qanastek/EMEA-V3 huggingface dataset:
disorders Skin and subcutaneous
Disturbi tal- ġilda u tat- tessuti
Rash*
Raxx *
tissue disorders Musculoskeletal and connective tissue and bone disorders
subkutanji Disturbi muskolu - skeletriċi u tat - tessut konnettiv
Acne Back pain
Akne Uġigħ fid- dahar
Reproductive system and breast disorders
Disturbi tas - sistema riproduttiva u tas- sider
General disorders Fatigue and administration site conditions
Disturbi ġenerali Għejja u kundizzjonijiet ta ’ mnejn jittieħed
Gait disturbance*
Disturbi fil- pass *
Investigations Injury, poisoning *Cross refer to Section 4.4.
Klassifika tas- Sistema ta ’
Weight decrease Head injury Contusion
* Referenza inkroċjata ma ’ Sezzjoni 4. 4.
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Wara doża eċċessiva akuta, l- istonku jista ’ jiġi mbattal b’ ħasil ta ’ l- istonku jew permezz ta ’ emesi.
There is no specific antidote for Inovelon.
M’ hemm l- ebda antidotu speċifiku għal Inovelon.
Treatment should be supportive and may include haemodialysis (see Section 5.2).
It- trattament għandu jkun wieħed t’ appoġġ u jista ’ jinkludi t- tisfija tad- demm (ara Sezzjoni 5. 2).
Multiple dosing of 7,200 mg/ day was associated with no major signs or symptoms.
Dożaġġ multiplu ta ’ 7, 200 mg/ kuljum ma kien assoċjat ma ’ l- ebda sinjal jew sintomu maġġuri.
7 Pharmacotherapeutic group: anti-epileptics, carboxamide derivatives; ATC-code:
Kategorija farmakoterapewtika: anti- epilletiċi, derivattivi tal- carboxamide Kodiċi ATC:
Mechanism of action Rufinamide modulates the activity of sodium channels, prolonging their inactive state.
Mekkaniżmu ta ’ azzjoni Rufinamide jimmodula l- attività tal- kanali tas- sodju b’ mod li jtawwal l- istat innattiv tagħhom.
Rufinamide is active in a range of animal models of epilepsy.
Rufinamide huwa attiv f’ serje ta ’ mudelli ta ’ annimali ta ’ l- epilessija.
Clinical experience Inovelon was administered in a double blind, placebo-controlled study, at doses of up to 45 mg/ kg/ day for 84 days, to 139 patients with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (including both atypical absence seizures and drop attacks). Male or female patients (between 4 and 30 years of age) were included if they were being treated with 1 to 3 concomitant fixed-dose antiepileptic drugs.
Esperjenza klinika Inovelon ġie mogħti fi studju double- blind, b’ kontrolli bi plaċebo, f’ dożi sa 45 mg/ kg/ kuljum għal 84 jum, lil 139 pażjent b’ aċċessjonijiet ikkontrollati inadegwatament assoċjati mas- Sindromu ta ’ Lennox - Gastaut (li jinkludu kemm aċċessjonijiet ta ’ assenza atipika u drop attacks).
Each patient had to have at least 90 seizures in the month prior to study entry.
Pazjenti maskili jew feminili (ta ’ bejn l- etajiet ta ’ 4 snin u 30 sena) kienu nklużi jekk kienu qed jiġu trattati b’ mediċini u qegħdin jieħdu minn 1 sa 3 mediċina kontra l- epilessija fl- istess ħin f’ doża fissa.
A significant improvement was observed for all three primary variables: the percentage change in total seizure frequency per 28 days during the maintenance phase relative to baseline (-35.8% on Inovelon vs. – 1.6% on placebo, p= 0.0006), the number of tonic-atonic seizures (-42.9% on Inovelon vs.
2.
2.2% on placebo, p = 0.0002), and the seizure severity rating from the Global Evaluation performed by the parent/ guardian at the end of the double-blind phase (much or very much improved in 32.2% on Inovelon vs.
2% fuq placebo, p = 0. 0002), u r- rata tas- severità ta ’ l- aċċessjoni mill- Evalwazzjoni Globali mwettqa mill- ġenitur/ gwardjan fl- aħħar tal- fażi double- blind (titjieb tajjeb u tajjeb ħafna fi 32, 2% fuq Inovelon vs.
14.5% on the placebo arm, p=0.0041).
14. 5% fuq il- placebo arm,
Population pharmacokinetic/ pharmacodynamic modelling demonstrated that the reduction of total and tonic-atonic seizure frequencies, the improvement of the global evaluation of seizure severity and the increase in probability of reduction of seizure frequency were dependent on rufinamide concentrations.
Mudelli farmakokinetiċi/ farmakodinamiċi tal- popolazzjoni wrew tnaqqis fil- frekwenza ta ’ aċċessjonijiet totali u toniċi- atoniċi, it- titjib fl- evalwazzjoni totali tas- severità ta ’ l- aċċessjoni u ż- żieda fil- probabbiltà ta ’ tnaqqis ta ’ frekwenza ta ’ l- aċċessjoni kienu dipendenti fuq il- konċentrazzjonijiet ta ’ rufinamide.
Absorption Maximum plasma levels are reached approximately 6 hours after administration.
Assorbiment Il- livelli massimi fil- plażma jintlaħqu madwar 6 sigħat wara l- għoti.
Peak concentration (Cmax) and plasma AUC of rufinamide increase less than proportionally with doses in both fasted and fed healthy subjects and in patients, probably due to dose-limited absorption behaviour.
L- ogħla konċentrazzjoni (Cmax) u l- AUC fil- plażma ta ’ rufinamide jiżdiedu inqas mill- proporzjon b’ dożi f’ suġġetti u pazjenti sajma u li jieklu b’ mod san u dan probabbilment hu dovut minħabba l- imġieba ta ’ l- assorbiment limitat tad- doża.
After single doses food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Wara dożi waħdiena l- ikel jżid il- bijodisponibilità (AUC) ta ’ rufinamide b’ madwar 34%, u l- ogħla konċentrazzjoni ta ’ plażma b’ 56%.
