qanastek/EMEA-V3 huggingface dataset:
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Axura 10 mg/ g oral drops, solution Memantine hydrochloride
Axura 10 mg/ g qtar orali, soluzzjoni Memantine hydrochloride
1 g solution (20 drops) contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
1 g (20 taqtira) ta ’ soluzzjoni fiha 10 mg memantine hydrochloride ekwivalenti għal 8. 31 mg memantine.
EU/ 1/ 02/ 218/ 006 100 g.
EU/ 1/ 02/ 218/ 004 20 g EU/ 1/ 02/ 218/ 005 50 g EU/ 1/ 02/ 218/ 006 100g
Lot {number}
{numru}
Axura 10 mg/ g solution
Axura 10 mg/ g soluzzjoni
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRAU L- PAKKETT LI JMISS MAL- PRODOTT
Not for separate sale.
Qtar orali, soluzzjoni, 50 g Komponent ta ’ multipakk li jikkonsisti minn 10 pakketti, kull wieħed minnhom fihom 1 b’ 50 g qtar orali, soluzzjoni.
100 D-60318 Frankfurt/ Main Germany
100 D- 60318 Frankfurt/ Main Il- Ġermanja.
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER WRAPPER LABEL ON MULTIPACKS (10x 50 g DROPS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TAT- TGEŻWIR TA ’ BARRA FUQ IL- MULTIPAKKS (10 x 50 g QTAR) MGEŻWRA FIL- FOJL (LI JINKLUDI L- KAXXA BLU)
Oral Drops, solution Multipack comprising 10 packs, each containing 1 bottle with 50 g oral drops, solution.
Qtar orali, soluzzjoni, 50 g Komponent ta ’ multipakk li jikkonsisti minn 10 pakketti, kull wieħed minnhom fihom 1 b’ 50 g qtar orali, soluzzjoni.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
KARTUNA GĦAL 28 PILLOLA - TRATTAMENT GĦAL PAKKETT TAL- BIDU - TRATTAMENT SKEDAT FUQ 4 ĠIMGĦAT
Memantine hydrochloride
Axura 5 mg pilloli miksijin b’ rita Axura 10 mg pilloli miksijin b’ rita Axura 15 mg pilloli miksijin b’ rita Axura 20 mg pilloli miksijin b’ rita Memantine hydrochloride
Axura 10 mg film-coated tablets contain lactose monohydrate.
Axura 10 mg pilloli miksijin b’ rita fihom lactose monohydrate.
Each pack with 28 film- coated tablets for a 4 week treatment schedule contains:
Kull pakkett ta ’ 28 pillola miksija b’ rita għal trattament skedat ta ’ 4 ġimgħat fih:
7 film-coated tablets. of Axura 5 mg 7 film-coated tablets of Axura 10 mg 7 film-coated tablets of Axura 15 mg 7 film-coated tablets of Axura 20 mg
7 pilloli miksijin b’ rita ta ’ Axura 5 mg 7 pilloli miksijin b’ rita ta ’ Axura 10 mg 7 pilloli miksijin b’ rita ta ’ Axura 15 mg 7 pilloli miksijin b’ rita ta ’ Axura 20 mg
51 EXP {MM/ YYYY}
JIS {XX/ SSSS}
EU/ 1/ 02/ 218/ 016 28 film-coated tablets EU/ 1/ 02/ 218/ 023 28 film-coated tablets
EU/ 1/ 02/ 218/ 016 28 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 023 28 pilloli miksijin b’ rita
Axura 5 mg, 10 mg, 15 mg, 20 mg tablets
Axura pilloli ta ’ 5 mg, 10 mg, 15 mg, 20 mg
CARTON FOR BLISTER PACK
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦALL- FOLJI
Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 20 mg pilloli miksijin b’ rita Memantine hydrochloride
840 (20x42) film-coated tablets.
