natgillin/translations-raw huggingface dataset:
This system delivers the prescribed concentration of nitric oxide to your baby ’ s lungs by diluting INOmax with an oxygen/ air mixture immediately before delivery.
Ta sistem dovaja predpisano količino dušikovega oksida v dojenčkova pljuča tako, da neposredno pred dovajanjem razredčuje zdravilo INOmax z mešanico kisik/ zrak.
For your baby ’ s safety, the delivery systems intended for administration of INOmax are fitted with devices that constantly measure the amount of nitric oxide, nitrogen dioxide, and oxygen being delivered to your baby ’ s lungs.
Za dojenčkovo varnost je sistem za dovajanje zdravila INOmax opremljen z napravami, ki nenehno merijo količino dušikovega oksida, dušikovega dioksida in kisika, ki se dovaja v pljuča vašega dojenčka.
Your baby ’ s doctor will decide how long your baby should be treated with INOmax.
Zdravnik se bo odločil, koliko časa bo vaš dojenček zdravljen z zdravilom INOmax.
If your baby stops using INOmax
Učinki po prenehanju zdravljenja z zdravilom INOmax:
At the end of therapy, the doctor will slowly lower the dose of INOmax being given to your baby.
Na koncu zdravljenja bo zdravnik odmerek zdravila INOmax, ki ga prejema vaš dojenček, počasi zmanjševal.
Treatment with INOmax should not be stopped suddenly, so that the circulation in your baby’ s lungs is able to adjust to oxygen/ air without INOmax.
Zdravljenje z zdravilom INOmax ne sme biti prekinjeno nenadoma, da se obtok v dojenčkovih pljučih lahko prilagodi kisiku/ zraku brez zdravila INOmax.
So when your baby’ s treatment with INOmax is almost finished, a gradual reduction in the amount of INOmax being administered to your baby will be supervised by your baby’ s doctor.
Ko se zdravljenje dojenčka z zdravilom INOmax zaključuje, bo zdravnik nadzoroval postopno zmanjšanje količine zdravila INOmax, ki ga dojenček prejema.
Low blood pressure has been known to occur if treatment with INOmax is stopped suddenly without first lowering the dose.
Znano je, da pride do pojava nizkega krvnega tlaka, če zdravljenje z zdravilom INOmax nenadoma prekinemo, ne da bi odmerek predhodno znižali.
If you have any other questions on the use of this product, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
Like all medicines, INOmax can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi dušikov oksid neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Your baby ’ s doctor will examine your baby closely for all side effects.
Zdravnik bo vašega dojenčka podrobno pregledal, da bi odkril vse neželene učinke.
The most common side effects relate to a very high concentration of nitric oxide reaching your baby ’ s blood, or side effects associated with formation of nitrogen dioxide:
Najpogostejši neželeni učinki se nanašajo na zelo visoko koncentracijo dušikovega oksida, ki pride v dojenčkovo kri, ali pa so povezani s tvorbo dušikovega dioksida.
• If too much nitric oxide reaches your baby ’ s blood, the capacity of his/ her blood to carry oxygen may be reduced.
• Če v kri vašega dojenčka pride preveč dušikovega oksida, se lahko zmanjša sposobnost njegove/ njene krvi za prenašanja kisika.
If this happens, your baby ’ s doctor will immediately reduce the dose of nitric oxide being given, and your baby ’ s blood will regain its ability to carry oxygen.
Če se to zgodi, bo zdravnik nemudoma zmanjšal odmerek dušikovega oksida in kri vašega dojenčka bo spet pridobila zmožnost prenašanja kisika.
• When nitric oxide and oxygen combine, they form a chemical called nitrogen dioxide.
• Ko se dušikov oksid in kisik pomešata, tvorita spojino, imenovano dušikov dioksid.
Nitrogen dioxide is associated with airway inflammation and damage, and should be maintained as low as possible.
