qanastek/EMEA-V3 huggingface dataset:
POSSIBLE SIDE EFFECTS in
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Pr
Like all medicines, Dynepo can cause side effects, although not everybody gets them. ic ed
Bħal kull mediċina oħra, Dynepo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
M
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are:
L- iktar effetti sekondarji frekwenti li kienu osservati (f’ 1% sa 10% tal- pazjenti) b’ Dynepo huma:
- increase in blood pressure.
- żieda fil- pressjoni tad- demm.
Even patients with normal blood pressure may have a marked rise in
Anki pazjenti bi pressjoni tad- demm normali jista ’ jkollhom żieda
their blood pressure and existing high blood pressure can get worse (See 2.
notevoli fil- pressjoni tad- demm tagħhom u pressjoni tad- demm għolja eżistenti tista ’ tmur għall - agħar (Ara 2.
Before you take Dynepo).
Qabel ma tuża Dynepo).
- if you are on haemodialysis you may experience blockage of the dialysis tubes as your anaemia
- Jekk inti fuq l- emodijaliżi, jista ’ jkollok imblukkar fit- tubi tad- dijaliżi hekk kif l- anemija tiegħek
improves (increase in red blood cells).
tmur għall- aħjar (żieda fiċ- ċelluli ħomor tad- demm).
An increase in the dose of the anticoagulation treatment is frequently required to prevent the blockage occurring.
Żieda fid- doża tal- kura kontra l- koagulazzjoni ta ’ spiss tkun meħtieġa biex jiġi evitat li jseħħ l- imblukkar.
Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
Effetti sekondarji oħrajn li jseħħu inqas ta ’ spiss (f’ 0. 1% sa 1% tal- pazjenti) jinkludu ħakk, uġigħ, reazzjoni fis- sit ta ’ l- injezzjoni (bħal uġigħ u ħruġ ta ’ demm), sindrome ta ’ l- influwenza, dijarea, dardir.
105 Convulsions have been rarely reported (less than 1 every 1000 patients).
t za Konvulżjonijiet kienu rarament irrappurtati (inqas minn 1 minn kull 1000 pazjent).
Dynepo may also cause changes in the composition of your blood.
Dynepo jista ’ jikkawża wkoll tibdil fil- kompożizzjoni tad- demm tiegħek.
This includes increase in the number of red blood cells and in the number of platelets.
riz numru ta ’ ċelluli ħomor tad- demm u fin- numru ta ’ plejtlets.
There may be also changes in the chemistry of your blood, including increase of creatinine, potassium levels.
Jista ’ jkun hemm ukoll tibdil fil- kimika tad- demm tiegħek, inklużi żieda fil- livelli tal- kreatinina u tal -
5.
aw 5.
HOW TO STORE DYNEPO
KIF TAĦŻEN DYNEPO
Keep out of the reach and sight of children.
x Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
ed Do not use after the expiry date stated on the carton and on the label of the syringe after “ EXP”.
du Tużax wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq it- tikketta tas- siringa wara “ JIS ”.
is Store in a refrigerator (2oC to 8oC).
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. ħa Aħżen fi friġġ (2oC to 8oC).
Keep the container in the outer carton in order to protect from
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
Do not freeze.
Tagħmlux fil- friża. ’ g im
th Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a sinlge maximum period of 5 days.
Siringi mimlija għal- lest mhux miftuħa jistgħu jinżammu barra mill- friġġ, iżda f’ temperatura ta ’ inqas minn 25oC għal perjodu wieħed sa massimu ta ’ 5 ijiem.
The 5 day period must end before the expiry date stated on the carton and label of the syringe after
Il- perjodu ta ’ 5 ijiem irid jintemm qabel id- data ta ’ skadenza li hemm fuq il- kaxxa tal- kartun u fuq it- tikketta tas- siringa wara ‘ JIS ’.
Following 5 days storage at below 25oC the pre-filled syringes must be discarded.
Wara 5 ijiem maħżuna il
er The solution is clear, colourless and waterlike with no visible particles.
Is- soluzzjoni hi ċara, bla kulur u qisha ilma, mingħajr ebda partikuli viżibbli.
Do not use it if it is cloudy or has visible particles.
Tużax jekk is- soluzzjoni tkun imċajpra jew fiha l- partikuli.
Do not shake the syringe before use. ng Discard the syringe after initial single use. lo
Iċċaqlaqx is- siringa qabel l- użu. in iċ
Ask your pharmacist how to no
Dawn il- miżuri jgħinu għal m
dispose of medicines no longer required.
protezzjoni ta ’ l- ambjent. t
FURTHER INFORMATION du
AKTAR TAGĦRIF ot od
What Dynepo contains ro
X’ fih Dynepo
- The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International
- Is- sustanza attiva hi epoetin delta, 0. 5 ml ta ’ soluzzjoni fih 1, 000 IU (Unitajiet Internazzjonali)
Units) (2,000 IU/ ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ ml), 0.3 ml of the lp
(2, 000 IU/ ml), 0. 5 ml ta ’ soluzzjoni fih 2, 000 IU (4, 000 IU/ ml), 0. 3 ml ta ’ soluzzjoni fih Pr
solution containing 3,000 IU (10,000 IU/ ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ ml), 0.3 ml of the a
3, 000 IU (10, 000 IU/ ml), 0. 4 ml ta ’ soluzzjoni fih 4, 000 IU (10, 000 IU/ ml), 0. 5 ml ta ’ soluzzjoni fih 5, 000 IU (10, 000 IU/ ml), 0. 3 ml ta ’ soluzzjoni fih 6, 000 IU (20, 000 IU/ ml), 0. 4 ml ta ’ soluzzjoni fih 8, 000 IU (20, 000 IU/ ml), jew 0. 5 ml ta ’ soluzzjoni fih 10, 000 IU (20, 000 IU/ ml) ta ’ epoetin delta.
