natgillin/translations-raw huggingface dataset:
For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91).
Pri bolnikih s perampanelom v odprtem podaljšanju (n = 112) je bila povprečna sprememba (SD) od izhodišča do konca odprtega zdravljenja (52 tednov) vrednosti t v globalnih kognitivnih funkcijah sistema CDR (minus) -1,0 (9,91).
The median percent change in primary generalised tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), P < 0.0001.
Mediana odstotna sprememba pogostnosti primarnih generaliziranih napadov s tonično-kloničnimi krči na 28 dni v obdobjih titriranja in vzdrževanja (kombinirano) v primerjavi z obdobjem pred randomizacijo je bila večja pri perampanelu (-76,5 %) kot pri placebu (-38,4 %), P < 0,0001.
If you forget to take Fycompa - If you forget to take Fycompa, wait until your next dose and then carry on as usual.
Če ste pozabili vzeti zdravilo Fycompa - Če ste pozabili vzeti zdravilo Fycompa, počakajte do naslednjega odmerka, nato pa nadaljujte kot običajno.
In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
In vitro je perampanel zavrl povečanje intracelularnega kalcija, ki ga sproži AMPA (vendar ga ne sproži NMDA).
Patients from the randomised trial were converted to perampanel over 6 weeks followed by a long term maintenance period (≥ 1 year).
Bolniki iz randomiziranega preskušanja so prešli na perampanel v obdobju 6 tednov, čemur je sledilo dolgo vzdrževalno obdobje (≥ 1 leto).
The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, demographically matched subjects.
Farmakokinetiko perampanela po enkratnem 1-mg odmerku so ocenili pri 12 osebah z blago in zmerno okvaro jeter (Child-Pugh A oz. B) in jo primerjali z 12 zdravimi prostovoljci z demografsko podobnostjo.
- If you have missed more than 7 days of treatment with Fycompa, talk to your doctor immediately.
- Če ste izpustili več kot 7 dni zdravljenja z zdravilom Fycompa, se takoj posvetujte z zdravnikom.
In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%.
Pri zdravih prostovoljcih je zdravilo Fycompa (6 mg enkrat na dan za 20 dni) zmanjšalo AUC midazolama za 13 %.
Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Pomožna snov z znanim učinkom: En mililiter peroralne suspenzije vsebuje 175 mg sorbitola (E420).
Uncommon (may affect more than 1 user in 1000) are: - thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
Občasni (pojavijo se lahko pri več kot 1 od 1000 bolnikov): - misli o samopoškodovanju ali samomoru (samomorilne misli), poskus samomora
7 film-coated tablets 28 film-coated tablets 98 film-coated tablets
7 filmsko obloženih tablet 28 filmsko obloženih tablet 98 filmsko obloženih tablet
The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) -1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) -2.2 (-5.2, 0.8).
Povprečna sprememba (SD) od izhodišča do konca dvojno slepega zdravljenja (19 tednov) vrednosti t v globalnih kognitivnih funkcijah sistema CDR je bila 1,1 (7,14) v skupini s placebom in (minus) -1,0 (8,86) v skupini s perampanelom, z razliko med tretiranima skupinama v povprečju najmanjših kvadratov (95 % IZ) = (minus) -2,2 (-5,2, 0,8).
Influence of Fycompa on AED concentration
Vpliv zdravila Fycompa na koncentracijo AEZ
You can take Fycompa with or without food and should always take it the same way.
Zdravilo Fycompa lahko vzamete s hrano ali brez nje, vendar vedno na enak način.
PVC/aluminium blisters
PVC/aluminijevi pretisni omoti
Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Podobne rezultate so opazili tudi pri ovrednotenju vseh napadov in njihove odsotnosti v primerjavi z miokloničnimi napadi.
- Don't take more Fycompa than your doctor has recommended.
- Ne vzemite večjega odmerka zdravila Fycompa, kot vam je priporočil zdravnik.
There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Ni bilo sprememb v klinični patologiji ali histopatologiji, ki bi jih bilo mogoče neposredno pripisati učinkom perampanela.
