qanastek/EMEA-V3 huggingface dataset:
For the full list of ge side effects reported with Zenapax, see the Package Leaflet.
Għal- lista sħiħa ta ’ ad l- effetti sekondarji irrapportati b’ Zenapax, ara l- Fuljett ta ’ Tagħrif.
Zenapax should not be used in people who may be hypersensitive (allergic) to daclizumab or any of lon the other ingredients.
Zenapax m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal daclizumab jew għal kwalunkwe sustanza oħra.
Zenapax must not be used in women who are breast feeding.
Zenapax m’ għandux jintuża f’ nisa li qed ireddgħu. ’ g ħ
Why has Zenapax been approved?
Għaliex ġie approvat Zenapax?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax’ s benefits are no
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ im
greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Zenapax huma akbar mir- riskji tiegħu għall- profilassi ta ’ irrifjutar akut ta ’ organi fi trapjant renali alloġeniku de novo, meta wżat f’ konkomitanza ma ’ reġimen immunosuppressiv, inklużi ciclosporin u kortikosterojdi f’ pazjenti li mhumiex immunizzati ħafna.
The Committee recommended that Zenapax t
Il- Kumitat irrikkmanda li Zenapax jingħata li l
be given marketing authorisation. uc
awtorizzazzjoni għat- tqegħid fis- suq. na
Other information about Zenapax:
Tagħrif ieħor dwar Zenapax:
The European Commission granted a marketing authorisation valid throughout the European Union rod
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Zenapax valida fl- Unjoni Ewropea kollha lil Roche Registration Limited fis- 26 ta ’ Frar 1999.
for Zenapax to Roche Registration Limited on 26 February 1999.
fis- suq ġiet imġedda fis- 26 ta ’ Frar 2004. d
The full EPAR for Zenapax can be found here. na
L- EPAR sħiħ għal Zenapax huwa disponibbli minn hawn. me
This summary was last updated in 10-2007. i dic Me
Dan is- sommarju ġie aġġornat l- aħħar f' 10- 2007. ott od Pr
Pharmaceutical Form Capsule, hard
Kapsula, iebsa
Route of Administration Oral use
Jittieħed mill- ħalq
Packaging Blister (PVC/ PVDC)
Folja (PVC/ PVDC)
What is Zerene?
X’ inhu Zerene?
Zerene is a medicine that contains the active substance zaleplon.
Zerene huwa mediċina li fiha s- sustanza attiva zaleplon.
What is Zerene used for?
Għal xiex jintuża Zerene?
Zerene is used for the treatment of adults with insomnia who have difficulty falling asleep.
Zerene jintuża fit- trattament ta ’ adulti li jbatu mill- insonnja li jsibuha diffiċli biex jorqdu.
It is used only when the insomnia is severe, disabling or causing extreme distress.
Jintuża biss meta l- insonnja tkun severa, tindebolixxi jew tikkawża għeja estrema.
How is Zerene used?
Kif jintuża Zerene?
Treatment with Zerene should be as short as possible and should last for no more than two weeks.
It- trattament b’ Zerene għandu jkun qasir kemm jista ’ jkun u m’ għandux idum aktar minn ġimagħtejn.
Zerene is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep.
Zerene jittieħed immedjatament qabel ma wieħed jidħol fis- sodda jew wara li l- pazjent ikun daħal fis - sodda u jkun qiegħed isibha diffiċli biex jorqod.
The maximum total daily dose of Zerene is 10 mg.
Id- doża rakkomandata hija 10 mg, għajr għall- anzjani u pazjenti b’ mard tal- fwied ħafif jew moderat, li għandhom jieħdu 5 mg Id- doża massima totali kuljum ta ’ Zerene hija 10 mg.
No food should be eaten with or shortly before taking Zerene, because it can reduce the medicine’ s effects.
Il- pazjenti m’ għandhomx jieklu meta jieħdu Zerene u lanqas ftit qabel ma jagħmlu dan, minħabba li dan jista ’ jirriżulta fit- tnaqqis tal- effetti tal- mediċina.
Zerene must not be taken by children or by patients who have severe liver or kidney problems.
Zerene m’ għandux jingħata lit- tfal jew lill- pazjenti bi problemi severi fil- fwied jew il- kliewi.
How does Zerene work?
Kif jaħdem Zerene?
The active substance in Zerene, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Is- sustanza attiva f’ Zerene, zaleplon, tapartjeni għal grupp ta ’ mediċini li huma relatati mal - benzodiazepines.
It is a gamma-amino butyric acid (GABA) agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Huwa agonist tal- aċdu butiriku gamma- amino (GABA - gamma- amino butyric acid receptor agonist), li jfisser li jeħel mar- riċetturi tan- newrotrasmettituri tal- GABA u jattivahom.
The powder in Zerene capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
It- trab fil- kapsuli Zerene huwa kkulurit blu skur ħafna biex jipprevjeni li jingħata lil xi ħadd mingħajr ma jkun jaf.
How has Zerene been studied?
Kif ġie studjat Zerene?
Zerene has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Zerene ġie studjat f’ total ta ’ 14- il studju, li involvew kważi 3, 500 adult u pazjenti anzjani.
Zerene was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Zerene tqabbel ma ’ plaċebo (trattament finta) jew ma ’ zolpidem jew triazolam (mediċini oħra użata fl- insonnja).
What benefit has Zerene shown during the studies?
X’ benefiċċji wera Zerene matul l- istudji mwettqa?
The time taken to fall asleep was reduced in adults taking Zerene 10 mg, and the effects were maintained for up to four weeks.
Iż- żmien sakemm jorqdu l- pazjenti naqas f’ adulti li kienu qegħdin jieħdu Zerene 10 mg, u l- effetti baqgħu hekk sa ’ erba ’ ġimgħat wara.
In elderly patients, the time taken to fall asleep was often decreased with Zerene 5 mg and was always decreased with Zerene 10 mg, when they were compared with placebo in the two-week studies.
