qanastek/EMEA-V3 huggingface dataset:
Tell your doctor if you are taking, or if you start or stop taking, any of these.
Għid lit- tabib tiegħek jekk tkun qed tieħu, jew li bdejt jew waqaft tieħu xi waħda minn dawn il - mediċini.
Hormonal contraceptives (such as the Pill) can affect the way Lamictal works Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil.
Kontraċettivi ormonali (bħall- Pillola) jistgħu ikollhom effett fuq kif jaħdem Lamictal It- tabib tiegħek għandu mnejn jirrakkomandalek li tuża xi tip partikolari ta ’ kontraċettiv ormonali, jew xi metodu ieħor ta ’ kontraċezzjoni, bħal kondoms, caps jew coils.
If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamictal.
Jekk qed tuża xi kontraċettiv ormonali bħal mhi l- Pillola, it- tabib tiegħek għandu mnejn jedħodlok xi kampjuni tad- demm biex jiċċekkja l- livell ta ’ Lamictal.
If you plan to start using a hormonal contraceptive:
Jekk tkun qed tippjana biex tibda tuża xi kontraċettiv ormonali:
Talk to your doctor, who will discuss suitable methods of contraception with you.
Kellem lit- tabib tiegħek, u dan itik pariri dwar xi metodi adattati ta ’ kontraċezzjoni għalik.
Lamictal can also affect the way hormonal contraceptives work, although it’ s unlikely to make them less effective.
Lamictal jista ’ wkoll jaffettwa l- mod kif jaħdmu l- kontraċettivi ormonali, għalkemm mhux probabbli li jagħmilhom inqas effettivi.
If you are using a hormonal contraceptive, and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods:
Jekk tkun tuża xi kontraċettiv ormonali, u tinduna b’ xi bidliet fil - menstruwazzjoni tiegħek, bħal xi ħruġ ta ’ demm mhux mistenni jew ‘ spotting ’ bejn ‘ period ’ u ieħor:
These may be signs that Lamictal is affecting the way your contraceptive is working.
Dawn jistgħu ikunu sinjali li Lamictal qed jaffettwa l- mod kif il- kontraċettiv qed jaħdem.
Pregnancy and breast feeding Talk to your doctor if you’ re pregnant, if you might be pregnant, or if you’ re planning to become pregnant.
Tqala u treddigħ Kellem lit- tabib tiegħek jekk int tqila, jekk tista ’ toħroġ tqila, jew jekk qed tippjana biex toħroġ tqila.
You should not stop treatment for your epilepsy while you’ re pregnant.
M’ għandekx twaqqaf it- trattament kontra l- epilessija meta tkun tqila.
However, there is an increased risk of birth defects in babies whose mothers took Lamictal during pregnancy.
Madankollu, hemm riskju akbar ta ’ difetti fi trabi li ommijiethom ikunu ħadu Lamictal waqt it- tqala.
These defects include cleft lip or cleft palate.
111 jew cleft palate.
Your doctor may advise you to take extra folic acid if you’ re planning to become pregnant and while you’ re pregnant.
It- tabib għandu mnejn jgħidlek biex tieħu aktar aċidu foliku jekk tkun qed tippjana biex toħroġ tqila u waqt li tkun fit- tqala.
Pregnancy may also alter the effectiveness of Lamictal, so your doctor may take samples of your blood to check the level of Lamictal, and may adjust your dose.
It- tqala tista ’ wkoll tibdel l- effettivita ’ ta ’ Lamictal, u għalhekk it- tabib għandu mnejn jieħu kampjuni ta ’ demmek biex jiċċekkja l- livell ta ’ Lamictal, u jista ’ jaġġustalek id- doża.
107 Talk to your doctor if you’ re breast feeding or planning to breast feed.
Kellem lit- tabib jekk tkun qed tredda ’ jew jekk bi ħsiebek tredda ’.
The active ingredient of Lamictal passes into breast milk and may affect your baby.
Is- sustanza attiva ta ’ Lamictal tgħaddi fil- ħalib tas- sider u tista ’ taffettwa t- tarbija tiegħek.
Your doctor will discuss the risks and benefits of breast feeding while you’ re taking Lamictal, and will check your baby from time to time if you decide to breast feed.
It- tabib tiegħek għandu jkellmek dwar ir- riskji u l- benefiċċji tat- treddigħ waqt li tkun fuq Lamictal, u jiċċekkja t- tarbija perjodikament jekk tiddeċiedi li tredda ’.
Driving and using machines Lamictal can cause dizziness and double vision.
Sewqan u tħaddim ta ’ makkinarju Lamictal jista ’ jikkawża xi sturdamenti u li tara doppju.
Don’ t drive or operate machines unless you are sure you’ re not affected.
Issuqx u tħaddimx makkinarju qabel ma tkun żgur li ma jaffettwakx.
If you have epilepsy, talk to your doctor about driving and using machines.
Jekk tbati bl- epilessija, kellem lit- tabib tiegħek dwar is- sewqan u l- użu ta ’ makkinarju.
Important information about some of the ingredients of Lamictal Lamictal tablets contain small amounts of a sugar called lactose.
Tagħrif importanti dwar xi ingredjenti ta ’ Lamictal Il- pilloli ta ’ Lamictal fihom ammonti żgħar ta ’ zokkor imsejjaħ lattosju.
If you have an intolerance to lactose or any other sugars:
Jekk għandek xi intolleranza għal - lattosju jew għal xi zokkor ieħor:
Tell your doctor, and don’ t take Lamictal.
Għarraf lit- tabib, u tieħux Lamictal.
HOW TO TAKE LAMICTAL
KIF GĦANDEK TIEĦU LAMICTAL
Always use Lamictal exactly as your doctor has told you to.
Dejjem uża Lamictal preċiżament kif jgħidlek it- tabib.
Check with your doctor or pharmacist if you’ re not sure.
Kellem lit- tabib jew lill- ispiżjar tiegħek jekk ma tkunx żgur.
How much Lamictal to take It may take a while to find the best dose of Lamictal for you.
Kemm għandek tieħu Lamictal Irid jgħaddi ftit taż- żmien qabel issir taf liema hi l- aħjar doża ta ’ Lamictal għalik.
The dose you take will depend on: • your age • whether you are taking Lamictal with other medicines • whether you have problems with your kidneys or liver.
