natgillin/translations-raw huggingface dataset:
- increase in heart rate (pulse),
- povišanje frekvence bitja srca (utripa),
- blockage in the gut or bowel,
- oviranje pretoka v črevesju ali mehurju,
- abnormal urine test (protein in the urine),
- nenormalen urinski test (beljakovine v seču),
- shortness of breath or low levels of oxygen in the blood.
- zasoplost ali nizko vsebnost kisika v krvi.
Rarely, such side effects as seizures (fits), headache, confusion, changes in vision, or an abnormal tube-like connection between the windpipe and the passage to the stomach (gullet), may occur.
Redko se lahko pojavijo neželeni učinki kot so epileptični napad, glavobol, zmedenost, spremembe vida ali cevi podobna neobičajna povezava med sapnikom in prehodom v želodec (požiralnikom).
You should seek help as soon as possible if you suffer from any of the below mentioned side effects
Če imate kateregakoli od spodaj naštetih neželenih učinkov, poiščite zdravniško pomoč takoj, ko je mogoče.
41 The very common (more than 1 in 10 patients) side effects which were not severe, include:
41 Zelo pogosti (pri več kot 1 od 10 bolnikov) neželeni učinki, ki pa niso bili hudi, vključujejo:
- pain,
- bolečino,
- constipation, bleeding from the lower part of the large bowel, inflammation of the mouth,
- zaprtje, krvavitev iz spodnjega dela debelega črevesa, vnetje v ustih,
- loss of appetite,
- izgubo apetita,
- protein in the urine,
- beljakovine v seču,
- fever,
- zvišana telesna temperatura,
- headache.
- glavobol.
The common (up to 1 in 10 patients) side effects which were not severe, include:
Pogosti neželeni učinki (pri do 1 od 10 bolnikov), ki pa niso bili hudi, vključujejo:
- shortness of breath,
- kratko sapo,
- runny nose,
- izcejanje iz nosu,
- dry skin, flaking and inflammation of the skin, change in skin colour,
- suho kožo, luskavost in vnetje kože, spremembo barve kože,
- change in the sense of taste,
- spremembo občutka okusa,
- problems with eye (tearing),
- težave z očmi (solzenje),
- voice changes, hoarseness.
- sprememba glasu, hripavost.
Other less common side effects of any severity which have been reported are heart failure, bleeding from the lining of the mouth or vagina, and abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected.
Drugi manj pogosti neželeni učinki katerekoli stopnje, o katerih so poročali, so srčno popuščanje, krvavitev iz sluznice ust ali nožnice ter cevi podobna neobičajna povezava med notranjimi organi in kožo ali drugimi tkivi, ki normalno niso povezani.
There have been very rare reports of patients developing a hole in the septum of the nose – the structure, which separates the nostrils.
Poročali so o zelo redkih primerih bolnikov, pri katerih se je pojavilo predrtje nosnega pretina – strukture, ki ločuje nosnici.
Some side effects are more common in elderly patients.
Nekateri neželeni učinki so pogostnejši pri starejših bolnikih.
These side effects include blood clot in the arteries which can lead to a stroke or a heart attack.
Ti neželeni učinki so krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada.
In addition, elderly patients have a higher risk of a reduction in the number of white cells in the blood, and cells that help the blood clot.
Dodatno starejše bolnike spremlja tudi večje tveganje za zmanjšanje števila belih krvničk in celic, ki pomagajo strjevati kri.
Other side effects reported with a higher frequency in elderly patients were diarrhoea, sickness, headache and fatigue.
Drugi neželeni učinki, o katerih so pri starejših bolnikih poročali pogosteje, so driska, slabost, glavobol in utrujenost.
These include; a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
To vključuje zmanjšanje števila belih krvnih celic v krvi, še posebno nevtrofilcev (vrsta belih krvnih celic, ki pomaga varovati pred okužbami), prisotnost beljakovin v seču, zmanjšanje ravni kalija, natrija ali fosforja (mineral) v krvi, zvišan sladkor v krvi, zvečanje alkalne fosfataze (encim), zmanjšanje hemoglobina (nahaja se v rdečih krvnih celicah, ki prenašajo kisik), ki je lahko hudo.