Distribution In in-vitro studies, only a small fraction of rufinamide (34%) was bound to human serum proteins with albumin accounting for approximately 80% of this binding.
8 Distribuzzjoni Fi studji in- vitro, porzjon żgħir ħafna biss ta ’ rufinamide (34%) kien marbut mal- proteini li jinsabu fis- sirum tal- bniedem bl- albumina li tagħmel madwar 80% ta ’ din ir- rabta.
This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other drugs.
Dan jindika riskju minimu ta ’ interazzjonijiet bejn mediċina- mediċina permezz ta ’ sostituzzjoni mis- siti ta ’ rabta waqt l- għoti flimkien ma ’ mediċini oħrajn.
Rufinamide was evenly distributed between erythrocytes and plasma.
Rufinamide kien mifrux indaqs bejn l- eritroċiti u l- plażma.
Biotransformation Rufinamide is almost exclusively eliminated by metabolism.
Biotrasformazzjoni Rufinamide jiġi kważi kollu eliminat bil- metaboliżmu.
The main pathway of metabolism is hydrolysis of the carboxylamide group to the pharmacologically inactive acid derivative CGP 47292.
Il- passaġġ ewlieni tal- metaboliżmu huwa l- idroliżi tal- grupp carboxylamide għad- derivat farmakoloġikament inattiv ta ’ l- aċidu CGP 47292.
Cytochrome P450-mediated metabolism is very minor.
Il- metaboliżmu li jsir permezz ta ’ ċitokromju P450 huwa tassew ftit.
The formation of small amounts of glutathione conjugates cannot be completely excluded.
Il- formazzjoni ta ’ ammonti żgħar ta ’ konjugati ta ’ glutathione ma tistax tiġi kompletament eskluża.
Rufinamide has demonstrated little or no significant capacity in-vitro to act as a competitive or mechanism-based inhibitor of the following human P450 enzymes:
Rufinamide wera ftit jew xejn kapaċità sinifikanti in- vitro sabiex jaġixxi bħala impeditur kompettiv jew wieħed ibbażżat fuq mekkaniżmu ta 'l- enżimi umani P450 li ġejjin:
CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 or CYP4A9/ 11-2.
CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 jew CYP4A9/ 11- 2.
Elimination The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Tneħħija Il- half- life ta 'l- tneħħija mill- plażma hija ta ’ madwar 6- 10 sigħat f’ suġġetti b’ saħħithom u pazjenti b’ epilessija.
When given twice daily at 12-hourly intervals, rufinamide accumulates to the extent predicted by its terminal half-life, indicating that the pharmacokinetics of rufinamide are time- independent (i. e. no autoinduction of metabolism).
Meta jingħata darbtejn kuljum f' intervalli ta '12- il siegħa, rufinamide jakkumula sa fejn hemm previst fil- half life terminali tiegħu, li jindika li l- farmakokinetiċi ta ’ rufinamide huma dipendenti fuq il- ħin (i. e. m’ hemm l- ebda awto- induzzjoni tal- metaboliżmu).
8 In a radiotracer study in three healthy volunteers, the parent compound (rufinamide) was the main radioactive component in plasma, representing about 80% of the total radioactivity, and the metabolite CGP 47292 constituting only about 15%.
Fi studju li sar b’ radiotracer fuq tliet volontieri b' saħħithom, il- kompost ewlieni (rufinamide) kien il - komponent radjuattiv ewlieni fil- plażma, b' dan jirrapreżenta madwar 80% tar- radjuattività totali, u b’ madwar 15% biss ikun magħmul mill- metabolit CGP 47292.
Renal excretion was the predominant route of elimination for drug related material, accounting for 84.7% of the dose.
L- tneħħija mill- kliewi kienet ir- rotta ewlenija ta 'l- tneħħija għal materjal relatat mal- mediċina, u dan jgħodd għal 84. 7% tad- doża.
Linearity/ non-linearity:
Linearità/ non- linearità:
The bioavailability of rufinamide is dependent on dose.
Il- biodisponibiltà ta 'rufinamide hija dipendenti fuq id- doża.
As dose increases the bioavailability decreases.
Hekk kif id- doża tiżdied, il - biodisponibiltà tonqos.
Pharmacokinetics in special patient groups Sex Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Sess Mudelli farmakokinetiċi tal- popolazzjoni ġew użati biex jevalwaw l- influwenza tas- sess fuq il- farmakokinetika ta ’ rufinamide.
Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Evalwazzjonijiet bħal dawn jindikaw li s- sess ma jaffetwax il- farmakokinetika ta ’ rufinamide b’ mod klinikament rilevanti.
Renal impairment The pharmacokinetics of a single 400 mg dose of rufinamide were not altered in subjects with chronic and severe renal failure compared to healthy volunteers.
Indeboliment fil- kliewi Il- farmakokinetika ta ’ doża waħda ta ’ 400 mg ta ’ rufinamide ma ġietx mibdula f’ suġġetti li għandhom indeboliment renali kroniku jew severi meta mqabbel ma ’ voluntieri b’ saħħithom.
However, plasma levels were reduced by approximately 30% when haemodialysis was applied after administration of rufinamide, suggesting that this may be a useful procedure in case of overdose (see Sections 4.2 and 4.9).
Madankollu, il - livelli ta ’ plażma ġew mnaqqsa b’ madwar 30% meta ġiet applikata dijaliżi tad- demm wara l- għoti ta ’ rufinamide, li jissuġġerixxi li din kienet proċedura utli f’ każ ta ’ doża eċċessiva (ara Sezzjonijiet 4. 2 u 4. 9).
Hepatic impairment No studies have been performed in patients with hepatic impairment and therefore Inovelon should not be administered to patients with severe hepatic impairment.
Indeboliment epatiku L- ebda studju ma twettaq fuq pazjenti b’ indeboliment epatiku u għalhekk Inovelon m’ għandux jingħata f’ pazjenti b’ indeboliment epatiku severi.