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 42 pillola miksija b’ rita 56 pillola miksija b’ rita 98 pillola miksija b’ rita 840 (20x42) pillola miksija b’ rita
EU/ 1/ 02/ 218/ 017 14 film-coated tablets EU/ 1/ 02/ 218/ 018 28 film-coated tablets EU/ 1/ 02/ 218/ 019 42 film-coated tablets EU/ 1/ 02/ 218/ 020 56 film-coated tablets EU/ 1/ 02/ 218/ 021 98 film-coated tablets EU/ 1/ 02/ 218/ 022 840 (20 x 42) film-coated tablets EU/ 1/ 02/ 218/ 024 14 film-coated tablets EU/ 1/ 02/ 218/ 025 28 film-coated tablets EU/ 1/ 02/ 218/ 026 42 film-coated tablets EU/ 1/ 02/ 218/ 027 56 film-coated tablets EU/ 1/ 02/ 218/ 028 98 film-coated tablets EU/ 1/ 02/ 218/ 029 840 (20 x 42) film-coated tablets
EU/ 1/ 02/ 218/ 017 14 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 018 28 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 019 42 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 020 56 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 021 98 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 022 840 (20 x 42) pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 024 14 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 025 28 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 026 42 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 027 56 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 028 98 pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 029 840 (20 x 42) pilloli miksijin b’ rita
Axura 20 mg tablets
Axura pilloli ta ’ 20 mg
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR 42 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
KARTUNA GĦAL 42 PILLOLA BĦALA PAKKETT INTERMEDJU / KOMPONENT TA ’ MULTIPAKK (MINGĦAJR IL- KAXXA BLU)
Component of a multipack comprising 20 packs, each containing 42 film-coated tablets.
42 pillola miksija b’ rita Komponent ta ’ multipakk li jikkonsisti minn 20 pakkett, kull wieħed minnhom fih 42 pillola miksija b’ rita.
Not for separate sale.
M’ għandux jinbiegħ separatament
EU/ 1/ 02/ 218/ 022 840 (20 x 42) film-coated tablets EU/ 1/ 02/ 218/ 029 840 (20 x 42) film-coated tablets
EU/ 1/ 02/ 218/ 022 840 (20 x 42) pilloli miksijin b’ rita EU/ 1/ 02/ 218/ 029 840 (20 x 42) pilloli miksijin b’ rita
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20x 42 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA TIKKETTA TAT- TGEŻWIR TA ’ BARRA GĦAL MULTIPAKKS (20x42) IMĠEŻWRA FIL - FOJL (LI JINKLUDI KAXXA BLU)
Multipack comprising 20 packs, each containing 42 film-coated tablets.
Multipakk li jikkonsisti minn 20 pakkett kull wieħed minnhom fih 42 pillola miksija b’ rita.
57 11.
56 11.
Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 20 mg pilloli miksija b’ rita Memantine hydrochloride
BATCH NUMBER Lot {number} See embossed stamp.
Lott {numru} Ara t- timbru intaljat.
PACKAGE LEAFLET
59 FULJETT TA ’ TAGĦRIF:
What Axura is and what it is used for 2.
X’ inhu Axura u għalxiex jintuża 2.
Before you take Axura 3.
Qabel ma tieħu Axura 3.
How to take Axura 4.
Kif għandek tieħu Axura 4.
How to store Axura 6.
Kif taħżen Axura 6.
WHAT AXURA IS AND WHAT IT IS USED FOR
X’ INHU AXURA U GĦALXIEX JINTUŻA
How does Axura work Axura belongs to a group of medicines known as anti-dementia medicines.
Kif jaħdem Axura Axura jagħmel parti minn grupp ta ’ mediċini magħrufa bħala mediċini kontra d- dimenzja.
Axura belongs to a group of medicines called NMDA- receptor antagonists.
Axura jagħmel parti minn grupp ta ’ mediċini li jissejħu antagonisti tar- riċettur- NMDA.
Axura acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Axura jaħdem fuq dawn ir- riċetturi- NMDA u jtejjeb it- trasmissjoni tas- sinjali fin- nervituri u l- memorja.
What is Axura used for Axura is used for the treatment of patients with moderate to severe Alzheimer’ s disease.
Għalxiex jintuża Axura Axura jintuża għall- kura ta ’ pazjenti bil- marda ta ’ Alzheimer minn moderata għal severa.
BEFORE YOU TAKE AXURA
QABEL MA TIEĦU AXURA
Do not take Axura
Tieħux Axura:
of Axura tablets (see section 6).
oħra tal- pilloli Axura (ara sezzjoni 6)
Take special care with Axura
Oqgħod attent ħafna b’ Axura
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).
In these situations the treatment should be carefully supervised, and the clinical benefit of Axura reassessed by your doctor on a regular basis.
F’ dawn il- każijiet il- kura għandha tkun sorveljata bir- reqqa, u l- benefiċċju kliniku ta ’ Axura 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 bil- 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.
61 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.
60 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.
Axura is not recommended for children and adolescents under the age of 18 years.
