qanastek/EMEA-V3 huggingface dataset:
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr orodispersible tablets.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu l- pilloli Azomyr li jinħallu fil- ħalq.
If you take more Azomyr orodispersible tablet than you should Take Azomyr orodispersible tablet only as prescribed for you.
Jekk tieħu Azomyr pillola li tinħall fil- ħalq aktar milli suppost Ħu l- pillola Azomyr li tinħall fil- ħalq biss kif ordnawlek.
However, if you take more Azomyr orodispersible tablet than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar pillola Azomyr li tinħall fil- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Azomyr orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Azomyr pillola li tinħall fil- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Like all medicines, Azomyr can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Azomyr jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
83 Meta Azomyr tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
HOW TO STORE AZOMYR ORODISPERSIBLE TABLET
KIF TAĦŻEN AZOMYR PILLOLA LI TINĦALL FIL- ĦALQ
Do not use Azomyr orodispersible tablet after the expiry date which is stated on the carton and blister.
Tużax Azomyr pillola li tinħall fil- ħalq wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja.
Tell your pharmacist if you notice any change in the appearance of Azomyr orodispersible tablet.
Għid lill- ispiżjar tiegħek jekk tara xi tibdil fid- dehra ta ’ Azomyr pillola li tinħall fil- ħalq.
What Azomyr orodispersible tablet contains
X’ fih Azomyr pillola li tinħall fil- ħalq:
What Azomyr orodispersible tablet looks like and contents of the pack
Id- Dehra ta ’ Azomyr pillola li tinħall fil- ħalq u l- kontenuti tal- pakkett
Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “ K” branded on one side.
Azomyr 2. 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ K ” fuq naħa.
Azomyr orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Azomyr pillola li tinħall fil- ħalq qegħda ppakkjata f’ dożi b’ waħdiet f’ pakketti ta ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 u 100 doża ta ’ pilloli li jinħallu fil- ħalq.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
84 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
86 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44-(0)1 707 363 636
85 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
87 PACKAGE LEAFLET:
86 FULJETT TA ’ TAGĦRIF:
Azomyr 5 mg orodispersible tablets desloratadine
Azomyr 5 mg pilloli li jinħallu fil- ħalq desloratadine
How to store Azomyr orodispersible tablet 6.
Kif taħżen Azomyr pillola li tinħall fil- ħalq 6.
Do not take Azomyr orodispersible tablet
Tieħux Azomyr pillola li tinħall fil- ħalq
Azomyr 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Azomyr 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 12 snin ‘ l fuq).
88 Taking Azomyr orodispersible tablet with food and drink Azomyr orodispersible tablet does not need to be taken with water or liquid.
87 Meta tieħu Azomyr pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Azomyr pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Water or other liquid is not needed to swallow the dose.
Azomyr pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Adults and adolescents (12 years of age and older): take one 5 mg Azomyr orodispersible tablet once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Azomyr pillola li tinħall fil- ħalq darba kuljum.
89 During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
88 Meta Azomyr tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “ A” branded on one side.
Azomyr 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ A ” fuq naħa.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
89 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
92 PACKAGE LEAFLET:
91 FULJETT TA ’ TAGĦRIF:
What Azomyr is and what it is used for 2.
X’ inhi Azomyr u għalxiex jintuża 2.
Azomyr oral solution is an antiallergy medicine that does not make you drowsy.
Azomyr soluzzjoni orali hija mediċina kontra l- allerġiji li ma traqdekx.
Azomyr oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is - sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Azomyr oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Azomyr soluzzjoni orali tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal - ġilda ikkawżata minn allerġija).
of Azomyr.
sustanzi oħra ta ’ Azomyr.
Azomyr oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Azomyr soluzzjoni orali tintuża fi tfal minn sena sa 11- il sena, adolexxenti (minn 12- il sena ’ l fuq), u adulti, inklużi l- anzjani.
93 Taking Azomyr with food and drink Azomyr may be taken with or without a meal.
92 Meta tieħu Azomyr ma ’ l- ikel u max- xorb Azomyr jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby, taking Azomyr oral solution is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Azomyr soluzzjoni orali mhux irrakkomandat.
Important information about some of the ingredients of Azomyr Azomyr oral solution contains sorbitol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Azomyr Azomyr soluzzjoni orali fiha sorbitol.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li ma tistax tiqħu ċerti tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral solution.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu s- soluzzjoni orali Azomyr.
If you take more Azomyr than you should Take Azomyr oral solution only as it is prescribed for you.
Jekk tieħu Azomyr aktar milli suppost Ħu Azomyr soluzzjoni orali biss kif ordnawlek.
However, if you take more Azomyr oral solution than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Azomyr soluzzjoni orali milli suppost, għamel kuntatt mat - tabib jew l- ispiżjar tiegħek.
Like all medicines, Azomyr oral solution can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Azomyr soluzzjoni orali jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Azomyr kienu rrapurtati kważi daqs kieku ħadu soluzzjoni jew pillola finta.
During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Azomyr tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa), u raxx kienu rrappurtati rari ħafna.
Azomyr oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap.
Azomyr soluzzjoni orali, jiġi fi fliexken ta ’ daqsijiet ta ’ 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluqin b’ għatu tal- plastik mhux faċli biex jiftħuh it- tfal.
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
94 Manifattur: SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju.
96 Welwyn Garden City Hertfordshire AL7 1TW Tel: +44-(0)1 707 363 636
95 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Azopt?
X’ inhu Azopt?
Azopt is a white eye drop suspension.
Azopt hija sospensjoni bajda ta ’ taqtir ta ’ l- għajnejn.
It contains the active substance brinzolamide (10 mg/ ml).
Huwa fih is- sustanza attiva brinzolamide (10 mg/ ml).
What is Azopt used for?
Għal xiex jintuża Azopt?
