qanastek/EMEA-V3 huggingface dataset:
Zonegran has been studied as an add-on to existing treatment in one main study involving 351 patients with partial seizures.
Zonegran ġie studjat bħala żieda mat- trattament eżistenti fi studju wieħed ewlieni li fih ħadu sehem 351 pazjent b’ epilessija parzjali.
The study compared the effects of three doses of Zonegran with those of placebo (a dummy treatment).
L- istudju qabbel l- effetti ta ’ tliet dożi ta ’ Zonegran ma ’ dawk ta ’ plaċebo (trattament finta).
The doses of Zonegran were increased gradually over six weeks before an 18-week period on a stable dose.
Id- dożi ta ’ Zonegran żdiedu gradwalment fuq perjodu ta ’ sitt ġimgħat qabel perjodu ta ’ 18- il ġimgħa fuq doża stabbli.
The main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien it- tibdil fil - frekwenza ta ’ l- attakki ta ’ epilessija parzjali bejn it- 12- il ġimgħa ta ’ qabel inbeda t- trattament u l - perjodu ta ’ 18- il ġimgħa meta ntużat id- doża stabbli.
What benefit has Zonegran shown during the studies?
X’ benefiċċju ta ’ Zonegran intwera f’ dawn l- istudji?
Zonegran was more effective than placebo at reducing the frequency of seizures.
Zonegran kien iktar effettiv mill- plaċebo fit- tnaqqis tal- frekwenza ta ’ l- epilessija.
The patients taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Il- pazjenti li kienu qed jieħdu 500 mg Zonegran kuljum kellhom tnaqqis medju ta ’ 51% fil- frekwenza ta ’ l- attakki ta ’ l - epilessija, meta mqabbla ma ’ 16% ta ’ dawk li kienu qed jingħataw il- plaċebo.
What is the risk associated with Zonegran?
X’ inhu r- riskju assoċjat ma ’ Zonegran?
The most common side effects with Zonegran (seen in more than 1 patient in 10) are anorexia (loss of appetite), agitation, irritability, confusion, depression, ataxia (inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels.
L- iktar effetti sekondarji komuni ma ’ Zonegran (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma l- anoressija (nuqqas ta ’ aptit), aġitazzjoni, irritabilità, konfużjoni, dipressjoni, diffikultà fil- ko - ordinazzjoni ta ’ movimenti muskolari), sturdament, tfixkil fil- memorja, ngħas kbir, diplopja (viżjoni doppja) u tnaqqis fil- livelli ta ’ bikarbonat fid- demm.
Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction).
F’ xi pazjenti li kienu qed jieħdu Zonegran, kien hemm raxx sever, inkluż is- sindromu Stevens- Johnson (tip ta ’ reazzjoni allerġika perikoluża ħafna).
For the full list of all side effects reported with Zonegran, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Zonegran, ara l- Fuljett ta ’ Tagħrif.
Zonegran should not be used in people who may be hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Zonegran m’ għandux jintuża minn persuni allerġiċi għal zonisamide, għal kwalunkwe mis- sustanzi l - oħrajn jew għas- sulphonamides (bħal xi antibijotiċi).
Why has Zonegran been approved?
Għaliex ġie approvat Zonegran?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zonegran’ s benefits are greater than its risks as adjunctive therapy in the treatment of adult patients with partial onset seizures, with or without secondary generalisation.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Zonegran huma ikbar mir- riskji tiegħu fit- trattament ta ’ pazjenti adulti b’ epilessija parzjali, b’ ġenerazzjoni sekondarja jew mingħajr ġenerazzjoni sekondarja.
The Committee recommended that Zonegran be given marketing authorisation.
Il- Kumitat irrakkomanda li Zonegran jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zonegran:
Tagħrif ieħor dwar Zonegran:
The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran to Eisai Limited on 10 March 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Zonegran lil Eisai Limited fl- 10 ta ’ Marzu 2005.
The full EPAR for Zonegran can be found here.
L- EPAR sħiħ għal Zonegran jista ’ jiġi kkonsultat hawn.
EU Number EU/ 1/ 04/ 307/ 001 EU/ 1/ 04/ 307/ 002 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 005 EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 010 EU/ 1/ 04/ 307/ 011 EU/ 1/ 04/ 307/ 012 EU/ 1/ 04/ 307/ 013
Numru ta ’ l- EU EU/ 1/ 04/ 307/ 001 EU/ 1/ 04/ 307/ 002 EU/ 1/ 04/ 307/ 003 EU/ 1/ 04/ 307/ 004 EU/ 1/ 04/ 307/ 005 EU/ 1/ 04/ 307/ 006 EU/ 1/ 04/ 307/ 007 EU/ 1/ 04/ 307/ 008 EU/ 1/ 04/ 307/ 009 EU/ 1/ 04/ 307/ 010 EU/ 1/ 04/ 307/ 011 EU/ 1/ 04/ 307/ 012 EU/ 1/ 04/ 307/ 013
Invented name Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran
Isem inventat Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran Zonegran
Strength 25 mg 25 mg 50 mg 100 mg 25 mg 100 mg 100 mg 100 mg 50 mg 50 mg 100 mg 50 mg 25 mg
Qawwa 25 mg 25 mg 50 mg 100 mg 25 mg 100 mg 100 mg 100 mg 50 mg 50 mg 100 mg 50 mg 25 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Għamla farmaċewtika Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini Użu għal fil- vini
Packaging blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu) blister (PVC/ PCTFE/ Alu)
Il- pakkett Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu) Folji (PVC/ PCTFE/ alu)
Package size 14 capsules 56 capsules 56 capsules 56 capsules 28 capsules 28 capsules 98 capsules 196 capsules 28 capsules 14 capsules 84 capsules 84 capsules 84 capsules
Kontenut 14 kapsula iebsin 56 kapsula iebsin 56 kapsula iebsin 56 kapsula iebsin 28 kapsula iebsin 28 kapsula iebsin 98 kapsula iebsin 196 kapsula iebsin 28 kapsula iebsin 14 kapsula iebsin 84 kapsula iebsin 84 kapsula iebsin 84 kapsula iebsin
Zonegran 25 mg hard capsules.