F’ pazjenti anzjani, iż- żmien li damu biex jorqdu ħafna drabi naqas b’ Zerene 5 mg u naqas dejjem b’ Zerene 10 mg, meta mqabbel mal- plaċebo fl- istudji ta ’ ġimagħtejn.
Zerene 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Zerene 10 mg kien iktar effikaċi mill- plaċebo fit- tnaqqis taż- żmien li damu biex jorqdu u fiż- żieda taż - żmien ta ’ irqad matul l- ewwel nofs tal- lejl.
Zerene also preserved sleep patterns in the studies that measured the time spent in different stages of sleep.
Zerene żamm ukoll il- mod kif kienu qegħdin jorqdu fl- istudji li kejlu ż- żmien fl- istadji differenti tal - irqad.
What is the risk associated with Zerene?
X’ inhu r- riskju assoċjat ma ’ Zerene?
The most common side effects with Zerene (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
L- aktar effetti sekondarji komuni b’ Zerene (li dehru f’ bejn 1 u 10 pazjenti minn kull 100) huma amnesija (problemi bil- memorja), parestesija (sensazzjonijiet anormali bħal tingiż), ħedla tan- ngħas u dismenorrea (mestrwazzjoni li tikkawża l- uġigħ).
For the full list of all side effects reported with Zerene, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati bi Zerene, ara l- Fuljett ta ’ Tagħrif.
Zerene should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients.
Zerene m’ għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal zaleplon jew għal xi ingredjenti oħra tiegħu.
It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
M’ għandux jintuża f’ pazjenti bi problemi severi fil- fwied jew il- kliewi, bis- sindromu ta ’ apnea tal- irqad (waqfien frekwenti tan- nifs waqt l- irqad), mijastenija gravis (marda li tikkawża indeboliment tal- muskoli) jew insuffiċjenza respiratorja severa (disturbi tan- nifs), jew f’ pazjenti ta ’ taħt it- 18- il sena.
Why has Zerene been approved?
Għaliex ġie approvat Zerene?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zerene’ s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Zerene akbar mir- riskji tiegħu għat- trattament ta ’ pazjenti bl- insonnja li jsibuha diffiċli biex jorqdu, meta id- disturb ikun sever, b’ indeboliment jew li jikkawża għeja kbira lill- individwi.
The Committee recommended that Zerene be given marketing authorisation.
Il- Kumitat irrakkomanda li Zerene jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zerene:
Tagħrif ieħor dwar Zerene:
The European Commission granted a marketing authorisation valid throughout the European Union for Zerene on 12 March 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq fl- Unjoni Ewropea kollha għal Zerene fit- 12 ta ’ Marzu 1999.
The full EPAR for Zerene is available here.
L- EPAR sħiħ għal Zerene jista ’ jiġi kkonsultat hawn.
Zerene 5 mg hard capsules
Zerene 5 mg kapsuli iebsin
Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Zerene hi maħsuba għat- trattament ta ’ pazjenti li jbatu minn problemi ta ’ insomnija u li jbatu biex jorqdu.
Zerene can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Zerene tista ’ tittieħed immedjatament qabel l- pazjent imur jorqod jew wara li jkun daħal jorqod u isibha diffiċli biex jorqod.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Zerene.
Jekk titieħed wara l- ikel, il- konċentrazzjoni massima tal- plażma tkun ittardjata b’ sagħtejn, iżda l- ammont li jiġi assorbit b’ kollox ma jinbidilx.
The total daily dose of Zerene should not exceed 10 mg in any patient.
L- ebda pazjent m’ għandu jieħu doża ta ’ aktar minn 10 mg ta ’ Zerene kuljum.
Elderly Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Zerene.
Pazjenti anzjani Pazjenti anzjani jistgħu jkun sensittivi għall- effetti ta ’ ipnotiċi; għalhekk hu rakkomandat li d- doża ta ’ Zerene tkun ta ’ 5 mg.
Paediatric patients Zerene is contraindicated in children (see section 4.3).
Tfal Zerene mhux maħsub biex jintuża fit- tfal
For severe hepatic impairment see section 4.3.
Insuffiċjenza tal- fwied Pazjenti bi problema epatika kemm jekk din tkun ħafifa kif ukoll jekk tkun moderata għandhom jiġu mogħtija doża ta ’ Zerene 5mg, għaliex ir- rata tal- eliminazzjoni f’ dawn il- pazjenti hija inqas. (ara sezzjoni 4. 3)
2 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Zerene pharmacokinetics is not altered in such patients.
L- ebda aġġustament fid- doża ma hi meħtieġa għal pazjenti li għandhom insuffiċjenza renali li tkun bejn ħafifa u moderata, għaliex il- farmakokinetiċi ta ’ Zerene ma jitbidlux f’ pazjenti bħal dawn.
(See section 4.5)
Meta Zerene tittieħed flimkien ma ’ prodotti mediċinali oħra magħrufa li jinfluwenzaw CYP3A4, hu mistenni li jkun hemm bidla fil- konċentrazzjoniet tal- plażma ta ’ zaleplon (Ara sezzjoni 4. 5).
To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Zerene (see section 4.7).
(ara sezzjoni 4. 7).
Renal impairment Zerene is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
4 Insuffiċjenza renali Zerene mhux indikat għal dawk il- pazjenti b’ insuffiċjenza renali gravi peress li ma ġiex studjat sewwa fuq dawn il- pazjenti.
Concomitant intake with alcohol is not recommended.
Zerene ma għandhiex tittieħed ma l - alkoħol.
Therefore, caution is advisable in co-administering cimetidine and Zerene.
Għalhekk mhux rakkomandat l- użu taċ- ċimetidin u Zerene.
Co-administration of Zerene with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon’ s plasma concentrations.
L- amministrazzjoni ta ’ Zerene ma ’ doża waħda 800 mg ta ’ erithromycin, li hu ta ’ tfixkil qawwi u selettiv ta ’ CYP3A4, ipproduċa żjieda ta ’ 34% fil- konċentrazzjonijiet tal- plażma ta ’ zaleplon.