Azopt is used to reduce intra-ocular pressure (pressure inside the eye) in patients with ocular hypertension (when the pressure in the eye is higher than normal) or open-angle glaucoma (a disease in which the pressure inside the eye rises because fluid cannot drain out of the eye).
Azopt jintuża biex inaqqas il- pressjoni intra- okulari (pressjoni ġewwa l- għajn) f’ pazjenti bi pressjoni okulari għolja (meta l- pressjoni fl- għajn hija ogħla min- normal) jew glawkoma ta ’ angolu miftuħ (marda fejn il- pressjoni ġewwa l- għajn togħla minħabba li l- fluwidu ma jkunx jista ’ joskula ’ l barra minn ġol- għajn).
Azopt is used as an add-on to beta-blockers or prostaglandin analogues (other medicines used for these conditions), or on its own in patients who cannot take or do not respond to beta-blockers.
Huwa jintuża bħala żieda ma ’ imblokkaturi- beta jew analogi prostaglandini (mediċini oħra użati f’ dawn il- kondizzjonijiet), jew waħdu f’ pazjenti li ma jistgħux jieħdu jew ma jistgħux jirrispondu għal imblokkaturi- beta.
How is Azopt used?
Kif jintuża Azopt?
The dose of Azopt is one drop into the affected eye(s) twice a day.
Id- doża ta ’ Azopt hija taqtira ġol- għajn( ejn) li għandha ssir darbtejn kuljum.
Some patients may have a better response with one drop three times a day.
Xi pazjenti jista ’ jkollhom reazzjoni aħjar b’ taqtira waħda tliet darbiet kuljum.
The suspension needs to be shaken before use.
Is- sospensjoni jeħtieġ li tiġi mħarrka qabel l- użu.
Azopt is not recommended for patients with liver disease, because of a lack of information on safety and effectiveness in this group.
Azopt mhux irrakkomandat għal pazjenti b’ mard tal- fwied, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effikaċja f’ dan il- grupp.
Azopt should not be used in patients with severe kidney disease.
Azopt m’ għandux jintuża f’ pazjenti b’ mard serju tal- kliewi.
There is limited information on the use of Azopt in children.
It- tagħrif fuq l- użu ta ’ Azopt fit- tfal huwa limitat.
How does Azopt work?
Kif jaħdem Azopt?
Raised intra-ocular pressure 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.
Pressjoni intra- okulari għolja tikkaġuna ħsara lir- retina (il- wiċċ sensittiv għad- dawl fuq in- naħa ta ’ wara ta ’ l- għajnejn) u lin- nerv ottiku li jibgħat sinjali mill- għajn għall- moħħ.
This can result in serious vision loss and even blindness.
Dan jista ’ jirriżulta f’ telf fil- viżta serju u anke għama.
By lowering the pressure, Azopt reduces the risk of damage.
Azopt inaqqas ir- riskju ta ’ ħsara, billi jbaxxi l- pressjoni.
The active substance in Azopt, brinzolamide, is a carbonic anhydrase inhibitor.
Is- sustanza attiva f’ Azopt, brinzolamide, hija impeditur ta ’ carbonic anhydrase.
It works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Huwa jaħdem billi jimblokka enzima msejħa carbonic anhydrase, li tipproduċi joni ta ’ bikarbonat fil- ġisem.
Bicarbonate is required for the production of the aqueous humour (the watery fluid in the eye).
Il- bikarbonat huwa meħtieġ għall- produzzjoni ta ’ sustanza ilmija ta 'l- ghajnejn (aqueous humour - fluwidu qisu ilma ġol- għajn).
By blocking the production of bicarbonate in the eye, Azopt slows down the production of aqueous humour, reducing the pressure within the eye.
Azopt idewwem il- produzzjoni tas- sustanza ilmija ta 'l- ghajnejn, u jnaqqas il- pressjoni ġewwa l- għajn, billi jimblokka l- produzzjoni tal- bikarbonat.
Reproduction is authorised provided the source is acknowledged. timolol (a beta-blocker).
Kif ġie studjat Azopt?
Two of these studies lasted three months, and the third, comparing Azopt with timolol, lasted 18 months.
Tnejn minn dawn l- istudji damu għaddejjin tliet xhur, u t- tielet, li qabbel Azopt ma ’ timolol, dam 18- il xahar.
Two studies compared the effects of adding Azopt, dorzolamide or placebo (a dummy treatment) to timolol over three months.
Żewġ studji qabblu l- effetti taż- żieda ta ’ Azopt, dorzolamide jew plaċebo (trattament finta) ma ’ timolol fuq tliet xhur.
Finally, two studies compared the effectiveness of Azopt used twice a day with that of timolol, when they were used as an add-on to travoprost (a prostaglandin analogue), in a total of 390 patients over 12 weeks.
Fl- aħħar, żewġ studji qabblu l - effikaċja ta ’ Azopt meta użat darbtejn kuljum ma ’ dik ta ’ timolol, meta intużaw bħala żieda ma ’ travoprost (analogu protaglandin), f’ total ta ’ 390 pazjent matul 12- il ġimgħa.
In all studies, the main measure of effectiveness was the change in eye pressure measured in ‘ millimetres of mercury’ (mmHg).
Fl- istudji kollha, il- kejl ewlieni ta ’ l- effikaċja kienet il- bidla fil- pressjoni ta ’ l- għajn imkejla f ’ ‘ millimetri ta ’ merkurju ’ (mmHg).
What benefit has Azopt shown during the studies?
X’ benefiċċji wera Azopt waqt l- istudji?
When used alone, Azopt was less effective than timolol.
Meta wżat waħdu, Azopt kien inqas effettiv minn timolol.
Azopt caused a reduction in eye pressure of between 2.7 and 5.7 mmHg, compared with a reduction of between 5.2 and 6.0 mmHg in those given timolol.