Zonegran 25 mg kapsuli iebsin
Each Zonegran hard capsule contains 25 mg of zonisamide.
Kull kapsula iebsa ta ’ Zonegran fiha 25 mg ta ’ zonisamide.
A white opaque body and a white opaque cap printed with a logo and “ ZONEGRAN 25” in black.
Korp opak abjad b’ għatu abjad li fuqu hemm stampat logo u “ ZONEGRAN 25 ” bl- iswed.
Zonegran is indicated as adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.
Zonegran hu indikat bħala terapija addizzjonali fil- kura ta ’ pazjenti adulti b’ puplesiji parzjali, bi jew mingħajr ġeneralizzazzjoni sekondarja.
Zonegran hard capsules are for oral use.
Il- kapsuli iebsin ta ’ Zonegran jittieħdu mill- ħalq.
Zonegran must be added to existing therapy and the dose should be titrated on the basis of clinical effect.
Zonegran irid jiżdied mat- terapija eżistenti u d- doża għandha tiġi ttritata fuq il- bażi ta ’ l- effett kliniku.
Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Intwera li dożi ta ’ 300 mg sa 500 mg kuljum kienu effettivi, għalkemm xi pazjenti, speċjalment dawk li ma jkunux jieħdu sustanzi li huma CYP3A4 inducing agents, jistgħu jirrispondu għal dożi iktar baxxi.
The recommended initial daily dose is 50 mg in two divided doses.
Id- doża rakkomandata tal- bidu hi ta ’ 50 mg kuljum maqsuma f’ żewġ dożi.
After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at one weekly intervals, in increments of up to 100 mg.
Wara ġimgħa, id- doża tista ’ tiżdied għal 100 mg kuljum, u wara dak il- perjodu, id- doża tista ’ tiżdied f’ intervalli ta ’ ġimgħa, f’ inkrementi sa 100 mg.
Use of two weekly intervals should be considered for patients with renal or hepatic impairment and patients not receiving CYP3A4-inducing agents (see Section 4.5).
L- użu ta ’ żewġ intervalli f’ ġimgħa għandu jiġi kkunsidrat għal pazjenti b’ indeboliment tal- kliewi jew tal- fwied u pazjenti li ma jkunux qed jirċievu sustanzi li huma CYP3A4 inducing agents (ara Sezzjoni 4. 5).
Zonegran can be administered once or twice daily after the titration phase.
Zonegran jista ’ jingħata darba jew darbtejn kuljum wara l- fażi tat- titrazzjoni.
Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
Għandha tingħata attenzjoni fil- bidu tal- kura f’ pazjenti anzjani għax hemm tagħrif limitat dwar l- użu ta ’ Zonegran f’ dawn il- pazjenti.
Prescribers should also take account of the safety profile of Zonegran (see Section 4.8).
Dawk li jagħtu r- riċetta għandhom jikkunsidraw ukoll il- profil tas - sigurtà ta ’ Zonegran (ara Sezzjoni 4. 8).
Children and adolescents
2 Tfal u adolexxenti
The safety and effectiveness in children and adolescents under 18 years have not been established.
Is- sigurtà u l- effettività fit- tfal u fl- adolexxenti taħt it- 18- il sena ma kienux stabbiliti.
Therefore use in these patients is not recommended.
Għalhekk, l- użu f’ dawn il- pazjenti mhux rakkomandat.
2 Patients with renal impairment
Pazjenti b’ indeboliment tal- kliewi
Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonegran might be required.
Għandha tingħata attenzjoni fil- kura ta ’ pazjenti b’ indeboliment tal- kliewi, għax hemm tagħrif limitat dwar l- użu f’ dawn il- pazjenti u titrazzjoni iktar bil- mod ta ’ Zonegran tista ’ tkun meħtieġa.
Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
Minħabba li zonisamide u l- metaboliti tiegħu jitneħħew mill- kliewi, dan għandu jitwaqqaf f’ pazjenti li jiżviluppaw insuffiċjenza renali jew fejn żieda sostnuta fil- kreatinina tas- serum li tkun klinikament sinifikanti, tkun osservata.
In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
F’ pazjenti b’ indeboliment tal- kliewi, it- tneħħija mill- kliewi ta ’ doża waħda ta ’ zonisamide kienet korrelata b’ mod pożittiv mat- tneħħija tal- kreatinina.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min.
L- AUC tal- plażma ta ’ zonisamide żdiedet b’ 35% f’ pazjenti bi tneħħija tal- kreatinina ta ’ < 20 ml/ min.
Use in patients with hepatic impairment has not been studied.
L- użu f’ pazjenti b’ indeboliment tal- fwied ma kienx studjat.
Therefore use in patients with severe hepatic impairment is not recommended.
Għalhekk, l- użu f’ pazjenti b’ indeboliment serju tal- fwied mhuwiex rakkomandat.
Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran may be required.
Għandha tingħata attenzjoni fil- kura ta ’ pazjenti b’ indeboliment tal- fwied li jkun minn ħafif sa moderat, u titrazzjoni iktar bil- mod ta ’ Zonegran tista ’ tkun meħtieġa.
