qanastek/EMEA-V3 huggingface dataset:
6.1 List of excipients povidone K29/ 32 sodium starch glycolate type A glucose liquid, spray dried erythrosine (E127) titanium dioxide (E171) aspartame (E951) tutti frutti flavour (contains sorbitol) carmellose sodium hydroxyethylcellulose.
povidone K29/ 32 sodium starch glycolate type A glucose liquid, spray dried erythrosine (E127) titanium dioxide (E171) aspartame (E951) tutti frutti flavour (contains sorbitol) carmellose sodium hydroxyethylcellulose.
6.4 Special precautions for storage Store in the original package, in order to protect from light.
6. 4 Prekawzjonijiet speċjali għall- ħażna
6.5 Nature and contents of container
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mid- dawl;
Sachets are made with a composite paper/ aluminium/ polyethylene film.
Il- qratas huma magħmula minn rita ta ’ karta/ aluminju/ polyethylene komposta.
Boxes of 30, 60 and 90 sachets.
Kaxex ta ’ 30, 60 u 90 qartas.
MARKETING AUTHORISATION HOLDER
Biocodex, 7 Avenue Gallieni, 94250 Gentilly, Franza.
EU/ 1/ 06/ 367/ 007-9
EU/ 1/ 06/ 367/ 007- 09
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI 04/ 01/ 2007 -
Diacomit 500 mg powder for oral suspension in sachets.
Diacomit 500 mg trab għal sospensjoni orali fi qratas.
Each sachet contains 500 mg of stiripentol
Kull qartas fih 500 mg ta ’ stiripentol
0.22 mg sodium per sachet.
0. 22 mg sodju kull qartas.
Each sachet contains 5mg of aspartame, 1000mg of glucose liquid spray and 4.8 mg of sorbitol.
Kull qartas fih 5mg ta ’ aspartame, 1000mg ta ’ likwidu ta ’ glukożju u 4. 8 mg ta ’ sorbitol.
30 4.4 Special warnings and precautions for use
31 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Effect of stiripentol on cytochrome P450 enzymes.
32 L- effett ta ’ stiripentol fuq enżimi ta ’ cytochrome P450.
31 At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2D6 and CYP3A4.
F’ konċentrazzjonijiet terapewtiċi, stiripentol jinibixxi sinifikattivament bosta iżoenzimi CYP450, per eżempju, CYP2C19, CYP2D6 u CYP3A4.
These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in side effects and adverse reactions.
Dawn l- interazzjonijiet jistgħu jirriżultaw fl- livelli sistemiċi miżjuda ta ’ dawn is- sustanzi attivi li jistgħu jirriżultaw f’ effetti farmakoloġiċi mqawwija u għal żieda fl- effetti mhux mixtieqa u reazzjonijiet avversi.
Caution must be exercised if clinical circumstances require combining stiripentol with drugs metabolised by CYP2C19 (e. g. citalopram, omeprazole) or CYP3A4 (e. g. several HIV protease inhibitors, antihistamines, astemizole, chlorpheniramine, calcium channel blockers, statins, oral contraceptives, codeine) due to the increased risk of adverse events (see further in this section for antiepileptic drugs).
Għandha tintuża l- kawtela jekk ċirkostanzi kliniċi jeħtieġu li stiripentol jiġi kkombinat ma ’ mediċini metabolizzati minn CYP2C19 (e. ż. citalopram, omeprazole) jew CYP3A4 (e. ż. inibituri HIV protease, antistaminiċi bħal astemizole, chlorpheniramine, imblokkaturi tal- kanali tal- kalċju, statins, kontraċettivi orali, kodeina) minħabba r- riskju akbar ta ’ reazzjonijiet avversi (ara aktar f’ din is- sezzjoni għal mediċini antiepilettiċi).
Monitoring of plasma concentrations or adverse effects is recommended.
Sorveljanza tal- konċentrazzjonijiet tal - plażma jew effetti avversi hija rrakkomandata.
Potential for stiripentol to interact with other medicinal products
Il- potenzjal għal stiripentol li jaffettwa prodotti mediċinali oħra
In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
Fin- nuqqas ta ’ dejta klinika disponibbli, għandha tittieħed il- kawtela ma ’ l- interazzjonijiet klinikament relevanti li ġejjin ma ’ stiripentol:
Undesirable combinations (to be avoided unless strictly necessary)
Kombinazzjonijiet mhux mixtieqa (li għandhom jiġu evitati kemm- il darba mhux strettament meħtieġ) - - Alkalojdi ergot tas- segala (ergotamine, dihydroergotamine) Ergotiżmu b’ possibbilità ta ’ nekrożi ta ’ l- estremitajiet (inibizzjoni ta ’ l- eliminazzjoni epatika ta ’ ergot tas- segala).
Combinations requiring precautions
33 Kombinazzjonijiet li jinħtieġu prekawzjonijiet
During pregnancy:
34 Waqt it- tqala::
33 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Patients with SMEI would not be expected to drive or operate machinery due to the nature of the underlying disease and the effects of long term administration of anticonvulsant drugs.
Pazjenti b’ SMEI m’ għandhomx ikunu mistennija li jsuqu jew iħaddmu inġenji minħabba n- natura tal - marda eżistenti u l- effetti ta ’ amministrazzjoni ta ’ mediċini kontra l- aċċessjonijiet fuq tul ta ’ żmien.
Diacomit may cause dizziness and ataxia that may affect ability to drive and use machines and patients should not drive or use machinery whilst on Diacomit therapy.
Diacomit jista ’ jikkaġuna sturdament u atassja li tista ’ teffettwa l- ħila li ssuq u li tuża l- inġenji u l - pazjenti m’ għandhomx isuqu jew jużaw inġenji waqt terapija b’ Diacomit
Nausea, vomiting
Nawsia, rimettar
Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p < 0.0001.
Il- persentaġġ ta ’ bidla mill- linja bażi kien ogħla fuq
The following pharmacokinetic properties of stiripentol have been reported from studies in adult healthy volunteers and adult patients.