Id- doża li tieħu tkun skond: • l- eta ’ tiegħek • jekk intix tieħu Lamictal ma ’ xi mediċini oħra • jekk għandekx xi problemi fil- kliewi jew fil- fwied.
Your doctor will start you on a low dose, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose).
It- tabib jibdielek b’ doża baxxa, u jżidielek bil- mod matul ftit ġimgħat sakemm jistabbilixxi d- doża li l- aktar tgħodd għalik (msejħa d- doża effettiva).
Never take more Lamictal than your doctor tells you to.
Qatt m’ għandek tieħu Lamictal aktar milli jgħidlek it- tabib.
The usual effective dose of Lamictal for adults and children aged over 12 years is between 100 mg and 400 mg each day.
Id- doża effettiva normali ta ’ Lamictal għal adulti u tfal ta ’ fuq it12- il sena hi ta ’ bejn 100 mg u 400 mg kuljum.
For children aged 2 to 12 years, the effective dose depends on their body weight — usually, it’ s between 1 mg and 15 mg for each kilogram of the child’ s weight, up to a maximum of 400 mg daily.
Fil- każ ta ’ tfal bejn sentejn u 12- il sena, id- doża effettiva tiddependi mill- piż tal- ġisem – normalment din tkun bejn 1 mg u 15 mg għal kull kilogramm li tiżen it- tarbija, sa massimu ta ’ 400 mg kuljum.
How to take your dose of Lamictal Tablets:
Kif għandek tieħu d- doża ta ’ Lamictal Pilloli:
Take your dose of Lamictal once or twice a day, as your doctor advises.
Ħu d- doża ta ’ Lamictal darba jew darbtejn kuljum, skond kif jgħidlek it- tabib.
You can take it with or without food.
Tista ’ teħodha ma ’ l- ikel jew anke mingħajr ikel.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you’ re being treated for and the way you respond to treatment. • Swallow your tablets whole.
It- tabib tiegħek jgħidlek jekk għandekx tibda jew twaqqaf xi mediċini oħra, dejjem skond il- kondizzjoni li għandek u l- mod ta ’ kif tkun sejra bit- trattament. • Ibla ’ l- pilloli sħaħ.
Don’ t break, chew or crush them. • Always take the full dose that your doctor has prescribed.
Taqsamhomx, terdagħhomx jew tfarrakhomx. • Dejjem ħu d- doża kollha li jagħtik it- tabib.
Never take only part of a tablet.
Qatt m’ għandek tieħu biċċa biss mill- pillola.
Dispersible/ chewable tablets:
112 Pilloli li jixterdu/ jiġu mimgħuda:
Take your dose of Lamictal once or twice a day, as your doctor advises.
Ħu d- doża ta ’ Lamictal li għandek tieħu darba jew darbtejn kuljum, skond ma jkun qallek it- tabib.
You can take it with or without food. • Always take the full dose that your doctor has prescribed.
Tista ’ teħodha ma ’ l- ikel jew mingħajr ikel. • Dejjem ħu d- doża sħiħa li jkun tak it- tabib.
Never take only part of a tablet.
Qatt m’ għandek tieħu biċċa biss ta ’ pillola.
108 Your doctor may also advise you to start or stop taking other medicines, depending on what condition you’ re being treated for and the way you respond to treatment.
It- tabib tiegħek jgħidlek jekk għandekx tibda jew twaqqaf xi mediċini oħra, dejjem skond il- kondizzjoni li għandek u l- mod ta ’ kif tkun sejra bit- trattament.
You can take Lamictal dispersible/ chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water:
Il- pilloli Lamictal < li jixterdu/ jiġu mimgħuda tista ’ tiblagħhom sħaħ ma ’ ftit ilma, jew billi tomgħodhom, jew tħollhom fl- ilma:
If you chew the tablet:
Jekk tomgħod il- pillola:
You may need to drink a little water at the same time to help the tablet dissolve in your mouth.
Jista ’ jkollok bżonn ta ’ ftit ilma fl- istess ħin biex tgħin lill- pillola tinħall f’ ħalqek.
Then drink some more water to make sure you have swallowed all the medicine.
Imbagħad ixrob daqsxejn ilma ieħor biex tkun żgur li tkun ħadt il- mediċina kollha.
To make a liquid medicine: • Put the tablet in a glass with at least enough water to cover the whole tablet. • Either stir to dissolve, or wait for about a minute, until the tablet is fully dissolved. • Drink all the liquid. • Add a little more water to the glass and drink that, to make sure you’ ve taken all the medicine.
Kif tħoll il- mediċina: • Qiegħed il- pillola f’ tazza bi ftit ilma, biżżejjed li jgħatti l- pillola kollha. • Hawwad biex tħollha, jew stenna għal xi minuta sakemm il- pillola tinħall kollha kemm hi. • Ixrob il- likwidu kollu. • Żid ftit ilma fit- tazza u ixorbu biex tkun żgur li ħadt il- mediċina kollha.
If you take more Lamictal than you should If anyone takes too much Lamictal:
Jekk tieħu Lamictal aktar milli suppost Jekk xi ħadd jieħu Lamictal żejjed:
Contact a doctor or pharmacist immediately.
Kellem lil xi tabib jew spiżjar mill- ewwel.
If possible, show them the Lamictal packet.
Jekk possibbli, urihom il- pakkett ta ’ Lamictal.
Someone who has taken too much Lamictal may have any of these symptoms: • rapid, uncontrollable eye movements (nystagmus) • clumsiness and lack of co-ordination, affecting their balance (ataxia) • loss of consciousness or coma.
Meta xi ħadd jieħu Lamictal żejjed jista ’ jkollu dawn is- sintomi li ġejjin: • movimenti mgħaġġla u bla kontroll ta ’ l- għajnejn (nistagmus) • imġiba bla ebda delikatezza u nuqqas ta ’ koordinament li jaffettwa l- bilanċ (atassija) • jista ’ jintilef minn sensih jew jidħol f’ koma.
If you forget to take Lamictal Don’ t take extra tablets or a double dose to make up for a forgotten dose.
Jekk tinsa ’ tieħu Lamictal Tiħux pilloli żejda jew xi doża doppja biex tpatti għal xi doża li tkun insejt tieħu.
If you have missed taking a dose of Lamictal:
Jekk taqbeż xi doża Lamictal:
Ask your doctor for advice on how to start taking it again.