The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
Neželeni učinek, ki je najpogosteje povzročil prekinitev jemanja (≥ 2 % v skupini, ki je prejemala perampanel, in pogostejši kot v skupini s placebom), je bila omotica.
What Fycompa looks like and contents of the pack All strengths of Fycompa are round, biconvex film-coated tablets 2 mg: orange, marked with E275 on one side and 2 on other side 4 mg: red, marked with E277 on one side and 4 on other side 6 mg: pink, marked with E294 on one side and 6 on other side 8 mg: purple, marked with E295 on one side and 8 on other side 10 mg: green, marked with E296 on one side and 10 on other side 12 mg: blue, marked with E297 on one side and 12 on other side
2 mg tableta: oranžna, z vtisom E275 na eni strani in "2" na drugi strani 4 mg tableta: rdeča, z vtisom E277 na eni strani in "4" na drugi strani 6 mg tableta: rožnata, z vtisom E294 na eni strani in "6" na drugi strani 8 mg tableta: vijolična, z vtisom E295 na eni strani in "8" na drugi strani 10 mg tableta: zelena, z vtisom E296 na eni strani in "10" na drugi strani 12 mg tableta: modra, z vtisom E297 na eni strani in "12" na drugi strani
Perampanel is dosed to clinical effect regardless of other AEDs.
Odmerjanje perampanela je neodvisno od drugih AEZ.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
V kliničnih študijah niso opazili neželenih učinkov, opazili pa so jih v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti.
Oral suspension 340 ml.
peroralna suspenzija 340 ml 1 plastenka
When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions.
Kadar so perampanel dali z zelo mastnim obrokom, sta bili Cmax in AUC0-inf enkratnega 12-miligramskega odmerka perampanela v obliki peroralne suspenzije približno 22 % oziroma 13 % manjši kot na tešče.
In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
In vivo je perampanel značilno podaljšal latentnost za epileptične napade v modelu napada, ki ga sproži AMPA.
Blister Pack (PVC/Aluminium blister)
Pretisni omot (pretisni omot iz PVC/aluminija)
For dosing please use the oral syringe and adaptor provided.
Za odmerjanje uporabljajte priloženo brizgo za peroralno dajanje in nastavek.
1) Active metabolite monohydroxycarbazepine was not assessed.
Aktivnega presnovka monohidroksikarbazepina niso ocenili.
If any of these happens, talk to your doctor or pharmacist.
Če se kar koli od tega zgodi, obvestite svojega zdravnika ali farmacevta.
Psychomotor performance
Psihomotorična sposobnost
You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.
Zdravila Fycompa ne smete jemati, če imate resne težave z jetri ali zmerne do resne težave z ledvicami.
Fycompa contains sorbitol
Zdravilo Fycompa vsebuje sorbitol
Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo.
Vsi napadi so bili odpravljeni pri 23,5 % (19/81) bolnikov, ki so prejemali perampanel, v primerjavi s 4,9 % (4/81) bolnikov, ki so prejemali placebo.
In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined oral contraceptive, Fycompa was shown to decrease the levonorgestrel exposure (mean Cmax and AUC values were each decreased by 40%).
Pri zdravih prostovoljkah se je pri 21-dnevnem jemanju zdravila Fycompa 12 mg (ne pa tudi pri 4 ali 8 mg/dan) sočasno s kombiniranim peroralnim kontraceptivom pokazalo zmanjšanje izpostavljenosti levonorgestrelu (povprečni vrednosti Cmax in AUC sta se zmanjšali za 40 %).
During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo.
Med 3-mesečnim obdobjem vzdrževanja je bilo 30,9 % (25/81) bolnikov na perampanelu v kliničnih študijah brez primarnih generaliziranih napadov s toničnokloničnimi krči, v primerjavi z 12,3 % (10/81) tistih, ki so prejemali placebo.
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
7 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet
1 bottle (340 ml) contains 170 mg perampanel.
Ena plastenka (340 ml) vsebuje 170 mg perampanela.