- The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium
- Is- sustanzi l- oħra ta ’ Dynepo huma sodium phosphate monobasic (monohydrate), sodium
phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections M
phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride u ilma għal injezzjonijiet.
Dynepo contains less than 1mmol of sodium (23 mg) per dose, i. e. it is essentially "sodium-free".
Dynepo fih inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull doża, i. e. hu essenzjalment “ sodium- free ”.
106 What Dynepo looks like and contents of the pack
106 Id- dehra ta ’ Dynepo u d- daqs tal- pakkett Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
The dosage of solution is:
Id- dożaġġ tas- soluzzjoni hu:
- 1,000 IU in 0.5 ml
- 1, 000 IU f’ 0. 5 ml
- 2,000 IU in 0.5 ml
- 2, 000 IU f’ 0. 5 ml
- 3,000 IU in 0.3 ml
- 3, 000 IU f’ 0. 3 ml
- 4,000 IU in 0.4 ml
- 4, 000 IU f’ 0. 4 ml
- 5,000 IU in 0.5 ml
- 5, 000 IU f’ 0. 5 ml
- 6,000 IU in 0.3 ml
- 6, 000 IU f’ 0. 3 ml
- 8,000 IU in 0.4 ml
- 8, 000 IU f’ 0. 4 ml
- 10,000 IU in 0.5 ml
- 10, 000 IU f’ 0. 5 ml
Available in packs of 6 pre-filled syringes.
riz Disponibbli f’ pakketti ta ’ 6 siringi mimlija għal- lest.
is or Dynepo is a clear, colourless and waterlike solution for injection containing epoetin delta.
to Dynepo hu soluzzjoni għall- injezzjoni ċara, bla kulur u qisha ilma, li fiha epoetin delta.
th Marketing Authorisation Holder and Manufacturer
aw Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal Dynepo hu Shire Pharmaceutical Contracts
au The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
x Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, Renju Unit
er The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P. O.
du Il- manifattur hu Shire Human Genetic Therapies AB, Åldermansgatan 2, P. O.
Box 1117 ng SE-221 04 Lund, Sweden. lo For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. no ct du ro ed M
Box 1117, SE- 221 04 ħa Lund, Svezja. ’ g
ic
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur im
in
ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
a
Luxembourg/ Luxemburg Belgique/ België/ Belgien, il
lp
Shire Pharmaceuticals Ltd Shire Pharmaceuticals Ltd Hampshire International Business Park, Hampshire International Business Park, al
107 Belgique/ België/ Belgien, Shire Pharmaceuticals Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire, RG 24 8EP Vereinigtes Königreich/ Royaume-Uni, Verenigd Kononkrijk Tel.: +44 1256 894 894
Chineham, Basingstoke Chineham, Basingstoke Hampshire, RG 24 8EP, Hampshire, RG 24 8EP in
Luxembourg/ Luxemburg Shire Pharmaceuticals Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire, RG 24 8EP, Vereinigtes Königreich/ Royaume-Uni Tel.: +44 1256 894 894
Vereinigtes Königreich/ Royaume- Uni Vereinigtes Königreich/ Royaume- Uni, Verenigd iċ
България / Č eská Republika/ Danmark/ Eesti/ Ελλάδα / Ireland/ Ísland/ Κύπρος / Latvija/
Tel.: +44 1256 894 894 Kononkrijk Tel.: +44 1256 894 894 ed
ed Lietuva/ Magyarország/ Malta/ Nederland/ Norge/ Österreich/ Polska/ România/ Slovenija/ Slovenská Republika/ Suomi/ Sverige/ United
България / Česká Republika / Danmark / Eesti / m
88, rue du Dome 92514 Boulogne-Billancourt Cedex Tel.: +33 (1) 46 10 90 00
88, rue du Dome Ελλάδα / Ireland / Ísland / Κύπρος / Latvija / 92514 Boulogne- Billancourt Cedex Lietuva / Magyarország / Malta / Nederland / Tel.: +33 (1) 46 10 90 00 Norge / Österreich / Polska / România / t
is Kingdom
Slovenija / Slovenská Republika / Suomi / ot
or Shire Pharmaceuticals Ltd
Sverige/ United Kingdom od
th Hampshire International Business Park, Chineham, Basingstoke
Shire Pharmaceuticals Ltd Hampshire International Business Park, Pr
au Hampshire, RG 24 8EP, Великобритания / Velká
Chineham, Basingstoke Hampshire, RG 24 8EP, Великобритания/ Velká Británie/ Storbritannien/ Ühendkuningriik / Hνωµέυο Βασίλειο/ United Kingdom/ Bretland / Lielbritānija/ Jungtinė Karalystė/ Nagy - Britannia/ Verenigd Koninkrijk / Storbritannia/ Wielka Brytania/ Marea Britanie/ Velika Britanija/ Vel’ ká Británia/ Iso -
er Británie/ Storbritannien/ Ühendkuningriik/ Hνω µέυο Βασίλειο / United Kingdom/ Bretland/ ng Lielbritā nija/ Jungtinė Karalystė / Nagy- Britannia/ Verenigd Koninkrijk/ lo Storbritannia/ Wielka Brytania/ Marea Britanie / Velika Britanija/ Vel’ ká Británia/ Iso- no
107 Britannia/ Storbritannien
Portugal Shire Pharmaceuticals Iberica, S. L.
