natgillin/translations-raw huggingface dataset:
• Complicated intra-abdmonial infections o intra-abdominal infection o intra-abdominal and bile-ducts infections o Infections of abdominal cavity, including pelvic area o Abdominal cavity infections including of the pelvic bone o Infections of the abdomen and the lesser pelvis
• Abdominalna okužba in okužba jeter, žolčnika in žolčevodov o Abdominalna okužba in okužba jeter, žolčnika in žolčevodov o Intraabdominalna okužba o Intraabdominalne okužbe in okužbe žolčevodov o Okužbe trebušne votline, vključno z medeničnim predelom o Okužbe trebušne votline, vključno z medenično kostjo o Okužbe trebuha in majhne medenice
• Complicated urinary tract infections
• Zapletene intraabdominalne okužbe
o gonococcal urethritis without signs of pelvic dissemination, in men o cervical gonorrhoea without signs of pelvic
o Gonokokni uretritis brez znakov širjenja v medenici, pri moških o Gonoreja materničnega vratu brez znakov širjenja v medenici o Gonoreja sečnice in materničnega vratu o Gonoreja (uretritis in cervicitis)
• Acute bacterial sinusitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Akutni bakterijski sinusitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
• Simple uncomplicated cystitis.
• Nezapleteni cistitis.
• Pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
• Medenična vnetna bolezen, vključno s primeri, ki jih povzroča občutljiva Neisseria gonorrhoeae
In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
[Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
• Gonoccocal urethritis and cervicitis due to susceptible Neisseria gonorrhoea
• Gonokokni uretritis in cervicitis, ki jih povzroča občutljiva Neisseria gonorrhoea
• Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae
• Gonokokni uretritis in cervicitis, ki ju povzroča občutljiva Neisseria gonorrhoeae
In [indication] [name of product] should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the treatment of these infections.
[Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
• Uncomplicated acute cystitis In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Nezapleteni akutni cistitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
• Acute otitis media In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Akutno vnetje srednjega ušesa [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
Chlamydia
Rufloksacin
• Community-acquired pneumonia In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Nezapleteni cistitis [Ime zdravila] se lahko uporablja za [indikacijo] samo, če uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za zdravljenje teh okužb, ni primerna.
This summary was last updated in 08-2017.
Povzetek je bil nazadnje posodobljen 08-2017.
The European Commission granted a marketing authorisation valid throughout the European Union for Gazyvaro on 23 July 2014.
Evropska komisija je dovoljenje za promet z zdravilom Gazyvaro, veljavno po vsej Evropski uniji, izdala 23. julija 2014.
What measures are being taken to ensure the safe and effective use of Gazyvaro?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gazyvaro?
The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are upper respiratory infections (such as throat and nose infections), pneumonia (lung infection), urinary tract infections, cold sores, coughs, diarrhoea, constipation, joint and back pain, headache, insomnia, hair loss, itching, fever, weakness, neutropenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), lymph node pain and reactions related to the infusion (which may include vomiting, dizziness, breathing difficulties, flushing, changes in blood pressure and rapid heart rate).
Najpogostejši neželeni učinki zdravila Gazyvaro (ki se pojavijo pri več kot 1 od 10 bolnikov) so okužbe zgornjih dihalnih poti (kot so okužbe grla in nosu), pljučnica (okužba pljuč), okužbe sečil, herpetični mehurčki, kašelj, driska, zaprtje, bolečina v sklepih in hrbtu, glavobol, nespečnost, izpadanje las, srbečica, zvišana telesna temperatura, šibkost, nevtropenija in levkopenija (nizko število belih krvnih celic), trombocitopenija (nizko število trombocitov), slabokrvnost (nizko število rdečih krvnih celic), bolečina v bezgavkah in reakcije, povezane z infundiranjem (ki lahko zajemajo bruhanje, vrtoglavico, težave z dihanjem, zardevanje, spremembe krvnega tlaka in hiter srčni utrip).
For CLL, 28-day cycles are used.
Pri KLL so bili uporabljeni 28-dnevni cikli.