Il- proprjetajiet farmakokinetiċi li ġejjin dwar stiripentol ġie rraportat minn studju fuq voluntiera adulti u pazjenti adulti.
35 Distribution:
Distribuzzjoni:
povidone K29/ 32 sodium starch glycolate type A glucose liquid, spray dried erythrosine (E127) titanium dioxide (E171) aspartame (E951) tutti frutti flavour (contains sorbitol) carmellose sodium hydroxyethylcellulose.
povidone K29/ 32 sodium starch glycolate type A glucose liquid, spray dried erythrosine (E127) titanium dioxide (E171) aspartame (E951) tutti frutti flavour (contains sorbitol) carmellose sodium hydroxyethylcellulose.
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mid- dawl..
6.6 Special precautions for disposal and other handling
38 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
04 January 2007 Date of latest renewal:
04/ 01/ 2007 -
37 ANNEX II
39 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Ċ OBBLIGAZZJONIJIET SPEĊIFIĊI — TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
Laboratoires BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANCE
Laboratoires BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANZA
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza qegħda f’ postha qabel mal- prodott jitqiegħed fis- suq u sakemm il- prodott jibqa ’ jintuża.
Risk Management plan
Pjan ta ’ Ġestjoni dwar ir- Riskju
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jimpenja ruħu li jagħmel l- istudji u l - attivitajiet ta ’ farmakoviġilanza kif 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 ta ’ Ġestjoni dwar ir- Riskju aġġornata għandha tiġi provduta skond il- Linji Gwida tas- CHMP dwar Sistemi ta ’ Ġestjoni dwar ir- Riskju għal prodotti mediċinali għal użu fuq il- bniedem.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Ċ OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the study within the specified time frame.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jtemm l- istudju fiż- żmien speċifikat.
The results of which shall be taken into account in the risk benefit balance during the assessment of the application for a renewal:
Ir - riżultati ta 'dawn l- istudju għandhom iservu ta' bażi għall- istima tal- profil bejn il- benefiċċju/ riskju waqt l- assessjar ta ’ l- applikazzjoni tat- tiġdid:
A multicentre randomised controlled trial comparing topiramate, stiripentol and clobazam as adjunctive therapy to valproate and clobazam in paediatric patients with Dravet’ s syndrome (SMEI) not adequately controlled with clobazam and valproate, and auxiliary pharmacogenetic study by 2010 (STP 167).
Prova randomised multiċentrali b’ kontrolli li tqabbel topiramate, stiripentol u clobazam bħala terapija aġġuntiva ma ’ valproate u clobazam f’ pazjenti pedjatriċi b’ sindromu ta ’ Dravet (SMEI) mhux adegwatament ikkontrollat b’ clobazam u valproate u studju farmakoġenetiku awżiljari sa l- 2010 (STP 167)
39 ANNEX III
41 ANNESS III
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
TAL- KARTUN
Diacomit 250 mg capsules Stiripentol
Diacomit 250 mg kapsuli Stiripentol
1 capsule contains 250 mg stiripentol.
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA 1 kapsula fiha 250 mg stiripentol.
0.16 mg sodium per capsule
0. 16 mg sodju għal kull kapsula.
30 hard capsules 60 hard capsules 90 hard capsules
30 kapsuli iebsin 60 kapsuli iebsin 90 kapsuli iebsin
These capsules should be swallowed whole with water.
Dawn il- kapsuli għandhom jinbelgħu sħaħ ma 'l- ilma.
The capsules should not be chewed.
Il- kapsuli m' għandhomx jiġu mimgħuda.
EXP.:
JIS.
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
BIOCODEX 7 avenue Gallieni 94250 Gentilly France Tel: + 33 1 41 24 30 00 e-mail: webar@biocodex. fr
BIOCODEX 7 avenue Gallieni 94250 Gentilly – Franza Tel: + 33 1 41 24 30 00 e- mail: webar@ biocodex. fr
EU/ 1/ 06/ 367/ 001 30 capsules EU/ 1/ 06/ 367/ 002 60 capsules EU/ 1/ 06/ 367/ 003 90 capsules
EU/ 1/ 06/ 367/ 001 30 kapsuli iebsin EU/ 1/ 06/ 367/ 002 60 kapsuli iebsin EU/ 1/ 06/ 367/ 003 90 kapsuli iebsin
Lot:
Lott.
Diacomit 250 mg capsules
DIACOMIT 250 mg kapsuli
43 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL TEXT
FLIEXKEN TAL- PLASTIK
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Diacomit 500 mg capsules Stiripentol
Diacomit 500 mg kapsuli Stiripentol
1 capsule contains 500 mg stiripentol.
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA 1 kapsula fiha 500 mg stiripentol.
0.32 mg sodium per capsule.
0. 32 mg sodju għal kull kapsula.
EU/ 1/ 06/ 367/ 004 30 capsules EU/ 1/ 06/ 367/ 005 60 capsules EU/ 1/ 06/ 367/ 006 90 capsules
EU/ 1/ 06/ 367/ 004 30 kapsuli iebsin EU/ 1/ 06/ 367/ 005 60 kapsuli iebsin EU/ 1/ 06/ 367/ 006 90 kapsuli iebsin
Diacomit 500 mg capsules
DIACOMIT 500 mg kapsuli
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Diacomit 250 mg powder for oral suspension Stiripentol
Diacomit 250 mg trab għal suspensjoni orali Stiripentol
1 sachet contains 250 mg stiripentol.
Qartas 1 fih 250 mg stiripentol
Aspartame (E951) Sorbitol Glucose liquid spray dried 0.11 mg sodium per sachet
Aspartame (E951), Sorbitol, sprej ta 'likwidu tal- Glucose mnixxef, 0. 11 mg sodju kull borża.
30 sachets, powder for oral suspension 60 sachets, powder for oral suspension 90 sachets, powder for oral suspension
30 borża, trab għal suspensjoni orali 60 borża, trab għal suspensjoni orali 90 borża, trab għal suspensjoni orali
The powder should be mixed in a glass of water and should be taken immediately after mixing during a meal.
