qanastek/EMEA-V3 huggingface dataset:
Lamictal 200 mg Tabletten zur Herstellung einer 200 mg Suspension zum Einnehmen
Suspension zum Einnehmen
GlaxoSmithKline α .ε .β .ε 266 Kifissias Ave 152 32 Halandri Athens Greece
GlaxoSmithKline α. ε. β. ε 266 Kifissias Ave 152 32 Halandri Athens Greċja
12 Greece
Greċja
Greece
14 Greċja
Dispersible/ Chewable Tablets
Pilloli li jinxterdu/ li tomgħodhom
13 Greece
Greċja
Greece
15 Greċja
MOM Park, Gesztenyes torony Hungary
MOM Park, Gesztenyes torony Ungerija
14 Hungary
Ungerija
Iceland
16 Islanda
15 Ireland
17 Irlanda
2 mg Dispersible Tablet
Pillola li tinxtered
Dispersible Tablets 5mg
5 mg
5 mg Dispersible Tablet
Pillola li tinxtered
Ireland
18 Irlanda
GlaxoSmithKline SpA Via Fleming 2 37135 Verona Italy
GlaxoSmithKline SpA Via Fleming 2 37135 Verona Italja
Italy
19 Italja
17 Italy
Italja
GlaxoSmithKline Latvia SIA Bruninieku iela 5 Riga LV-1001 Latvia
GlaxoSmithKline Latvia SIA Bruninieku iela 5 Riga LV- 1001 Latvja
2 mg dispersible tablets
2 mg dispersible tablets 2 mg
5 mg dispersible tablets
5 mg dispersible tablets 5 mg
25 mg dispersible tablets
25 mg dispersible tablets 25 mg
Latvia
20 Latvja
50 mg dispersible tablets
50 mg dispersible tablets 50 mg
100 mg dispersible tablets
100 mg dispersible tablets 100 mg
18 Lithuania
Litwanja
Lithuania
21 Litwanja
19 Lithuania
Litwanja
Luxembourg
22 Lussemburgu
20 Luxembourg
Lussemburgu
Luxembourg
23 Lussemburgu
Malta
24 Malta
Dispersible / Chewable Tablet
Pillola li tinxtered / li tomgħodha
22 The Netherlands
25 Olanda
GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo Norway
GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N- 0319 Oslo Norveġja
Norway
26 Norveġja
23 Norway
Norveġja
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS Renju Unit
Poland
27 Polonja
24 Poland
Polonja
Poland
28 Polonja
António Loureiro Borges 3 Arquiparque - Miraflores 1495 - 131 Algés Portugal
António Loureiro Borges 3 Arquiparque - Miraflores 1495 - 131 Algés Portugall
25 Portugal
Portugall
Portugal
29 Portugall
26 Portugal
Portugall
Portugal
30 Portugall
27 Portugal
Portugall
Romania
31 Romanija
25 mg
25 50 mg
Romania
Romanija
28 Romania
Romanija
Dispersible/ Chewable Tablet
Pillola li tinxtered / li tomgħodha
Romania
32 Romanija
Galvaniho 7/ A 82104 Bratislava Slovakia
Galvaniho 7/ A 82104 Bratislava Slovakkja
29 Slovakia
Slovakkja
Slovakia
33 Slovakkja
Ljubljana Knezov stradon 90 1000 Ljubljana Slovenia
Ljubljana Knezov stradon 90 1000 Ljubljana Slovenja
25 mg tablete 25 mg
25 mg tablete
Tablet
25 50 mg
Slovenia
34 Slovenja
30 Slovenia
Slovenja
Slovenia
35 Slovenja
GlaxoSmithKline S. A Severo Ochoa 2 28760 Tres Cantos Madrid Spain
GlaxoSmithKline S. A Severo Ochoa 2 28760 Tres Cantos Madrid Spanja
31 Spain
Spanja
Spain
36 Spanja
32 Sweden
Svezja
GlaxoSmithKline AB Box 516 169 29 Solna Sweden
GlaxoSmithKline AB Box 516 169 29 Solna Svezja
Sweden
Svezja
Sweden
37 Svezja
Soluble Tablet
Pillola li tinħall
33 Sweden
Svezja
Sweden
38 Svezja
United Kingdom
Renju Unit
Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom
Fil- kummerċ GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Renju Unit
34 United Kingdom
Renju Unit
United Kingdom
39 Renju Unit
35 United Kingdom
Renju Unit
United Kingdom
40 Renju Unit
36 United Kingdom
Renju Unit
United Kingdom
41 Renju Unit
37 United Kingdom
Renju Unit
United Kingdom
42 Renju Unit
38 United Kingdom
Renju Unit
39 ANNEX II
43 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL - KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA 'TAGĦRIF IPPREŻENTATI MILL- EMEA
40 SCIENTIFIC CONCLUSIONS
44 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LAMICTAL AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU GLOBALI TA 'L- EVALWAZZJONI XJENTIFIKA TA' LAMICTAL U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Lamotrigine (the active substance of Lamictal) is a well-known anti-epileptic agent approved for the treatment of epileptic seizures in most EU-member states on a National basis.
Lamotriġina (lamotrigine - is- sustanza attiva ta 'Lamictal) hija aġent antiepilettiku magħruf approvat għat - trattament ta' kriżijiet epilettiċi f' ħafna mill- Istati Membri ta 'l- UE fuq skala nazzjonali.
It is indicated as monotherapy as well as adjuvant therapy in partial seizures with or without secondary generalisation, primary generalised seizures and some specific seizure types.
Huwa indikat bħala monoterapija kif ukoll bħala terapija aġġuntiva (adjuvant) fil- kriżijiet parzjali li jista 'jkollhom ġeneralizzazzjoni sekondarja, fil- kriżijiet primarji ġeneralizzati u xi tipi speċifiċi ta' kriżijiet.
In addition Lamictal has been approved for use in bipolar patients in several EU member states except in the UK, Netherlands, France and Cyprus.
Barra minn hekk Lamictal ġie approvat għall- użu f' pazjenti bipolari f' ħafna Stati Membri ta 'l- UE ħlief fir- Renju Unit, fl - Olanda, fi Franza u f' Ċipru.
Apart from the indication in bipolar disorder the SPC of Lamictal in the different EU members show a large overlap.
Minbarra l- indikazzjoni fid- disturb bipolari l- SPC ta 'Lamictal fil- membri differenti ta' l- UE juru ħafna aspetti komuni.