Staqsi lit- tabib għal parir dwar kif terġa ’ tibda.
It’ s important that you do this.
Hu importanti ħafna li dan tagħmlu.
Don’ t stop taking Lamictal without advice Take Lamictal for as long as your doctor recommends.
Twaqqafx Lamictal mingħajr ma tieħu parir Ħu Lamictal sa kemm jibqa ’ jgħidlek it- tabib.
Don’ t stop unless your doctor advises you to.
Twaqqfux jekk mhux bil- parir tat- tabib.
If you are taking Lamictal for epilepsy To stop taking Lamictal, it is important that your dose is reduced gradually, over about 2 weeks.
Jekk qed tieħu Lamictal għal epilessija Biex tieqaf milli tieħu Lamictal, importanti ħafna li d- doża titnaqqas bil- mod matul ġimagħtejn.
If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.
Jekk twaqqfu f’ salt, tista ’ terġa ’ taqbdel l- epilessija jew tiżdidlek fil- qawwa tagħha.
If you are taking Lamictal for bipolar disorder Lamictal may take some time to work, so you are unlikely to feel better straight away.
Jekk qed tieħu Lamictal għal xi mard bi- polari Lamictal jista ’ jieħu xi ftit ħin biex jagħmel effett, għalhekk m’ huwiex previst li tħossok aħjar mill- ewwel.
If you stop taking Lamictal, your dose will not need to be reduced gradually.
Jekk tieqaf tieħu Lamictal, m’ għandekx għalfejn twaqqaf id- doża bil- mod.
But you should still talk to your doctor first, if you want to stop taking Lamictal.
Imma xorta waħda għandek l - ewwel tkellem lit- tabib jekk tkun trid twaqqaf Lamictal.
Like all medicines, Lamictal can cause side effects, but not everyone gets them.
Bħal kull mediċina oħra, Lamictal jista ’ jikawża effetti sekondarji għalkemm mhux f’ kulħadd.
Symptoms of these reactions include: • skin rashes or redness • a sore mouth or eyes • a high temperature (fever), flu-like symptoms or drowsiness
Reazzjoni allerġika jew reazzjoni fil- ġilda li tista ’ tkun gravi: fittex l- għajnuna tat- tabib mill- ewwel
109 • swelling around your face, or swollen glands in your neck, armpit or groin • unexpected bleeding or bruising, or your fingers turning blue • a sore throat, or more infections (such as colds) than usual.
Fost dawn is- sintomi hemm dawn li ġejjin: • raxx jew ħmura fil- ġilda • ħruq fil- ħalq jew fl- għajnejn • deni għoli, sintomi ta ’ influwenza jew nagħas • nefħa fil- wiċċ, jew glandoli minfuħin fl- għonq, taħt id- dirgħajn jew fl- irqiq ta ’ bejn il- koxxa u ż - żaqq • ħruġ ta ’ demm jew tbenġil mhux mistenni, jew swaba jsiru vjola • ħruq fil- gerżuma, jew infezzjonijiet (bħal irjieħ) aktar mis- soltu.
In many cases, these symptoms will be signs of less serious side effects.
Ħafna drabi dawn is- sintomi jkunu sinjali ta ’ effetti sekondarji mhux daqshekk serji.
But you must be aware that they are potentially serious — so, if you notice any of these symptoms:
Biss trid iżżomm f’ rasek li jistgħu ikunu gravi – għalhekk, jekk tara xi sintomi bħal dawn li ġejjin:
See a doctor as soon as possible.
Kellem tabib kemm jista ’ jkun malajr.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamictal.
It- tabib jista ’ jiddeċiedi li jagħmillek testijiet tal- fwied, tal - kliewi jew tad- demm, u jista ’ wkoll jgħidlek biex twaqqaf Lamictal.
Very common side effects These may affect more than 1 in 10 people: • headache • feeling dizzy • feeling sleepy or drowsy • clumsiness and lack of co-ordination (ataxia) • double vision or blurred vision • feeling sick (nausea) or being sick (vomiting) • skin rash.
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni: • uġigħ ta ’ ras • sturdamenti • nagħas jew telqa • nuqqas ta ’ delikatezza fil- movimenti u nuqqas ta ’ koordinament (atassija) • tara doppju jew imċajpar • ma tħossokx tajjeb (dardir) jew tħoss li ma tiflaħx (remettar) • raxx fil- ġilda
Common side effects These may affect up to 1 in 10 people: • aggression or irritability • rapid, uncontrollable eye movements (nystagmus) • shaking or tremors • difficulty in sleeping • diarrhoea • dry mouth • feeling tired • pain in your back or joints, or elsewhere.
Effetti sekondarji komuni Dawn jistgħu jaffettwaw sa 1 minn kull 10 persuni: • aggressjoni jew irritabilita ’ • movimenti mgħaġġla u bla kontroll ta ’ l- għajnejn • rogħda • nuqqas ta ’ rqad • dijareja • ħalq xott • għeja • uġigħ fid- dahar jew fil- ġogi, jew f’ xi postijiet oħra.
Rare side effects These may affect up to 1 in 1,000 people: • itchy eyes, with discharge and crusty eyelids (conjunctivitis) • a rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens– Johnson syndrome).
• ħakk fl- għajnejn, għajnejn inixxu u qxur fit- tebqa ta ’ l- għajn (konġuntivite) • kondizzjoni rari fil- ġilda, b’ ħafna nuffati, u ħruġ ta ’ demm mix- xofftejn, mill- għajnejn, mill- ħalq, mill- imnieħer u mill- partijiet ġenitali (sindrome Stevens – Johnson)
Very rare side effects These may affect up to 1 in 10,000 people: • hallucinations (‘ seeing’ or ‘ hearing’ things that aren’ t really there) • confusion or agitation • feeling ‘ wobbly’ or unsteady when you move about • uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness • a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis) • in people who already have epilepsy, seizures happening more often • changes in liver function, which will show up in blood tests, or liver failure • changes which may show up in blood tests — including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia • a disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)
Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa 1 minn kull 10, 000 persuni: • alluċinazzjonijiet (‘ tara ’ jew ‘ tisma ’ affarijiet li fil- fatt ma jkunux hemm) • taħwid jew aġitazzjoni • tħossok se taqa ’ jew ma taqgħax meta tiċċaqlaq • movimenti bla kontroll tal- ġisem (liwi involontarju), spażmi mhux kontrollati li jaffettwaw l - għajnejn, ir- ras u t- torso (koreoatetożi), jew movimenti oħra mhux normali tal- ġisem bħal skossi, rogħda jew ebusija. • reazzjoni qawwija fil- ġilda, li tibda bi ħmura w uġigħ f’ xi partijiet, u li tiżviluppa f’ nuffati kbar u mbagħad qxur li jaqgħu mill- ġilda (nekroliżi tossika tal- ġilda)
a high temperature (fever) swell ing around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy)
temperatura għolja (deni) nefħa fil- wiċċ (edema) jew glandoli minfuħa fl- għonq, fil- ħofra tad- dirgħajn jew fl- irqid ta ’ bejn il - koxxa u ż- żaqq (limfadenopatija)
in people who already have Parkinson’s disease, worsening of the symptoms.