The pattern of side effects was considered acceptable in the light of the medicine's benefit.
Neželeni učinki se zdijo sprejemljivi glede na koristi zdravila.
Patients who respond to treatment, may continue to receive Gazyvaro once every two months for up to two years,as long as they benefit from it.
Bolniki, ki se odzovejo na zdravljenje, lahko še naprej prejemajo zdravilo Gazyvaro enkrat vsake dva meseca do največ dve leti ali dokler jim zdravilo Gazyvaro koristi.
This is a summary of the European public assessment report (EPAR) for Gazyvaro.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Gazyvaro.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gazyvaro have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Gazyvaro
Druge informacije o zdravilu Gazyvaro
It is not intended to provide practical advice on how to use Gazyvaro.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
As serious side effects including allergic reactions can develop treatment should be given in facilities where these reactions can be treated appropriately.
Pojavijo se lahko resni neželeni učinki, vključno z alergijskimi reakcijami, zato se zdravilo lahko daje le v prostorih z ustrezno opremo za zdravljenje teh reakcij.
The European Medicines Agency decided that Gazyvaro's benefits are greater than its risks and recommended that it be approved for use in the European Union (EU).
Evropska agencija za zdravila je zaključila, da so koristi zdravila Gazyvaro večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
The summaries of the opinion of the Committee for Orphan Medicinal Products for Gazyvaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
Povzetek mnenja Odbora za zdravila sirote za zdravilo Gazyvaro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:(KLL in FL).
Treatment with Gazyvaro is given in six or eight cycles and each cycle lasts 21 or 28 days.
Zdravljenje z zdravilom Gazyvaro se daje v šestih ali osmih ciklih, od katerih vsak traja 21 oziroma 28 dni.
What are the risks associated with Gazyvaro?
Kakšna tveganja so povezana z zdravilom Gazyvaro?
• previously untreated chronic lymphocytic leukaemia (CLL).
• s predhodno nezdravljeno kronično limfocitno levkemijo (KLL).
CLL is a cancer of B-lymphocytes, a type of white blood cell.
KLL je rak limfocitov B, ki so vrsta belih krvnih celic.
Patients may also be given other medicines to prevent infusion-related reactions and other side effects.
Bolniki lahko po potrebi prejmejo tudi druga zdravila za preprečevanje pojava z infuzijo povezanih reakcij in drugih neželenih učinkov.
What is Gazyvaro and what is it used for?
Kaj je zdravilo Gazyvaro in za kaj se uporablja?
For more information about treatment with Gazyvaro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Gazyvaro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Gazyvaro have been shown in studies?
Kakšne koristi je zdravilo Gazyvaro izkazalo v študijah?
It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed during or up to 6 months after such treatment.
Uporablja se tudi z zdravilom bendamustin pri bolnikih, katerih bolezen se še ni odzvala na zdravljenje z zdravilom rituksimab ali je pri njih rak v zadnjih šestih mesecih po takem zdravljenju napredoval.
The full EPAR for Gazyvaro 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 Gazyvaro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because the number of patients with CLL and with FL is low, the diseases are considered ‘rare', and Gazyvaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 October 2012 and 19 June 2015.
Ker je bolnikov s KLL malo, velja ta bolezen za redko, zato je bilo zdravilo Gazyvaro 10 oktobra 2012 in 19. junija 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The Agency considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated.
Agencija je menila, da je bila korist zdravila Gazyvaro pri podaljšanju časa preživetja bolnikov s KLL in folikularnim limfomom do poslabšanja bolezni jasno dokazana.
A dose of 100 mg of Gazyvaro is given on day one of the first cycle under close supervision of an experienced doctor who should monitor the patient for infusion-related reactions.
Pri KLL je prvi dan prvega cikla treba dati 100-miligramski odmerek, in sicer pod skrbnim nadzorom izkušenega zdravnika, ki mora bolnika spremljati za primer pojava z infuzijo povezanih reakcij.
Why is Gazyvaro approved?
Zakaj je bilo zdravilo Gazyvaro odobreno?
In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells are made) and in lymph nodes.