Axura mhux rakkomandat fit- tfal u adolexxenti taħt it- 18- il sena.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In particular, Axura may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
B’ mod partikolari, Axura jista ’ jibdel l- effetti tal- mediċini li ġejjin u d- doża tagħhom jista ’ jkollha bżonn tinbidel mit- tabib tiegħek.
If you go into hospital, let your doctor know that you are taking Axura.
Jekk tmur l- isptar għarraf lit- tabib tiegħek li qed tieħu Axura
Taking Axura with food and drink 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.
Meta tieħu Axura ma ’ l- ikel u max- xorb 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 ħażina renali (funjonament ħażin tal- kliewi)) jew infezzjonijiet severi tal- passaġġ awrinarju, (struttura li ġġorr l- awrina) għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal- mediċina tiegħek.
Women taking Axura should not breast-feed.
Nisa li qed jieħdu Axura m’ għandhomx ireddgħu.
Driving and using machines Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Sewqan u tħaddim ta ’ magni It- tabib tiegħel ser jgħidlek jekk il- marda tiegħek tħallikx issuq u tħaddem magni b’ mod sigur.
Also, Axura may change your reactivity, making driving or operating machinery inappropriate.
Minbarra hekk, Axura jista ’ jibdillek il- ħila biex tirreaġixxi, u għalhekk ma jkunx xieraq li ssuq jew tħaddem magni.
Important information about some of the ingredients of Axura This medicinal product contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Axura Dan il- prodott mediċinali fih ukoll lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will advise you.
It- tabib tiegħek għandu jagħtik il- parir dovut.
HOW TO TAKE AXURA
KIF GĦANDEK TIEĦU AXURA
Always take Axura exactly as your doctor has told you.
61 Dejjem għandek tieħu Axura skond il- parir tat- tabib.
Dosage The recommended dose of Axura for adults and elderly patients is 20 mg once a day.
Dożaġġ Id- doża rakkomandata ta ’ Axura għall- adulti u pazjenti anzjani hija 20 mg darba kuljum.
one and a half 10 mg tablet
pillola u nofs ta ’ 10mg
two 10 mg tablets once a day
żewġ pilloli ta ’ 10 mg darba kuljum
This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablet once a day in the third week.
Din tiżdied għal pillola waħda darba kuljum (1 x10 mg) fit- tieni ġimgħa u għal pillola 1 u nofs darba kuljum fit- tielet ġimgħa.
From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).
Mir- 4 ġimgħa ’ l quddiem, id- doża li ġeneralment tingħata hija ta ’ 2 pilloli 1 darba kuljum (1x20 mg).
Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Dożaġġ f’ pazjenti b’ indeboliment tal- funzjoni tal- kliewi Jekk għandek indeboliment tal- funzjoni tal- kliewi, it- tabib tiegħek ser jiddeċiedi dwar doża li tkun tixraq għal kundizzjoni tiegħek.
To benefit from your medicine you should take it regularly every day at the same time of the day.
Kif jingħata Axura għandha tingħata b’ mod orali darba kuljum Biex tikseb benefiċċju mil- mediċina tiegħek, għandek tkompli teħodha kuljum fl- istess ħin tal- ġurnata.
Duration of treatment Continue to take Axura as long as it is of benefit to you.
Kompli ħu Axura sakemm tibqa tikseb benefiċċju minnu.
If you take more Axura than you should
Jekk tieħu Axura aktar milli suppost
- In general, taking too much Axura should not result in any harm to you.
- B’ mod ġenerali, meta tieħu wisq Axura m’ għandha tiġrilek l- ebda ħsara.
- If you take a large overdose of Axura, contact your doctor or get medical advice, as you may
- Jekk tieħu doża eċċessiva kbira ta ’ Axura, għamel kuntatt mat- tabib tiegħek jew ikseb parir
If you forget to take Axura
Jekk tinsa tieħu Axura
- If you find you have forgotten to take your dose of Axura, wait and take your next dose at the
- Jekk tinduna li nsejt tieħu doża ta ’ Axura, stenna u ħu d- doża li jmissek fil- ħin tas- soltu.
Like all medicines, Axura can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Axura jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
63 Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure
62 Komuni (jaffettwa 1 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 1 f’ 1000 persuna): • Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, insuffiċjenza tal- qalb u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
Very Rare (affects less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
Rari ħafna (jaffettwa anqas minn 1 f’ 10, 000 persuna): • Aċċessjonijiet.
These events have been reported in patients treated with Axura.
Dawn il- kazijiet gew irrapurtati minn pazjenti li hadu Axura.
