natgillin/translations-raw huggingface dataset:
Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.
Poleg tega je bilo zdravilo Idelvion učinkovito pri zdravljenju epizod krvavitev, ko so se pojavile; približno 93 % epizod krvavitev so obvladali s samo eno injekcijo zdravila Idelvion.
The summary of the opinion of the Committee for Orphan Medicinal Products for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Idelvion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Idelvion was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Ker je bolnikov s hemofilijo B malo, velja ta bolezen za redko, zato je bilo zdravilo Idelvion 4. februarja 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or other ingredients of the medicine.
Zdravila Idelvion ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
The active substance in Idelvion, albutrepenonacog alfa, works in the body in the same way as human factor IX.
Zdravilna učinkovina zdravila Idelvion, albutrepenonakog alfa, deluje v telesu enako kot humani faktor IX.
What are the risks associated with Idelvion?
Kakšna tveganja so povezana z zdravilom Idelvion?
Idelvion can only be obtained with a prescription, and treatment should be supervised by a doctor with experience in treating haemophilia.
Izdaja zdravila Idelvion je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
The dose and the frequency of the injections depend on the patient's bodyweight and whether Idelvion is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Idelvion uporablja za zdravljenje ali preprečevanje krvavitve, resnosti bolnikovega pomanjkanja faktorja IX, obsega in mesta krvavitve ter bolnikove starosti in telesne mase.
The full EPAR for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Idelvion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Idelvion and what is it used for?
Kaj je zdravilo Idelvion in za kaj se uporablja?
What benefits of Idelvion have been shown in studies?
Kakšne koristi je zdravilo Idelvion izkazalo v študijah?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Idelvion is available as powder and solvent that are mixed together to make a solution for injection into a vein.
Zdravilo Idelvion je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
Why is Idelvion approved?
Zakaj je bilo zdravilo Idelvion odobreno?
Studies show that Idelvion is effective at preventing and treating bleeding episodes in patients with haemophilia B, and its safety is comparable to that of other factor IX products.
Študije so pokazale, da zdravilo Idelvion učinkovito preprečuje in zdravi epizode krvavitev pri bolnikih s hemofilijo B in da je varnost zdravila primerljiva z varnostjo drugih zdravil s faktorjem IX.
For more information about treatment with Idelvion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Idelvion preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Idelvion, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Idelvion naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Idelvion je zdravilo, ki se uporablja za preprečevanje in zdravljenje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor IX.
For the full list of side effects reported with Idelvion, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Idelvion, glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Idelvion.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Idelvion work?
Kako zdravilo Idelvion deluje?
How is Idelvion used?
Kako se zdravilo Idelvion uporablja?
Idelvion contains the active substance albutrepenonacog alfa.
Vsebuje zdravilno učinkovino albutrepenonakog alfa.
The following medicines are particularly important:
Posebej pomembna so naslednja zdravila:
Give the child something to drink.
Otroku dajte piti.
• if you or your child are repeatedly sick, or
• če ste vi ali vaš otrok pogosto bolni, ali
Date of first authorisation: 22 May 2014 Date of latest renewal:
Datum prve odobritve: 22. maj 2014 Datum zadnjega podaljšanja:
Not recommended (no data available)
ni priporočljivo (podatki niso na voljo)
• if your immune system is not working
• če vaš imunski sistem ne deluje
• if you are allergic to other medicines
• če ste alergični na druga zdravila
Repeat this procedure every time you need to give the medicine.
Ponovite ta postopek vsakič, ko morate dati zdravilo.
(nearest)
(najbližja)
Don't worry if not all of the powder dissolves.
Ne skrbite, če se ves prašek ne bo raztopil.
• if you have a severe medical condition, which may require immediate hospitalisation
• če imate resno zdravstveno stanje, ki morda zahteva takojšnjo hospitalizacijo
These symptoms can also be caused by other infections.
Ti simptomi so lahko tudi posledica drugih okužb.
It is best to take this in the mornings with breakfast.
Odmerek je najbolje zaužiti zjutraj z zajtrkom.
Specific studies have not been conducted to assess the reduction in the risk of complications.
Specifičnih študij za oceno zmanjšanja tveganja zapletov niso opravili.
• Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.
• Bolnike, še posebej otroke in mladostnike je treba skrbno spremljati glede pojava sprememb v vedenju, ki so opisane zgoraj.
These may be signs of rare but serious side effects.
To so lahko znaki redkih vendar resnih neželenih učinkov.
It is usually convenient to take one dose in the morning and one in the evening.
Ponavadi je najbolj priročno, če vzamete en odmerek zjutraj in enega zvečer.
6 years
6 leta
Stir the mixture well.