Pri KLL se rakavi limfociti B prehitro razmnožujejo in nadomestijo normalne celice v kostnem mozgu (kjer krvne celice nastajajo) in v bezgavkah.
For practical information about using Gazyvaro, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Gazyvaro naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The study compared Gazyvaro plus other chemotherapy medicines with rituximab plus other chemotherapy medicines, and over a follow-up period of about three years on average, 17% (101 of 601 patients) given Gazyvaro died or their disease got worse, whereas 24% (144 of 601 patients) given rituximab died or their disease got worse.
V študiji so primerjali zdravilo Gazyvaro v kombinaciji z drugimi zdravili za kemoterapijo z rituksimabom v kombinaciji z drugimi zdravili za kemoterapijo in v povprečnem nadaljevalnem obdobju približno treh let je 17 % (101 od 601) bolnikov, ki so prejemali zdravilo Gazyvaro, umrlo ali se je njihova bolezen poslabšala, medtem ko je bil pri bolnikih, ki so prejemali rituksimab, njihov delež 24 % (144 od 601).
Gazyvaro is a cancer medicine used to treat adult patients with:
Zdravilo Gazyvaro je zdravilo za zdravljenje raka, ki se uporablja pri odraslih bolnikih:
Gazyvaro can only be obtained with a prescription and treatment should be given under the close supervision of an experienced doctor.
Predpisovanje in izdaja zdravila Gazyvaro je le na recept, zdravljenje pa se lahko izvaja samo pod skrbnim nadzorom izkušenega zdravnika.
Gazyvaro has also been investigated in a study involving 321 patients with FL in whom treatment with rituximab had either not worked or had stopped working.
Zdravilo Gazyvaro je bilo raziskano tudi v študiji, v katero je bilo vključenih 321 bolnikov s folikularnim limfomom, pri katerih zdravljenje z rituksimabom ni učinkovalo ali je prenehalo učinkovati.
Gazyvaro is available as a concentrate that is made up into a solution for infusion (drip) into a vein and given over several hours.
Zdravilo Gazyvaro je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalno infuzijo) v veno, ki traja več ur.
Gazyvaro was shown to be of benefit in one main study involving 1,202 patients with previously untreated FL.
Koristi zdravila Gazyvaro so bile dokazane v eni glavni študiji pri 1 202 bolnikih s predhodno nezdravljenim folikularnim limfomom.
The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD20, which is found on the surface of Blymphocytes.
Zdravilna učinkovina v zdravilu Gazyvaro, obinutuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino CD20, ki je prisotna na površini limfocitov B, in se veže nanjo.
In case of infusion-related reactions to the first 100 mg dose, the second dose should be delayed until day 2.
Če pride do reakcij, povezanih z infuzijo, je treba drugi odmerek odložiti do naslednjega dneva.
For FL, Gazyvaro is given at a dose of 1,000 mg on day 1, 8 and 15 of the first 21 or 28-day treatment cycle.
Pri folikularnem limfomu je treba zdravilo Gazyvaro dati v odmerku 1 000 mg 1, 8 in 15. dan prvega 21- oziroma 28-dnevnega cikla zdravljenja.
For the remaining cycles, the dose is given on day one only.
V preostalih ciklih je treba odmerek dati samo prvi dan cikla.
Patients treated with Gazyvaro and bendamustine lived significantly longer on average without their disease getting worse than patients treated with bendamustine alone (29.2 months versus 13.7 months).
Bolniki, ki so jih zdravili z zdravilom Gazyvaro in bendamustinom, so v povprečju živeli brez poslabšanja bolezni veliko dlje kot bolniki, ki so jih zdravili samo s bendamustinom (29,2 meseca v primerjavi s 13,7 meseca).
By attaching to CD20 on Blymphocytes, obinutuzumab makes the B-lymphocytes a target for the body's immune (defence) system, which kills the B-lymphocytes.
Obinutuzumab z vezavo na CD20 na limfocitih B povzroči, da ti postanejo tarča imunskega (obrambnega) sistema, ki jih ubije.