A routine dosage adjustment of Zerene is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Aġġustament fir- rutina ta ’ Zerene mhix kunsidrata neċessarja, u l- pazjenti għandhom ikunu mgħarrfa li effetti sedattivi jistgħu jiżdiedu.
Co-administration of Zerene together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon’ s efficacy.
L- amministrazzjoni ta ’ Zerene flimkien ma prodotti li jistimulaw CYP3A4 bħal ma hu rifampicin, carbamazepine, u phenobarbitone, jistgħu jirriżultaw f’ nuqqas fl- effikaċja ta ’ zaleplon.
Zerene did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
5 Zerene ma teffettwax il- profili tal- farmakokinetika u tal- farmakodinamika ta ’ digoxin u ta ’ warfarin, żewġ komponenti li għandhom indiċi terapewtiċi dojoq.
In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Zerene.
Ma dan kollu, ibuprofen, bħala eżempju tal - komponenti li jbiddlu l- eleminazzjoni renali, urew li m’ għandhomx interazzjoni ma ’ Zerene.
Use of Zerene is not recommended during pregnancy.
Għalkemm fi studji fuq l- annimali ma dehrux effetti teratoġeniċi jew embrjotossiċi, m’ hemmx tagħrif kliniku biżżejjed fuq Zerene biex juri li hi jew mhix ta ’ ħsara matul it- tqala jew it- treddigħ.
Because zaleplon is excreted in the breast milk, Zerene should not be administered to breast-feeding mothers.
Billi zaleplon joħroġ mal- ħalib tad- treddigħ, Zerene m’ għandhiex tiġi amministrata lill- ommijiet li jkunu qegħdin ireddgħu.
Zerene has major influence on the ability to drive and use machines.
Zerene iħalli effetti maġġuri fuq il- ħila ta ’ bniedem biex iħaddem magni u jsuq.
There is limited clinical experience with the effects of an acute overdose of Zerene, and overdose levels in humans have not been determined.
L- esperjenza klinika fuq l- effetti ta ’ doża eċċessiva ta ’ Zerene huma limitati, u l- livelli ta ’ dożi eċċessivi fil- bniedem għandhom ma ġewx determinati.
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Zerene overdose.
Studji fuq l- annimali juru li flumazenil hu oppost għal zaleplon u għandu jkun kunsidrat fl- immaniġjar tad- doża eċċessiva ta ’ Zerene.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Zerene.
Flimkien mas- sottotip tal- karaterristiċi ta ’ tagħqid mar- riċettur, b’ selettività għolja u b’ affinita baxxa għal riċetur tat- tip 1 għal benżodjażepin, dawn il- propjetajiet huma responsabbli għal karaterristiċi globali ta ’ Zerene.
Zerene’ s efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
L- effikaċja ta ’ Zerene kienet imkejjla kemm fi studji fuq l- irqad li saru fil- laboratorji fejn intużaw miżuri oġġettivi polisomnigrafi (PSG) ta ’ l- irqad, kif ukoll fi studji fuq pazjenti barra mill- isptar fejn kienu użati kwestjonarji.
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Zerene 10 mg.
In- nuqqas ta ’ rqad fl- istudji ta ’ pazjenti barra mill- isptar ġie imnaqqas b’ Zerene 10mg, sa 4 ġimgħat f’ pazjenti li ma kenux anzjani.
In elderly patients, sleep latency was often significantly decreased with Zerene 5 mg and was consistently decreased with Zerene 10 mg compared with placebo in 2-week studies.
F’ pazjenti anzjani, in- nuqqas ta ’ rqad kien imnaqqas b’ mod sinjifikattiv b’ doża ta ’ 5mg Zerene u kien imnaqqas b’ mod konformi b’ Zerene 10mg meta komparat
Results from the 2- and 4- week studies showed that no pharmacological tolerance developed with any dose of Zerene.
Riżultati minn studji ta ’ ġimagħtejn u erba ’ ġimgħat juru li l- ebda toleranza farmakoloġika ma żviluppat b’ xi doża ta ’ Zerene.
In Zerene studies using objective PSG measures, Zerene 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
Fi studji ta ’ Zerene fejn intużaw il- kejlijiet oġġettivi tal- PSG, Zerene ta ’ 10mg kienet superjuri għal - plaċebo biex jonqos in- nuqqas ta ’ rqad u biex tiżdied id- dewmien tar- raqda fl- ewwel nofs tal- lejl.
Zerene has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Zerene uriet li iżżomm l- istadji ta ’ l- irqad, fi studji kontrollati fejn ġie mkejjel il- perċentwali ta ’ żmien ta ’ l- irqad ta ’ kull stadju.
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Zerene at recommended doses in humans.
Kollox ma ’ kollox, ir- riżultati ta ’ qabel studji kliniċi ma jurux li hemm periklu sinjifikanti għall - bniedem bl- użu ta ’ Zerene skond id- dożi rakkomandati.
Zerene has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will change colour and become cloudy.
Zerene hi ddisinjata li jekk il- kontenut tal- kapsula jinħall f’ likwidu, il- likwidu ibiddel kuluru u jsir mċajpar.
Zerene 10 mg hard capsules
Zerene 10 mg kapsuli iebsin
12 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Zerene pharmacokinetics is not altered in such patients.
L- ebda aġġustament fid- doża ma hi meħtieġa għal pazjenti li għandhom insuffiċjenza renali li tkun bejn ħafifa u moderata, għaliex il- farmakokinetiċi ta ’ Zerene ma jitbidlux f’ pazjenti bħal dawn.
(See section 4.5).
Meta Zerene tittieħed flimkien ma ’ prodotti mediċinali oħra magħrufa li jinfluwenzaw CYP3A4, hu mistenni li jkun hemm bidla fil- konċentrazzjoniet tal- plażma ta ’ zaleplon (Ara sezzjoni 4. 5).