Children (2-12 years) Children generally have lower clearance of rufinamide than adults, and this difference is related to body size.
Tfal (2- 12- il sena) It- tfal ġeneralment għandhom rata ta ’ tneħħija ta ’ rufinamide aktar baxxa, u din id- differenza hi relatata mal- piż korporali.
Studies in new-born infants or infants and toddlers under 2 years of age have not been conducted.
Ma sarux studji fuq tfal li għadhom jitwieldu jew trabi u tfal żgħar li huma taħt is- sentejn.
Elderly A pharmacokinetic study in elderly healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
9 Anzjani Studju farmakokinetiku f’ voluntiera anzjani b’ saħħithom ma wriex differenza sinifikanti fil- parametri farmakokinetiċi meta mqabbla ma ’ adulti iżgħar.
Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Studji konvenzjonali dwar is- sigurtà farmakoloġika ma rrivelaw l- ebda perikli f’ dożi klinikament rilevanti.
Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver changes, including bile thrombi, cholestasis and liver enzyme elevations thought to be related to increased bile secretion in this species.
Tossiċitajiet osservati fil- klieb f’ livelli simili għal esposizzjoni umana fid- doża massima rakkomandata kienu bidliet fil- fwied, li jinkludi trombi biljari, kolestasi u elevazzjonijiet ta ’ l- enżimi tal- fwied li huma maħsuba li huma relatati ma ’ nixxiegħa ogħla ta ’ bilja f’ din l- ispeċi.
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
L- ebda evidenza ta ’ risku assoċjat ma ġie identifikat fl- istudji tossiċi ta ’ dożi ripetuti fil- firien u x- xadini.
In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
Fi studji tossikoloġiċi dwar ir- riproduzzjoni u l- iżvilupp, kien hemm tnaqqis fl- iżvilupp tal- fetu u s - sopravivenza, u xi trabi mwielda mejta li kienu sekondarji għat- tossiċità ta ’ l- omm.
However, no effects on morphology and function, including learning or memory, were observed in the offspring.
Madankollu, ma kien hemm l- ebda effetti osservati fuq il- morfoloġija u l- funzjoni, inkluż it- tagħlim jew il- memorja fuq il- wild.
Inovelon was not teratogenic in mice, rats or rabbits.
Inovelon ma kienx teratoġeniku fuq il- ġrieden, il- firien jew il- fniek.
Rufinamide was not genotoxic and had no carcinogenic potential.
Rufinamide ma kienx ġenotossiku u ma kellux potenzjal karċinoġeniku.
Adverse effects not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to human use was myelofibrosis of the bone marrow in the mouse carcinogenicity study.
Effetti avversi mhux osservati fi studji kliniċi, imma li dehru fl- annimali f’ livelli ta ’ espożizzjoni simili għal- livelli ta ’ espożizzjoni klinika u b’ rilevanza possibbli għall- użu fil- bniedem kienet majelofibrosi tal- mudullun fl- istudju dwar il- karċinoġeniċità tal- ġurdien.
Benign bone neoplasms (osteomas) and hyperostosis seen in mice were considered a result of the activation of a mouse specific virus by fluoride ions released during the oxidative metabolism of rufinamide.
Neoplażmi (osteomi) ta ’ l- għadam beninnji u l- iperstosi osservati fil- ġrieden kienu ikkonsidrati bħala riżultat ta ’ l- attivazzjoni ta ’ vajrus speċifiku tal- ġurdien minn ijoni tal- fluoride rilaxxati waqt il- metaboliżmu ossidattiv ta ’ rufinamide.
9 Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13 week study with significant response at the high dose in male.
Dwar il- potenzjal imunotossiku, timu żgħira u involuzzjoni tat- timu kienu osservati fi klieb fi studju ta ’ 13- il ġimgħa b’ rispons sinifikanti fid- doża għolja fir- raġel.
In the 13 week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
Fl- istudju ta ’ 13- il ġimgħa, il- mudullun tal- mara u bidliet fil- limfojde kienu rraportati fid- doża għolja b’ inċidenza żgħira.
In rats decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
Fil- firien, ċellularità mnaqqsa tal- mudullun u atropija timika kienu osservati fl- istudju karċinoġeniku biss.
Core:
Il- qalba:
Lactose monohydrate Cellulose, microcrystalline Maize starch Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous
Lactose monohydrate Cellulose, microcrystalline Lamtu tal- qamħirrun Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silika kollojdali, anidru
Film coating:
Il- kisi tar- rita:
Opadry 00F44042 [consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172)].
Opadry 00F44042 [li jikkonsisti minn hypromellose, macrogols (8000), titanium dioxide (E171), talkum u ferric oxide aħmar (E172)].
Do not store above 30ºC.
Taħżinx f’ temperatura ‘ l fuq minn 30 ºC
100 mg Aluminium/ aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
100 mg Aluminju/ strixxi ta ’ l- aluminju, pakketti ta ’ 10, 30, 50, 60 u 100 pillola miksija b’ rita.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali
Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, UK
Eisai Limited, Mosquito Way, Hatfield, Herts, AL10 9SN, Ir- Renju Unit
16th January 2007
16 ta ’ Jannar 2007
Inovelon 200 mg film-coated tablets
Inovelon 200 mg pilloli miksija b’ rita
200 mg Each film-coated tablet contains 200 mg rufinamide.
100 mg Kull pillola miksija b’ rita fiha 100 mg rufinamide.
40 mg lactose monohydrate/ film coated tablet.
20 mg lactose monohydrate/ pillola miksija b’ rita.
200 mg Pink, ‘ ovaloid’, slightly convex, scored on both sides, embossed ‘Є 262’ on one side and blank on the other side.
100 mg Pillola roża, forma ovali, daqsxejn mżaqqa, imnaqqxa fuq iż- żewġ naħat, fuq naħa minnhom hemm ‘ Є261 ’ imbuzzati u xejn fuq in- naħa l- oħra.
12 Use in adults and children four years of age or older of 30 kg or over Treatment should be initiated at a daily dose of 400 mg.
