FrancophonIA/ELRC3.0 huggingface dataset:
English: For all patients under the age of 1 year, 3 mg/kg should be used to determine dose regardless of the weight of the patient.
Slovenian: Za vse bolnike, mlajše od 1 leta, je pri določitvi odmerka treba upoštevati odmerek 3 mg/kg ne glede na maso bolnika.
English: What you need to know before you take Ebilfumin Do not take Ebilfumin:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ebilfumin Ne jemljite zdravila Ebilfumin:
English: Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of oseltamivir in its adopted therapeutic indications.
Slovenian: Če primerjamo meje izpostavljenosti s pričakovanimi mejami izpostavljenosti pri ljudeh, te ugotovitve ne spremenijo razmerja med koristjo in tveganjem zdravila Ebilfumin pri odobrenih terapevtskih indikacijah.
English: Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested (1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-day- old rat pups, including death.
Slovenian: Medtem ko zelo veliki peroralni enkratni odmerki soli oseltamivirjevega fosfata, do najvišjega preizkušenega odmerka (1.310 mg/kg), nimajo neželenih učinkov pri odraslih podganah, so taki odmerki povzročili zastrupitve pri mladih 7 dni starih podganah, vključno s smrtjo.
English: General Information
Slovenian: Splošne informacije
English: Required volume of vehicle
Slovenian: Potreben volumen vehikla
English: The mixture should be stirred and given entirely to the patient.
Slovenian: Mešanico je treba premešati in bolniku dati celotno vsebino.
English: Step 3: Choose the correct amount for your child's weight
Slovenian: 3. korak: Izberite ustrezni odmerek glede na otrokovo maso
English: Patients who are unable to swallow capsules may receive appropriate extemporaneous formulation, see section 6.6 for preparation.
Slovenian: Bolniki, ki ne morejo pogoltniti kapsul, lahko dobijo ustrezno sprotno (ex-tempore) izdelano obliko, za pripravo glejte poglavje 6.6.
English: However, the duration of treatment of influenza in immunocompromised adult patients should be 10 days, as there are no studies of a shorter course of oseltamivir in this patient group (see section 5.1).
Slovenian: Vendar pa naj zdravljenje gripe pri imunsko ogroženih odraslih bolnikih traja 10 dni, ker študij krajšega zdravljenja z oseltamivirjem pri tej skupini bolnikov ni (glejte poglavje 5.1).
English: Stir the mixture with the teaspoon for about 2 minutes.
Slovenian: Suspenzijo mešajte s čajno žličko približno 2 minuti.
English: The capsule contains a white granulated powder.
Slovenian: Kapsule vsebujejo bel zrnat prah.
English: To find the correct amount to use, find the patient's weight on the left of the table.
Slovenian: Za uporabo pravilne količine zdravila poiščite bolnikovo telesno maso na levi strani preglednice.
English: It is important to complete the whole 5-day course, even if you start to feel better quickly.
Slovenian: Pomembno je, da z jemanjem zdravila ne prenehate predčasno (pred 5 dnevi), tudi če se že prej počutite dobro.
English: Post-exposure prevention: The recommended post-exposure prevention dose of Ebilfumin is:
Slovenian: Preprečevanje po izpostavljenosti virusu: priporočeni odmerki zdravila Ebilfumin za preprečevanje bolezni po izpostavljenosti virusu so:
English: Dermatitis (including allergic and atopic dermatitis)
Slovenian: (vključno z alergijskim in atopičnim dermatitisom)
English: Approximately 50 % of the animals treated with the unformulated active substance showed erythema after challenging the induced animals.
Slovenian: Pri približno 50 % živali, ki so jim dajali neformulirano učinkovino, se je po dajanju odmerka pojavil eritem.
English: The primary efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza.
Slovenian: Primarni parameter učinkovitosti vseh študij je bila incidenca laboratorijsko potrjene gripe.
English: • If you need smaller doses, making Ebilfumin suspension from capsules involves extra steps.
Slovenian: • Kadar potrebujete manjše odmerke, priprava suspenzije vključuje dodatne korake.