Azopt ikkaġuna tnaqqis tal- pressjoni ta ’ l - għajn ta ’ bejn 2. 7 u 5. 7 mmHg, meta mqabbel ma ’ tnaqqis ta ’ bejn 5. 2 u 6. 0 mmHg f’ dawk mogħtija timolol.
In a patient with glaucoma, the eye pressure is generally higher than 21 mmHg.
F’ pazjent bil- glawkoma, il- pressjoni ta ’ l- għajn hija ġeneralment aktar għolja minn 21 mmHg.
Azopt was as effective as dorzolamide when used alone or as an add-on to timolol, with decreases in pressure of between 3.4 and 5.7 mmHg.
Azopt kien effettiv daqs dorzolamide meta użat waħdu jew bħala mediċina miżjuda ma ’ timolol, bi tnaqqis fil- pressjoni ta ’ bejn 3. 4 u 5. 7 mmHg.
Dorzolamide led to decreases of between 4.3 and 4.9 mmHg.
Dorzolamide wassal għal tnaqqis ta ’ madwar 4. 3 u 4. 9 mmHg.
Azopt was also more effective than placebo when used as an add-on to timolol.
Azopt kien ukoll aktar effettiv minn plaċebo meta użat bħala mediċina miżjuda ma ’ timolol.
When used as an add-on to travoprost, Azopt had a similar effectiveness to timolol in reducing eye pressure.
Meta intuża bħala żieda ma ’ travoprost, Azopt wera effikaċja simili għal timolol fit- tnaqqis tal - pressjoni ta ’ l- għajnejn.
In both studies, adding either Azopt or timolol caused a further decrease in eye pressure of around 3.5 mmHg after 12 weeks.
Fiż- żewġ studji, iż- żieda ta ’ Azopt jew timolol irriżultat f’ iktar tnaqqis tal - pressjoni ta ’ l- għajnejn ta ’ madwar 3. 5 mmHg wara 12- il ġimgħa.
Overall, Azopt showed similar effectiveness when used twice or three times per day.
Kollox ma ’ kollox, Azopt wera effikaċja simili meta użat darbtejn jew tliet darbiet kuljum.
However, the results suggested that some patients may show a greater reduction in eye pressure when using the drops three times per day.
Madankollu, ir- riżultati issuġġerew li xi pazjenti jistgħu juru tnaqqis akbar fil- pressjoni ta ’ l- għajn meta jużaw it- taqtir tliet darbiet kuljum.
What is the risk associated with Azopt?
X’ inhu r- riskju assoċjat ma ’ Azopt?
The most common side effects with Azopt (seen in between 1 and 10 patients in 100) are dysgeusia (a bitter or unusual taste in the mouth), headache, blepharitis (inflammation of the eyelids), blurred vision, eye irritation, eye pain, dry eye, eye discharge, eye pruritus (itching), sensation of a foreign body in the eyes, ocular hyperaemia (red eye) and dry mouth.
L- aktar effetti sekondarji komuni b’ Azopt (dehru f’ madwar pazjent 1 u 10 minn kull 100) huma diżgwiżja (togħma morra jew mhux tas- soltu fil- ħalq), uġigħ ta ’ ras, blefarite (infjammazzjoni ta ’ tebqiet l- għajnejn), viżta mċajpra, irritazzjoni ta ’ l- għajnejn, uġigħ fl- għajnejn, għajnejn xotti, materja ta ’ l- għajnejn, ħakk ta ’ l- għajnejn, sensazzjoni ta ’ materja estranja għal ġisem fl- għajn, iperemija okulari (għajn ħamra) u ħalq xott.
For the full list of all side effects reported with Azopt, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Azopt, ara l- Fuljett ta ’ Tagħrif.
Azopt should not be used in people who may be hypersensitive (allergic) to brinzolamide or any of the other ingredients, or to sulphonamides (such as some antibiotics).
Azopt m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal brinzolamide jew għal xi sustanzi attivi oħra, jew għal sulfonamidi (bħalma huma antibijotiċi).
It should also not be used in patients with severe kidney disease or hyperchloraemic acidosis (excess acid in the blood caused by too much chloride).
M’ għandux jintuża f’ pazjenti b’ mard tal- kliewi serju jew aċidożi iperklorimika (eċċess ta ’ aċidu fid- demm ikkaġunat minn chloride żejjed).
Azopt contains benzalkonium chloride, which is known to discolour soft contact lenses.
Azopt fih benzalkonium chloride, li huwa magħruf li jdennes il- kulur ta ’ lentijiet ta ’ kuntatt rotob.
Therefore, care should be taken by people who wear soft contact lenses.
Għaldaqstant, nies li jilbsu lentijiet ta ’ kuntatt rotob għandhom joqogħdu attenti.
Why has Azopt been approved?
Għaliex ġie approvat Azopt?
The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt’ s benefits are greater than its risks for the decrease of elevated intra-ocular pressure in ocular hypertension and open-angle glaucoma.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Azopt huma akbar mir- riskji tiegħu għat- tnaqqis tal- pressjoni intra- okulari għolja fi pressjoni okulari għolja u fi glawkoma ta ’ l- angolu miftuħ.
The Committee recommended that Azopt be given marketing authorisation.
Il- kumitat irrikkmanda li Azopt jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Azopt:
Tagħrif ieħor dwar Azopt:
The European Commission granted a marketing authorisation valid throughout the European Union for Azopt to Alcon Laboratories (UK) Limited on 9 March 2000.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Azopt valida fl- Unjoni Ewropea kollha lil Alcon Laboratories (UK) Limited fid- 9 ta ’ Marzu 2000.
The marketing authorisation was renewed on 9 March 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fid- 9 ta ’ Marzu 2005.
The full EPAR for Azopt can be found here.
L- EPAR sħiħ għalAzopt jista ’ jiġi kkonsultat hawn.
