FrancophonIA/ELRC3.0 huggingface dataset:
English: This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
Slovenian: Postopek opisuje pripravo 6 mg/ml suspenzije, ki bo enemu bolniku zadoščala za 5 dnevni potek zdravljenja ali 10 dnevni potek preprečevanja bolezni.
English: At 500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day administered from 7 to 21 days post partum).
Slovenian: Pri odmerkih 500 mg/kg, danih tudi pri kroničnem zdravljenju (500 mg/kg/dan danih od 7 do 21 dni po skotitvi), niso opazili neželenih učinkov.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: 10 kg to 15 kg 30 mg
Slovenian: 10 kg do 15 kg 30 mg
English: The following dosing regimen is recommended for treatment of infants 0 - 12 months of age:
Slovenian: Priporočena shema za zdravljenje dojenčkov, starih od 0 do 12 mesecev, je:
English: Use of oseltamivir must not affect the evaluation of individuals for annual influenza vaccination.
Slovenian: Zdravilo Ebilfumin ni nadomestilo cepljenja proti gripi Uporaba zdravila Ebilfumin ne sme vplivati na evaluacijo posameznikov za letno cepljenje proti gripi.
English: Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate).
Slovenian: Oseltamivirjev fosfat je predzdravilo aktivnega presnovka (oseltamivir karboksilat).
English: Description of selected adverse reactions
Slovenian: Opisi izbranih neželenih učinkov
English: In the pooled treatment study population, which included both influenza-positive and -negative subjects (ITT), primary efficacy was reduced proportionally to the number of influenza-negative individuals.
Slovenian: V združeni populaciji zdravljenih preskušancev, ki je zajemala bolnike, okužene z virusom influence in bolnike, ki niso bili okuženi z virusom influence (z namenom zdraviti), je bila primarna učinkovitost zmanjšana sorazmerno s številom bolnikov, ki niso bili okuženi z virusom influence.
English: If the commercially manufactured oseltamivir powder for oral suspension and the pharmacy compounded suspension is also not available, Ebilfumin suspension may be prepared at home.
Slovenian: Če komercialno izdelanega oseltamivir praška za peroralno suspenzijo in tudi suspenzije pripravljene v lekarni ni na voljo, se lahko suspenzija zdravila Ebilfumin pripravi doma.
English: No phase 2 conjugates of either compound have been identified in vivo.
Slovenian: Konjugatov faze II oseltamivirja ali njegovih presnovkov in vivo niso odkrili.
English: Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Slovenian: Nato določite število kapsul in količino vehikla (voda, ki vsebuje 0,05 % m/v natrijevega benzoata kot konzervans), ki so potrebni za pripravo celokupnega volumna (izračunanega iz zgornje preglednice) 6 mg/ml suspenzije pripravljene v lekarni, kot je prikazano v spodnji preglednici:
English: ≤ 7 kg up to 40 ml
Slovenian: ≤ 7 kg do 40 ml
English: The proportion of patients with secondary infections in the standard dose group and double dose group was comparable (8.2% vs 5.1%).
Slovenian: Delež bolnikov s sekundarnimi okužbami je bil med skupinama primerljiv (8,2 % v skupini z običajnim odmerkom in 5,1 % v skupini z dvojnim odmerkom).
English: Elderly No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.
Slovenian: Prilagajanje odmerkov ni potrebno, razen če ima bolnik zmerno ali hudo ledvično okvaro.
English: The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households that included adults, adolescents, and children aged 1 to 12 years, both as index cases and as family contacts.
Slovenian: Učinkovitost oseltamivirja pri preprečevanju naravno pridobljene okužbe gripe je bila dokazana v študiji preprečevanja po predhodni izpostavljenosti v gospodinjstvih, ki je vključevala odrasle, mladostnike in otroke, stare od 1 do 12 let, in sicer tiste, ki so že imeli klinične simptome gripe, in tiste, ki so bili v stiku z družinskimi člani.
English: Ebilfumin is not a flu vaccine
Slovenian: Zdravilo Ebilfumin ni cepivo proti gripi
English: Oseltamivir reduced the time to alleviation of all symptoms by 0.7 days (95 % CI 0.1 - 1.6 days; p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza by one day (95 % CI 0.4 - 1.7 days; p < 0.001) compared to placebo.
