qanastek/EMEA-V3 huggingface dataset:
No unexpected adverse events have been observed with AZOPT when used as adjunctive therapy to travoprost.
Ma kienux osservati avvenimenti avversi mhux mistennija b’ AZOPT meta dan intuża bħala kura miżjuda ma ’ travoprost.
The adverse events seen with the adjunctive therapy have been observed with each active substance alone.
L- avvenimenti avversi osservati bil- kura miżjuda kienu osservati b’ kull waħda mis- sustanzi attivi separatament.
No case of overdose has been reported.
L- ebda każ ta ’ doza eċċessiva ma ’ ġie irrapurtat.
Treatment should be symptomatic and supportive.
Il- kura għandha tkun skond is- sintomi u ta ’ t- tip suportiv.
Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur.
Jista ’ jkun hemm żbilanċ fl- elektroliti, stat aċidotiku, u possibbilment xi effetti mhux mixtieqa fuq is- sistema nervuża.
Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.
Il- livelli ta ’ l- elektroliti fid- demm (partikolarment potassium) u l- livelli tal- pH fid- demm għandhom jitkejjlu.
Antiglaucoma preparations and miotics, carbonic anhydrase inhibitors.
Prodotti li jintużaw għall- kura tal- glawkoma u mijotiċi, inibituri tal- carbonic anhydrase.
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye.
Carbonic anhydrase (CA) huwa enżima li tinstab f’ ħafna tessuti tal- ġisem, fosthom fl- għajnejn.
Carbonic anhydrase catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.
Carbonic anhydrase jikataliżża ir- reaazzjoni riversibli li tinvolvi l- idrazzjoni ta ’ carbon dioxide u d- disidrazzjoni ta ’ carbonic acid.
Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport.
7 L- inibizzjoni tal- carbonic anhydrase fil- proċċess ciljari tal- għajnejn inaqqas is- sekrezzjoni ta ’ l- aqueous humour, billi jnaqqas il- produzzjoni tal- bicarbonate ions li jikkawza tnaqqis fit- trasport tas- sodium u tal- fluwidu.
The result is a reduction in intraocular pressure (IOP) which is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.
Dan iwassal għal tnaqqis fil- pressjoni ta ’ l- għajn (IOP) li huwa il- fattur ta ’ riskju għoli fil- patoġenesi ta ’ ħsara fl- optic nerf u fit- telf tal- vista tal- glawkoma.
Brinzolamide, an inhibitor of carbonic anhydrase II (CA-II), the predominant iso-enzyme in the eye, with an in vitro IC50 of 3.2 nM and a Ki of 0.13 nM against CA-II.
Brinzolamide, inibitur tal- carbonic anhydrase II (CA- II), li huwa l- iżo- enżima prinċipali fl- għajn, b ’ IC50 in- vitro ta ’ 3. 2 nM u Ki ta 0. 13 nM kontra il- CA- II.
7 The IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin analogue travoprost was studied.
Kien studjat l- effett ta ’ tnaqqis ta ’ IOP ta ’ Azopt bħala kura miżjuda ma ’ l- analogu ta ’ prostaglandin, travoprost.
Following a 4 week run-in with travoprost, patients with an IOP ≥ 19 mmHg were randomized to receive added treatment with brinzolamide or timolol.
Wara prova ta ’ 4 ġimgħat b’ travoprost, pazjenti b’ IOP ≥19 mmHg kienu randomised biex jirċievu kura addizzjonali bi brinzolamide jew timolol.
An additional decrease in mean diurnal IOP of 3.2 to 3.4 mmHg for the brinzolamide group and 3.2 to 4.2 mmHg for the timolol group were observed.
Kien osservat tnaqqis addizzjonali fil- medja ta ’ IOP ta ’ matul il- ġurnata ta ’ 3. 2 sa 3. 4 mmHg għall- grupp ta ’ brinzolamide u ta ’ 3. 2 sa 4. 2 mmHg għall- grupp ta ’ timolol.
There was an overall higher incidence of non-serious ocular adverse events, mainly related to signs of local irritation, in the brinzolamide/ travoprost groups.
Fil- gruppi ta ’ brinzolamide/ travoprost kien hemm inċidenza globali ogħla ta ’ avvenimenti avversi mhux serji, fil- biċċa l- kbira relatati ma ’ sinjali ta ’ irritazzjoni lokali.
The events were mild and did not affect the overall discontinuation rates in the studies (see section 4.8).
L- avvenimenti kienu ħfief u ma ’ affetwawx ir- rati globali ta ’ twaqqif fl- istudji (ara sezzjoni 4. 8)
A clinical trial was conducted with AZOPT in 32 paediatric patients less than 6 years of age, diagnosed with glaucoma or ocular hypertension.
Sar studju kliniku b’ AZOPT fuq 32 pazjenti tfal ta ’ inqas minn 6 snin li kienu qed isofru minn glawkoma jew pressjoni għolja fl- għajnejn.
Some patients were naive to IOP therapy whilst others were on other IOP-lowering medicinal product(s).
Xi wħud mill- pazjenti ma ’ kienu fuq l- ebda terapija waqt li oħrajn kienu qed jieħdu xi prodott( i) mediċinali oħra biex titbaxxa l- pressjoni tal- għajnejn.
Those who had been on previous IOP medicinal products were not required to discontinue their IOP medicinal product(s) until initiation of monotherapy with AZOPT.
Dawk li kienu qed jieħdu xi prodotti mediċinali oħra biex ibaxxu l- pressjoni fl- għajnejn, ma kellhomx għalfejn iwaqqfu l- prodott( i) mediċinali tagħhom sakemm inbdiet il- monoterapija b’ AZOPT.
Among patients who were naive to IOP therapy (10 patients), the efficacy of AZOPT was similar to that seen previously in adults, with mean IOP reductions from baseline ranging up to 5 mmHg.
Fost dawk il- pazzjenti li ma kienu fuq l- ebda terapija (10 pazjenti), l- effikaċja ta AZOPT kienet simili ta ’ dik osservata iktar kmieni fl- adulti, b’ medja ta ’ tnaqqis tal- pressjoni fl- għajnejn mill- bażi li wassal sa 5 mmHg.
Among patients who were on topical IOP-lowering medicinal products (22 patients), mean IOP increased slightly from baseline in the AZOPT group.
Fost il- pazjenti li kienu qed jieħdu xi prodotti mediċinali biex titbaxxa l- pressjoni fl- għajnejn (22 pazjent), il- medja tat- tnaqqis tal- pressjoni fl- għajn żdied kemmxejn mill- bażi, fil- grupp li ngħata AZOPT.