sintomi li jgħaddu għall- agħar f’ dawk li jbatu bil- marda Parkinson’ s.
If you get side effects If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Jekk ikollok effetti sekondarji Jekk xi effetti sekondarji jsiru aktar qawwija jew jinkwetawk, jew jekk tosserva xi effetti sekondarji li mhumiex imniżżla hawn fuq jekk jogħġbok kellem lit- tabib jew lill- ispiżjar tiegħek
HOW TO STORE LAMICTAL
KIF TAĦŻEN LAMICTAL
Keep Lamictal out of the sight and reach of children.
Tħallix Lamictal fejn jarawh jew jista ’ jintlaħaq minn tfal.
Do not use Lamictal after the expiry date shown on the blisters, carton or bottle.
Tużax Lamictal wara d- data ta ’ skadenza kif tidher fuq l- istrixxi, fuq il- kartuna jew fuq il- flixkun.
The expiry date refers to the last day of that month.
Id- data ta ’ l- iskadenza tirreferixxi għall- aħħar data ta ’ dak ix- xahar.
Lamictal does not require any special storage conditions.
Lamictal m’ għandux bżonn ta ’ kondizzjonijiet speċjali għall- ħażna.
If you have any unwanted Lamictal tablets, don’t dispose of them in your waste water or your household rubbish.
Jekk jibqagħlek xi pilloli ta ’ Lamictal li m’ għandekx bżonnhom, tarmihomx ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Take them back to your pharmacist, who will dispose of them in a way that won’t harm the environment.
Ħudhom lura lill- ispiżjar tiegħek biex jiddisponi minnhom b’ mod li ma jagħmilx ħsara lill- ambjent.
What Lamictal tablets contain The active substance is lamotrigine.
X’ fihom il- pilloli Lamictal Is- sustanza attiva hi lamotrigine.
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Kull pilola fiha 25 mg, 50 mg, 100 mg jew 200 mg lamotrigine.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (Type A), iron oxide yellow (E172) and magnesium stearate.
L- ingredjenti l- oħra huma: monoidrat tal- lattosju, ċellulosju mikrokristallin, providone K30, sodium starch glycolate (Tip A), ossidu isfar tal- ħadid (E172) u stearat tal- manjesju.
What Lamictal dispersible/chewable tablets contain The active substance is lamotrigine.
X’ fihom il- pilloli Lamictal li jixterdu/ jiġu mimgħuda Is- sustanza attiva hi lamotrigine.
Each dispersible/chewable tablet contains 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Kull pillola li tixtered / tiġi mimgħuda jkun fiha 2 mg, 5 mg, 25 mg, 50 mg, 100 mg jew 200 mg lamotrigine.
The other ingredients are: calcium carbonate, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycolate (Type A), povidone K30, saccharin sodium, magnesium stearate, blackcurrant flavour.
Is- sustanzi l- oħra huma: karbonat tal- kalċju, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycolate (Tip A), povidone K30, sodju tas- sakkarina, stearat tal- manjesju, sustanza b’ togħma ta ’ ribes.
What Lamictal tablets look like and contents of the pack Lamictal tablets (all strengths) are square with rounded corners, and pale, yellowish brown in colour.
L- għamla tal- pilloli Lamictal u kontenut tal- pakkett Il- pilloli Lamictal (ta ’ kull qawwa) huma kwadri b’ kantunieri fit- tond, u ta ’ kulur kannella safrani mitfi.
Not all listed pack sizes may be available in your country.
Jista ’ jagħti l- każ li mhux il- pakketti msemmijin kollha jkunu disponibbli fil- pajjiż li tgħix fih.
Lamictal 25 mg tablets are marked ‘GSEC7’ on one side and ‘25’ on the other.
Il- pilloli Lamictal tal- 25 mg huma mmarkati ‘ GSEC7 ’ fuq naħa u ‘ 25 ’ fuq l- oħra.
Each pack contains blisters of 14, 21, 30, 42, 50, 56 or 100 tablets.
Kull pakkett fih strxxi ta ’ 14, 21, 30, 42, 50, 56 jew 100 pilloli.
Starter packs containing 21 or 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Pakketti li tibda bihom ta ’ 21 jew 42 pilloli huma wkoll disponibbli għal użu matul l- ewwel ġimgħat tat- trattament meta d- doża tibda tiżdied bil- mod il- mod.
Lamictal 50 mg tablets are marked ‘GSEE1’ on one side and ‘50’ on the other.
115 Il- pilloli Lamictal tal- 50 mg huma mmarkati ‘ GSEE1 ’ fuq naħa u ‘ 50 ’ fuq l- oħra.
Each pack contains blisters of 14, 30, 42, 56, 90 or 100 tablets.
Kull pakkett fih strxxi ta ’ 14, 30, 42, 56, 90 jew 100 pilloli.
Starter packs containing 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Pakketti li tibda bihom ta ’ 42 pilloli huma wkoll disponibbli għal użu matul l- ewwel ġimgħat tat- trattament meta d- doża tibda tiżdied bil- mod il- mod.
Lamictal 100 mg tablets are marked ‘GSEE5’ on one side and ‘100’ on the other.
Il- pilloli Lamictal tal- 100 mg huma mmarkati ‘ GSEE5 ’ fuq naħa waħda u ‘ 100 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 30, 50, 56, 60, 90 or 100 tablets.