Portugal Deutschland Shire Pharmaceuticals Iberica, S. L.
28008 Madrid, Espanha
Shire Deutschland GmbH & Co. KG Paseo Pintor Rosales, 40 Bajo Izda.
Tel.: + 49 221 802 500 lp
Siegburger Str.
Tel.: +34 91 550 06 91
126 28008 Madrid, Espanha 50679 Köln Tel.: +34 91 550 06 91 Tel.: + 49 221 880 4730
España Shire Pharmaceuticals Iberica, S. L. a
t za Italia España Shire Italia S. p. A Shire Pharmaceuticals Iberica, S. L.
Paseo Pintor Rosales, 40 Bajo Izda. in
riz Corso Italia, 29 Paseo Pintor Rosales, 40 Bajo Izda.
Corso Italia, 29
50123 Firenze Tel.: + 39 055 288860 28008 Madrid
28008 Madrid Tel.: +34 91 550 06 91 ic ed M
to Tel.: +34 91 550 06 91
50123 Firenze Tel.: + 39 055 288860
aw Dan il- fuljett kien approvat l- aħħar
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
x Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
This section contains information on how to give yourself an injection of Dynepo.
du ħa Tagħrif dwar kif għandek tagħti injezzjoni ta ’ Dynepo lilek innifsek Din is- sezzjoni fiha tagħrif dwar kif għandek tagħti injezzjoni ta ’ Dynepo lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Huwa ’ g importanti li ma tippruvax tinjetta lilek innifsek jekk ma tkunx ingħatajt taħriġ speċjali mingħand it - tabib jew in- ners tiegħek.
Dynepo is provided with a needle guard for your protection and you will be shown how to
Dynepo hu pprovdut bi protezzjoni tal- labra għall- protezzjoni tiegħek, u t - im
108 use this by your doctor or nurse.
tabib jew in- ners tiegħek ser juruk kif tużaha.
If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Jekk m’ intix ċert dwar kif tinjetta ruħek, jew jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi it- tabib jew lin- ners tiegħek biex jgħinuk. il
How do I inject Dynepo myself?
Kif ninjetta Dynepo jien stess?
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection.
ta` taħt il- ġilda.
Your dose of Dynepo may vary depending on your weight and on your response to the treatment.
It - in
Your doctor or nurse will tell you how much Dynepo you need and how frequently it should be injected.
tabib jew in- ners tiegħek ser jgħidulek kemm teħtieġ Dynepo u kemm- il darba għandu jiġi injettat. iċ
ed To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.
Tagħmir li jkollok bżonn Biex tagħti lilek innifsek injezzjoni taħt il- ġilda, ser ikollok bzonn ta ’ siringa Dynepo ġdida mimlija ed
is What should I do before I give myself a subcutaneous injection of Dynepo?
għal- lest bil- protezzjoni tal- labra. m
Take your Dynepo pre-filled syringe out of the refrigerator.
Oħroġ is- siringa mimlija għal- lest b’ Dynepo mill- friġġ.
Do not shake the pre-filled syringe.
Iċċaqlaqx is- siringa mimlija għal- lest. t ot
Check that it is the correct dose that your doctor has prescribed.
Iċċekkja li jkun fiha d- doża korretta li għaliha t- tabib tiegħek ikun tak ir- riċetta.
Check the expiry date on the pre-filled syringe label (EXP:).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tas- siringa mimlija għal- lest (JIS:).
Do not use it if the date has passed the last day of the month shown.
Tużahiex jekk od
Check the appearance of Dynepo.
Iċċekkja d- dehra ta ’ Dynepo.
It must be clear.
Pr
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in you hand for a few minutes.
Għal injezzjoni iktar komda, ħalli s- siringa mimlija għal- lest toqgħod 30 minuta biex tilħaq it - temperatura tal- kamra jew żomm is- siringa mimlija għal- lest b’ mod ġentili f’ idejk għal ftit minuti.
Do not warm lo Dynepo in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Dynepo bi kwalunkwe mod ieħor (pereżempju, issaħħnux fil- microwave jew f’ ilma jaħraq).
Do not remove the cover from the syringe until you are ready to inject. no
Tneħħix l- għatu mis- siringa sakemm tkun lest/ a biex tinjetta.
Wash your hands thoroughly.
Aħsel idejk sewwa.
Find a comfortable, well-lit place and put the Dynepo pre-filled syringe where you can reach it. ct
Sib post komdu, imdawwal tajjeb u s- siringa Dynepo mimlija għal- lest fejn tista ’ tilħaqha.
How do I prepare my Dynepo injection? du
108 Kif għandi nipprepara l- injezzjoni tiegħi b’ Dynepo?
Before you inject Dynepo you must do the following: ro
Qabel ma tinjetta Dynepo, għandek tagħmel dan li ġej:
rubber guard from the needle without twisting.
Żomm l- immuntar tas- siringa mill- ġenb tat- tagħmir u neħħi l- għatu tal- plastik u l- protezzjoni tal- lasktu bil- mod minn mal- labra mingħajr ma tilwiha.
Pull straight.
Iġbed bi dritt.
Do not touch the needle or push the plunger. a
Tmissx il- labra u timbuttax il- planġer.
You may notice a small air bubble in the pre-filled syringe.
