qanastek/EMEA-V3 huggingface dataset:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Alcon-Couvreur N.V Rijksweg 14 B-2870 Puurs Belgium
Rijksweg 14 B- 2870 Puurs Il- Belgium
CONDITIONS OF THE MARKETING AUTH ORISATION
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version in version 4.0 dated 21 June 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 4. 0, datata 21 ta ’ Ġunju 2007, ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija f’ postha u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 01 dated 30 September 2007 (with effective date 16 May 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 01 datata 30 ta ’ Settembru 2007 (b’ effett mis- 16 ta ’ Mejju 2008) tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess waqt mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) ta ’ wara.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 5 ml + CARTON FOR 3 x 5 ml BOTTLES
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦALL- FLIXKUN WIEĦED TA ’ 5 ml + KARTUNA GĦAL 3 FLIEXKEN TA ’ 5 ml
AZARGA 10 mg/ ml + 5 mg/ml eye drops, suspension Brinzolamide/Timolol
AZARGA 10 mg/ ml + 5 mg/ ml qtar għall- għajnejn, suspensjoni Brinzolamide/ Timolol
1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate)
1 ml ta ’ suspensjoni fih 10 mg brinzolamide u 5 mg timolol (bħala timolol maleate)
Contains: benzalkonium chloride, mannitol (E421), carbopol 974P, tyloxapol, disodium edetate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
Fih: benzalkonium chloride, mannitol (E421), carbopol 974P, tyloxapol, disodium edetate, sodium chloride, hydrochloric acid u/ jew sodium hydroxide (għall- aġġustament tal- pH), ilma ippurifikat.
See the package leaflet for further information.
Għall- aktar tagħrif ara l- fuljett ta ’ tagħrif.
Eye drops, suspension 1 x 5 ml 3 x 5 ml
Qtar għall- għajnejn, suspensjoni 1 x 5 ml 3 x 5 ml
EXP Discard 4 weeks after first opening.
Armi 4 ġimgħat wara li nfetaħ l- ewwel darba.
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAL- FLIXKUN
AZARGA 10 mg/ml + 5 mg/ml eye drops Brinzolamide/Timolol Ocular use
AZARGA 10 mg/ ml + 5 mg/ ml qtar għall- għajnejn Brinzolamide/ Timolol Użu għall- għajnejn
EXPIRY DATE
Infetaħ:
19 PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension Brinzolamide/Timolol
AZARGA 10 mg/ ml + 5 mg/ ml qtar għall- għajnejn, suspensjoni Brinzolamide/ Timolol
It may harm them even if
Tista ’
What AZARGA is and what it is used for 2.
X’ inhu AZARGA u għalxiex jintuża 2.
Before you use AZARGA 3.
Qabel ma tuża AZARGA 3.
How to use AZARGA 4.
Kif għandek tuża AZARGA 4.
How to store AZARGA 6.
Kif taħżen AZARGA 6.
WHAT AZARGA IS AND WHAT IT IS USED FOR
X’ INHU AZARGA U GĦALXIEX JINTUŻA
AZARGA is used to treat high pressure in the eye.
AZARGA jintuża biex jikkura pressjoni għolja fl- għajn.
This pressure can lead to an illness called glaucoma.
Din il- pressjoni tista ’ twassal għall- marda li tissejjaħ glawkoma.
It contains two active substances which work together to reduce pressure within the eye.
AZARGA huwa taħlita ta ’ kura għall- glawkoma Fih żewġ sustanzi attivi li jaħdmu flimkien biex innaqqsu l- pressjoni fl- għajn.
BEFORE YOU USE AZARGA
Tużax AZARGA
Do not use AZARGA − if you are allergic to any of the ingredients of AZARGA.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi sustanzi ta ’ AZARGA.
For a full list of ingredients please see section 6. − if you have respiratory problems such as asthma, bronchitis or other types of breathing problems. − if you have a slow heart beat, heart failure or disorders of heart rhythm. − if you have too much acidity in your blood (a condition called hyperchloraemic acidosis). − if you have severe kidney problems.
Għal- lista
Take special care with AZARGA
kompleta ta ’ sustanzi, jekk jogħġbok, ara sezzjoni 6.
• if you have angina (chest pains), circulation problems or low blood pressure.
- jekk għandek problemi respiratorji bħal ażżma, bronkite jew tipi oħra ta ’ problemi bin- nifs.
AZARGA may make any of these worse.
- jekk għandek rata ta ’ taħbit tal- qalb baxxa, insuffiċjenza tal- qalb jew disturbi bir- ritmu tal- qalb.
If you are concerned about any changes in these symptoms, tell your doctor as soon as possible. • if you get any severe allergic reaction while you are using AZARGA, whatever the cause, adrenaline treatment may not be as effective.
- jekk għandek aċidu żejjed fid- demm tiegħek (kondizzjoni li tissejjaħ aċidożi iperklorimika).
So, when receiving any other treatment please tell the health professional that you are taking AZARGA. • if you have diabetes.
Oqgħod attent ħafna b’ AZARGA • jekk għandek anġina (weġgħat fis- sider), problemi taċ- ċirkulazzjoni jew pressjoni tad- demm baxxa.
AZARGA can mask the symptoms of low blood sugar (hypoglycaemia) such as shakiness and dizziness, so you need to use it with care. • if you have liver problems.
Jekk inti mħasseb dwar xi tibdil f’ dawn is- sintomi, għid lit- tabib tiegħek malajr kemm jista ’ jkun. • jekk ikollok xi reazzjoni allerġika severa waqt li qed tuża AZARGA, tkun xi tkun il- kawża, kura b’ adrenalina tista ’ ma tkunx effettiva bħas- soltu.
Talk to your doctor.
Għalhekk, meta tirċievi xi kura oħra, jekk jogħġbok, għid lill- professjonist fil- qasam tas- saħħa li qed tieħu AZARGA.