Nevertheless differences exist with respect to the precise wording of the epilepsy indication, restriction of age-categories, seizure types, dose recommendations and interactions.
Madankollu jeżistu differenzi fil- formulazzjoni ta 'l- indikazzjoni ta' l- epilessija, ir - restrizzjoni tal- kategoriji relatati ma 'l- età, it- tipi ta' kriżijiet, id- dożi rakkomandati u l- interazzjonijiet.
Hence an article 30 procedure (Directive 2001/ 83/ EC) for harmonisation of the SPC of lamotrigine across Europe has been initiated by the Marketing Authorisation Holder.
Għalhekk inbdiet proċedura skond l- Artikolu 30 (Direttiva 2001/ 83/ KE) għall- armonizzazzjoni ta 'l- SPC ta' lamotriġina fl- Ewropa mill- MAH.
This referral is undertaken following concerns related to divergent decisions on approval of the bipolar indication for lamotrigine across EU Member States.
Dan ir- riferiment qiegħed isir b' konsegwenza ta 'tħassib relatat ma' deċiżjonijiet diverġenti dwar l- approvazzjoni ta 'l- indikazzjoni bipolari għal lamotriġina fl- Istati Memberi ta' l- UE.
The main areas of disharmony of the existing Summary of Product Characteristics concerned the Therapeutic Indications.
Id- diskrepanzi ewlenin fis- Sommarju tal- Karatteristiċi tal- Prodott eżistenti huma relatati ma 'l - Indikazzjonijiet Terapewtiċi.
In addition, the assessment of quality issues has led to the harmonisation of the pharmaceutical forms (tablet and dispersible/ chewable tablet) across the EU.
Barra minn hekk, il- valutazzjoni ta 'l- aspetti ta' kwalità wasslet għall- armonizzazzjoni tal- forom farmaċewtiċi (pilloli u pilloli jinħallu/ jintmagħdu) fl- UE.
“ Adults and children above 12 years {Tradename} is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
"Adulti u tfal ta '' l fuq minn 12- il sena {Isem kummerċjali} huwa indikat għall- użu bħala terapija aġġuntiva jew monoterapija fit- trattament ta 'l - epilessija, għal kriżijiet parzjali u ġeneralizzati, inklużi l- kriżijiet toniko- kloniċi u l- kriżijiet assoċjati mas - Sindromu Lennox- Gastaut".
The age range will be modified to reflect the ages for which supporting data are available, adults and patients aged 13 years and older (adolescents).
Il- faxxa ta 'l- età sejra tiġi modifika biex tirrifletti l- etajiet li għalihom huwa disponibbli tagħrif ta' sostenn, adulti u pazjenti ta '13- il sena u iktar (adolexxenti).
Monotherapy in Lennox-Gastaut Syndrome is rarely achievable, as usually more than one medicinal product is needed to control the symptoms.
Fis- Sindromu Lennox- Gastaut il- monoterapija rarament tkun tista 'tintlaħaq, għax ġeneralment ikun jeħtieġ aktar minn prodott mediċinali wieħed biex jikkontrolla s- sintomi.
The indication will specify that the target population is “ Adults and adolescents aged 13 years and above”.
L- indikazzjoni tispeċifika li l- popolazzjoni fil- mira hija "Adulti u adolexxenti minn 13- il sena 'l fuq".
“ Children 2 to 12 years {Tradename} is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
"Tfal ta 'bejn sentejn u 12- il sena {Isem kummerċjali} huwa indikat bħala terapija aġġuntiva fit- trattament ta' l- epilessija, għal kriżijiet parzjali u ġeneralizzati inklużi l- kriżijiet toniko- kloniċi u l- kriżijiet assoċjati mas- Sindromu Lennox- Gastaut".
The age range will be modified considering that patients aged 12 years fall within the definition of adolescents.
Il- faxxa ta 'l- età sejra tiġi modifikata meta wieħed jikkunsidra li pazjenti ta' 12- il sena jaqgħu taħt id - definizzjoni ta 'adolexxenti.
Efficacy as monotherapy treatment of typical absence seizures was demonstrated.
Intweriet effikaċja bħala trattament monoterapewtiku tal- kriżi ta 'assenza tipika (typical absence seizures).
The indication will specify that the target population is “ Children and adolescents aged 2 to 12 years“.
L- indikazzjonijiet jispeċifikaw li l- popolazzjoni fil- mira hija "Tfal u adolexxenti ta 'bejn sentejn u 12- il sena".
“ After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on {Tradename} monotherapy”.
"Wara li jkun intlaħaq kontroll epilettiku waqt it- terapija aġġuntiva, mediċini antiepilettiċi konkomitanti (AEDs) ikunu jistgħu jiġu rtirati u l- pazjenti jitkomplew fuq monoterapija bi {Isem kummerċjali}".
The CHMP concluded that conversion to monotherapy is not an indication but information on correct use of the product.
Is- CHMP ikkonkluda li l- qlib għal monoterapija mhijiex indikazzjoni, iżda tagħrif dwar l- użu korrett tal - prodott.
This text should be therefore moved to section 4.2, Posology and method of administration.
Dan it- test għandu għalhekk jitressaq għas- sezzjoni 4. 2, Pożoloġija u metodu ta 'kif jingħata.
41 Bipolar disorder
45 Disturb bipolari
“ Adults 18 years and above {Tradename} is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes”.
"Adulti minn 18- il sena 'l fuq {Isem kummerċjali} huwa indikat għall- prevenzjoni ta' episodji ta 'burdati f' pazjenti li jbatu minn disturb bipolari, predominantament bil- prevenzjoni ta' episodji depressivi".
The CHMP was of the opinion that lamotrigine is effective in preventing one aspect of mood episodes in Bipolar disorder, depressive episodes, while prevention of manic or hypomanic episodes has not been proven.
Is- CHMP kien tal- fehma li lamotriġina hija effikaċi fil- prevenzjoni ta 'aspett wieħed biss ta' l- episodji tal - burdata fid- disturb bipolari, episodji depressivi, filwaqt li l- prevenzjoni ta 'episodji ta' manija jew ta 'ipomanija ma ġewx ippruvati.
It should be also underlined that lamotrigine is not indicated for acute treatment.
Ta 'min li wieġed jenfasizza wkoll li lamotriġina mhijiex indikata għat - trattament akut.
The target population will be Bipolar I patients, as these patients were included in the clinical studies.