Tista ’ tinnota bużżieqa żgħira ta ’ l- arja fis- siringa mimlija għal- lest.
You do not have to remove the air in
M’ hemmx bżonn li tneħħi l- bużżieqa ta ’ l- arja qabel ma tinjetta.
Injecting the solution with the air bubble is harmless. ic
Li tinjetta s- soluzzjoni bil- bużżieqa ta ’ l- arja mhux ser jagħmillek ħsara.
You can now use the pre-filled syringe. ed
Issa tista ’ tuża s- siringa mimlija għal- lest.
M
t za Fejn għandi ninjetta lili nnifsi?
The most suitable places to inject yourself are:
riz L- aktar postijiet adattati biex tinjetta lilek innifsek huma:
• The top of your thighs; and • The abdomen, except for the area around the naval.
to • in- naħa ta ’ fuq tal- koxox; u • ż- żaqq, ħlief għaż- żona madwar iż- żokra.
Change the place that you inject each time so you don’ t become sore in one area.
aw Ibdel il- post li fih tinjetta kull darba biex ma jkollokx uġigħ f’ żona waħda.
If someone else is injecting for you, they can also use the back of your arms.
Jekk xi ħaddieħor qed jagħtik l- injezzjoni, in- naħa ta ’ wara ta ’ dirgħajk jista ’ jintuża wkoll.
109 How do I give my injection?
x du Kif ninjetta lili nnifsi?
2.
Naddaf il- ġilda tiegħek billi toqros il- ġilda bejn is- saba ’ l- kbir u s- saba ’ l- werrej, mingħajr ma tagħfasha. ħa 2.
Put the needle fully into the skin as shown by your nurse or doctor.
Daħħal il- labra kollha fil- ġilda kif urewk in- ners jew it- tabib tiegħek.
Pull slightly on the plunger to check that a blood vessel has not been punctured.
Iġbed ftit il- planġer biex tiċċekkja li ma taqqabtx xi vina/ arterja.
If you see blood in the syringe, remove the needle and put it in another place.
Jekk tara d- demm fis- siringa, ’ g neħħi l- labra u poġġiha daħħalha f’ post ieħor.
Depress the plunger slowly and evenly while holding the syringe barrel, always keeping your skin pinched.
Agħfas il- planġer bil- mod u b’ mod konsistenti filwaqt li żżomm il- bettija tas- siringa, dejjem im
Ensure that you only inject the amount as instructed by your doctor or nurse.
Aċċerta ruħek li tinjetta biss l- ammont kif qalulek it- tabib jew in- ners tiegħek.
After injecting the liquid, remove the needle and let go of your skin.
Wara li tinjetta l- likwidu, neħħi l- labra u erħi l- ġilda tiegħek. il
Let go of the plunger allowing the syringe to move up inside the device until the entire needle is guarded.
Erħi l- planġer u ħalli s- siringa titla ’ ’ l fuq ġot- tagħmir sakemm il- labra kollha tkun protetta.
Only use each syringe for one injection.
Uża biss kull siringa għal injezzjoni waħda. al in
is or Remember
Ftakar:
th If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Jekk ikollok xi problema,, jekk jogħġbok tibżax titlob l- għajnuna jew tieħu parir minn ghand it- tabib iċ
au Disposing of used syringes
jew in- ners tiegħek. ed
er Your Dynepo syringe is provided with a needle guard to prevent needle stick injuries after use, so no special disposal precautions are required. ng lo no ct du ro ed M
Kif tarmi s- siringi uzati Is- siringa Dynepo tiegħek hi pprovduta bi protezzjoni tal- labra biex jiġu evitati korrimenti minħabba m
ic
Għalhekk, l- ebda prekawzjonijiet speċjali għar- rimi m’ huma meħtieġa. t ot od Pr
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta 'CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Ebixa?
X' inhu Ebixa?
Ebixa is a medicine containing the active substance memantine hydrochloride.
Ebixa hija mediċina li fiha s- sustanza attiva memantina idroklorur (memantine hydrochloride).
It is available as oblong tablets (white:
Hija disponibbli f' pilloli f' forma oblonga (bojod:
5 mg and 10 mg; orange:
10 mg; oranġjo:
15 mg; red:
15 mg; ħomor:
20 mg) and as oral drops (0.5 mg per drop).
20 mg) u f' forma ta 'taqtir orali (0. 5 mg kull taqtira).
The 10 mg tablets have a special score line that enables them to be easily broken in two.
Il- pillolli ta 'l- 10 mg għandhom linja ta' qsim speċjali li tippermetti li tinqasam faċilment fi tnejn.
What is Ebixa used for?
Għal xiex jintuża Ebixa?
Ebixa is used to treat patients with moderate to severe Alzheimer’ s disease.
Ebixa jintuża għat- trattament ta 'pazjenti bil- marda ta' Alzheimer moderata jew gravi.
Alzheimer’ s disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Il- marda ta 'Alzheimer hija tip ta' demenza (disturb tal- moħħ) li tolqot il- memorja, il- kapaċità intellettwali u l - komportament.
How is Ebixa used?
Kif jintuża Ebixa?
Treatment should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’ s disease.
It- trattament għandu jibda u jiġi mmonitorjat minn tabib li għandu l- esperjenza fid- dijanjożi u t - trattament tal- marda ta 'Alzheimer.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Ebixa by the patient.
It- trattament għandu jinbeda biss jekk ikun hemm min jieħu ħsieb li jissorvelja l- użu ta 'Ebixa mill- pazjent.