HOW TO STORE AXURA
KIF TAĦŻEN AXURA
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP.
Tużax Axura wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja wara JIS.
What Axura contains
X’ fih Axura:
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 li hi ekwivalenti għal 8. 31 mg memantine.
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 (1: 1), sodium lauryl sulphate, polysorbate 80, talkum, triacetin u emulsjoni simethicone, kollha fil- kisja tal- pillola.
What Axura looks like and contents of the pack
Id- Dehra ta ’ Axura u l- kontenuti tal- pakkett:
Axura 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 ’ Axura jiġu bħala pilloli bojod jagħtu fl- offwajt, oblong u ġejjin għal ponta fin- nofs, imbuzzati l- barra, miksijin b’ rita u b’ xaqq minn fejn jinqasmu fuq iż- żewġ naħat.
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets, 980 (10 x 98) tablets or 1000 (20 x 50) tablets.
Il- pilloli Axura jiġu f’ pakketti ta ’ folji b’ 14- il pillola, 28 pillola, 30 pillola, 42 pillola, 50 pillola, 56 pillola, 98 pillola, 100 pillola, 112- il pillola, 980 (10 x 98) pillola jew 1000 (20 x 50) pillola.
64 Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Merz Pharmaceuticals GmbH Eckenheimer Landstr.
63 Merz Pharmaceuticals GmbH Eckenheimer Landstr.
100 D-60318 Frankfurt/ Main Germany.
100 D- 60318 Frankfurt/ Main Il- Ġermanja.
Ltd Farrugia Buildings Triq tat-Torba Attard BZN 12 Tel: +356 21 43 74 15
Ltd Farrugia Buildings Triq it- Torba Ħ’ Attard BZN 12 Tel: +356 21 43 74 15
Eesti Österreich H.
64 Eesti Österreich H.
Latvija H.
65 Latvija H.
66
66 FULJETT TA ’ TAGĦRIF:
How does Axura work Axura belongs to a group of medicines known as anti-dementia medicines.
Axura jagħmel parti minn grupp ta ’ mediċini magħrufa bħala mediċini kontra d- dimenzja.
What is Axura used for Axura is used for the treatment of patients with moderate to severe Alzheimer’ s disease.
Axura jintuża għall- kura ta ’ pazjenti bil- marda ta ’ Alzheimer minn moderata għal severa.
of Axura oral drops, solution (see section 6).
oħra li jinsabu fil- qtar, soluzzjoni Axura (ara sezzjoni 6)
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
67 Jekk tbati minn indeboliment renali (problemi bil- 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.
68 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- tratatment tal- marda ta ’ Parkinson), ketamine, (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment tintuża 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
B’ mod partikolari, Axura jista ’ jibdel l- effetti tal- mediċini li ġejjin u d- doża tagħhom jista ’ jkollha bżonn tinbidel mit- tabib tiegħek. 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
This medicinal product contains sorbitol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Axura Dan il- prodott mediċinali fih ukoll sorbitol.
Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i. e. essentially potassium-free.
Minbarra hekk, din il- mediċina fiha potassju, f’ anqas minn 1 mmol (39 mg) kull doża, i. e. tista ’ titqies li ma fihiex potassium.
69 3.
68 3.
Always take Axura exactly as your doctor has told you.
Dejjem għandek tieħu Axura eżatt kif qallek it- tabib.
The usual starting dose is 10 drops once a day (1x 5 mg) for the first week.
Id- doża tas- soltu tal- bidu hija 10 taqtiriet darba kuljum (1 x 5 mg) għall- ewwel ġimgħa.
This is increased to 20 drops once a day (1x 10 mg) in the second week and to 30 drops once a day taken in the third week.
Din tiżdied għal 20 taqtira darba kuljum (2 x 10 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 (1x 20 mg).
Mir- raba ’ ġimgħa ’ l quddiem, id- doża rakkomandata hija ta ’ 40 taqtira darba kuljum (1 x 20 mg).
Administration Axura should be administered orally once a day.
Kif jingħata Axura għandha tingħata b’ mod orali darbta kuljum.
The drops should be swallowed with some water.
Biex tikseb benefiċċju mil- mediċina tiegħek, għandek tkompli tiħodha kuljum fl- istess ħin tal- ġurnata. Il- qtar għandhom jinbelgħu ma ’ ftit ilma.
Duration of treatment Continue to take Axura as long as it is of benefit to you.
Kemm għandha ddum il- kura Kompli ħu Axura sakemm tibqa tikseb benefiċċju minnu.