Renal impairment Zerene is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
14 Insuffiċjenza renali Zerene mhux indikat għal dawk il- pazjenti b’ insuffiċjenza renali gravi peress li ma ġiex studjat sewwa fuq dawn il- pazjenti.
15 4.6 Pregnancy and lactation
15 Zerene ma teffettwax il- profili tal- farmakokinetika u tal- farmakodinamika ta ’ digoxin u ta ’ warfarin, żewġ komponenti li għandhom indiċi terapewtiċi dojoq.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Zerene.
Flimkien mas- sottotip tal- karaterristiċi ta ’ tagħqid mar- riċettur, b’ selettività għolja u b’ affinita baxxa għal riċetur tat- tip 1 għal benżodjażepin, dawn il- propjetajiet huma ontrollati għal karaterristiċi globali ta ’ ontro.
Zerene’ s efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
L- effikaċja ta ’ ontro kienet imkejjla kemm fi ontr fuq l- irqad li saru fil- laboratorji fejn intużaw ontro oġġettivi polisomnigrafi (PSG) ta ’ l- irqad, kif ukoll fi ontr fuq ontroll barra mill- isptar fejn kienu użati kwestjonarji.
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Zerene 10 mg.
In- nuqqas ta ’ rqad fl- istudji ta ’ ontroll barra mill- isptar ġie imnaqqas b’ Zerene 10mg, sa 4 ġimgħat f’ pazjenti li ma kenux ontrol.
In elderly patients, sleep latency was often significantly decreased with Zerene 5 mg and was consistently decreased with Zerene 10 mg compared with placebo in 2-week studies.
F’ pazjenti ontrol, in- nuqqas ta ’ rqad kien imnaqqas b’ mod sinjifikattiv b’ doża ta ’ 5mg ontro u kien imnaqqas b’ mod ontroll b’ Zerene 10mg meta komparat
Zerene has been shown to
18 mal- plaċebo fi ontr ta ’ ġimagħtejn. ontro- tnaqqis fin- nuqqas t’ irqad kien sinifikament different minn dak osservat bil- plaċebo. ontrolla minn ontr ta ’ ġimagħtejn u erba ’ ġimgħat juru li l- ebda ontrollat farmakoloġika ma żviluppat b’ xi doża ta ’ ontro.
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 5 MG – PACK SIZES 7, 10 AND 14 CAPSULES
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TAL- PAKKETT TA ’ BARRA TEST GĦAL KARTUN TA ’ FOLJI TA ’ ZERENE 5 MG KAPSULI – PAKETTI TA ’ 7, 10 U 14- IL KAPSULA
Zerene 5 mg hard capsules zaleplon
Zerene 5 mg kapsuli iebsin zaleplon
Each hard capsule contains 5 mg zaleplon
Kull kapsula Zerene fiha 5 mg zaleplon
EU/ 1/ 99/ 099/ 001 7 capsules EU/ 1/ 99/ 099/ 002 10 capsules EU/ 1/ 99/ 099/ 003 14 capsules
EU/ 1/ 99/ 099/ 001 7 kapsuli EU/ 1/ 99/ 099/ 002 10 kapsuli EU/ 1/ 99/ 099/ 003 14- il kapsula
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI TEST GĦAL FOLJI TA ’ ZERENE 5 MG KAPSULI
Zerene 5 mg hard capsules zaleplon
Zerene 5 mg kapsuli iebsin (zaleplon)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 10 MG – PACK SIZES 7, 10 AND 14 CAPSULES
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TAL- PAKKETT TA ’ BARRA TEST GĦAL KARTUN TA ’ FOLJI TA ’ ZERENE 10 MG KAPSULI – PAKETTI TA ’ 7, 10 U 14- IL KAPSULA
Zerene 10 mg hard capsules zaleplon
Zerene 10 mg kapsuli iebsin zaleplon
Each hard capsule contains 10 mg zaleplon
Kull kapsula Zerene fiha 10mg zaleplon
EU/ 1/ 99/ 099/ 004 7 capsules EU/ 1/ 99/ 099/ 005 10 capsules EU/ 1/ 99/ 099/ 006 14 capsules
EU/ 1/ 99/ 099/ 004 7 kapsuli EU/ 1/ 99/ 099/ 005 10 kapsuli EU/ 1/ 99/ 099/ 006 14- il kapsula
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI TEST GĦAL FOLJI TA ’ ZERENE 10 MG KAPSULI
What Zerene is and what it is used for 2.
X’ inhu Zerene u għalfejn jintuża 2.
Before you take Zerene 3.
Qabel tieħu Zerene 3.
How to take Zerene 4.
Kif jittieħed Zerene 4.
How to store Zerene 6.
Kif taħżen Zerene 6.
WHAT ZERENE IS AND WHAT IT IS USED FOR
X’ INHU ZERENE U GĦALFEJN JINTUŻA
Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Zerene huwa prodott mediċinali tal- klassi benzodiazepines, li għandhom effett ipnotiku.
Zerene will help you to sleep.
Zerene hija kapsula li tgħinek torqod.
BEFORE YOU TAKE ZERENE
QABEL TIEĦU ZERENE
Do not take Zerene if you have
Tieħux Zerene:
• hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene • sleep apnoea syndrome (stopping breathing for short periods while asleep) • severe kidney or liver problems • myasthenia gravis (very weak or tired muscles) • severe breathing or chest problems
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zaleplon jew xi sustanzi oħra ta ’ Zerene, li jinkludu indigo carmine (E132) • tbati minn apnea waqt l- irqad (waqfien ta ’ nifs għall- ħinijiet qosra waqt l- irqad) • problemi gravi tal- kliewi u tal- fwied • myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena) • problemi fit- teħid tan- nifs jew problemi tas- sider
Children under 18 years of age must not take Zerene.
Tfal taħt it- 18- il sena m’ għandhomx jingħataw Zerene.
Take special care with Zerene
Oqgħod attent ħafna b’ Zerene:
• Never drink alcohol while you are being treated with Zerene.