Following topical ocular administration, brinzolamide is absorbed into the systemic circulation.
Wara li jingħata b’ mod topiku fl- għajn, brinzolamide jiġi asorbit fiċ- ċirkolazzjoni sistemika.
Due to its high affinity for CA-II, brinzolamide distributes extensively into the RBCs and exhibits a long halflife in whole blood (mean of approximately 24 weeks).
Minħabba l- affinita għolja li għandu għal CA- II, brinzolamide jiġi distribwit estensivament fl- RBCs u għandu half- life twila fid- demm (medja ta ’ bejn wieħed u ieħor 24 gimgħa).
In humans, the metabolite N-desethylbrinzolamide is formed, which also binds to CA and accumulates in RBCs.
Fil- bnedmin, il- prodott li jiħroġ wara l- metaboliżmu huwa N- desethylbrinzolamide, li wkoll jingħaqad ma CA u jakkumula fir- RBCs.
This metabolite binds mainly to CA-I in the presence of brinzolamide.
Dan il- prodott tal- metaboliżmu jingħaqad prinċipalment ma ’ CA- I fil- preżenza ta ’ brinzolamide.
In plasma, both brinzolamide and N-desethylbrinzolamide concentrations are low and generally below assay quantitation limits (< 7.5 ng/ ml).
Il- konċentrazzjoni ta ’ brinzolamide u ta ’ N- desethylbrinzolamide fil- plażma hija baxxa ħafna u ġeneralment tkun inqas mill- ammont li jista jiġi kwantifikat b' analiżi (< 7. 5 ng/ ml).
Binding to plasma proteins is not extensive (about 60%).
Ma ’ tantx jeħel mal- proteini tal- plażma (bejn wieħed u ieħor 60%).
Brinzolamide is eliminated primarily by renal excretion (approximately 60%).
Il- biċċa l- kbira ta ’ brinzolamide, tiġi eliminata mill- ġisem mill- kliewi (bejn wieħed u ieħor 60%).
About 20% of the dose has been accounted for in urine as metabolite.
Madwar 20% tad- doża toħrog fl- awrina bħala prodott tal- metaboliżmu.
Brinzolamide and N-desethyl-brinzolamide are the predominant components in the urine along with trace levels of the N-desmethoxypropyl and O-desmethyl metabolites.
Il- komponenti prinċipali fl- awrina huma brinzolamide u N- desethylbrinzolamide, bi traċċi ta ’ N- desmethoxypropyl u O- desmethyl bħala prodotti tal- metaboliżmu.
In an oral pharmacokinetic study, healthy volunteers received 1 mg capsules of brinzolamide twice daily for up to 32 weeks and RBC CA activity was measured to assess the degree of systemic CA inhibition.
Fi studju farmakokinetiku, li sar, numru ta ’ volontiera b’ saħħithom ġew mogħtija mil- ħalq kapsuli ta ’ 1 mg brinzolamide darbtejn kuljum għal 32 gimgħa u l- attivita tal- RBC CA kienet imkejjla biex jiġi determinat l- ammont ta ’ inibizzjoni tal- CA sistemiku.
Brinzolamide saturation of RBC CA-II was achieved within 4 weeks (RBC concentrations of approximately 20 µM).
Kien hemm saturazzjoni b’ brinzolamide tal- RBC CA- II fi żmien erba ’ ġimgħat (b’ konċentrazzjoni fir- RBCs ta ’ bejn wieħed u ieħor 20 µM).
N-Desethyl-brinzolamide accumulated in RBCs to steady state within 20-28 weeks reaching concentrations ranging from 6-30 µM.
N- desethyl- brinzolamide akkumula fir- RBCs wara 20- 28 gimgħa u laħaq konċentrazzjonijiet fi stat fiss ta ’ 6- 30 µM.
The inhibition of total RBC CA activity at steady state was approximately 70-75%.
L- inibizzjoni totali tal- attivita tar- RBC CA fl- istat fiss kien ta ’ bejn wieħed u ieħor 70- 75%.
Subjects with moderate renal impairment (creatinine clearance of 30-60 ml/ minute) were administered 1 mg of brinzolamide twice daily orally for up to 54 weeks.
Persuni li jbgħatu minn indeboliment moderat fil- kliewi (il- clearance tal- krejatinina ta ’ 30- 60 ml/ minuta) ġew mogħtija 1 mg ta ’ brinzolamide mill- ħalq darbtejn kuljum għall- 54 ġimgħa.
Brinzolamide RBC concentration ranged from about 20 to 40 µM by week 4 of treatment.
Il- konċentrazzjoni ta ’ brinzolamide fir- RBCs varjat minn 20 sa 40 µM sar- raba ’ ġimgħa tal- kura.
At steady-state, brinzolamide and its metabolite RBC concentrations ranged from 22.0 to 46.1 and 17.1 to 88.6 µM, respectively.
Fl- istat fiss, il- konċentrazzjonijiet ta ’ brinzolamide u tal- prodott tal- metaboliżmu tiegħu varjaw minn 22. 0 sa 46. 1 u 17. 1 sa 88. 6 µM rispettivament.
N-desethyl-brinzolamide RBC concentrations increased and total RBC CA activity decreased with decreasing creatinine clearance but brinzolamide RBC concentrations and CA-II activity remained unchanged.
8 Il- konċentrazzjoni ta ’ N- desethyl- brinzolamide fir- RBCs żdiedet u l- attivita totali tal- RBS CA naqset minħabba t- tnaqqis tal- clearance tal- krejatinina, iżda il- konċentrazzjoni ta ’ brinzolamide fir- rBCs u l- attivita tal- CA- II baqgħu l- istess.
In subjects with the highest degree of renal impairment inhibition of total CA activity was greater although it was inferior to 90% at steady-state.
F’ persuni b’ indeboliment serju fil- kliewi, l- inibizzjoni tal- attivita totali tal- CA kienet akbar għalkemm kienet inqas minn 90% fl- istat fiss.
In a topical ocular study, at steady-state, brinzolamide RBC concentrations were similar to those found in the oral study, but levels of N-desethyl-brinzolamide were lower.
Fi studju dwar l- użu topiku fl- għajnejn, fl- istat fiss, il- konċentrazzjoni ta ’ brinzolamide fir- RBCs kienet simili ta ’ dak li deher fl- istudju fejn ingħata mil- ħalq, iżda l- livelli ta ’ N- desethyl- brinzolamide kienu aktar baxxi.