In general, the observed side effects are mild to moderate.
Komuni (jaffettwa 1 f’ 100 persuna): • Uġigħ ta ’ ras, ngħas, stitkezza, sturdament u pressjoni għolja tad- demm.
70 Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure 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) Very Rare (affects less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
Mhux komuni (jaffettwa 1 f’ 1000 persuna): • Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, insuffiċjenza tal- qalb u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
These events have been reported in patients treated with Axura.
Dawn il- kazijiet gew irrapurtati minn pazjenti li hadu l- Axura.
- Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Axura after the expiry date which is stated on the carton and the bottle label after the EXP.
Tużax Axura wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- flixkun wara JIS.
Each one gram of oral drops, solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Kull gramma waħda ta ’ qtar orali fiha 10 mg memantine hydrochloride li hi ekwivalenti għal 8. 31 mg memantine.
The other ingredients are: potassium sorbate, sorbitol E420 and purified water.
Is- sustanzi l- oħra huma: potassium sorbate, sorbitol E420 u ilma purifikat.
Axura oral drops, solution is presented as a clear, colourless to light yellowish solution.
Il- qtar orali ta ’ Axura, soluzzjoni jiġu bħala soluzzjoni ċara, bla kulur tagħti fl- isfar ċar.
Axura oral drops, solution is available in bottles of 20 g, 50 g, 100 g or 10 x 50 g.
Il- qtar orali Axura, soluzzjoni jiġu fi fliexken ta ’ 20 g, 50 g, 100 g jew 10 x 50 g.
71 Merz Pharmaceuticals GmbH Eckenheimer Landstr.
70 Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Eesti H.
71 Eesti Österreich H.
Κύπρος Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Γερμανία Tel: +49 (0)69 1503 - 1
72 Κύπρος Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Γερμανία Tel: +49 (0) 69 1503 - 1
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 5 mg pilloli miksijin b’ rita Axura 10 mg pilloli miksijin b’ rita Axura 15 mg pilloli miksijin b’ rita Axura 20 mg pilloli miksijin b’ rita Memantine hydrochloride
Further information
1 X’ inhu Axura u għalxiex jintuża 2 Qabel ma tieħu Axura 3 Kif għandek tieħu Axura 4 Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Axura 6 Aktar tagħrif
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain.
It- telf tal- memorja fil- marda ta ’ Alzheimer jiġi minħabba disturbi fis- sinjali tal- messaġġi fil- moħħ.
Axura is used for the treatment of patients with moderate to severe Alzheimer’s disease.
Għalxiex jintuża Axura Axura jintuża għall- kura ta ’ pazjenti bil- marda ta ’ Alzheimer minn moderata għal severa.
In these situations the treatment should be carefully supervised, and the clinical benefit of Axura reassessed by your doctor on a regular basis.
74 F’ dawn il- każijiet il- kura għandha tkun sorveljata bir- reqqa, u l- benefiċċju kliniku ta ’ Axura jiġi evalwat mill- ġdid mit- tabib tiegħek fuq bażi regolari.
75 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 tintuża għas- sogħla) u antagonisti oħra ta ’ NMDA fl- istess ħin għandu jkun evitat.
Taking Axura with food and drink 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.
Meta tieħu Axura ma ’ l- ikel u max- xorb 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 ħażina renali (funzjonament ħażin tal- kliewi)) jew infezzjonijiet severi tal- passaġġ awrinarju, għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal- mediċina tiegħek.
Axura 10 mg film-coated tablets contains lactose.
75 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Axura Il- pilloli miksijin b’ rita t’ Axura 10 mg fihom il- lattosju.
The Axura treatment initiation pack is only to be used for the beginning of the treatment with Axura.
Il- pakkett għal bidu tat- trattament ta ’ Axura għandu jintuża biss fil- bidu tat- trattament b’ Axura.
76 Always take Axura exactly as your doctor has told you.
Dejjem għandek tieħu Axura skond il- parir tat- tabib.
Dosage The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Axura dose during the first 3 weeks of treatment.
Dożaġġ Id- doża rakkomandata ta ’ Axura hija ta ’ 20 mg kuljum li tintlaħaq billi tiżdided b’ mod gradwali id- doża ta ’ Axura matul l- ewwel tliet ġimgħat ta ’ trattament.
Take one tablet once a day.
Ħu pillola waħda kuljum:
Maintenance dose The recommended daily dose is 20 mg once a day.
Doża ta ’ manteniment Id- doża rakkomandata tas- soltu hija ta ’ 20 mg kuljum.