HOW TO STORE AVASTIN
SHRANJEVANJE ZDRAVILA AVASTIN
Keep the vial in the outer carton.
Shranjujte vialo v zunanji ovojnini.
Do not use after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake Uporabno do.
Discard any unused medicine.
Neuporabljeno raztopino je treba zavreči.
What Avastin contains
Kaj vsebuje zdravilo Avastin
- The active substance is bevacizumab.
- Zdravilna učinkovina je bevacizumab.
- The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for
- Pomožne snovi so trehaloza dihidrat, natrijev fosfat, polisorbat 20 in voda za injekcije.
What Avastin looks like and contents of the pack Avastin is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Izgled zdravila Avastin in vsebina pakiranja Avastin je bistra, brezbarvna do rahlo rjava tekočina v stekleni viali z gumijastim zamaškom.
Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.
Vsaka viala vsebuje 100 mg bevacizumaba v 4 ml raztopine ali 400 mg bevacizumaba v 16 ml raztopine.
Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.
Imetnik dovoljenja za promet z zdravilom Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, Velika Britanija
Roche Pharma AG, Emil-Barell-Str.
Izdelovalec Roche Pharma AG, Emil- Barell- Str.
1, 79639 Grenzach-Wyhlen, Germany.
1, 79639 Grenzach- Wyhlen, Nemčija
Ireland Roche Products (Ireland) Ltd.
43 Ireland Roche Products (Ireland) Ltd.
Strength
Jakost 30 µg
Route of Administration
Pot uporabe Intramuskular
Packaging
Ovojnina prašek: viala (steklena);
30 µg (6 million IU)
(6 milijonov IU)
Powder and solvent for solution for injection
Prašek in vehikel za suspenzijo za
Intramuscular use
na uporaba
powder: vial (glass); solvent: pre- filled syringe (glass)
vehikel: napolnjena injekcijska brizga
powder:
prašek:
30 µg; solvent:
30 µg; vehikel:
4 vials with Bioset device +4 pre-filled syringes
4 viale z napravo Bioset + 4
30 µg/ 0.5 ml (6 million IU)
30 µg /
Solution for injection
0, 5 ml napolnjena injekcijska
Intramuscular use
4 napolnjene
pre-filled syringe (glass)
(6 milijonov IU)
0.5 ml
na uporaba
4 pre-filled syringes + 4 needles
injekcijske brizge + 4 igle
Solution for injection
Suspenzija za
Intramuscular use
Intramuskular
pre-filled syringe (glass)
napolnjena injekcijska
12 pre-filled syringes + 12 needles
injekcijske brizge + 12 igle
Avonex is a powder and solvent in a vial, which are made up into a solution for injection, and a solution for injection in a pre-filled syringe.
Zdravilo Avonex obsega prašek in vehikel v viali, ki se zmešata v raztopino za injiciranje, in raztopino za injiciranje v predhodno napolnjeni brizgi.
Each vial and syringe contains 30 micrograms (6 million international units or ‘ MIU’) of the active substance, interferon beta-1a.
Vsaka viala in vsaka napolnjena brizga vsebuje 30 mikrogramov (6 milijonov mednarodnih enot ali i. e.) zdravilne učinkovine interferon beta- 1a.
Avonex is used to treat the following groups: • patients with relapsing multiple sclerosis (MS).
Zdravilo Avonex se uporablja za zdravljenje: • bolnikov s ponavljajočo se multiplo sklerozo (MS).
This is the type of MS where the patient has attacks (relapses) within periods with no symptoms.
Gre za vrsto multiple skleroze, pri kateri se ponovni napadi (relapsi) pri bolniku pojavljajo med obdobji brez simptomov.
Avonex slows the progression of disability and reduces the number of relapses; • patients who have experienced the signs of MS for the first time, when these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Zdravilo Avonex upočasnjuje napredovanje prizadetosti in zmanjšuje pogostost relapsov; • bolnikov, ki so prvikrat doživeli znake MS, so pa ti dovolj resni, da upravičujejo zdravljenje z injiciranjem kortikosteroidov (protivnetnih zdravil).