21
21 • jekk għandek dijabete.
Talk to your doctor.
Kellem lit- tabib tiegħek. • jekk għandek għajnejn xotti jew problemi tal- korneja.
AZARGA is not recommended for children under 18 years.
Kellem lit- tabib tiegħek. • AZARGA mhux irrakkomandat għall- użu fit- tfal taħt 18- il sena.
AZARGA can affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma.
AZARGA jista ’ jkollu effett jew jiġi affettwat minn mediċini oħra li qed tieħu, inkluż qtar għall - għajnejn oħra għall- kura tal- glawkoma.
Tell your doctor if you are taking or intend to take medicines to lower blood pressure, heart medicines, medicines to treat diabetes, medicines to treat gastric ulcers, or antifungal, antiviral or antibiotic medicines.
Għid lit- tabib tiegħek jekk qed tieħu jew għandek ħsieb tieħu mediċini biex ibaxxu il- pressjoni tad- demm, mediċini għall- qalb, mediċini biex jikkuraw id- dijabete, mediċini biex jikkuraw ulċeri fl- istonku, jew mediċini kontra l- moffa, kontra l- virusis jew anti- bijotiċi.
You should not use AZARGA if you are pregnant or might get pregnant.
M’ għandekx tuża AZARGA jekk inti tqila, jew tista ’ toħroġ tqila.
Talk to your doctor before you use AZARGA.
Kellem lit- tabib tiegħek qabel tuża AZARGA.
If you are breast-feeding, you can use AZARGA.
Jekk qed tredda ’, inti tista ’ tuża AZARGA.
Do not drive or use machines until your vision is clear.
Issuqx u tużax magni qabel il- vista tiegħek tkun ċara.
You may find that your vision is blurred for a time just after using AZARGA.
Jista ’ jkun li l- vista tiegħek tkun imċajpra għal xi ħin hekk kif tuża AZARGA.
One of the active ingredients may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination.
Wieħed mis- sustanzi attivi jista ’ jnaqqas il- ħila ta ’ pazjenti anzjani li jwettqu qadjiet li jinħtieġu akutezza mentali u / jew koordinazzjoni fiżika.
If affected take care when driving or using machines.
Jekk affettwat oqgħod attent meta ssuq jew tuża ’ magni.
Important information about some of the ingredients of AZARGA
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ AZARGA
There is a preservative in AZARGA (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation.
Hemm preservattiv f’ AZARGA (benzalkonium chloride) li jista ’ jbiddel il- kulur ta ’ lentijiet rotob u għandu mnejn jikkawża rritazzjoni fl- għajn.
Therefore, do not wear contact lenses whilst using AZARGA.
Għalhekk, tilbisx lentijiet tal- kuntatt waqt li qed tuża AZARGA.
Wait 15 minutes after using AZARGA before putting your lenses back in.
Stenna 15- il minuta wara li tuża AZARGA qabel terġa tilbes il- lentijiet tiegħek.
HOW TO USE AZARGA
KIF GĦANDEK TUŻA AZARGA
Always use AZARGA exactly as your doctor has told you.
Dejjem għandek tuża AZARGA skond il- parir eżatt tat- tabib.
The usual dose is
Id- doża li ssoltu tingħata hija
One drop in the affected eye or eyes, twice a day-morning and night.
Qatra waħda fl- għajn jew għajnejn affettwata/ i, darbtejn kuljum- filgħodu u filgħaxija.
Only use AZARGA in both eyes if your doctor told you to.
Uża AZARGA fl- għajnejn it- tnejn biss jekk qallek hekk it- tabib tiegħek.
22 • Get the AZARGA bottle and a mirror. • Wash your hands. • Shake well before use. • Twist off the bottle cap. • Hold the bottle, pointing down, between your thumb and fingers. • Tilt your head back.
• Aqbad il- flixkun ta ’ AZARGA u mera. • Aħsel idejk. • Ħawwad sew qabel l- użu. • Neħħi l- għatu tal- flixkun. • Żomm il- flixkun wiċċu ’ l isfel bejn subgħajk il- kbir u s- swaba l- oħra. • Itfa rasek lura.
Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye.
B’ seba ’ nadif, niżżel il- kappell ta ’ għajnejk sakemm ikun hemm ‘ spazju ’ bejn il - kappell t’ għajnejk u l- għajn tiegħek.
Use the mirror if it helps. • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Jekk jgħin uża l- mera. • Tmisx għajnejk jew il- kappell ta ’ l- għajn, il- postijiet tal- madwar jew superfiċji oħra bil- qattara tal- flixkun.
It could infect the drops. • Gently press on the base of the bottle to release one drop of AZARGA at a time. • Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2). • After using AZARGA, press a finger into the corner of your eye, by the nose (picture 3).
Dan jista ’ jinfetta l- qtar. • Għafas il- bażi tal- flixkun bil- mod biex tinżel qatra waħda ta ’ AZARGA kull darba. • Tgħafasx il- flixkun bis- saħħa: huwa maħsub biex għafsa bil- mod fuq il- qiegħ tal- flixkun tkun biżżejjed (stampa 2). • Wara li tuża AZARGA, għafas b’ subgħajk il- kantuniera ta ’ għajnejk, in- naħa ta ’ l- imnieħer (stampa 3).
This helps to stop AZARGA getting into the rest of the body. • If you use drops in both eyes, repeat the steps for your other eye. • Close the bottle cap firmly immediately after use. • Use up one bottle before opening the next bottle.
Dan jgħin biex iwaqqaf lil AZARGA milli jidħol fil- bqija tal- ġisem • Jekk tuża l- qtar fiż- żewġ għajnejn, irrepeti l- proċedura għall- għajnek l- oħra. • Għalaq l- għatu tal- flixkun tajjeb immedjatament wara l- użu. • Uża l- flixkun kollu qabel tiftaħ ieħor.