Therefore, the possibility of decreased efficacy of progestative-containing oral contraceptives should be considered for women needing Fycompa 12 mg/day and an additional reliable method (intra-uterine device (IUD), condom) is to be used (see section 4.4).
Zato je treba pri ženskah, ki potrebujejo zdravilo Fycompa 12 mg/dan, pomisliti na možnost zmanjšane učinkovitosti peroralnih kontraceptivov, ki vsebujejo progestagen, in uporabiti dodatne zanesljive metode preprečevanja nosečnosti (maternični vložek (IUD), kondom) (glejte poglavje 4.4).
DO NOT TAKE Fycompa: - If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking perampanel.
NE JEMLJITE zdravila Fycompa: - če se je po uporabi perampanela pri vas kadar koli pojavil hud kožni izpuščaj ali lupljenje kože,
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism.
Perampanel se hitro absorbira po peroralnem dajanju brez znakov znatne presnove prvega prehoda.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fycompa.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila Fycompa posvetujte s svojim zdravnikom.
- The other ingredients are sorbitol (E420) liquid (crystallising), microcrystalline cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid), citric acid, anhydrous (E330), sodium benzoate (E211) and purified water.
- Druge sestavine zdravila so sorbitol (E420) tekoči (kristalizirajoči), mikrokristalna celuloza (E460), natrijev karmelozat (E466), poloksamer 188, 30-odstotna simetikonska emulzija (vsebuje prečiščeno vodo, silikonsko olje, polisorbat 65, metilcelulozo, koloidni silicijev dioksid, makrogol stearat, sorbinsko kislino, benzojsko kislino in žveplovo kislino), brezvodna citronska kislina (E330), natrijev benzoat (E211) in prečiščena voda
What Fycompa contains - The active substance is perampanel.
Kaj vsebuje zdravilo Fycompa - Učinkovina je perampanel.
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose (30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic development.
V študiji plodnosti pri podganah so pri visokih odmerkih (30 mg/kg) pri samicah opazili podaljšane in neredne estrusne cikle, vendar te spremembe niso vplivale na sposobnost razmnoževanja in zgodnji razvoj zarodkov.
Concomitant CYP 3A inducing anti-epileptic medicinal products
Sočasna uporaba antiepileptičnih zdravil, ki spodbujajo encim CYP3A
Fycompa is for oral use.
Zdravilo Fycompa je namenjeno za peroralno uporabo.
Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Filmska obloga (2 mg, 4 mg, 6 mg, 8 mg, 10 mg in 12 mg tablete): hipromeloza 2910, smukec, makrogol 8000, titanov dioksid (E171), barvila*
Influence of AED on Fycompa concentration
Vpliv AEZ na koncentracijo zdravila Fycompa
A statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment Phase) as compared to the placebo group was observed with perampanel treatment at doses of 4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305).
Pri zdravljenju s perampanelom so opazili značilno bolj učinkovit učinek na zmanjšanje pogostnosti napadov (izhodišče do faze zdravljenja) v 28 dneh pri odmerkih 4 mg/dan (študija 306), 8 mg/dan (študije 304, 305 in 306) in 12 mg/dan (študiji 304 in 305) v primerjavi z zdravljenjem s placebom.
Eligible patients on a stable dose of 1 to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline period were randomised to either perampanel or placebo.
Primerni bolniki, ki so prejemali stabilen odmerek 1 do 3 zdravil AEZ in so imeli vsaj 3 primarne generalizirane napade s tonično-kloničnimi krči v 8-tedenskem izhodiščnem obdobju, so bili randomizirani v skupino s perampanelom ali placebom.
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily tablet as originally instructed by your doctor.
- Če ste izpustili manj kot 7 dni zdravljenja z zdravilom Fycompa, nadaljujte z jemanjem tablete vsak dan, kot vam je prvotno naročil vaš zdravnik.
Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Ena kartonska škatla vsebuje eno plastenko, dve 20-mililitrski merilni brizgi za peroralno dajanje in vtisljiv nastavek za plastenko (press-in bottle adapter - PIBA) iz LDPE.
