qanastek/EMEA-V3 huggingface dataset:
To benefit from your medicine you should take it regularly every day at the same time of the day.
Biex tikseb benefiċċju mil- mediċina tiegħek, għandek tkompli teħodha kuljum fl- istess ħin tal- ġurnata.
The tablets should be swallowed with some water.
Il- pilloli għandhom jinbelgħu ma ’ ftit ilma.
The tablets can be taken with or without food.
Il- pilloli jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
Duration of treatment
Kemm għandha ddum il- kura
Continue to take Ebixa as long as it is of benefit to you.
Kompli ħu Ebixa sakemm tibqa ’ tikseb benefiċċju.
Your doctor should assess your treatment on a regular basis.
It- tabib tiegħek għandu jevalwa l- kura tiegħek fuq bażi regolari.
If you take more Ebixa than you should
Jekk tieħu Ebixa aktar milli suppost
- In general, taking too much Ebixa should not result in any harm to you.
- B’ mod ġenerali, meta tieħu wisq Ebixa m’ għandha tiġrilek l- ebda ħsara.
You may experience
Jista ’ jkollok aktar
„ Possible side effects“.
sintomi li hemm imsemmija f’ sezzjoni 4. “ Effetti sekondarji li jista ’ jkollu ”.
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may
- Jekk tieħu doża eċċessiva kbira ta ’ Ebixa, għamel kuntatt mat- tabib tiegħek jew ikseb parir
need medical attention.
mediku, għax jista ’ jkollok bżonn attenzjoni medika.
If you forget to take Ebixa
67 Jekk tinsa tieħu Ebixa
- If you find you have forgotten to take your dose of Ebixa, wait and take your next dose at the
- Jekk tinduna li nsejt tieħu doża ta ’ Ebixa, stenna u ħu d- doża li jmissek fil- ħin tas- soltu.
- Do not take a double dose to make up for a forgotten dose.
- M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Ebixa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ebixa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In general, the observed side effects are mild to moderate.
B’ mod ġenerali, l- effetti sekondarji li jidhru jkunu ħfief għal moderati.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation dizziness and high blood pressure
Komuni (jaffettwa minn 1 sa 10 utenti f’ 100): • Uġigħ ta ’ ras, ngħas, stitkezza, sturdament u pressjoni għolja tad- demm.
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/ thromboembolism)
Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, Insufiċjenza kardijaka u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
Very Rare (affects less than 1 user in 10,000): • Seizures
Rari ħafna (jaffettwa inqas minn utent 1 f’ 10, 000): • Aċċessjonijiet.
Not known (frequency cannot be estimated from the available data) • Inflammation of the pancreas and psychotic reactions
Mhux magħruf (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli): • Infjammazzjoni tal- frixa u reazzjonijiet psikotiċi
Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Il- marda ta ’ Alzheimer kienet assoċjata ma ’ dipressjoni, ħsibijiet ta ’ suwiċidju u suwiċidju.
These events have been reported in patients treated with Ebixa.
Dawn il- kazijiet gew irrapurtati minn pazjenti li hadu Ebixa.
HOW TO STORE EBIXA
KIF TAĦŻEN EBIXA
Do not use Ebixa after the expiry date which is stated on the carton and the blister after EXP.
Tużax Ebixa wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja wara JIS.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ta ’ xi kundizzjonijet ta ’ ħażna speċjali.
What Ebixa contains
X’ fih Ebixa:
The active substance is memantine hydrochloride.
Is- sustanza attiva hi memantine hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.
Is- sustanzi l- oħra huma lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc u magnesium stearate, kollha fil- qalbha tal- pillola; u methacrylic acid - ethyl acrylate copolymer
67 What Ebixa looks like and contents of the pack
Id- Dehra ta ’ Ebixa u l- kontenuti tal- pakkett:
Ebixa film-coated tablets are presented as white to off-white, centrally tapered oblong biconvex, film- coated tablets with a single breakline on both sides.
Il- pilloli miksijin b’ rita ta ’ Ebixa jiġu bħala pilloli bojod jagħtu fl- offwajt, oblong imbuzzat li ġej għal ponta fin- nofs, miksijin b’ rita u b’ xaqq minn fejn jinqasmu fuq iż- żewġ naħat.
Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 49 x 1 tablets, 50 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 tablets, 100 x 1, 112 tablets, 980 (10 x 98) tablets or 1000 (20 x 50) tablets.
Il- pilloli miksijin b’ rita ta ’ Ebixa jiġu f’ pakketti ta ’ folji b ’ 14- il pillola, 28 pillola, 30 pillola, 42 pillola, 49 x 1 pillola, 50 pillola, 56 pillola, 56 x 1 pillola, 70 pillola, 84 pillola, 98 pillola, 98 x 1 pillola, 100 pillola, 100 x 1 pillola, 112- il pillola, 980 (10 x 98) pillola jew 1000 (20 x 50) pillola.
The pack sizes 49 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Il- paketti bid- daqsijiet ta ’ 49 x 1, 56 x 1, 98 x 1 u 100 x 1 pilloli miksijin b’ rita huma preżentati f’ folji ta ’ dożi individwali.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u manifattur:
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby Denmark.