If you use more AZARGA than you should, rinse your eye with warm water.
Jekk tuża AZARGA aktar milli suppost laħlaħ għajnek b’ ilma sħun.
Do not put in any more drops until it is time for your next regular dose.
Tużax aktar qtar qabel ikun il - ħin għad- doża li jmiss tas- soltu.
If you forget to use AZARGA, continue with the next dose as planned.
Jekk tinsa tuża AZARGA, kompli bid- doża li jmiss kif ippjanat.
Do not use a double dose to make up for the forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Do not use more than one drop in the affected eye(s) twice daily.
M’ għandekx tuża aktar minn qatra waħda fl- għajn/ ejn affettwata/ i darbtejn kuljum.
If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Jekk tieqaf tuża AZARGA mingħajr ma tkellem lit- tabib tiegħek, il- pressjoni ġewwa għajnejk ma tkunx ikkontrollata u dan jista ’ jwassal għal telf tal- vista.
If you are using other eye drops, wait at least 5 minutes between using AZARGA and the other drops.
Jekk qed tuża qtar ta ’ l- għajnejn oħra, ħalli mill- anqas 5 minuti bejn l- użu ta ’ AZARGA u tal- qtar ieħor.
Like all medicines, AZARGA can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, AZARGA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you are worried, talk to your doctor or pharmacist.
Jekk qed tinkwieta, kellem lit- tabib jew lill- ispiżjar tiegħek.
The following side effects have been seen with AZARGA:
B’ AZARGA kienu osservati l- effetti sekondarji li ġejjin:
Common side effects (affects 1 to 10 users in 100)
23 Effetti sekondarji komuni (jaffettwaw 1 sa 10 persuni li qed jużawh minn kull 100).
Effects in the eye: blurred vision, eye irritation, eye pain, abnormal sensation in eyes
Effetti fl- għajn: vista mċajpra, irritazzjoni fl- għajn, uġigħ fl- għajn, sensazzjoni mhux normali fl - għajnejn
General side effects: bad taste
Effetti sekondarji ġenerali: togħma ħażina
Uncommon side effects (affects 1 to 10 users in 1,000)
Effetti sekondarji mhux komuni (jaffettwaw 1 sa 10 persuni li qed jużawh minn kull 1, 000).
23 Effects in the eye: eye surface inflammation with surface damage, inflammation inside the eye, red eye, itchy eye; eyelid itching, redness, swelling, or crusting; eye discharge, eye allergy, dry eye, tired eyes
Effetti fl- għajn: infjammazzjoni tas- superfiċje tal- għajn bi ħsara fis- superfiċje, infjammazjoni ġewwa l- għajn, għajn ħamra, ħakk fl- għajn; ħakk, ħmura, nefħa, jew qxur fil- kappell tal- għajn; tnixxija mill - għajn, allerġija fl- għajn, għajn tinħass xotta, għeja fl- għajnejn
General side effects: chronic lung disease, decreased blood pressure, throat irritation, cough, difficulty sleeping, skin inflammation, redness or itching, runny nose, hair disorder
Effetti sekondarji ġenerali: marda kronika tal- pulmun, tnaqqis fil- pressjoni tad- demm, irritazzjoni fil - griżmejn, sogħla, diffikultà biex torqod, infjammazzjoni, ħmura jew ħakk tal- ġilda, imnieħer iqattar, disturb fix- xagħar
Additionally:
Oħrajn:
AZARGA is a combination of 2 currently marketed medicines.Side effects that have been observed with the individual medicines which may occur with AZARGA are as follows:
Effetti sekondarji li kienu osservati bil - mediċini ndividwali u li jistgħu jseħħu b’ AZARGA huma kif ġej:
Effects in the eye: damage to the optic nerve, increased pressure in eye, deposits on the eye surface, corneal disorder, decreased eye sensation, inflammation or infection of the conjunctiva, abnormal, double or reduced vision, increased pigmentation of the eye, growth on surface of eye, increased tear production, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the eyelids, inflammation of the eyelid glands
Effetti fl- għajn: ħsara lin- nerv ottiku, żjieda tal- pressjoni fl- għajn, depożiti fuq is- superfiċje tal- għajn, disturb tal- korneja, tnaqqis fis- sensazzjoni tal- għajn, infjammazzjoni jew infezzjoni tal- konġuntiva, vista mhux normali, doppja jew imnaqqsa, żjieda fil- pigmentazzjoni tal- għajn, tkabbir fuq is- superfiċje tal- għajn, żjieda fil- produzzjoni ta ’ dmugħ, nefħa fl- għajn, sensittività għad- dawl, tnaqqis fit- tkabbir jew fil- kwantità ta ’ xagħar tal- għajnejn, kappell tal- għajn baxx, infjammazzjoni tal- glandoli tal - kappell tal- għajn
General side effects:
Effetti sekondarji ġenerali:
Heart and circulation: changes in heart rate or rhythm, chest pain, reduced heart function, stopping of the heart, increased blood pressure, decreased blood flow to the brain, stroke, swelling of the extremities
Qalb u ċirkolazzjoni: bidla fir- rata jew fir- ritmu tal- qalb, uġigħ fis- sider, tnaqqis fil- funzjoni tal- qalb, waqfien tal- qalb, żjieda fil- pressjoni tad- demm, tnaqqis fl- ammont ta ’ demm li jmur għall- moħħ, puplesija, nefħa fl- estremitajiet
Respiratory: shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma
Respiratorji: qtugħ ta ’ nifs jew diffikultà biex tieħu n- nifs, sintomi ta ’ riħ, konġestjoni fis- sider, infezzjoni fis- sinus, għatis, imnieħer fgat, imnieħer xott, fsada mill- imnieħer, ażma
Nervous system and general disorders: depression, difficulty with memory, headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, drowsiness, generalised or severe weakness