Dušikov dioksid je povezan z vnetji in poškodbami dihalnih poti, zato ga moramo držati na kar najnižji ravni.
Furthermore, although both nitric oxide and the presence of nitrogen dioxide at high nitric oxide concentrations may cause tissue damage, the long-term clinical significance is unknown.
Nadalje, čeprav tako dušikov oksid kot tudi dušikov dioksid, ki je prisoten pri visokih koncentracijah dušikovega oksida, lahko povzročita poškodbe tkiv, njuna dolgoročna klinična pomembnost ni znana.
Therefore, your baby ’ s doctor will consider this potential risk in balance with the immediate benefits, which the short-term treatment with INOmax may provide and will carefully monitor the dose of nitric oxide being given.
Zato bo dojenčkov zdravnik ocenil morebitno tveganje v primerjavi s takojšnjimi koristmi, ki bi jih prineslo kratkotrajno zdravljenje z zdravilom INOmax, in bo pozorno spremljal odmerek dušikovega oksida, ki ga dojenček prejema.
Side effects with INOmax include deficient oxygenation of the blood due to sudden withdrawal of the treatment, low blood pressure, blood in urine, high blood sugar, blood poisoning, infection, and skin infection.
Med neželene učinke zdravila INOmax sodijo nezadostna oksigenacija krvi zaradi nenadne prekinitve zdravljenja, nizek krvni tlak, kri v urinu, visok krvni sladkor, zastrupitev krvi, okužbe in okužbe kože.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after your baby leaves the hospital, please tell your baby ’ s doctor.
21 Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, tudi ko dojenček zapusti bolnišnico, obvestite dojenčkovega zdravnika.
HOW TO STORE INOmax
SHRANJEVANJE ZDRAVILA INOmax
Do not use INOmax after the expiry date which is stated on the label.
Zdravila INOmax ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Storage in the pharmacy department The gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only.
Shranjevanje v lekarnah Jeklenke shranjujte v zračnih, čistih in zaklenjenih prostorih, namenjenih le shranjevanju plinov za medicinske namene.
Storage in the medical department The gas cylinder should be put in an equipped site with appropriate material in order to hold the cylinder vertically.
Shranjevanje v medicinskih oddelkih Jeklenko morate namestiti v prostor, opremljen z ustreznimi materiali, ki omogočajo, da je jeklenka postavljena pokončno.
What INOmax contains
Kaj vsebuje zdravilo INOmax
The active substance in INOmax is nitric oxide.
Zdravilna učinkovina v zdravilu INOmax je dušikov oksid.
INOmax is available in 2 litre and 10 litre aluminium gas cylinder.
Zdravilo INOmax je na voljo v 2- litrskih in 10- litrskih aluminijastih jeklenkah.
Marketing Authorisation Holder INO Therapeutics AB SE-181 81 Lidingo Sweden
Imetnik dovoljenja za promet z zdravilom INO Therapeutics AB SE- 181 81 Lidingo Švedska
Manufacturer AGA Medical Zone Industrielle de Limay Porcheville 3, avenue Ozanne 78440 Gargenville France
Izdelovalec AGA Medical Zone Industrielle de Limay Porcheville 3, avenue Ozanne 78440 Gargenville Francija
It is available as oval pink tablets containing 100 mg, 200 mg or 400 mg rufinamide.
Na voljo je v obliki ovalnih, rožnatih tablet, ki vsebujejo 100 mg, 200 mg ali 400 mg rufinamida.
Inovelon is used to treat patients aged 4 years or older who have Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood.
Zdravilo Inovelon se uporablja pri zdravljenju bolnikov, starih 4 leta ali več, z Lennox- Gastautovim sindromom, redko obliko epilepsije, ki navadno prizadene otroke, a se lahko nadaljuje tudi v odraslem obdobju.
Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Lennox- Gastautov sindrom je ena izmed najtežjih oblik epilepsije pri otrocih.