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Id- Danimarka
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- medicina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Deutschland Lundbeck GmbH Karnapp 25 D-21079 Hamburg Tel: +49 40 23649 0
69 Deutschland Lundbeck GmbH Karnapp 25 D- 21079 Hamburg Tel: +49 40 23649 0
France Lundbeck SAS 37 Avenue Pierre 1er de Serbie F-75008 Paris Tél: +33 1 53 67 42 00
România France Lundbeck Export A/ S, Lundbeck SAS 37 Avenue Pierre 1er de Serbie F- 75008 Paris Tél: +33 1 53 67 42 00
Κύπρος Lundbeck Hellas A. E Θεμ.
70 Κύπρος Lundbeck Hellas A. E Θεμ.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
70 PACKAGE LEAFLET:
71 FULJETT TA ’ TAGĦRIF:
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Il - moħħ fih l- hekk imsejjħa riċetturi- N- methyl- D- aspartate (NMDA) li jieħdu sehem fit- trasmissjoni tas - sinjali fin- nervituri importanti għat- tagħlim u l- memorja.
Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Ebixa jaħdem fuq dawn ir- riċetturi- NMDA u jtejjeb it - trasmissjoni tas- sinjali fin- nervituri u l- memorja.
Ebixa is used for the treatment of patients with moderate to severe Alzheimer’ s disease.
Ebixa jintuża għall- kura ta ’ pazjenti bil- marda ta ’ Alzheimer moderata għal severa.
Do not take Ebixa
Tieħux Ebixa:
of Ebixa oral drops (see section 6).
oħra li jinsabu fil- qtar tas- soluzzjoni orali ta ’ Ebixa (ara sezzjoni 6)
from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
tal- qalb konġestiva jew minn pressjoni għolja li ma tistax tikkontrollha (pressjoni tad- demm għolja).
71 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
72 Jekk tbati minn indeboliment renali (problemi fil- kliewi), it- tabib tiegħek għandu jżommlok il - funzjoni tal- kliewi taħt osservazzjoni mill- qrib u jekk ikun hemm bżonn jadatta d- dożi ta ’ memantine kif ikun jixraq
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
L- użu ta ’ prodotti mediċinali msejjħa amantadine (għat- trattament tal- marda ta ’ Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment tintu# a għas- sogħla) u antagonisti oħra ta ’ NMDA fl- istess ħin għandu jkun evitat.
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma ’ hydrochlorothiazide) antikolinerġiċi (sustanzi li ġeneralment jintużaw għall- kura ta ’ disturbi fil- movimenti jew spażmi fl- imsaren) mediċini kontra l- aċċessjonijiet (mediċini li jintużaw biex ikunu evitati jew iserrħu l- aċċessjonijiet) barbiturati (sustanzi li ġeneralment jintużaw biex jgħinuk torqod) agonisti dopaminerġiċi (sustanzi bħal L- dopa, bromocriptine) newrolettiċi (sustanzi li jintużaw għall- kura ta ’ disturbi tal- moħħ) mediċini orali kontra l- koagulazzjoni tad- demm
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Għandek tgħarraf lit- tabib tiegħek jekk dan l- aħħar bdilt id- dieta tiegħek jew bi ħsiebek tibdel id- dieta tiegħek b’ mod sostanzjali (eż minn dieta normali għal waħda veġetarjana stretta) jew jekk qed tbati minn stat ta ’ aċidożi tubulari renali (RTA, jiżdiedu s- sustanzi li jiffurmaw l- aċidu fid- demm minħabba funzjoni renali batuta (il- kliewi ma jaħdmux tajjeb)) jew infezzjonijiet severi tal- passaġġ awrinarju, (struttura li minnha tgħaddi l- awrina) għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal - mediċina tiegħek.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
It- tabib tiegħek ser jgħidlek jekk il- marda tiegħek tħallikx issuq u tħaddem magni b’ mod sigur.
This medicinal product contains sorbitol.
73 Dan il- prodott mediċinali fih ukoll sorbitol.
72 Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i. e. essentially potassium-free.
Minbarra hekk, din il- mediċina fiha potassium, anqas minn 1 mmol (39 mg) kull doża, i. e. tista ’ titqies li ma fihiex potassju.
Always take Ebixa exactly as your doctor has told you.
Dejjem għandek tieħu Ebixa eżatt kif qallek it- tabib.
The recommended dose of Ebixa for adults and elderly patients is 20 mg once a day.
Id- doża rakkomandata ta ’ Ebixa għall- adulti u pazjenti anzjani hija 20 mg darba kuljum.
10 drops
10 taqtiriet
20 drops
20 taqtira
30 drops
30 taqtira
40 drops
40 taqtira
The usual starting dose is 10 drops once a day (1x 5 mg) for the first week.
Id- doża tas- soltu tal- bidu hija ta ’ 10 taqtiriet darba kuljum (1 x 5 mg) għall- ewwel ġimgħa.
This is increased to 20 drops once a day (1x10 mg) in the second week and to 30 drops once a day taken in the third week.
Din tiżdied għal 20 taqtira darba kuljum (1x10 mg) fit- tieni ġimgħa u għal 30 taqtira darba kuljum fit- tielet ġimgħa.