Ebixa should be given once a day, with or without food, at about the same time every day.
Ebixa għandu jingħata darba kuljum, fuq stonku vojt jew le, f' madwar l- istess ħin kuljum.
To prevent side effects, the dose of Ebixa is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg.
Bil- għan li jiġu prevenuti effetti sekondarji, id- doża ta 'Ebixa tiżdied progressivament matul l- ewwel tliet ġimgħat tat- trattament: matul l- ewwel ġimgħa, id- doża ta' 5 mg; fit- tieni ġimgħa, titla 'għal 10 mg; u matul it- tielet ġimgħa, għal 15 mg.
From week four onwards, the recommended maintenance dose is 20 mg once a day.
Mir- raba 'ġimgħa' l quddiem, id- doża rakkomandata għandha tinżamm 20 mg darba kuljum.
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Id- doża tista 'teħtieġ li titnaqqas f' pazjenti li għandhom problemi moderati jew gravi fil- kliewi tagħhom.
The safety and effectiveness of Ebixa have not been established in patients with severe liver problems.
Is- sigurtà u l- effikaċja ta 'Ebixa ma ġewx stabbiliti f' pazjenti bi problemi gravi tal- fwied.
For more information, see the Package Leaflet.
Għal iktar tagħrif, ara l- Fuljett ta 'Tagħrif.
How does Ebixa work?
Kif jaħdem Ebixa?
The active substance in Ebixa, memantine hydrochloride, is an antidementia medicine.
Is- sustanza attiva f' Ebixa, memantina idroklorur, hija mediċina kontra d- demenza.
The cause of Alzheimer’ s disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.
Il- kawża tal- marda ta 'Alzheimer mhijiex magħrufa, iżda t- telf tal- memorja huwa forsi kkawżat minn disturb tas- sinjali ta' messaġġi fil- moħħ.
Ebixa works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Ebixa jaħdem billi jimblokka tipi speċjali ta 'riċetturi msejħin riċetturi NMDA li magħhom normalment jeħel il- glutammat, li huwa newrotrasmettitur.
Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
In- newrostrasmittituri huma sustanzi kimiċi fis- sistema nervuża li jippermettu li ċelluli tan- nervaturi jikkomunikaw ma 'xulxin.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer’ s disease.
Tibdil fil- mod ta 'kif il- glutammat jittrasmetti sinjali fil- moħħ ġew kollegati ma' telf tal- memorja osservata fil- marda ta 'Alzheimer.
In addition, high levels of glutamate in the brain can cause the nerve cells in the brain to become overstimulated, which may result in cell damage or death.
Barra minn dan, livelli għolja ta 'glutammat fil- moħħ jistgħu
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. jikkawżaw li ċelluli tan- nervaturi fil- moħħ jiġu stimulati żżejjed, li jista 'jirriżulta fi ħsara taċ- ċelluli jew mewt.
By blocking NMDA receptors, memantine hydrochloride blocks these effects of glutamate, improving the transmission of signals in the brain and reducing the symptoms of Alzheimer’ s disease.
Bl- imblukkar tar- riċetturi NMDA, il- memantina idroklorur timblokka dawn l- effetti tal - glutammat, billi tejjeb it- trasmissjoni ta 'sinjali fil- moħħ u tnaqqas is- sintomi tal- marda ta' Alzheimer.
How has Ebixa been studied?
Kif ġie studjat Ebixa?
Ebixa has been studied in three main studies including a total of 1,125 patients with Alzheimer’ s disease, some of whom had taken other medicines for their disease in the past.
Ebixa ġie studjat fi tliet studji prinċipali li involvew total ta '1, 124 pazjent bil- marda ta' Alzheimer, xi wħud minnhom ħadu mediċini oħrajn għal din il- marda fil- passat.
The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
L- ewwel studju involva 252 pazjent b' marda minn moderatament gravi għal gravi, filwaqt li t- tnejn l - oħra involvew total ta '873 pazjent bil- marda fi stadju ħafif jew moderat.
The effects of Ebixa were compared with those of placebo (a dummy treatment) over 24 to 28 weeks.
L- effetti ta 'Ebixa tqabblu ma' dawk tal- plaċebo (trattament finta) fuq 24 sa 28 ġimgħa.
The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Il- kejl ewlieni ta 'l- effikaċja kienu l- bidla tas- sintomi fi tliet oqsma prinċipali: funzjonali (il- grad ta' diżabilità), konjittiv (kapaċità tal- ħsieb, tagħlim u memorja) u globali (kombinazzjoni ta 'oqsma diversi inklużi l- funzjoni ġenerali, sintomi konjittivi, komportament u l- kapaċità li wieħed jagħmel l - attivitajiet ta' kuljum).
Ebixa was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Ebixa ġiet studjata wkoll fi tliet studji addizzjonali li involvew total ta '1, 186 pazjent bil- marda fi stadju ħafif jew gravi.
What benefit has Ebixa shown during the studies?
Liema benefiċċju wera Ebixa waqt l- istudji li ġew imwettqa?
Ebixa was more effective than placebo at controlling the symptoms of Alzheimer’ s disease.
Ebixa kien aktar effikaċi mill- plaċebo biex jikkontrolla s- sintomi tal- marda ta 'Alzheimer.
In the study of moderately severe to severe disease, patients taking Ebixa had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Fl- istudju ta 'mard minn moderatament gravi għal gravi, pazjenti li kienu qed jieħdu Ebixa kellhom inqas sintomi minn dawk li kienu qed jieħdu l- plaċebo wara 28 ġimgħa, kif imkejla fuq punteġġi kemm globali kif ukoll funzjonali.