Pharmaceutical form
Daqs tal- pakkett
Packaging
AZOPT
Package size
Flixkun (LDPE)
Azopt Azopt Azopt
EU/ 1/ 00/ 129/ 003
Eye drops, suspension Eye drops, suspension Eye drops, suspension
qtar għall- għajnejn, suspensjoni
Ocular use Ocular use Ocular use
Użu għall- għajn
Bottle (LDPE) Bottle (LDPE) Bottle (LDPE)
Flixkun (LDPE)
1 bottle 1 bottle 3 bottles
3 Fliexken
AZOPT 10 mg/ ml eye drops, suspension
AZOPT 10 mg/ ml qtar għall- għajnejn, suspensjoni.
1 ml of suspension contains 10 mg brinzolamide.
1 ml ta ’ suspensjoni fiha 10 mg brinzolamide.
Excipients: benzalkonium chloride 0.15 mg, (see section 4.4).
Sustanzi mhux attivi: benzalkonium chloride 0. 15 mg, (ara sezzjoni 4. 4).
For a full list of excipients, (see section 6.1).
Għal- lista kompleta ta ’ sustanzi mhux attivi, (ara sezzjoni 6. 1).
Eye drops, suspension.
Qtar għall- għajnejn, suspensjoni.
Azopt is a white to off-white suspension.
Azopt huwa suspensjoni ta ’ lewn bajdani jew kważi bajdani
AZOPT is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see section 5.1).
Pressjoni għolja ġewwa l- għajn Glawkoma ta ’ tip ‘ open- angle ’ bħala monoterapija f’ pazjenti li mhux qed jirrispondu għall- kura bil- beta- blokers jew f’ pazjenti fejn il - beta- blokers huma kontra- indikati, jew bħala kura flimkien mal- beta- blokers jew analogi ta ’ prostaglandin (ara sezzjoni 5. 1).
When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT in the conjunctival sac of the affected eye(s) twice daily.
Meta jiġi wżat bħala monoterapija jew flimkien ma ’ xi kura oħra, id- doża ta ’ AZOPT hija ta ’ qatra waħda fil- borża konġuntivali tal- għajn( ejn) affettwata( i) darbtejn kuljum.
Some patients may have a better response with one drop three times a day.
Xi pazjenti għandhom mnejn jirrispondu aħjar għall- kura meta jużaw qatra waħda tlett darbiet kuljum.
Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended.
Huwa rrakkomondat li jkun hemm okklużjoni nasolakrimali jew li ġentilment jingħalaq il- kappell tal http: // www. emea. europa. eugħajn wara li jitqattar il- qtar.
This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
Dan jista ’ jnaqqas l- assorbiment sistemiku tal- prodotti mediċinali mill- għajn u jirriżulta f’ inqas effetti sistemiċi mhux mixtieqa.
When substituting another ophthalmic antiglaucoma agent with AZOPT, discontinue the other agent and start the following day with AZOPT.
Meta mediċina oħra ta ’ l- għajnejn li tintuża kontra l- glawkoma tiġi sostitwita b’ AZOPT, għandu jitwaqqaf l- użu tal- mediċina l- oħra u AZOPT jibda jintuża l- għada.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
Fil- każ li jkunu qed jintużaw aktar minn prodott mediċinali topiku wieħed fl- għajnejn, għandu jkun hemm interval ta ’ mill- inqas 5 minuti bejn applikazjoni u oħra.
Shake well before use.
Ħallat sewwa qabel ma tużah.
To prevent contamination of the dropper tip and suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Biex tevita ’ kontaminazzjoni tat- tarf tal- qattara u tas- soluzzjoni, oqgħod attent li ma ’ tmissx il- kappell ta ’ l- għajnejn, l- erja ta ’ madwar l- għajnenjn jew xi superfiċji oħra bit - tarf tal- qattara tal- flixkun.
Keep the bottle tightly closed when not in use.
Żomm il- flixkun magħluq sewwa meta mhux qed tuzah.
Use in elderly No dosage alteration in elderly patients is necessary.
Użu fl- anzjani M’ hemmx bżonn ta ’ tibdil fid- doża f’ pazjenti anzjani.
2 Use in children The efficacy and safety of AZOPT in patients below the age of 18 have not been established and its use is not recommended in these patients.
2 Użu fit- tfal L- effikaċja u s- sigurta ta ’ AZOPT f’ pazjenti taħt it- 18- il sena ma ’ gietx stabbilita u għalhekk l- użu tiegħu mhux irrakkomandat f’ dawn il- pazjenti.
However, there is limited experience in children.
Użu f’ pazjenti b’ indeboliment fil- fwied u fil- kliewi.
The safety and efficacy of AZOPT have been studied in a small number of paediatric patients less than 6 years of age (see also 4.4, 4.8 and 5.1).
AZOPT ma ’ ġietx studjat f’ pazjenti li għandhom indeboliment fil- kliewi jew fil- fwied u għalhekk l- użu tiegħu mhux irrakkomandat f’ dawn il- pazjenti.
Use in hepatic and renal impairment AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in such patients.
Is- sigurta ’ u l- effikaċja ta ’ AZOPT ġew studjati f’ numru żgħir ta ’ pazjenti tfal taħt is- 6 snin (ara wkoll 4. 4, 4. 8 u 5. 1)
AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/ min) or in patients with hyperchloraemic acidosis.
AZOPT ma ’ ġiex studjat f’ pazjenti li għandhom indeboliment serju fil- kliewi (clearance tal http: // www. emea. europa. eukrejatinina < 30 ml/ min) jew f’ pazjenti li jsofru minn aċidożi iperklorimika.
Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZOPT is therefore contra-indicated in such patients (see also 4.3).