Il- popolazzjoni fil- mira sejra tkun rappreżentata minn pazjenti bipolari tat- tip I, billi dawn il- pazjenti ġew inklużi fl- istudji kliniċi.
- Quality aspects
- Aspetti tal- kwalità
The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Is- sustanza mediċinali u l- prodott mediċinali ġew deskritti b' mod xieraq u ġeneralment ġiet ipprovduta dokumentazzjoni sodisfaċenti.
The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
L- eċċipjenti użati fil- formulazzjonijiet tal- prodott mediċinali u tal- proċessi produttivi huma standard għall- forom farmeċewtiċi proposti.
The results indicate that the drug substance and drug product can be reproducibly manufactured.
Ir- riżultati jindikaw li s- sustanza mediċinali u l- prodott mediċinali jistgħu jiġu mmanifatturati b' mod riproduċibbli.
- Clinical aspects
- Aspetti kliniċi
The use of lamotrigine in the proposed harmonised indications has been generally well substantiated according to the available clinical data submitted by the Marketing Authorisation Holder.
L- użu ta 'lamotriġina fl- indikazzjonijiet armonizzati proposti ġeneralment kien sostanzjat tajjeb skond it - tagħrif kliniku diponibbli ppreżentat mill- MAH.
The benefit/ risk ratio of adjunctive treatment of partial and generalised seizures in adults and adolescents aged 13 years and above, was confirmed to be positive.
Il- bilanċ bejn il- benefiċċji u r- riskji ta 'trattament aġġuntiv tal- kriżijiet parzjali u ġeneralizzati fl- adulti u l - adolexxenti minn 13- il sena' l fuq, kien konfermat bħala wieħed pożittiv.
Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/ 89, UK74) reassure on the efficacy of lamotrigine on this seizure types.
Għalkemm il- MAH ma wettaqx studji speċifiċi b' lamotriġina użata esklussivament għall- monoterapija tal - kriżijiet toniko- kloniċi ġeneralizzati primarji, it- tagħrif mill- istudji kkontrollati dwar il- monoterapija inizjali (studji UK49/ 89, UK74) jagħti garanziji fuq l- effikaċja ta 'lamotriġina fuq dawn it- tipi ta' kriżijiet.
The benefit/ risk of lamotrigine as add-on treatment in primary generalised tonic clonic seizures in children is also considered favourable.
Il- bilanċ bejn il- benefiċċji u r- riskji ta 'Lamotriġina bħala trattament miżjud tal- kriżijiet kloniko- toniċi ġeneralizzati primarji fit- tfal huwa wkoll ikkunsidrat favorevoli.
Lennox-Gastaut Syndrome is a difficult to treat condition and monotherapy is rarely achieved.
Is- Sindromu Lennox- Gastaut huwa kundizzjoni li diffiċli biex tiġi ttrattata u rarament tintlaħaq b' monoterapija.
Treatment is initiated as monotherapy, but almost inevitably soon other antiepileptics will be added to control the symptoms.
It- trattament jinbeda bħala monoterapija, iżda kważi inevitabbilment jiżdiedu antiepilettiċi oħra biex jikkontrollaw is- sintomi.
There is no consensus on which drug should be used as initial treatment; however, the data analysed do not exclude that lamotrigine could be the initial agent.
Ma hemmx kunsens fuq liema mediċina għandha tintuża bħala trattament inizjali; madankollu, it- tagħrif analizzat ma jeskludix li lamotriġina jista 'jkun l- aġent inizjali.
The maintenance effect on typical absence seizures remains unclear, thus a warning will be included in the SPC stating that “ In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients”.
L- effett taż- żamma (maintenance effect) fuq il- kriżijiet ta 'assenza tipika jibqa' mhux ċar, għalhekk se tiġi inkluża twissija fl- SPC li tgħid li "Fit- tfal li jkunu qed jieħdu lamotriġina għat- trattament tal- kriżijiet ta 'assenza tipika, huwa possibbli li l- effikaċja ma tinżammx fil- pazjenti kollha".
Bipolar Disorder
Disturb bipolari
The CHMP was concerned about the suitability of lamotrigine used as mood stabiliser.
Is- CHMP kien imħasseb dwar kemm huwa xieraq li lamotriġina jintuża bħala stabilizzatur tal- burdata.
In fact, according to available data the mood stabilising property of lamotrigine appears to be due to the prevention of depressive episodes and not to the prevention of manic episodes.
Fil - fatt, skond it- tagħrif disponibbli, il- karatteristika li tistabbilizza l- burdata f' lamotriġina jidher li sseħħ minħabba l- prevenzjoni ta 'episodji depressivi u mhux minħabba l- prevenzjoni ta' episodji ta 'manija.
A mood stabilising claim implies the protection from both manic and depressive episodes.
Dikjarazzjoni ta 'stabilizzazzjoni tal- burdata timplika l- protezzjoni kemm minn episodji ta' manija kif ukoll minn dawk depressivi.
The prevention of recurrence of both type of episodes has not been shown for lamotrigine.
Il- prevenzjoni tat- tqanqil mill- ġdid taż- żewġ tipi ta 'episodji ma ntwerietx għal lamotriġina.
In addition, the patients studied were diagnosed with Bipolar I disorder; therefore the results of these studies may not be extrapolated to Bipolar II disorder.
Barra minn hekk, billi l- pazjenti li ħadu sehem fl- istudji kienu jbatu min disturb bipolari tat- tip I, ir- riżultati ta 'dawn l- istudji ma jistgħux jiġu estrapolati għad- disturb bipolari tat- tip II.
42 A CNS Scientific Advisory Group (SAG) was also consulted to advise the CHMP on Bipolar disorder and its treatment.
46 Barra minn dan, is- CHMP ikkuntattja Grupp ta 'Konsulenza Xjentifika (SAG) dwar l- SNC għal konsulenza dwar id- disturb bipolari u dwar it- trattament relatat.
Specifically, the SAG was asked to clarify the definition of a mood stabiliser and the need for a medicinal product to act on both poles of the disorders.
Speċifikament, l- SAG intalab ukoll jiċċara d - definizzjoni ta 'stabilizzatur tal- burdata u l- ħtieġa li prodott mediċinali jaġixxi fuq iż- żewġ estremi tad - disturbi.
Also, the current standard treatments for Bipolar disorder and the feasibility of monotherapy were discussed.
Barra minn hekk, ġew diskussi wkoll it- trattamenti standard attwali għad- disturb bipolari u l - fattibilità tal- monoterapija.