Carbonic anhydrase activity was approximately 40-70% of predose levels.
L- attivita tal- carbonic anhydrase bejn wieħed u ieħor kienet ta ’ 40- 70% tal- livelli ta ’ qabel id- doża.
8 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
Topical ocular administration of brinzolamide to rabbits for one to six months resulted in slight, statistically significant increases in corneal thickness when given at concentrations of 1%, 2% and 4%, four times a day; these changes were not observed in other species.
Kien hemm żieda zgħira, li hi statistikament sinifikanti, fil- ħxuna tal- korneja meta brinzolamide ntuża f’ konċentrazzjonijiet ta ’ 1%, 2% u 4% erba darbiet kuljum; dawn it- tibdiliet ma ’ ġewx osservati fi speċi oħra.
Chronic administration of brinzolamide to rats at a dose level of 8 mg/ kg/ day (up to 250 times the recommended human ophthalmic dose) resulted in changes associated with the pharmacology of carbonic anhydrase inhibition (i. e., urine volume and electrolyte changes, slight differences in serum electrolytes).
L- aministrazzjoni kronika ta ’ brinzolamide lill- firien b’ dożi ta ’ 8 mg/ kg/ ġurnata (sa 250 darba iktar mid- doża rakkomandata fl- għajnejn tal- bnedmin) irriżultat f’ tibdiliet marbuta mal- farmakoloġija tal- inibizzjoni tal- carbonic anhydrase (jiġifieri, tibdiliet fil- volum ta ’ l- awrina u fl- elektroliti, differenzi żgħar fl- elektoliti tas- serum).
A statistically significant increase in urinary bladder tumours was observed in female mice given brinzolamide 10 mg/ kg/ day (250 times the recommended human ophthalmic dose), orally, for 24 months.
Kien hemm żieda, li kienet statistikament sinifikanti, fin- numru ta ’ tumuri li deheru fil- borża tal- awrina ta ’ ġrieden tas- sess femminili li ngħataw 10 mg/ kg/ ġurnata ta ’ brinzolamide mill- ħalq (250 darba iktar mid- doża irrakomandat fl- għajnejn tal- bnedmin) għall- 24 xagħar.
Dose-related proliferative changes in the urinary bladder were observed among female mice at 1, 3 and 10 mg/ kg/ day, and among males at 3 and 10 mg/ kg/ day.
Tibdiliet fil- borża tal- awrina tal- ġrieden tas- sess femminili relatati ma ’ tibdiliet fid- dożi ġew osservati f’ dożi ta ’ 1, 3 u 10 mg/ kg/ ġurnata u fl- irġiel f’ dożi ta 3 u 10 mg/ kg/ ġurnata.
The elevated bladder tumour incidence, which was statistically significant, was primarily due to the increased incidence of a tumour considered unique to mice.
L- inċidenza ta ’ tumuri fil- borża tal- awrina, li kienet statistikament sinifikanti, għoliet, l- aktar minħabba l- fatt li l- inċindenża tiżdied għal tumur li hu uniku għal firien.
Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/ kg/ day (125 times the recommended human ophthalmic dose) revealed no effect on foetal development despite significant maternal toxicity.
Studji tossiċi fuq l- iżvilupp fil- fniek b’ dożi ta ’ 6 mg/ kg/ ġurnata ta ’ brinzolamide mogħtija mill- ħalq (125 darba iktar mid- doża irrakomandat fl- għajnejn tal- bnedmin) ma ’ wrew l- ebda effett fuq l- iżvilupp tal- fetu minkejja l- fatt li kien hemm tossiċita materna sinifikativa.
Similar studies in rats resulted in slightly reduced ossification of skull and sternebrae of foetuses of dams receiving brinzolamide at doses of 18 mg/ kg/ day (375 times the recommended human ophthalmic dose), but not 6 mg/ kg/ day.
Studji simili fil- firien urew li kien hemm tnaqqis żgħir fl- ossifikazzjoni tal- għadam tar- ras u ta ’ l- isternebrae tal- fetu, f’ bhejjem li ngħataw dożi ta ’ 18 mg/ kg/ ġurnata ta ’ brinzolamide (375 darba akbar mid- doża rakkomandata għal użu fl- għajnejn tal- bnedmin) iżda dawn l- effetti ma deherux meta ngħataw doża ta ’ 6 mg/ kg/ ġurnata.
These findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Kien hemm tnaqqis fil- piż tal- fetu, li kien relatat mad- doża, fil - ġriewi ta ’ bhejjem li kienu qed jingħataw doża ta ’ brinzolamide mill- ħalq.
Dose-related decreases in foetal weights were observed in pups of dams receiving brinzolamide orally ranging from a slight decrease (about 5-6%) at 2 mg/ kg/ day to nearly 14% at 18 mg/ kg/ day.
Dan it- tnaqqis kien ivarja bejn tnaqqis żgħir (bejn 5- 6%) b’ doża ta ’ 2 mg/ kg/ ġurnata sa kważi 14% b’ doża ta 18 mg/ kg/ ġurnata.
Benzalkonium chloride, mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, hydrochloric acid/ sodium hydroxide (to adjust pH) purified water.
Benzalkonium chloride, mannitol, carbomer 974p, tyloxapol, edetate disodium, sodium chloride, hydochloric acid/ sodium hydroxide (biex jikkontrollaw il- pH), Ilma pur.
4 weeks after first opening.
4 ġimgħat wara li jinfetaħ l- ewwel darba.
This medicinal product does not require any special storage conditions.
Dan il- prodott m’ għandu l- ebda struzzjonijiet speċjali għal ħażna.
5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).
Fliexken opaki magħmula mill- polietilin ta ’ densita baxxa ta ’ volum ta ’ 5 u 10 ml b’ tapp tal- kamin magħmul minn polipropalin (bil- qattara).
The following pack sizes are available: outer cartons containing 1 x 5 ml, 3 x 5 ml and 1 x 10 ml bottles.
Il- prodott jiġi f’ dawn il- pakketti: kaxxa li fiha flixkun x 5 ml, 3 fliexken x 5 ml u flixkun x 10 ml.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu fis- suq.
No special requirements.
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema L- ebda ħtiġijiet speċjali.
Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom.
Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD Renju Unit
EU/ 1/ 00/ 129/ 001-3
EU/ 1/ 00/ 129/ 001- 3.