From the fourth week on, the recommended dose is 40 drops once a day (1x20 mg).
Mir- raba ’ ġimgħa ’ l quddiem, id- doża rakkomandata hija ta ’ 40 taqtira darba kuljum (1x20 mg).
To benefit from your medicine you should take it regularly every day at the same time of the day.
Biex tikseb benefiċċju mil- mediċina tiegħek għandek tkompli teħodha kuljum fl- istess ħin tal- ġurnata.
The drops should be swallowed with some water.
Il- qtar għandhom jinbelgħu ma ’ ftit ilma.
The drops can be taken with or without food.
Il- qtar jistgħu jittieħdu ma ’ l- ikel jew fuq stonku vojt.
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need
- Jekk tieħu doża eċċessiva kbira ta ’ Ebixa, għamel kuntatt mat- tabib tiegħek jew ikseb parir
medical attention.
mediku, għax jista ’ jkollok bżonn attenzjoni medika.
If you forget to take Ebixa
74 Jekk tinsa tieħu Ebixa
73 If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure
Komuni (jaffettwa minn 1 sa 10 utenti f’ 100 persuna): • Uġigħ ta ’ ras, ngħas, stitkezza, sturdament u pressjoni għolja tad- demm.
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/ thromboembolism)
Mhux komuni (jaffettwa minn 1 sa 10 utent f’ 1, 000 persuna): • Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, Insufiċjenza kardijaka u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
Very Rare (affects less than 1 user in 10,000): • Seizures
Rari ħafna (jaffettwa anqas minn utent 1 f’ 10, 000 persuna): • Aċċessjonijiet
These events have been reported in patients treated with Ebixa.
Dawn il- kazijiet gew irrapurtati minn pazjenti li hadu l- Ebixa.
Do not use Ebixa after the expiry date which is stated on the carton and the bottle label after EXP.
Tużax Ebixa wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- flixkun wara JIS.
Do not store above 30ºC.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Once opened, the contents of the bottle should be used within 3 months.
La darba jinfetaħ, il- kontenuti tal- flixkun għandhom jintużaw fi żmien 3 xhur.
What Ebixa contains
X’ fih Ebixa
Each one gram of oral drops, solution contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
Kull gramma ta ’ qtar orali fiha 10 mg memantine hydrochloride (ekwivalenti għal 8. 31 mg memantine).
The other ingredients are potassium sorbate, sorbitol E420 and purified water.
75 Is- sustanzi l- oħra huma potassium sorbate, sorbitol E420 u ilma purifikat.
What Ebixa looks like and contents of the pack
Id- Dehra ta ’ Ebixa u l- kontenuti tal- pakkett:
Ebixa oral drops, solution is presented as a clear, colourless to light yellowish solution.
Is- soluzzjoni ta ’ qtar orali Ebixa, tiġi bħala soluzzjoni ċara, bla kulur tagħti fl- isfar ċar.
74 Ebixa oral drops, solution is available in bottles of 20 g, 50 g, 100 g or 10 x 50 g.
Is- soluzzjoni ta ’ qtar orali Ebixa, tiġi fi fliexken ta ’ 20 g, 50 g, 100 g jew 10 x 50 g.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u Manifattur:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eesti H.
76 Eesti Österreich H.
Latvija H.
77 Latvija H.
77 PACKAGE LEAFLET:
78 FULJETT TA ’ TAGĦRIF:
Ebixa 5 mg film-coated tablets Ebixa 10 mg film-coated tablets Ebixa 15 mg film-coated tablets Ebixa 20 mg film-coated tablets Memantine hydrochloride
Ebixa 5 mg pilloli miksijin b’ rita Ebixa 10 mg pilloli miksijin b’ rita Ebixa 15 mg pilloli miksijin b’ rita Ebixa 20 mg pilloli miksijin b’ rita Memantine hydrochloride
In this leaflet
F’ dan il- fuljett
Further information
1 X’ inhu Ebixa u għalxiex jintuża 2 Qabel ma tieħu Ebixa 3 Kif għandek tieħu Ebixa 4 Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Ebixa 6 Aktar tagħrif
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Il- moħħ fih l- hekk imsejjħa riċetturi- N- mthyl D- aspartate (NMDA) li jieħdu sehem fit- trasmissjoni tas- sinjali fin- nervituri importanti għat- tagħlim u l- memorja.
78 In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
79 F’ dawn il- każijiet il- kura għandha tkun sorveljata bir- reqqa, u l- benefiċċju kliniku ta ’ Ebixa jiġi evalwat mill- ġdid mit- tabib tiegħek fuq bażi regolari.
If you suffer from renal impairment (kidney problems) your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Jekk tbati minn indeboliment renali (problemi fil- fwied), it- tabib tiegħek għandu jżommlok il- funzjoni tal- kliewi taħt osservazzjoni mill- qrib u jekk ikun hemm bżonn jadatta d- dożi ta ’ memantine kif ikun jixraq.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
L- użu ta ’ prodotti mediċinali msejjħa amantadine (għat- trattament tal- marda ta ’ Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment użata għas- sogħla) u antagonisti oħra ta ’ NMDA fl- istess ħin għandu jkun evitat.