The group concurred that theoretically a mood stabiliser should be able to prevent both manic and depressive recurrences, the characteristic features of Bipolar Disorder, but as of now we do not possess such an ideal mood stabiliser.
Il- grupp irraġuna li teorikament stabilizzatur tal- burdata għandu jkun kapaċi jipprevjeni kemm episodji ta 'manija kif ukoll dawk depressivi, li huma karatteristiċi tad- disturb bipolari, iżda sa issa stabilizzatur tal - burdata ideali mhuwiex disponibbli.
Although the disorder is a heterogeneous disease with contrasting therapeutic needs, it was recognised that depressive aspect is the most worrying and a drug able to prevent depressive episodes is therefore of value.
Għalkemm id- disturb huwa marda eteroġenea bi ħtiġijiet terapewtiċi kontrastanti, ġie rikonoxxut li l- aspett depressiv bħala inkewtanti ħafna u għalhekk ikun utli li jkun hemm mediċina biex tipprevjeni episodji depressivi.
In the clinical practice, the approved drugs for Bipolar disorder generally need to be combined to achieve an acceptable control of the symptoms.
Fil- prattika klinika, il- mediċini approvati għad- disturb bipolari ġeneralment jeħtieġu jkunu kkombinati biex jinkiseb kontroll aċċettabbli tas- sintomi.
Monotherapy should be the most desirable achievement, as the safety concerns tend to be reduced when only one drug is used, but at the present it is rarely obtained.
Il- monoterapija għandha tkun l- aktar għan mixtieq, billi t- tħassib dwar is- sigurtà għandu t- tendenza li jonqsu meta tkun qed tintuża mediċina waħda biss, iżda fil- preżent il - monoterapija hija fattibbli f' każijiet rari biss.
Usually treatment is started as monotherapy; then if the control of the symptoms is not reached, other medicines are added based on the experience of the physician.
Ġeneralment, it- trattament jinbeda bħala monoterapija; imbagħad jekk ma jkunx hemm kontroll tas- sintomi, jiżdiedu mediċini oħra abbażi ta 'l- esperjenza tat- tabib.
The CHMP, taking into consideration the assessment of the studies and the recommendation of the SAG concluded that lamotrigine should be used for the prevention of depressive episode in patients with Bipolar I disorder who experience predominantly depressive episodes.
Is- CHMP, wara li kkunsidra l- valutazzjoni ta 'l- istudji u r- rakkomandazzjonijiet ta' l- SAG u kkonkluda li lamotriġina għandu jintuża għall- prevenzjoni ta 'episodji depressivi f' pazjenti li jbatu minn disturb bipolari tat- tip I li jkunu jesperjenzaw primarjament episodji depressivi.
As the efficacy has been demonstrated for prevention of recurrence only, lamotrigine is not indicated for the acute treatment of manic or depressive episodes.
Billi l- effikaċja ntweriet biss bħall - prevenzjoni ta 'attakki reċidivi, lamotriġina mhijiex indikata għat- trattament akut ta' l- episodji ta 'manija jew depressivi.
GROUNDS FOR AMENDMENT OF THE SUMMARYIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA 'TAGĦRIF
- The scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- riferiment kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, tat- tikketta u tal -
labelling and package leaflet.
fuljett ta 'tagħrif.
- The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta 'tagħrif proposti mid- Detenturi ta' l -
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee
Awtorizzazzjoni għat- Tqegħid fis- Suq ġew ivvalutati abbażi tad- diskussjoni xjentifika fi ħdan il- Kumitat
- The CHMP concluded that the data are supportive of the following indications:
- is- CHMP ikkonkluda li t- tagħrif jappoġġa l- indikazzjonijiet li ġejjin:
“ Epilepsy
"Epilessija
Adults and adolescents aged 13 years and above
Adulti u adolexxenti minn 13- il sena 'l fuq
- Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including
- It- trattament aġġuntiv jew monoterapewtiku tal- kriżijiet parzjali u tal- kriżijiet ġeneralizzati, inklużi
tonic-clonic seizures.
l- kriżijiet toniko- kloniċi.
- Seizures associated with Lennox-Gastaut syndrome.
- Kriżijiet relatati mas- sindromu ta 'Lennox- Gastaut.
Lamictal is given as adjunctive therapy
Lamictal jingħata bħala terapija aġġuntiva iżda
but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.
jista 'jkun il- mediċina antiepilettika inizjali (AED) użata għas- sindromu ta' Lennox- Gastaut.
Children and adolescents aged 2 to 12 years
Tfal u adolexxenti ta 'bejn sentejn u 12- il sena
- Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic
- Trattament aġġuntiv tal- kriżijiet parzjali u tal- kriżijiet ġeneralizzati, inklużi l- kriżjiet toniko- kloniċi
seizures and the seizures associated with Lennox-Gastaut syndrome.
u l- kriżijiet assoċjati mas- sindromu ta 'Lennox- Gastaut.
- Monotherapy of typical absence seizures.
- Monoterapija tal- kriżijiet ta 'assenza tipika (typical absence seizures).
Bipolar disorder
Disturb bipolari
Adults aged 18 years and above
Adulti minn 18- il sena 'l fuq
- Prevention of depressive episodes in patients with bipolar I disorder who experience
- Prevenzjoni ta 'episodji depressivi f' pazjenti b' disturb bipolari tat- tip I li jesperjenzaw episodji
predominantly depressive episodes (see section 5.1).
predominantament depressivi (ara s- sezzjoni 5. 1).
Lamictal is not indicated for the acute treatment of manic or depressive episodes”.
Lamictal mhuwiex indikat għat- trattament akut ta 'episodji ta' manija jew depressivi ".
43 the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lamictal and associated names (see Annex I).
47 Is- CHMP irrakkomanda l- emendar ta 'l- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq li, is- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta' tagħrif għalihom huma stabbiliti fl- Anness III għal Lamictal u l- ismijiet assoċjati (ara l- Anness I).
44 ANNEX III
48 ANNESS III
45 SUMMARY OF PRODUCT CHARACTERISTICS
49 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Lamictal and associated names (see Annex I) 25 mg tablets.
Lamictal u ismijiet assoċjati (ara l- Anness I) pilloli ta ’ 25 mg.
Lamictal and associated names (see Annex I) 50 mg tablets.
Lamictal u ismijiet assoċjati (ara l- Anness I) pilloli ta ’ 50 mg.
Lamictal and associated names (see Annex I) 100 mg tablets.