Effect of food
L- effett ta ’ l- ikel
Zonegran may be taken with or without food (see Section 5.2).
Zonegran jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel (ara Sezzjoni 5. 2).
Withdrawal of Zonegran
Meta tieqaf tieħu Zonegran
When Zonegran treatment is to be discontinued, it should be withdrawn gradually.
Meta l- kura b’ Zonegran titwaqqaf, dan għandu jsir b’ mod gradwali.
In clinical studies, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic drug doses.
Fi studji kliniċi, tnaqqis fid- doża ta ’ 100 mg f’ intervalli ta ’ ġimgħa ntużaw b’ aġġustament fl- istess ħin ma ’ mediċini anti- epilettiċi oħrajn.
Hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
Sensittività eċċessiva għal zonisamide, għal xi sustanzi mhux attivi jew għal sulfonamides.
Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
Raxx serju jseħħ b’ rabta mat- terapija b’ Zonegran, li jinkludi każijiet tas- sindrome ta ’ Stevens- Johnson.
Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash.
Trid tingħata konsiderazzjoni lit- twaqqif tal- kura b’ Zonegran f’ pazjenti li jiżviluppaw raxx li ma jkunx jista ’ jiġi spjegat b’ mod ieħor.
All patients who develop a rash while taking Zonegran must be closely supervised, with additional levels of caution applied to those patients receiving concomitant antiepileptic agents that may independently induce skin rashes.
Il- pazjenti kollha li jiżviluppaw raxx meta jkunu qed jieħdu Zonegran, iridu jkunu ssorveljati mill- qrib, b’ livelli addizzjonali ta ’ attenzjoni mogħtija lil dawk il- pazjenti li jkunu qed jirċievu mediċini anti- epilettiċi fl- istess ħin li jistgħu indipendentement jikkaġunaw raxx tal - ġilda.
In accordance with current clinical practice, discontinuation of Zonegran in patients with epilepsy must be accomplished by gradual dose reduction, to reduce the possibility of seizures on withdrawal.
Skond il- prattika klinika kurrenti, it- twaqqif ta ’ Zonegran f’ pazjenti li jkollhom l- epilessija, irid isir permezz ta ’ tnaqqis gradwali tad- doża, biex titnaqqas il- possibbiltà ta ’ puplesiji meta titwaqqaf il - mediċina.
There are insufficient data for the withdrawal of concomitant antiepileptic medications once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
M’ hemmx biżżejjed informazzjoni dwar it- twaqqif fl- istess ħin ta ’ mediċini anti- epilettiċi ġaladarba jkun inkiseb il- kontroll b’ Zonegran fis- sitwazzjoni add- on, sabiex tilħaq il- monoterapija b’ Zonegran.
Therefore withdrawal of concomitant anti-epileptic agents must be undertaken with caution.
Għalhekk, it- twaqqif fl- istess ħin ta ’ mediċini anti- epilettiċi, irid issir bl- attenzjoni.
Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Zonegran hu derivattiv ta ’ benzisoxazole li fih grupp ta ’ sulphonamide.
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal.
Reazzjonijiet avversi serji bbażati fuq l- immunità li huma assoċjati ma ’ prodotti mediċinali li fihom grupp sulphonamide 3 jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi li jinkludu anemija aplastika, li b’ mod rari ħafna jistgħu jkunu fatali.
Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Każijiet ta ’ agranuloċitosi, tromboċitopenja, lewkopenja, anemija aplastika, panċitopenja u lewkoċitosi kienu rrappurtati.
There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Hemm tagħrif inadegwat biex tiġi evalwata r- relazzjoni, jekk hemm, bejn id- doża u t- tul ta ’ żmien tal- kura u dawn l- avvenimenti.
3 Kidney stones have occurred in patients treated with Zonegran.
Il- ġebel fil- kliewi seħħ f’ pazjenti kkurati b’ Zonegran.
Zonegran should be used with caution in patients who have risk factors for nephrolithiasis, including prior stone formation, a family history of nephrolithiasis and hypercalcuria.
Zonegran għandu jintuża bl- attenzjoni f’ pazjenti li jkollhom fatturi ta ’ riskju għal nefrolitijasi, li jinkludu formazzjoni ta ’ ġebel fil- passat, storja medika tal- familja ta ’ nefrolitijasi u iperkalkurja.
Such patients may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Dawn il- pazjenti jistgħu jkunu f’ riskju ogħla għal formazzjoni ta ’ ġebel fil- kliewi u sinjali u sintomi assoċjati bħal kolika tal- kliewi, uġigħ tal- kliewi jew uġigħ fil- ġenb tal- ġisem.
In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Flimkien ma ’ dan, pazjenti li jkunu qed jieħdu mediċini oħrajn marbuta ma ’ nefrolitijasi, jistgħu jkunu f’ riskju ogħla.
Increasing fluid intake and urine output may help reduce the risk of stone formation, particularly in those with predisposing risk factors.
Li wieħed iżid il- fluwidu li jittieħed u t- tneħħija ta ’ l- awrina, jista ’ jgħin biex inaqqas ir- riskju tal- formazzjoni tal- ġebla, partikularment f’ dawk il- persuni b’ fatturi ta ’ riskju li jippredisponuhom.
Zonegran should be used with caution in patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate, as there are insufficient data to rule out a pharmacodynamic interaction (see Section 4.5).
Zonegran għandu jintuża bl- attenzjoni f’ pazjenti li jkunu qed jiġu kkurati fl- istess ħin bl- inibituri ta ’ carbonic anhydrase bħal topiramate, għax hemm huma informazzjoni insuffiċjenti biex tiġi eskluża interazzjoni farmakodinamika (ara Sezzjoni 4. 5).
Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Każijiet ta ’ nuqqas ta ’ għaraq u temperatura tal- ġisem għolja kienu rrappurtati primarjament f’ pazjenti pedjatriċi.
Heat stroke requiring hospital treatment was diagnosed in some cases.
Puplesija kkawżata mis- sħana li teħtieġ kura fl- isptar kienet iddijanjostikata f’ xi każijiet.
Most reports occurred during periods of warm weather.
Il - biċċa l- kbira tar- rapporti seħħew matul perjodi ta ’ temp sħun.
Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures.
Il- pazjenti jew dawk li jieħdu ħsiebhom għandhom ikunu mwissija biex iżommu l- pazjent idratat kif suppost u biex jevitaw l- espożizzjoni għal temperaturi eċċessivi.
Caution should be used when Zonegran is prescribed with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Għandha tingħata attenzjoni meta tingħata riċetta għal Zonegran ma ’ prodotti mediċinali oħrajn li jippredisponu lil pazjenti għal mard assoċjat mas- sħana; dawn jinkludu inibituri ta ’ carbonic anhydrase u prodotti mediċinali b’ attività antikolinerġika.
In patients taking Zonegran who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
F’ pazjenti li jkunu qed jieħdu Zonegran li jiżviluppaw is- sinjali u s- sintomi kliniċi tal- pankreatite, hu rakkomandat li l- livelli ta ’ lipase u amylase tal- frixa ikunu mmonitorjati.
If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of Zonegran be considered and appropriate treatment initiated.
Jekk il- pankreatite tkun evidenti, u fl- assenza ta ’ xi kawża oħra ovvja, hu rakkomandat li jiġi kkunsidrat it- twaqqif ta ’ Zonegran, u tinbeda kura adattata.
In patients taking Zonegran, in whom severe muscle pain and/ or weakness develop either in the presence or absence of a fever, it is recommended that markers of muscle damage be assessed, including serum creatine phosphokinase and aldolase levels.
F’ pazjenti li jkunu qed jieħdu Zonegran, li jiżviluppaw uġigħ u/ jew dgħjufija severi, flimkien mad - deni, jew mingħajru, hu rakkomandat li l- markaturi tal- ħsara tal- muskoli jkunu evalwati, li jinkludu l - livelli tas- serum creatine phosphokinase u aldolase.
If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that Zonegran discontinuation be considered and appropriate treatment initiated.
Jekk dawn ikunu għolja, fl- assenza ta ’ kawża oħra ovvja, bħal trawma jew puplesiji grand mal, hu rakkomandat li t- twaqqif tal- kura b’ Zonegran jiġi kkunsidrat, u li tinbeda l- kura adattata.
Women of child-bearing potential must use adequate contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni adegwata matul il- kura b’ Zonegran, u għal xahar wara t- twaqqif tal- kura (ara Sezzjoni 4. 6).
Physicians treating patients with Zonegran should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether OCs, or the doses of the OC components, are adequate based on the individual patient’ s clinical situation.
It- tobba li jkunu qed jikkuraw il- pazjenti b’ Zonegran għandhom jippruvaw jiżguraw li tintuża kontraċezzjoni adattata, u għandhom jużaw ġudizzju kliniku meta jagħmlu evalwazzjoni ta ’ jekk l- OCs, jew id- dożi tal- komponenti ta ’ l- OC, humiex ibbażati b’ mod adegwat fuq is- sitwazzjoni klinika tal- pazjent individwali.
Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), which may cause allergic reactions.
Zonegran 100 mg kapsuli iebsin fihom kulur isfar imsejjaħ sunset yellow FCF (E110), li jista ’ jikkawża reazzjonijiet allerġiċi.
There is limited data from clinical studies in patients with a body weight of less than 40 kg.
Hemm tagħrif limitat minn studji kliniċi f’ pazjenti b’ piż tal- ġisem ta ’ inqas minn 40 kg.
Therefore these patients should be treated with caution.
Għalhekk, dawn il- pazjenti għandhom jiġu kkurati bl- attenzjoni.
Zonegran may cause weight loss.
Zonegran jistgħu jikkawża telf ta ’ piż.
A dietary supplement or increased food intake may be considered if the patient is losing weight or is underweight whilst on this medication.
Suppliment tad- dieta jew żieda fl- ammont ta ’ ikel jistgħu jiġu kkunsidrati jekk il- pazjent ikun qed jitlef il- piż jew ikollu piż baxx waqt li jkun qed jieħu din il - mediċina.
If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
Jekk iseħħ telf sostanzjali fil- piż, it- twaqqif ta ’ Zonegran għandu jiġi kkunsidrat.
Effect of Zonegran on cytochrome P450 enzymes
L- effett ta ’ Zonegran fuq l- enzimi ta ’ cytochrome P450
In vitro studies using human liver microsomes show no or little (< 25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately two- fold or greater than clinically relevant unbound serum concentrations.
Studji in vitro bl- użu ta ’ mikrosomi tal- fwied uman juru ftit jew xejn (< 25%) inibizzjoni ta ’ cytochrome isozymes P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A4 f’ livelli ta ’ zonisamide ta ’ madwar id- doppju jew iktar mill- konċentrazzjonijiet mhux imwaħħlin fis- serum li huma klinikament rilevanti.
Therefore Zonegran is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Għalhekk Zonegran mhux mistenni li jaffettwa l- farmakokinetiċi ta ’ prodotti mediċinali oħrajn permezz ta ’ mekkaniżmi medjati minn cytochrome P450, kif muri għal carbamazepine, phenytoin, ethinylestradiol u desipramine in vivo.