12 It- trattament għandu jinbeda b’ doża ta ’ 400 mg kuljum.
13 concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of Inovelon.
M’ hemmx bizzejjed data dwar it- twaqqif ta ’ prodotti medicinali anti- epilettiċi oħra li jkunu qegħdin jittieħdu fl- istess waqt, la darba l- kontroll fuq l- aċċessjonijiet ikun sar biż- żieda ta ’ Inovelon.
Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see Section 4.8).
13 It- trattament b’ rufinamide kien assoċjat ma ’ sturdamenti, ħedla, atassja u disturbi fil- pass, li jistgħu jżidu l- każijiet ta ’ waqgħat aċċidentali f’ din il- popolazzjoni (ara Sezzjoni 4. 8).
Potential for Inovelon to affect other medicinal products
Il- potenzjal ta ’ Inovelon li jaffettwa prodotti mediċinali oħrajn 14 Prodotti mediċinali anti- epilettiċi oħrajn
Rufinamide appears 14 not to have clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate or valproate steady state concentrations.
Rufinamide jidher li ma kellu l- ebda effett klinikament relevanti fuq konċentrazzjonijiet ta ’ fissi ta ’ carbamazepine, lamotrigine, phenobarbital, topiramate jew valproate.
Since rufinamide may decrease phenytoin clearance and increase average steady state plasma concentrations of co-administered phenytoin, consideration should be given to reducing the dose of phenytoin.
Billi rufinamide jista ’ inaqqas ir- rata ta ’ l- tneħħija ta ’ phenytoin u jżid il- medja ta ’ konċentrazzjoni ta ’ stat fiss fil- plażma ta ’ phenytoin li jkun ġie mogħti miegħu, għandu jiġi kkunsidrat li titnaqqas id- doża ta ’ phenytoin.
Studies in animals revealed no teratogenic effect but foetotoxicity in presence of maternal toxicity (see Section 5.3).
15 Studji fl- annimali ma wrewx effetti teratoġenici imma tossicità fil- fetu fil- preżenza ta ’ tossicità fl - omm (ara Sezzjoni 5. 3).
15 Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw miżuri kontraċettivi waqt it- trattament b’ Inovelon.
Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Section 4.5).
It- tobba għandhom jipprovaw li kontraċezzjoni xierqa tiġi wżata u għandhom jużaw il- ġudizzju kliniku meta jassessjaw jekk kontraċettivi orali, jew id- dożi tal- komponenti tal- kontraċettiv orali, humiex adegwati msejsa fuq is- sitwazzjoni klinika individwali tal- pazjenti (ara Sezzjoni 4. 5).
Common Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis Rhinitis
Komuni
Metabolism and Nutrition disorders Psychiatric disorders
Sinusite Rinite Disturbi tas - sistema immunitarja Disturbi fil - metaboliżmu u n - nutrizzjoni Disturbi psikjattriċi
Anorexia Eating disorder Decreased appetite Anxiety Insomnia
Anoreksja Disturbi biex tiekol Nuqqas t’ aptit Ansjetà Nuqqas ta ’ rqad
Nervous system disorders
Sensittività eċċessiva *
Somnolence* Headache Dizziness*
Disturbi tas - Ħedla * sistema nervuża Uġigħ ta 'ras Sturdament *
Status epilepticus* Convulsion Coordination Abnormal* Nystagmus Psychomotor hyperactivity Tremor
Status epilepticus * Aċċessjoni Koordinazzjoni Anormali * Nystagmus Iperattività psiko- motriċi Tertir
increase
Akne Uġigħ fid- dahar
tissue disorders Musculoskeletal and connective tissue and bone disorders
Disturbi tas - sistema riproduttiva u tas- sider
Acne Back pain
Oligomenorea
Reproductive system and breast disorders
Disturbi ġenerali Għejja u kundizzjonijiet ta ’ mnejn jittieħed
Oligomenorrhoea
Disturbi fil- pass *
Very
l- Organi Komuni Ħafna Stħarriġ Korriment, avvelenament
Common Common
Komuni Tnaqqis fil- piż Feriti fir- ras Kontużjoni
Investigations Injury, poisoning *Cross refer to Section 4.4.
* Referenza inkroċjata ma ’ Sezzjoni 4. 4.
Pharmacotherapeutic group: anti-epileptics, carboxamide derivatives; ATC-code:
Kategorija farmakoterapewtika: anti- epilletiċi, derivattivi tal- carboxamide Kodiċi ATC:
After single
L- ogħla konċentrazzjoni (Cmax) u l- AUC fil- plażma ta ’ rufinamide jiżdiedu inqas mill- proporzjon b’ dożi f’ suġġetti u pazjenti sajma u li jieklu b’ mod san u dan probabbilment hu dovut minħabba l- imġieba ta ’ l- assorbiment limitat tad- doża.
18 doses food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Wara dożi waħdiena l- ikel jżid il- bijodisponibilità (AUC) ta ’ rufinamide b’ madwar 34%, u l- ogħla konċentrazzjoni ta ’ plażma b’ 56%.
Distribution In in-vitro studies, only a small fraction of rufinamide (34%) was bound to human serum proteins with albumin accounting for approximately 80% of this binding.
18 Distribuzzjoni Fi studji in- vitro, porzjon żgħir ħafna biss ta ’ rufinamide (34%) kien marbut mal- proteini li jinsabu fis- sirum tal- bniedem bl- albumina li tagħmel madwar 80% ta ’ din ir- rabta.
In a radiotracer study in three healthy volunteers, the parent compound (rufinamide) was the main radioactive component in plasma, representing about 80% of the total radioactivity, and the metabolite CGP 47292 constituting only about 15%.
Fi studju li sar b’ radiotracer fuq tliet volontieri b' saħħithom, il- kompost ewlieni (rufinamide) kien il - komponent radjuattiv ewlieni fil- plażma, b' dan jirrapreżenta madwar 80% tar- radjuattività totali, u b’ madwar 15% biss ikun magħmul mill- metabolit CGP 47292.