Lamictal u ismijiet assoċjati (ara l- Anness I) pilloli ta ’ 100 mg.
Lamictal and associated names (see Annex I) 200 mg tablets.
Lamictal u ismijiet assoċjati (ara l- Anness I) pilloli ta ’ 200mg.
Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets.
Lamictal u ismijiet assoċjati Lamictal u ismijiet assoċjati Lamictal u ismijiet assoċjati Lamictal u ismijiet assoċjati Lamictal u ismijiet assoċjati Lamictal u ismijiet assoċjati
Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets.
(ara l- Anness I) pilloli ta ’ 2mg li jixterdu / jiġu mimgħuda (ara l- Anness I) pilloli ta ’ 5mg li jixterdu / jiġu mimgħuda (ara l- Anness I) pilloli ta ’ 25mg li jixterdu / jiġu mimgħuda (ara l- Anness I) pilloli ta ’ 50mg li jixterdu / jiġu mimgħuda (ara l- Anness I) pilloli ta ’ 100mg li jixterdu / jiġu mimgħuda (ara l- Anness I) pilloli ta ’ 200mg li jixterdu / jiġu mimgħuda
[See Annex I - To be completed nationally]
(Ara l- Anness I – Biex timtela mill- pajjiż partikolari)
Each Lamictal 25 mg tablet contains 25 mg lamotrigine.
Kull pillola Lamictal 25 mg fiha 25 mg lamotrigine.
Each tablet contains 23.5 mg lactose.
Kull pillola fiha 23. 5 mg lattosju.
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Kull pillola Lamictal 50 mg fiha 50 mg lamotrigine.
Each tablet contains 46.9 mg lactose.
Kull pillola fiha 46. 9 mg lattosju.
Each Lamictal 100 mg tablet contains 100 mg lamotrigine.
Kull pillola Lamictal 100 mg fiha 100 mg lamotrigine.
Each tablet contains 93.9 mg lactose.
Kull pillola fiha 93. 9 mg lattosju.
Each Lamictal 200 mg tablet contains 200 mg lamotrigine.
Kull pillola Lamictal 200 mg fiha 200 mg lamotrigine.
Each tablet contains 109.0 mg lactose.
Kull pillola fiha 109. 0 mg lattosju.
Each Lamictal 200 mg dispersible/ chewable tablet contains 200 mg lamotrigine.
Kull pillola Lamictal 2 mg li tixtered/ tiġi mimgħuda fiha 2 mg lamotrigine Kull pillola Lamictal 5 mg li tixtered/ tiġi mimgħuda fiha 5 mg lamotrigine Kull pillola Lamictal 25 mg li tixtered/ tiġi mimgħuda fiha 25 mg lamotrigine Kull pillola Lamictal 50 mg li tixtered/ tiġi mimgħuda fiha 50 mg lamotrigine Kull pillola Lamictal 100 mg li tixtered/ tiġi mimgħuda fiha 100 mg lamotrigine Kull pillola Lamictal 200 mg li tixtered/ tiġi mimgħuda fiha 200 mg lamotrigine
Dispersible/ chewable tablet.
Pillola, Pillola li tixtered/ tiġi mimgħuda
25 mg tablets:
Pilloli ta ’ 25 mg:
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “ GSEC7” on one side and “ 25” on the other.
Ta ’ kulur isfar- kannella mitfi, b’ numru ta ’ faċċati, super- ellittiċi, immarkati “ GSEC7 ” fuq naħa u “ 25 ” fuq l - oħra
50 mg tablets:
Pilloli ta ’ 50 mg:
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “ GSEE1” on one side and “ 50” on the other.
Ta ’ kulur isfar- kannella mitfi, b’ numru ta ’ faċċati, super- ellittiċi, immarkati “ GSEE1 ” fuq naħa u “ 50 ” fuq l - oħra
100 mg tablets:
Pilloli ta ’ 100 mg:
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “ GSEE5” on one side and “ 100” on the other.
Ta ’ kulur isfar- kannella mitfi, b’ numru ta ’ faċċati, super- ellittiċi, immarkati “ GSEE5 ” fuq naħa u “ 100 ” fuq l- oħra
47 200 mg tablets:
51 Pilloli ta ’ 200 mg:
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “ GSEE7” on one side and “ 200” on the other.
Ta ’ kulur isfar- kannella mitfi, b’ numru ta ’ faċċati, super- ellittiċi, immarkati “ GSEE7 ” fuq naħa u “ 200 ” fuq l- oħra.
2 mg dispersible/ chewable tablets:
Pilloli ta ’ 2 mg li jixterdu/ jiġu mimgħuda:
White to off-white round tablet with a blackcurrant odour.
Pillola bajda jew tagħti fl- abjad b’ riħa ta ’ ribes.
One side has a bevelled edge and is marked “ LTG” above the number 2.
Naħa waħda ċċanfrinata u mmarkata “ LTG ” fuq in- numru 2.
The other side is marked with two overlapping super-ellipses at right angles.
In- naħa l- oħra mmarkata b’ żewġ super- ellissi li jirkbu waħda ’ ll- oħra f’ angli retti.
The tablets may be slightly mottled.
Il- pilloli jistgħu ikunu ttikkjati bi ftit kuluri.
5 mg dispersible/ chewable tablets:
Pilloli ta ’ 5 mg li jixterdu/ jiġu mimgħuda:
White to off-white, elongated, biconvex tablet with a blackcurrant odour, marked “ GS CL2” on one side and “ 5” on the other.
Pillola bajda jew tagħti fl- abjad, ġejja fit- tul, bi- konvessa b’ riħa ta ’ ribes, immarkata “ GS CL2 ” fuq naħa u “ 5 ” fuq l- oħra.
The tablets may be slightly mottled.
Il- pilloli jistgħu ikunu ttikkjati bil- kulur.
25 mg dispersible/ chewable tablets:
Pilloli 25 mg li jistgħu jixterdu/ jiġu mimgħuda:
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “ GSCL5” on one side “ 25” on the other.
Pillola bajda jew tagħti fl- abjad, b’ numru ta ’ faċċati, super- ellittika, u b’ riħa ta ’ ribes, immarkata “ GSCL5 ” fuq naħa u “ 25 ” fuq l- oħra.
The tablets may be slightly mottled.
Il- pilloli jistgħu ikunu ttikkjati bil - kulur.
50 mg dispersible/ chewable tablets:
Pilloli ta ’ 50 mg li jixterdu/ jiġu mimgħuda:
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “ GSCX7” on one side and “ 50” on the other.