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma ’ hydrochlorothiazide) antikolinerġiċi (sustanzi li ġeneralment jintużaw għall- kura ta ’ disturbi fil- movimenti jew spażmi fl- imsaren) mediċini kontra l- aċċessjonijiet (mediċini li jintużaw biex ikunu evitati jew iserrħu l- aċċessjonijiet) barbiturati (sustanzi li ġeneralment jintużaw biex jgħinuk torqod) agonisti dopaminerġiċi (sustanzi bħal L- dopa, bromocriptine) newrolettiċi (sustanzi li jintużaw għall- kura ta ’ disturbi tal- moħħ) nediċini orali kontra l- koagulazzjoni tad- demm
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Għandek tgħarraf lit- tabib tiegħek jekk dan l- aħħar bdilt id- dieta tiegħek jew bi ħsiebek tibdel id- dieta tiegħek b’ mod sostanzjali (eż minn dieta normali għal waħda veġetarjana stretta) jew jekk qed tbati minn stat ta ’ aċidożi tubulari renali (RTA, jiżdiedu s- sustanzi li jiffurmaw l- aċidu fid- demm minħabba funzjoni renali batuta (il- kliewi ma jaħdmux tajjeb)) jew infezzjonijiet severi tal- passaġġ awrinarju, (struttura li minnha tgħaddi l- awrina) għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal- mediċina tiegħek.
Important information about some of the ingredients of Ebixa
80 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ebixa
79 Ebixa 10 mg film-coated tablets contain lactose.
Il- pilloli miksijin b’ rita t’ Ebixa 10 mg fihom il- lattosju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal ċertu tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
The Ebixa treatment initiation pack is only to be used for the beginning of the treatment with Ebixa.
Il- pakkett għal bidu tat- trattament ta ’ Ebixa għandu jintuża biss fil- bidu tat- trattament b’ Ebixa.
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Ebixa dose during the first 3 weeks of treatment.
Id- doża rakkomandata ta ’ Ebixa hija ta ’ 20 mg kuljum li tintlaħaq billi tiżdided b’ mod gradwali id- doża ta ’ Ebixa matul l- ewwel tliet ġimgħat ta ’ trattament.
The treatment scheme is also indicated on the treatment initiation pack.
L- iskema tat- trattament hija wkoll indikata fil- pakkett tal- bidu ta ’ trattament.
Take one tablet once a day.
Ħu pillola waħda kuljum.
Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Ġimgħa 1 (jum 1- 7) Ħu pillola miksija b’ rita waħda ta ’ 5 mg kuljum (bajda għal offwajt, ovali- oblong) għal 7 t’ ijiem.
Take one 10 mg tablet once a day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Ġimgħa 2 (jum 8- 14) Ħu pillola miksija b’ rita waħda ta ’ 10 mg kuljum (bajda għal offwajt, oblong ġejja għal punta fin- nofs, imbuzzata ’ l barra fuq iż- żewġ naħat, b’ linja ta ’ briexxfuq iż- żewġ naħat) għal 7 t’ ijiem.
Take one 15 mg tablet once a day (grey-orange, oval-oblong film) for 7 days.
Ġimgħa 3 (jum 15- 21) Ħu pillola miksija b’ rita waħda kuljum ta ’ 15 mg (oranġjo- griża, ovali- oblong b’ rita) għal 7 t’ ijiem.
Take one 20 mg tablet per day (grey-red, oval-oblong film) for 7 days.
Ġimgħa 4 (jum 22- 28) Ħu pillola miksija b’ rita waħda kuljum ta ’ 20 mg (ħamra- griża ovali- oblong b’ rita) għal 7 t’ ijiem
5 mg tablet
pillola ta ’ 5 mg
10 mg tablet
pillola ta ’ 10 mg
15 mg tablet
pillola ta ’ 15 mg
20 mg tablets once a day
pillola ta ’ 20 mg darba kuljum
The recommended daily dose is 20 mg once a day.
Id- doża rakkomandata tas- soltu hija ta ’ 20 mg kuljum.
For continuation of the treatment please consult your doctor.
Sabiex tkompli t- trattament jekk jogħġbok ikkonsulta t- tabib tiegħek.
Administration
81 Kif jingħata
To benefit from your medicine you should take it regularly every day at the same time of the day.
Ebixa għandha tingħata b’ mod orali darba kuljum Biex tikseb benefiċċju mil- mediċina tiegħek, għandek tkompli teħodha kuljum fl- istess ħin tal- ġurnata.
80 Duration of treatment
Kemm għandha ddum il- kura
If you forget to take Ebixa
Jekk tinsa tieħu Ebixa
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation dizziness and high blood pressure
Komuni (jaffettwa minn utent 1 sa 10 f’ 100): • Uġigħ ta ’ ras, ngħas, stitkezza, sturdament u pressjoni għolja tad- demm.
Very Rare (affects less than 1 user in 10,000): • Seizures
Rari ħafna (jaffettwa anqas minn 1 f’ 10, 000 persuna): • Aċċessjonijiet.
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
Mhux magħruf (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli): • Infjammazzjoni tal- frixa u reazzjonijiet psikotiċi
Do not use Ebixa after the expiry date which is stated on the carton and the blister after EXP.