Fycompa is not recommended during pregnancy.
- Uporaba zdravila Fycompa med nosečnostjo ni priporočljiva.
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose as originally instructed by your doctor.
- Če ste izpustili manj kot 7 dni zdravljenja z zdravilom Fycompa, nadaljujte z jemanjem odmerka vsak dan, kot vam je prvotno naročil vaš zdravnik.
Fycompa contains a medicine called perampanel.
Zdravilo Fycompa vsebuje zdravilno učinkovino, imenovano perampanel.
Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332).
Primarni generalizirani napadi s tonično-kloničnimi krči Perampanel kot adjuvantno zdravljenje pri bolnikih starosti 12 let in več z idiopatsko generalizirano epilepsijo, ki so imeli primarne generalizirane napade s tonično-kloničnimi krči, so proučili v multicentrični, randomizirani, dvojno slepi, s placebom kontrolirani študiji (študija 332).
Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised tonic-clonic seizures.
Primarni generalizirani napadi s tonično-kloničnimi krči Perampanel v odmerku do 8 mg/dan se je izkazal za učinkovitega pri primarnih generaliziranih napadih s tonično-kloničnimi krči.
Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much they work.
Jemanje zdravila Fycompa skupaj s kakim drugim zdravilom proti epilepsiji, ki vsebuje sorbitol, lahko vpliva na učinkovitost obeh zdravil.
1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%-1.0% on placebo.
1,7 % do 5,8 % bolnikov, ki so v kliničnih študijah prejemali perampanel, je bilo v 3-mesečnem vzdrževalnem obdobju brez napadov, v primerjavi z 0 % do 1,0 % odstotka bolnikov, ki so prejemali placebo.
Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals.
Bolnike, ki sočasno uporabljajo druga zdravila, ki ne skrajšajo razpolovnega časa perampanela (glejte poglavje 4.5), titriramo v intervalih, ki niso krajši kot 2 tedna.
Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Učinek induktorjev citokroma P450 na farmakokinetiko perampanela
In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7%, 4.2% and 13.7% in patients randomised to receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% in patients randomised to receive placebo.
V kontroliranih kliničnih preskušanjih 3. faze pri bolnikih z napadi parcialnega izvora je bila stopnja prekinitve kot posledica neželenega učinka 1,7 %, 4,2 % oz. 13,7 % pri bolnikih, randomiziranih v skupino s perampanelom s priporočenimi odmerki 4 mg, 8 mg oz. 12 mg/dan in 1,4 % pri bolnikih, randomiziranih v skupino s placebom.
Dysarthria Balance disorder Irritability
Bolezni živčevja omotica zaspanost ataksija disartrija motnje ravnotežja razdražljivost
Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2).
Odvisno od kliničnega odziva in prenašanja posameznika je mogoče odmerek povečevati ali zmanjševati za 2 mg (glejte poglavje 4.2).
Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia.
Simptomi DRESS med drugim običajno obsegajo zvišano telesno temperaturo, izpuščaj, povezan z vpletenostjo drugih organskih sistemov, limfadenopatijo, nenormalne rezultate preiskav jetrnih funkcij in eozinofilijo.
In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% (6/27) on perampanel compared to 12.1% (4/33) on placebo.
Pri bolnikih s sočasnimi napadi z absencami (odsotnostni napadi) so bili napadi odpravljeni pri 22,2 % (6/27) bolnikov, ki so prejemali perampanel, v primerjavi z 12,1 % (4/33) bolnikov, ki so prejemali placebo.
Fycompa 2 mg film-coated tablets Pack of 7 only for first week of dosing, 28 and 98
Fycompa 2 mg filmsko obložene tablete Pakiranje po 7 samo za odmerjanje v prvem tednu, 28 in 98
Insert the oral syringe into the opening of the adaptor as far as possible.
V odprtino nastavka vstavite brizgo za peroralno dajanje tako daleč, kot gre.