Pillola bajda jew tagħti fl- abjad, b’ numru ta ’ faċċati, super- ellittika u b’ riħa ta ’ ribes, immarkata “ GSCX7 ” fuq naħa u “ 50 ” fuq l- oħra.
The tablets may be slightly mottled.
Il- pilloli jistgħu ikunu ttikkjati bil - kulur
100 mg dispersible/ chewable tablets:
Pilloli ta ’ 100 mg li jixterdu/ jiġu mimgħuda:
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “ GSCL7” on one side and “ 100” on the other.
Pillola bajda jew tagħti fl- abjad, b’ numru ta ’ faċċati, super- ellittika u b’ riħa ta ’ ribes, immarkata “ GSCL7 ” fuq naħa u “ 100 ” fuq l- oħra.
200 mg dispersible/ chewable tablets:
Pilloli ta ’ 200 mg li jixterdu/ jiġu mimgħuda:
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “ GSEC5” on one side and “ 200” on the other.
Pillola bajda jew tagħti fl- abjad, b’ numru ta ’ faċċati, super- ellittika, u b’ riħa ta ’ ribes, immarkata “ GSEC5 ” fuq naħa u “ 200 ” fuq l- oħra.
The tablets may be slightly mottled.
Il- pilloli jistgħu ikunu ttikkjati bil- kulur
Adults and adolescents aged 13 years and above
Adulti u adolexxenti minn 13- il sena ’ l fuq
- Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including
- Trattament addizzjonali jew monoterapetwiku ta ’ attakki parzjali u attakki ġeneralizzati, inklużi attakki
tonic-clonic seizures.
toniċi- kloniċi
- Seizures associated with Lennox-Gastaut syndrome.
- Attakki assoċjati mas- sindrome Lennox- Gastaut.
Lamictal is given as adjunctive therapy
Lamictal jingħata bħala trattament addizjonali imma
but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.
jista ’ jkun il- mediċina anti- eppilettika inizjali (AED) biex tibda ’ l- kura fis- sindrome Lennox- Gastaut.
Children and adolescents aged 2 to 12 years
Tfal u adolexxenti ta ’ minn sentejn sa 12- il sena
- Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic
- Trattament addizzjonali ta ’ attakki parzjali jew attakki ġeneralizzati, inklużi attakki
seizures and the seizures associated with Lennox-Gastaut syndrome.
toniċi- kloniċi u attakki assoċjati mas- sindrome Lennox- Gastaut.
- Monotherapy of typical absence seizures.
- Monoterapija ta ’ attakki ta ’ assenza tipika.
Bipolar disorder
Mard bipolari
Adults aged 18 years and above
Adulti ta ’ minn 18- il sena ’ l fuq
- Prevention of depressive episodes in patients with bipolar I disorder who experience
- Prevenzjoni ta ’ episodji depressivi f’ pazjenti b’ mard bipolari I li jgħaddu minn episodji ta ’ depressjoni
predominantly depressive episodes (see section 5.1).
predominanti (ara sezzjoni 5. 1)
Lamictal is not indicated for the acute treatment of manic or depressive episodes.
52 Lamictal m’ għandux jintuża għat- trattament akut ta ’ episodji manijaċi dew depressivi.
48 4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Lamictal tablets should be swallowed whole, and should not be chewed or crushed.
Il- pilloli Lamictal għandhom jinbelgħu sħaħ, u m’ għandhomx jiġu mimgħuda jew imfarrka.
Lamictal dispersible/ chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water.
Il- pilloli Lamictal li jixterdu jew jiġu mimgħuda li jiġu mimgħuda, imxerrda fi ftit ilma (kemm titgħatta l - pillola kollha) jew jinbelgħu sħaħ ma ’ ftit ilma.
If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.
Jekk id- doża kalkolata ta ’ lamotrigine (per eżempju fit- trattament ta ’ tfal b’ epilessija jew pazjenti b’ indeboliment tal- fwied) ma tkunx tagħmel daqs żewġ pilloli sħaħ, id- doża li għandha tingħata hi dik li tkun daqs in- numru iżgħar ta ’ pilloli sħaħ.
Restarting therapy
Bidu ta ’ terapija mill- ġdid
Prescribers should assess the need for escalation to maintenance dose when restarting Lamictal in patients who have discontinued Lamictal for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine (see section 4.4).
Min jikteb il- mediċina għandu jqis il- bżonn ta ’ żjieda għal doża li tkun meħtieġa meta Lamictal jerġa ’ jingħata lil pazjenti li jkunu waqfu milli jieħdu Lamictal għal xi raġuni, billi r- riskju ta ’ raxx qawwi hu assoċjat ma ’ dożi għolja fil- bidu li jeċċedu ż- żjieda ta ’ doża rakkomandata ta ’ lamotrigine (ara sezzjoni 4. 4).
The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose.
Aktar ma jkun twil l- intervall ta ’ ħin mill- aħħar doża, aktar għandu jitqies kemm għandha tkun iż- żjieda tad - doża li tkun meħtieġa.
When the interval since discontinuing lamotrigine exceeds five half-lives (see section 5.2), Lamictal should generally be escalated to the maintenance dose according to the appropriate schedule.
Meta l- intervall mill- aħħar li jkun ittieħed lamotrigine ikun jaqbeż ħames half- lives (ara sezzjoni 5. 2), Lamictal għandu ġeneralment jiżdied sa ma jilħaq id- doża meħtieġa skond l- iskeda li tkun tapplika.
It is recommended that Lamictal not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.
Hu rakkomandat li Lamictal m’ għandux jinbeda f’ pazjenti li jkunu waqqfuh minħabba raxx assoċjat ma ’ xi trattament ta ’ qabel b’ lamotrigine sakemm il- benefiċċju li jista ’ jinkiseb ma jkunx biċ- ċar aktar importanti mir- riskju.
The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below.
Iż- żjieda ta ’ doża u d- dożi meħtieġa rakkomandati għal adulti u adolexxenti ta ’ 13- il sena u aktar (Tabella 1) u għal tfal u adolexxenti ta ’ bejn is- 2 u t- 12- il sena (Tabella 2) jidhru hawn taħt.
Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).
Minħabba r- riskju ta ’ raxx id- doża tal- bidu u ż- żjieda sussegwenti tad- doża m’ għandhomx jiġi maqbuża (ara sezzjoni 4. 4).
When concomitant AEDs are withdrawn or other AEDs/ medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics (see section 4.5).