Disturbi fis- sistema nervuża u ġenerali: depressjoni, diffikultà bil- memorja, uġigħ ta ’ ras, nervi, irritabilità, għeja, tregħid, tħossok mhux normali, ħass ħażin, sturdament, ħedla ta ’ ngħas, debbulizza ġeneralizzata jew severa
Gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal pain, inflammation of the throat, dry or abnormal sensation in mouth, decreased taste sensation, indigestion, stomach ache
Ta ’ l- Istonku: tqalligħ, rimettar, dijarea, gass intestinali jew uġigħ addominali, infjammazzjoni tal - griżmejn, ħalq xott jew sensazzjoni mhux normali fil- ħalq, tnaqqis fis- sensazzjoni tat- togħma, indiġestjoni, uġigħ fl- istonku
Blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test
Demm: valuri ta ’ testijiet tal- funzjoni tal- fwied mhux normali, żjieda fil- livelli ta ’ chlorine fid- demm, jew tnaqqis fl- għadd ta ’ ċelluli ħomor tad- demm kif osservat f’ test tad- demm
Allergy: increased allergic symptoms
Allerġija: żjieda fis- sintomi ta ’ allerġija
Ear: ringing in the ears, sensation of spinning or dizziness
Widnejn: żanżin fil- widnejn, tħoss kollox idur bik jew sturdament
Skin: itching, rash, abnormal or decreased skin sensation, loss of hair
24 Ġilda: ħakk, raxx, sensazzjoni mhux normali jew imnaqqsa fil- ġilda, telf ta ’ xagħar
Muscular: generalised back, joint, or muscle pain, muscle spasms, pain in extremities, muscle weakness
Muskolari: uġigħ ġeneralizzat, fid- dahar, ġogi jew muskoli, spażmi muskolari, uġigħ fl- estremitajiet, indebboliment muskolari
Kidney: kidney pain such as lower back pain, frequent urination
Kliewi: uġigħ fil- kliewi bħal uġigħ fil- parti t’ isfel tad- dahar, awrina frekwenti
Reproduction: decreased sex drive, male sexual difficulty
Riproduzzjoni: tnaqqis fil- ħajra għas- sess, diffikultà sesswali fl- irġiel
Metabolism: low blood sugar
Metaboliżmu: zokkor fid- demm baxx
HOW TO STORE AZARGA
KIF TAĦŻEN AZARGA
Do not use AZARGA after the expiry date which is stated on the bottle and the carton after EXP.
Tużax AZARGA wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa wara “ JIS ”.
This medicine does not require any special storage conditions.
Din il- mediċini m’ għandhiex bżonn kondizzjonijiet speċjali ta ’ ħażna.
Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle.
Biex tipprevjeni nfezzjonijiet armi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba, u uża flixkun ġdid.
Write down the date of opening on the bottle label and carton label in the space provided.
Ikteb id- data meta ftaħt il- flixkun fl- ispazju pprovdut fuq it- tikketta tal- flixkun u tal - kaxxa.
Ask your pharmacist how to dispose of medicines you no longer require.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What AZARGA contains
X’ fih AZARGA
The active substances are brinzolamide and timolol.
Is- sustanzi attivi huma brinzolamide u timolol.
One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol.
Ml ta ’ suspensjoni fih 10 mg ta ’ brinzolamide u 5 mg ta ’ timolol.
The other ingredients are benzalkonium chloride, carbopol 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide.
Is- sustanzi l- oħra huma benzalkonium chloride, carbopol 974P, disodium edetate, mannitol (E421), ilma ppurifikat, sodium chloride, tyloxapol, hydrochloric acid u/ jew sodium hydroxide.
Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Jiġu miżjuda ammonti żgħar ta ’ hydrochloric acid u/ jew sodium hydroxide biex il- livelli ta ’ aċidità (livelli tal- pH) jinżammu normali.
What AZARGA looks like and the contents of the pack
Id- Dehra ta ’ AZARGA u l- kontenuti tal- pakkett
AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles.
AZARGA huwa likwidu (suspensjoni uniform ta ’ kulur abjad sa off- white) fornuta f’ pakkett li fih flixkun tal- plastik wieħed ta ’ 5 ml b’ għatu bil- kamin jew f’ pakkett li fih 3 fliexken ta ’ 5 ml.
Marketing Authorisation Holder
25 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom
Pentagon ParkBoundary Way Hemel Hempstead Herts HP2 7UD Ir- Renju Unit
Rijksweg 14 B-2870 Puurs Belgium
Alcon- Couvreur N. V Rijksweg 14 B- 2870 Puurs Il- Belġju
25 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
26 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
What is AZILECT?
X’ inhu AZILECT?
AZILECT is a medicine containing the active ingredient rasagiline.
AZILECT hu mediċina li jkun fiha s- sustanza attiva rasagiline.
It is available as white round tablets (1 mg).
Jiġi bħala pilloli bojod ovali (1 mg).
What is AZILECT used for?
Għalxiex jintuża AZILECT?
AZILECT is used for the treatment of Parkinson’ s disease.
AZILECT jintuża għat- trattament tal- marda tal- Parkinson.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Il- marda tal- Parkinson hi diżordni progressiva tal- moħħ li tikkawża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
AZILECT can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson’ s disease) in patients who are having ‘ fluctuations’ towards the end of the period between levodopa doses.
AZILECT jista ’ jintuża waħdu, jew bħala żieda għal levodopa (mediċina oħra użata fil- marda ta ’ Parkinson) fil - pazjenti li jkollhom ‘ varjazzjonijiet ’ lejn tmiem il- perjodu bejn id- dożi ta ’ levodopa.
Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off’ and immobile.