Kull pakkett fih strixxi ta ’ 30, 50, 56, 90 jew 100 pilloli.
Lamictal 200 mg tablets are marked ‘GSEE7’ on one side and ‘200’ on the other.
Il- pilloli Lamictal tal- 200 mg huma mmarkati ‘ GSEE7 ’ fuq naħa waħda u ‘ 200 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 30, 56 or 100 tablets.
Kull pakkett fih strixxi ta ’ 30, 56 jew 100 pilloli.
111 What Lamictal dispersible/chewable tablets look like and contents of the pack Lamictal dispersible/chewable tablets (all strengths) are white to off-white, and may be slightly mottled.
Kif jidhru fl- għajn il- pilloli Lamictal < li jixterdu/ jiġu mimgħuda > < li jixterdu > u l- kontenut tal - pakketti Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda (ta ’ kull qawwa) huma ta ’ kulur bejn abjad u bejn jagħti fl - abjad, u jistgħu jkunu ttikkjati bil- kulur.
They smell of blackcurrant.
Fihom riħa ta ’ ribes.
Not all listed pack sizes may be available in your country.
Mhux il- pakketti kollha jistgħu ikunu disponibbli fil- pajjiż li tgħix fih.
Lamictal 2 mg dispersible/chewable tablets are round.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda taż- żewġ mg huma tondi.
They are marked ‘LTG’ above the number ‘2’ on one side; and with two ovals overlapping at right angles on the other.
Ikunu immarkati ‘ LTG ’ fuq in- numru ‘ 2 ’ fuq naħa waħda; u b’ żewġ forom ovali waħda tirkeb lill- oħra b’ anglu rett fuq in- naħa l- oħra.
Lamictal 5 mg dispersible/chewable tablets are elongated with curved sides.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda li jixterdu tal- 5 mg huma twal b’ kurva fil- ġnub.
They are marked ‘GS CL2’ on one side; and ‘5’ on the other.
Huma mmarkati ‘ GS CL2 ’ fuq naħa waħda; u ‘ 5 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 10, 14, 28, 30, 50 or 56 tablets.
Kull pakkett fih strixxi ta ’ 10, 14, 28, 30, 50 jew 56 pilloli.
Lamictal 25 mg dispersible/chewable tablets are square with rounded corners.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda li jixterdu tal- 25 mg huma kwadri u ttundjati fil- ġnub.
They are marked ‘GSCL5’ on one side; and ‘25’ on the other.
Huma mmarkati ‘ GSCL5 ’ fuq naħa waħda; u ‘ 25 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets.
Kull pakkett fih strixxi ta ’ 10, 14, 21, 28, 30, 42, 50, 56 jew 60 pilloli.
Starter packs containing 21 or 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
Hawn ukoll pakketti biex tibda bihom ta ’ 21 jew 42 pilloli biex jintużaw fl- ewwel ġimgħat tat- trattament meta d- doża tkun qed tiżdied bil- mod il- mod.
Lamictal 50 mg dispersible/chewable tablets are square with rounded corners.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda li jixterdu tal- 50 mg huma kwadri u ttundjati fil- ġnub.
They are marked ‘GSCX7’ on one side; and ‘50’ on the other.
Huma mmarkati ‘ GSCX7 ’ fuq naħa waħda; u ‘ 50 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 tablets.
Kull pakkett fih strixxi ta ’ 10, 14, 30, 42, 50, 56, 60, 90, 100 jew 200 pilloli.
Starter packs containing 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
Hawn ukoll pakketti biex tibda bihom ta ’ 42 pilloli biex jintużaw fl - ewwel ġimgħat tat- trattament meta d- doża tkun qed tiżdied bil- mod il- mod.
Lamictal 100 mg dispersible/chewable tablets are square with rounded corners.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda li jixterdu tal- 100 mg huma kwadri u ttundjati fil- ġnub.
They are marked ‘GSCL7’ on one side; and ‘100’ on the other.
Huma mmarkati ‘ GSCL7 ’ fuq naħa waħda; u ‘ 100 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Kull pakkett fih strixxi ta ’ 10, 30, 50, 56, 60, 90, 100 jew 200 pilloli.
Lamictal 200 mg dispersible/chewable tablets are square with rounded corners.
Il- pilloli Lamictal li jixterdu/ jiġu mimgħuda li jixterdu tal- 200 mg huma kwadri u ttundjati fil- ġnub.
They are marked ‘GSEC5’ on one side; and ‘200’ on the other.
Huma mmarkati ‘ GSEC5 ’ fuq naħa waħda; u ‘ 200 ’ fuq in- naħa l- oħra.
Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Kull pakkett fih strixxi ta ’ 10, 30, 50, 56, 60, 90, 100 jew 200 pilloli
Manufacturer: < Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom. >
Manufattur: < Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Renju Unit. >
Grunwaldzka 189, 60-322 Poznan, Poland. >
Grunwaldzka 189, 60- 322 Poznan, Polonja. >
< Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany. >
116 < Glaxo Wellcome GmbH & Co., Industriestrasse 32- 36, 23843 Bad Oldesloe, Ġermanja. >
< GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgaria. >
< GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgarija. >
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spain. >
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spanja. >
112 ANNEX IV
117 ANNESS IV
CONDITION OF THE MARKETING AUTHORISATION(S)
KUNDIZZJONIJIET GĦALL- AWTORIZZAZZJONI( JIET) GĦAT- TQEGĦID FIS- SUQ
113 CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE
118 KUNDIZZJONJIET MEQJUSA ESSENZJALI GĦALL- UŻU EFFETTIV U SIGUR TAL - PRODOTT MEDIĊINALI INKLUŻA L- FARMAKOVIĠILANZA
The Marketing Authorisation Holder commits to timely submission of MR/national variations to implement labelling changes, which may be agreed following Pharmacovigilance Working Party (PhVWP) recommendation concerning suicidal ideation and behaviour with anti-epileptic drugs.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu sabiex jagħti fil- ħin ir - rikonnoxximent reċiproku (MR) / varjazzjonjiet nazzjonali għall- implimentazzjoni ta ’ tibdiliet fuq it- tikketta, bi qbil u b’ mod konformi mar- rakkomandazzjoni tal- Grupp ta ’ Ħidma tal- Farmakoviġilanza (PhVWP) fir - rigward ta ’ ideat u mġieba relatati mas- suwiċidju b’ mediċini għal kontra l- epilessija.