Inovelon is used as an add-on to other anti-epileptic medicines.
Zdravilo Inovelon se uporablja kot pomožno zdravilo pri zdravljenju z drugimi zdravili proti epilepsiji.
Because the number of patients with Lennox-Gastaut syndrome is low, the disease is rare, and Inovelon was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 20 October 2004.
Bolnikov z Lennox- Gastautovim sindromom je malo in je bolezen redka, zato je bilo zdravilo Inovelon 20. oktobra 2004 določeno kot „ zdravilo sirota “ (zdravilo za redke bolezni).
Treatment with Inovelon should be initiated by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders).
Zdravljenje z zdravilom Inovelon mora uvesti pediater (zdravnik, ki je specializiran za zdravljenje otrok) ali nevrolog (zdravnik, ki zdravi možganske bolezni).
The dose of Inovelon depends on the patient ’ s age and weight and whether the patient is also taking valproate (another anti-epileptic medicine).
Odmerek zdravila Inovelon je odvisen od starosti in teže bolnika ter tega ali bolnik jemlje tudi valproat (drugo zdravilo proti epilepsiji).
This is then adjusted every other day according to the patient ’ s response to treatment.
Ta odmerek se nato glede na odziv bolnika na zdravljenje prilagaja vsak drugi dan.
Inovelon should be taken with water and food twice a day, once in the morning and once in the evening.
Zdravilo Inovelon je treba zaužiti skupaj z vodo dvakrat na dan, enkrat zjutraj in enkrat zvečer.
If the patient cannot swallow the tablets, they can be crushed and mixed in a glass of water.
Če bolnik tablet ne more pogoltniti, se jih lahko zdrobi in zmeša v kozarcu vode.
Inovelon should be used with caution by patients who have problems with their liver.
Bolniki z jetrnimi težavami morajo Inovelon uporabljati previdno.
It acts by attaching to special channels on the surface of brain cells (sodium channels), which control the electrical activity of the cells.
Deluje tako, da se veže na posebne kanalčke na površini možganskih celic (natrijevi kanalčki), ki nadzirajo električno aktivnost celic.
By attaching to the channels, rufinamide prevents them switching from an inactive state to an active state.
Ko se rufinamid veže na te kanalčke, jim prepreči, da bi prešli iz nedejavnega v dejavno stanje.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Inovelon been studied?
Kako je bilo zdravilo Inovelon raziskano?
The effects of Inovelon were first tested in experimental models before being studied in humans.
Učinki zdravila Inovelon so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of Inovelon involved 139 patients aged between 4 and 30 years, of whom three quarters were below 17 years old.
Glavna študija je vključevala 139 bolnikov starih od 4 do 30 let, od katerih jih je bilo tri četrtine mlajših od 17 let.
All of the patients had Lennox-Gastaut syndrome that was not controlled despite continuous treatment for at least 4 weeks with up to 3 other anti-epileptic medicines.
Vsi bolniki so imeli Lennox- Gastautov sindrom, ki ga ni bilo mogoče nadzorovati kljub vsaj 4 tedne trajajočemu zdravljenju z do 3 drugimi zdravili proti epilepsiji.
The study compared the effects of adding Inovelon or adding a placebo (a dummy treatment) to the other medicines the patients were taking.
V študiji so primerjali učinke dodajanja zdravila Inovelon ali dodajanja placeba (zdravila brez zdravilne učinkovine) k zdravljenju z drugimi zdravili, ki so jih bolniki že jemali.
The main measures of effectiveness were the change in the number of seizures in the 4 weeks after Inovelon or placebo was added, compared with the 4 weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient’ s parent or guardian.
Glavna merila učinkovitosti so bile spremembe v številu napadov v 4 tednih po začetku uporabe zdravila Inovelon ali placeba glede na 4 tedne pred uporabo tega, kot tudi spremembe v resnosti napadov, ki so jih ocenjevali starši ali skrbniki bolnika s pomočjo razvrščanja po lestvici s sedmimi stopnjami.