It- trab għandu jiġi mħallat f' tazza ta 'l- ilma u għandu jittieħed immedjatament wara t- taħlita waqt ikla.
EU/ 1/ 06/ 367/ 007 30 sachets EU/ 1/ 06/ 367/ 008 60 sachets EU/ 1/ 06/ 367/ 009 90 sachets
EU/ 1/ 06/ 367/ 007 30 borża, trab għal suspensjoni orali EU/ 1/ 06/ 367/ 008 60 borża, trab għal suspensjoni orali EU/ 1/ 06/ 367/ 009 90 borża, trab għal suspensjoni orali
Diacomit 250 mg powder for oral suspension
DIACOMIT 250 mg trab għal sospensjoni orali
51 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL TEXT
QARTAS
Diacomit 250 mg powder for oral suspension Stiripentol For oral use.
Diacomit 250 mg trab għal suspensjoni orali Stiripentol
EXP.:
EXP.
250 mg stiripentol
250 mg stiripentol.
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Diacomit 500 mg powder for oral suspension Stiripentol
Diacomit 500 mg trab għal suspensjoni orali Stiripentol
1 sachet contains 500 mg stiripentol.
Qartas 1 fih 500 mg stiripentol
Aspartame (E951) Sorbitol Glucose liquid spray dried 0.22 mg sodium per sachet
Aspartame (E951), Sorbitol, sprej ta 'likwidu tal- Glucose mnixxef, 0. 22 mg sodju kull borża.
BIOCODEX 7 avenue Gallieni 94250 Gentilly France Tel: + 33 1 41 24 30 00 e-mail: webar@biocodex
BIOCODEX 7 avenue Gallieni 94250 Gentilly – Franza Tel: + 33 1 41 24 30 00 e- mail: webar@ biocodex. fr
EU/ 1/ 06/ 367/ 010 30 sachets EU/ 1/ 06/ 367/ 011 60 sachets EU/ 1/ 06/ 367/ 012 90 sachets
EU/ 1/ 06/ 367/ 010 30 borża, trab għal suspensjoni orali EU/ 1/ 06/ 367/ 011 60 borża, trab għal suspensjoni orali EU/ 1/ 06/ 367/ 012 90 borża, trab għal suspensjoni orali
Diacomit 500 mg powder for oral suspension
DIACOMIT 500 mg trab għal sospensjoni orali
54 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL TEXT
MATERJAL STAMPAT FUQ IT- TIKKETTA TAL- QARTAS
Diacomit 500 mg powder for oral suspension Stiripentol For oral use.
Diacomit 500 mg trab għal suspensjoni orali Stiripentol
500 mg stiripentol
500 mg stiripentol.
56 PACKAGE LEAFLET:
58 FULJETT TA ’ TAGĦRIF:
Diacomit 250 mg hard capsules Stiripentol Diacomit 500 mg hard capsules Stiripentol
Diacomit 250 mg kapsuli ebsin Stiripentol Diacomit 500 mg kapsuli ebsin Stiripentol
Read all of this leaflet carefully before your child starts taking this medicine.
Aqra sew dan il- fuljett kollu qabel ma t- tifel/ tifla tiegħek jibdew jużaw din il- mediċina.
If you have any further questions, ask your child’ s doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek.
This medicine has been prescribed for your child.
Din il- mediċina ġiet mogħtija lit- tifel/ tifla tiegħek.
It may harm them, even if their symptoms are the same as your child’ s.
Tista 'tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tat- tifel/ tifla tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’ s doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek.
What Diacomit is and what it is used for 2.
X' inhu Diacomit u għalxiex jintuża 2.
Before your child takes Diacomit 3.
Qabel ma t- tifel/ tifla tiegħek jieħdu Diacomit 3.
How to take Diacomit 4.
Kif għandek tieħu Diacomit 4.
Possible side effects 5 How to store Diacomit 6.
Effetti sekondarji li jista 'jkollu 5 Kif taħżen Diacomit 6.
WHAT DIACOMIT IS AND WHAT IT IS USED FOR
X' INHU DIACOMIT U GĦALXIEX JINTUŻA
Diacomit belongs to a group of medicines called antiepileptics.
Diacomit jappartjeni għal kategorija ta 'mediċini msejħa anti- epilettiċi.
It is used in conjunction with clobazam and valproate to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’ s syndrome), which affects children.
Huwa jintuża flimkien ma 'clobazam u valproate biex tiġi kkurata ċerta forma ta' epilessija msejħa epilessija mijoklonika akuta fl- infanzja (sindrome ta 'Dravet), li taffettwa lit- tfal.
Your child’ s doctor has prescribed this medicine to help treat your child’ s epilepsy.
It- tabib tat- tifel/ tifla tiegħek ordna din il- mediċina biex tgħin fil- kura ta 'l- epilessija tat- tifel/ tifla tiegħek.
It should always be taken in combination with other prescribed antiepileptic medicines under the direction of a doctor.
Hija għandha dejjem tittieħed flimkien ma 'mediċini anti- epilettiċi oħra ordnati taħt il- gwida ta' tabib.
BEFORE YOUR CHILD TAKES DIACOMIT
QABEL MA T- TIFEL/ TIFLA TIEGĦEK JIEĦDU DIACOMIT
Your child must NOT take Diacomit • if your child is allergic (hypersensitive) to stiripentol or to any of the other ingredients of Diacomit. • if your child has ever experienced attacks of delirium.