For the remaining 5 cycles, Gazyvaro 1,000 mg is given on day one only.
V preostalih 5 ciklih je treba samo prvi dan cikla dati 1 000-miligramski odmerek.
Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;
Zdravilo Gazyvaro se uporablja skupaj s klorambucilom (drugim zdravilom za zdravljenje raka) pri bolnikih, za katere fludarabin ni priporočljiv.
In one main study involving 781 patients, those treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with chlorambucil alone (26.7 months versus 11.1 months).
V eni glavni študiji, v kateri je sodelovalo 781 bolnikov, so tisti, ki so jih zdravili z zdravilom Gazyvaro in klorambucilom, v povprečju živeli brez poslabšanja bolezni veliko dlje kot bolniki, ki so jih zdravili samo s klorambucilom (26,7 meseca v primerjavi z 11,1 meseca).
In CLL, Gazyvaro has been shown to significantly delay the disease getting worse in previously untreated patients who had other medical conditions and were therefore ineligible for fludarabinebased therapy.
Zdravilo Gazyvaro je znatno upočasnilo slabšanje KLL pri predhodno nezdravljenih bolnikih, ki so imeli tudi druge bolezni, zaradi katerih niso bili primerni za zdravljenje s fludarabinom.
Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2 months).
Podobno so bolniki, ki so jih zdravili z zdravilom Gazyvaro in klorambucilom, živeli brez poslabšanja bolezni veliko dlje kot bolniki, ko so jih zdravili z rituksimabom in klorambucilom (26,7 meseca v primerjavi s 15,2 meseca).
Further doses of 1,000 mg are then given on days 8 and 15 of the first cycle.
Nato je treba 8. in 15. dan prvega cikla dati naslednja 1 000-miligramska odmerka.
Once the disease has responded to treatment, Gazyvaro is then used on its own for the maintenance treatment of FL.
Po zdravljenju z bendamustinom se zdravilo Gazyvaro uporablja samostojno kot vzdrževalno zdravljenje folikularnega limfoma.
How does Gazyvaro work?
Kako zdravilo Gazyvaro deluje?
How is Gazyvaro used?
Kako se zdravilo Gazyvaro uporablja?
A second dose of 900 mg can be given on the same day, if the patient does not have any reactions.
Če reakcij ni, lahko bolnik isti dan prejme drugi, 900-miligramski odmerek.
Gazyvaro contains the active substance obinutuzumab.
Zdravilo Gazyvaro vsebuje zdravilno učinkovino obinutuzumab.
• follicular lymphoma (FL), another type of cancer of B-lymphocytes.
• s folikularnim limfomom (FL), drugo vrsto raka limfocitov B. Zdravilo Gazyvaro se uporablja v kombinaciji s kemoterapijo (drugim zdravilom za raka) pri bolnikih, ki prej niso bili zdravljeni zaradi napredovalega folikularnega limfoma.
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Ponedeljek Torek Sreda Četrtek Petek Sobota Nedelja
The median duration of treatment was 9.3 months.
Mediani čas zdravljenja je bil 9,3 meseca.
December 2023
januarja 2020 decembra 2023
‡ Includes all preferred terms with the word ‘fracture' in bones.
‡ Vključuje vse prednostne izraze z besedo "zlom" v kosteh
At the time of the primary analysis there were 1,633 patients randomised.
V času primarne analize je bilo randomiziranih 1.633 bolnikov.
See results below (Table 2).
Glejte rezultate spodaj (preglednica 2).
You need to know the names of the medicines you take.
Poznati morate imena zdravil, ki jih jemljete.
Based on Kaplan-Meier estimates.
Na podlagi Kaplan-Meierjevih ocen.
Medicinal products which prolong the QT interval
Zdravila, ki lahko podaljšajo interval QT
Therefore, in the three studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Zato se je v vseh treh študijah priporočalo, da bolniki ohranijo svoje študijsko zdravljenje, dokler ne dosežejo kriterijev za prekinitev, ki so določeni spodaj za vsako študijo.