Date of first authorisation:
Data ta ’ l- ewwl awtorizzazzjoni:
9 March 2000 Date of last renewal:
9 ta ’ Marzu 2000 Data tal- aħħar tiġdid:
9 March 2005
9 ta ’ Marzu 2005
A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Alcon Cusi S. A., Camil Fabra 58 08320 El Masnou, Barcelona, Spanja.
• OTHER CONDITIONS
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI GĦANDHOM X’ JAQSMU MA ’ L- UŻU TAL- PRODOTT B’ MOD SIGUR U EFFETTIV.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmokoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 4. 0 ippreżentata f ’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija mplimentata 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 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation 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 iddettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 01 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, kull RMP imġedded għandu jiġi ppreżentat fl- istess żmien mar- Rapport Perijodiku Aġġornat dwar is- Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted
12 Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat
12 • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Fi żmien 60 ġurnata wara li tintlaħaq mira mportanti dwar farmakoviġilanza jew tnaqqis ta ’ riskji
• At the request of the EMEA
Fuq talba ta ’ l- EMEA
PSURs to be submitted annually until the second Renewal application.
PSUR’ s għandhom jintbagħtu kull sena sat- tieni applikazzjoni ta ’ tiġdied.
13 ANNEX III
13 ANNESSI III
CARTON FOR SINGLE BOTTLE, 5 ml, 10 ml + CARTON FOR 3 x 5 ml BOTTLES
KAXXA TA ’ FLIXKUN WIEĦED TA ’ VOLUM TA ’ 5 ml, 10 ml + KAXXA TA ’ TLETT T’ IFLIXKEN ta ’ 5 ml
AZOPT 10 mg/ ml eye drops, suspension Brinzolamide
AZOPT 10 mg/ ml, qtar għall- għajnejn, suspensjoni.
1 ml of suspension contains 10 mg of Brinzolamide
1 ml ta ’ suspensjoni fiha 10 mg Brinzolamide
Benzalkonium chloride, mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, hydrochloric acid/ sodium hydroxide (to adjust pH) and purified water.
Benzalkonium chloride, mannitol, carbomer 974P, tyloxapol, edetate, sodium, sodium chloride, hydrochloric acid/ sodium hydroxide (biex jikontrolaw il- pH) u ilma pur.
Contains benzalkonium chloride.
Għandu fih il - benzalkonium chloride.
See leaflet for further information.
Aqra il- fuljett ta ’ tagħrif għal aktar informazzjoni.
Eye drops, suspension; 5 ml 10 ml 3 x 5ml
Qtar għall- għajnejn, suspensjoni; 5 ml 10 ml 3 x 5 ml
Shake well before use.
Ħaltu sewwa qabel ma ’ tużah.
EXP: xx/ xxxx Discard four weeks after first opening.
JIS {XX/ SSSS} Armi 4 ġimgħat wara li tiftħu l- ewwel darba.
Opened (3):
Miftuh (3):
Pentagon Park Boundary Way Hemel Hempstead Herts, HP2 7UD United Kingdom.
Pentagon Park Boundary Way Hemel Hempstead Herts, HP2 7UD Renju Unit
Lot.: xxxxx
Lott: xxxxx
17 16 INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL, 5 ml & 10 ml
17 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻAGĦAR EWLENIN
AZOPT 10 mg/ ml eye drops, suspension.
AZOPT 10 mg/ ml qtar għall- għajnejn, suspensjoni.
Ocular use.
Jintuża fl- għajnejn
Discard 4 weeks after first opening.
Armi 4 ġimgħat wara li tiftħu l- ewwel darba.
EXP: xx/ xxxx
JIS {XX/ SSSS}
PACKAGE LEAFLET
19 FULJETT TA ’ TAGĦRIF:
AZOPT 10 mg/ ml eye drops, suspension Brinzolamide
AZOPT 10 mg/ ml qtar għall- għajnejn, suspensjoni Brinzolamide
It may harm them even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What AZOPT is and what it is used for 2.
X’ inhu AZOPT u għalxiex jintuża 2.
Before you use AZOPT 3.
Qabel ma tuża AZOPT 3.
How to use AZOPT 4.
Kif għandek tuża AZOPT 4.
How to Store AZOPT 6.
Kif taħżen AZOPT 6.
WHAT AZOPT IS AND WHAT IT IS USED FOR
X’ INHU AZOPT U GĦALXIEX JINTUŻA
AZOPT is one of a group of medicines for glaucoma called carbonic anhydrase inhibitors.
AZOPT huwa wieħed minn grupp ta ’ mediċini għall- glawkoma msejħa inibituri ta ’ carbonic anhydrase.
It works by cutting down the production of liquid, which lowers the pressure in the eye.
Jaħdem billi jnaqqas il- produzzjoni ta ’ likwidu, u dan inaqqas il- pressjoni fl- għajn.
It may be used on its own or with other drops called beta-blockers or prostaglandin analogues, which also reduce pressure.
Jista ’ jintuża waħdu jew flimkien ma ’ qtar oħra msejħa imblokkaturi tar- riċetturi Beta jew analogi tal- prostaglandin, li wkoll inaqqsu l- pressjoni fil- għajn.
AZOPT eye drops are used to treat high pressure in the eye.
Il- qtar tal- għajnejn AZOPT huwa użat għal kura ta ’ pressjoni għolja fl- għajnejn.
This pressure can lead to an illness called glaucoma.
Din il- pressjoni għolja tista twassal għal marda li tisejjaħ glawkoma.
High pressure in the eye.
Pressjoni għolja fl- għajn:
Your eyeballs contain a clear, watery liquid which feeds the inside of the eye.
Għajnejk fihom likwidu ċarr li jitma il- parti ta ’ ġewwa tal- għajn.
Liquid is always emptying out of the eye, and more liquid is always being produced.
Il- likwidu dejjem jiżvojta mill- għajn waqt li aktar likwidu jiġi produċut.
If the eye fills up faster than it empties, the pressure inside the eye builds up.
Jekk l- għajn timtela b’ dan il- likwidu aktar malajr milli tiżvojta, il- pressjoni ġewwa l- għajn tibda takkumula.
If it gets too high it can damage your sight.
Jekk din tkun għolja wisq, tista issir xi ħsara lill- vista tiegħek.
BEFORE YOU USE AZOPT
QABEL MA ’ TUŻA AZOPT
Do not use AZOPT
Tużax AZOPT
- if you have kidney problems.