It- tifel/ tifla tiegħek M' GĦANDHOMX jieħdu Diacomit • jekk it- tifel/ tifla tiegħek huma allerġiċi għal stiripentol jew xi sustanzi oħra ta 'Diacomit. • jekk it- tifel/ tifla tiegħek xi darba esperjenzaw attakki ta' delirju
Take special care with Diacomit • if your child has kidney or liver problems. • if your child is using medicines containing:
Oqgħod attent ħafna b' Diacomit • jekk it- tifel/ tifla tiegħek għandhom problemi tal- kliewi jew tal- fwied. • jekk it- tifel/ tifla tiegħek qegħdin jużaw mediċini li fihom:
- cisapride (used to treat symptoms of night time heartburn);
- cisapride (użat biex jiġu kkurati sintomi tal- qrusa ta 'l- istonku bil- lejl);
- pimozide (used to treat the symptoms of Tourette's syndrome e. g. vocal outbursts and
- pimozide (użat biex jiġu kkurati s- sintomi tas- sindrome ta 'Tourette, eż. żbroffi vokali u mhux
uncontrolled, repeated movements of the body);
ikkontrollati, movimenti ripetuti tal- ġisem);
- ergotamine (used to treat migraine);
- ergotamine (użat għall- kura ta 'l- emigranja);
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to
- dihydroergotamine (użat biex jiġu mtaffija s- sinjali u s- sintomi ta 'kapaċita' mentali mnaqqsa
the aging process);
minħabba l- proċess tax- xjuħija);
- halofantrine (an antimalarial drug);
- halofantrine (mediċina kontra l- malarja);
- quinidine (used to treat abnormal heart rhythms);
- quinidine (użat għall- kura ta 'ritmi abnormali tal- qalb);
- bepridil (used to control chest pain);
- bepridil (użat għall- kontroll ta 'l- uġigħ fis- sider);
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart
- cyclosporine, tacrolimus, sirolimus (it- tlieta użati biex jinibixxu r- rifjut ta 'trapjanti tal- fwied,
transplants);
kliewi jew qalb);
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- statins (simvastatin and atorvastatin, it- tnejn użati biex inaqqsu l- ammont ta 'kolesterol fid -
• if your child uses one of the following products:
59 • jekk it- tifel/ tifla tiegħek jużaw wieħed mill- prodotti li ġejjin:
- antiepileptic medicines containing:
- mediċini anti- epilettiċi li fihom:
57 phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
- medicines containing:
- mediċini li fihom:
midazolam or triazolam (drugs used to reduce anxiety and sleeplessness – in combination with Diacomit they may make your child very sleepy); chlorpromazine (used for mental illness such as psychosis).
midazolam or triazolam (mediċini użati biex inaqqsu l- ansjeta 'u n- nuqqas ta' rqad – flimkien ma 'Diacomit dawn jistgħu jagħmlu lit- tifel/ tifla tiegħek bi ngħas ħafna); chlorpromazine (użat għal mard mentali bħall- psikosi).
- medicines, beverages and foods containing:
- mediċini, xorb u ikel li fihom:
caffeine or theophylline (these substances help restore mental alertness).
kafeina jew teofillina (dawn is- sustanzi jgħinu biex tintradd lura l- koxjenza mentali).
The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
L- użu ma 'Diacomit għandu jiġi evitat billi jista' jżid il- livelli tad- demm tagħhom, li jwassal għal disturbi diġestivi, taħbit tal- qalb mgħaġġel u nuqqas ta 'rqad.
Using other medicines If your child needs to use other medicines, please see above “ Take special care with Diacomit”.
Meta tuża mediċini oħra Jekk it- tifel/ tifla tiegħek ikollhom bżonn jużaw mediċini oħra, jekk jogħġbok ara fuq “ Oqgħod attent ħafna b' Diacomit ”.
Please tell your child’ s doctor or pharmacist if your child is using or has recently used any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek jekk dawn qegħdin jieħdu jew ħadu dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Taking Diacomit with food and drink Your child should take Diacomit with food, it should NOT be taken on an empty stomach.
Meta tieħu Diacomit ma ’ l- ikel u max- xorb It- tifel/ tifla tiegħek għandhom jieħdu Diacomit ma 'l- ikel, huwa M' GĦANDUX jittieħed fuq stonku vojt.
Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
TIĦUX Diacomit mal- ħalib jew ma 'prodotti tal- ħalib (jogurt, ġobon artab frisk, eċċ.), meraq tal - frott, xarbiet bil- gass jew ikel u xorb li fihom il- kafeina jew it- teofillina (pereżempju cola, ċikkulata, kafe', te u xarbiet ta 'l- enerġija).
Pregnancy During pregnancy, effective antiepileptic treatment must NOT be stopped.
Tqala Matul it- tqala, kura effettiva kontra l- epilessiji M' GĦANDHIEX tiġi mwaqqfa.
If your child may be or is pregnant, please ask your child’ s doctor for advice.
Jekk it- tifla tiegħek tista 'tkun jew hija tqila, jekk jogħġbok itlob il- parir tat- tabib tat- tifla tiegħek.
Ask your child’ s doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tat- tifla tiegħek qabel tieħu xi mediċina.
Breast-feeding Breast-feeding is not recommended during treatment with this medicine.
Treddigħ Mhux rakkomandat treddigħ matul il- kura b' din il- mediċina.
Driving and using machines This medicine may make your child feel sleepy.
Sewqan u tħaddim ta 'magni Din il- mediċina tista' tagħmel lit- tifel/ tifla tiegħek iħossuhom bi ngħas.
Your child should not use any tools, machines, ride or drive if affected in this way.
It- tifel/ tifla tiegħek m' għandhomx jagħmlu użu minn għodda jew iħaddmu magni, jirkbu jew isuqu jekk ikunu affettwati b' dan il- mod.
Check with your child’ s doctor.
Iċċekkja mat- tabib tat- tifel/ tifla tiegħek.
HOW TO TAKE DIACOMIT
KIF GĦANDEK TIEĦU DIACOMIT
Your child should always take these capsules exactly as your child’ s doctor has told you.
It- tifel/ tifla tiegħek dejjem għandhom jieħdu dawn il- kapsuli skond il- parir tat- tabib.
You should check with your child’ s doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l- ispiżjar tat- tifel/ tifla tiegħek jekk ikollok xi dubju.
Dosage The dose is adjusted by the doctor according to your child’ s condition, generally 50 mg per kg bodyweight and per day.