Il- varjazzjonijiet huma marbuta ma ’ tnaqqis fl- effetti ta ’ levodopa, meta l- pazjent jgħaddi minn tibdiliet ta ’ malajr bejn stat li fih ikun jista ’ jimxi għal stat fejn ikun immobbli (il - ‘ fażi ta ’ l- immobilità ’).
AZILECT can only be obtained with a prescription.
AZILECT jista ’ jinkiseb biss b’ riċetta ta ’ tabib.
How is AZILECT used?
Kif jintuża AZILECT?
The standard dose of AZILECT is one tablet once a day, taken with or without food.
Id- doża standard ta ’ AZILECT hi pillola waħda kuljum, meħuda ma ’ jew mingħajr l- ikel.
AZILECT should not be used in patients who have severe problems with their liver and it should be avoided in those with moderate liver problems.
AZILECT m’ għandux jintuża minn pazjenti li jkollhom problemi severi fil- fwied u għandu jiġi evitat f’ dawk bi problemi moderati fil- fwied.
Patients with mild liver problems should use AZILECT with caution and should stop treatment if their liver problems get worse.
Il- pazjenti bi problemi ħfief fil- fwied għandhom jużaw AZILECT b’ kawtela u għandhom iwaqqfu t- trattament jekk il- problemi tal- fwied imorru jiggravaw.
How does AZILECT work?
Kif jaħdem AZILECT?
The active substance in AZILECT, rasagiline, is a monoamine oxidase-B inhibitor.
Is- sustanza attiva f’ AZILECT, rasagiline, hija inibitur tal- monoamine oxidase- B.
It blocks the enzyme monoamine oxidase type B, which breaks down the ‘ neurotransmitter’ dopamine in the brain.
Jimblokka l- enzim monoamine oxidase Tip B, li jkisser in - ‘ newrotrażmettitur ’ imsejjaħ dopamina fil- moħħ.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
In - newrotrasmettituri huma kimiċi li jippermettu liċ- ċelloli tan- nervituri jikkomunikaw ma ’ xulxin.
In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Fil - marda tal- Parkinson, iċ- ċelloli li jipproduċu d- dopamina jibdew imutu u l- ammont ta ’ dopamina fil - moħħ jonqos.
The patients then lose their ability to control their movements reliably.
Imbagħad, il- pazjenti jitilfu l- abilità li jikkontrollaw il- movimenti b’ mod affidabbli.
By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, AZILECT improves the signs and symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
Billi jżid il- livelli ta ’ dopamina fil- partijiet tal- moħħ li jikkontrollaw il- moviment u l- ko- ordinazzjoni, AZILECT itejjeb is- sinjali u s- sintomi tal- marda ta ’ Parkinson, bħall- ebusija u t- tnaqqis fil- ħeffa taċ - ċaqliq.
How has AZILECT been studied?
Kif ġie studjat AZILECT?
The effects of AZILECT were first tested in experimental models before being studied in humans.
L- effetti ta ’ AZILECT għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bniedem.
AZILECT has been studied in three main studies involving a total of 1,563 patients with Parkinson’ s disease.
AZILECT ġie studjat fi tliet studji ewlenin li fihom b’ kollox ħadu sehem 1, 563 pazjent bil- marda tal - Parkinson.
(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 In the first study, the effects of two different doses of AZILECT taken alone were compared to those of placebo (a dummy treatment) in 404 patients with early-stage disease.
(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 Fl- ewwel studju, l- effetti ta ’ żewġ dożi differenti ta ’ AZILECT meħud waħdu tqabblu ma ’ dawk ta ’ plaċebo (trattament finta) f’ 404 pazjenti bil- marda fl- istadju bikri.
The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson’ s Disease Rating Scale, UPDRS).
Il- mezz ewlieni tal- kejl ta ’ l - effettività kien it- tibdil fis- sintomi matul perjodu ta ’ 26 ġimgħa, kif valutat bi skala standard (Unified Parkinson’ s Disease Rating Scale, UPDRS).
The other two studies involved a total of 1,159 patients with later stage disease, where AZILECT was added to the patients’ existing treatment including levodopa.
Fiż- żewġ studji l- oħra b’ kollox ħadu sehem 1, 159 pazjent b’ marda fi stadju iktar avvanzat, fejn AZILECT żdied mat- trattament eżistenti tal- pazjent inkluż levodopa.
It was compared with placebo or entacapone (another medicine for Parkinson’ s disease).
AZILECT tqabbel ma ’ plaċebo jew entacapone (mediċina oħra għall- marda ta ’ Parkinson).
The studies lasted 26 and 18 weeks, respectively.
L- istudji damu 26 u 18- il ġimgħa rispettivament.
The main measure of effectiveness was the time spent in the ‘ off’ state during the day, as recorded in patient diaries.
Il- mezz ewlieni għall- kejl ta ’ l- effettività kienu iż- żmien li fih il- pazjent kien fi stat ta ’ immobilità matul il- jum, kif reġistrat fid- djarji tal- pazjenti.
What benefit has AZILECT shown during the studies?
X’ inhuma l- benefiċċji ta ’ AZILECT li ntwerew waqt l- istudji?
AZILECT was more effective than placebo in all studies.
AZILECT kien effettiv iktar mill- plaċebo fl- istudji kollha.
In the study where AZILECT was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
Fl- istudju li fih AZILECT intuża waħdu, il - pazjenti li kienu qed jieħdu 1 mg tal- mediċina darba kuljum kellhom tnaqqis medju ta ’ 0. 13 punti fil - punteġġ UPDRS fis- 26 ġimgħa minn punteġġ inizjali ta ’ 24. 69.
This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Dan tqabbel ma ’ żieda ta ’ 4. 07 punti fil- pazjenti li kienu qed jieħdu l- plaċebo minn valur inizjali ta ’ 24. 54.