82 Tużax Ebixa wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja wara JIS.
81 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each tablet contains 5/ 10/ 15/ 20 mg of memantine hydrochloride equivalent to 4.15/ 8.31/ 12.46/ 16.62 mg memantine.
Kull pillola fiha 5/ 10/ 15/ 20 mg memantine hydrochloride li hi ekwivalenti għal 4. 15/ 8. 31/ 12. 46/ 16. 62 mg memantine.
The other ingredients for Ebixa 5/ 15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Is- sustanzi l- oħra f’ Ebixa 5/ 15 u 20 mg huma microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, li lkoll jinsabu fil- qalba tal- pillola; u hypromellose, macrogol 400, titanium dioxide (E 171) kif ukoll iron oxide yellow u red (E 172), li jinsabu fil- kisja tal- pilloli miksijin b’ rita ta ’ Ebixa 15 mg u Ebixa 20 mg.
The other ingredients for Ebixa 10 mg film-coated tablets are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.
Is- sustanzi l- oħra tal- pilloli miksija b’ rita ta ’ Ebixa 10 mg huma lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc u magnesium stearate, li jinsabu fil- qalba tal- pillolau methacrylic acid - colloidal anhydrous silica, talc u magnesium stearate, kollha fil- qalba tal- pillola; u methacrylic acid - ethyl acrylate copolymer (1: 1), sodium lauryl sulphate, polysorbate 80, talc, triacetin u simethicone emulsion, ilkoll fil- kisja tal- pillola.
What Ebixa looks like and contents of the pack
Id- dehra ta ’ Ebixa u l- kontenuti tal- pakkett:
Ebixa 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘ 5’ on one side and imprint ‘ MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ Ebixa 5 mg huma bojod għal offwajt, f’ għamla ovali- oblong b’ intaljar ta ’ ‘ 5 ’ fuq naħa waħda u intaljar ta ’ ‘ MEM ’ fuq in- naħa l- oħra.
Ebixa 10 mg film-coated tablets are presented as white to off-white, centrally tapered oblong biconvex, film-coated tablets with a single breakline on both sides.
Il- pilloli miksijin b’ rita ta ’ Ebixa 10 mg huma bojod għal offwajt, oblong u ġejjin għal ponta fin- nofs, imbuzzati ’ l barra, b’ xaqq wieħed fuq iż- żewġ naħat.
Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘ 15’ on one side and imprint ‘ MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ Ebixa 15 mg huma oranġjo għal oranġjo griżi, ovali- oblong b’ intaljar ta ’ ‘ 15 ’ fuq naħa u intaljar ta ’ ‘ MEM ’ fuq naħa oħra.
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Il- pilloli miksijin b’ rita ta ’ Ebixa 20 mg huma ħomor ċari għal ħomor griżi, pilloli miksijin b’ rita li huma ovali- oblong b’ intaljar ta ’ ‘ 20 ’ fuq naħa u intaljar ta ’ ‘ MEM ’ fuq naħa oħra.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby Denmark.
Lundbeck A/ S Ottiliavej 9 DK- 2500 Valby Id- Danimarka.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL - Dublin 24 Tel: +353 1 468 9800
84 Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL - Dublin 24 Tel: +353 1 468 9800
84 PACKAGE LEAFLET:
85 FULJETT TA ’ TAGĦRIF:
of Ebixa tablets (see section 6).
oħra tal- pilloli Ebixa (ara sezzjoni 6).
from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
tal- qalb konġestiva jew minn pressjoni għolja li ma tistax tikkontrollha (pressjoni għolja tad - demm).
85 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
86 Jekk tbati minn indeboliment renali, (problemi fil- kliewi) it- tabib tiegħek għandu jżommlok il - funzjoni tal- kliewi taħt osservazzjoni mill- qrib u jekk ikun hemm bżonn jadatta d- dożi ta ’ memantine kif ikun jixraq.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function))or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Għandek tgħarraf lit- tabib tiegħek jekk dan l- aħħar bdilt id- dieta tiegħek jew bi ħsiebek tibdel id- dieta tiegħek b’ mod sostanzjali (eż minn dieta normali għal waħda veġetarjana stretta) jew jekk qed tbati minn stat ta ’ aċidożi tubulari renali (RTA, jiżdiedu s- sustanzi li jiffurmaw l- aċidu fid- demm minħabba funzjoni renali batuta) jew infezzjonijiet severi tal- passaġġ awrinarju (struttura li minnħa tgħaddi l- awrina), għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal- mediċina tiegħek.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Minbarra hekk, Ebixa jista ’ jibdillek il- ħila biex tirreaġixxi, u għalhekk ma jkunx xieraq li ssuq jew tħaddem magni.
Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ebixa
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme.
Sabiex tnaqqas ir- riskju ta ’ effetti sekondarji din id- doża tinkiseb bil- mod bl- iskema ta ’ kura ta ’ kuljum kif ġej:
For up-titration other tablet strengths are available.
Għal tittrazzjoni ’ l fuq pilloli ta ’ qawwiet oħra huma disponibbli.
At the beginning of treatment you will start by using Ebixa 5 mg film-coated tablets once a day.