What benefit has Inovelon shown during the studies?
Kakšne koristi je zdravilo Inovelon izkazalo med raziskavami?
Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the 4-week period before Inovelon was started.
Pri bolnikih, ki so jemali zdravilo Inovelon, so opazili zmanjšanje števila vseh napadov za 35, 8% od povprečno 290 napadov v 4 tednih pred začetkom jemanja zdravila Inovelon.
There was a 1.6% reduction in the patients who added placebo to their existing treatment.
Pri bolnikih, ki so kot pomožno zdravilo prejemali placebo, so opazili zmanjšanje števila napadov za 1, 6%.
Patients adding Inovelon also had a 42.5% reduction in the number of ‘ tonic-atonic’ seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared to a 1.9% increase in those adding placebo.
Pri bolnikih, ki so dobili Inovelon, so opazili tudi zmanjšanje števila tonično- atoničnih napadov za 42, 5% (tip napada, ki je običajno prisoten pri bolnikih z Lennox- Gastautovim sindromom, pri katerem bolnik pogosto pade na tla), v primerjavi z zvečanjem za 1, 9% pri tistih, ki so jemali placebo.
An improvement in the severity of seizures was reported for about half of the patients adding Inovelon, compared to a third of those adding placebo.
O zmanjšanju resnosti napadov so poročali pri približno polovici bolnikov, ki so kot pomožno zdravilo prejemali Inovelon, v primerjavi s tretjino tistih, ki so kot pomožno zdravilo prejemali placebo.
The most common side effects with Inovelon (seen in more than 1 in 10 patients) were somnolence (sleepiness), headache, dizziness, nausea (feeling sick), vomiting, and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Inovelon (opaženi pri več kot 1 bolniku od 10) so bili zaspanost, glavobol, vrtoglavost, navzeja (slabost), bruhanje in utrujenost.
For the full list of all side effects reported with Inovelon, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Inovelon, najdete v Navodilu za uporabo.
Inovelon should not be used in patients who may be hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients.
Zdravila Inovelon se ne sme uporabljati pri bolnikih, ki utegnejo biti preobčutljivi za (alergični na) rufinamid, triazolne derivate (kot so nekatera zdravila za zdravljenje glivičnih okužb) ali katero koli drugo snov.
The Committee for Medicinal Products for Human Use (CHMP) decided that Inovelon’ s benefits are greater that its risks for use as adjunctive therapy in the treatment of seizures associated with Lennox- Gastaut syndrome in patients 4 years and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila Inovelon kot pomožnega zdravila pri zdravljenju napadov povezanih z Lennox- Gastautovim sindromom pri bolnikih starih 4 leta in več, večje od z njim povezanih tveganj.
They recommended that Inovelon be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Inovelon.
Which measures are being taken to ensure the safe use of Inovelon?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Inovelon?
The company that makes Inovelon will closely monitor the safety of the medicine.
Družba, ki izdeluje zdravilo Inovelon, bo natančno spremljala varnost zdravila.
This will include monitoring of cases of ‘ status epilepticus’, a dangerous condition where the brain is in a persistent state of seizure.
To vključuje spremljanje primerov „ epileptičnega statusa “, nevarnega stanja pri katerem so možgani v stanju nenehnega napada.
This follows cases of this condition being seen in patients taking Inovelon during its development.
Pri tem spremljajo primere tega stanja opažene pri bolnikih, ki so zdravilo Inovelon jemali v času njegovega razvijanja.
Other information about Inovelon:
Druge informacije o zdravilu Inovelon:
The European Commission granted a marketing authorisation valid throughout the European Union for Inovelon to Eisai Limited on 16 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Inovelon, veljavno po vsej Evropski uniji, odobrila družbi Eisai Limited dne 16. januarja 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Inovelon is available here.