In the two studies of mild to moderate disease, patients on Ebixa had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Fiż- żewġ studji ta 'mard ħafif għal moderat, il- pazjenti li kienu qed jieħdu Ebixa kellhom sintomi inqas gravi wara 24 ġimgħa, kif imkejla fuq l- punteġġi globali u konjittivi.
However, when these results were considered along with those of the three additional studies, it was noted that the effect of Ebixa was smaller in patients with mild disease.
Madankollu, meta dawn ir- riżultati ġew ikkunsidrati flimkien ma 'dawk tat- tliet studji addizzjonali, ġie nnotat li l- effett ta' Ebixa kien iżgħar f' pazjenti b' mard fi stadju ħafif.
What is the risk associated with Ebixa?
X' inhu r- riskju assoċjat ma 'Ebixa?
The most common side effects with Ebixa (seen in between 1 and 10 patients in 100) are headache, somnolence (sleepiness), hypertension (high blood pressure), constipation and dizziness.
L- aktar effetti sekondarji b' Ebixa (li dehru f' madwar 1 u 10 pazjenti minn kull 100) huma wġigħ ta 'ras, ħedla tan- ngħas ipertensjoni (pressjoni tad- demm għolja), stitikezza u sturdament.
For the full list of all side effects reported with Ebixa, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Ebixa, ara l- Fuljett ta' Tagħrif.
Ebixa should not be used in people who may be hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Ebixa ma għandux jintuża minn persuni li jista 'jkunu ipersensittivi (allerġiċi) għal memantina idroklorur jew għal xi sustanzi oħra.
Why has Ebixa been approved?
Għaliex ġie approvat Ebixa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ebixa’ s benefits are greater than its risks for the treatment of patients with moderate to severe Alzheimer’ s disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Ebixa jgħaddu r- riskji tiegħu għat- trattament ta' pazjenti li jbatu mill- marda ta 'Alzheimer minn moderata għal gravi.
The Committee recommended that Ebixa be given marketing authorisation.
Il- Kumitat irrakkomanda li Ebixa jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ebixa:
Informazzjoni oħra dwar Ebixa:
The European Commission granted a marketing authorisation valid throughout the European Union to H.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha lil H.
Lundbeck A/ S for Ebixa on 15 May 2002.
Lundbeck A/ S għal Ebixa fil- 15 ta 'Mejju 2002.
The marketing authorisation was renewed on 15 May 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 15 ta 'Mejju 2007.
The full EPAR for Ebixa can be found here.
L- EPAR sħiħ għal Ebixa jista 'jiġi kkonsultat hawn.
This summary was last updated in 05-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
folja (alu/ PP) folja (alu/ PP) folja (alu/ PP)
30 tablets 50 tablets 100 tablets
30 pillola 50 pillola 100 pillola
Oral drops solution Oral drops solution Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Soluzzjoni ta ’ qtar orali Soluzzjoni ta ’ qtar orali Soluzzjoni ta ’ qtar orali Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
bottle (glass) bottle (glass) bottle (glass) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja r (alu/ PP)
1 bottle 1 bottle 1 bottle 28 tablets 56 tablets 112 tablets 49 x 1 tablets 100 x 1 tablets 1000 tablets (20 x 50 tablets)
1 x flixkun 1 x flixkun 1 x flixkun 28 pillola 56 pillola 112- il pillola 49 pillola x 1 1 x 100 pillola 1000 pillola (20 x 50 pillola)
10 mg/ g 10 mg
10 mg/ g 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 5mg+10 mg+15m g+20mg
Oral drops solution Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
bottle (glass) blister (PVC/ PVdC/ alu)
flixkun (ħġieġ) folja (PVC/ PVdC/ alu) folja (PVC/ PVdC/ alu) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP)
10 bottles 56 x 1 tablets
10 fliexken 56 pillola x 1 98 pillola x 1 14- il pillola 42 pillola 70 pillola 84 pillola 98 pillola 980 (10 x 98) pillola 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg pillola
EU/ 1/ 02/ 219/ 015
EU/ 1/ 02/ 219/ 023
blister (PVC/ PVdC/ alu)
folja (alu/ PP)
98 x 1 tablets
14 pillola
EU/ 1/ 02/ 219/ 016 EU/ 1/ 02/ 219/ 017 EU/ 1/ 02/ 219/ 018 EU/ 1/ 02/ 219/ 019 EU/ 1/ 02/ 219/ 020 EU/ 1/ 02/ 219/ 021 EU/ 1/ 02/ 219/ 022
EU/ 1/ 02/ 219/ 024 EU/ 1/ 02/ 219/ 025 EU/ 1/ 02/ 219/ 026 EU/ 1/ 02/ 219/ 027 EU/ 1/ 02/ 219/ 028 EU/ 1/ 02/ 219/ 029 EU/ 1/ 02/ 219/ 030 EU/ 1/ 02/ 219/ 031 EU/ 1/ 02/ 219/ 032 EU/ 1/ 02/ 219/ 033 EU/ 1/ 02/ 219/ 034
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 5mg+10 mg+15mg+20mg
20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP)
14 tablets 42 tablets 70 tablets 84 tablets 98 tablets 980 (10 x 98) tablets 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
28 pillola 42 pillola 49 x 1 pillola 56 pillola 56 x 1 pillola 70 pillola 84 pillola 98 pillola 98 x 1 pillola 100 x 1 pillola 112 pillola
EU/ 1/ 02/ 219/ 023 EU/ 1/ 02/ 219/ 024 EU/ 1/ 02/ 219/ 025 EU/ 1/ 02/ 219/ 026 EU/ 1/ 02/ 219/ 027 EU/ 1/ 02/ 219/ 028 EU/ 1/ 02/ 219/ 029 EU/ 1/ 02/ 219/ 030 EU/ 1/ 02/ 219/ 031 EU/ 1/ 02/ 219/ 032 EU/ 1/ 02/ 219/ 033