Fil- bidu tat- trattament għandek tibda billi tuża pilloli miksija b’ rita ta ’ Ebixa 5 mg darba kuljum.
This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Din id- doża għandha tiżdied kull ġimgħa b’ 5 mg sakemm id- doża (ta ’ manteniment) rakkomandata tintlaħaq.
The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg darba kuljum, li tintlaħaq fil- bidu tar- raba ’ ġimgħa.
Like all medicines, Ebixa can cause side effects, although not everybody gets them.
88 Bħal kull mediċina oħra, Ebixa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Headache, sleepiness, constipation dizziness and high blood pressure
Komuni (jaffettwa minn 1 sa 10 utenti f’ 100): • Uġigħ ta ’ ras, ngħas, stitkezza, sturdament u pressjoni għolja tad- demm.
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Mhux komuni (jaffettwa minn 1 sa 10 utenti f’ 1000 persuna): o Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, Insufiċjenza kardijaka u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Kull pillola miksija b’ rita fiha 20 mg memantine hydrochloride li hi ekwivalenti għal 16. 62 mg memantine.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Is- sustanzi l- oħra huma microcrystalline cellulose, colloidal anhydrous silica, talc u magnesium stearate, kollha fil- qalbha tal- pillola; u hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow u red (E172), kollha fil- kisja tal- pillola.
Ebixa film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20’ on one side and imprint ‘MEM’ on the other side.
Il- pilloli miksija b’ rita ta ’ Ebixa jiġu bħala pilloli ħomor ċari għal ħomor griżi, pilloli miksija b’ rita li huma ovali- oblong b’ intaljar ta ’ ‘ 20 ’ fuq naħa u intaljar ta ’ ‘ MEM ’ fuq naħa oħra..
The pack sizes 49 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Il- pilloli miksijin b’ rita ta ’ Ebixa jiġu f’ pakketti ta ’ folji bi 14- il pillola, 28 pillola, 42 pillola, 49 x 1 pillola, 56 pillola, 56 x 1 pillola, 70 pillola, 84 pillola, 98 pillola, 98 pillola x 1 u 100 x 1 pillola miksija f’ rita f’ folja ta ’ doża waħda.
Not all pack sizes may be marketed.
89 Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali.
Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark.
Lundbeck A/ S Ottiliavej 9 DK- 2500 Valby Id- Danimarka.
Ελλάδα Lundbeck Hellas S.A.
90 Ελλάδα Lundbeck Hellas S. A.
91
91 Lietuva H.
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta’ l- alutazzjoni Pubblika Ewropew (EPAR).
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.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, 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 teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek.
What is ECALTA?
X’ inhi ECALTA?
ECALTA is a powder and solvent that are made up into a concentrate, which is diluted to make a solution for infusion (drip into a vein).
ECALTA hija trab u solvent li jitħalltu f’ konċentrat, li huwa dilwit biex jagħmel soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance anidulafungin.
Hija fiha s- sustanza attiva anidulafungin.
What is ECALTA used for?
Għal x’ hiex tintuża ECALTA?
ECALTA is used to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called Candida sp.). ‘ Invasive ’ means that the fungus has spread into the blood.
ECALTA tintuża biex tittratta kandidjażi invażiva (tip ta ’ infezzjoni fungali ikkaġunata minn fungu bħal ħmira msejjaħ Candida sp.). ‘ Invażiva ’ tfisser li l- fungu nfirex għal ġod- demm.
ECALTA is only used in adults who are not neutropenic (who do not have low levels of neutrophils, a type of white blood cell).
ECALTA tintuża biss fl- adulti li m’ humiex newtropeniċi (li m’ għandhomx livelli baxxi ta ’ newtrofili, tip ta ’ ċellola bajda tad- demm).
The medicine can only be obtained with a prescription.
Il- mediċina tinkiseb biss permezz ta ’ riċetta ta ’ tabib.
How is ECALTA used?
Kif tintuża ECALTA?
Treatment with ECALTA should be initiated by a doctor who has experience in the management of invasive fungal infections.
Kura b’ ECALTA għandu jinbeda minn tabib li għandu esperjenza fil- ġestjoni ta ’ infezzjonijiet fungali invażivi.
ECALTA is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
ECALTA tingħata bħala doża inizjali ta ’ 200 mg fl- ewwel jum, segwita b’ 100 mg kuljum fit - tieni jum.
ECALTA should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
ECALTA għandha tingħata biss permezz ta ’ infużjoni, bir- rata massima ta ’ 1. 1 mg kull minuta biex tevita l- effetti sekondarji: din tikkorrispondi għal madwar tliet sigħat għall- infużjoni inizjali, u siegħa u nofs għall- infużjonijiet sussegwenti.
The duration of treatment depends on how the patient responds.
It- tul ta ’ żmien tat- trattament jiddependi fuq kif jirrispondi l- pazjent.
In general, treatment should continue for at least two weeks after the last time that fungus is found in the patient ’ s blood.
B’ mod ġenerali, il- kura għandha tkompli għal ta ’ l- anqas ġimagħtejn wara l - aħħar darba li l- fungu jinstab fid- demm tal- pazjent.
How does ECALTA work?
Kif taħdem ECALTA?