19 Elderly A pharmacokinetic study in elderly healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
19 Anzjani Studju farmakokinetiku f’ voluntiera anzjani b’ saħħithom ma wriex differenza sinifikanti fil- parametri farmakokinetiċi meta mqabbla ma ’ adulti iżgħar.
Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13 week study with significant response at the high dose in male.
Dwar il- potenzjal imunotossiku, timu żgħira u involuzzjoni tat- timu kienu osservati fi klieb fi studju ta ’ 13- il ġimgħa b’ rispons sinifikanti fid- doża għolja fir- raġel.
3 years.
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
20 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
200 mg Aluminium/ aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
100 mg Aluminju/ strixxi ta ’ l- aluminju, pakketti ta ’ 10, 30, 50, 60 u 100 pillola miksija b’ rita.
Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, UK
Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, Ir- Renju Unit
Inovelon 400 mg film-coated tablets
Inovelon 400 mg pilloli miksija b’ rita
400 mg Each film-coated tablet contains 400 mg rufinamide.
100 mg Kull pillola miksija b’ rita fiha 100 mg rufinamide.
80 mg lactose monohydrate/ film coated tablet.
20 mg lactose monohydrate/ pillola miksija b’ rita.
400 mg Pink, ‘ ovaloid’, slightly convex, scored on both sides, embossed ‘Є 263’ on one side and blank on the other side.
100 mg Pillola roża, forma ovali, daqsxejn mżaqqa, imnaqqxa fuq iż- żewġ naħat, fuq naħa minnhom hemm ‘ Є261 ’ imbuzzati u xejn fuq in- naħa l- oħra.
22 Use in adults and children four years of age or older of 30 kg or over Treatment should be initiated at a daily dose of 400 mg.
22 It- trattament għandu jinbeda b’ doża ta ’ 400 mg kuljum.
23 Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see Section 4.8).
23 It- trattament b’ rufinamide kien assoċjat ma ’ sturdamenti, ħedla, atassja u disturbi fil- pass, li jistgħu jżidu l- każijiet ta ’ waqgħat aċċidentali f’ din il- popolazzjoni (ara Sezzjoni 4. 8).
Potential for Inovelon to affect other medicinal products
Il- potenzjal ta ’ Inovelon li jaffettwa prodotti mediċinali oħrajn 24 Prodotti mediċinali anti- epilettiċi oħrajn
Since rufinamide may decrease phenytoin clearance and increase 24 average steady state plasma concentrations of co-administered phenytoin, consideration should be given to reducing the dose of phenytoin.
Billi rufinamide jista ’ inaqqas ir- rata ta ’ l- tneħħija ta ’ phenytoin u jżid il- medja ta ’ konċentrazzjoni ta ’ stat fiss fil- plażma ta ’ phenytoin li jkun ġie mogħti miegħu, għandu jiġi kkunsidrat li titnaqqas id- doża ta ’ phenytoin.
Studies in animals revealed no teratogenic effect but foetotoxicity in presence of maternal toxicity (see Section 5.3).
25 Studji fl- annimali ma wrewx effetti teratoġenici imma tossicità fil- fetu fil- preżenza ta ’ tossicità fl - omm (ara Sezzjoni 5. 3).
25 Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw miżuri kontraċettivi waqt it- trattament b’ Inovelon.
28 doses food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Wara dożi waħdiena l- ikel jżid il- bijodisponibilità (AUC) ta ’ rufinamide b’ madwar 34%, u l- ogħla konċentrazzjoni ta ’ plażma b’ 56%.
Distribution In in-vitro studies, only a small fraction of rufinamide (34%) was bound to human serum proteins with albumin accounting for approximately 80% of this binding.
28 Distribuzzjoni Fi studji in- vitro, porzjon żgħir ħafna biss ta ’ rufinamide (34%) kien marbut mal- proteini li jinsabu fis- sirum tal- bniedem bl- albumina li tagħmel madwar 80% ta ’ din ir- rabta.
29 Elderly A pharmacokinetic study in elderly healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
29 Anzjani Studju farmakokinetiku f’ voluntiera anzjani b’ saħħithom ma wriex differenza sinifikanti fil- parametri farmakokinetiċi meta mqabbla ma ’ adulti iżgħar.
400 mg Aluminium/ aluminium blisters, packs of 10, 30, 50, 60, 100 and 200 film-coated tablets.
100 mg Aluminju/ strixxi ta ’ l- aluminju, pakketti ta ’ 10, 30, 50, 60 u 100 pillola miksija b’ rita.
Eisai Manufacturing Limited Mosquito Way Hatfield Herts AL10 9SN United Kingdom
Eisai Manufacturing Limited Mosquito Way Hatfield Herts AL10 9SN Ir- Renju Unit
Medicinal product subject to restricted medical prescription (see Annex I:
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2).
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza hija stabbilita u qed tiffunzjona qabel mal- prodott jitqiegħed fis- suq.
The MAH commits to performing a post-marketing safety study (registry) and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
L- MAH jikkommetti ruħu biex iwettaq studju dwar is- sigurtà wara t- tqegħid fis- suq (reġistru) u attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan aġġornat dwar il- Maniġġar tar- Riskju għandu jiġi provdut skond il- Linja- gwida CHMP fuq Sistemi ta ’ Maniġġar ta ’ Riskju għal prodotti mediċinali għall- użu tal- bniedem.
Inovelon 100 mg film-coated tablets Rufinamide
Inovelon 100 mg pilloli miksija b’ rita Rufinamide
Each tablet contains 100 mg rufinamide
Kull pillola fiha 100 mg rufinamide
See leaflet for further information.
Ara l- fuljett għal aktar tagħrif.
10 10 film-coated tablets 30 30 film-coated tablets 50 50 film-coated tablets 60 60 film-coated tablets 100 100 film-coated tablets
10 10 pilloli miksija b’ rita 30 30 pillola miksija b’ rita 50 50 pillola miksija b’ rita 60 60 pillola miksija b’ rita 100 100 pillola miksija b’ rita
Oral Use Read the package leaflet before use.