- jekk għandek xi mard fil- kliewi
- if you are allergic to brinzolamide or any of the other ingredients.
- jekk inti allerġiku għal brinzolamide jew xiwieħed mill- ingredjenti.
- if you are allergic to medicines called sulphonamides.
- jekk inti allerġiku għall- mediċini li jisejħu sulfonamides.
AZOPT may cause the same allergy.
Azopt jista jikawża l- istess forma
- if you have a condition called hyperchloraemic acidosis (too much acidity in your blood).
- jekk tbagħti minn kondizzjoni li tisejjaħ aċidosi ħiperklorimika (aċċidita għolja fid- demm
- Ask your doctor for advice.
- Staqsi lit- tabib tiegħek għall- parir.
Take special care with AZOPT 21 Talk to your doctor
20 Oqgħod attent ħafna b’ AZOPT
- if you have liver problems.
- jekk għandek xi mard fil- fwiet.
- if you have dry eyes or cornea problems.
- Jekk għandek għajnejk xotti jew għandek xi problema fil- korneja.
Talk to your doctor.
Tkellem mat- tabib
- if you wear soft contact lenses.
- Jekk tuża l- lentijiet tal- kuntatt rotob.
Wait 15 minutes after using
Tużax il- qtar waqt li għandek il- lentijiet tal- kuntatt ġo
the drops before putting your lenses back in to your eyes.
Wara li tqatar, stenna 10- 15- ilminuta qabel ma tilbes il- lentijiet tal- kuntatt f’ għajnejk.
A preservative in AZOPT (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.
Preservativ li jinstab ġo AZOPT (benzalkonium chloride) jista joħloq irritazzjoni fl- għajnejn u huwa mgħaruf li jagħmel il- ħsara lill- lentijiet tal- kuntatt rotob.
AZOPT is not to be used by people under 18 of years of age unless advised by your doctor.
AZOPT m’ għandux jintuża minn persuni taħt it- 18– ilsena, ħlief fuq il- parir tat- tabib tiegħek.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 WHAT AZOPT IS AND WHAT IT IS USED FOR), talk to your doctor.
Jekk qed tieħu xi inibitur ieħop ta ’ carbonic anhydrase (acetazolamide jew dorzolamide, ara sezzjoni 1, X’ INHU AZOPT U GĦALXIEX JINTUŻA), kellem lit- tabib tiegħek.
If you are pregnant, or might get pregnant, talk to your doctor before you use AZOPT.
Jekk int tqila, jew tista ’ toħroġ tqila, tkellem mat- tabib tiegħek qabel ma ’ tuża AZOPT.
If you are breast-feeding, don’ t use AZOPT; it may get into your milk.
Jekk qed tredda ’, m’ għandekx tuża AZOPT; dan jista ’ joħroġ fil- ħalib tiegħek.
Ask your doctor or pharmacist for advice before taking any medicine
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving or using machines You may find that your vision is blurred for a time just after you use AZOPT.
Jista jkun li għal ftit ħin wara li tqattar AZOPT, il- vista tiegħek tiċċajpar xi ftit.
Some people have found themselves sleepy or dizzy when taking AZOPT.
Xi nies ħassewhom għajjenin jew storduti meta użaw AZOPT.
Do not drive or use machines until this has worn off.
Issuqx jew tużax magni sakemm jgħaddu dawn is- sintomi.
Important information about some of the ingredients of AZOPT If you wear soft contact lenses.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ AZOPT Jekk tilbes lentijiet tal- kuntatt rotob.
Do not use the drops while your contact lenses are in your eyes.
Tużax il- qtar waqt li l- lentijiet tal- kuntatt huma f’ għajnejk.
Wait 15 minutes after using the eye drops before putting your lenses back into your eyes.
Stenna 15- il minuta wara l- użu tal- qtar tal- għajnejn qabel ma terġa ’ tpoġġi l- lentijiet tal- kuntatt lura f’ għajnejk.
A preservative in AZOPT (benzalkonium chloride) can affect soft lenses.
Preservattiv f’ AZOPT (benzalkonium chloride) jista ’ jkollu effett fuq il- lentijiet tal- kuntatt rotob.
HOW TO USE AZOPT
KIF GĦANDEK TUŻA AZOPT
Always use AZOPT exactly as your doctor has told you.
Dejjem għandek tuża AZOPT skond il- parir tat- tabib.
1 drop in the eye or eyes, twice a day-morning and night.
Qatra waħda ġo l- għajn jew għajnejn, darbtejn kuljum- filgħodu u filgħaxija.
Use this much unless your doctor told you to do something different.
Uża din il- kwantita sakemm ma jgħidlekx mod ieħor it- tabib tiegħek.
Only use AZOPT in both eyes if your doctor told you to.
Għandek tuża AZOPT f’ għajnejk it- tnejn biss jekk jgħidlek it- tabib.
Take it for as long as your doctor told you to.
Uża għal kemm qallek it- tabib.
Only use AZOPT for dropping in your eyes.
Uża AZOPT bħala qtar fl- għajnejn biss.
Turn the page for more advice
Aqleb il- paġna għal aktar tgħarif
HOW TO USE AZOPT (continued)
KIF JINTUŻA AZOPT (ikompli)
< see side 1
Kemm għandek t’ uża < ara naħa 1
• Get the AZOPT bottle and a mirror • Wash your hands • Shake the bottle and twist off the cap • Hold the bottle, pointing down, between your thumb and middle finger • Tilt your head back.
• Aqbad il- flixkun ta ’ AZOPT u mera. • Aħsel idejk. • Ħallat il- flixkun u neħħilu t- tapp. • Żomm il- flixkun wiċċu ‘ l isfel bejn subgħajk il- kbir u subgħajk tan- nofs. • Itfa ’ rasek naqra lura.
Pull down your eyelid with a clean finger, until there is a ‘ pocket’ between the eyelid and your eye.
B’ saba ’ nadif, niżżel il- kappell tan- naħa t’ isfel ta ’ għajnejk sakemm jifforma speċi ta ’ but bejn il- kappell t’ għajnejk u l- għajn.
The drop will go in here (picture 1) • Bring the bottle tip close to the eye.
Il- qatra ser tidħol hawn ġew (stampa 1). • Ġib il- qattara tal- flixkun viċin tal- għajn.
Use the mirror if it helps • Don’ t touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Uża l- mera, jekk taħseb li tgħinek iktar,. • M’ għandekx tmiss għajnejk jew il- kappell t’ għajnejk, jew xi parti qrib ta ’ għajnejk jew xi superfiċji oħra bil- qattara tal- flixkun.