It is used when the patient is considered to be at high risk of developing MS.
Uporablja se pri bolnikih, ki jim grozi veliko tveganje za razvoj MS.
Before using Avonex, doctors need to exclude other causes for the symptoms.
Pred samo uporabo zdravila Avonex morajo zdravniki izključiti druge možne vzroke simptomov.
Avonex is used in patients aged 12 years or over.
Zdravilo Avonex se uporablja pri bolnikih, starih 12 let in več.
Avonex treatment should be started by a doctor who has experience in the management of MS.
Zdravljenje z zdravilom Avonex mora začeti zdravnik z izkušnjami z zdravljenjem MS.
The recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Priporočeni odmerek zdravila Avonex je 30 mikrogramov, ki se daje z injekcijo v mišico enkrat tedensko.
This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows about half the dose of Avonex to be injected.
V tem primeru je treba uporabiti predhodno napolnjeno brizgo, na katero je pritrjen poseben pripomoček, ki omogoča injiciranje zgolj polovičnega odmerka zdravila Avonex.
Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Zdravljenje z zdravilom Avonex je treba prekiniti pri bolnikih, pri katerih se je razvila progresivna (napredujoča) MS.
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
MS je bolezen živčnega sistema, pri kateri vnetje poškoduje zaščitno ovojnico okrog živcev.
This is called ‘ demyelination’.
To se imenuje „ demielinizacija “.
The active substance in Avonex, interferon beta-1a, belongs to the group ‘ interferons’.
Zdravilna učinkovina v zdravilu Avonex, interferon beta- 1a, sodi v skupino interferonov.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferoni so naravne spojine, ki jih telo proizvaja za obrambo proti napadom, kot so okužbe, ki jih povzročajo virusi.
The exact way that Avonex works in MS is not yet known but interferon beta seems to calm the immune system down, and prevents relapses of MS.
Natančen način delovanja zdravila Avonex pri MS še ni popolnoma znan, toda vse kaže, da interferon beta pomirja imunski sistem in preprečuje ponovne napade MS.
Interferon beta-1a is produced by a method known as ‘ recombinant DNA technology’: the interferon beta-1a is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Interferon beta- 1a proizvede celica, ki je prejela gen (DNK), s katerim lahko tvori interferon beta- 1a.
The replacement interferon beta-1a acts in the same way as naturally produced interferon beta.
Nadomestni interferon beta- 1a deluje na enak način kot naravno proizvedeni interferon beta.
Avonex has been studied in three main studies.
Zdravilo Avonex so preučevali v okviru treh glavnih študij.
The first study compared Avonex with placebo (a dummy treatment) in 301 patients with relapsing MS.
V prvi so primerjali zdravilo Avonex s placebom (zdravilom brez zdravilne učinkovine) pri 301 bolniku s ponavljajočo se MS.
The patients had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Ti bolniki so imeli vsaj dve ponovitvi v preteklih treh letih ali vsaj eno ponovitev, če so bolni manj kot tri leta.
The second study compared the effectiveness of the 60- and 30-microgram doses in 802 patients.
Druga študija je primerjala učinkovitost 60- mikrogramskega odmerka s 30- mikrogramskim odmerkom pri 802 bolnikih.
The third study involved 383 patients who had experienced a single attack of demyelination and compared the effectiveness of Avonex with that of placebo in reducing the risk of a second attack.
Tretja študija je vključevala 383 bolnikov, ki so doživeli en demielinizacijski napad, v njej pa so primerjali učinkovitost zdravila Avonex s placebom pri zmanjševanju tveganja za pojav drugega napada.
However, it presented information from published studies on the use of Avonex in children aged between 12 and 18 years.
Družba ni izvedla nobenih uradnih študij na bolnikih, mlajših od 16 let, je pa predstavila informacije iz objavljenih študij uporabe zdravila Avonex pri otrocih, starih od 12 do 18 let.
In the first study, 22% of the patients with relapsing MS who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability by the end of two years.
V prvi študiji se je pri 22% bolnikov s ponavljajočo se MS, zdravljenih z zdravilom Avonex, in pri 35% bolnikov, zdravljenih s placebom, prizadetost poslabšala do konca drugega leta.