To benefit from your medicine you should take it regularly every day at the same time of the day.
76 Axura għandha tingħata b’ mod orali darba kuljum Biex tikseb benefiċċju mil- mediċina tiegħek, għandek tkompli teħodha kuljum fl- istess ħin tal- ġurnata.
„Possible side effects“.
sintomi li hemm imsemmija f’ sezzjoni 4. “ Effetti sekondarji li jista ’ jkollu ”.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure 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) Very Rare (affects less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
Mhux komuni (jaffettwa 1 f’ 1000 persuna): • Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, insuffiċjenza tal- qalb u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
If any o f the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Medicines should not be disposed of via wastewater or household waste.
77 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.
78 hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 15 mg and Axura 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Is- sustanzi l- oħra f’ Axura 5/ 15 u 20 mg 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 ’ Axura 15 mg u Axura 20 mg.
The other ingredients for Axura 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 ’ Axura 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 Axura looks like and contents of the pack
Id- dehra ta ’ Axura u l- kontenuti tal- pakkett:
Axura 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 ’ Axura 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.
Axura 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 ’ Axura 10 mg huma bojod għal offwajt, oblong u ġejjin għal ponta fin- nofs, imbuzzati ’ l barra, b’ xaqq waħda fuq iż- żewġ naħat.
Axura 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 ’ Axura 15 mg huma oranġjo għal oranġjo griżi, ovali- oblong b’ intaljar ta ’ ‘ 15 ’ fuq naħa u intaljar ta ’ ‘ MEM ’ fuq naħa oħra.
Axura 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20’ on one side and imprint ‘MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ Axura 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.
100 D-60318 Frankfurt/Main Germany.
100 D- 60318 Frankfurt/ Main Il- Ġermanja.
България Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Германия Tel.: +49 (0)69 1503 – 1
78 България Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Германия Tel.: +49 (0) 69 1503 – 1
Ltd Farrugia Buildings
Ltd Farrugia Buildings Triq it- Torba Ħ’ Attard BZN 12 Tel: +356 21 43 74 15
Merz Pharma Austria GmbH Guglgasse 17 A- 11110 Wien Tel: +43 (1) 869 16 04
Merz Pharma Austria GmbH Guglgasse 17 A - 1110Wien Tel: +43 (1) 869 16 04
France Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Allemagne Tél: +49 (0)69 1503 – 1
France Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100
România Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Germania Tel.: +49 (0)69 1503 – 1
România Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100
Ireland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Germany Tel: +49 (0)69 1503 – 1
D- 60318 Frankfurt Allemagne Tél: +49 (0) 69 1503 – 1
Slovenija Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Nemčija Tel: +49 (0)69 1503 - 1
D- 60318 Frankfurt Germania Tel.: +49 (0) 69 1503 – 1
Ísland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Þýskaland
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Germany Tel: +49 (0) 69 1503 – 1
Slovenská republika Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Nemecko
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Nemčija Tel: +49 (0) 69 1503 - 1
80 Tel: +49 (0)69 1503 – 1
Ísland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Þýskaland Tel: +49 (0) 69 1503 – 1
Tel: +49 (0)69 1503 - 1
Slovenská republika Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D- 60318 Frankfurt Nemecko Tel: +49 (0) 69 1503 - 1
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Axura 5.
of Axura tablets (see section 6).
oħra tal- pilloli Axura (ara sezzjoni 6).
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
81 Jekk tbati minn indeboliment renali (problemi bil- 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.
82 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.
Taking Axura with food and drink 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.
Meta tieħu Axura ma ’ l- ikel u max- xorb 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 ħażina renali (funzjonament ħażin tal- kliewi) jew infezzjonijiet severi tal- passaġġ awrinarju, (struttura li ġġorr l- awrina) għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal- mediċina tiegħek.
Driving and using machines Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Minbarra hekk, Axura jista ’ jibdillek il- ħila biex tirreaġixxi, u għalhekk ma jkunx xieraq li ssuq jew tħaddem magni.
Also, Axura may change your reactivity, making driving or operating machinery inappropriate.
Jekk it- tabib tiegħek qallek li xi tipi ta ’ zokkor ma jaqblux miegħek, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Always take Axura exactly as your doctor has told you.
Dejjem għandek tieħu Axura skond il- parir tat- tabib.
83 At the beginning of treatment you will start by using Axura 5 mg film-coated tablets once a day.
Fil- bidu tat- trattament għandek tibda billi tuża pilloli miksija b’ rita ta ’ Axura 5 mg darba kuljum.