It could infect the drops • Gently press on the base of the bottle to release one drop of AZOPT at a time. • Don’ t squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2) • After using AZOPT, press a finger to the corner of your eye, by the nose (picture 3).
Il- flixkun huwa magħmul biex meta timbotta l- qiegħ tniżżel qatra waħda (stampa 2). • Wara li tqattar AZOPT, għafas b’ subgħajk il- kantuniera ta ’ għajnejk fin- naħħa ta ’ mnieħrek (Stampa 3).
This helps to stop AZOPT getting into the rest of the body. • If you take drops in both eyes, repeat the steps for your other eye. • Put the bottle cap back on firmly immediately after use • Use up one bottle before opening the next bottle.
Dan ser jgħin biex iwaqqaf lil AZOPT milli jidħol fil- bqija ta ’ ġismek. • Jekk qed tuża l- qtar f’ għajnejk it- tnejn, erġa ’ rrepeti l- proċeduri hawn fuq imsemija għal għajnek l- oħra. • Għalaq il- flixkun sewwa x’ ħin tispiċċa. • Uża flixkun wieħed qabel ma ’ tiftaħ ieħor.
If you get too much in your eyes, rinse it all out with warm water.
Jekk jinżlu ħafna qtar ta ’ AZOPT ġewwa għajnejk, laħalħu l- barra b’ ilma fietel.
Don’ t put in any more drops until it’ s time for your next regular dose.
Terġax tqattar sakemm jasallek il- ħin tad- doża li jmiss.
If you forget to use AZOPT, use a single drop as soon as you remember, and then go back to your regular routine.
Jekk tinsa tuża AZOPT, għamel qatra waħda malli tiftakkar, imbagħad erġa ’ lura għal kif kont qed tqattar qabel.
Do not use a double dose to make up.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using AZOPT without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Jekk tieqaf tuża AZOPT mhux fuq il- parir tat- tabib tiegħek, il- pressjoni f’ għajnejk tista ’ ma tkunx ikkontrollata, u dan jista ’ jwassal għal telf tal- vista.
If you are using other eye drops, leave at least 5 minutes between putting in AZOPT and the other drops.
Jekk qed tuża xi qtar tal- għajnejn oħra, stenna mill- anqas 5 minuti bejn l- użu ta ’ AZOPT u l- użu ta ’ qtar oħra.
Like all medicines, AZOPT can cause side effects, although not everyone gets them.
Bħal kull mediċina oħra, AZOPT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You can usually carry on taking the drops, unless the effects are serious
Ġeneralment tista tkompli tuża l- qtar, sakemm l- effetti mhux mixtieqa ma jkunux ta ’ natura serja.
23 Common side effects (1 to 10 users in 100) Effects in the eye: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye sensation, redness of the eye, eyelid itching, redness, or swelling.
Effetti fl- għajn: vista mċajpra, irritazzjoni tal- għajn, uġigħ fl- għajn, tnixxija mill- għajn, ħakk fl- għajn, l- għajn tinħass xotta, sensazzjoni mhux normali fl- għajn, ħmura fl- għajn, ħakk fil- kappell ta ’ l- għajn, ħmura jew nefħa
General side effects: bad taste, headache, dry mouth
Effetti sekondarji ġenerali: togħma ħażina, uġigħ ta ’ ras, ħalq xott
Uncommon side effects (1 to 10 users in 1,000) Effects in the eye: increased pressure in eye, damage to the optic nerve, abnormal, double, or reduced vision, sensitivity to light, inflammation or infection of the conjunctiva, eye allergy, eye swelling, corneal disorder, inflammation of the eyelid glands, decreased eye sensation, growth on surface of eye, increased pigmentation of the eye, tired eyes, eyelid crusting, or increased tear production.
Effetti fl- għajn: żieda tal- pressjoni fl- għajn, ħsara lin- nerv optiku, vista mhux normali, imnaqqsa, jew tara doppju, sensittività għad- dawl, infjammazzjoni jew infezzjoni tal- konġuntiva, allerġija fl- għajn, nefħa fl- għajn, distubi fil- korneja, infjammazzjoni tal- glandoli tal- kappell tal- għajn, tnaqqis fis- sensazzjoni tal- għajn, bħal qoxra fuq il- wiċċ tal- għajn, żieda fil- pigmentazzjoni tal- għajn, għeja fl- għajn, qoxra fuq il- kappell tal- għajn, żieda fid- dmugħ
General side effects: decreased or irregular heart rate, reduced heart function, chest pain, asthma, difficulty breathing, shortness of breath, decreased red blood cell count in blood, increased chlorine level in blood, dizziness, drowsiness, difficulty with memory, depression, difficulty sleeping, nervousness, irritability, fatigue, generalized weakness, feeling abnormal, pain, shaking, ringing in ears, decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, cough, sinus infection, throat irritation, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus, abdominal pain, nausea, upset stomach, frequent bowel movements, diarrhoea, intestinal gas, digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, dry nose, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, loss of hair
Effetti sekondarji ġenerali: rata li tħabbat il- qalb imnaqqsa jew irregolari, funzjoni tal- qalb imnaqqsa, uġigħ fis- sider, ażżma, diffikultà biex tieħu n- nifs, qtugħ ta ’ nifs, tnaqqis fl- għadd ta ’ ċelluli ħomor fid- demm, żjieda fil- livelli ta ’ chlorine fid- demm, sturdament, ħedla, diffikultà bil- memorja, depressjoni, diffikultà biex torqod, nervi, irritabilità, għeja, indebboliment ġeneralizzat, tħossok mhux normali, uġigħ, tregħid, żarżir fil- widnejn, tnaqqis fil- ħajra sesswali, diffikultà sesswali fl- irġiel, sintomi ta ’ riħ, konġestjoni fis- sider, sogħla, infezzjoni fis- sinus, irritazzjoni fil- griżmejn, sensazzjoni mhux normali jew imnaqqsa fil- ħalq, infjammazzjoni tal- kisja ta ’ ġewwa ta ’ l- esofagu, uġigħ addominali, dardir, stonku mdardar, purgar frekwenti, dijarea, gass fl- imsaren, disturbi fis- sistema diġestiva, uġigħ fil- kliewi, uġigħ fil- muskoli, spażmi fil- muskoli, uġigħ ta ’ dahar, fsada mill- imnieħer, imnieħer xott, imnieħer iqattar, imnieħer misdud, għatis, raxx, sensazzjoni mhux normali fil- ġilda, ħakk, jaqa ’ x- xagħar
Effects in the eye: eyelid abnormality, decreased growth or number of eyelashes
Effetti fl- għajn: abnormalità fil- kappell ta ’ l- għajn, tnaqqis fit- tkabbir u ammont ta’ xagħar ta ’ xfar il- għajn
General side effects: increased allergic symptoms, increased blood pressure, increased heart rate, abnormal liver blood tests, vomiting, frequent urination, swelling of the extremities, decreased sensation, decreased taste sensation, joint pain, pain in extremity, skin redness, inflammation, or itching
Effetti sekondarji ġenerali: żjieda fis- sintomi allerġiċi, żjieda fil- pressjoni, żjieda fir- rata li tħabbat il- qalb, testijiet tad- demm tal- fwied mhux normali, rimettar, tgħaddi l- awrina frekwenti, nefħa fl- estremitajiet, sensazzjoni mnaqqsa, sensazzjoni tat- togħma mnaqqsa, uġigħ fil- ġogi, uġigħ fl- estremitajiet, ħmura fil- ġilda, infjammazzjoni, jew ħakk
HOW TO STORE AZOPT
KIF TAĦŻEN AZOPT
Do not use AZOPT after the expiry date which is stated on the bottle and box after “ EXP”.