1/ 2 2
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
EU/ 1/ 02/ 219/ 035
20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg
Ebixa
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
20 mg
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Pillola miksija b’ rita
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
folja (alu/ PP)
14 tablets 28 tablets 42 tablets 49 x 1 tablets 56 tablets 56 x 1 tablets 70 tablets 84 tablets 98 tablets 98 x 1 tablets 100 x 1 tablets
840 pillola (20 x 42 pillola)
Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita
Oral use Oral use Oral use
Użu orali
112 tablets 840 tablets (20 x 42 tablets) 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg pillola
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
14 tablets 28 tablets 42 tablets 49 x 1 tablets 56 tablets 56 x 1 tablets 70 tablets 84 tablets 98 tablets 98 x 1 tablets 100 x 1 tablets 112 tablets 840 tablets (20 x 42 tablets)
28 pillola 42 pillola 49 x 1 pillola 56 pillola 56 x 1 pillola 70 pillola 84 pillola 98 pillola 98 x 1 pillola 100 x 1 pillola 112 pillola 840 pillola (20 x 42 pillola)
Ebixa 10 mg film-coated tablets
Ebixa 10 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
Kull pillola miksija b’ rita fiha 10 mg memantine hydrochloride (ekwivalenti għal 8. 31 mg memantine).
Each film-coated tablet contains 166 mg lactose, see section 4.4.
Kull pillola miksija b’ rita fiha 166 mg lattosju, ara sezzjoni 4. 4.
Film-coated tablets.
Pillola miksija b’ rita.
White to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
Pilloli miksijin b’ rita bojod jagħtu fl- offwajt, oblong u ippuntati fin- nofs, imbuzzati miż- żewġ naħat, b’ xaqq minn fejn tista ’ taqsam iż- żewġ naħat.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ nofsijiet ugwali.
Treatment of patients with moderate to severe Alzheimer’ s disease.
Kura ta ’ pazjenti bil- marda ta ’ Alzheimer moderata għal severa.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia.
Il- kura għandha tibda tingħata u tibqa taħt superviżjoni ta ’ tabib li jkollu esperjenza bid- dijanjożi u l - kura tad- dimenzja ta ’ Alzheimer.
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.
It- terapija għandha tinbeda biss jekk ikun hemm persuna li timmoniterja t- teħid tal- prodott mediċinali mill- pazjent.
Diagnosis should be made according to current guidelines.
Id- dijanjożi għandha ssir skond il- linji gwida li hemm bħalissa.
Ebixa should be administered once a day and should be taken at the same time every day.
Ebixa għandha tingħata darba kuljumu għandha tittieħed fl- istess ħin darba kuljum.
The tablets can be taken with or without food.
Il- pilloli miksija b’ rita jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
Dose titration
Tittrazzjoni tad- doża
The maximum daily dose is 20 mg per day.
Id- doża massima ta ’ kuljum hija ta ’ 20 mg kuljum.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Sabiex jitnaqqas ir- riskju ta ’ effetti mhux mixtieqa d- doża ta ’ manteniment tinkiseb billi tittella ’ bil- mod minn doża ta ’ 5 mg fil- ġimgħa għall- ewwel 3 ġimgħat kif ġej:
Week 1 (day 1-7):
L- 1 ġimgħa (jum 1- 7):
The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Il- pazjent għandu jieħu nofs pillola miksija b’ rita ta ’ 10 mg kuljum (5 mg) għal 7 t’ ijiem
Week 2 (day 8-14):
It- 2 ġimgħa:
The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Il- pazjent għandu jieħu pillola miksija b’ rita ta ’ 10 mg (10 mg) kuljum għal 7 t’ ijiem
Week 3 (day 15-21):
It- 3 ġimgħa:
The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Il- pazjent għandu jieħu pillola u nofs miksija b’ rita ta ’ 10 mg (15 mg) kuljum għal 7 t’ ijiem.
From Week 4 on:
Mir- 4 ġimgħa ’ l quddiem:
2 The patient should take two 10 mg film-coated tablets (20 mg) per day.
2 Il- pazjent għandu jieħu żewġ pilloli miksija b’ rita ta ’ 10 mg (20 mg) kuljum.
Maintenance dose
Doża ta ’ manteniment
The recommended maintenance dose is 20 mg per day.
Id- doża rakkomandata hi ta ’ 20 mg kuljum
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two tablets once a day) as described above.
Minn studji kliniċi, id- doża rakkomandata għal pazjenti li għandhom ’ l fuq minn 65 sena hija 20 mg kuljum (żewġ pilloli darba kuljum) kif spjegat hawn fuq.
Ebixa is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Ebixa mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/ min) no dose adjustment is required.
F’ pazjenti b’ funzjoni renali indebolita b’ mod ħafif (tneħħija tal- kreatinina 50- 80 ml/ min) m’ hemmx bżonn li tinbidel id- doża.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment renali moderat (tneħħija tal- kreatinina 30 – 49 ml/ min) id- doża għandha tkun 10 mg kuljum.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/ day according to standard titration scheme.