Slovenian: Oseltamivir je zmanjšal čas izboljšanja vseh simptomov za 0,7 dni (95-% interval zaupanja 0,1 - 1,6 dni; p = 0,022), trajanje zvišane telesne temperature (≥ 37,8 °C), kašelj in nahod pa za en dan (95-% interval zaupanja 0,4 - 1,7 dni; p < 0,001)
English: Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
Slovenian: leta, mora temeljiti na presoji zdravnika, po preučitvi možne koristi zdravljenja v primerjavi z možnim tveganjem za dojenčka.
English: In this study, the rate of major congenital heart defects following oseltamivir exposure during the first trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98).
Slovenian: V tej študiji je bil delež večjih prirojenih srčnih napak po izpostavljenosti oseltamivirju v prvem trimesečju 1,76 % (7 dojenčkov od 397 nosečnosti) v primerjavi z 1,01 % pri nosečnostih splošne populacije brez izpostavljenosti zdravilu (razmerje obetov 1,75; 95-% interval zaupanja: 0,51
English: Resistant strains selected during oseltamivir treatment have been isolated from both immunocompetent and immunocompromised patients.
Slovenian: Odporne seve, izbrane med zdravljenjem z oseltamivirjem, so izolirali iz bolnikov, ki so imeli normalen imunski odziv in iz imunsko ogroženih bolnikov.
English: Children 1 year or older, weighing less than 40 kg Child's weight
Slovenian: Otroci, stari 1 leto ali več, ki tehtajo manj kot 40 kg
English: You should use only 75 mg capsules for 75 mg doses.
Slovenian: Za odmerek 75 mg lahko uporabite samo 75 mg kapsule.
English: Capsule size: 4
Slovenian: Velikost kapsule: 4
English: You should use only 30 mg capsules for 30 mg and 60 mg doses.
Slovenian: Za odmerke po 30 mg in 60 mg lahko uporabite samo 30 mg kapsule.
English: * There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, please use an alternative capsule strength.
Slovenian: * Ciljne koncentracije ni mogoče doseči z uporabo celega števila kapsul, zato prosimo, da uporabite drugo jakost kapsul.
English: Ebilfumin contains sodium
Slovenian: Zdravilo Ebilfumin vsebuje natrij
English: Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active metabolite (oseltamivir carboxylate).
Slovenian: Oseltamivir se po peroralnem zaužitju oseltamivirjevega fosfata (predzdravila) hitro absorbira iz gastrointestinalnega trakta in se znatno večinoma z jetrnimi esterazami pretvori v aktivni presnovek (oseltamivir karboksilat).
English: This is suitable for younger children and babies: they usually need an Ebilfumin dose of less than 30 mg. See the lower set of instructions.
Slovenian: To je običajno primerno za mlajše otroke in dojenčke, ki potrebujejo odmerek zdravila Ebilfumin manjši od 30 mg.
English: The bitter taste can be masked by products such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce).
Slovenian: Grenak okus lahko zakrijemo z izdelki, kot so sladkana voda, čokoladni sirup, češnjev sirup, prelivi za sladice (kot je karamelni ali čokoladni preliv).
English: In children, the most commonly reported adverse reaction was vomiting.
Slovenian: Pri otrocih je bil najpogosteje poročani neželeni učinek bruhanje.
English: Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce.
Slovenian: Primeri: čokoladen sirup; češnjev sirup; prelivi za sladice, kot je karamelni preliv.
English: Volume per dose (6 mg/ml)
Slovenian: Volumen na odmerek (6 mg/ml)
English: Ebilfumin is not a substitute for influenza vaccination.
Slovenian: Zdravilo Ebilfumin ni nadomestilo cepljenja proti gripi.
English: A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs.
Slovenian: Pri “testih maksimizacije” so na morskih prašičkih opazili potencial za preobčutljivost kože za oseltamivir.
English: Haemodialysis patients
Slovenian: hemodializni bolniki
English: Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment.
Slovenian: Zdravljenje gripe: prilagajanje odmerkov je priporočljivo za odrasle in mladostnike (stare od 13 do 17 let) z zmerno ali hudo ledvično okvaro.
English: Recommended dose for 10 days
Slovenian: Priporočeni odmerek za 10 dni
English: Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle.
Slovenian: Prenesite suspenzijo v temno obarvano stekleno ali temno obarvano polietilen tereftalat (PET)
English: ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Slovenian: V določeno kategorijo so neželeni učinki v preglednici dodani glede na skupno analizo kliničnih študij.