4 Potential for Zonegran to affect other medicinal products
Il- potenzjal għal Zonegran li jaffettwa prodotti mediċinali oħrajn
Anti-epileptic drugs In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Mediċini anti- epilettiċi F’ pazjenti epilettiċi, id- dożaġġ fl- istat fiss b’ Zonegran ma rriżulta fl- ebda effetti farmakokinetiċi li kienu klinikament rilevanti fuq carbamazepine, lamotrigine, phenytoin, jew sodium valproate.
Oral contraceptives In clinical studies in healthy subjects, steady-state dosing with Zonegran did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Kontraċettivi orali Fi studji kliniċi f’ persuni b’ saħħithom, id- dożaġġ fl- istat fiss b’ Zonegran ma affettwax il - konċentrazzjonijiet fis- serum ta ’ ethinylestradiol jew norethisterone f’ kontraċezzjoni orali kombinata.
Carbonic anhydrase inhibitors There are insufficient data to rule out possible pharmacodynamic interactions with carbonic anhydrase inhibitors such as topiramate.
Inibituri ta ’ carbonic anhydrase Hemm informazzjoni insuffiċjenti biex teskludi l- interazzjonijiet farmakodinamiċi li huma possibbli ma ’ inibituri ta ’ carbonic anhydrase bħal topiramate.
P-gp substrate An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/ L and there is the theoretical potential for zonisamide to affect the pharmacokinetics of drugs which are P-gp substrates.
Substrati ta ’ P- gp Studju in vitro juri li zonisamide hu inibitur dgħajjef ta ’ P- gp (MDR1) b’ IC50 ta ’ 267 µmol/ L u hemm il- potenzjal teoretiku li zonisamide jaffettwa l- farmakokinetika ta ’ mediċini li huma substrati ta ’ P- gp.
Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving drugs which are P-gp substrates (e. g. digoxin, quinidine).
L- attenzjoni hi rakkomandata meta tibda jew twaqqaf il- kura b’ zonisamide jew meta tibdel id- doża ta ’ zonisamide f’ pazjenti li qed jirċievu wkoll mediċini li huma substrati ta ’ P- gp (eż. digoxin, quinidine).
Potential medicinal product interactions affecting Zonegran
Interazzjonijiet potenzjali tal- prodott mediċinali li jaffettwaw Zonegran
In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Fi studji kliniċi, l- għoti flimkien ta ’ lamotrigine ma kellu l- ebda effett apparenti fuq il- farmakokinetiċi ta ’ zonisamide.
The combination of Zonegran with other medicinal products that may lead to urolithiasis may enhance the risk of developing kidney stones; therefore the concomitant administration of such medicinal products should be avoided.
Il- kumbinazzjoni ta ’ Zonegran ma ’ prodotti mediċinali oħrajn li tista ’ twassal għal urolitijasi, tista ’ tkabbar ir- riskju li jiżviluppa ġebel fil- kliewi; għalhekk l- għoti fl- istess ħin ta ’ prodotti mediċinali bħal dawn għandu jiġi evitat.
Zonisamide is metabolised partly by CYP3A4 (reductive cleavage), and also by N-acetyl-transferases and conjugation with glucuronic acid; therefore, substances that can induce or inhibit these enzymes may affect the pharmacokinetics of zonisamide:
Zonisamide hu metabolat parzjalment minn CYP3A4 (reductive cleavage), u wkoll minn N- acetyl - transferases u konjugazzjoni ma ’ glucuronic acid; għalhekk, sustanzi li jistgħu jikkaġunaw jew jinibixxu dawn l- enzimi, jistgħu jaffettwaw il- farmakokinetiċi ta ’ zonisamide:
- Enzyme Induction:
- Induzzjoni ta ’ l- Enzimi:
Exposure to zonisamide is lower in epileptic patients receiving
L- espożizzjoni għal zonisamide hi iktar baxxa f’ pazjenti epilettiċi li
CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
jkunu qed jirċievu sustanzi li huma CYP3A4 inducing agents bħal phenytoin, carbamazepine, u phenobarbitone.
These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Dawn l- effetti x’ aktarx li mhumiex ser ikunu ta ’ rilevanza klinika meta Zonegran jiżdied mat- terapija eżistenti; madankollu, jista ’ jseħħ tibdil fil- konċentrazzjonijiet ta ’ zonisamide jekk l- użu fl- istess ħin ta ’ mediċini anti- epilettiċi jew prodotti mediċinali oħrajn li jinduċu CYP3A4 jitwaqqfu, isirilhom aġġustament fid- doża jew jiġu introdotti, u aġġustament fid- doża ta ’ Zonegran jista ’ jkun meħtieġ.
Rifampicin is a potent CYP3A4 inducer.
Rifampicin hu inducer qawwi ta ’ CYP3A4.
If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
Jekk l - għoti flimkien hu meħtieġ, il- pazjent għandu jkun immonitorjat mill- qrib, u d- doża ta ’ Zonegran u ta ’ sottostrati oħrajn ta ’ CYP3A4 tkun aġġustata skond il- bżonn.
- CYP3A4 Inhibition:
- Inibizzjoni ta ’ CYP3A4:
Based upon clinical data, known specific and non-specific CYP3A4
Ibbażat fuq informazzjoni klinika, inibituri magħrufa speċifiċi u mhux
inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
speċifiċi ta ’ CYP3A4 jidher li m’ għandhom l- ebda effett klinikament rilevanti fuq il- parametri ta ’ l- espożizzjoni farmakokinetika ta ’ zonisamide.
