mg/ml suspension Total volume of compounded suspension to be prepared
Število kapsul in količina vehikla, potrebna za pripravo celokupnega volumna 6 mg/ml suspenzije pripravljene v lekarni Celokupen volumen suspenzije, ki jo je potrebno pripraviti
Infants (<1year) * Full genotyping was not performed in all studies.
* Popolne genotipizacije v vseh študijah niso izvedli.
For storage conditions of the pharmacy compounded suspension, see section 6.3.
Za pogoje shranjevanja suspenzije pripravljene v lekarni, glejte poglavje 6.3.
This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2).
To temelji na farmakokinetičnih in varnostnih podatkih, ki kažejo, da ta odmerek pri dojenčkih, starih od 0 do 12 mesecev, zagotavlja plazemske koncentracije predzdravila in aktivnega presnovka, za katere se pričakuje, da so klinično učinkovite, z varnostnim profilom, primerljivim s tistim pri starejših otrocih in odraslih (glejte poglavje 5.2).
Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.
Pri pripravi tekočine zdravila Ebilfumin za otroke in kadar dajemo kapsule ali tekočino zdravila Ebilfumin otrokom, je potrebna previdnost.
Treatment of influenza in immunocompromised adults: A randomized, double blind study, to evaluate safety and characterize the effects of oseltamivir on the development of resistant influenza virus (primary analysis) in influenza-infected adult immunocompromised patients, included 151 patients evaluable for efficacy of oseltamivir (secondary analysis, not powered).
Zdravljenje gripe pri imunsko ogroženih odraslih: randomizirana, dvojno slepa študija za oceno varnosti in ovrednotenje učinkov oseltamivirja na razvoj odpornega virusa gripe (primarna analiza) pri odraslih imunsko ogroženih bolnikih, okuženih z gripo, je vključila 151 bolnikov, pri katerih je bilo mogoče oceniti učinkovitost oseltamivirja (sekundarna analiza, brez moči).
Mix the sweet food and Ebilfumin suspension well.
Dobro premešajte sladko hrano in suspenzijo zdravila Ebilfumin.
No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
Podatki o varnosti in učinkovitosti oseltamivirja pri bolnikih z resnim ali nestabilnim zdravstvenim stanjem, ki lahko potrebujejo hospitalizacijo, niso na voljo.
Older people and patients with chronic cardiac and/or respiratory disease The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease).
Populacijo, vključeno v študije zdravljenja gripe, sestavljajo drugače zdravi odrasli/mladostniki in “ogroženi'' bolniki (bolniki z večjim tveganjem za razvoj zapletov, povezanih z gripo, npr. starejši ljudje in bolniki s kronično srčno ali respiratorno boleznijo).
Based on preclinical data, there is no evidence that oseltamivir has an effect on male or female fertility (see section 5.3).
Glede na predklinične podatke ni dokazov, da bi zdravilo Ebilfumin vplivalo na plodnost moških ali žensk (glejte poglavje 5.3).
The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness.
Pogosti znaki gripe so nenadno zvišanje telesne temperature (več kot 37,8 oC), kašelj, zamašen nos, bister izcedek iz nosu, glavoboli, bolečine v mišicah in huda utrujenost.
There was no resistance observed during a 12-week prophylaxis study in immunocompromised patients.
Med 12 tednov trajajočo študijo preprečevanja pri imunsko ogroženih bolnikih odpornosti niso opazili.
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in oseltamivir prophylaxis clinical studies.
V 12-tedenski študiji preprečevanja gripe pri 475 imunsko ogroženih bolnikih, vključno z 18 otroki, starimi od 1 do 12 let in več, je bil varnostni profil pri 238 bolnikih, ki so prejemali oseltamivir, v skladu s tistim, ki so ga predhodno ugotovili v kliničnih študijah preprečevanja gripe z zdravilom Ebilfumin.
• Water
• vodo
Do not use 30 mg capsules
Ne uporabljajte 30 mg kapsul
Less than 20 % of an oral radiolabelled dose is eliminated in faeces.
Z blatom se izloči manj kot 20 % radioaktivno označenega peroralnega odmerka.
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households and two seasonal prevention studies.
Učinkovitost oseltamivirja v preprečevanju naravno pojavljajoče se gripe so dokazali v študiji preprečevanja okužbe po predhodni izpostavljenosti v gospodinjstvih in v dveh študijah preprečevanja sezonske okužbe.
• Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
• kožne reakcije (vnetje kože, rdeč in srbeč izpuščaj, luščenje kože)
Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use oseltamivir.
Zato morajo zdravniki pri predpisovanju zdravila Ebilfumin upoštevati najnovejše razpoložljive informacije o občutljivosti vzorcev trenutno krožečega virusa na oseltamivir.
The total duration of fever was reduced by one day in the groups treated with oseltamivir.
Čas trajanja zvišane telesne temperature se je v skupini, ki je prejemala oseltamivir, skrajšal za en dan.
Foetal exposure in the rats and rabbits was approximately 15 to 20 % of that of the mother.
Izpostavljenost zarodka pri podganah in kuncih je bila približno 15 do
Resistance mutations tend to be viral sub-type specific.
Take mutacije so ponavadi specifične za virusni podtip.
Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are unaffected by co-administration with food.
Koncentracija predzdravila in aktivnega presnovka v plazmi je sorazmerna odmerku, sočasno uživanje hrane pa nanjo ne vpliva.
Take Ebilfumin as soon as possible, ideally within two days of the flu symptoms starting.
Zdravilo Ebilfumin začnite jemati čim prej, najbolje v prvih dveh dneh po pojavu simptomov gripe.
Influenza, usually called flu, is an infection caused by a virus.
Influenca oz. gripa je okužba, ki jo povzroča virus.
Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 years) compared to adults less than 65 years of age given comparable doses of oseltamivir.
Izpostavljenost aktivnemu presnovku v stanju dinamičnega ravnovesja je bila pri dajanju primerljivih odmerkov oseltamivirja od 25 do 35 % večja pri starejših ljudeh (starih od 65 do 78 let) kakor pri odraslih ljudeh, mlajših od 65 let.
Adults, adolescents 13 years and over, and children weighing 40 kg and over
Odrasli, mladostniki, stari 13 let in več, in otroci, težji od 40 kg
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness.
Bolezni jeter, žolčnika in žolčevodov, vključno s hepatitisom in zvišanimi vrednostmi jetrnih encimov pri bolnikih z boleznijo, podobno gripi.
The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 23 litres in humans, a volume equivalent to extracellular body fluid.
Srednji volumen porazdelitve oseltamivir karboksilata v stanju dinamičnega ravnovesja je pri ljudeh približno 23 litrov, kar je enako volumnu ekstracelularne telesne tekočine.
Information for the user
Informacije za bolnika
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.
Če je v posodi ostalo še nekaj mešanice, posodo sperite z majhno količino vode, bolnik pa naj to preostalo mešanico popije.