23 Tużax AZOPT wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna wara “ JIS ”.
The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar,
You must throw away a bottle four weeks after you first opened it, to prevent infections.
Biex tevita infezzjonijiet, għandek tarmi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba.
Write down the date you opened each bottle in the space below and in the space on the bottle label and box.
Niżżel id- data li fiha tkun ftaħt kull flixkun fl- ispazju taħt u fl- ispazju fuq it- tikketta tal- flixkun u l- kartuna.
For a pack containing a single bottle, write only one date.
Għall- pakkett li fih flixkun wieħed, niżżel data waħda biss.
24 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
6 FURTHER INFORMATION
6 AKTAR TAGĦRIF
What AZOPT contains
X’ fih AZOPT
The active substance is brinzolamide 10 mg/ ml.
Is- sustanza attiva hi brinzolamide 10 mg/ ml.
The other ingredients are: benzalkonium chloride, carbomer 974P, edetate disodium, mannitol, purified water, sodium chloride, tyloxapol.
Is- sustanzi l- oħra huma: benzalkonium chloride, carbomer 974P, edetate disodium, mannitol, ilma ppurifikat, sodium chloride, tyloxapol.
Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Jiġu miżjuda ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide biex iżommu normali l- livelli ta ’ l- aċidità (livelli tal- pH).
What AZOPT looks like and the contents of the pack AZOPT is a milky liquid (a suspension) supplied in a pack containing a 5 ml or a 10 ml plastic (droptainer) bottle with a screw cap, or in a pack containing three 5 ml plastic (droptainer) bottles with screw caps.
Id- Dehra ta ’ AZOPT u l- kontenuti tal- pakkett AZOPT huwa likwidu qisu ħalib (suspensjoni) disponibbli f’ pakkett li fih flixkun tal- plastik (droptainer) ta ’ 5 ml jew 10 ml b’ għatu tal- kamin, jew f’ pakkett li fih tlett ifliexken tal- plastik (droptainer) ta ’ 5 ml b’ għotjien tal- kamin.
The marketing authorisation holder
Id- Detentur ta ’ l- Awtorizzazzjoni Il- Manifattur għat- tqegħid fis- Suq
S. A.
Alcon Laboratories (UK) Ltd., S. A.
Alcon - Couvreur N. V., Rijksweg 14, B-2870 Puurs, Belgium
Alcon- Couvreur N. V., Pentagon Park Rijksweg 14, Boundary Way, B- 2870 Puurs, Hemel Hempstead, Il- Belġju Herts., HP2 7UD, Ir- Renju Unit.
25 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
24 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
This leaflet was last approved on XXXXX
Dan il- fuljett kien approvat l- aħħar f’ XXXXX
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni ddettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
Route of Administration
Isem inventat
0.5 mg 1 mg 0.5 mg 1 mg
0. 5 mg 0. 5 mg 1 mg 1 mg
bottle (HDPE) bottle (HDPE) blister (alu/ alu) blister (alu/ alu)
Flixkun (HDPE) Folja (alu/ alu) Flixkun (HDPE) Folja (alu/ alu)
30 tablets 30 tablets 30 x 1 tablets 30 x 1 tablets
30 pillola 30 x 1 pillola 30 pillola 30 x 1 pillola
0.05 mg/ ml
0. 05 mg/ ml 0. 5 mg 1 mg
Oral solution
Soluzzjoni orali Pillola miksija b’ rita Pillola miksija b’ rita
bottle (HDPE)
Użu orali Użu orali Użu orali
210 ml
Flixkun (HDPE) 210 ml Folja (alu/ alu) Folja (alu/ alu)
90 x 1 tablets 90 x 1 tablets
1 flixkun+ mgħarfa għall- qies 90 x 1 pillola 90 x 1 pillola
Baraclude 0.5 mg film-coated tablets
Baraclude 0. 5 mg pilloli miksijin b’ rita
Each tablet contains 0.5 mg entecavir (as monohydrate).
Kull pillola fiha 0. 5 mg entecavir (bħala monoidrat).
Excipients: each tablet contains 120.5 mg lactose.
Sustanzi mhux attivi: kull pillola fiha 120. 5 mg ta ’ lactose.
White to off-white and triangular-shaped tablet with “ BMS ” debossed on one side and “ 1611” on the other.
Pillola ta ’ lewn abjad għal abjad fl- isfar f’ għamla triangolari b ’ “ BMS ” imnaqqxa fuq naħa u “ 1611 ” fuq in- naħa l- oħra.
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Baraclude huwa indikat għat- trattament ta ’ infezzjoni kronika bil- virus ta ’ l- epatite B (HBV) f’ adulti b’ mard ikkumpensat tal- fwied u b’ evidenza ta ’ replikazzjoni virali attiva, b’ livelli kostantament għoljin ta ’ alanine aminotransferase (ALT) fis- serum u b’ evidenza istoloġika ta ’ infjammazzjoni attiva u/ jew fibrożi.
This indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Din l- indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi fuq pazjenti nucleoside naïve li għandhom infezzjoni bl- HBV, kemm pożittivi għal HBeAg kif ukoll negattivi għal HBeAg.