English: These reactions were seen at doses of 657 mg/kg and higher.
Slovenian: Ti učinki so bili opaženi pri odmerkih, enakih ali večjih od 657 mg/kg.
English: The susceptibility to oseltamivir and the prevalence of such viruses appear to vary seasonally and geographically.
Slovenian: Občutljivost na oseltamivir in razširjenost teh virusov se pojavlja različno glede na sezono in geografska območja.
English: Recommended doses are detailed in the table below.
Slovenian: Priporočeni odmerki so opisani v spodnji preglednici.
English: Psychiatric disorders and nervous system disorders Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Slovenian: Psihiatrične motnje in bolezni živčevja Gripa je lahko povezana s številnimi nevrološkimi in vedenjskimi simptomi, ki lahko vključujejo dogodke kot so halucinacije, delirij, nenavadno vedenje, in so v nekaterih primerih lahko tudi smrtni.
English: Patients with Resistance Mutations (%) Phenotyping* Geno- and Phenotyping*
Slovenian: Bolniki z virusnimi sevi, odpornimi na oseltamivir (%) Fenotipizacija* Genotipizacija in fenotipizacija*
English: The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older).
Slovenian: Poročila o neželenih učinkih pri dojenčkih, starih od 0 do 12 mesecev, so večinoma podobna poročilom o neželenih učinkih pri starejših otrocih (starih 1 leto ali več).
English: • Ear inflammation and other ear disorders
Slovenian: • vnetje ušes in ostale ušesne bolezni
English: Ebilfumin hard capsules are bioequivalent formulations.
Slovenian: Trde kapsule zdravila Ebilfumin so bioekvivalentne oblike.
English: However treatment-emergent resistance to oseltamivir did not affect treatment response and caused no prolongation of influenza symptoms.
Slovenian: Vendar odpornost na oseltamivir, ki se je razvila med zdravljenjem, ni vplivala na odziv na zdravljenje in ni povzročila podaljšanja simptomov gripe.
English: Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading.
Slovenian: Zdravilo Ebilfumin ni cepivo: zdravi okužbo, ali prepreči širjenje virusa gripe.
English: (Note: The drug substance, oseltamivir phosphate, readily dissolves in water.
Slovenian: (Opomba: Učinkovina, oseltamivir fosfat, se zlahka raztopi v vodi.
English: For people who find it hard to take capsules, including very young children, a liquid medicine may be available.
Slovenian: Za bolnike, ki težko jemljejo kapsule, vključno z zelo majhnimi otroci, je možna uporaba suspenzije zdravila.
English: First, calculate the total volume needed to be compounded and dispensed for each patient.
Slovenian: Najprej izračunajte celokupen volumen susupenzije, ki jo je potrebno pripraviti in izdati za vsakega bolnika.
English: What Ebilfumin is and what it is used for
Slovenian: Kaj je zdravilo Ebilfumin in za kaj ga uporabljamo
English: Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk.
Slovenian: Na voljo so zelo omejene informacije o dojenih otrocih katerih matere jemljejo oseltamivir in o izločanju oseltamivirja v materino mleko.
English: Overdose has been reported more frequently for children than adults and adolescents.
Slovenian: O prevelikem odmerjanju so poročali pogosteje pri otrocih kot pri odraslih in mladostnikih.
English: Younger children cleared both the pro-drug and its active metabolite faster than adults, resulting in a lower exposure for a given mg/kg dose.
Slovenian: Pri mlajših otrocih sta se predzdravilo in njegov aktivni presnovek izločala hitreje kot pri odraslih, česar rezultat je bila manjša izpostavljenost danemu odmerku v mg/kg telesne mase.
English: In the majority of cases reporting overdose, no adverse events were reported.
Slovenian: V večini primerov, kjer so poročali o prevelikem odmerjanju, niso poročali o neželenih dogodkih.
English: Clinical studies: The risk of emergence of influenza viruses with reduced susceptibility or frank resistance to oseltamivir has been examined during Roche-sponsored clinical studies.