Mešanico dobro premešajte.
Talk to your doctor if this applies to you.
Obvestite zdravnika, če se to zgodi vam.
Rare but serious effects: get medical help at once
Redki, vendar resni neželeni učinki: takoj poiščite medicinsko pomoč
Home preparation
Priprava doma
These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Ti dogodki se lahko pojavijo pri razvoju encefalitisa ali encefalopatije, lahko pa se pojavijo brez očitne hude bolezni.
This leaflet was last revised in {MM/YYYY} {month YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
• Neuropsychiatric disorders, as described below.
• nevropsihiatrične bolezni, kot so opisane spodaj.
For treating flu, take two doses daily.
Za zdravljenje gripe, jemljite dva odmerka na dan.
• if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na oseltamivir ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
Of those, 851 children received treatment with oseltamivir suspension.
Od teh je 851 otrok prejelo zdravljenje z oseltamivir suspenzijo.
• Altered level of consciousness
• spremenjena raven zavesti
• Convulsions and delirium, including altered level of consciousness
• konvulzije in delirij, vključno s spremenjeno ravnijo zavesti,
In 2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe.
V Evropi je bila leta 2008 H275Y najdena v > 99 % krožečih H1N1 izolatov gripe.
• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents.
• če ste opazili spremembe v obnašanju ali razpoloženju (nevropsihiatrični dogodki), še posebej pri otrocih in mladostnikih.
• Two small bowls (use separate pairs of bowls for each child)
• dve manjši posodi (za vsakega otroka uporabljajte ločen par posod)
Body Weight (rounded to the nearest 0.5 kg)
Telesna masa (zaokrožena na najbližjih 0,5 kg)
• Sleeping difficulties
• težave s spanjem
This pharmacy preparation is the preferred option.
Pripravek, izdelan v lekarni, je prednostna izbira.
The clinical significance of this finding is not clear, as the study had limited power.
Klinični pomen te najdbe zaradi omejene moči študije ni jasen.
Be careful with the powder, because it may irritate your skin and eyes.
Previdno ravnajte s praškom, saj lahko draži vašo kožo in oči.
This is usually suitable for children over 1 year.
To je običajno primerno za otroke starejše od 1 leta.
Influenza was confirmed in 163 out of 377 index cases.
Gripo so potrdili pri 163 od 377 posameznikov.
If you notice any of these symptoms, especially in younger people, get medical help immediately.
Če opazite katerega koli od teh simptomov, še posebej pri mlajših osebah, takoj poiščite medicinsko pomoč.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet:
They help to ease or prevent the symptoms of the flu virus infection.
Pomagajo olajšati ali preprečiti simptome okužbe z virusom gripe.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations.
Uporabo protivirusnih zdravil za zdravljenje in preprečevanje gripe moramo določiti na osnovi uradnih priporočil.
Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Bolnike je treba skrbno spremljati glede sprememb vedenja ter pri vsakem bolniku ovrednotiti koristi in tveganja nadaljnjega zdravljenja (glejte poglavje 4.8).
Pour all of the powder into the bowl, whatever the dose you are making.
Ves prašek stresite v posodo, neglede na to kateri odmerek pripravljate.
These medicines prevent the flu virus from spreading inside the body.
Ta zdravila preprečijo virusu gripe, da bi se razširil po telesu.
Children with pre-existing bronchial asthma
Otroci s predhodno bronhialno astmo
Many of the side effects listed below may also be caused by influenza.
Številne neželene učinke, ki so navedeni spodaj, lahko povzroči tudi sama gripa.
For adult patients with a weak immune system, treatment will continue for 10 days.
Pri odraslih bolnikih s šibkim imunskim sistemom bo zdravljenje trajalo 10 dni.
It is recommended that this information be provided by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
Priporočljivo je, da se ta informacija doda na pomožno nalepko na steklenici ali pa se doda izjava k navodilom farmacevta.
A few cases resulted in self-injury, some with fatal outcome.
V redkih primerih so vodili do samopoškodbe, v nekaterih primerih s smrtnim izidom.
• Confusion, abnormal behaviour
• zmedenost, nenormalno vedenje,
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Preden dobite to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
Metabolite exposures are also more variable in the youngest infants.
Izpostavljenost presnovku je prav tako bolj spremenljiva pri najmlajših dojenčkih.
In addition, there is evidence from observational studies showing benefit of the current dosing regimen in this patient population.
Poleg tega dokazi iz opazovalnih študij kažejo na koristi veljavnega režima odmerjanja pri tej populaciji bolnic.
If you notice any of these symptoms, get medical help immediately.