A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Tnaqqis fil- punteġġ ta ’ l - UPDRS juri jindika titjib fis- sintomi, waqt li żieda tindika teħżin fis- sintomi.
When used as an add-on to levodopa, 1 mg AZILECT reduced the time in the ‘ off’ state more than placebo did.
Meta ntuża bħala żieda għal- levodopa, 1 mg ta ’ AZILECT naqqas il- ħin fl - ‘ istat ta ’ l- immobilità ’ iktar mill- plaċebo.
In both studies, patients adding AZILECT spent an average of around one hour less in the ‘ off’ state than those adding placebo.
Fiż- żewġ studji, il- pazjenti damu medja ta ’ madwar siegħa inqas fl - ‘ istat ta ’ immobilità ’ minn dawk li żiedu l- plaċebo.
A similar decrease in time spent in the ‘ off’ state was seen in patients taking entacapone.
Kien hemm tnaqqis simili fil- ħin li l- pazjenti li kienu qed jieħdu entacapone damu fil - ‘ fażi ta ’ l- immobilità ’.
What is the risk associated with AZILECT?
X’ inhu r- riskju assoċjat ma ’ AZILECT?
The most common side effect with AZILECT (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarju komuni ma ’ AZILECT (li deher f’ iktar minn pazjenti wieħed minn kull 10) hu l- uġigħ ta ’ ras.
For the full list of all side effects reported with AZILECT, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ AZILECT, ara l - Fuljett ta ’ Tagħrif.
AZILECT should not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients.
AZILECT ma għandux jintuża f’ persuni allerġiċi għal rasagiline jew għal xi sustanza oħra tiegħu.
AZILECT should not be used with other monoamine oxidase inhibitors or pethidine (a painkiller).
AZILECT m’ għandux jintuża ma ’ inibituri oħra tal- monoamine oxidase jew ma ’ pethidine (mediċina għal kontra l- uġigħ).
There should be at least 14 days between stopping treatment with AZILECT and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Għandu jitħalla perjodu ta ’ mill- inqas 14- il jum bejn it- twaqqif tat- trattament b’ AZILECT u l- bidu ta ’ trattament b’ inibitur ieħor tal- monoamine oxidase jew bil- pethidine.
Caution is also needed by patients taking AZILECT at the same time as other medicines.
Meta pazjenti jkunu qed jieħdu AZILECT fl- istess ħin li jkunu qed jieħdu mediċini oħra, dan għandu jsir b’ kawtela kbira.
See the Package Leaflet for more information.
Ara l- Fuljett ta ’ Tagħrif għal iktar tagħrif.
Why has AZILECT been approved?
Għaliex ġie approvat AZILECT?
The Committee for Medicinal products for Human Use (CHMP) decided that AZILECT’ s benefits are greater than its risks for the treatment of idiopathic Parkinson’ s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Il- Kumitat tal- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ AZILECT huma ikbar mill- benefiċċji tiegħu fit- trattament tal- marda tal- Parkinson idjopatika bħala monoterapija (mingħajr levodpa) jew bħala terapija miżjuda (ma ’ levodopa) f’ pazjenti b ’ varjazzjonijiet ta ’ tmiem id- doża.
The Committee recommended that AZILECT be given marketing authorisation.
Il- Kumitat irrakkomanda li AZILECT jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about AZILECT:
Tagħrif ieħor dwar AZILECT:
The European Commission granted a marketing authorisation valid throughout the European Union for AZILECT to Teva Pharma GmbH on 21 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal AZILECT lil Teva Pharma GmbH fil- 21 ta ’ Frar 2005.
The full EPAR for AZILECT can be found here.
L- EPAR sħiħ għal AZILECT jista ’ jinstab hawnhekk.
AZILECT 1 mg tablets
AZILECT 1 mg pilloli
Each tablet contains 1 mg rasagiline (as mesilate).
Kull pillola fiha 1 mg rasagiline (bħala mesilate).
White to off-white, round, flat, bevelled tablets, debossed with “ GIL” and “ 1” underneath on one side and plain on the other side.
Pilloli bojod għal offwajt, tondi, ċatti, b’ xifer imżerżaq, mnaqqxa b ’ “ GIL ” u “ 1 ” minn taħt fuq naħa waħda u mingħajr ebda marka speċjali n- naħa l- oħra.
AZILECT is indicated for the treatment of idiopathic Parkinson’ s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
AZILECT huwa indikat għat- trattament tal- marda ta ’ Parkinson (PD) idjopatika, bħala monoterapija (mingħajr levodopa) jew bħala terapija miżjuda (ma ’ levodopa) f’ pazjenti b’ tibdil fil- kundizzjoni tagħhom fl- aħħar tad- doża.
Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.
Rasagiline jittieħed mill- ħalq, f’ doża ta ’ 1 mg darba kuljum, flimkien jew mingħajr levodopa.
It may be taken with or without food.
Jista ’ jittieħed kemm ma ’ l- ikel kif ukoll fuq stonku vojt.
No change in dosage is required for elderly patients.
M’ hemmx għalfejn tibdil fid- doża fl- anzjani.
Children and adolescents (< 18 years):
Tfal u adoloxenti (< 18 years):
Not recommended as the safety and efficacy have not been established in this population.
Mhux rikkmandat għaliex is- sigurta` u l- effikaċja ma ġietx stabbilita f’ din il- popolazzjoni.
Patients with hepatic impairment:
Pazienti b’ indeboliment tal- fwied:
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3).
L- użu ta’ rasagiline f’ pazjenti b’ indeboliment sever tal- fwied huwa kontra- indikat (ara sezzjoni 4. 3).
Rasagiline use in patients with moderate hepatic impairment should be avoided.
L- użu ta ’ rasagiline għandu jiġi evitat f’ pazjenti b’ indeboliment moderat tal- fwied.