Peress li l- biċċa l- kbira ta ’ brinzolamide u s- sustanza prinċipali li tiġi magħmula wara l- metaboliżmu tiegħu jiġu mneħħija mill- kliewi, AZOPT m’ għandux jintuża f ’ dawn il- pazjenti (ara wkoll sezzjoni 4. 3).
• Hypersensitivity to brinzolamide or any of the excipients. • Known hypersensitivity to sulphonamides (see also 4.4). • Severe renal impairment. • Hyperchloraemic acidosis (see also 4.2).
Aċidozi iperklorimika (ara wkoll sezzjoni 4. 2).
AZOPT is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
AZOPT huwa mediċina tat- tip sulfonamide u inibitur tal- carbonic anhydrase, u għalkemm jintuża b’ mod topiku, jiġi assorbit b’ mod sistemiku.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Disturbi fl- acid- base ġew irrapurtati bl- użu ta ’ inibituri tal- carbonic anhydrase meħudin mill- ħalq.
Brinzolamide has not been studied in pre-term infants (less than 36 weeks gestational age) or those less than 1 week of age.
Brinzolamide ma ġiex studjat fi trabi li twieldu qabel iż- żmien (inqas min 36 gimgħa tqala) jew f’ dawk li kellhom eta` ta ’ inqas minn gimgħa.
Patients with significant renal tubular immaturity or abnormalities should only receive brinzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.
Pazjenti li għandhom xi immaturita fit- tubi tal- kliewi jew xi anormalita ’ oħra għandhom jieħdu brinzolamide biss wara li jiġi evalwat il- bilanċ bejn ir- riskju u l- benefiċċju minħabba l- possibbilta ta ’ aċidożi metabolika.
The same types of undesirable effects that are attributable to sulphonamides may occur with topical administration.
Għalhekk, l- istess effetti mhux mixtieqa relatati mas- sulfonamides jistgħu jidhru meta jiġu wżati b’ mod topiku.
If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Jekk ikun hemm sinjali ta ’ reazzjonijiet serji jew sensittivita eċċessiva, l- użu ta ’ dan il- prodott għandu jitwaqqaf minnufih.
There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and AZOPT.
Hemm potenzjal li jiżdiedu l- effetti sistemiċi tal- inibizzjoni ta ’ carbonic anhydrase f’ pazjenti li qed jieħdu l- inibituri tal- carbonic anhydrase mill- ħalq u qed jużaw AZOPT ukoll.
The concomitant administration of AZOPT and oral carbonic anhydrase inhibitors has not been studied and is not recommended.
L- użu ta ’ AZOPT flimkien ma ’ l- inibituri tal- carbonic anhydrase meħudin mill- ħalq ma ’ ġewx studjati u għalhekk mhux irrakkomandat li jintużaw flimkien.
There is limited experience with AZOPT in the treatment of patients with pseudoexfoliative glaucoma or pigmentary glaucoma.
Hemm esperjenza limitata ħafna dwar l- użu ta ’ AZOPT għall- kura ta ’ pazjenti bi glawkoma psewdoesfoljattiva jew glawkoma pigmentorja.
AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma therapy.
L- aktar studji li saru kienu dwar l- użu ta ’ AZOPT flimkien ma ’ timolol bħala kura għall- glawkoma.
Additionally the IOP-reducing effect of Azopt as adjunctive therapy to the prostaglandin analogue travoprost has been studied.
Barra dan kien studjat l- effett ta ’ tnaqqis ta ’ IOP ta ’ Azopt bħala kura miżjuda ma ’ l- analogu ta ’ prostaglandin, travoprost.
No long term data are available on the use of AZOPT as adjunctive therapy to travoprost. (see section 5.1)
Mhux disponnibli tagħrif fit- tul dwar l- użu ta ’ AZOPT bħala kura miżjuda ma ’ travoprost (ara sezzjoni 5. 1).
AZOPT has not been studied in patients with narrow-angle glaucoma.
AZOPT ma ’ ġiex studjat f’ pazjenti li jbatu minn glawkoma tat- tip ‘ narrow angle ’.
The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
3 Ir- rwol ta ’ brinzolamide fuq il- funzjoni ta ’ l- endotilju tal- korneja ma ’ ġiex mistħarreg f’ pazjenti li għandhom il- korneja kompromessa (partikolarment f’ pazjenti li għandhom għadd baxx ta ’ ċelloli endotiljali).
Specifically, patients wearing contact lenses have not been studied and careful monitoring of these patients when using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and wearing contact lenses might increase the risk for the cornea.
Speċifikament, pazjenti li jilbsu l- lentijiet tal- kuntatt ma ’ ġewx studjati u għalhekk huwa rrakkomandat li dawn il- pazjenti jkunu osservati tajjeb waqt l- użu ta ’ brinzolamide, peress li l http: // www. emea. europa. euinibituri tal- carbonic anhydrase jistgħu jaffetwaw l- idrazzjoni tal- korneja u l- użu tal- lentijiet tal- kuntatt f’ dawn iċ- ċirkostanzi jistgħu jżidu r- riskju għall- korneja.
Likewise, in other cases of compromised corneas such as patients with diabetes mellitus, careful monitoring is recommended.
Bl- istess mod, f’ każijiet oħra fejn il- korneja tkun kompromessa bħal f’ pazjenti li jbagħtu minn dijabete mellitus, huwa rrakkomandat li dawn il- pazjenti jkunu osservati tajjeb.
3 Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Benzalkonium chloride li ġeneralment jintuża bħala preservativ fil- prodotti tal- għajnejn, gie rrapurtat li jista jikkawza punctate keratopathy, u/ jew toxic ulcerative keratopathy.
Since AZOPT contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Peress li AZOPT fih benzalkonium chloride, hu importanti li meta l- prodott jiġi wżat għal zmien twil f’ pazjenti li għandhom għajnejn xotti, jew f’ kundizjonijiet fejn il- korneja hija kompromessa, il- pazjenti jkunu osservati tajjeb.