Povzetek mnenja Odbora za zdravila sirote v zvezi z zdravilom Inovelon je na voljo tukaj.
The full EPAR for Inovelon can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Inovelon je na voljo tukaj.
This summary was last updated in 01-2007.
Ta povzetek je bil nazadnje posodobljen 01 - 2007.
EU/ 1/ 06/ 378/ 001
Številka EU EU/ 1/ 06/ 378/ 001
Inovelon
Izmišljeno ime Inovelon
100 mg
jakost 100 mg
Film-coated tablet
farmacevtska oblika Filmsko obložena tableta
Oral use
pot uporabe Peroralna uporaba
blister (PA/ AL/ PVC)
ovojnina pretisni omot (PA/ AL/ PVC)
10 tablets
velikost pakiranja 10 tablete
blister (PA/ AL/ PVC)
pretisni omot (PA/ AL/ PVC)
100 mg Each film-coated tablet contains 100 mg rufinamide.
100 mg Ena filmsko obložena tableta vsebuje 100 mg rufinamida.
20 mg lactose monohydrate/ film coated tablet.
20 mg laktoze monohidrata / filmsko obloženo tableto.
For a full list of excipients, see Section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
100 mg Pink, ‘ ovaloid’, slightly convex, scored on both sides, embossed ‘Є 261’ on one side and blank on the other side.
100 mg Rožnata, ‘ ovalna, rahlo konveksna, z zarezo na obeh straneh, z vtisnjenim napisom ‘ Є261 ’ na eni strani in brez napisa na drugi strani.
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years and older.
Inovelon je indiciran kot pomožno zdravilo pri zdravljenju epileptičnih napadov, povezanih z Lennox- Gastautovim sindromom, pri bolnikih starih 4 leta in starejših.
Treatment with Inovelon should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Zdravljenje z Inovelonom naj uvede specialist pediater ali nevrolog z izkušnjami pri zdravljenju epilepsij.
Inovelon is for oral use.
Inovelon je namenjen za peroralno uporabo.
It should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Jemlje se dvakrat na dan s kozarcem vode, zjutraj in zvečer, v dveh enakih razdeljenih odmerkih.
As a food effect was observed, it will preferable to administer Inovelon with food (see Section 5.2).
Ker so opazili učinek hrane, je bolje jemati Inovelon s hrano (glejte poglavje 5. 2).
If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Če bolnik težko požira, lahko tablete zdrobi in jih vzame v pol kozarca vode.
Use in children four years of age or older and less than 30 kg Patients < 30 kg not receiving valproate:
Uporaba pri otrocih, starih štiri leta ali starejših, katerih telesna masa ne presega 30 kg Bolniki s telesno maso, manjšo od 30 kg, ki ne jemljejo valproata:
According to clinical response and tolerability, the dose may be increased by 200 mg/ day increments, as frequently as every two days, up to a maximum recommended dose of 1000 mg/ day.
Glede na klinični odziv in prenašanje zdravila lahko odmerek zvečujemo postopoma po 200 mg/ dan celo vsak drugi dan do največjega priporočenega odmerka 1000 mg/ dan.
Doses of up to 3600 mg/ day have been studied in a limited number of patients.
Pri omejenem številu bolnikov so proučevali odmerke do 3600 mg/ dan.
Patients < 30 kg also receiving valproate medication:
Bolniki s telesno maso, manjšo od 30 kg, ki jemljejo tudi valproat:
As valproate significantly decreases clearance of Inovelon, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Ker valproat signifikantno zmanjša očistek Inovelona, priporočamo bolnikom s telesno maso, manjšo od 30 kg, ki sočasno jemljejo valproat, manjši maksimalni odmerek Inovelona.
According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/ day, to the maximum recommended dose of 600 mg/ day.