• Qatt tixrob alkoħol meta tkun qed tiġi ittrattat b’ Zerene.
Alcohol can increase the undesirable effects of any medicine taken to help you sleep. • Use with extreme caution if you have ever been addicted to medicines or alcohol. • If you are taking any medicines belonging to the sleep inducing group, including Zerene, there is a possibility that you may become dependent on them.
L- alkoħol jista ’ iżid l- effetti mhux mixtieqa ta ’ kull mediċina li tgħinek fl- irqad. • Uża attenzjoni akbar jekk inti xi darba kont tabbuża bl - alkoħol jew mediċini. • Jekk qed tieħu xi mediċini li jappartjenu għal grupp ta ’ mediċini li jinduċu l- irqad, li jinkludu Zerene, hemm il- possibilità li tista ’ ssir dipendenti fuqhom. • Tużax Zerene jew xi mediċina oħra ta ’ l- irqad għal aktar żmien milli jgħidlek it- tabib.
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
33 • Tiħux it- tieni doża ta ’ Zerene fl- istess lejl. • Jekk tibqa ’ ma tistax torqod kellem lit- tabib tiegħek • Nuqqas ta ’ sabar, aġitazzjoni, irritabilita, aggressjoni, ħsibijiet mhux tas- soltu, delużjoni, ħmar il- lejl, alluċinazzjonijiet, psikożi, mġieba mhux tas- soltu ġew innotati f’ nies li uzaw mediċina tal- irqad bħal Zerene.
33 • Do not use Zerene or any other sleeping medicine for longer than your doctor tells you to. • Do not use a second dose of Zerene within a single night. • If your sleeplessness persists or worsens after a short course of Zerene treatment contact your doctor. • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Jekk taħseb li għandek xi wieħed minn dawn is- sintomi ara lit- tabib tiegħek. • Hemm iċ- ċans li tista ’ jkollok esperjenza temporanja ta ’ ċerta tip ta ’ telf ta ’ memorja (amnesija) u nuqqas ta ’ ko- ordinazzjoni meta tieħu mediċina tal- irqad.
This can usually be avoided if you remain inactive for at least 4 hours after taking Zerene. • There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event.
Din tista ’ ħafna drabi tiġi evitata jekk iżżomm ruħek inattiv sa 4 sigħat wara li tieħu Zerene. • Hemm ċans li tista ’ tesperjenza somnambuliżmu (ħmar il- lejl), li jinkludi t- teħid ta ’ ikel jew sewqan meta persuna ma tkunx imqajjma sew mingħajr ebda memorja tal- każ.
Some can cause drowsiness and should not be taken while taking Zerene.
Xi wħud jistgħu jikkaġunaw in- ngħas u m’ għandhomx jittieħdu meta tieħu Zerene.
When Zerene is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Meta Zerene tittieħed ma ’ mediċini oħra li jaġixxu fuq il- moħħ, il- kombinazzjoni tista ’ tagħmlhek aktar bi ngħas milli suppost.
Taking Zerene with food and drink
Meta tieħu Zerene ma l- ikel u max- xorb:
It is not recommended that you take Zerene with or immediately after eating a large meal as it may work more slowly.
Mhux rakkomandabli li tieħu Zerene ma ’ jew eżatt wara ikla kbira għax din tista ’ iġib dewmien biex tibda taħdem.
Never drink alcohol while you are being treated with Zerene (see “ Take Special care with Zerene ”).
(ara “ Ħu attenzjoni speċjali b’ Zerene ”).
Zerene should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Zerene m’ għandiex tingħata f’ każijiet bħal dawn, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- tqal.
Zerene should not be taken at this time because there is not enough clinical data available to assess its safety during breast-feeding.
Zerene m’ għandiex tittieħed f’ dan iż- żmien, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- treddigħ.
Zerene may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Zerene jista ’ jħeddlek, jikkawza nuqqas ta ’ konċentrazzjoni jew telf ta’ memorja jew indeboliment fil - muskoli.
Important information about some of the ingredients of Zerene
34 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zerene
HOW TO TAKE ZERENE
KIF GĦANDEK TIEĦU ZERENE
Always take Zerene exactly as your doctor has told you.
• Ħu d- doża eżatta li t- tabib tiegħek kitiblek.
You should not take a second dose within a single night.
Tbiddilx id- doża qabel titkellem mat- tabib tiegħek. • Id- doża ta ’ Zerene għall- adulti hija ta ’ 10mg eżatt qabel tidħol torqod jew meta tkun dħalt torqod u issibha diffiċli biex torqod.
Zerene has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Zerene hu ddisinjat li jekk il- kontenut tal- kapsula jinħall f’ likwidu, il- likwidu ibiddel kuluru u jsir imċajpar.
If you take more Zerene than you should
Jekk tieħu Zerene aktar milli suppost:
If you forget to take Zerene
Jekk tinsa tieħu Zerene:
If you stop taking Zerene
Jekk tieqaf tieħu Zerene:
Like all medicines, Zerene can cause side effects, although not everybody gets them.
Bħal kull mediċina, Zerene jista’ jħalli effetti mhux mixtieqa, għalkemm mhux kulhadd jiġi affettwat bl- istess mod.
HOW TO STORE ZERENE
KIF TAĦŻEN ZERENE
Do not use Zerene after the expiry date, which is stated on the carton after EXP.
Tużax Zerene wara d- data ta ’ skadenza li tidher fuq it- tikketta li hemm fuq il- kartuna.
What Zerene contains
X’ fih Zerene
The active substance in each Zerene hard capsule is zaleplon 5 mg.
Is- sustanza attiva f’ kull kapsula iebsa ta ’ Zerene hi zaleplon 5 mg.
What Zerene looks like and contents of the pack
36 Id- dehra tal- prodott u d- daqs tal- pakkett:
Zerene 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “ W”, and white body, with gold imprint “ 5 mg”.