AZOPT has not been studied in patients wearing contact lenses.
AZOPT ma ’ ġiex studjat f’ pazjenti li jilbsu l- lentijiet tal- kuntatt.
AZOPT contains the preservative benzalkonium chloride which may cause eye irritation.
AZOPT fih il- preżervattiv, benzalkonium chloride li jista joħloq irritazzjoni fl- għajnejn.
Benzalkonium chloride may be absorbed by soft contact lenses and is known to discolour soft contact lenses.
Il- benzalkonium chloride jista jiġi asorbit mil- lentijiet tal- kuntatt rotob u jbidlilhom il- kulur tagħhom.
Therefore, patients must be instructed to wait 15 minutes after instillation of AZOPT before inserting contact lenses.
Għalhekk, il- pazjenti għandhom ikunu jafu li wara li jqattru AZOPT, għandhom jistennew 15- il minuta qabel ma jilbsu l- lentijiet tal- kuntatt.
AZOPT must not be administered while wearing contact lenses.
AZOPT m’ għandux jintuża waqt li hemm il- lentijiet tal- kuntatt fl- għajnejn.
Potential rebound effects following cessation of treatment with AZOPT have not been studied; the IOP-lowering effect is expected to last for 5-7 days.
Ma ’ ġiex studjat il- possibilta ’ ta ’ l- effetti kuntrarji li jista ’ jkun hemm wara li wieħed jieqaf juża AZOPT; l- effet li l- IOP hu mistenni li jdum minn 5 sa 7 ijiem.
Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/ or physical coordination in elderly patients.
L- inibituri tal- carbonic anhydrase li jittieħdu mill- ħalq jistgħu jikkawzaw diffikulta f’ pazjenti anzjani biex jagħmlu ċerti affarijiet li jirikjedu l- konċentrazzjoni tal- moħħ u/ jew il- ko- ordinazzjoni fisika.
AZOPT is absorbed systemically and therefore this may occur with topical administration.
AZOPT huwa assorbit b’ mod sistemiku u dan jista ’ jseħħ wara li jintuża b’ mod topiku.
Specific interaction studies with other medicinal products have not been performed with AZOPT.
Ma ’ sarux studji speċifiċi dwar interazzjonijiet ta ’ AZOPT ma ’ mediċini oħra.
In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations without evidence of adverse interactions.
Fi studji kliniċi, AZOPT intuża flimkien ma ’ preparazzjonijiet għall- għajnejn ta ’ timolol u analogi ta ’ prostaglandin mingħajr ma kien hemm evidenza ta ’ xi interazzjonijiet avversi.
Association between AZOPT and miotics or adrenergic agonists has not been evaluated during adjunctive glaucoma therapy.
L’ assoċjazzjoni bejn AZOPT u mijotiċi jew agonisti adrenerġici ma ’ ġewx evalwati ma ’ tul il- kura aġuvanti tal- glawkoma.
AZOPT is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically.
AZOPT huwa inibitur tal- carbonic anhydrase u għalkemm jintuża b’ mod topiku, dan jiġi assorbitb’ mod sistemiku.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Disturbi tat- tip acid- base dehru meta ntużaw l- inibituri tal- carbonic anhydrase.
The potential for interactions must be considered in patients receiving AZOPT.
Il- possibilta ’ li jkun hemm interazzjonijiet għandha tiġi kkunsidrat f’ pazjenti li qed jieħdu AZOPT.
The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2C8 and CYP2C9.
L- iżozimi taċ- ċitokromju P- 450 li jieħdu sehem fil- metaboliżmu ta ’ brinzolamide jinkludu CYP3A4 il- prinċipali), CYP2A6, CYP2C8 u CYP2C9.
It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4.
Huwa mistenni li l- inibituri ta ’ CYP3A4 bħal ma ’ huma ketoconazole, itraconazole, clortrimazole, ritonavir u troleandomycin jimpedixxu il- metaboliżmu ta ’ brinzolamide li jseħħ permezz ta ’ CYP3A4.
Caution is advised if CYP3A4 inhibitors are given concomitantly.
Wieħed għandu joqgħod attent meta l- inibituri tal- CYP3A4 jittieħdu flimkien ma ’ AZOPT.
However, accumulation of brinzolamide is unlikely as renal elimination is the major route.
Madanakollu, mhux mistenni li ikun hemm akkumulazzjoni ta ’ brinzolamide peress li l- biċċa l- kbira tiegħu titneħħa mill- ġisem permezz tal- kliewi.
Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
Brinzolamide mhux inibitur ta ’ l- iżożimi taċ- citokromju P- 450.
Pregnancy There are no adequate data from the use of brinzolamide in pregnant women.
Tqala Ma hemm l- ebda informazzjoni dwar l- użu ta ’ brinzolamide fin- nisa tqal.
Studies in animals have shown reproductive toxicity (see 5.3).
Studji fuq il- bhejjem urew li kien hemm tossiċita ’ fis- sistema riprodutiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Mhux magħruf jekk hemmx riskju meta ntużat mill- bniedem.
AZOPT should not be used during pregnancy unless clearly necessary.
AZOPT m’ għandux jintuża fit- tqala jekk mhux verament neċessarju.
Nursing mothers It is not known whether brinzolamide is excreted in human milk, however, this substance is excreted in rat milk.
4 Nisa li Qed Ireddgħu Mhux magħruf jekk brinzolamide joħroġx mal- ħalib tas- sider tal- bnedmin, madanakollu, hu mgħaruf li jidher fil- ħalib tas- sider tal- firien.
It is strongly recommended to avoid the use of AZOPT when breast-feeding.
Għalhekk, l- użu ta ’ AZOPT mhux irrakomandat għan- nisa li qed ireddgħu.
Temporary blurred vision or other visual disturbances, may affect the ability to drive or use machines (see also 4.8 Undesirable effects).