Użu Orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA (IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXP (MM/ YYYY)
JIS (XX/ SSSS)
Eisai Ltd., Mosquito Way, Hatfield, Herts, AL10 9SN, UK
Eisai Ltd., Mosquito Way, Hatfield, Herts, AL10 9SN, Ir- Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Inovelon 100 mg tablets
Inovelon 100 mg pilloli
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Eisai Ltd.
Eisai Ltd..
{MM/ YYYY}
JIS (XX/ SSSS)
Inovelon 200 mg film-coated tablets Rufinamide
Inovelon 200 mg pilloli miksija b’ rita Rufinamide
Each tablet contains 200 mg rufinamide
Kull pillola fiha 200 mg rufinamide
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Inovelon 200 mg tablets
Inovelon 200 mg pilloli
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Inovelon 400 mg film-coated tablets Rufinamide
Inovelon 400 mg pilloli miksija b’ rita Rufinamide
Each tablet contains 400 mg rufinamide
Kull pillola fiha 400 mg rufinamide
10 10 film-coated tablets 30 30 film-coated tablets 50 50 film-coated tablets 60 60 film-coated tablets 100 100 film-coated tablets 200 200 film-coated tablets
10 10 pilloli miksija b’ rita 30 30 pillola miksija b’ rita 50 50 pillola miksija b’ rita 60 60 pillola miksija b’ rita 100 100 pillola miksija b’ rita 200 200 pillola miksija b’ rita
Read the package leaflet before use.
Użu Orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP (MM/ YYYY)
42 JIS (XX/ SSSS)
Inovelon 400 mg tablets
Inovelon 400 mg pilloli
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
45 PACKAGE LEAFLET:
45 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNA
Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Inovelon 100 mg pilloli miksija b’ rita Inovelon 200 mg pilloli miksija b’ rita Inovelon 400 mg pilloli miksija b’ rita Rufinamide
Read all of this leaflet carefully before you start taking this medicine
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jaggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What Inovelon is and what it is used for 2.
X' inhu Inovelon u għalxiex jintuża 2.
Before you take Inovelon 3.
Qabel ma tieħu Inovelon 3.
How to take Inovelon 4.
Kif għandek tieħu Inovelon 4.
How to store Inovelon 6.
Kif taħżen Inovelon 6.
WHAT INOVELON IS AND WHAT IT IS USED FOR
X' INHU INOVELON U GĦALXIEX JINTUŻA
Inovelon contains rufinamide, which is an antiepileptic medicine.
Inovelon fih rufinamide, li hi mediċina anti- epilettika.
It is used to treat seizures associated with Lennox-Gastaut syndrome.
Hi użata biex tittratta l- aċċessjonijiet li huma assoċjati mas- sindromu Lennox- Gastaut.
BEFORE YOU TAKE INOVELON
QABEL MA TIEĦU INOVELON
Do not take Inovelon
Tieħux Inovelon
- if you are allergic (hypersensitive) to rufinamide or any of the other ingredients of Inovelon and
- jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal rufinamide jew sustanza oħra ta ’
triazole derivatives.
Inovelon u derivattivi ta ’ triazole
Take special care with Inovelon
Oqgħod attent ħafna b' Inovelon
- if you suffer from liver problems, because there is limited information on the use of Inovelon in
- jekk inti tbati minn problemi tal- fwied, minħabba li hemm informazzjoni limitata fuq l- użu ta ’
this group and the dose of your medicine may need to be increased more slowly.
Inovelon f’ dan il- grupp u d- doża tal- mediċina tiegħek għandha mnejn ikollha tiġi miżjuda aktar bil- mod.
- if you get a skin rash.
- Jekk inti ikollok raxx tal- ġilda.
See your doctor immediately as very occasionally this may become serious.
Ara lit- tabib tiegħek minnufih għax ħafna drabi din tista ’ ssir serja.
- if you suffer an increase in the number or severity or duration of your seizures, you should contact
- Jekk tbati minn żieda fl- għadd jew s- severità jew it- tul ta ’ l- aċċessjonijiet tiegħek, għandek
your doctor immediately.
tikkuntattja lit- tabib tiegħek minnufih.
- if you experience dizziness or sleepiness inform your doctor.
- Jekk tbati minn sturdamenti jew ħedla għarraf lit- tabib tiegħek.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Jekk jogħġbok ikkonsulta mat- tabib tiegħek, anke jekk dawn l- istqarriet kienu applikabbli għalik fil- passat.
46 Taking other medicines
Meta tieħu mediċini oħra
If your doctor prescribes or recommends an additional treatment for epilepsy (e. g. valproate) you must tell him you are taking Inovelon as your dose may need adjusting.
46 Jekk it- tabib tiegħek jikteb jew jirrakomanda trattament addizzjonali għall- epilessija (eż. valproate) għandek tgħarrfu li qed tieħu Inovelon billi d- doża tiegħek għandha mnejn trid tiġi aġġustata.
Taking Inovelon with food and drink
Meta tieħu Inovelon ma ’ l- ikel u max- xorb
Inovelon should preferably be taken with food.
Inovelon għandu preferibbilment jittieħed ma ’ l- ikel.
As a precaution, do not take Inovelon with alcohol.
Bħala prekawzjoni, tieħux Inovelon ma ’ l - alkoħol.
If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Jekk inti mara li jista ’ jkollok it- tfal, għandek tuża miżuri ta ’ kontraċettzjoni meta tieħu Inovelon.
If you are pregnant, or think you might be pregnant, or are planning to get pregnant, tell your doctor.
Jekk inti tqila, jew taħseb li inti tqila, jew qed tippjana li tinqabad tqila, għarraf lit- tabib tiegħek.
You must only take Inovelon during your pregnancy if your doctor tells you to.
Għandek tieħu Inovelon waqt it- tqala biss jekk it- tabib tiegħek jgħidlek biex tagħmel dan.
You must not breast-feed while taking Inovelon.
M’ għandekx tredda ’ waqt li tkun qed tieħu Inovelon.