Zerene, 5 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras kannella ċara, b ’ intaljar “ W ” lewn id- deheb fuq il- korp, u “ 5 mg ” intaljati lewn id- deheb.
• hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene • sleep apnoea syndrome (stopping breathing for short periods while asleep) • severe kidney of liver problems • myasthenia gravis (very weak or tired muscles) • severe breathing or chest problems
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zaleplon jew xi sustanzi oħra ta ’ Zerene, li jinkludu indigo carmine (E132) • tbati minn apnea waqt l- irqad (waqfien ta ’ nifs għall- ħinijiet qosra waqt l- irqad) • problemi gravi tal- kliewi u tal- fwied • myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena) • problemi fit- teħid tan- nifs jew problemi tas- sider
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
40 • Tiħux it- tieni doża ta ’ Zerene fl- istess lejl. • Jekk tibqa ’ ma tistax torqod kellem lit- tabib tiegħek • Nuqqas ta ’ sabar, aġitazzjoni, irritabilita, aggressjoni, ħsibijiet mhux tas- soltu, delużjoni, ħmar il- lejl, alluċinazzjonijiet, psikożi, mġieba mhux tas- soltu ġew innotati f’ nies li uzaw mediċina tal- irqad bħal Zerene.
40 • Do not use Zerene or any other sleeping medicine for longer than your doctor tells you to. • Do not use a second dose of Zerene within a single night. • If your sleeplessness persists or worsens after a short course of Zerene treatment contact your doctor. • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Jekk taħseb li għandek xi wieħed minn dawn is- sintomi ara lit- tabib tiegħek. • Hemm iċ- ċans li tista ’ jkollok esperjenza temporanja ta ’ ċerta tip ta ’ telf ta ’ memorja (amnesija) u nuqqas ta ’ ko- ordinazzjoni meta tieħu mediċina tal- irqad.
Never drink alcohol while you are being treated with Zerene (see “ Take Special care with Zerene”).
(ara “ Ħu attenzjoni speċjali b’ Zerene ”).
Zerene should not be taken at this time because there are not enough clinical data available to assess its safety during breast-feeding.
Zerene m’ għandiex tittieħed f’ dan iż- żmien, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- treddigħ.
Important information about some of the ingredients of Zerene
41 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zerene
Do not use Zerene after the expiry date which is stated on the carton after EXP.
Tużax Zerene wara d- data ta ’ skadenza li tidher fuq it- tikketta li hemm fuq il- kartuna.
The active substance in each Zerene hard capsule is zaleplon 10 mg.
Is- sustanza attiva ta ’ kull kapsula iebsa ta ’ Zerene hi zaleplon 10 mg.
What Zerene looks like and contents of the pack
43 Id- Dehra tal- prodott u d- daqs tal- pakkett:
Zerene 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint “ W”, and white body, with pink imprint “ 10 mg”.
Zerene, 10 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras bajda ċara, b ’ intaljar “ W ” lewn roza fuq il- korp, u “ 10 mg ” intaljati lewn roza.
What is Zerit?
X’ inhu Zerit?
Zerit is a medicine containing the active substance stavudine.
Zerit hija mediċina li fiha s- sustanza attiva stavudine.
It is available as capsules containing 15 mg (red and yellow), 20 mg (brown), 30 mg (light and dark orange) and 40 mg (dark orange) stavudine.
Hija tiġi bħala kapsuli li fihom 15 mg (ħomor u sofor), 20 mg (kannella), 30 mg (oranġjo ċari u skuri) u 40 mg (oranġjo skur) ta ’ stavudine.
Zerit is also available as a powder to make up into an oral solution.
Zerit tiġi wkoll bħala trab li jitħallat f’ soluzzjoni orali.
What is Zerit used for?
Għal xiex jintuża Zerit?
Zerit is an antiviral medicine.
Zerit hija mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Tintuża f’ kumbinazzjoni ma ’ mediċini antivirali oħra biex tikkura adulti u tfal li huma infettati bil- vajrus ta ’ l- immunodefiċjenza tal- bniedem (HIV), il- vajrus li jikkaġuna sindromu ta ’ immunodefiċjenza akkwistata (AIDS).
How is Zerit used?
Kif jintuża Zerit?
Treatment with Zerit should be initiated by a doctor who has experience in the treatment of HIV infection.
Il- kura b’ Zerit għandha tinbeda minn tabib li għandu esperjenza fil- kura ta ’ infezzjoni bl- HIV.
The dose to use is calculated based on the age and weight of the patient.
Id- doża li għandha tintuża hija ikkalkulata abbażi ta ’ l- età u l- piż tal- pazjent.
It is taken every 12 hours.
Zerit tiġi meħuda kull 12 – il siegħa.
Adults weighing less than 60 kg and children weighing over 30 kg take 30 mg, and adults over 60 kg take 40 mg.
Adulti li jiżnu inqas minn 60 kg u tfal li jiżnu aktar minn 30 kg jieħdu 30 mg u adulti ta ’ aktar minn 60 kg jieħdu 40 mg kull 12- il siegħa.
Children over the age of 14 days receive 1 mg per kilogram body weight, unless they weigh more than 30 kg.
Tfal ta ’ età ta ’ aktar minn 14- il jum jirċievu 1 mg g] al kull kilogramm ta ’ piż korporju, sakemm ma jiżnux aktar minn 30 kg.
Babies less than 13 days old should be given 0.5 mg/ kg body weight.
Trabi ta ’ età inqas minn 13- il jum għandhom jingħataw 0. 5 mg/ kg ta ’ piż korporju.
Zerit should be taken on an empty stomach, at least one hour before a meal.
Zerit għandu jittieħed fuq stonku vojt, ta ’ l- inqas siegħa qabel l- ikel.
If this is not possible, it may be taken with a light meal.
Jekk dan mhuwiex possibbli, jista ’ jittieħed ma ’ ikla ħafifa.
The capsules should be swallowed whole or opened carefully and their contents mixed with food.