Steady-state dosing of either ketoconazole (400 mg/ day) or cimetidine (1200 mg/ day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Id- dożaġġ fl- istat fiss ta ’ jew ketoconazole (400 mg/ kuljum) jew cimetidine (1200 mg/ kuljum) ma kellu l- ebda effetti klinikament rilevanti
Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Għalhekk, it- tibdil fid- dożaġġ ta ’ Zonegran m’ għandux ikun meħtieġ meta jingħata flimkien ma ’ inibituri magħrufa ta ’ CYP3A4.
Zonegran must not be used during pregnancy unless clearly necessary, in the opinion of the physician, and only if the potential benefit is considered to justify the risk to the foetus.
Zonegran m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku, fl- opinjoni tat- tabib, u biss jekk il- benefiċċju potenzjali jkun ikkunsidrat li jiġġustifika r- riskju lill- fetu.
The need for anti- epileptic treatment should be reviewed in patients planning to become pregnant.
Il- bżonn ta ’ kura anti - epilettika għandu jkun evalwat f’ pazjenti li qed jippjanaw li joħorġu tqal.
If Zonegran is prescribed, careful monitoring is recommended.
Jekk tingħata riċetta għal Zonegran, monitoraġġ bl- attenzjoni hu rakkomandat.
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy.
Parir mingħand speċjalista għandu jingħata lil nisa li x’ aktarx li joħorġu tqal sabiex tiġi kkunsidrata l - aħjar kura matul it- tqala.
5 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jingħataw parir mingħand speċjalista dwar l- effetti possibbli ta ’ Zonegran fuq il- fetu, u r- riskju għandu jiġi diskuss mal- pazjenta fir- rigward tal- benefiċċji qabel tinbeda l- kura.
The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medication.
Ir- riskju ta ’ difetti tat- twelid jiżdied b’ fattur ta ’ minn 2 sa 3 fit- trabi ta ’ ommijiet ikkurati b’ mediċini anti- epilettiċi.
The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect.
L- iktar difetti li kienu rrappurtati b’ mod frekwenti huma difetti ta ’ qsim fix- xufftejn, malformazzjonijiet kardjovaskulari u difett fit- tubu newrali.
Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy.
Terapija b’ mediċini anti- epilettiċi multipli tista ’ tkun assoċjata ma ’ riskju ogħla ta ’ malformazzjonijiet konġenitali milli minn monoterapija.
Women of childbearing potential must use adequate contraception during treatment with Zonegran, and for one month after discontinuation.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni adegwata matul il- kura b’ Zonegran, u għal xahar wara li jieqfu jieħduh.
There are no adequate data from the use of Zonegran in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Zonegran f’ nisa tqal.
Studies in animals have shown reproductive toxicity (see Section 5.3).
Studji fuq l- annimali wrew tossiċità riproduttiva (ara Sezzjoni 5. 3).
No sudden discontinuation of anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child.
M’ għandu jsir l- ebda twaqqif għal għarrieda tat- terapija anti- epilettika, għax dan jista ’ jwassal għal puplesiji breakthrough, li jista ’ jkollhom konsegwenzi serji kemm għall- omm u anke għat- tarbija.
Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma.
Zonisamide jitneħħa fil- ħalib tal- bniedem; il- konċentrazzjoni fil- ħalib tas- sider hi simili għall- plażma ta ’ l- omm.
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from Zonegran therapy.
Trid tittieħed deċiżjoni dwar jekk it- treddigħ għandux jitwaqqaf jew jekk it- terapija b’ Zonegran għandhiex titwaqqaf.
Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed.
Minħabba ż- żmien twil li zonisamide idum fil- ġisem, it- treddigħ m’ għandux jitkompla sa xahar wara li t- terapija b’ Zonegran tkun tlestiet.
Some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase.
Xi pazjenti jista ’ jkollhom ngħas jew diffikultà biex jikkonċentraw, partikularment kmieni fil- kura jew wara żieda fid- doża.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e. g., driving or operating machinery.
Il- pazjenti għandhom jingħataw parir biex joqogħdu attenti waqt attivitajiet li jeħtieġu grad għoli ta ’ attenzjoni; eż., sewqan jew it- tħaddim ta ’ makkinarju.
Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
Zonegran ingħata lil iktar minn 1, 200 pazjent fi studji kliniċi, li iktar minn 400 minnhom irċivew Zonegran għal mill- inqas sena.
In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Flimkien ma ’ dan, kien hemm esperjenza estensiva ta ’ wara l- bejgħ b’ zonisamide fil- Ġappun sa mill- 1989 u fl- Istati Uniti sa mis- sena 2000.
It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Għandu jkun innutat li Zonegran hu derivattiv ta ’ benzisoxazole, li fih grupp ta ’ sulphonamide.
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see Section 4.4).
Reazzjonijiet avversi serji bbażati fuq l- immunità li huma assoċjati ma ’ prodotti mediċinali li fihom grupp sulphonamide jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi li jinkludu anemija aplastika, li b’ mod rari ħafna tista ’ tkun fatali (ara Sezzjoni 4. 4).
The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
L- iktar reazzjonijiet avversi komuni fi studji kkontrollati dwar terapija addizzjonali kienu: ngħas, sturdament u anoreksja.
Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Reazzjonijiet avversi assoċjati ma ’ Zonegran miksuba minn studji kliniċi u sorveljanza ta ’ wara l- bejgħ huma elenkati hawn taħt.