Slovenian: Klinične študije: tveganje za pojav virusov gripe z zmanjšano občutljivostjo ali odkrito odpornostjo na oseltamivir so proučevali v kliničnih študijah, ki jih je sponzorirala družba Roche.
English: Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Slovenian: Učinkovitost so dokazali pri zdravljenju, ki se je pričelo v dveh dneh po prvem nastopu simptomov.
English: Data from 504 influenza B infected subjects were pooled across all studies for analysis.
Slovenian: Podatke 504 bolnikov, okuženih z virusom influence tipa B, so združili v analizo iz vseh študij.
English: The primary efficacy parameter for this study was the incidence of laboratory-confirmed clinical influenza in the households.
Slovenian: Osnovni parameter učinkovitosti za to študijo je bila incidenca klinične laboratorijsko potrjene influence v gospodinjstvu.
English: It is not further metabolised and is eliminated in the urine.
Slovenian: Naprej se ne presnavlja in se v tej obliki izloči z urinom.
English: Treatment dose (for 5 days)
Slovenian: Odmerek za zdravljenje (za 5 dni)
English: Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
Slovenian: V obdobjih, ko ni epidemije, so gripi podobni simptomi ponavadi posledica drugih okužb ali bolezni.
English: Immunocompromised patients and young children are at a higher risk of developing oseltamivir-resistant virus during treatment.
Slovenian: Imunsko ogroženi bolniki in mlajši otroci imajo med zdravljenjem veliko tveganje za razvoj virusov, odpornih na oseltamivir.
English: Oseltamivir has no influence on the ability to drive and use machines.
Slovenian: Oseltamivir nima vpliva na sposobnost vožnje in upravljanja strojev.
English: PVC/PE/PVdC/Al blisters or HDPE containers with LDPE lid (and a desiccant).
Slovenian: Pretisni omoti PVC/PE/PVdC/Al ali HDPE vsebniki z LDPE pokrovom (in sušilo).
English: Do not break or chew the capsules.
Slovenian: Kapsul ne smete lomiti ali žvečiti.
English: Other medicines and Ebilfumin
Slovenian: Druga zdravila in zdravilo Ebilfumin
English: The majority of patients that developed resistance were transplant recipients (8/10 patients in the standard dose group and 2/2 patients in the double dose group).
Slovenian: Večina bolnikov, pri katerih se je razvila odpornost, je bila prejemnikov presajenih organov (8/10 bolnikov v skupini z običajnim odmerkom in 2/2 bolnika v skupini z dvojnim odmerkom).
English: Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional to declining renal function.
Slovenian: Jemanje 100 mg oseltamivirjevega fosfata dvakrat na dan 5 dni pri bolnikih, ki so imeli ledvično okvaro različnih stopenj, je pokazalo, da je izpostavljenost oseltamivir karboksilatu obratno sorazmerna zmanjšanju ledvičnega delovanja.
English: Limited data demonstrated that oseltamivir and the active metabolite were detected in breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant.
Slovenian: Omejeni podatki kažejo, da so oseltamivir in aktivni presnovek odkrili v materinem mleku, vendar so bile ravni zelo nizke, kar bi imelo za posledico subterapevtski odmerek za dojenčka.
English: Place an appropriate expiration date label according to storage condition (see section 6.3).
Slovenian: V skladu s pogoji shranjevanja dodajte primerno nalepko z datumom izteka roka uporabnosti (glejte poglavje 6.3).
English: Extrapolation of the animal data provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.
Slovenian: Ekstrapolacija podatkov pri živalih daje oceno 0,01 mg/dan za oseltamivir in 0,3 mg/dan za aktivni presnovek.
English: once daily mg per kg = mg for each kilogram of the infant's body weight.
Slovenian: 3 mg na kg, enkrat na dan mg na kg = mg za vsak kilogram dojenčkove telesne mase.
English: In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate for, or an inhibitor of, the major cytochrome P450 isoforms.