- If you find you have forgotten to take your dose of Axura, wait and take your next dose at the
Jekk tinduna li nsejt tieħu doża ta ’ Axura, stenna u ħu d- doża li jmissek fil- ħin tas- soltu.
usual time.
-
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure 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) Very Rare (affects less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreasand psychotic reactions
83 • Għeja, infezzjonijiet tal- moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, insuffiċjenza tal- qalb u emboli tad- demm fil- vini (trombożi/ tromboemboliżmu)
84 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Each film-coated tablet contains 20 mg of 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.
Axura 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 ’ Axura 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..
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or 840 (20 x 42) tablets
Il- pilloli miksijin b’ rita ta ’ Axura jiġu f’ pakketti ta ’ folji bi 14- il pillola, 28 pillola, 42 pillola, 56 pillola, 98 pillola, jew 840 (20 x 42) pillola.
Merz Pharma GmbH + Co.
84 Merz Pharma GmbH + Co.
Eesti Österreich H.
85 Eesti Österreich H.
Merz Pharma Austria GmbH Guglgasse 17 A- 1110 Wien Tel: +43 (1) 869 16 04
Merz Pharmaceuticals GmbH Guglgasse 17 A - 1110 Wien Tel: +43 (1) 869 16 04
Latvija H.
86 Latvija H.
What is Azarga?
X’ inhu Azarga?
Azarga is an eye drop suspension that contains two active substances, brinzolamide and timolol.
Azarga huwa sospensjoni tal- qtar tal- għajnejn li fih żewġ sustanzi attivi, brinzolamide u timolol.
What is Azarga used for?
Għal xiex jintuża Azarga?
Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Azarga jintuża biex inaqqas il- pressjoni intra- okulari (IOP, il- pressjoni ta ’ ġol- għajn).
It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Jintuża fl- adulti bil- glawkoma b’ angolu miftuħ (marda fejn il- pressjoni tal- għajn togħla minħabba li l- fluwidu ma jkunx jista ’ joħroġ minn ġol- għajn) jew pressjoni okulari għolja (meta l- pressjoni fl- għajn tkun ogħla min- normal).
Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
Azarga jintuża meta jkun ġie ppruvat trattament b’ mediċina li jkun fiha biss sustanza attiva waħda iżda li ma jkunx naqqas l- IOP biżżejjed.
How is Azarga used?
Kif jintuża Azarga?
Azarga is given as one drop into the affected eye(s) twice a day.
Azarga jingħata bħala qatra waħda fl- għajn( ejn) affettwata( i) darbtejn kuljum.
The suspension needs to be shaken well before use.
Is- sospensjoni tkun trid titħawwad sew qabel ma tintuża.
How does Azarga work?
Kif jaħdem Azarga?
Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
L- IOP għoli jikkawża ħsara lir- retina (is- superfiċje sensittiva għad- dawl fuq wara tal- għajn) u lin- nerv ottiku li jibgħat sinjali mill- għajn għall- moħħ.
This can result in serious vision loss and even blindness.
Dan iwassal f’ telf serju fil- viżta u anke li l- persuna tagħma.
By lowering the pressure, Azarga reduces the risk of damage.
Bit- tnaqqis tal- pressjoni, Azarga jnaqqas ir- riskju tal- ħsara.
Azarga contains two active substances, brinzolamide and timolol.
Azarga fih żewġ sustanzi attivi, brinzolamide u timolol.
The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways.
Iż- żewġ sustanzi jaħdmu bit- tnaqqis tal - produzzjoni tal- aqueous humour (il- fluwidu maħlul fil- għajn) b’ modi differenti.
Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Brinzolamide huwa inibitur tal- anidrażi karbonika (carbonic anhydrase) li jaħdem billi jimblokka l- enzim magħruf bħala carbonic anhydrase, li jipproduċi joni tal- bikarbonat fil- ġisem.
Bicarbonate is required for the production of the aqueous humour.
Il- bikarbonat huwa meħtieġ għall - produzzjoni tal- aqueous humour.
Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Brinzolamide ilu li ġie awtorizzat fl- Unjoni Ewropea (UE) kollha bħala Azopt sa mill- 2000.
Timolol is a beta-blocker that has been commonly used to treat glaucoma since the 1970s.
Timolol huwa beta- blocker li ntuża b’ mod komuni fit- trattament tal - glawkoma sa mis- sebgħinijiet.
The combined effect of the two substances is greater than either substance used alone.