Vista mċajpra għal żmien qasir jew xi disturbi oħra fil- vista jistgħu jaffetwa l- ħila tas- sewqan jew it- tħaddim ta ’ magni (ara wkoll sezzjoni 4. 8 Effetti mhux mixtieqa).
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Jekk, malli jqattar jara mċajpar għal zmien qasir, il- pazjent għandu jistenna sakemm il- vista terġa ’ lura għan- normal qabel ma jsuq jew iħaddem xi magni.
In clinical studies involving over 1800 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ ml, the most frequently reported treatment-related adverse events were: dysgeusia (5.8%) (bitter or unusual taste, see description below) and temporary blurred vision (5.8%) upon instillation, lasting from a few seconds to a few minutes (see also 4.7 Effects on ability to drive and use machines).
Fi studji kliniċi li saru fuq iktar minn 1800 pazjent li ġew ikkurati b’ AZOPT bħala monoterapija jew bħala terapija flimkien ma ’ 5 mg/ ml timolol maleate, l- effeti mhux mixtieqa relatati mal- kura, li kienu l- aktar komuni kienu: disġewżja (5. 8%) (togħma morra jew mhux tas- soltu, ara id- deskrizzjoni hawn taħt) u vista mċajpra għal żmien qasir (5. 8%) malli tqattar, li damet minn ftit sekondi sa ftit minuti (ara wkoll sezzjoni 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni).
The following undesirable effects were assessed to be treatment-related and are classified according to the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1000), or very rare (< 1/ 10,000).
L- effetti mhux mixtieqa li ġejjin kienu stmati bħala relatati mal- kura u huma ikklassifikati skond il- konvenzjoni li ġejja: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1000), jew rari ħafna (< 1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond kemm huma serji.
Uncommon: cardio-respiratory distress, angina pectoris, bradycardia, heart rate irregular
Mhux komuni: problemi kardjo- respiratorji, angina pectoris, qalb tħabbat bil- mod, qalb tħabbat b’ mod irregolari
Uncommon: red blood cell count decreased, blood chloride increased
Mhux komuni: tnaqqis fl- għadd ta ’ ċelluli ħomor tad- demm, żieda ta ’ chloride fid- demm
Common: dysgeusia, headache Uncommon: somnolence, motor dysfunction, amnesia, memory impairment, dizziness, paraesthesia
Komuni: disġewżja, uġigħ ta ’ ras Mhux komuni: ngħas, funzjoni motorja mhux normali, amnesija, indeboliment tal- memorja, sturdament, parasteżija
Common: blepharitis, blurred vision, eye irritation, eye pain, dry eye, eye discharge, eye pruritus, foreign body sensation in eyes, ocular hyperaemia Uncommon: corneal erosion, keratitis, punctate keratitis, keratopathy, deposit eye, corneal staining, corneal epithelium defect, intraocular pressure increased, optic nerve cup/ disc ratio increased, corneal oedema, conjunctivitis, meibomianitis, diplopia, glare, photophobia, photopsia, visual acuity reduced, allergic conjunctivitis, pterygium, scleral pigmentation, asthenopia, ocular discomfort, abnormal sensation in eye, keratoconjunctivitis sicca, hypoaesthesia eye, subconjunctival cyst, conjunctival hyperaemia, eyelids pruritus, eyelid margin crusting, lacrimation increased
Komuni: blefarite, vista mċajpra, irritazzjoni tal- għajn, uġigħ fl- għajn, l- għajn tinħass xotta, tnixxija mill- għajn, ħakk fl- għajn, sensazzjoni ta ’ xi ħaġa fl- għajnejn, iperimja ta ’ l- għajnejn Mhux komuni: barxa tal- korneja, keratite, keratite bit- tikek, keratopatija, depositu fl- għajn, tebgħa fil- korneja, difett fl- epitilju tal- kornea, żieda fil- pressjoni ta ’ ġo l- għajn, żieda fil- proporzjon tat- tazza/ disk tan- nerv ottiku, edima fil- korneja, konġuntivite, meibomianitis, diplopja, leħħa, fotofobija, fotopsija, vista mċajpra, konġuntivite allerġika, pteriġjum, pigmentazzjoni ta ’ l- isklera, astenopja, skomdu fl- għajn, sensazzjoni mhux normali fl- għajn, keratokonġunktivitexotta, ipoestesija ta ’ l- għajn, ċeste taħt il- konġunktiva, iperimja konġunktivali, ħakk fil- kappell ta ’ l- għajn, qoxra fix- xifer tal- kappell ta ’ l- għajn, żieda fid- dmugħ
Uncommon: tinnitus
Mhux komuni: tinnitus
Gastrointestinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
Common: dry mouth Uncommon: oesophagitis, diarrhoea, nausea, dyspepsia, upper abdominal pain, abdominal discomfort, stomach discomfort, flatulence, frequent bowel movements, gastrointestinal disorder, hypoaesthesia oral, paraesthesia oral
Mhux komuni: qtugħ ta ’ nifs, iperattività tal- bronki, sogħla, epistassi, uġigħ fil- gerżuma irritazzjoni fil- griżmejn, konġestjoni ta ’ l- imnieħer, konġestjoni fl- apparat respiratorju ta ’ fuq, taqtir wara l- imnieħer, rinoreja, għatis, imnieħer xott
5 Renal and urinary disorders:
5 Disturbi gastro- intestinali:
Uncommon: renal pain
Mhux komuni: uġigħ fil- kliewi
Uncommon: urticaria, rash, rash maculo-papular, pruritus generalized, alopecia, skin tightness
Mhux komuni: urtikarja, raxx, raxx makulo- papulari, ħakk kullimkien, alopeċja, ġilda tinħass miġbuda
Uncommon: back pain, muscle spasms, myalgia
Mhux komuni: uġigħ fid- dahar, spażmi tal- muskoli, majalġja
Uncommon: nasopharyngitis, pharyngitis, sinusitis
Mhux komuni: nasofarinġite, farinġite, sinusite
Injury, poisoning and procedural complications:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura:
Uncommon: foreign body in eye
Mhux komuni: tħoss bħal żrara fl- għajn
General disorders and administrative site conditions:
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata:
Uncommon: pain, chest discomfort, asthenia, fatigue, feeling abnormal, feeling jittery, irritability
Mhux komuni: uġigħ, skomdu fis- sider, astenja, għeja, tħossok mhux normali, tħossok nervuż, irritabilità
Uncommon: erectile dysfunction
Mhux komuni: funzjoni erettili mhux normali
Uncommon: apathy, depression, depressed mood, libido decreased, nightmare, insomnia, nervousness
Mhux komuni: apatija, depressjoni, burdata depressa, tnaqqis fil- libido, inkubi, nuqqas ta ’ rqad, nervi
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with AZOPT are listed below.