English: vertigo), Fatigue, Pyrexia , Pain in limb
Slovenian: (vključno z vrtoglavico), utrujenost, pireksija, bolečina v okončinah
English: Neuraminidase enzyme IC50 values for oseltamivir for clinically isolated influenza A ranged from 0.1 nM to 1.3 nM, and for influenza B was 2.6 nM. Higher IC50 values for influenza B, up to a median of 8.5 nM, have been observed in published studies.
Slovenian: IC50-vrednosti oseltamivirja za encim nevraminidazo so znašale pri klinično izoliranem virusu influence A od 0,1 nM do 1,3 nM, za virus influence B pa 2,6 nM.
English: • methotrexate (used to treat e.g. rheumatoid arthritis)
Slovenian: • metotreksat (uporablja se za zdravljenje npr. revmatoidnega artritisa),
English: 30 mg single dose * Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used.
Slovenian: 30 mg v enkratnem odmerku * Podatki so iz študij pri bolnikih na kontinuirani ambulantni peritonealni dializi (CAPD); kadar se uporablja avtomatska peritonealna dializa (APD), lahko pričakujemo večji očistek oseltamivir karboksilata.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oseltamivir in one or more subsets of the paediatric population in influenza.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Ebilfumin za eno ali več skupin pediatrične populacije pri gripi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Children 1 to 12 years
Slovenian: Otroci od 1 do 12 let
English: For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg
Slovenian: Na primer: Če 6-mesečnik tehta 8 kg, je odmerek
English: • probenecid (used to treat gout)
Slovenian: • probenecid (uporablja se za zdravljenje putike).
English: Treatment: The following weight-adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older:
Slovenian: Zdravljenje: priporočeni odmerki glede na telesno maso za dojenčke in otroke, stare 1 leto ali več, so:
English: • Sore throat
Slovenian: • vneto grlo
English: Table 2 Adverse reactions in studies investigating oseltamivir for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.]) System Organ Class (SOC)
Slovenian: Preglednica 2 Neželeni učinki v študijah, ki so preučevale zdravljenje in preprečevanje gripe pri otrocih z zdravilom Ebilfumin (odmerjanje glede na starost/telesno maso [30 mg do 75 mg enkrat na dan)]
English: The overall safety profile of oseltamivir is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with oseltamivir or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving oseltamivir or placebo/no treatment for the prophylaxis of influenza in clinical trials.
Slovenian: 1.473 pediatričnih bolnikov, ki so se zdravili za gripo z zdravilom Ebilfumin ali placebom, in na podatkih 3.990 odraslih/mladostnikov in 253 pediatričnih bolnikov, ki so v kliničnih študijah za profilakso gripe prejemali zdravilo Ebilfumin ali placebo/niso prejemali zdravljenja.
English: Exposure does not exceed that for treatment of infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see Section 4.8).
Slovenian: (3 mg/kg dvakrat dnevno), in pričakujemo lahko primerljiv varnostni profil (glejte poglavje 4.8).
English: Ebilfumin can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).
Slovenian: Jemanje s hrano zmanjša možnost slabega počutja (siljenje na bruhanje ali bruhanje).
English: There are no data available for infants below 1 year of age for post exposure prevention of influenza.
Slovenian: Na voljo ni podatkov za preprečevanje gripe po predhodni izpostavljenosti virusu pri dojenčkih, mlajših od 1 leta.
English: A funnel may be used to eliminate any spillage.
Slovenian: Za preprečitev morebitnega razlitja lahko uporabite lij.
English: Neuropsychiatric events have been reported during administration of oseltamivir in patients with influenza, especially in children and adolescents.
Slovenian: Pri bolnikih z gripo so med jemanjem zdravila Ebilfumin poročali o nevropsihiatričnih dogodkih, še posebej pri otrocih in mladostnikih.
English: Adults, and adolescents 13 years and over
Slovenian: Odrasli in mladostniki stari 13 let in več
English: The frequency of these effects is reduced if the medicinal product is taken with food.
Slovenian: Če zdravilo zaužijemo s hrano, se pogostnost neželenih učinkov zmanjša.
English: Post-exposure prevention: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults.
Slovenian: Preprečevanje po izpostavljenosti virusu: priporočeni odmerek za preprečevanje gripe po neposrednem stiku z okuženim posameznikom je za mladostnike (stare od 13 do 17 let) in odrasle 75 mg oseltamivirja enkrat na dan, 10 dni.