The active substance in ECALTA, anidulafungin, is an antifungal medicine, which belongs to the group ‘ echinocandins’.
Is- sustanza attiva f’ ECALTA, anidulafungin, hija mediċina kontra l- fungu, li tappartieni għall- grupp ‘ echinocandins ’.
It works by interfering with the production of a component of the fungal cell wall called 1,3-β -D-glucan, which is necessary if the fungus is to continue living and growing.
Hija taħdem billi tiddisturba l- produzzjoni ta ’ komponent tal- ħajt taċ- ċellola fungali msejjaħ 1, 3- β- D- glucan, li huwa neċessarju biex il- fungu jkompli jgħix u jikber.
Fungal cells treated with ECALTA have incomplete or defective cell walls, making them fragile and unable to grow.
Ċelloli fungali ittrattati b’ ECALTA għandhom ħitan taċ- ċelloli mhux kompluti jew diffettużi, li tagħmilhom fraġli u bla ħila li jikbru.
The list of fungi against which ECALTA is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Il- lista ta ’ fungi kontra liema ECALTA hija attiva tista ’ tinstab fis- Sommarju tal - Karatteristiċi tal- prodott (ukoll parti mill- EPAR).
How has ECALTA been studied?
Kif ġiet studjata ECALTA?
The effects of ECALTA were first tested in experimental models before being studied in humans.
L- effetti ta ’ ECALTA l- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bnedmin.
ECALTA has been studied in one main study involving 261 patients with invasive candidiasis.
ECALTA ġiet studjata fi studju wieħed ewlieni li nvolva 261 pazjent b’ kandidjażi invażiva.
The effects of ECALTA were compared with those of fluconazole (another antifungal medicine).
L- effetti ta ’ ECALTA kienu mqabbla ma ’ dawk ta ’ fluconazole (mediċina oħra kontra l- fungi).
The main measure of effectiveness 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Iż- żewġ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged was the proportion of patients who had responded to treatment at the end of the treatment.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged mediċini ngħataw permezz ta ’ infużjoni, għal madwar 14- il jum u 42- il jum.
A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Reazzjoni kienet definita bħala titjib sinifikanti jew komplut tas- sintomi, bla ebda ħtieġa ta ’ trattament ieħor kontra l- fungi u mingħajr ebda sejba ta ’ Candida fil- kampjuni meħuda mill- pazjent.
What benefit has ECALTA shown during the studies?
X’ benefiċċju wriet ECALTA waqt l- istudji?
ECALTA was more effective than fluconazole in treating invasive candidiasis.
ECALTA kienet aktar effettiva minn fluconazole fit- trattament ta ’ kandidjażi invażiva.
At the end of intravenous therapy, 96 (76%) of the 127 patients receiving ECALTA had responded to treatment, compared with 71 (60%) of the 118 receiving fluconazole.
Fit- tmiem ta ’ terapija intravenuża, 96 (76%) mill- 127 pazjent li kienu qed jirċievu ECALTA irrispondew għat - trattament, meta mqabbla ma ’ 71 (60%) mill- 118 li kienu qed jirċievu fluconazole.
What is the risk associated with ECALTA?
X’ inhu r- riskju assoċjat ma’ ECALTA?
The most common side effects with ECALTA (seen in between 1 and 10 patients in 100) are coagulopathy (problems with blood clotting), convulsion (fits), headache, diarrhoea, vomiting, nausea (feeling sick), increased blood creatinine levels (a marker of kidney problems), rash, pruritus (itching), hypokalaemia (low levels of potassium in the blood), flushing, and raised blood levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin and gamma- glutamyltransferase (markers of liver problems).
L- aktar effetti sekondarji komuni b’ ECALTA (li dehru f’ madwar pazjent 1 u 10 minn kull 100) huma koagulopatija (problemi bit- tgħaqqid tad- demm), aċċessjoni( jiet), uġigħ ta ’ ras, dijarea, remettar, nawżja (dardir), livelli miżjuda ta ’ kreatinin fid- demm (sinjal ta ’ problemi fil- kliewi), raxx, prurite (ħakk), ipokalemija (livelli baxxi ta ’ potassju fid- demm), ħmura fil- wiċċ, u livelli għoljin ta ’ alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin u gamma - glutamyltransferase fid- demm (sinjali ta ’ problemi fil- fwied).
For the full list of all side effects reported with ECALTA, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ ECALTA, ara l- Fuljett ta ’ Tagħrif.
ECALTA should not be used in people who may be hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
ECALTA m’ għandhiex tintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal anidulafungin jew għal xi waħda mis- sustanzi l- oħra, jew għal xi mediċini oħra fil- klassi echinocandin.
Once made up into an infusion, ECALTA contains alcohol in an amount that is comparable to a small glass of wine or beer.
Meta titħallat f’ infużjoni, ECALTA fiha alkoħol f’ ammont li jitqabbel ma ’ tazza żgħira inbid jew birra.
This will need to be taken into consideration when it is given to some patients (such as pregnant women, alcoholic patients or those with liver disease).
Dan għandu jitqies meta tingħata lil xi pazjenti (bħalma huma nisa tqal, pazjenti alkoħoliċi jew dawk b’ mard tal- fwied).