In vitro assessment of drug interactions
Ocena medsebojnega delovanja zdravila in vitro
Perampanel suspension should be taken orally once daily at bedtime.
Suspenzija perampanela se jemlje peroralno enkrat na dan ob uri, ko gre bolnik spat.
Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals.
Bolnike, ki sočasno uporabljajo zdravila, ki skrajšajo razpolovni čas perampanela (glejte poglavje 4.5), titriramo v intervalih, ki niso krajši kot 1 teden.
The metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy subjects administered radiolabeled perampanel and supported by in vitro studies using recombinant human CYPs and human liver microsomes.
Na podlagi rezultatov kliničnih študij pri zdravih preiskovancih, ki so prejeli radioaktivno označeni perampanel, ki jih podpirajo študije in vitro z uporabo rekombinantnih humanih encimov CYP in humanih jetrnih mikrosomov.
Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid Citric acid, anhydrous (E330)
30-odstotna simetikonska emulzija, ki vsebuje prečiščeno vodo, silikonsko olje, polisorbat 65, metilcelulozo, koloidni silicijev dioksid, makrogol stearat, sorbinsko kislino, benzojsko kislino in žveplovo kislino brezvodna citronska kislina (E330) natrijev benzoat (E211) prečiščena voda
Larger effects cannot be excluded when perampanel is combined with a CYP3A inhibitor with longer half-life than ketoconazole or when the inhibitor is given for a longer treatment duration.
Če se perampanel kombinira z zaviralcem CYP3A z daljšim razpolovnim časom kot ketokonazol, ali če se zaviralec daje daljše obdobje zdravljenja, ni mogoče izključiti večjega vpliva na farmakokinetiko.
- If you are allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).
mehurji na koži in/ali rane v ustih, - če ste alergični na perampanel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Carton of 7, 28 and 98 tablets
Škatla s 7, 28 in 98 tabletami
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Jedro tablete (6 mg, 8 mg, 10 mg in 12 mg tablete): laktoza monohidrat, nizko substituirana hidroksipropilceluloza, povidon, mikrokristalna celuloza, magnezijev stearat (E470b)
It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Na voljo je v 340-mililitrski plastenki z 2 merilnima brizgama za peroralno dajanje in vtisljivim nastavkom za plastenko (press-in bottle adapter - PIBA) iz LDPE.
In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% in patients randomised to receive perampanel 8 mg, and 1.2% in patients randomised to receive placebo.
V kontroliranem kliničnem preizkušanju 3. faze pri bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči je bila stopnja prekinitve jemanja zaradi neželenega učinka 4,9 % pri bolnikih, randomiziranih v skupino za prejemanje 8 mg perampanela, ter 1,2 % pri bolnikih, randomiziranih v skupino s placebom.
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons.
Perampanel je prvi predstavnik novega razreda zdravil in je selektiven, nekompetitiven antagonist ionotropnih receptorjev glutamat α-amino-3-hidroksi-5-metil-4-izoksazolepropionske kisline (AMPA) na postsinaptičnih nevronih.
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early embryonic development.
V študiji plodnosti pri podganah so pri visokih odmerkih (30 mg/kg) pri samicah opazili podaljšane in neredne estrus cikle pri največjem tolerančnem odmerku, vendar te spremembe niso vplivale na sposobnost razmnoževanja in zgodnji razvoj zarodkov.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.
Pred začetkom jemanja zdravila Fycompa se posvetujte z zdravnikom ali s farmacevtom, če imate težave z jetri ali zmerne do hude težave z ledvicami.
Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Ena filmsko obložena tableta vsebuje 2 mg, 4 mg, 6 mg, 8 mg, 10 mg ali 12 mg perampanela.
Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Peroralna suspenzija perampanela je bioekvivalentna enakemu odmerku perampanela v miligramih v obliki tablet na tešče.
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg depending on your response.
- Vaš zdravnik lahko odmerek povečuje v korakih po 2 mg (4 ml), da dosežete vzdrževalni odmerek med 4 mg (8 ml) in 12 mg (24 ml), odvisno od vašega odziva.