The second study showed that there is no difference between the two doses in terms of effectiveness.
Druga študija je pokazala, da z vidika učinkovitosti ni nikakršnih razlik med obema odmerkoma.
In the third study, the estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
V tretji študiji so ocenili, da je tveganje za pojav drugega demielinizacijskega napada manjše pri bolnikih, ki so se zdravili z zdravilom Avonex, kot pri bolnikih, zdravljenih s placebom: pri bolnikih, zdravljenih z zdravilom Avonex, je bilo izkazano tveganje 21% v dveh letih in 35% v treh, medtem ko je bilo pri bolnikih, ki so prejemali placebo, 39% v dveh letih in 50% v treh.
In patients aged between 12 and 18 years, the published studies showed that the patients had a decrease in the rate of relapse.
Objavljene študije so pri bolnikih, starih od 12 do 18 let, pokazale, da se je pri tej populaciji stopnja ponovnih napadov zmanjšala.
The most common side effects with Avonex (seen in more than 1 patient in 10) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Avonex (opaženi pri več kot 1 bolniku od 10), so glavobol, gripi podobni simptomi, pireksija (povišana telesna temperatura), mrzlica in potenje.
The side effects are similar in children.
Pri otrocih prihaja do podobnih neželenih učinkov.
For the full list of all side effects reported with Avonex, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Avonex, glejte navodilo za uporabo.
Avonex should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients.
Zdravila Avonex ne smejo uporabljati osebe, ki imajo anamnezo preobčutljivosti na (alergije na) naravni ali rekombinantni interferon beta, humani albumin ali katero koli drugo sestavino zdravila.
The pre-filled syringes do not contain human albumin.
Predhodno napolnjene injekcijske brizge ne vsebujejo humanega albumina.
Avonex treatment must not be started during pregnancy.
Zdravljenje z zdravilom Avonex se ne sme začeti med nosečnostjo.
If a woman becomes pregnant while taking the medicine, she should consult her doctor.
Če ženska zanosi med jemanjem zdravila, naj se posvetuje s svojim zdravnikom.
Avonex must also not be used in patients who are currently suffering from severe depression or have thoughts about suicide.
Zdravilo Avonex se prav tako ne sme uporabljati pri bolnikih, ki trpijo za hudo depresijo ali imajo samomorilne misli.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avonex’ s benefits are greater than its risks for treatment of patients diagnosed with relapsing MS, or with a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Avonex pri zdravljenju bolnikov z diagnozo ponavljajoče se multiple skleroze ali pri zdravljenju bolnikov, ki so doživeli en sam demielinizacijski napad z aktivnim vnetnim procesom, če je bil dovolj resen, da upravičuje zdravljenje z injiciranjem kortikosteroidov, večje od z njim povezanih tveganj.
The Committee recommended that Avonex be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Avonex odobri dovoljenje za promet.
Avonex was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Avonex je bilo prvotno odobreno v „ izjemnih okoliščinah “, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 22 March 2006.
Ker je družba posredovala zahtevane dodatne informacije, so „ izjemne okoliščine “ 22. marca 2006 prenehale veljati.
2/ 3 Other information about Avonex:
2/ 3 Druge informacije o zdravilu Avonex:
The marketing authorisation was renewed on 13 March 2002 and 13 March 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 13. marca 2002 in dne 13. marca 2007.
The marketing authorisation holder is Biogen Idec Limited.
Imetnik dovoljenja za promet z zdravilom je družba Biogen Idec Limited.
The full EPAR for Avonex is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Avonex je na voljo tukaj.
Each BIO-SET vial contains 30 micrograms (6 million IU) of interferon beta-1a.
Ena viala BIO- SET vsebuje 30 mikrogramov (6 milijonov i. e.) interferona beta- 1a.
Following reconstitution with the solvent (water for injections) the vial contains 1.0 ml of solution.
Po rekonstituciji z vehiklom (vodo za injekcije) vsebuje viala 1, 0 ml raztopine.
Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contains 6 million IU of antiviral activity.
Po standardu Svetovne zdravstvene organizacije (SZO) mednarodni standard za interferon, 30 mikrogramov zdravila AVONEX vsebuje 6 milijonov i. e. protivirusne aktivnosti.