Because ECALTA can affect liver function, patients who show signs of liver problems during treatment should be carefully monitored.
Minħabba li ECALTA tista ’ taffettwa l- funzjoni tal- fwied, pazjenti li juru sinjali ta ’ problemi fil- fwied waqt it- trattament għandhom jiġu sorveljati bir- reqqa.
Why has ECALTA been approved?
Għaliex ġiet approvata ECALTA?
The Committee for Medicinal Products for Human Use (CHMP) concluded that ECALTA’ s benefits are greater than its risks in the treatment of invasive candidiasis in adult non-neutropenic patients.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ ECALTA huma akbar mir- riskji tagħha fit- trattament ta ’ kandidjażi invażiva f’ pazjenti adulti mhux newtropeniċi.
However, the Committee noted that the main study of ECALTA included an insufficient number of patients with neutropenia to demonstrate the medicine ’ s effectiveness in this group.
Madankollu, il- Kumitat innota li l- istudju ewlieni ta ’ ECALTA inkluda numru insuffiċjenti ta ’ pazjenti b’ newtropinja biex juri l- effettività tal- mediċina f’ dan il- grupp.
In addition, it noted that ECALTA has been studied mainly in patients with candidaemia (Candida sp. in the blood), and only in a limited number of patients with deep tissue infections or abscesses.
Barra minn hekk innota li ECALTA ġiet studjata prinċipalment f’ pazjenti b’ kandidimja (Candida sp. fid- demm), u f’ numru limitat biss ta ’ pazjenti b’ infezzjonijiet tat- tessuti tal- fond jew axxessi.
The Committee recommended that ECALTA be given marketing authorisation.
Il- Kumitat irrakkomanda li ECALTA tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about ECALTA:
Tagħrif ieħor dwar ECALTA:
The European Commission granted a marketing authorisation valid throughout the European Union for ECALTA to Pfizer Limited on 20 September 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal ECALTA valida fl- Unjoni Ewropea kollha lil Pfizer Limited fl- 20 ta ’ Settembru 2007.
The full EPAR for ECALTA can be found here.
L- EPAR sħiħ għal ECALTA jista ’ jinstab hawn.
Route of EU number
ta ’ l- EU
Powder and solvent for concentrate for solution for infusion
Trab u solvent għal konċentrat għal soluzzjoni għall- infużjoni
ECALTA 100 mg powder and solvent for concentrate for solution for infusion.
ECALTA 100 mg trab u solvent għal konċentrat għal soluzzjoni għall- infużjoni.
Each vial contains 100 mg anidulafungin.
Kull kunjett fih 100 mg anidulafungin.
The reconstituted solution contains 3.33 mg/ ml anidulafungin and the diluted solution contains 0.36 mg/ ml anidulafungin.
Is- soluzzjoni rikostitwita fiha 3. 33 mg/ ml anidulafungin u s- soluzzjoni dilwita fiha 0. 36 mg/ ml anidulafungin.
Excipients:
Sustanza mhux attiva:
Fructose 102.5 mg per vial Ethanol 6 g per vial
Fructose 102. 5 mg kull kunjett Ethanol 6 g kull kunjett
Powder and solvent for concentrate for solution for infusion.
Trab u solvent għal konċentrat għal soluzzjoni għall- infużjoni.
White to off-white lyophilised solid.
Solidu lajofilizzat ta ’ lewn abjad għal abjad jagħti fil- griż.
Clear colourless solution.
Soluzzjoni ċara bla kulur.
The reconstituted solution has a pH of 4.0 to 6.0.
Is- soluzzjoni rikostitwita għandha pH ta ’ 4. 0 sa 6. 0.
Treatment of invasive candidiasis in adult non-neutropenic patients.
Kura ta ’ candidiasis invażiva f’ pazjenti adulti mhux newtropeniċi.
ECALTA has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease (see section 4.4 and section 5.1).
ECALTA ġie studjat primarjament f’ pazjenti b’ infezzjoni b’ Candida fid- demm u numru limitat ta ’ pazjenti b’ infezzjoni ta ’ Candida f’ tessuti fondi ta ’ taħt il- ġilda, jew b’ mard li jikkawża axxessi (ara sezzjoni 4. 4 u 5. 1).
Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections.
Kura b’ ECALTA għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta ’ infezzjonijiet fungali invażivi.
Specimens for fungal culture should be obtained prior to therapy.
Il- kampjuni għal koltura fungali għandhom jinkisbu qabel it- terapija.
Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
It- terapija tista ’ tkun mibdija qabel ma r- riżultati tal- koltura jkunu magħrufa u tista ’ tiġi aġġustata kif meħtieġ ladarba jkunu disponibbli.
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
F- Jum 1għandha tingħata loading dose waħda ta ’ 200 mg, segwita suċċessivament minn 100 mg kuljum.
Duration of treatment should be based on the patient ’ s clinical response.
It- tul tal- kura għandu jkun ibbażat fuq ir- rispons kliniku tal- pazjent.
In general, antifungal therapy should continue for at least 14 days after the last positive culture.
B’ mod ġenerali, it - terapija antifungali għandha tkompli għal mill- anqas 14- il jum wara l- aħħar koltura pożittiva.