London, 23 July 2008 Doc.
Londra, 23 ta ’ Lulju 2008 Dok.
EMEA/ CHMP/ 212114/ 2008
EMEA/ 476663/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Lamictal and associated names
OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 30 GĦAL Lamictal u ismijiet assoċjati
International Non-Proprietary Name (INN): lamotrigine
Denominazzjoni Komuni Internazzjonali (DKI): lamotrigine
BACKGROUND INFORMATION Lamictal and associated names, 25 mg, 50 mg, 100 mg, 200 mg tablet and 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, dispersible / chewable tablet, is an antiepileptic drug, used for the treatment of epilepsy and Bipolar Disorder.
INFORMAZZJONI TA ’ SFOND Lamictal u ismijiet assoċjati, pilloli ta ’ 25 mg, 50 mg, 100 mg, 200 mg u pilloli li jdubu / li jintmagħdu ta ’ 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, huwa mediċina antiepilettika, użata għat- trattament tal- epilessija u ta ’ Disturbi Bipolari.
On 1 March 2007, GlaxoSmithKline Research & Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
Fl- 1 ta ’ Marzu 2007, GlaxoSmithKline Research & Development Limited ippreżenta referenza skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata, lill- EMEA, sabiex jiġu armonizzati s- Sommarji tal- Karatteristiċi tal- Prodott (SPC), it- Tikketta u l- Fuljett ta ’ Tagħrif awtorizzati fuq livell nazzjonali inkluż l- aspetti ta ’ kwalità tal- prodott mediċinali Lamictal u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Lamictal and associated names approved across EU Member States, with respect to the indication,
Il- bażi għar- referenza kienet li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) inkluż l- aspetti tal- kwalità ta ’ Lamictal u l- ismijiet assoċjati approvati madwar l- Istati Membri tal- UE, fir- rigward tal- indikazzjoni.
Adults and children above 12 years Lamictal 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 Lamictal huwa indikat sabiex jintuża bħala terapija aġġuntiva jew bħala monoterapija fit- trattament tal- epilessija, għal attakki ta ’ puplesija parzjali u attakki ta ’ puplesija ġeneralizzati inkluż attakki ta ’ puplesija toniċi- kloniċi u attakki ta ’ puplesija assoċjati mas- Sindrome ta ’ Lennox- Gastaut.
Children 2 to 12 years Lamictal 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 Lamictal huwa indikat bħala terapija aġġuntiva fit- trattament tal- epilessija, għal attakki ta ’ puplesija parzjali u attakki ta ’ puplesija ġeneralizzati inkluż attakki ta ’ puplesija toniċi- kloniċi u attakki ta ’ puplesija assoċjati mas- Sindrome ta ’ Lennox- Gastaut.
After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on Lamictal monotherapy.
Wara li jkun inkiseb kontroll epilettiku matul terapija aġġuntiva, mediċini antiepilettiċi konkomittanti (AEDs) jistgħu jiġu rtirati u l- pazjenti jistgħu jitkomplew fuq monoterapija b’ Lamictal.
Adults 18 years and above Lamictal is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
Adulti ta ’ 18- il sena u ‘ l fuq Lamictal huwa indikat għall- prevenzjoni ta ’ episodji ta ’ burdati f’ pazjenti b’ disturb bipolari, l- iktar billi jimpedixxi episodji dipressivi.
With respect to quality aspects,
Fir- rigward tal- 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 b’ mod ġenerali, ġiet ipprovduta dokumentazzjoni sodisfaċenti.
The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Is- sustanzi mhux attivi użati fil- formolazzjonijiet tal- prodott mediċinali u l- proċessi ta ’ manifattura huma standard għall- forom farmaċewtiċi 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.
The procedure started on 29 March 2007.
Il- proċedura nbdiet fid- 29 ta ’ Marzu 2007.
The Marketing Authorisation Holder provided supplementary information on 16 October 2007.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda tagħrif supplimentari fis- 16 ta ’ Ottubru 2007.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Matul il- laqgħa tiegħu ta ’ bejn il- 21 u l- 24 ta ’ April 2008, is- CHMP, fid- dawl tat- tagħrif ġenerali ppreżentat u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall - armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif inkluż l- aspetti ta ’ kwalità kienet aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Lamictal and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ April 2008, u rrakkomanda l- armonizzazzjoni tal- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif inkluż l- aspetti ta ’ kwalità għal Lamictal u ismijiet assoċjati.
The list of product names concerned is given in Annex I.
Il- lista ta ’ ismijiet ta ’ prodotti konċernati hija mogħtija fl- Anness I.
A Decision was issued by the European Commission on 23 July 2008.
Deċiżjoni mill- Kummissjoni Ewropea nħarġet fit- 23 ta ’ Lulju 2008.
European Medicines Agency Evaluation of Medicines for Human Use
Aġenzija Ewropea dwar il- Mediċini Evalwazzjoni tal- Mediċini għall- Użu tal- Bniedem
London, 18 September 2007 EMEA/ 283378/ 2007
Londra, 18 ta ’ Settembru 2007 EMEA/ 448450/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Lansoprazole and associated names International Non-Proprietary Name (INN): lansoprazole
OPINJONI WARA REFERENZA SKOND L’ ARTIKOLU 29( 4) 1 GĦALL - Lansoprazole u prodotti simili tiegħu Isem Internazzjonali Mhux Patentat (INN): lansoprazole
BACKGROUND INFORMATION Lansoprazole 15 & 30 mg gastro-resistant capsules, hard are generic preparations containing lansoprazole as the active substance.
INFORMAZZJONI ĠENERALI Kapsuli gastro- reżistenti iebsin Lansoprazole tal- 15 u 30 mg, huma preparazzjonijiet ġeneriċi li fihom lansoprazole bħala s- sustanza attiva.
Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro-oesophageal reflux disease and associated conditions.
Lansoprazole huwa inibitur proton pump li jinibixxi t- tnixxija ta ’ l - aċidu gastriku li jintuża fit- trattament ta ’ ulċeri duwodenali u beninni fl- istonku, marda reflux gastro - esofagali u kundizzjonijiet assoċjati.
TEVA UK Limited submitted applications for mutual recognition of Lansoprazole and associated names, 15 and 30 mg, gastro-resistant capsules, hard, on the basis of the marketing authorisation granted by the United Kingdom on 9 December 2005.