The frequencies are arranged according to the following scheme:
Il- frekwenzi huma organizzati skond l- iskema li ġejja:
very common common uncommon rare very rare
komuni hafna komuni mhux komuni
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1,000 < 1/ 100 ≥ 1/ 10,000 < 1/ 1,000 < 1/ 10,000 including isolated reports
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1, 000 < 1/ 100
Uncommon
Mhux Komuni Pnewmonja Infezzjoni fl - apparat ta ’ l - awrina
Blood and lymphatic system disorders
Disturbi fid - demm u fis - sistema limfatika Disturbi fis - sistema immunitarja
Ecchymosis
Ekkimożi Sensittività eċċessiva
Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Agranuloċitosi Anemija aplastika Lewkoċitosi Lewkopenja Limfadenopatija Panċitopenja, Tromboċitopenja
Immune system disorders
Disturbi fil - metaboliżmu u fin- nutrizzjoni
Hypersensitivity
Aċidożi metabolika
Metabolism and nutrition disorders
Disturbi
Anorexia
Aġitazzjoni
Hypokalaemia
Daħk/ tbissim /
Metabolic acidosis
Rabja
Psychiatric Disorders
Alluċinazzjoni
Agitation Irritability Confusional state Depression
psikjatriċi
Affect lability Anxiety Insomnia Psychotic disorder
Irritabilità
Anger Aggression Suicidal ideation Suicide attempt
biki patoloġiku
Hallucination
Aggressjoni
Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Stat ta ’ konfużjoni Dipressjoni
Ataxia Dizziness Memory impairment Somnolence Diplopia
Ansjetà Nuqqas ta ’ rqad Mard psikotiku
Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Ħsibijiet suwiċidi Tentattiv ta ’ suwiċidju
Convulsion
Disturbi fis -
Amnesia Coma Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome Status epilepticus Dyspnoea Pneumonia aspiration Respiratory disorder
Atassja
Gastrointestinal disorders
Bradifrenija
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
Konvulżjoni
Vomiting
Amnesija
Pancreatitis
Sturdament
Hepatobiliary disorders
Disturbi fl -
Cholecystitis Cholelithiasis
Indeboliment tal- memorja
Hepatocellular damage
attenzjoni Nystagmus
Skin and subcutaneous tissue disorders
Puplesija grand mal Sindrome mjasteniku
Rash
Ngħas Diplopja
Anhidrosis Erythema multiforme Pruritis Stevens-Johnson syndrome
Parestesija Taħwid fid - diskors Rogħda
Musculoskeletal and connective tissue disorders
Sindrome malinn newroleptiku Status epilepticus Dispnea Aspirazzjoni pnewmonja Mard respiratorju
Rhabdomyolysis
Disturbi gastro - intestinali
Renal and urinary disorders General disorders and administration site conditions
Uġigħ ta ’ żaqq Stitikezza Dijarea Dispepsja Dardir
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Disturbi fil- fwied u fil- marrara
Calculus urinary
Koleċistite Kolelitijasi
Hydronephrosis Renal failure Urine abnormality
Ħsara epatoċellulari
7 System Organ Class (MedDRA terminology)
7 Klassi ta ’ l - Organu tas - Sistema (Terminoloġija MedDRA)
Investigations
Disturbi fil- kliewi
Decreased bicarbonate
Nefrolitijasi
Weight decreased
Idronefrosi
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
u fis- sistema urinarja Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Injury, poisoning and procedural complications
Għeja kbira Mard bħal dak ta ’ l - influwenza Deni
In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Flimkien ma ’ dan kien hemm każijiet iżolati ta ’ mewt għal għarrieda u mhux spjegata f’ pazjenti bl - epilessija (Sudden Unexplained Death in Epilepsy Patients - SUDEP), li kienu qed jirċievu Zonegran.
Additional information on special populations:
Informazzjoni addizzjonali dwar popolazzjonijiet speċjali:
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events:
L- evalwazzjoni tad- dejta ta ’ wara l- bejgħ tissuġġerixxi li pazjenti li għandhom 65 sena jew iktar, jirrappurtaw frekwenza ogħla ta ’ l- avvenimenti li ġejjin mill- popolazzjoni ġenerali:
Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Is- sindrome ta ’ Stevens- Johnson (SJS) u s- sindrome ta ’ Sensittività Eċċessiva Kkaġunata mill- Mediċina (DIHS).
There have been cases of accidental and intentional overdose in adult and paediatric patients.
Kien hemm każijiet ta ’ doża eċċessiva aċċidentali u intenzjonata f’ pazjenti adulti u pedjatriċi.
In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt.
F’ xi każijiet, id- dożi eċċessivi kienu mingħajr sintomi, partikularment fejn l- emesi jew il- ħasil ta ’ l- istonku kienu fil- pront.
In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression.
F’ każijiet oħrajn, id- doża eċċessiva kienet segwita minn sintomi bħal ngħas, dardir, gastrite, nystagmus, myoclonus, koma, bradikardija, funzjoni mnaqqsa tal- kliewi, pressjoni tad- demm baxxa ħafna u dipressjoni respiratorja.
A very high plasma concentration of 100.1 μ g/ ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Konċentrazzjoni għolja ħafna tal- plażma ta ’ 100. 1 μg/ ml zonisamide kienet irreġistrata madwar 31 siegħa wara li pazjent ħa doża eċċessiva ta ’ Zonegran u clonazepam; il- pazjent sar komatuż u kellu dipressjoni respiratorja, iżda ġie f’ sensih ħamest ijiem wara u ma ġarrab l- ebda kundizzjonijiet jew mard b’ konsegwenza ta ’ dan.
No specific antidotes for Zonegran overdose are available.
M’ hemm l- ebda antidoti speċifiċi disponibbli għal doża eċċessiva ta ’ Zonegran.
Following a suspected recent overdose, emptying the stomach by gastric lavage or by induction of emesis may be indicated with the usual precautions to protect the airway.