Groups of medicinal products that can be affected include, but are not limited to:
Skupine zdravil na katere je možen vpliv, vendar ni omejen, so:
NR = Not Reached.
ND = ni doseženo.
Date of first authorisation: 21 June 2013 Date of latest renewal: 8 February 2018
Datum prve odobritve: 21 junij 2013 Datum zadnjega podaljšanja: 8. februar 2018
Xtandi is indicated for:
Zdravilo Xtandi je indicirano za:
No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.
Med temi starejšimi bolniki in mlajšimi bolniki v celoti niso opazili razlik glede varnosti in učinkovitosti.
Other possible side effects include:
Med drugimi možnimi neželenimi učinki so:
Theoretically, induction of these transporters is also possible, and the net effect is presently unknown.
Indukcija teh prenašalcev v teoriji je tudi možna, vendar celotni učinek trenutno ni znan.
Although there was a limited response in some patients from treatment with enzalutamide after abiraterone, the reason for this finding is currently unknown.
Čeprav so imeli nekateri bolniki omejen odziv na zdravljenje z enzalutamidom po abirateronu, razlog za to ugotovitev trenutno ni znan.
UGT1A1 may have been induced as well.
Možna je bila tudi indukcija UGT1A1.
Concomitant use with other medicinal products
Sočasna uporaba z drugimi zdravili
- If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility')
če ste noseči ali bi lahko zanosili (glejte "Nosečnost, dojenje in plodnost").
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Bolniki z redko prirojeno motnjo intolerance za fruktozo ne smejo jemati tega zdravila.
The clinical relevance of this observation remains unknown.
Klinična pomembnost teh ugotovitev ni znana.
The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect.
Zmanjšanje koncentracij v plazmi je lahko precejšnje, kar vodi do izgube ali zmanjšanega kliničnega učinka.
Keep a list of them with you to show to your doctor when you are prescribed a new medicine.
Njihov seznam imejte pri sebi, da ga boste pokazali svojemu zdravniku, ko vam bo predpisal kakšno novo zdravilo.
These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
Ta zdravila lahko vplivajo na učinek zdravila Xtandi, ali pa lahko zdravilo Xtandi vpliva na učinek teh zdravil.
- This medicine could possibly have an effect on male fertility.
To zdravilo lahko vpliva na moško plodnost.
Patients with serum creatinine > 177 μmol/L (2 mg/dL) were excluded from clinical trials.
Bolniki s kreatininom v serumu > 177 µmol/l (2 mg/dl) so bili izključeni iz kliničnih preskušanj.
This includes rare cases of seizure with complications leading to death.
To vključuje redke primere konvulzij z zapleti, ki so povzročili smrt.
P-gp substrates
Substrati P-gp
Changes in the reproductive organs in both species were consistent with the pharmacological activity of enzalutamide and reversed or partially resolved after an 8-week recovery period.
Spremembe reproduktivnih organov obeh živalskih vrst so se skladale s farmakološko aktivnostjo enzalutamida in so izginile ali so se delno popravile po 8-tedenskem obdobju okrevanja.
The other ingredients of the film-coated tablets are:
Druge sestavine filmsko obloženih tablet so:
There are insufficient data to evaluate potential differences in the pharmacokinetics of enzalutamide in other races.
Podatki ne zadoščajo za ocenitev možnih razlik v farmakokinetiki enzalutamida pri drugih rasah.
ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: Prostate Specific Antigen
ECOG: Eastern Cooperative Oncology Group; BPI-SF: skrajšan vprašalnik za opis bolečine; PSA: prostatični specifični antigen
Changes in PSA serum concentration independently do not always predict clinical benefit.
Neodvisne spremembe koncentracij PSA v serumu vedno ne napovedujejo kliničnih koristi.
Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
Napad krčev je verjetnejši, če vzamete večji odmerek tega zdravila od priporočenega, če jemljete nekatera druga zdravila, ali če imate večje tveganje za napad krčev kot običajno.
Most patients in the controlled clinical trials (> 74%) were Caucasian.
Večina bolnikov v kontroliranih kliničnih preskušanjih (> 74 %) je bila belcev.