L- effett kombinat taż- żewġ sustanzi huwa ikbar minn waħda mis- sustanza użata waħidha.
How has Azarga been studied?
Kif ġie studjat Azarga?
The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients.
L- effetti ta ’ Azarga għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
Reproduction is authorised provided the source is acknowledged. the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients.
It- tieni wieħed kien studju ta ’ 12- il xahar li qabbel Azarga mal- kombinazzjoni ta ’ timolol u dorzolamide (inibitur tal- anidrażi karbonika) f’ 437 pazjent.
In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment.
Fiż- żewġ studji, il- miżura ewlenija tal- effikaċja kienet it- tibdil fl- IOP matul l- ewwel sitt xhur ta ’ trattamant.
IOP was measured in ‘ millimetres of mercury’ (mmHg).
L- IOP tkejjel bil - ‘ millimetri tal- merkurju ’ (mmHg).
What benefit has Azarga shown during the studies?
Liema benefiċċju wera Azarga matul dawn l- istudji?
Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide.
Azarga kien kien iktar effikaċi miż- żewġ sustanzi użati waħedhom u kien effikaċi daqs il - kombinazzjoni ta ’ timolol u dorzolamide.
In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga.
Fl- ewwel studju, l- IOP naqas minn madwar 21 mmHg b’ bejn 8. 0 u 8. 7 mmHg fil- pazjenti li kienu qed jużaw Azarga.
This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol.
Dan tqabbel ma ’ bejn 5. 1 u 5. 6 mmHg f’ dawk li kienu qed jużaw brinzolamide u bejn 5. 7 u 6. 9 mmHg f’ dawk li kienu qed jużaw timolol.
In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.
Fit- tieni studju, l- IOP kien naqas minn madwar 26 mmHg b’ madwar 8. 3 mmHg wara sitt xhur fiż - żewġ gruppi ta ’ pazjenti.
What is the risk associated with Azarga?
X’ inhuma r- riskji assoċjati ma ’ Azarga?
The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are dysgeusia (a bitter or unusual taste in the mouth), blurred vision, eye pain, eye irritation and the sensation of a foreign body in the eyes.
L- iktar effetti sekondarji komuni b’ Azarga (li dehru f’ bejn pazjent wieħed u għaxra minn kull mija) huma d- disġewsija (dysgeusia) (togħma morra jew mhux tas- soltu fil- ħalq), viżta mċajpra, uġigħ fil - għajn, irritazzjoni fil- għajn u sensazzjoni ta ’ oġġett barrani fl- għajnejn.
For the full list of all side effects reported with Azarga, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rapportati b’ Azarga, ara l- Fuljett ta ’ Tagħrif.
Azarga should not be used in patients who may be hypersensitive (allergic) to the active substances, any of the other ingredients, other beta-blockers (such as some heart medicines) or sulphonamides (such as some antibiotics).
Azarga m’ għandux jintuża f’ pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għas- sustanzi attivi, għal kwalunkwe mill- ingredjenti l- oħra, għal beta- blockers oħrajn (bħal xi mediċini tal- qalb) jew sulfonamidi (bħal xi antibijotiċi).
It must not be used by patients who:  have had asthma;  have severe chronic obstructive pulmonary disease (a disease causing narrowing of the airways);  have certain heart problems;  have a severe allergy affecting the nose and airways;  have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);  have severe kidney problems.
M’ għandux jintuża minn pazjenti li:  kellhom l- ażżma;  ikollhom marda pulmonarja ostruttiva kronika (marda li twassal għal tidjiq fil- pajpijiet tan- nifs);  ikollhom ċerti problemi tal- qalb;  ikollhom allerġija severa li taffettwa lill- imnifsejn u l- pajpijiet tan- nifs;  ikollhom aċidożi iperkloremika (aċidu eċċessiv fid- demm ikkawżat minn klorur żejjed);  ikollhom problemi severi fil- kliewi.
Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Azarga fih benzalkonium chloride, li huwa magħruf li jtellef il- kulur ta ’ lentijiet tal- kuntatt rotob.
Therefore, care should be taken by people who wear soft contact lenses.
Għalhekk, in- nies li jilbsu l- lentijiet tal- kuntatt rotob iridu joqogħdu attenti ħafna.
Why has Azarga been approved?
Għaliex ġie approvat Azarga?
The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Uman (CHMP) innota li l- kombinazzjoni taż- żewġ sustanzi f’ Azarga tissimplifika t- terapija u tgħin lill- pazjenti jżommu mat- trattament tagħhom.