Do not drive or operate machinery if you feel drowsy, dizzy or experience blurred vision whilst taking this medicine.
Issuqx jew tħaddem magni jekk tħossok bin- ngħas, stordut/ a jew ikollok il- vista mċajpra meta tkun qed tieħu din il- mediċina.
Be particularly careful at the start of treatment or after your dose is increased.
Oqgħod aktar attent, b’ mod partikolari, fil- bidu tat- trattament jew wara li tiżdiedlek id- doża.
Important information about some of the ingredients of Inovelon
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Inovelon
Inovelon contains lactose.
Inovelon fih il- lattożju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tibda tieħu dan il- prodott.
HOW TO TAKE INOVELON
KIF GĦANDEK TIEĦU INOVELON
Always take Inovelon exactly as your doctor has told you.
Dejjem għandek tieħu Inovelon skond il- parir tat- tabib.
You must check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Il- pilloli Inovelon għandhom jittieħdu darbtejn kuljum ma ’ l- ilma, filgħodu u filgħaxija.
Inovelon can be taken with food.
Inovelon jista ’ jittieħed ma ’ l- ikel.
If you have difficulty swallowing, you can crush the tablet.
Jekk għandek diffikultà biex tibla, tista ’ titħan il- pillola.
Then mix the powder in about half a glass (100 ml) of water and drink immediately.
Imbagħad ħallat it - trab b’ madwar nofs tazza (100 ml) ilma u ixrob minnufih.
The usual starting dose in children weighing less than 30 kg is 200 mg a day taken in two doses.
Id- doża li ġeneralment tintuża fil- bidu fuq tfal li jiżnu inqas minn 30 kg hi ta ’ 200 mg kull ġurnata li tittieħed f’ żewġ dożi.
The dose will be adjusted for you by your doctor and may be increased by 200 mg at intervals of two days, to a daily dose of no more than 1000 mg.
Id- doża ser tiġi aġġustata għalik mit- tabib tiegħek u tista ’ tiżdied sa 200 mg f’ intervalli ta ’ jumejn, sa doża ta ’ kuljum ta ’ mhux aktar minn 1000 mg.
The usual starting dose in adults and children weighing 30 kg or over is 400 mg a day taken in two doses.
Id- doża li ġeneralment tintuża fil- bidu fuq adulti u tfal li jiżnu aktar minn 30 kg jew aktar hi ta ’ 400 mg kull ġurnata li tittieħed f’ żewġ dożi.
The dose will be adjusted for you by your doctor and may be increased by 400 mg at intervals of two days, to a daily dose of no more than 3200 mg, depending upon your weight.
Id- doża ser tiġi aġġustata għalik mit- tabib tiegħek u tista ’ tiżdid sa 400 mg intervalli ta ’ jumejn kull ġurnata sa doża ta ’ kuljum ta ’ mhux aktar minn 3200 mg, skond il- piż korporali tiegħek.
Some patients may respond to lower doses.
Xi pazjenti jafu jirrispondu għal dożi iżgħar.
The dose may be increased more slowly if you experience side effects.
Id- doża tista ’ tiġi miżjuda bil- mod jekk ikollok xi effetti sekondarji.
47 Inovelon is meant to be taken as a long-term medicine.
Inovelon huwa maħsub biex jittieħed bħala mediċina fuq perijodu ta ’ żmien twil.
Do not reduce your dose or stop your medicine unless your doctor tells you to.
Inti m’ għandekx tnaqqas id- doża jew twaqqaf il- mediċina, ħlief meta it- tabib jgħidlek biex tagħmel hekk.
If you take more Inovelon than you should
Jekk tieħu Inovelon aktar milli suppost
If you may have taken more Inovelon than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
47 Jekk inti ħadt aktar Inovelon milli suppost, għid lil min jieħu ħsiebek (qarib/ a jew ħabib/ a), lit- tabib jew lill- ispiżjar tiegħek, jew ikkuntattja l- eqreb dipartiment ta ’ l- emerġenza ta ’ l- isptar, u ħu l - mediċina tiegħek miegħek.
You may become sleepy and could lose consciousness.
Jista ’ jkun li torqod jew titlef il- koxjenza.
Do not drive at this time.
Issuqx f’ dan il- waqt.
If you forget to take Inovelon
Jekk tinsa tieħu Inovelon
If you forget to take a dose, continue taking your medicine as normal.
Jekk tinsa tieħu doża, kompli bħal qabel u ħu l- mediċina tiegħek bħas- soltu.
Do not take a double dose to make up for forgotten dose.
Tieħux doża doppja sabiex tagħmel tajjeb għal doża li tkun insejt tieħu.
If you miss more than one dose, seek advice from your doctor.
Jekk ma tieħux aktar minn doża waħda, fittex il - parir tat- tabib tiegħek.
If you stop taking Inovelon
Jekk tieqaf tieħu Inovelon
If your doctor advises you to stop treatment, follow your doctor’ s instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
Jekk it- tabib tiegħek jirrakkomandalek sabiex twaqqaf it- trattament, segwi l- istruzzjonijiet tat- tabib dwar it- tnaqqis gradwali ta ’ Inovelon sabiex jitnaqqas ir- riskju ta ’ żieda fl- aċċessjonijiet.
Like all medicines, Inovelon can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Inovelon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor if you have any of the following and if they are too uncomfortable for you:
Għid lit- tabib tiegħek jekk tinnota xi wieħed minn dawn l- effetti l- oħra u jekk iġegħluk tħossok skomdu ħafna:
Very common (more than 1 in 10 patients) side effects of Inovelon are:
Effetti kollaterali komuni (aktar minn pazjent 1 f’ 10) ta ’ Inovelon huma:
Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
Sturdament, uġigħ ta ’ ras, tqallih, rimettar, ħedla, għejja.
Less commonly reported (more than 1 in a 100 patients) side effects of Inovelon are:
Effetti kollaterali anqas komuni rrapportati (aktar minn pazjent 1 f’ 100) ta ’ Inovelon huma:
Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/ seizures, unusual eye movements, blurred vision, trembling.