Če opazite katerega od teh simptomov, takoj poiščite medicinsko pomoč.
The undissolved powder is just inactive ingredients.
Neraztopljen prašek so samo neaktivne pomožne snovi.
The effects on breast-fed infants are unknown.
Učinki na dojene otroke niso znani.
- The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
- Primernost uporabe zdravila Ebilfumin za preprečevanje gripe moramo določiti za vsak posamezen primer posebej, odvisno od okoliščin in skupine ljudi, ki potrebuje zaščito.
• if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.
• če se simptomi gripe poslabšajo ali, če se zvišana telesna temperatura ne zniža, čimprej obvestite zdravnika.
Information for healthcare professionals only Patients who are unable to swallow capsules:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Bolniki, ki ne morejo požirati kapsul:
(Regarding neuropsychiatric disorders, see section 4.4.)
(Glede nevropsihiatričnih bolezni glejte poglavje 4.4.)
30 mg twice daily * This table is not intended to contain all possible weights for this population.
30 mg dvakrat na dan *Preglednica ne predvideva vseh možnih telesnih mas te populacije.
Swallow the capsules whole with water.
Pogoltnite cele kapsule z vodo.
Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical efficacy study.
Farmakokinetične študije večkratnega odmerjanja so opravili pri majhnem številu otrok, ki so bili vključeni v klinično študijo učinkovitosti.
Hafnarfjörður Iceland
Hafnarfjörður Islandija
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
V posebnih primerih, kot je v primeru široko razširjene gripe in pri bolnikih s šibkim imunskim sistemom, se z zdravljenjem nadaljuje še do 6 ali 12 tednov.
A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were influenza-positive.
Drugo študijo so opravili pri 334 astmatičnih otrocih, starih od 6 do 12 let, od tega jih je 53,6 % imelo gripo.
• if you have chronic heart disease or respiratory disease.
• če imate kronično bolezen srca ali bolezen dihal.
0 - 12 months
0 do12 mesecev
You must use the amount of oral capsules or suspension prescribed by the doctor.
Jemati morate toliko peroralnih kapsul ali suspenzije, kot vam je predpisal zdravnik.
Shelf life of 6 weeks at 2°C - 8°C.
Rok uporabe je 6 tednov pri temperaturi 2 °C - 8 °C.
The mixture must be swallowed immediately after its preparation.
Mešanico mora bolnik zaužiti takoj po pripravi.
The reported adverse events were consistent with the established safety profile in older children.
Neželeni učinki, o katerih so poročali, so sovpadali z uveljavljenim varnostnim profilom pri starejših otrocih.
In the overall treatment population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited patients.
Med vso zdravljeno populacijo je bila okužba gripe potrjena pri 67 % (razpon od 46 % do 74 %) vključenih bolnikov.
Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Za te bolnike, pri katerih je lahko zaradi nerazvitih fizioloških funkcij potrebno drugačno odmerjanje, ni na voljo zadostnih podatkov.
The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %).
Vezava oseltamivir karboksilata na plazemske beljakovine pri ljudeh je zanemarljiva (približno 3 %).
True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community.
Prava okužba z gripo se pojavi le med letnimi izbruhi (epidemijami), ko se virusi gripe širijo v bližnji okolici.
Give the whole contents of the second bowl (Ebilfumin suspension with sweet food added) to the child straight away.
Takoj dajte celotno vsebino druge posode (suspenzijo zdravila Ebilfumin z dodano sladko hrano) otroku.
Put an ancillary label on the bottle indicating “Shake Gently Before Use”.
Na steklenico nalepite pomožno nalepko z napisom “Pred uporabo nežno pretresite”.
Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Na steklenico nalepite nalepko, ki vključuje bolnikovo ime, navodila za odmerjanje, rok uporabnosti zdravila, ime zdravila in katerokoli drugo potrebno informacijo, ki je v skladu z lokalnimi predpisi v lekarni.
Incidence of Oseltamivir Resistance in Clinical Studies Patient Population
Incidenca odpornosti na oseltamivir v kliničnih študijah Populacija bolnikov
Look up the child's weight on the left side of the table.
Poiščite otrokovo telesno maso na levi strani preglednice.
Amount of Ebilfumin suspension
Količina suspenzije Ebilfumin
These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues.
Ti neželeni učinki se največkrat pojavijo po prvem odmerku zdravila in v nadaljevanju zdravljenja izginejo.
(Note: This compounded suspension should be gently shaken prior to administration to minimise the tendency for air entrapment.)
(Opomba: Suspenzijo je potrebno pred uporabo nežno pretresti, da se izločijo zračni mehurčki.)
In general, the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents.