Reazzjonijiet avversi identifikati mill- esperjenza ta ’ wara t- tqegħid fis- suq li ma kienux irrapportati qabel fi provi kliniċi b’ AZOPT huma elenkati taħt.
They are derived from spontaneous reports for which the frequency cannot be estimated.
Huma miġbura minn rapporti spontanji li l- frekwenza tagħhom ma tistax tiġi stmata.
Thus, the frequency grouping is categorised as not known.
Għalhekk il- frekwenza hija kklassifikata bħala mhux magħrufa.
Cardiac disorders: arrhythmia, palpitations, tachycardia, hypertension, blood pressure increased, heart rate increased
Disturbi fil- qalb: arritmija, palpitazzjonijiet, takikardja, pressjoni għolja, żjieda fil- pressjoni, taħbit tal- qalb mgħaġġel
Nervous system disorders: tremor, hypoaesthesia, ageusia
Disturbi fis- sistema nervuża: tregħid, ipoestesija, aġewsja
Eye disorders: corneal epithelium disorder, corneal disorder, visual disturbance, eye swelling, eye allergy, madarosis, eyelid disorder, eyelid oedema, erythema of eyelid
Disturbi fl- għajnejn: disturbi fl- epitilju tal- korneja, disturbi fil- korneja, disturbi fil- vista, nefħa fl- għajn, allerġija fl- għajn, madarosi, disturbi fil- kappell ta ’ l- għajn, edima fil- kappell ta ’ l- għajn, ħmura tal- kappell ta ’ l- għajn
Ear and labyrinth disorders: vertigo
Disturbi fil- widnejn u fis- sistema labirintika: vertigo
Respiratory, thoracic and mediastinal disorders: asthma
Disturbi respiratorji, toraċiċi u medjastinali: ażżma
Gastrointestinal disorders: vomiting
Disturbi gastro- intestinali: rimettar
Renal and urinary disorders: pollakiuria
Disturbi fil- kliewi u fis- sistema urinarja: pollakurja
Skin and subcutaneous tissue disorders: dermatitis, erythema
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: dermatite, eritema
Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity
Disturbi muskolu- skeltrali u tal- connective tissue: artralġja, uġigħ fl- estremitajiet
6 Immune system disorders: hypersensitivity
6 Infezzjonijiet u infestazzjonijiet: rinite
Hepatobiliary disorders: liver function test abnormal
Disturbi fis- sistema immuni: sensittività eċċessiva
In small short-term clinical trials, approximately 12.5% of paediatric patients were observed to experience drug related adverse effects, the majority of which were local, nonserious ocular effects such as conjunctival hyperaemia, eye irritation, eye discharge, and lacrimation increased (see section 5.1).
Fi provi kliniċi żgħar u ta ’ żmien qasir, madwar 12. 5% tal- pazjenti pedjatriċi kienu osservati li kellhom effetti avversi relatati mal- mediċina, li l- biċċa l- kbira minnhom kienu effetti lokalizzati mhux serji marbuta ma ’ l- għajn, bħal iperimja konġunktivali, irritazzjoni fl- għajn, tnixxija mill- għajn u żieda fid- dmugħ (ara sezzjoni 5. 1).
Dysgeusia (bitter or unusual taste in the mouth following instillation) was the most frequently reported systemic undesirable effect associated with the use of AZOPT during clinical studies.
Waqt provi kliniċi, disġewżja (togħma morra jew mhux tas- soltu fil- ħalq wara l- installazzjoni) kienet l- aktar effett sistemiku, mhux mixtieq, assoċjat ma ’ l- użu ta ’ AZOPT, irrapportat b’ mod frekwenti.
It is likely caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal.
X’ aktarx li hija kkawżata li l- qtar ta ’ l- għajnejn jgħaddi għan- nasofarinġi mill- kanal nasolakrimali.
Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce the incidence of this effect (see also 4.2 Posology and method of administration).
Okklużjoni nasolakrimali jew għeluq bil- mod tal- kappell ta ’ l- għajn wara l- installazzjoni tista ’ tgħin biex tnaqqas l- inċidenza ta ’ dan l- effett (ara ukoll 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata).
AZOPT is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
AZOPT huwa inibitur sulphonamide ta ’ carbonic anhydrase b’ assorbiment sistemiku.
Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
Effetti gastro- intestinali, fis- sistema nervuża, ematoloġiċi, fil- kliewi u fil- metaboliżmu, ġeneralment huma assoċjati ma ’ inibituri sistemiċi ta ’ carbonic anhydrase.
The same type of undesirable effects that are attributable to oral carbonic anhydrase inhibitors may occur with topical administration.
L- istess tip ta ’ effetti mhux mixtieqa attribwiti lill- inibituri orali ta ’ carbonic anhydrase jistgħu jseħħu meta jingħata lokalment.