Dożaġġ It- tabib jaġġusta d- doża skond il- kondizzjoni tat- tifel/ tifla tiegħek, ġeneralment 50 mg għal kull kilogramm ta 'piż tal- ġisem kuljum.
How to take the Diacomit capsules These capsules should be swallowed whole with water.
Kif għandek tieħu l- kapsuli Diacomit Dawn il- pilloli għandhom jinbelgħu sħaħ ma 'l- ilma.
For food and drinks to be avoided, see the section “ Taking Diacomit with food and drink” above.
Għall - ikel u x- xorb li jridu jiġu evitati, ara s- sezzjoni “ Meta tieħu Diacomit ma 'l- ikel u max- xorb ” hawn fuq.
When to take Diacomit Your child should take this medicine two or three times a day at regular intervals as directed by your child’ s doctor.
60 Meta għandek tieħu Diacomit It- tifel/ tifla tiegħek għandhom jieħdu din il- mediċina darbtejn jew tliet darbiet kuljum f' intervalli regolari kif ordnat mit- tabib.
58 Dose adjustment Any increase in dose should be gradual over 3 days while the dose of the other antiepileptic medicine(s) is reduced at the same time.
Aġġustament fid- doża Kwalunkwe żieda fid- doża għandha tkun gradwali fuq 3 ijiem filwaqt li d- doża tal- mediċina( i) anti - epilettika( ċi) l- oħra tiġi mnaqqsa fl- istess ħin.
Your child’ s doctor will tell you the new dose of the other antiepileptic medicine(s).
It- tabib tat- tifel/ tifla tiegħek jgħidlek id- doża l- ġdida tal - mediċina( i) anti- epilettika( ċi) l- oħra.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child’ s doctor or pharmacist.
Jekk ikollok l- impressjoni li l- effett ta 'din il- mediċina huwa qawwi wisq jew dgħajjef wisq, kellem lit - tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek.
The dose will be adjusted by the doctor according to your child’ s condition.
Id- doża tkun aġġustata mit- tabib skond il- kondizzjoni tat - tifel/ tifla tiegħek.
Please consult your child’ s doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
Jekk jogħġbok ikkonsulta lit- tabib tat- tifel/ tifla tiegħek f' każ ta 'xi effetti sekondarji billi t- tabib jista' jkollu bżonn jaġġusta d- doża ta 'din il- mediċina u tal- mediċina( i) anti- epilettika( ċi) l- oħra.
There are slight differences between the Diacomit capsules and powder for oral suspension.
Hemm differenzi kemxejn żgħar bejn il- kapsuli Diacomit u t- trab għal suspensjoni orali.
If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor.
Jekk it- tfal tiegħek jkollhom kwalunkwe problema meta jinqalbu mill- kapsuli għat- trab għal suspensjoni orali jew viċi- versa, jekk jogħġbok għarraf lit- tabib tiegħek.
If your child takes more Diacomit than he or she should Contact your child’ s doctor if you know or think your child has taken more medicine than he or she should have.
Jekk it- tifel/ tifla tiegħek jieħdu Diacomit aktar milli suppost Ikkuntattja lit- tabib tat- tifel/ tifla tiegħek jekk taf jew taħseb li t- tifel/ tifla tiegħek ħadu mediċina aktar milli suppost.
If your child forgets to take Diacomit It is important that your child takes this medicine regularly at the same time each day.
Jekk it- tifel/ tifla tiegħek jinsew jieħdu Diacomit Importanti li t- tifel/ tifla tiegħek jieħdu din il- mediċina b' mod regolari fl- istess ħin kuljum.
If your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose.
Jekk it - tifel/ tifla tiegħek jinsew jieħdu doża, huma għandhom jeħduha malli tiftakar sakemm ma jkunx wasal il- ħin għad- doża li jmiss.
In that case carry on with the next dose as normal.
F' dak il- każ kompli bid- doża li jmiss bħas- soltu.
Your child should not take a double dose to make up for a forgotten individual dose.
It- tifel/ tifla tiegħek m' għandhomx jieħdu doża doppja biex ipattu għal kull doża li nsew jieħdu.
If your child stops taking Diacomit Your child must not stop taking this medicine unless the doctor tells you to.
Jekk it- tifel/ tifla tiegħek jieqfu jieħdu Diacomit It- tifel/ tifla tiegħek m' għandhomx jieqfu jieħdu din il- mediċina qabel ma jgħidlek it- tabib.
Stopping treatment suddenly can lead to an outbreak of seizures.
It- twaqqif tal- kura f' daqqa jista 'jwassal għal tifqigħa ta' aċċessjonijiet.
If you have any further questions on the use of this product, ask your child’ s doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tat - tifel/ tifla tiegħek.
Like all medicines, Diacomit can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Diacomit jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (more than one in 10 patients): • loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate); • insomnia (sleeplessness), drowsiness; • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (muscle disorders).
Effetti sekondarji komuni ħafna (aktar minn 1 minn kull 10 pazjenti): • telf ta 'l- aptit, tnaqqis fil- piż (speċjalment meta jingħata mal- mediċina anti- epilettika sodium valproate); • insomnja (nuqqas ta' rqad), ngħas; • atassja (inkapaċita 'li tikkoordina l- movimenti tal- muskoli), ipotonija (nuqqas ta' saħħa fil - muskoli), distonija (disturbi fil- muskoli).
Common side effects (between one in 100 patients and one in 10 patients): • raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate; • aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable); • sleep disorders (abnormal sleeping); • hyperkinesis (exaggerated movements); • nausea, vomiting; • a low number of a type of white blood cells.
Effetti sekondarji komuni (bejn 1 minn kull 100 pazjent u 1 minn kull 10 pazjenti): • livelli ogħla ta 'enzimi tal- fwied, speċjalment meta jingħata ma' xi waħda mill- mediċini anti - epilettiċi carbamazepine u sodium valproate; • aggressivita ', irritabilita', aġitazzjoni, eċċitabilita 'eċċessiva (stat ta' eċċitabilita 'mhux tas- soltu); • disturbi ta' l- irqad (irqad abnormali); • iperkinesi (movimenti esaġerati); • dardir, rimettar; • ammont baxx ta 'tip ta' ċelloli bojod tad- demm.