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
Trattament b’ rasagiline għandu jinbeda b’ kawtela f’ pazjenti b’ insuffiċienza ħafifa tal- fwied.
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4).
Rasagiline għandha titwaqqaf f’ dawk il- pazjenti fejn l- indeboliment ħafif tal- fwied jiggrava għal wieħed moderat (ara sezzjoni 4. 4).
No change in dosage is required for renal impairment.
M’ hemmx bżonn tibdil fid- doża meta jkun hemm indeboliment renali.
Concomitant treatment with other monoamine oxidase (MAO) inhibitors or pethidine (see section 4.5).
Trattament flimkien ma ’ impedituri oħrajn ta ’ monoamine oxidase (MAO) jew pethidine (ara sezzjoni 4. 5).
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
Iridu jkunu għaddew mill- inqas 14 il- ġurnata bejn il- waqfien ta ’ trattament b’ rasagiline u l- bidu ta ’ trattament b’ impedituri ta ’ MAO jew b ’ pethidine.
Rasagiline is contraindicated in patients with severe hepatic insufficiency.
Rasagiline huwa kontra- indikat f’ pazjenti b’ insuffiċjenza severa tal- fwied.
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
L- użu ta ’ rasagiline flimkien ma ’ fluoxetine jew fluvoxamine għandu jiġi evitat (ara sezzjoni 4. 5).
At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline.
Iridu jkunu għaddew mill- inqas ħames ġimgħat mill- waqfien ta ’ trattament b’ fluoxetine qabel ma jinbeda trattament b’ rasagiline.
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Iridu jkunu għaddew mill- inqas 14 il- ġurnata bejn il- waqfien ta ’ trattament b’ rasagiline u l- bidu ta ’ trattament b ’ fluoxetine u fluvoxamine.
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medications containing ephedrine or pseudoephedrine is not recommended (see section 4.5).
L- użu ta ’ rasagiline flimkien ma ’ dextromethorphan jew simpatomimetiċi oħrajn bħal dawk li jinstabu f’ dekonġestjonanti ta ’ l- imnieħer u dawk orali jew mediċini ta ’ kontra l- irjiħat li fihom ephedrine u pseudoephedrine, m’ huwiex rikkmandat (ara sezzjoni 4. 5).
During the clinical development programme the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
Wara li feġġew xi każijiet ta ’ melanoma waqt il- programm ta ’ żvillup kliniku, bdiet tiġi eżaminata l - possibilta` ta ’ xi konnessjoni ma ’ rasagiline.
The data collected suggests that Parkinson’ s disease, and not any drug in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
It- tagħrif li nġabar jissuġġerixxi li hija l- marda ta ’ Parkinson, u mhux xi mediċina partikolari, li hija assoċjata ma ’ riskju ogħla ta ’ kanċer tal- ġilda (mhux esklusivament melanoma).
Any suspicious skin lesion should be evaluated by a specialist.
Leżjonijiet fil- ġilda li jkunu suspettużi għandhom jiġu eżaminati minn speċjalista.
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
Trattament b’ rasagiline għandu jinbeda b’ kawtela f’ pazjenti b’ insuffiċjenza ħafifa tal- fwied.
Rasagiline use in patients with moderate hepatic impairment should be avoided.
L- użu ta’ rasagiline għandu jiġi evitat f’ pazjenti b’ indeboliment moderat tal- fwied.
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
Rasagiline għandu jitwaqqaf f’ dawk il- pazjenti fejn l- indeboliment ħafif tal- fwied jiggrava għal wieħed moderat (ara sezzjoni 5. 2).
There are a number of known interactions between non selective MAO inhibitors and other medicinal products.
Hemm numru ta ’ interazzjonijiet bejn impedituri mhux selettivi ta ’ MAO u prodotti mediċinali oħrajn.
Rasagiline should not be administered along with other MAO inhibitors as there may be a risk of non- selective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Rasagiline m’ għandux jingħata flimkien ma ’ impedituri oħrajn ta ’ MAO għaliex jista ’ jkun hemm riskju ta ’ inibizzjoni mhux selettiva ta ’ MAO li tista ’ twassal għal kriżi ipertensiva (ara sezzjoni 4. 3).
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors as well as with another selective MAO-B inhibitor.
Reazzjonijiet serji avversi ġew irrapportati waqt l- użu flimkien ta ’ pethidine u impedituri ta ’ MAO kif ukoll ma ’ impeditur ieħor selettiv għal MAO- B.
The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
L- użu ta ’ rasagiline flimkien ma ’ pethidine huwa kontra- indikat (ara sezzjoni 4. 3).
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
L- użu ta ’ rasagiline flimkien ma ’ fluoxetine jew fluvoxamine għandu jkun evitat (ara sezzjoni 4. 4).
With MAO inhibitors as well as with another selective MAO-B inhibitor there have been reports of drug interactions with the concomitant use of sympathomimetic medicinal products.
Kien hemm rapporti li impedituri ta ’ MAO kif ukoll ta ’ impeditur ieħor selettiv għal MAO- B ma ’ jaqblux ma ’ prodotti mediċinali simpatomimetiċi meta jittieħdu flimkien.
Therefore, in view of the MAO inhibitory activity of rasagiline concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medications, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Għaldaqstant, minħabba l - attivita` inibitorja ta ’ rasagiline għal MAO, mhuwiex rikkmandat l- użu ta ’ rasagiline flimkien ma ’ simpatomimetiċi inklużi dawk presenti f ’ dekonġestjonanti ta ’ l- imnieħer u dawk orali u mediċini kontra l- irjiħat li fihom ephedrine jew pseudoephedrine (ara sezzjoni 4. 4).
There have been reports of drug interactions with the concomitant use of dextromethorphan and non selective MAO inhibitors.
Kien hemm rapporti li impedituri ta ’ MAO li m’ humiex selettivi ma jaqblux ma ’ dextromethorphan meta jittieħdu flimkien.