With respect to patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Fir- rigward ta ’ pazjenti b’ epatite B refrattarja għal lamivudine, ara sezzjonijiet 4. 4 u 5. 1.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
It- terapija trid tinbeda minn tabib b’ esperjenza fil- maniġment ta ’ infezzjoni kronika ta ’ l- epatite B.
Baraclude should be taken orally, once-daily.
Baraclude irid jittieħed mill- ħalq, darba kuljum.
Nucleoside naïve patients: the recommended dose is 0.5 mg once daily, with or without food.
Pazjenti nucleoside- naive: id- doża rakkomandata hija ta ’ 0. 5 mg darba kuljum, ma ’ l- ikel jew mhux ma ’ l- ikel.
Lamivudine-refractory patients (i. e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before or more than 2 hours after a meal) (see section 5.2).
Pazjenti refrattarji għal lamivudine (jiġifieri b’ evidenza ta ’ viremja waqt li jkunu fuq lamivudine jew fil- preżenza ta ’ tibdil ġenetiku għar- reżistenza għal lamivudine [LVDr]) (ara sezzjonijiet 4. 4 u 5. 1): id - doża rakkomandata hija ta ’ 1mg darba kuljum, li trid tittieħed fuq stonku vojt (iktar min sagħtejn qabel jew iktar minn sagħtejn wara l- ikel) (ara sezzjoni 5. 2).
Duration of therapy: the optimal duration of treatment is unknown.
Tul tat- terapija: l- aħjar tul ta ’ żmien tat- trattament mhuwiex magħruf.
Treatment discontinuation may be considered as follows:
Il- waqfien tat- trattament jista ’ jiġi kkunsidrat kif ġej:
In HBeAg positive patients, treatment should be administered at least until HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
F’ pazjenti li huma pożittivi għal HBeAg, it- trattament irid jingħata ta ’ l- inqas sakemm ikun hemm serokonverżjoni ta ’ HBe (telf ta ’ HBeAg u DNA ta ’ HBV bi kxif ta ’ anti- HBe f’ żewġ kampjuni tas- serum li jkunu ttieħdu konsekuttivament u ta ’ l- inqas 3- 6 xhur minn xulxin) jew sakemm ikun hemm serokonverżjoni ta ’ HBs jew sakemm ikun hemm evidenza ta ’ nuqqas fl - effikaċja (ara sezzjoni 4. 4).
In HBeAg negative patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
F’ pazjenti li jirriżultaw negattivi għal HBeAg, it- trattament irid jingħata għallinqas sakemm ikun hemm serokonverżjoni ta ’ HBs jew sakemm ikun hemm evidenza ta ’ nuqqas fl- effikaċja.
With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
2 Bi trattment imtawwal għal iktar min sentejn, hija rrakkomandata valutazzjoni mill- ġdid biex jiġi kkonfermat li t- tkomplija tat- terapija magħżula tibqa ’ tajba għall- pazjent.
2 Children and adolescents:
Tfal u Adoloxxenti:
Baraclude is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Baraclude mhux irrakkomandat għall użu fit- tfal u adoloxxenti taħt it- tmintax- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly: no dosage adjustment based on age is required.
Anzjani: m’ hemmx bżonn ta ’ aġġustament fid- doża minħabba l- età.
The dose should be adjusted according to the patient ’ s renal function (see dosage recommendations in renal impairment and section 5.2).
Id- doża trid tiġi aġġustata skond il- funzjoni renali tal- pazjent (ara r- rakkomandazzjonijiet fuq id- dożi f’ indeboliment renali u f’ sezzjoni 5. 2).
Gender and race: no dosage adjustment based on gender or race is required.
Ġeneru u razza: m’ hemmx bżonn ta ’ aġġustament fid- doża minħabba raġunijiet ta ’ ġeneru jew razza.
Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Indeboliment tal- kliewi: il- clearance ta ’ entecavir tonqos man- nuqqas fil- clearance tal- kreatinina (ara sezzjoni 5. 2).
Dose adjustment is recommended for patients with creatinine clearance < 50 ml/ min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Huwa rrakkomandat aġġustament fid- doża għal pazjenti bi clearance tal- kreatinina < 50ml/ min, inkluż dawk il- pazjenti fuq emodijaliżi jew fuq dialiżi peritoneali ambulatorja kontinwa (CAPD).
A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended.
Tnaqqis fid- doża ta ’ kuljum bl- użu ta ’ Baraclude soluzzjoni orali, kif iddettaljat fit- tabella, hu rrakkomandat.
As an alternative, in case the oral solution is not available, the dose can be adjusted by increasing the dosage interval, also shown in the table.
Bħala alternattiva, f’ każ li s- soluzzjoni orali ma tkunx disponibbli, id- doża tista ’ tiġi aġġustata billi jiżdied l- intervall bejn id- dożi, muri wkoll fit- tabella.
The proposed dose modifications are based on extrapolation of limited data, and their safety and effectiveness have not been clinically evaluated.
Il- modifikazzjonijiet proposti fid - doża huma bbażati fuq estrapolazzjoni ta ’ informazzjoni limitata, u s- sigurtà u l- effikaċja tagħhom ma ġewx evalwati klinikament.
Therefore, virological response should be closely monitored.
Għalhekk, ir- rispons viroloġiku għandu jiġi mmonitorjat mill- qrib.
Baraclude dosage*
Doża ta ’ Baraclude *
Creatinine clearance (ml/ min)
Pazjenti nucleoside- naive
Nucleoside naïve patients
Rifrattorji għal Lamivudine
Lamivudine-refractory
kreatinina (ml/ min)
0.5 mg once daily 0.25 mg once daily* OR 0.5 mg every 48 hours
0. 25 mg darba kuljum * JEW 0. 5 mg kull 48 siegħa
1 mg once daily 0.5 mg once daily
0. 5 mg darba kuljum
0.15 mg once daily* OR 0.5 mg every 72 hours
0. 15 mg darba kuljum * JEW 0. 5 mg kull 72 siegħa
0.3 mg once daily* OR 0.5 mg every 48 hours
0. 3 mg darba kuljum * JEW 0. 5 mg kull 48 siegħa
< 10 Haemodialysis or CAPD**
0. 05 mg darba kuljum *
0.05 mg once daily* OR 0.5 mg every 5-7 days
0. 5 mg kull 5 – 7t ijiem
0.1 mg once daily* OR 0.5 mg every 72 hours
0. 5 mg kull 72 siegħa