Slovenian: Študije in vitro so pokazale, da niti oseltamivir niti aktivni presnovek nista substrat ali zaviralec izooblik citokroma P450.
English: • Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
Slovenian: • okužba zgornjega dela dihal (vnetje nosu, grla in sinusov)
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors, ATC code: J05AH02
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci nevraminidaze, oznaka ATC: J05AH02.
English: See Section 5.2 for exposure simulation details.
Slovenian: Za podrobnosti glede simulacije izpostavljenosti glejte poglavje 5.2.
English: Treatment and prevention of influenza in children:
Slovenian: Zdravljenje in preprečevanje gripe pri otrocih:
English: Results of the conventional rodent carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some tumours that are typical for the rodent strains used.
Slovenian: Podatki običajnih študij kancerogenega potenciala pri podganah so pokazali tendenco za od odmerka odvisno povečanje incidence nekaterih tumorjev, ki so značilni za uporabljene vrste glodavcev.
English: The difference is how often it is given.
Slovenian: Razlika je v pogostnosti jemanja.
English: The primary endpoint in this study was the incidence of laboratory-confirmed clinical influenza as determined by viral culture and/or a four-fold rise in HAI antibodies.
Slovenian: Primarni cilj študije je bil določiti incidenco klinične laboratorijsko potrjene gripe, določene na osnovi virusne kulture in/ali štiri-kratnega povečanja HAI protiteles.
English: 137.5 ml (or 150 ml)*
Slovenian: 137.5 ml (ali 150 ml)*
English: Treatment of influenza in pregnant women: No controlled clinical studies have been conducted on the use of oseltamivir in pregnant women, however, there is evidence from post-marketing and retrospective observational studies showing benefit of the current dosing regimen in this patient population in terms of lower morbidity/mortality.
Slovenian: Zdravljenje gripe pri nosečnicah: Kontroliranih kliničnih študij o uporabi oseltamivirja pri nosečnicah niso izvedli, vendar so iz obdobja po prihodu zdravila na trg in opazovalnih študij na voljo dokazi o koristi veljavnega režima odmerjanja pri tej populaciji bolnic v smislu manjše obolevnosti/smrtnosti.
English: • Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
Slovenian: • angionevrotični edem: nenaden pojav hudega otekanja kože v glavnem okoli glave in vratu, vključno z očmi in jezikom, s težavami pri dihanju;
English: Results from pharmacokinetic analyses indicate a lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 5.2, Pharmacokinetics, Special Population).
Slovenian: Rezultati farmakokinetične analize kažejo na manjšo izpostavljenost aktivnemu presnovku, vseeno pa pri nosečnicah za zdravljenje ali preprečevanje gripe prilagajanje odmerkov ni priporočljivo (glejte poglavje 5.2, Farmakokinetične lastnosti, Posebne populacije).
English: Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Slovenian: Pri odločitvi glede uporabe oseltamivirja za zdravljenje in preprečevanje gripe je treba upoštevati vse, kar je znanega o značilnostih krožečih virusov gripe, razpoložljive informacije za vsako sezono o občutljivosti vzorcev na zdravilo proti gripi in vpliv bolezni na različnih geografskih območjih in na različne skupine bolnikov (glejte poglavje 5.1).
English: - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
Slovenian: - Preventiva po predhodni izpostavljenosti virusu pri posameznikih, starih 1 leto ali več, ki so bili v stiku s klinično diagnosticirano gripo, ko je virus influence razširjen v okolici.
English: Therefore, dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation).
Slovenian: Zato pri nosečnicah za zdravljenje ali preprečevanje gripe prilagajanje odmerkov ni priporočljivo (glejte poglavje 4.6 Plodnost, nosečnost in dojenje).
English: The active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface.
Slovenian: Aktivni presnovek je selektivni zaviralec nevraminidaznih encimov virusa influence, glikoproteinov, ki so na površini viriona.
English: Treatment: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily.
Slovenian: Zdravljenje: priporočeni odmerek za zdravljenje dojenčkov, starih od 0 do 12 mesecev, je 3 mg/kg dvakrat na dan.