Glede na klinični odziv in prenašanje zdravila lahko čez najmanj 2 dni odmerek zvečamo za 200 mg/ dan na največji priporočeni odmerek, ki je 600 mg/ dan.
2 Use in adults and children four years of age or older of 30 kg or over Treatment should be initiated at a daily dose of 400 mg.
2 Uporaba pri odraslih in otrocih, starih štiri leta ali starejših, ki tehtajo 30 kg ali več Zdravljenje je treba začeti z dnevnim odmerkom 400 mg.
According to clinical response and tolerability, the dose may be increased by 400 mg/ day increments, as frequently as every two days, up to a maximum recommended dose as indicated in the table below.
Glede na klinični odziv in prenašanje zdravila lahko odmerek zvečujemo postopoma po 400 mg/ dan celo vsak drugi dan do največjega priporočenega odmerka, navedenega v spodnji preglednici.
Weight range Maximum recommended dose (mg/ day)
največji priporočeni odmerek (mg/ dan)
Doses of up to 4000 mg/ day (in the 30-50 kg range) or 4800 mg/ day (over 50 kg) have been studied in a limited number of patients.
Pri omejenem številu bolnikov so proučevali odmerke do 4000 mg/ dan (v razponu telesne mase 30- 50 kg) oziroma do 4800 mg/ dan (preko 50 kg).
Elderly There is limited information on the use of Inovelon in the elderly.
Starejši bolniki Podatki o uporabi Inovelona pri starejših bolnikih so omejeni.
Since, the pharmacokinetics of rufinamide are not altered in the elderly (see Section 5.2), dosage adjustment is not required in patients over 65 years of age.
Ker farmakokinetika rufinamida pri starejših ni spremenjena (glejte poglavje 5. 2), prilagajanje odmerjanja pri bolnikih, starejših od 65 let, ni potrebno.
Patients with renal impairment A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see Section 5.2).
Bolniki z okvaro ledvic Študija na bolnikih z težko okvaro ledvic je pokazala, da prilagajanje odmerkov pri teh bolnikih ni potrebno (glejte poglavje 5. 2).
Patients with hepatic impairment Use in patients with hepatic impairment has not been studied.
Bolniki z okvaro jeter Uporabe zdravila pri bolnikih z okvaro jeter niso proučevali.
Therefore, use in patients with severe hepatic impairment is not recommended.
Zato uporaba zdravila pri bolnikih s težko okvaro jeter ni priporočljiva.
Effect of food Inovelon should preferably be taken with food (see Section 5.2).
Učinek hrane Inovelon je priporočljivo jemati s hrano (glejte poglavje 5. 2).
Discontinuation of Inovelon When Inovelon treatment is to be discontinued, it should be withdrawn gradually.
Ukinitev Inovelona Ko želimo zdravljenje z Inovelonom prekiniti, moramo to storiti postopoma.
In clinical trials Inovelon discontinuation was achieved by reducing the dose by approximately 25% every two days.
V kliničnih preskusih so dosegli ukinitev Inovelona tako, da so odmerek zmanjševali za približno 25% vsak drugi dan.
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Nekontrolirane odprte študije kažejo na trajno dolgoročno učinkovitost, čeprav nobena kontrolirana študija ni trajala dalj od treh mesecev.
Hypersensitivity to the active substance, triazole derivatives or to any excipients.
Preobčutljivost za zdravilno učinkovino, triazolne derivate ali katerokoli pomožno snov.
These events led to rufinamide discontinuation in 20% of the cases.
Ti dogodki so povzročili ukinitev rufinamida pri 20% primerov.
If patients develop new seizure types and/ or experience an increased frequency of status epilepticus that is different from the patient ’ s baseline condition, then the benefit risk ratio of the therapy should be reassessed.
Če se pri bolnikih pojavi nova vrsta napadov in/ ali imajo pogosteje epileptični status kot sicer, je treba ponovno pretehtati razmerje med koristjo in tveganjem zdravljenja.