Jekk il- pazjent ikun jittollerha sew wara mill- anqas 7 ijiem ta ’ kura, id- doża tista ’ tiġi miżjuda sa 20 mg/ jum skond l- iskema standard ta ’ kif għandha tiżdied.
In patients with severe renal impairment (creatinine clearance 5 – 29 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment sever renali (tneħħija tal- kreatinina 5- 29 ml/ min) id- doża ta ’ kuljum għandha tkun 10 mg kuljum.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
F’ pazjenti b’ indeboliment epatiku ħafif għal moderat (Child- Pugh A u Child- Pugh B) m’ hemmx bżonn ta ’ tibdil fid- dożaġġ.
No data on the use of memantine in patients with severe hepatic impairment are available.
M’ hemmx tagħrif dwar l- użu ta ’ memantine f’ pazjenti b’ indeboliment epatiku sever.
Administration of Ebixa is not recommended in patients with severe hepatic impairment.
It- teħid ta ’ Ebixa mhux rakkomandat f’ pazjenti li għandhom indeboliment epatiku sever.
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Hija rakkomandata l- attenzjoni f’ pazjenti li jbatu b’ epilessija, passat ta ’ aċċessjonijiet jew pazjenti li għandhom fatturi li minħabba fihom ikollhom tendenza għall- epilessija.
Concomitant use of N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
L- użu fl- istess ħin ta ’ antagonisti- N- methyl- D- aspartate (NMDA) bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Dawn is- sustanzi jaħdmu fuq l- istess sistema ta ’ riċettur bħal memantine, u għalhekk effetti avversi (l- aktar relatati mas- sistema nervuża ċentrali (SNĊ)) jistgħu jseħħu b’ mod aktar frekwenti jew aktar bil- qawwa (ara wkoll sezzjoni 4. 5).
Some factors that may raise urine pH (see section 5.2 “ Elimination”) may necessitate careful monitoring of the patient.
Xi fatturi li jistgħu jgħollu l- pH ta ’ l- awrina (ara sezzjoni 5. 2 “ Eliminazzjoni ”) jistgħu jeħtieġu monitoraġġ bir- reqqa tal- pazjent.
These factors include drastic changes in diet, e. g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Dawn il- fatturi jinkludu bidla drastika tad- dieta, eż. minn dieta li tinkludi l- laħam għal waħda veġetarjana, jew it- teħid ta ’ ammonti kbar ta ’ buffers gastriċi alkalini.
Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Minbarra hekk, il- pH ta ’ l- awrina tista ’ titla minħabba każijiet ta ’ aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal- passaġġ awrinarju b’ Proteus bacteria.
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Fil- parti l- kbira tal- provi kliniċi, pazjenti li ftit qabel kellhom infart mijokardijaku, insuffiċjenza mhux kompensata tal- qalb konġestiva (NYHA III- IV), jew pressjoni għolja mhux kontrollata kienu esklużi.
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Minħabba f’ hekk hemm tagħrif limitat u pazjenti b’ dawn il- kondizzjonijiet għandhom jinżammu taħt superviżjoni mill- qrib.
The tablets contain lactose monohydrate.
Sustanzi mhux attivi: Il- pilloli fihom lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi rari li jintirtu ta ’ intolleranza għal galactose, nuqqas ta ’ Lapp lactase jew mal assorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
Minħabba l- effetti farmakoloġiċi u l- mekkaniżmu ta ’ kif jaħdem memantine, jistgħu jseħħu dawn l- interazzjonijiet li ġejjin:
3 • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
• Il- mod kif jaħdem jindika li l- effeti ta ’ L- Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma ’ antaginisti ta ’ NMDA bħal memantine.
The effects of barbiturates and neuroleptics may be reduced.
L- effetti ta ’ barbiturati u newrolettiċi jistgħu jiddgħajjfu.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Meta memantine jingħata flimkien ma ’ mediċini antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn ta ’ bidla fid- doża. • L- użu ta ’ memantine u amantadine għandu jkun evitat, minħabba r- riskju ta ’ psikożi farmakotossika.
Both compounds are chemically related NMDA-antagonists.
Iż- żewġ sustanzi huma antagonsiti- NMDA kimikament relatati.
The same may be true for ketamine and dextromethorphan (see also section 4.4).
Dan jista ’ jgħodd ukoll għal ketamine u dextromethorphan (ara wkoll sezzjoni 4. 4).
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Hemm rapport wieħed ta ’ każ li kien publikat dwar riskju li jista ’ jkun hemm meta memantine jingħata ma ’ phenytoin. • Sustanzi attivi oħra bħal cimetidine, ranitidine, procainamide, quinidine, quinine u nicotine li jużaw l- istess sistema ta ’ trasport ketajoniku renali bħal amantadine jistgħu ukoll jinteraġixxu ma ’ memantine u b’ hekk jista ’ jkun hemm riskju ta ’ livelli ogħla fil- plażma. • Jista ’ jkun hemm possibilità ta ’ livelli ta ’ hydrochlorthiazide (HCT) imnaqqsa fis- serum meta memantine jingħata ma ’ HCT jew kwalunkwe taħlita ma ’ HCT. • Fl- esperjenza wara t- tqegħid fis- suq, każijiet iżolati b’ żidiet fil- proporzjon internazzjonali normalizzat (INR) kienu rrappurtati f’ pazjenti li kienu qed jingħataw fl- istess waqt warfarin.