V splošnem je bil varnostni profil pri “ogroženih'' bolnikih kakovostno podoben tistemu pri drugače zdravih odraslih /mladostnikih.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na kapsulo, kar v bistvu pomeni ‘brez natrija'.
But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back.
Vendar, če prenehate z jemanjem zdravila Ebilfumin prej, kot vam je predpisal zdravnik, se lahko simptomi gripe ponovijo.
Treatment and prevention of influenza in adults and adolescents:
Zdravljenje in preprečevanje gripe pri odraslih in mladostnikih:
The 2009 H1N1 influenza (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.
Leta 2009 je bila gripa H1N1 (''prašičja gripa'') skoraj konstantno občutljiva na oseltamivir, poročali so samo o posameznih primerih odpornosti v povezavi s terapevtskim in profilaktičnim režimom.
Table 2 shows the most frequently reported ARs from paediatric clinical trials.
Preglednica 2 kaže najpogosteje poročane neželene učinke iz pediatričnih kliničnih študij.
In all phase III treatment studies, patients were recruited only during the period in which influenza was circulating in the local community.
V vse študije faze III so bili bolniki vključeni le v obdobju, ko je bila gripa prisotna v okolici.
In the oseltamivir treated group, the median duration of illness was not reduced significantly.
V skupini, ki je prejemala oseltamivir, mediana časa trajanja bolezni ni bila pomembno zmanjšana.
Instruct the parent or caregiver that any remaining material following completion of therapy must be discarded.
Poučite starše ali skrbnike, da je po končani terapiji potrebno vso preostalo raztopino zavreči.
The pharmacy preparation should be preferred to home preparation.
Priprava v lekarni ima prednost pred pripravo doma.
Do not take Ebilfumin.
Ne jemljite zdravila Ebilfumin.
For dosing, see section 4.2.
Za odmerjanje glejte poglavje 4.2.
Please use alternative capsule strength*
Prosimo, uporabite drugo jakost kapsul*
• Two small bowls
• dve manjši posodi
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
V splošnem je bil profil neželenih učinkov pri otrocih s predhodno bronhialno astmo kakovostno podoben tistemu pri drugače zdravih otrocih.
People who find it hard to take capsules can use a liquid form of this medicine (oral suspension).
Bolniki, ki težko požirajo kapsule, lahko uporabijo tekočo obliko tega zdravila (peroralno suspenzijo).
Reykjavíkurvegi 76-78, 220 Hafnarfjörður Iceland
Reykjavíkurvegi 76-78, 220 Hafnarfjörður Islandija
At least 75 % of an oral dose reaches the systemic circulation as the active metabolite.
Vsaj 75 % peroralnega odmerka doseže sistemski obtok v obliki aktivnega presnovka.
Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Reykjavíkurvegi 76-78 220 Hafnarfjörður Islandija
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.
Klinično pomembna medsebojna delovanja med zdravili, ki vključujejo kompeticijo za renalno tubularno sekrecijo, niso verjetna zaradi znane varnostne širine večine teh substanc, eliminacijskih lastnosti aktivnega presnovka (glomerulna filtracija in anionska tubularna sekrecija) in eliminacijske kapacitete teh poti.
Make sure you have the right size dispenser.
Prepričajte se, da imate pravilno velikost odmernika.
The rate of clearance of the active metabolite, corrected for bodyweight, decreases with ages below one year.
Stopnja očistka aktivnega presnovka, korigiranega za telesno maso, se zmanjšuje s starostjo pod 1 letom.
Give the whole contents of the bowl to the patient straight away.
Takoj dajte celotno vsebino posode bolniku.
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Metoda zdravljenja se lahko zamenja iz APD v CAPD, če nefrolog presodi, da je to potrebno.
Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.
Encimska aktivnost virusne nevraminidaze je pomembna tako za vstop virusa v neokuženo celico kot za sproščanje novonastalih virusnih delcev iz okuženih celic in za nadaljnjo širitev virusne okužbe po telesu.
Developing oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from less than 1% in adults to 18% in infants aged below 1 year.
Pri otrocih je bil med zdravljenjem razvoj virusnih sevov, odpornih na oseltamivir, pogostejši kot pri odraslih v razponu od manj kot 1 % pri odraslih do 18 % pri dojenčkih, mlajših od 1 leta.
Adults, adolescents and infants and children 1 year of age or older who are unable to swallow intact capsules
Odrasli, mladostniki in dojenčki ter otroci, stari 1 leto ali več, ki cele kapsule ne morejo pogoltniti
Statistical analyses are therefore presented only for influenza-infected subjects.
Statistične analize so tako na voljo le za bolnike, ki so bili okuženi z virusom influence.