English: [Only applicable for outer packaging:] Ebilfumin 75 mg
Slovenian: [Uporablja se samo za zunanjo ovojnino:] Ebilfumin 75 mg
English: Ebilfumin 30 mg hard capsules Ebilfumin 45 mg hard capsules Ebilfumin 75 mg hard capsules
Slovenian: Ebilfumin 30 mg trde kapsule Ebilfumin 45 mg trde kapsule Ebilfumin 75 mg trde kapsule
English: Recommended dose for 5 days
Slovenian: Priporočeni odmerek za 5 dni
English: Post-exposure prevention: In a study in contacts (12.6 % vaccinated against influenza) of an index case of influenza, oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in the index case and continued for seven days.
Slovenian: Preprečevanje po predhodni izpostavljenosti virusu: v študiji so posameznikom (12,6 % cepljenih proti gripi), ki so prišli v stik z osebo, okuženo z virusom influence, začeli dajati oseltamivir v odmerku 75 mg enkrat na dan v dveh dneh po nastopu simptomov.
English: Preventing flu:
Slovenian: Preprečevanje gripe:
English: Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient's weight Body weight (kg)
Slovenian: Volumen 6 mg/ml suspenzije pripravljene v lekarni, na osnovi bolnikove telesne mase Telesna masa (kg)
English: Do not try to make a 75 mg dose by using the contents of 30 mg or 45 mg capsules.
Slovenian: Ne poskušajte narediti 75 mg odmerka z uporabo vsebine iz 30 mg ali 45 mg kapsul.
English: Capsule size: 2
Slovenian: Velikost kapsule: 2
English: 11 capsules (825 mg)
Slovenian: 11 kapsul (825 mg)
English: Severe concomitant condition
Slovenian: Resna spremljajoča stanja
English: Due to the wide safety margin of the active metabolite, no dose adjustments are required in adults due to their immunocompromised status.
Slovenian: prilagoditve odmerkov pri odraslih zaradi imunske ogroženosti niso potrebne.
English: In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was similar among age cohorts with vomiting, diarrohea and diaper rash being the most frequently reported adverse events (see section 5.2).
Slovenian: Pediatrična populacija (dojenčki, mlajši od enega leta) V dveh študijah, v katerih so opredelili farmakokinetiko, farmakodinamiko in varnostni profil oseltamivirja pri 135 z gripo okuženih otrocih, mlajših od 1 leta, je bil varnostni profil med vsemi starostnimi skupinami podoben, z bruhanjem, drisko in pleničnim izpuščajem kot najbolj pogosto poročanimi neželenimi učinki (glejte poglavje 5.2).
English: • chlorpropamide (used to treat diabetes)
Slovenian: • klorpropamid (uporablja se za zdravljenje sladkorne bolezni),
English: This dosing recommendation is not intended for premature infants, i.e. those with a postconceptual age less than 36 weeks.
Slovenian: Priporočilo za odmerjanje ni namenjeno nedonošenčkom, to je mlajšim od 36 tednov postkoncepcijske starosti.
English: According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratory-confirmed clinical influenza among children was significantly reduced from 19 % (21 / 111) in the group not receiving prevention to 7 % (7 / 104) in the group receiving prevention (64.4 % reduction [95 % CI 15.8 - 85.0; p = 0.0188]).
Slovenian: Glede na analizo podskupin pri otrocih, starih od 1 do 12 let, je bila pojavnost klinične laboratorijsko potrjene influence med otroci značilno zmanjšana iz 19 % (21/111) v skupini, ki ni prejemala zdravila za preprečevanje na 7 % (7/104) v skupini, ki je prejemala zdravilo za preprečevanje gripe (64,4-% znižanje [95-% interval zaupanja 15,8 - 85,0; p = 0,0188]).
English: There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Slovenian: Zadostnih kliničnih podatkov za pripravo priporočil o odmerjanju pri dojenčkih in otrocih (starih 12 let ali manj) z ledvično okvaro ni na voljo.
English: The NNT for the total paediatric population was 9 (95 % CI 7 - 24) and 8 (95 % CI 6, upper limit not estimable) in the whole population (ITT) and in paediatric contacts of infected index cases (ITTII), respectively.
Slovenian: NNT za celotno populacijo otrok (vseh z namenom zdraviti) je bilo 9 (95-% interval zaupanja 7 - 24) in 8 (95-% interval zaupanja 6, zgornja meja ni ocenjena) za populacijo otrok, ki je bila v stiku z okuženimi (z namenom zdraviti tiste, ki so bili okuženi).
English: • Runny nose
Slovenian: • zamašen nos
English: > 7 kg to 10 kg
Slovenian: > 7 kg do 10 kg
English: Commercially manufactured oseltamivir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed.