Wara doża eċċessiva ssusspettata riċenti, it- tbattil ta ’ l- istonku permezz ta ’ ħasil gastriku jew permezz ta ’ l- induzzjoni ta ’ l - 8 emesi, jistgħu jkunu indikati bil- prekawzjonijiet tas- soltu biex jipproteġu l- passaġġ tan- nifs.
General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Kura ġenerali ta ’ appoġġ hi indikata, li tinkludi monitoraġġ frekwenti ta ’ sinjali vitali u osservazzjoni mill - qrib.
Zonisamide has a long elimination half-life so its effects may be persistent.
Zonisamide għandu half- life ta ’ l- eliminazzjoni li hi twila, u għalhekk l- effetti tiegħu jistgħu jkunu persistenti.
Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Għalkemm ma kienitx formalment studjata għall- kura ta ’ doża eċċessiva, l - emodijaliżi naqqset il- konċentrazzjonijiet fil- plażma ta ’ zonisamide f’ pazjent li kellu funzjoni mnaqqsa tal- kliewi, u dan jista ’ jkun ikkunsidrat bħala kura ta ’ doża eċċessiva jekk ikun klinikament indikat.
Zonisamide is a benzisoxazole derivative.
Zonisamide hu derivattiv ta ’ benzisoxazole.
It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Hu mediċina anti- epilettika b’ attività dgħajfa in- vitro ta ’ carbonic anhydrase.
It is chemically unrelated to other anti-epileptic agents.
Kimikament mhuwiex relatat ma ’ sustanzi anti- epilettiċi oħrajn
Anti-epileptics, ATC code:
Anti- epilettiċi, Kodiċi ATC:
These studies show that the median
L- effikaċja ntweriet b’ Zonegran f’ 4 studji double- blind, ikkontrollati bil- plaċebo għal perjodi li damu sa 24 ġimgħa b’ dożaġġ li ngħata jew darba jew darbtejn kuljum.
8 reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Dawn l- istudji juru li t- tnaqqis medjan fil- frekwenza parzjali tal- puplesija hu relatat mad- doża ta ’ Zonegran, b’ effikaċja sostnuta f’ dożi ta ’ 300- 500 mg kuljum.
The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
L- attività kontra l- konvulżjonijiet ta ’ zonisamide kienet evalwata f’ varjetà ta ’ mudelli, f’ diversi speċi b’ puplesiji li kienu jew ikkaġunati jew konġeniti, u zonisamide jidher li jaġixxi bħala anti- epilettiku broad- spectrum f’ dawn il- mudelli.
Zonisamide prevents maximal electroshock seizures and restricts seizure spread, including the propagation of seizures from cortex to sub-cortical structures and suppresses epileptogenic focus activity.
Zonisamide jevita puplesiji tat- tip maximal electroshock u jnaqqas il- firxa tal- puplesiji, li jinkludu l- propagazzjoni ta ’ puplesiji mill- kortiċi sa l- istrutturi sotto- kortikali u jrażżan l- attività epilettoġenika tal- fokus.
Unlike phenytoin and carbamazepine however, zonisamide acts preferentially on seizures originating in the cortex.
Madankollu, b’ kuntrast ma ’ phenytoin u carbamazepine, zonisamide jaġixxi b’ mod preferenzjali fuq puplesiji li joriġinaw fil- kortiċi.
The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Il- mekkaniżmu ta ’ l- azzjoni ta ’ zonisamide mhuwiex spegat b’ mod sħiħ, iżda jidher li jaġixxi fuq il - kanali tal- voltage- sensitive sodium u calcium, u b’ hekk jinterrompi s- synchronised neuronal firing, u jnaqqas il- firxa tad- discharges tal- puplesiji u jinterrompi l- attività epilettika sussegwenti.
Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition.
Zonisamide għandu wkoll effett modulatorju fuq l- inibizzjoni newronali medjata mill- GABA.
Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing.
Zonisamide hu kważi kompletament assorbit wara l- għoti mill- ħalq, u ġeneralment jilħaq il - konċentrazzjonijiet massimi fis- serum jew fil- plażma fi żmien minn sagħtejn sa 5 sigħat mid- dożaġġ.
The first-pass metabolism is believed to be negligible.
Il- metaboliżmu first- pass hu maħsub li hu negliġibbli.
Absolute bioavailability is estimated to be approximately 100%.
Il- bijodisponibilità assoluta hi stmata li hi ta ’ madwar 100%.
Oral bioavailability is not affected by food, although peak plasma and serum concentrations may be delayed.
Il- bijodisponibilità orali mhijiex affettwata mill- ikel, għalkemm jista ’ jkun hemm dewmien biex jintlaħqu l- konċentrazzjonijiet massimi fil- plażma u fis- serum.
Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
Il- valuri ta ’ l- AUC u tas- Cmax ta ’ zonisamide żdiedu b’ mod kważi lineari wara doża waħda fuq il - medda tad- doża ta ’ 100- 800 mg u wara dożi multipli fuq il- medda tad- doża ta ’ 100- 400 mg darba kuljum.
The increase at steady state was slightly more than expected on the basis of dose, probably due to the saturable binding of zonisamide to erythrocytes.
Iż- żieda fl- istat fiss kienet ftit iktar minn dak mistenni fuq il- bażi tad- doża, probabbilment minħabba t- twaħħil saturabbli ta ’ zonisamide ma ’ l- eritroċiti.
Steady state was achieved within 13 days.
L- istat fiss intlaħaq fi żmien 13- il jum.
Slightly greater than expected accumulation occurs relative to single dosing.
Akkumulazzjoni ftit ikbar minn dik mistennija sseħħ fir- rigward ta ’ doża waħda.