TEVA UK Limited ippreżentat applikazzjonijiet għar- rikonoxximent reċiproku tal- kapsuli gastro- reżistenti Lansoprazole tal- 15 u 30 mg u ismijiet assoċjati, skond l- awtorizzazzjoni għat- tqegħid fis- suq mogħtija mir - Renju Unit fid- 9 ta ’ Diċembru 2005.
The Mutual Recognition Procedure started on 07 June 2006.
Il- Proċedura għar- Rikonoxximent Reċiproku bdiet fis- 7 ta ’ Ġunju 2006.
The Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, the Netherlands, Norway, Poland, Portugal, the Slovak Republic, Spain and Sweden.
L- Istat Membru ta ’ referenza kien ir- Renju Unit u l- Istati Membri Konċernati kienu l- Awstrija, il- Belġju, ir - Repubblika Ċeka, id- Danimarka, il- Finlandja, Franza, il- Ġermanja, l- Ungerija, l- Irlanda, l- Olanda, in - Norveġja, il- Polonja, il- Portugall, ir- Repubblika tas- Slovakkja, Spanja, u l- Iżvezja.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma setgħux jilħqu ftehim dwar ir- Rikonoxximent Reċiproku ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq mogħtija mill- Istat Membru ta ’ Referenza.
The Czech Republic, Spain and Portugal referred the reasons for disagreement to the EMEA on 30 November 2006.
Ir- Repubblika Ċeka, Spanja u l- Portugall, irreferew ir- raġunijiet għan- nuqqas ta ’ qbil lill- EMEA fit- 30 ta ’ Novembru 2006.
The reasons for disagreement were, that some Member States have raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.
Ir- raġunijiet għan- nuqqas ta ’ qbil kienu, li xi Stati Membri qajmu oġġezzjonijiet dwar is- saħħa pubblika fuq il- bażi li filwaqt li l- bijoekwivalenza ġiet ippruvata fi stat ta ’ sawm, din ma ġietx ippruvata f’ kundizzjonijiet meta ttieħed l- ikel.
The arbitration procedure started on 14 December 2006 with the adoption of a list of questions.
Il- proċedura arbitrarja bdiet fl- 14 ta ’ Diċembru 2006 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The Rapporteur was Dr.
Ir- Rapporteur kien Dr.
Frits Lekkerkerker and Co-Rapporteur was Dr.
Frits Lekkerkerker u l- Ko- Rapporteur kien Dr.
The Marketing Authorisation Holder provided written explanations on 30 March 2007.
Id- detentur ta ’ l- Awtorizzazzjoni Għat - Tqegħid fis- Suq ipprovda spjegazzjonijiet bil- miktub fit- 30 ta ’ Marzu 2007.
During their 18 – 21 June 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Lansoprazole and associated names, that the objections raised by the Czech Republic, Spain and Portugal should not prevent the granting of a Marketing Authorisation and that the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Waqt il- laqgħa tagħhom ta ’ bejn it- 18 u l- 21 ta ’ Ġunju 2007, il- CHMP, fid- dawl tat- tagħrif ġenerali mogħti u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien ta ’ l- opinjoni li, l- proporzjon ta ’ riskju/ benefiċċju kien favorevoli għal Lansoprazole u ismijiet assoċjati, li l- oġġezzjonijiet imressqa mir- Repubblika Ċeka, Spanja u l- Portugall m’ għandhomx iċaħħdu l- għoti ta ’ Awtorizzazzjoni għal Tqegħid fis- Suq u li s- Sommarju tal - Karatteristiċi tal- Prodott validu, it- tikketta u l- fuljett ta ’ tagħrif huma l- verżjonijiet finali miksuba waqt il - proċedura ta ’ koordinazzjoni tal- Grupp.
A positive opinion was adopted by consensus on 21 June 2007.
Ġiet adottata opinjoni pożittiva b’ kunsens fil- 21 ta ’ Ġunju 2007.
The list of the product names concerned is given in Annex I.
Il- lista ta ’ ismijiet ta ’ prodotti konċernati tinsab fl- Anness 1.
The scientific conclusions are provided in Annex II.
Il- konklużjonijiet xjentifiċi jinsabu fl- Anness II.
The final opinion was converted into a Decision by the European Commission on 18 September 2007.
L- opinjoni finali ġiet mibdula f’ Deċiżjoni mill- Kummissjoni Ewropea fit- 18 ta ’ Settembru 2007.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, SIDIEN TA` L- AWTORIŻŻAZZJONI TAL - KUMMERĊ TA` L- APPLIKANT F` L- ISTATI MEMBRI Stat Membru
Marketing Authorisation Holder
Sid ta` l - Awtoriżżazzjoni tal - Kummerċ
Name
Isem Ivvintat / Isem
Route of administration
Kif jingħata
Box 217, 3640 AE Mijdrecht The Netherlands
Box
Gastro-resistant capsule, hard
Kapsula gastro - reżistenti, iebsa.
Box 217, 3640 AE Mijdrecht The Netherlands
217, 3640 AE Mijdrecht The Netherlands
Lansoprazol IPS 15 mg
Lansoprazol IPS 15 mg maagsapresistente capsules
Gastro-resistant
Kapsula gastro - reżistenti, iebsa.
maagsapresistente capsules
Lansoprazol IPS 30 mg maagsapresistente capsules
IPS N. V.
30 mg
Dráž ní 7, 627 00 Brno Czech Republic
Lansoprazol - TEVA
Lansoprazol - TEVA 15 mg 15 mg
15 mg 15 mg
Lansoprazol - TEVA 30 mg 30 mg
30 mg 30 mg
Denmark
Ġermanja
Teva Pharma B. V.
TEVA Generics GmbH
Industrieweg 23, P. O.
Lansoprazol- TEVA®
Lansoprazol TEVA 15 mg 15 mg enterokapsler
15 mg 15 mg
Gastro-resistant capsule, hard
Kapsula gastro -
Denmark
Kandelstraße 10, D- 79199 Kirchzarten
Industrieweg 23, P. O.
magensaftresistente Hartkapseln
Box 217, 3640 AE Mijdrecht The Netherlands
reżistenti, iebsa.
Finland
Danimarka
Lansoprazol Teva,
217, 3640 AE Mijdrecht The Netherlands
France
Box
TEVA Classics S. A.