Slovenian: Komercialno izdelan oseltamivir prašek za peroralno suspenzijo (6 mg/ml) je najbolj primerna oblika za pediatrične in odrasle bolnike, ki imajo težave pri požiranju kapsul ali kjer so potrebni manjši odmerki.
English: When commercially manufactured oseltamivir powder for oral suspension is not available, a pharmacy compounded suspension prepared from Ebilfumin capsules must be used (see detailed instructions above).
Slovenian: Kadar komercialno izdelane peroralne suspenzije zdravila Ebilfumin ni na voljo, je treba uporabiti suspenzijo pripravljeno v lekarni iz Ebilfumin kapsul (glejte podrobna navodila zgoraj).
English: [Only applicable for outer packaging:] Ebilfumin 30 mg
Slovenian: [Uporablja se samo za zunanjo ovojnino:] Ebilfumin 30 mg
English: Since neuraminidase activity is extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread.
Slovenian: Ker je nevraminidaza aktivna v ekstracelularni tekočini, se oseltamivir karboksilat porazdeljuje na ista mesta kakor virus.
English: Clinical and surveillance data: Natural mutations associated with reduced susceptibility to oseltamivir in vitro have been detected in influenza A and B viruses isolated from patients without exposure to oseltamivir.
Slovenian: Klinični podatki in podatki, pridobljeni s spremljanjem zdravila po prihodu na trg: pri virusih gripe A in B, izoliranih iz bolnikov, ki niso bili izpostavljeni oseltamivirju, so in vitro odkrili naravne mutacije, povezane z zmanjšano občutljivostjo za oseltamivir.
English: Shellac Glaze-45% (20% esterified) Black iron oxide (E172) Propylene glycol (E1520) Ammonium hydroxide 28% (E527)
Slovenian: propilenglikol (E1520) amonijev hidroksid 28% (E527)
English: Cardiac arrhythmia
Slovenian: Srčne bolezni srčna aritmija
English: In influenza-positive patients with chronic cardiac and/or respiratory disease, the combined incidence of lower respiratory tract complications (mainly bronchitis) treated with antibiotics was 17 % (22/133) in the placebo group and 14 % (16/118) in the oseltamivir treated population (p = 0.5976).
Slovenian: Pri bolnikih s kronično boleznijo srca ali boleznijo dihal ali obojim, okuženih z virusom influence, je bila skupna pogostnost zapletov v respiratornem traktu (v glavnem bronhitis), zdravljenih z antibiotiki, 17 % (22/133) v placebo skupini in 14 % (16/118) v skupini, zdravljeni z oseltamivirjem (p = 0,5976).
English: Limited data indicate that oseltamivir and the active metabolite are excreted in human milk.
Slovenian: Omejeni podatki kažejo, da se oseltamivir in aktivni presnovek izločata v mleko tudi pri ljudeh.
English: In the event that commercially manufactured oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules or patients can prepare the suspension from capsules at home.
Slovenian: V primeru, da komercialno izdelanega oseltamivir praška za peroralno suspenzijo ni na voljo, lahko farmacevt pripravi suspenzijo (6 mg/ml) iz zdravila Ebilfumin kapsule ali bolnik pripravi suspenzijo iz kapsul doma..
English: The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.
Slovenian: Prosimo glejte spodaj za ustrezno velikost odmernika, ki ga morate uporabiti za odvzem pravilnega volumna suspenzije zdravila Ebilfumin (6 mg/ml).
English: Syringes of appropriate volume and grading should be provided for administering the pharmacy compounded suspension as well as for the procedures involved in the home preparation.
Slovenian: Brizge ustreznega volumna in z ustreznimi oznakami za odmerjanje morajo biti na voljo za pripravo suspenzije v lekarni, kot tudi za postopke pri pripravi doma.
English: [Only applicable for outer packaging:] Ebilfumin 45 mg
Slovenian: [Uporablja se samo za zunanjo ovojnino:] Ebilfumin 45 mg
English: 3 mg/kg once daily
Slovenian: 3 mg/kg enkrat na dan
English: dose for 5 days
Slovenian: odmerjanje za 5 dni
English: Τηλ: +30 210 5401500
Slovenian: Τηλ: +30 210 5401500 Ελλάδα
English: dose for 10 days
Slovenian: odmerjanje za 10 dni
English: Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury
Slovenian: • privide, halucinacije, agitacijo, anksioznost, nočne more.