Uncommon side effects (between one in 1,000 patients and one in 100 patients): • double vision when used in combination with the antiepileptic medicine carbamazepine; • sensitivity to light; • rash, skin allergy, urticaria (pinkish, itchy swellings on the skin); • fatigue (tiredness).
61 Effetti sekondarji mhux komuni (bejn 1 minn kull 1, 000 pazjent u 1 minn kull 100 pazjent): • vista doppja meta jintuża flimkien mal- mediċina anti- epilettika carbamazepine; • sensittivita 'għad- dawl; • raxx, allerġija tal- ġilda, urtikarja (nefħiet roża li jġegħluk tħokk fuq il- ġilda); • għeja.
59 To eliminate these side effects, your child’ s doctor may have to change the dose of concomitant medicines, or the dosage of Diacomit.
Biex jelimina dawn l- effetti sekondarji, it- tabib tat- tifel/ tifla tiegħek jista 'jkollu bżonn jaġġusta d- doża ta' mediċini konkomitanti, jew id- doża ta 'Diacomit.
If any of these side effects persists or gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’ s doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jippersisti jew jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tat- tifel/ tifla tiegħek.
HOW TO STORE DIACOMIT
KIF TAĦŻEN DIACOMIT
• Keep out of the reach and sight of children. • Your child should not take Diacomit after the expiry date, which is stated on the label.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • It- tifel/ tifla tiegħek m' għandhomx jieħdu Diacomit wara d- data ta 'skadenza li tidher fuq it - tikketta.
The expiry date refers to the last day of that month. • Store in the original package, in order to protect from light..
Id- data ta 'skadenza tirreferi għall- aħħar ġurnata ta' dak ix- xahar. • Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
What Diacomit 250 mg contains • The active substance is stiripentol.
X' fih Diacomit 250 mg • Is- sustanza attiva hi stiripentol.
Each capsule contains 250 mg of stiripentol. • The other ingredients in this medicine are povidone K29/ 32, sodium starch glycolate type A and magnesium stearate. • The capsule shell is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).
Kull kapsula fiha 250 mg ta 'stiripentol. • Is- sustanzi l- oħra f' din il- mediċina huma povidone K29/ 32, sodium starch glycolate type A u magnesium stearate. • Il- qoxra tal- kapsula hija magħmula minn gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).
What Diacomit 500 mg contains • The active substance is stiripentol.
X' fih Diacomit 500 mg • Is- sustanza attiva hi stiripentol.
Each capsule contains 500 mg of stiripentol. • The other ingredients in this medicine are povidone K29/ 32, sodium starch glycolate type A and magnesium stearate. • The capsule shell is made of gelatin, titanium dioxide (E171).
Kull kapsula fiha 500 mg ta 'stiripentol. • Is- sustanzi l- oħra f' din il- mediċina huma povidone K29/ 32, sodium starch glycolate type A u magnesium stearate. • Il- qoxra tal- kapsula hija magħmula minn gelatin, titanium dioxide (E171).
What Diacomit 250 mg looks like and contents of the pack Diacomit 250mg capsules are pink.
Id- dehra ta 'Diacomit 250 mg u l- kontenut tal- pakkett Il- kapsuli ta' Diacomit 250 mg huma roża.
The capsules are supplied in plastic bottles containing 30, 60 and 90 capsules in cardboard cartons.
Il- kapsuli huma fornuti fi fliexken tal- plastik li jesgħu 30, 60 u 90 kapsula ġo pakketti tal- kartun.
Diacomit is also available as 500 mg capsules for oral use and 250 mg and 500 mg powder for oral suspension in sachets.
Diacomit huwa disponibbli wkoll bħala kapsuli ta '500 mg għal użu orali u 250 mg u 500 mg trab għal suspensjoni orali fi qratas.
What Diacomit 500 mg looks like and contents of the pack Diacomit 500mg capsules are white.
Id- dehra ta 'Diacomit 500 mg u l- kontenut tal- pakkett Il- kapsuli ta' Diacomit 500 mg huma bojod.
Diacomit is also available as 250 mg capsules for oral use and 250 mg and 500 mg powder for oral suspension in sachets.
Diacomit huwa disponibbli wkoll bħala kapsuli ta '250 mg għal użu orali u 250 mg u 500 mg trab għal suspensjoni orali fi qratas.
Marketing Authorisation Holder Biocodex 7 avenue Gallieni - 94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex. fr
Biocodex 7 avenue Gallieni - 94250 Gentilly – Franza
Manufacturer Biocodex 1 avenue Blaise Pascal - F-60000 Beauvais - France
Biocodex 1 avenue Blaise Pascal - F- 60000 Beauvais - Franza
60 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This medicine has been given “ conditional approval”.
Din il- mediċina ngħatat “ approvazzjoni b' kondizzjoni ”.
This means that there is more definitive evidence to come about this medicine for the treatment of this form of epilepsy when stiripentol is used in conjunction with clobazam and valproate.
Dan ifisser li trid tingħata aktar evidenza definittiva dwar din il- mediċina għall- kura ta 'din il- forma ta' epilessija meta stiripentol jintuża flimkien ma 'clobazam u valproate.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi l - informazzjoni l- ġdida dwar il- mediċina kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
Detailed information on this medicine is available on the European Medicine Agency (EMEA) website: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europea. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għal websites oħra dwar mard rari u kura.
61 PACKAGE LEAFLET:
63 FULJETT TA ’ TAGĦRIF:
Diacomit 250 mg powder for oral suspension in sachets Stiripentol Diacomit 500 mg powder for oral suspension in sachets Stiripentol
Diacomit 250 mg trab għal suspensjoni orali fi qratas Stiripentol Diacomit 500 mg trab għal suspensjoni orali fi qratas Stiripentol
Your child must NOT take Diacomit • if your child is allergic (hypersensitive) to stiripentol or to any of the other ingredients of Diacomit. • if your child has ever experienced attacks of delirium.