Meta xi AEDs oħra li jkunu qed jittieħdu flimkien jitwaqqfu jew meta xi AEDs/ prodotti mediċinali oħra jiżdiedu ma ’ trattamenti li jkun fihom lamotrigine, għandu jiġi meqjus x’ effett dan jista ’ jkollu fuq il - farmakokinetiċi ta ’ lamotrigine (ara sezzjoni 4. 5).
49 Table 1:
53 Tabella 1:
Adults and adolescents aged 13 years and above – recommended treatment regimen in epilepsy
Adulti u adolexxenti ta ’ minn 13- il sena ’ l fuq – metodu rakkomandat ta ’ trattament għal epilessija
Treatment regimen
Metodu ta ’ trattament
Weeks 1 + 2
Ġimgħat 1 + 2
Weeks 3 + 4
Ġimgħat 3 + 4
Usual maintenance dose
Doża normali meħtieġa
25 mg/ day (once a day)
25 mg/ kuljum (darba kuljum)
50 mg/ day (once a day)
50 mg/ kuljum (darba kuljum)
100 − 200 mg/ day (once a day or two divided doses)
100 − 200 mg/ kuljum (darba kuljum jew żewġ dożi maqsuma)
To achieve maintenance, doses may be increased by maximum of 50 - 100 mg every one to two weeks until optimal response is achieved
Biex tintlaħaq stabbilizzazzjoni, id- dożi jistgħu jiżdiedu sa massimu ta ’ 50 – 100 mg kull ġimgħa jew tnejn sakemm jintlaħaq l- aħjar rispons.
500 mg/ day has been required by some patients to achieve desired response
Xi pazjenti kienu jeħtieġu 500 mg/ kuljum biex jiksbu l- aħjar rispons.
This dosage regimen
Terapija addizzjonali B ’ valproate (impeditur ta ’ glukuronidazzjoni ta ’ lamotrigine – ara sezzjoni 4. 5):
should be used with valproate regardless of any
Dan il- metodu ta ’ dożaġġ għandu jintuża ma ’ valproate ikunu x’ ikunu l - prodotti mediċinali li jittieħdu fl- istess ħin.
To achieve maintenance, doses may be increased by maximum of 25 - 50 mg every one to two weeks until optimal response is achieved
12. 5 mg/ kuljum 25 mg/ kuljum 100 − 200 mg/ kuljum (darba kuljum jew (mogħtija f’ 25 (darba kuljum) maqsuma f’ żewġ dożi). mg darba iva u darba le) Biex jinkiseb il- livell ta ’ stabbilizzazzjoni meħtieġ, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 20- 50 mg kull ġimgħa jew tnejn sakemm jinkiseb l- aħjar rispons.
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
Terapija addizzjonali MINGĦAJR valproate u B’ indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
This dosage regimen should be used without valproate but with:
Dan id- dożaġġ għandu jintuża mingħajr valproate iżda bi: phenytoin carbamazepine phenobarbitone primidone rifampicin
100 mg/ day (two divided doses)
100 mg/ kulju m (żewġ dożi maqsuma)
increased by maximum of 100 mg every one to two weeks until optimal response is achieved
200 − 400 mg/ kuljum (żewġ dożi maqsuma) Biex jinkiseb il- livell ta ’ stabbilizzazzjoni meħtieġ, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 100 mg kull ġimgħa jew tnejn sakemm jinkiseb l- aħjar rispons
700 mg/ day has been required by some patients to achieve desired response
Xi pazjenti kienu jeħtieġu 700 mg/ kuljum biex jiksbu r- rispons mixtieq
This dosage regimen should be used with other medicinal products that do
Terapija addizzjonali MINGĦAJR valproate u MINGĦAJR indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5) Dan id- dożaġġ għandu jintuża ma ’ prodotti mediċinali oħra li mhumiex
100 − 200 mg/ day (once a day or two divided doses)
50 mg/ kuljum 100 − 200 mg/ kuljum (darba kuljum) (darba kuljum jew żewġ dożi maqsuma)
not significantly inhibit or induce lamotrigine glucuronidation
impedituri jew indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine
To achieve maintenance, doses may be increased by maximum of 50 - 100 mg every one to two weeks until optimal response is achieved
Biex jinkiseb livell ta ’ stabbilizzazzjoni tajjeb, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 50- 100 mg kull ġimgħa jew tnejn sakemm jinkiseb l- aħjar rispons
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.
F’ pazjenti li jkunu jieħdu prodotti mediċinali li għad mhux magħruf jekk il- farmakokinetiċi tagħhom ma ’ lamotrigine jaqblux jew le (ara sezzjoni 4. 5), għandu jintuża d- dożaġġ rakkomandat għal lamotrigine flimkien ma valproate.
50 Table 2:
54 Tabella 2:
Children and adolescents aged 2 to 12 years - recommended treatment regimen in epilepsy (total daily dose in mg/ kg body weight/ day)
Tfal u adolexxenti ta ’ minn sentejn sa 12- il sena – programm ta ’ dożaġġ rakkomandat għal epilessija (doża totali ta ’ kuljum f’ mg/ piż tal- ġisem/ kuljum
Usual maintenance dose
Doża biex jinkisbu livelli normali ta ’ stabbilizzazzjoni
Monotherapy of typical absence seizures:
Monoterapija ta ’ attakki tipiċi ta ’ assenza
0.3 mg/ kg/ day (once a day or two divided doses)
0. 3 mg/ kg/ kulju m (darba kuljum jew żewġ dożi maqsuma)
0.6 mg/ kg/ day (once a day or two divided doses)
0. 6 mg/ kg/ kulj um (darba kuljum jew żewġ dożi maqsuma)
1 – 10 mg/ kg/ day, although some patients have required higher doses (up to 15 mg/ kg/ day) to achieve desired response (once a day or two divided doses)
1 – 10 mg/ kg/ kuljum, għalkemm xi pazjenti kellhom bżonn ta ’ dożi akbar (sa 15 mg/ kg/ kuljum) biex jinkisbeb ir - rispons meħtieġ (darba kuljum jew żewġ dożi maqsuma)
To achieve maintenance, doses may be increased by maximum of 0.6 mg/ kg/ day every one to two weeks until optimal response is achieved Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation – see section 4.5):
Biex jinkisbu livelli tajba ta ’ stabbilizzazzjoni, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 0. 6 mg/ kg/ kuljum kull ġimgħa jew tnejn sakemm jinkiseb l- aħjar rispons Terapija addizzjonali B’ valproate (impeditur ta ’ glukuronidazzjoni ta ’ lamotrigine – ara sezzjoni 4- 5):
This dosage regimen should be used with valproate regardless of any
Dan il- programm ta ’
0.15 mg/ kg/ day* 0.3 mg/ kg/ day 1 − (once a day) (once a day)
0. 15 mg/ kg/ kulju 0. 3 mg/ kg/ kulj 1 − 5 mg/ kg/ kuljum (darba kuljum jew
5 mg/ kg/ day (once a day or two divided doses)
dożaġġ għandu jintuża ma ’ m * (darba valproate ikunu x’ ikunu kuljum) mediċini oħra li jkunu jittieħdu fl- istess ħin
other concomitant medicinal products
um (darba kuljum)
To achieve maintenance, doses may be increased by maximum of 0.3 mg/ kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200 mg/ day
żewġ dożi maqsuma) Biex jinkisbu livelli tajba ta ’ stabbilizzazzjoni, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 0. 3 mg/ kg / kull ġimgħa jew tnejn sakemm jinkiseb l - aħjar rispons, bl- ogħla doża għandha tkun 200 mg/ kuljum.