English: Contents of the pack and other information What Ebilfumin contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ebilfumin
English: A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza.
Slovenian: Skupno 1.473 otrok (vključujoč drugače zdrave otroke, stare 1 - 12 let in otroke z astmo stare 6 - 12 let) je sodelovalo v kliničnih študijah, kjer je bil oseltamivir dan za zdravljenje gripe.
English: Look at the right column to check the number of capsules you will need to give the patient for a single dose.
Slovenian: Nato v stolpcu na desni strani poglejte koliko kapsul boste potrebovali za bolnika za en odmerek.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
English: When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Slovenian: Kadar so poročali o neželenih učinkih, so bili ti podobni tistim, o katerih so poročali pri jemanju običajnih odmerkov in so navedeni v poglavju 4.
English: Exposure to the pro-drug is less than 5 % relative to the active metabolite.
Slovenian: Izpostavljenost predzdravilu je manj kot 5 % glede na aktivni presnovek.
English: Draw it up carefully so as not to include air bubbles.
Slovenian: Suspenzijo povlecite v odmernik previdno, da ne vsebuje zračnih mehurčkov.
English: Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33 % in individual studies.
Slovenian: Zdravljenje okužbe z virusom influence tipa B: od vseh bolnikov, ki so bili okuženi z virusom influence, jih je bilo 15 % okuženih z virusom influence tipa B. V posameznih študijah so bili ti odstotki od 1 do 33.
English: - Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Slovenian: - Zdravilo Ebilfumin je indicirano za preprečevanje gripe po izpostavljenosti virusu pri dojenčkih, mlajših od 1 leta, med izbruhom pandemije gripe (glejte poglavje 5.2).
English: Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1).
Slovenian: Občutljivost krožečih sevov virusa gripe na oseltamivir je zelo spremenljiva (glejte poglavje 5.1).
English: • Mild to severe liver function disorders
Slovenian: • blaga do huda motnja jetrnih funkcij
English: Infants less than 1 year To make a smaller single dose, you need:
Slovenian: Dojenčki, stari manj kot 1 leto Za pripravo manjših odmerkov potrebujete:
English: In most cases of overdose, people have not reported any side effects.
Slovenian: V večini primerov, ko je prišlo do prevelikega odmerjanja, ljudje niso poročali o kakršnih koli neželenih učinkih.
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Ebilfumin suspension involves additional steps.
Slovenian: Kadar so na voljo le 75 mg kapsule in potrebujemo 30 mg ali 45 mg odmerek, so v postopku priprave suspenzije zdravila Ebilfumin potrebni dodatni koraki.
English: The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
Slovenian: bodisi prvi ali drugi dan zdravljenja in je spontano prenehala v enem do dveh dneh.
English: 60 ml or 75 ml*
Slovenian: 60 ml ali 75 ml*
English: Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge studies in healthy volunteers.
Slovenian: Aktivnost oseltamivirja proti virusu influence A in B so dokazali v študijah na zdravih prostovoljcih.
English: 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.
Slovenian: 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.
English: Recommended dose for prevention
Slovenian: Priporočeni odmerek za preprečevanje
English: • Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
Slovenian: • Zdravilo Ebilfumin se uporablja pri odraslih, mladostnikih, otrocih in dojenčkih (vključno z donošenimi novorojenčki) za zdravljenje gripe (influence).
English: For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture.
Slovenian: Za pripravo doma se mora posebej priložiti odmernik za odvzem pravilnega volumna vode in za odmerjanje mešanice zdravila Ebilfumin-voda.
English: 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.
Slovenian: 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.
English: With a suitable stirring device, stir for 2 minutes.
Slovenian: S primerno mešalno napravo mešamo 2 minuti.
English: During treatment with Ebilfumin, tell a doctor immediately:
Slovenian: Med zdravljenjem z zdravilom Ebilfumin morate nemudoma povedati svojemu zdravniku:
English: Draw up the correct amount of liquid mixture from the first bowl.
Slovenian: Povlecite pravilno količino suspenzije iz prve posode.