It- tifel/ tifla tiegħek M' GĦANDHOMX jieħdu Diacomit • jekk it- tifel/ tifla tiegħek huma allerġiċi għal stiripentol jew xi sustanzi oħra ta 'Diacomit. • jekk it- tifel/ tifla tiegħek xi darba esperjenzaw attakki ta' delirju.
- cisapride (used to treat symptoms of night time heartburn);
- cisapride (użat biex jiġu kkurati sintomi ta 'qrusa ta' l- istonku bil- lejl);
• if your child uses one of the following products:
64 • jekk it- tifel/ tifla tiegħek jużaw wieħed mill- prodotti li ġejjin:
62 phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
If your child has problems with certain ingredients of Diacomit (e. g. aspartame, glucose, sorbitol).
Jekk it- tifel/ tifla tiegħek għandhom problemi b' ċerti sustanzi ta 'Diacomit (eż. aspartame, glucose, sorbitol).
In this case, please see below: “ Important information about some of the ingredients of Diacomit”.
F' dan il- każ, jekk jogħġbok ara hawn isfel: “ Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Diacomit ”.
Using other medicines If your child needs to use other medicines, please see above “ Take special care with Diacomit”.
Meta tuża mediċini oħra Jekk it- tifel/ tifla tiegħek ikollhom bżonn jużaw mediċini oħra, jekk jogħġbok ara hawn fuq “ Oqgħod attent ħafna b' Diacomit ”.
Important information about some of the ingredients of Diacomit Contains a source of phenylalanine.
Fih sors ta 'phenylalanine.
May be harmful for people with phenylketonuria.
Jista 'jagħmel il- ħsara lil persuni b' phenylketonuria.
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 xi intolleranza għal xi tipi ta 'zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
Your child should always take the contents of each sachet exactly as your child’ s doctor has told you.
It- tifel/ tifla tiegħek dejjem għandhom jieħdu l- kontenut ta 'kull qartas skond il- parir tat- tabib.
63 How to take the Diacomit powder for oral suspension The powder should be mixed in a glass of water and should be taken immediately after mixing during the meal.
Kif għandek tieħu t- trab ta 'Diacomit għal suspensjoni orali It- trab għandu jiġi mħallat f' tazza ta' l- ilma u għandu jittieħed immedjatament wara t- taħlita waqt l - ikla.
For food and drinks to be avoided, see the section “ Taking Diacomit with food and drink” above.
Għall- ikel u x- xorb li jridu jiġu evitati, ara s- sezzjoni “ Meta tieħu Diacomit ma 'l- ikel u max - xorb ” hawn fuq.
When to take Diacomit Your child should take this medicine two or three times a day at regular intervals as directed by your child’ s doctor.
Meta għandek tieħu Diacomit It- tifel/ tifla tiegħek għandhom jieħdu din il- mediċina darbtejn jew tliet darbiet kuljum f' intervalli regolari kif ordnat mit- tabib.
Dose adjustment Any increase in dose should be gradual over 3 days while the dose of the other antiepileptic medicine(s) is reduced at the same time.
Aġġustament fid- doża Kwalunkwe żieda fid- doża għandha tkun gradwali fuq 3 ijiem filwaqt li d- doża tal- mediċina( i) anti - epilettika( ċi) l- oħra tiġi mnaqqsa fl- istess ħin.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA 'JKOLLU 4.
Very common side effects (more than one in 10 patients): • loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate); • insomnia (sleeplessness), drowsiness; • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (muscle disorders).
66 Effetti sekondarji komuni ħafna (aktar minn 1 minn kull 10 pazjenti): • telf ta 'l- aptit, tnaqqis fil- piż (speċjalment meta jingħata mal- mediċina anti- epilettika sodium valproate); • insomnja (nuqqas ta' rqad), ngħas; • atassja (inkapaċita 'li tikkoordina l- movimenti tal- muskoli), ipotonija (nuqqas ta' saħħa fil - muskoli), distonija (disturbi fil- muskoli).
Common side effects (between one in 100 patients and one in 10 patients): • raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate; • aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable); • sleep disorders (abnormal sleeping);
Effetti sekondarji komuni (bejn 1 minn kull 100 pazjent u 1 minn kull 10 pazjenti): • livelli ogħla ta 'enzimi tal- fwied, speċjalment meta jingħata ma' xi waħda mill- mediċini anti - epilettiċi carbamazepine jew sodium valproate; • aggressivita ', irritabilita', aġitazzjoni, eċċitabilita 'eċċessiva (stat ta' eċċitabilita 'mhux tas- soltu); • disturbi ta' l- irqad (irqad abnormali); • iperkinesi (movimenti esaġerati); • dardir, rimettar; • ammont baxx ta 'tip ta' ċelloli bojod tad- demm.
Uncommon side effects (between one in 1,000 patients and one in 100 patients): • double vision when used in combination with the antiepileptic medicine carbamazepine; • sensitivity to light; • rash, skin allergy, urticaria (pinkish, itchy swellings on the skin); • fatigue (tiredness).
Effetti sekondarji mhux komuni (bejn 1 minn kull 1, 000 pazjent u 1 minn kull 100 pazjent): • vista doppja meta jintuża flimkien mal- mediċina anti- epilettika carbamazepine; • sensittivita 'għad- dawl; • raxx, allerġija tal- ġilda, urtikarja (nefħiet roża li jġegħluk tħokk fuq il- ġilda); • għeja.
To eliminate these side effects, your child’ s doctor may have to change the dose of concomitant medicines, or the dosage of Diacomit.
Biex jelimina dawn l- effetti sekondarji, it- tabib tat- tifel/ tifla tiegħek jista 'jkollu bżonn jaġġusta d- doża ta' mediċini konkomitanti, jew id- doża ta 'Diacomit.