217, 3640 AE Mijdrecht The Netherlands
Germany
Franza
Germany
reżistenti, iebsa.
Hungary
2 Ungerija
TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H- 1074, Hungary
TEVA Magyarország Rt Rákóczi út 70- 72, Budapest,
Lansoflux Teva 15 mg 15 mg kapszula
15 mg 15 mg
TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H- 1074, Hungary
H- 1074, Hungary
Lansoflux Teva 30 mg 30 mg kapszula
30 mg 30 mg
Teva Pharma B. V., Industrieweg 23, P. O.
Teva Pharma B. V.,
Box 217, 3640 AE Mijdrecht, The Netherlands,
Lansoprazole TEVA
Lansoprazole TEVA 15 mg 15 mg Gastro-resistant Capsules
15 mg 15 mg
Teva Pharma B. V., Industrieweg 23, P. O.
Box
Box 217, 3640 AE Mijdrecht, The Netherlands,
217, 3640 AE Mijdrecht, The Netherlands,
Lansoprazol
Swensweg 5, Postbus 552,
United Kingdom
Teva Pharma B. V.,
TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Lansoprazol TEVA
Lansoprazole 15 mg 15 mg Gastro-resistant Capsules
15 mg 15 mg
United Kingdom
reżistenti, iebsa.
TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
217, 3640 AE Mijdrecht, The Netherlands,
4 Norway
Polonja
Teva Pharma B. V.,
Teva Pharmaceuticals Polska Sp. z o. o.
capsule, hard
E.
Teva Pharma B. V., Industrieweg 23, P. O.
Plater 53, 00- 113 Warsaw Poland
Poland
L- Isvezja
Teva Pharmaceuticals Polska Sp. z o. o.
reżistenti, iebsa.
Sweden
Ir- Renju Unit
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
TEVA UK Limited TEVA UK Limited
Lansoprazol TEVA 15 mg 15 mg enterokapslar, hårda
15 mg Gastro - 15 mg
Sweden
3 Hampden Park,
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
Hampden Park, Eastbourne,
Lansoprazol TEVA 30 mg 30 mg enterokapslar, hårda
30 mg Gastro - 30 mg
5 ANNEX II
5 KONKLUŻJONIJIET XJENTIFICI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOLE AND ASSOCIATED NAMES (see Annex I)
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TAL- LANSOPRAZOLE U ISMIJIET ASSOĊJATI (Ara Anness I)
Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro- oesophageal reflux disease and associated conditions.
Lansoprazole 15 & 30 mg kapsuli gastro- reżistenti, iebsin (Teva UK Ltd) huma preparazzjonijiet ġeneriċi li jimpedixxu t- tnixxija ta ’ l- aċidu gastriku u huma wżati għat- trattament ta ’ ulċeri duwodenali u gastriċi beninni, mard ta ’ rifluss gastro- oesofaġiku u kondizzjonijiet assoċjati.
In September 2006, a Mutual Recognition Procedure was started for Lansoprazole involving 16 CMS with the UK as Reference Member State (RMS).
F’ Settembru 2006, inbdiet Proċedura ta ’ Rikonoxximent Reċiproku għal Lansoprazole li nvolviet 16 - il CMS bir- Renju Unit bħala Stat Membru ta ’ Referenza (RMS).
On 30 November 2006, the application has been referred and submitted for arbitration according to Article 29 of Directive 2001/ 83/ EC, as amended.
Fit- 30 ta ’ Novembru 2006, l- applikazzjoni ġiet irreferuta u sottomessa għal arbitraġġ skond l- Artikolu 29 tad- Direttiva 2001/ 83/ EC, kif emendat.
The objecting Concerned Member States raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.
L- Istati Membri kkonċernati li oġġezzjonaw qajjmu oġġezzjonijiet ta ’ saħħa pubblika fuq il- bażi li waqt li l- bijoekwivalenza kienet ipprovata fl- istat ta ’ sawm, l- istess ma kienx il- każ taħt kondizzjonijiet mitmugħa.
The RMS approved the product on the basis of the results of the fasted study showed unequivocal equivalence as shown by the 90% confidence intervals (CI) for the AUC and Cmax which were within the conventional 80-125% bioequivalence range.
L- RMS approva l- prodott fuq il- bażi tar- riżultati ta ’ studju sajjem li wrew ekwivalenza mhux ekwivoka kif muri mid- 90% intervalli ta ’ kunfidenza (CI) għall- AUC u s - Cmax li kienu fi ħdan il - medda konvenzjonali ta ’ bijoekwivalenza 80- 125%.
Although the CI for the fed study results (CI for AUCinf.
Għalkemm il- CI għar- riżultati ta ’ l- istudji bl- ikel (CI għal AUCinf.
78– 110%) were outside the conventional limits they comply with the wider 75-133% criterion.
78– 110%) kienu barra mil- limiti konvenzjonali li jikkonformaw mal- kriterju usa ’ 75- 133%.
It was considered that this wider criterion can be applied in this case because of the extremely high intra-subject variability (70- 82%) under fed conditions shown in this study.
Tqies li dan il- kriterju usa ’ jista ’ jiġi applikat f’ dan il- każ minħabba l- varjabilità estremament għolja (70 - 82%) fis- suġġetti nfushom taħt kondizzjonijiet bl- ikel murija f’ dan l- istudju.
The results were also considered acceptable on clinical grounds as lansoprazole’ s efficacy is largely independent of dose at this therapeutic dose range.
Ir- riżultati kienu wkoll ikkonsidrati aċċettabbli fuq bażijiet kliniċi minħabba li l- effikaċja tal - lansoprazole hija fil- parti l- kbira indipendenti mid- doża f’ din il- medda ta ’ doża terapewtika.
Documentation presented to the CHMP shows that the test and reference products are essentially similar.
Dokumentazzjoni ippreżentata lis- CHMP turi li t- test u l- prodotti ta ’ referenza huma essenzjalment simili.
Both products show pronounced food effect although the generic product appears to be more affected largely because of the high intra-subject variability.
Iż- żewġ prodotti juru effett ta ’ l- ikel li jidher ħafna għalkemm il- prodott ġeneriku jidher li huwa effettwat prinċipalment minħabba l- varjabilità għolja fis- suġġetti infushom.