The vial contains a white to off-white cake.
Viala vsebuje bel do smetanasto bel liofilizat
AVONEX is indicated for the treatment of
AVONEX je namenjen za zdravljenje
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
V kliničnih študijah so to opisali kot dva ali več akutnih poslabšanj (relapsov) v preteklih treh letih, brez dokazov o postopnem napredovanju med relapsi; AVONEX upočasnjuje napredovanje prizadetosti in zmanjšuje pogostost relapsov.
• Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
• bolnikov, ki so doživeli en demielinizacijski napad z aktivnim vnetnim procesom, če je bil dovolj resen, da upravičuje zdravljenje z intravenoznimi kortikosteroidi, če so bile druge možne diagnoze izključene in če je bolnik uvrščen v visoko stopnjo tveganja, da se bo pri njem/ njej razvila klinično jasna multipla skleroza (glejte poglavje 5. 1).
The recommended dosage for the treatment of relapsing MS is 30 micrograms (1 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6).
Priporočen odmerek za zdravljenje ponavljajoče se MS je 30 mikrogramov (1 ml raztopine), injiciranih intramuskularno (i. m.) enkrat tedensko (glejte poglavje 6. 6).
Children and adolescents:
2 Otroci in mladostniki:
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Uradnih kliničnih preskušanj ali farmakokinetičnih študij na otrocih ali mladostnikih niso izvedli.
2 from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Omejeni objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki so prejemali AVONEX 30 mikrogramov i. m. enkrat tedensko, podoben tistemu, ki so ga opazili pri odraslih.
There is no information on the use of AVONEX in children under 12 years of age and therefore AVONEX should not be used in this population.
Zaradi tega se zdravila AVONEX ne sme uporabljati pri tej populaciji.
Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
V klinične študije ni bilo vključeno zadostno število bolnikov, starih 65 let ali več, da bi lahko ugotovili, če se ti odzivajo drugače kot mlajši bolniki.
However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Vendar pa na osnovi podatkov o izločanju zdravilne učinkovine ni teoretičnega razloga za morebitne zahteve po zmanjševanju odmerka pri starostnikih.
The intramuscular injection site should be varied each week (see section 5.3).
Mesto intramuskularnega injiciranja naj se spremeni vsak teden (glejte poglavje 5. 3).
Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician.
Dolgoročno zdravljenje mora zdravnik določiti pri vsakem posameznem bolniku posebej.
- Initiation of treatment in pregnancy (see section 4.6).
- uvedba zdravljenja med nosečnostjo (glejte poglavje 4. 6).
- Patients with a history of hypersensitivity to natural or recombinant interferon -ß, human
- pri bolnikih, ki so že imeli preobčutljivostno reakcijo na naravni ali rekombinantni interferon- β,
albumin or to any excipients.
humani albumin ali katero od pomožnih snovi.
- Patients with current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8).
- pri bolnikih s prisotno hudo depresijo in/ ali samomorilnimi nagnjenji (glejte poglavji 4. 4 in 4. 8).
AVONEX should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Previdnost pri dajanju zdravila AVONEX je potrebna pri bolnikih s preteklimi ali trenutno prisotnimi depresivnimi motnjami, zlasti tistimi, ki so povezane s samomorilnimi nagnjenji (glejte poglavje 4. 3).
Patients should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Bolnikom, ki se zdravijo, naročite, naj svojega zdravnika takoj obvestijo o vseh morebitnih simptomih depresije in/ ali samomorilnih mislih.
Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Bolnike z depresijo morate skrbno spremljati med zdravljenjem in jih ustrezno zdraviti.
Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Po potrebi tudi ukinite terapijo z zdravilom AVONEX (glejte poglavji 4. 3 in 4. 8).
AVONEX should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Previdnost je potrebna pri dajanju zdravila AVONEX bolnikom z znano nagnjenostjo h krčem, kot tudi tistim, ki se zdravijo z antiepileptiki, zlasti še, če se njihove epilepsije z antiepileptiki ne da ustrezno obvladovati (glejte poglavji 4. 5 in 4. 8).