Each sachet contains 250 mg of stiripentol. • The other ingredients in this medicine are povidone K29/ 32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
Kull qartas fih 250 mg ta 'stiripentol. • Is- sustanzi l- oħra f' din il- mediċina huma povidone K29/ 32, sodium starch glycolate type A, likwidu tal- glucose (sprej imnixxef), erythrosine (E127), titanium dioxide (E171), aspartame (E951), togħma ta' tutti frutti (fiha s- sorbitol), carmellose sodium, hydroxyethylcellulose.
Each sachet contains 500 mg of stiripentol. • The other ingredients in this medicine are povidone K29/ 32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
Kull qartas fih 500 mg ta 'stiripentol. • Is- sustanzi l- oħra f' din il- mediċina huma povidone K29/ 32, sodium starch glycolate type A, likwidu tal- glucose (sprej imnixxef), erythrosine (E127), titanium dioxide (E171), aspartame (E951), togħma ta' tutti frutti (fiha s- sorbitol), carmellose sodium, hydroxyethylcellulose.
What Diacomit 250 mg looks like and contents of the pack This medicine is a pale pink powder supplied in sachets.
Id- dehra ta 'Diacomit 250 mg u l- kontenut tal- pakkett
Cartons contain either 30, 60, or 90 sachets.
Il- pakketti fihom 30, 60 jew 90 qartas.
Diacomit is also available as 250 mg and 500 mg capsules for oral use and 500 mg powder for oral suspension in sachets.
Diacomit huwa disponibbli wkoll bħala kapsuli ta '250 mg u 500 mg għal użu orali u 500 mg trab għal suspensjoni orali fi qratas.
What Diacomit 500 mg looks like and contents of the pack This medicine is a pale pink powder supplied in sachets.
Id- dehra ta 'Diacomit 500 mg u l- kontenut tal- pakkett Din il- mediċina hija trab roża mitfi fornut fi qratas.
Diacomit is also available as 250 mg and 500 mg capsules for oral use and 250 mg powder for oral suspension in sachets.
Diacomit huwa disponibbli wkoll bħala kapsuli ta '250 mg u 500 mg għal użu orali u 250 mg trab għal suspensjoni orali fi qratas.
Marketing Authorisation Holder Biocodex 7 avenue Gallieni - 94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex. fr
Biocodex 7 avenue Gallieni - 94250 Gentilly – Franza Tel: + 33 1 41 24 30 00 - e- mail: webar@ biocodex. fr
65 Manufacturer Biocodex 1 avenue Blaise Pascal - F-60000 Beauvais - France
Biocodex 1 avenue Blaise Pascal - F- 60000 Beauvais - Franza
0047 67 15 92 30 e-mail: firmapost@desitin. no
0047 67 15 92 30
London, 21 August 2008 Doc.
Londra, 21 ta ’ Awwissu 2008 Dok.
Questions and answers on the withdrawal of the marketing application for Diractin
Mistoqsija u tweġiba dwar l- irtirar tal- applikazzjoni għat- tqegħid fis- suq għal Diractin
International non-proprietary name (INN): ketoprofen
Denominazzjoni Komuni Internazzjonali (DKI): ketoprofen
On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
Fit- 23 ta ’ Lulju 2008, IDEA AG għarrfet uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) bl- intenzjoni li tirtira l- applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis - suq għal Diractin, għall- kura tas- sintomi ta ’ infjammazzjoni u uġigħ assoċjati ma ’ osteoartrite.
What is Diractin?
X’ inhu Diractin?
Diractin is a medicine that contains the active substance ketoprofen.
Diractin huwa mediċina li fiha s- sustanza attiva ketoprofen.
It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel.
Kellu jkun disponibbli bħala ġell li fih 22. 9 mg ta ’ ketoprofen għal kull gramma tal- ġel.
What was Diractin expected to be used for?
Għal x’ hiex kien mistenni li jintuża Diractin?
Diractin was expected to be used to treat the symptoms of inflammation and pain associated with osteoarthritis (a condition that causes swelling and pain in the joints).
Diractin kien mistenni li jintuża sabiex jikkura s- sintomi tal- infjammazzjoni u l- uġigħ assoċjati mal - osteoartrite (kundizzjoni li tikkawża nefħa u uġigħ fil- ġogi).
How is Diractin expected to work?
Kif huwa mistenni li jaħdem Diractin?
The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID).
Is- sustanza attiva f’ Diractin, ketoprofen, hija mediċina anti- infjammatorja mhux sterojde (NSAID).
It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Huwa mistenni li jaħdem billi jimblokka enzim imsejjaħ cyclo- oxygenase, li jipproduċi prostaglandins, sustanzi li huma involuti fil- proċess ta ’ infjammazzjoni.
By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis.
Billi jnaqqas il- produzzjoni ta ’ prostaglandins, Diractin huwa mistenni li jnaqqas l- infjammazzjoni u l- uġigħ ikkawżati minn osteoartrite.
In Diractin gel, the ketoprofen is contained in special, small, fatty particles (called ‘ Transfersomes’) that are expected to carry the ketoprofen through the skin and release it deep below the skin, where the inflammation in osteoarthritis occurs.
F’ ġell Diracten, il- ketoprofen jinsab f’ partikoli speċjali, żgħar u mxaħħmin (imsejħin ‘ Transfersomes ’) li huma mistennija li jġorru l- ketoprofen mill- ġilda u jirrilaxxawh ’ l ġewwa taħt il - ġilda, fejn isseħħ l- infjammazzjoni fl- osteoartrite.
What documentation did the company present to support its application to the CHMP?
X' dokumentazzjoni ppreżentat il- kumpanija għas- sostenn tal- applikazzjoni tagħha lis- CHMP?
The effects of Diractin were first tested in experimental models before being studied in humans.
L- effetti ta ’ Diractin ġew ittestjati għall- ewwel darba f’ mudelli sperimentali qabel ma ġew studjati fuq il- bniedem.