Il- kapsuli għandhom jinbelgħu sħaħ jew jinfetħu bir- reqqa u l- kontenuti tagħhom imħallta ma ’ l- ikel.
The oral solution should be used in patients below three months of age.
Is- soluzzjoni orali għandha tintuża f’ pazjenti taħt l- età ta ’ tliet xhur.
The dose may need to be adjusted in patients who have problems with their kidneys or certain side effects.
Jaf ikun hemm bżonn li d- doża tiġi aġġustata f’ pazjenti li għandhom problemi bil- kliewi tagħhom jew b’ ċerti effetti sekondarji.
How does Zerit work?
Kif jaħdem Zerit?
The active substance in Zerit, stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Is- sustanza attiva f’ Zerit, stavudine, hija impeditur ta ’ nucleoside reverse transcriptase (NRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Hija timblokka l- attività ta ’ reverse transcriptase, enzima magħmula minn HIV li tħallih jinfetta ċ- ċelloli u jagħmel aktar vajrusis.
By blocking this enzyme, Zerit, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Billi jimblokka din l- enzima, Zerit, meħud ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Zerit does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zerit ma jikkurax infezzjoni bl- HIV jew AIDS, iżda jista ’ jittardja l- ħsara lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjati ma ’ AIDS.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Zerit been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Zerit?
The effectiveness of Zerit was assessed in four main studies.
L- effikaċja ta ’ Zerit kienet stmata f’ erba ’ studji ewlenin.
The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months.
L- ewwel studju qabbel l- effetti ta ’ Zerit meħud waħdu ma ’ dawk ta ’ zidovudine (mediċina antivirali oħra) fi 822 pazjent infettati bl- HIV li kienu ilhom jieħdu zidovudine għal ta ’ mill- inqas sitt xhur.
Its main measure of effectiveness was how long it took for the patients to develop a disease associated with AIDS or to die.
Il- miżura ewlenija ta ’ l- effikaċja tiegħu kien kemm jittieħed żmien għal pazjenti biex jiżviluppaw marda assoċjata ma ’ AIDS jew biex imutu.
The second study compared two doses of Zerit in over 13,000 patients who did not respond to, or could not take, other types of antiviral medicine.
It- tieni studju qabbel żewġ dożi ta ’ Zerit f’ aktar minn 13, 000- il pazjent li ma rreaġixxewx għal, jew ma setgħux jieħdu, tipi oħra ta ’ mediċina antivirali.
This study measured survival rates.
L- istudju kejjel ir- rati ta ’ sopravivenza.
Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz (other antiviral medicines) in 467 treatment-naïve patients (who had not taken treatment for HIV infection before).
Żewġ studji addizzjonali stmaw l- effiaċja ta ’ Zerit, meħud f’ kumbinazzjoni ma ’ lamivudine u efavirenz (mediċini antivirali oħra) f’ 467 pazjent li ma kinux ħadu l- kura għal infezzjoni bl- HIV qabel.
The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count) after 48 weeks of treatment.
Il- miżuri ewlenin ta ’ l- effikaċja kienu l- livelli ta ’ HIV fid- demm (tagħbija virali) u n- numru ta ’ ċelloli- T CD4 fid- demm (għadd taċ- ċelloli CD4) wara 48 ġimgħa ta ’ kura.
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Ċelloli- T CD4 huma ċelloli tad- demm bojod li huma importanti f’ li jgħinu biex jiġġieldu l- infezzjonijiet, iżda li huma maqtula minn HIV.
What benefit has Zerit shown during the studies?
X’ benefiċċju wera Zerit waqt l- istudji?
The studies showed that Zerit could reduce the rates of disease progression in HIV-infected patients.
L- istudji wrew li Zerit jista ’ jnaqqas ir- rati ta ’ progressjoni tal- mard f’ pazjenti infettati bl- HIV.
Patients taking Zerit alone developed an AIDS-related disease or died at a similar rate to those taking zidovudine.
Pazjenti li qed jieħdu Zerit waħdu żviluppaw marda relatata ma ’ l- AIDS jew mietu f’ rata simili għal dawk li kienu qed jieħdu zidovudine.
Patients taking either of two doses of Zerit also had similar survival rates over 22 weeks.
Pazjenti li qed jieħdu jew waħda jew l- oħra miż- żewġ dożi ta ’ Zerit kellhom ukoll rati simili ta ’ sopravivenza fuq 22- il ġimgħa.
When taken in combination with lamivudine and efavirenz, around 70% of the patients taking Zerit had viral loads below 400 copies/ ml after 48 weeks.
Meta meħud f’ kombinazzjoni ma ’ lamivudine u efavirenz, madwar 70% tal- pazjenti li kienu qed jieħdu Zerit kellhom tagħbijiet virali taħt 400 kopji/ ml wara 48- il ġimgħa.
The patients ’ CD4 cell counts also rose from around 280 cells/ mm3 before treatment by an average of around 185 cells/ mm3.
L- għadd taċ- ċelloli CD4 tal- pazjenti, li qabel il- kura kien ta ’ madwar 280 ċelloli/ mm3 żdied ukoll b’ medja ta ’ madwar 185 ċelloli/ mm3..
What is the risk associated with Zerit?
X’ inhu r- riskju assoċjat ma ’ Zerit?
The most common side effects when taking Zerit (seen in between 1 and 10 patients in 100) are peripheral neuropathy (damage to the nerves in the extremities causing tingling, numbness and pain in the hands and feet), diarrhoea, nausea, abdominal (tummy) pain, dyspepsia (heartburn), fatigue (tiredness), lipodystrophy (redistribution of body fat), dizziness, insomnia (difficulty sleeping), abnormal thinking, somnolence (sleepiness), depression, rash, pruritus (itching) and hyperlactataemia (elevated lactic acid levels in the blood).