Problemi assoċjati man- nervi li jinkludu: diffikultà biex timxi, moviment anormali, aċċessjonijiet/ attakki ta ’ puplesija, movimenti ta ’ l- għajnejn mhux tas- soltu, vista mċajpra,, tertir.
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Problemi assoċjati ma ’ l- istonku li jinkludu: uġigħ fl- istonku, stitikezza, indiġestjoni, ippurgar merħi (dijarrea), telf jew bidla fl- aptit, telf fil- piż.
Infections:
Infezzjonijiet:
Ear infection, flu, nasal congestion, chest infection.
Infezzjonijiet tal- widnejn, mnieħer miżdud, infezzjoni fis- sider.
In addition patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury.
Barra minn hekk pazjenti kellhom: ansjetà, insomnija, l- imnieħer jinfaraġ, akne, raxx, uġigħ fid- dahar, pirjid mhux frekwenti, slieħ, feriti fir- ras.
48 Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are:
Mhux komuni (bejn 1 pazjent f’ 100 u 1 f’ 1000) effetti kollaterali ta ’ Inovelon huma:
Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
Reazzjonijiet allerġiċi u żieda fil- markers tal- funzjoni tal- fwied (żieda fl- enżimi epatiċi).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti l- oħra jaggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE INOVELON
KIF TAĦŻEN INOVELON.
Keep Inovelon out of the reach and sight of children.
Żomm Inovelon fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Inovelon after the expiry date which is stated on the blister and carton.
48 Tużax Inovelon wara d- data ta ’ skadenza li tidher fuq l- istrixxa u fuq il- kartuna.
Do not store above 30°C.
Taħżinx f' temperatura ’ l fuq minn 30°C.
Do not use Inovelon if you notice a change in colour of the tablets.
Tużax Inovelon jekk tinnota bidla fil- kulur tal- pilloli.
These measures will help to protect the environment.
Dawn il- miżuri ser jgħinu jipproteġu l- ambjent.
What Inovelon contains
X’ fih Inovelon
- The active substance is rufinamide.
- Is- sustanza attiva hi rufinamide.
Each Inovelon 100 mg film-coated tablet contains 100 mg of rufinamide.
Kull pillola Inovelon ta ’ 100 mg miksija b’ rita fiha 100 mg ta ’ rufinamide.
Each Inovelon 200 mg film-coated tablet contains 200 mg of rufinamide.
Kull pillola Inovelon ta ’ 200 mg miksija b’ rita fiha 200 mg ta ’ rufinamide.
Each Inovelon 400 mg film-coated tablet contains 400 mg of rufinamide.
Kull pillola Inovelon ta ’ 400 mg miksija b’ rita fiha 400 mg ta ’ rufinamide.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch,
- Is- sustanzi l- oħra huma lactose monohydrate, microcrystalline cellulose, lamtu tal- qamħirrun,
croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate u silika kollojdali anidra.
The film-coating consists of Opadry 00F44042 [hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172)].
Il- kisi tar- rita tikkonsisti minn Opadry 00F44042 [hypromellose, macrogols (8000), titanium dioxide (E171), talkum u ferric oxide aħmar (E172)].
What Inovelon looks like and contents of the pack
Id- dehra ta ’ Inovelon u l- kontenut tal- pakkett
• Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 261’ on one side and blank on the other side.
• Il- pilloli Inovelon 100 mg huma pilloli roża, ta ’ forma ovali, daqsxejn mżaqqa, miksijin b’ rita, minquxa fuq iż- żewġ naħat, fuq naħa minnhom hemm l- karattri ‘ Є261 ’ imbuzzati u xejn fuq in- naħa l- oħra.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Dawn jistgħu jinkisbu f’ pakketti ta ’ 10, 30, 50, 60, u 100 pillola miksija b’ rita.
• Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 262’ on one side and blank on the other side.
• Il- pilloli Inovelon 200 mg huma pilloli roża, ta ’ forma ovali, daqsxejn mżaqqa, miksijin b’ rita, minquxa fuq iż- żewġ naħat, fuq naħa minnhom hemm l- karattri ‘ Є262 ’ imbuzzati u xejn fuq in- naħa l- oħra.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Dawn jistgħu jinkisbu f’ pakketti ta '10, 30, 50, 60, u 100 pillola miksija b’ rita.
• Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 263’ on one side and blank on the other side.
• Il- pilloli Inovelon 400 mg huma pilloli roża, ta ’ forma ovali, daqsxejn mżaqqa, minquxa fuq iż- żewġ naħat, fuq naħa minnhom hemm l- karattri ‘ Є263 ’ imbuzzati u xejn fuq in- naħa l- oħra.
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Marketing Authorisation Holder:
l- Manifattur:
Eisai Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, UK.
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, Ir- Renju Unit
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom
49 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Detailed information on this product is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) f’ http: // www. emea. europa. eu.
What is Insulatard?
X’ inhu Insulatard?
Insulatard is a range of insulin suspensions for injection.
Insulatard hu medda ta ’ sospensjonijiet ta ’ insulina għall- injezzjoni.
Insulatard is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Insulatard jeżisti bħala fjali, cartridges (Penfill), jew pinen mimlija minn qabel (InnoLet, NovoLet u FlexPen).
Insulatard contains the active substance insulin human (rDNA).
Insulatard fih is - sustanza attiva insulina tal- bniedem (rDNA).
What is Insulatard used for?
Għal xiex jintuża Insulatard?
Insulatard is used in patients with diabetes.
Insulatard jintuża f’ pazjenti bid- dijabete.
How is Insulatard used?
Kif jintuża Insulatard?
Insulatard is given subcutaneously (under the skin) by injection, usually in the thigh.
Insulatard jingħata b’ injezzjoni taħt il- ġilda, ġeneralment fil- koxxa.
If convenient, it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Jekk ikun konvenjenti, l- injezzjoni tista ’ tingħata fil- ħajt addominali (fiż- żaqq), fir- reġjun gluteali (fil- warrani) jew fir- reġjun tad- deltoid (fl- ispalla).