Therefore, in view of the MAO inhibitory activity of rasagiline the concomitant administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Għaldaqstant, minħabba l- attivita` inibitorja ta ’ rasagiline għal MAO, mhuwiex rikkmandat l- użu ta ’ rasagiline flimkien ma ’ dextromethorphan (ara sezzjoni 4. 4).
Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), tricyclic, tetracylic antidepressants and MAO inhibitors as well as with another selective MAO-B inhibitor.
Reazzjonijiet serji avversi kienu rraportati bl- użu ta ’ impedituri selettivi tal- ġbir mill- gdid ta ’ serotonin (mediċini SSRI), antidepressanti triċikliċi u tetraċikliċi u impedituri ta ’ MAO kif ukoll ma ’ impeditur ieħor selettiv għal MAO- B.
Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
Għaldaqstant, antidepressanti għandhom jingħataw b’ kawtela minħabba l- attivita` inibitorja ta ’ rasagiline għal MAO.
In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy there was no clinically significant effect of levodopa treatment on rasagiline clearance.
3 It- trattament b’ levodopa ma kellu ebda effett li hu klinikament sinifikanti fuq it- tneħħija ta ’ rasagiline, f’ pazjenti bil- marda ta ’ Parkinson li jieħdu trattament kroniku b’ levodopa bħala terapija miżjuda ma ’ mediċini oħrajn.
In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
Studji dwar il- metaboliżmu in vitro indikaw li cytochrome P450 1A2 (CYP1A2) huwa l- enzim prinċipali risponsabli għall- metaboliżmu ta ’ rasagiline.
Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Meta rasagiline u ciprofloxacin (impeditur ta ’ CYP1A2) ittieħdu flimkien, l- AUC ta ’ rasagiline żdied b ’ 83%.
3 theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
Meta rasagiline u theophylline (sustrat ta ’ CYP1A2) ittieħdu flimkien, ma kien hemm ebda effett farmakokinetiku fuq ebda prodott.
Thus, potent CYP1A2 inhibitors may alter rasagiline plasma levels and should be administered with caution.
Għalhekk impedituri qawwija ta ’ CYP1A2 għandhom jingħataw b’ attenzjoni għaliex jistgħu jbiddlu l - livelli ta ’ rasagiline fil- plażma.
There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Hemm riskju li f’ pazjenti li jpejpu, l- livelli fil- plażma ta ’ rasagiline jistgħu jinżlu minħabba l - induzzjoni ta ’ l- enzim CYP1A2 li hu risponsabli għall- metaboliżmu.
In vitro studies showed that rasagiline at a concentration of 1 µg/ ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ ml in Parkinson’ s disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Studji in vitro wrew li rasagiline f’ konċentrazzjoni ta ’ 1 µg/ ml (ekwivalenti għal livell li hu 160 darba iżjed mill- medja ta ’ Cmax ~ 5. 9- 8. 5 ng/ ml f ’ pazjenti bil- marda ta ’ Parkinson wara dożi multipli ta ’ rasagiline 1 mg), ma jinibixxix iżoenzimi cytochrome P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 u CYP4A.
These results indicate that rasagiline’ s therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Dawn ir- risultati jindikaw li x’ aktarx konċentrazzjonijiet terapewtiċi ta ’ rasagiline ma jfixklux b’ mod li huwa klinikament sinifikanti s- sustrati ta ’ dawn l - enzimi.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.
It- tneħħija orali ta ’ rasagiline tiżdied b ’ 28% meta rasagiline u entacapone jittieħdu f’ istess ħin.
Tyramine/ rasagiline interaction:
Interazzjoni bejn tyramine/ rasagiline:
Results of four tyramine challenge studies (in volunteers and PD patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/ day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/ rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Risultati ta ’ erba ’ studji ta ’ ċalinġ fuq tyramine (f’ voluntiera u pazjenti b ’ PD), flimkien ma ’ risultati ta ’ monitoraġġ id- dar ta ’ l- pressjoni ta’ d- demm wara l- ikel (ta ’ 464 pazjent li rċievew 0. 5 jew 1 mg/ ġurnata ta ’ rasagiline jew plaċebo bħala terapija miżjuda ma ’ levodopa għal sitt xhur mingħajr restrizzjonijiet għal tyramine), flimkien ma ’ l- fatt li ma kienx hemm rapporti ta ’ interazzjoni bejn tyramine/ rasagiline fl- istudji kliniċi mingħajr restrizzjonijiet għal tyramine, wrew li rasagiline jista ’ jintuża mingħajr periklu bla restizzjonijiet ta ’ tyramine fid- dieta.
For rasagiline no clinical data on exposed pregnancies is available.
M’ hemm l- ebda tagħrif kliniku dwar tqala esposta għal rasagiline.
Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fl- annimali ma jindikawx effetti ħżiena kemm diretti u kemm indiretti fuq it- tqala, l- iżvillup ta ’ l- embriju/ l- fetu, il- ħlas jew l - iżvillup wara t- twelid (ara sezzjoni 5. 3).
Caution should be exercised when prescribing to pregnant women.
Għandha tintuża l- kawtela meta tinkiteb preskrizzjoni waqt it- tqala.
Experimental data indicated that rasagiline inhibits prolactin secretion and, thus, may inhibit lactation.
Tagħrif esperimentali indika li rasagiline jimpedixxi s- sekrezzjoni ta ’ prolactin u għalhekk jista ’ jwaqqaf it- treddigħ.
It is not known whether rasagiline is excreted in human milk.
Mhux magħruf jekk rasagiline jitneħħiex fil- ħalib ta ’ l- omm.
Caution should be exercised when rasagiline is administered to a breast-feeding mother.
Rasagiline għandu jingħata b’ attenzjoni lin- nisa li jkunu qed ireddgħu.