L- aktar effetti sekondarji komuni meta qed tieħu Zerit (dehru f’ madwar pazjent 1 u 10 minn kull 100) huma newropatija periferali (ħsara lin- nervituri fl- estremitajiet li jikkaġunaw textix, tirżiħ u uġigħ fl - idejn u s- saqajn), dijarea, nawsja, uġigħ addominali (ta ’ żaqq), dispepsja (ħruq ta ’ stonku), għeja kbira, lipodistrofija (distribuzzjoni mill- ġdid tax- xaħam tal- ġisem), sturdament, insomnja (diffikultà fl - irqad), ħsibijiet anormali, somnolenza (ngħas eċċessiv), depressjoni, raxx, prurite (ħakk) u iperlaktatimja (livelli għolja ta ’ aċidu lattiku fid- demm).
For the full list of side effects reported with Zerit, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Zerit, ara l- Fuljett ta ’ Tagħrif.
Zerit should not be used in people who may be hypersensitive (allergic) to stavudine or any of the other ingredients.
Zerit m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal stavudine jew għal xi sustanza oħra tiegħu.
As with other anti-HIV medicines, patients taking Zerit may also be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal b’ mediċini kontra HIV oħra, pazjenti li qed jieħdu Zerit jistgħu jkunu wkoll f’ riskju ta ’ osteonekrożi (mewt ta ’ tessut ta ’ l- għadam) jew sindromu ta ’ attivazzjoni immunitarja mill- ġdid (sintomi ta ’ infezzjoni ikkaġunati mis- sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Zerit.
Pazjenti li għandhom problemi bil- fwied tagħhom (inkluża infezzjoni epatite B jew Ċ) jistgħu jkunu f’ riskju ogħla ta ’ ħsara fil- fwied waqt li qed jieħdu Zerit.
As with all other NRTIs, Zerit may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Zerit during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal bl- NRTIs l- oħra kollha, Zerit jista ’ wkoll jikkaġuna aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem) u, fi trabi ta ’ ommijiet li qed jieħdu Zerit waqt it - tqala, funzjoni mitokondrijali imxekkla (ħsara lill- komponenti li jipproduċu l- enerġija fiċ- ċelloli li jistgħu jikkaġunaw problemi fid- demm).
Why has Zerit been approved?
Għaliex ġie approvat Zerit?
The Committee for Medicinal products for Human Use (CHMP) noted that there was good evidence for Zerit’ s effectiveness when taken with other antiviral medicines for the treatment of HIV infection in adults.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) innota li kien hemm evidenza tajba ta ’ l- effikaċja ta ’ Zerit meta meħud ma ’ mediċini antivirali oħra għal kura ta ’ infezzjoni bl- HIV fl- adulti.
It also concluded that there are positive data, albeit limited, supporting its effectiveness in HIV-infected children.
Huwa ikkonkluda wkoll li hemm dejta pożittiva, għalkemm limitata, li ssostni l- effikaċja tiegħu fi tfal infettati bl- HIV.
The Committee decided that Zerit’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV infected patients.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Zerit huma akbar mir- riskji tiegħu f’ kumbinazzjoni ma ’ prodotti mediċinali antiretrovirali oħra għall- kura ta ’ pazjenti infettati bl- HIV.
It recommended that Zerit be given marketing authorisation.
Huwa irrikmanda l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zerit:
Tagħrif ieħor dwar Zerit:
The European Commission granted a marketing authorisation valid throughout the European Union for Zerit to BRISTOL-MYERS SQUIBB PHARMA EEIG on 8 May 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Zerit valida għall- Unjoni Ewropea kollha lil BRISTOL- MYERS SQUIBB PHARMA EEIG fit- 8 ta ’ Mejju 1996.
The marketing authorisation was renewed on 8 May 2001 and 8 May 2006.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 8 ta ’ Mejju 2001 u fit- 8 ta ’ Mejju 2006.
The full EPAR for Zerit is available here.
L- EPAR sħiħ għal Zerit huwa disponibbli minn hawn.
Pharmaceutical form
Folja (aclar/ alu)
Route of administration Packaging
Folja (aclar/ alu)
Content (concentration)
Folja (aclar/ alu)
Package size
Flixkun (HDPE)
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Użu orali
Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu) Oral use Bottle (HDPE) Oral use Blister (aclar/ alu)
Folja (aclar/ alu)
60 capsules 56 capsules 60 capsules 56 capsules 60 capsules 56 capsules 60 capsules 56 capsules
56 kapsula
Powder for oral solution
Trab li jinħall f' likwidu u
200 mg (1 mg/ ml) 1 Bottle after reconstitution
200 mg (1 mg/ ml) 1 flixkun
1/ 1  EMEA 2006
1/ 1 EMEA 2005
Zerit 15 mg hard capsule
Zerit 15 mg kapsula iebsa
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUSTANZA KWALITTATIVA U KWANTITATTIVA
Each hard capsule contains 15 mg of stavudine.
Kull kapsula iebsa fiha 15 mg ta ’ stavudine.
For a full list of excipients, see section 6.1.
Għal- lista kompleta sħiħa ta ’ sustanzi mhux attivi ara sezzjoni 6. 1
The hard capsule is red and yellow, opaque and imprinted with “ BMS” over a BMS code “ 1964” on one side and “ 15” on the other side.
Il- kapsula iebsa hija aħmar u isfar, opaka u għandha l- kliem “ BMS ” mixquxa fuq il- kodiċi BMS “ 1964 ” fuq naħa waħda u “ 15 ” fuq in- naħa l- oħra.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected patients.
Zerit huwa indikat biex jingħata flimkien ma prodotti antiretrovirali mediċinali oħra, għall- kura ta ’ pazjenti infettati bl- HIV.
Oral use.
Jittieħed mil- ħalq.
The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4).
It- terapija għandha tibda ’ tingħata minn tabib li għandu esperjenza fil- kura ta ’ infezzjoni bl- HIV (ara wkoll sezzjoni 4. 4).
Adults: the recommended dosage is:
Adulti: id- doża rrikmandata hija:
Patient weight < 60 kg ≥ 60 kg
Piż tal- pazjent < 60 kg ≥ 60 kg