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
Terapija addizzjonali MINGĦAJR valproate B’ indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
This dosage regimen should be used without valproate but with:
Dan il- programm ta ’ dożaġġ għandu jintuża
0.6 mg/ kg/ day (two divided doses)
0. 6 mg/ kg/ kulju 1. 2 m (żewġ dożi
1.2 mg/ kg/ day 5 − 15 mg/ kg/ day (two divided (once a day or two divided doses) doses) To achieve maintenance, doses may be
mg/ kg/ kulj 5 − 15 mg/ kg/ kuljum (darba kuljum jew um (żewġ dożi żewġ dożi maqsuma)
phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ ritonavir
phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ ritonavir
increased by maximum of 1.2 mg/ kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400 mg/ day
stabbilizzazzjoni, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 1. 2 mg/ kg / kull ġimgħa jew tnejn sakemm jinkiseb l - aħjar rispons, bl- ogħla doża għandha tkun 400 mg/ kuljum.
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation
Dan il- programm ta ’
0.3 mg/ kg/ day (once a day or two divided doses)
0. 3 mg/ kg/ kulju 0. 6 mg/ kg/ kulj 1 – 10 mg/ kg/ kuljum (darba kuljum jew
0.6 mg/ kg/ day 1 − 10 mg/ kg/ day (once a day or (once a day or two divided doses) two divided doses) To achieve maintenance, doses may be increased by maximum of 0.6 mg/ kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200 mg/ day
Biex jinkisbu livelli tajba ta ’ stabbilizzazzjoni, id- dożi jistgħu jiżdiedu b’ massimu ta ’ 0. 6 mg/ kg / kull ġimgħa jew tnejn sakemm jinkiseb l - aħjar rispons, bl- ogħla doża biex jinkisbu l- aħjar riżultati ta ’ stabbilizzazzjoni tkun 200 mg/ kuljum.
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.
lamotrigine jaqblux jew le (ara sezzjoni 4. 5), għandu jintuża l- programm ta ’ dożaġġ rakkomandat għal lamotrigine flimkien ma valproate.
2 mg dispersible/ chewable tablets - where this is the lowest marketed strength: < * If the calculated daily dose in patients taking valproate is 1 mg or more but less than 2 mg, then Lamictal 2 mg dispersible/ chewable tablets may be taken on alternate days for the first two weeks.
55 Pilloli li jixterdu/ li jiġu mimgħuda ta ’ 2 mg – meta din tkun l- inqas qawwija fis- suq: < * Jekk id- doża kalkolata għal kuljum f’ pazjenti fuq il- valproate hi 1 mg jew aktar iżda inqas minn 2 mg, hemmhekk pilloli Lamictal ta ’ 2 mg li jixterdu/ jiġu mimgħuda jistgħu jittieħdu darba iva u oħra le għall - ewwel ġimgħatejn.
If the calculated daily dose in patients taking valproate is less than 1 mg, then Lamictal should not be administered. >
Jekk id- doża kalkolata għal kuljum f’ pazjenti fuq valproate tkun inqas minn 1 mg, hemmhekk Lamictal m’ għandux jingħata >.
51 5 mg dispersible/ chewable tablets - where 2 mg dispersible/ chewable tablets are not marketed and Lamictal 5 mg dispersible/ chewable tablets are the lowest marketed strength: < * If the calculated daily dose in patients taking valproate is 2.5 mg or more but less than 5 mg, then Lamictal 5 mg dispersible/ chewable tablets may be taken on alternate days for the first two weeks.
Pilloli li jixterdu/ jiġu mimgħuda ta ’ 5 mg – meta pilloli ta ’ 2 mg li jixterdu/ jiġu mimgħuda ma jkunux fis - suq u pilloli Lamictal ta ’ 5 mg li jistgħu jixterdu / jiġu mimgħuda huma l- inqas qawwija fis- suq: < * Jekk id- doża kalkolata għal kuljum f’ pazjenti fuq il- valproate hi 2. 5 mg jew aktar iżda inqas minn 5 mg, hemmhekk pilloli Lamictal ta ’ 5 mg li jixterdu/ jiġu mimgħuda jistgħu jittieħdu darba iva u oħra le għall - ewwel ġimgħatejn.
If the calculated daily dose in patients taking valproate is less than 2.5 mg, then Lamictal should not be administered. >
Jekk id- doża kalkolata għal kuljum f’ pazjenti fuq valproate tkun inqas minn 2. 5 mg, hemmhekk Lamictal m’ għandux jingħata >.
To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur.
Biex ikun żgurat li tinżamm doża terapewtika il- piż ta ’ tarbija għandu jiġi monitorjat u d- doża għandha tiġi riveduta skond il- bidliet fil- piż.
It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.
X’ aktarx li pazjenti ta ’ bejn is- sentejn u sitt snin ikollhom bżonn ta ’ doża ta ’ stabbilizzazzjoni fl- ogħla livell ta ’ l- iskala rakkomandata.
If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on Lamictal monotherapy.
Jekk jinkiseb kontroll epilettiku flimkien ma ’ trattament addizzjonali, AEDs konkomitanti jistgħu jitwaqqfu u l- pazjenti jistgħu ikomplu b’ monoterapija ta ’ Lamictal.