natgillin/translations-raw huggingface dataset:
Important information about some of the ingredients of Azomyr orodispersible tablet This product contains aspartame.
Pomembne informacije o nekaterih sestavinah zdravila Azomyr orodisperzibilna tableta To zdravilo vsebuje aspartam.
HOW TO TAKE AZOMYR ORODISPERSIBLE TABLET
KAKO JEMATI ZDRAVILO AZOMYR ORODISPERZIBILNA TABLETA
Children 6 to 11 years of age: take one 2.5 mg Azomyr orodispersible tablet once a day.
Otroci, stari od 6 do 11 let, naj jemljejo eno 2, 5 mg orodisperzibilno tableto zdravila Azomyr enkrat na dan.
Adults and adolescents (12 years of age and older): take two 2.5 mg Azomyr orodispersible tablets once a day.
Zaužijte dva odmereka zdravila Azomyr 2, 5 mg orodisperzibilna tableta enkrat na dan.
However, if you take more Azomyr orodispersible tablet than you were told to, contact your doctor or pharmacist.
Pri naključnem prevelikem odmeranju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Azomyr orodisperzibilna tableta kot bi morali, posvetujte s svojim zdravnikom ali farmacevtom.
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.
Če ste pozabili vzeti zdravilo Azomyr orodisperzibilna tableta Če ste pozabili vzeti odmerek pravočasno, ga vzemite čimprej, potem pa nadaljujte z ustaljenim režimom odmerjanja.
Like all medicines, Azomyr can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Azomyr neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
However, fatigue, dry mouth and headache were
Pri odraslih je bila pogostnost neželenih učinkov pri jemanju zdravila Azomyr približno enaka kot pri jemanju tablet placeba, vendar so pri njih pogosteje poročali o pojavu utrujenosti, suhih ust in glavobola med jemanjem zdravila kot med jemanjem tablet placeba.
HOW TO STORE AZOMYR ORODISPERSIBLE TABLET
SHRANJEVANJE ZDRAVILA AZOMYR ORODISPERZIBILNA TABLETA
Do not use Azomyr orodispersible tablet after the expiry date which is stated on the carton and blister.
Zdravila Azomyr orodisperzibilna tableta ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
Tell your pharmacist if you notice any change in the appearance of Azomyr orodispersible tablet.
Ne uporabljajte zdravila Azomyr orodisperzibilna tableta, če opazite kakršnekoli spremembe videza.
What Azomyr orodispersible tablet looks like and contents of the pack
Izgled zdravila orodisperzibilna tableta in vsebina pakiranja
Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “ K” branded on one side.
Azomyr 2, 5 mg orodisperzibilne tablete so svetlo rdeče okrogle pikčaste tablete z oznako ″ K ″ na eni strani.
Marketing Authorisation Holder and Manufacturer
82 Imetnik dovoljenja za promet z zdravilom in izdelovalec
How to store Azomyr orodispersible tablet 6.
Shranjevanje zdravila Azomyr orodisperzibilna tableta 6.
Do not take Azomyr orodispersible tablet
Ne uporabljajte zdravila Azomyr orodisperzibilna tableta
Azomyr 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Azomyr 5 mg orodisperzibilna tableta je indiciran za zdravljenje odraslih in mladostnikov (starost 12 let ali več).
88 Taking Azomyr orodispersible tablet with food and drink Azomyr orodispersible tablet does not need to be taken with water or liquid.
85 Jemanje zdravila Azomyr orodisperzibilna tableta skupaj s hrano in pijačo Zdravila Azomyr orodisperzibilna tableta vam ni treba jemati z vodo ali tekočino.
Adults and adolescents (12 years of age and older): take one 5 mg Azomyr orodispersible tablet once a day.
Zaužijte en odmerek zdravila Azomyr 5 mg orodisperzibilna tableta enkrat na dan.
In adults, side effects were about the same as with a dummy tablet.
Pri odraslih je bila pogostnost neželenih učinkov pri jemanju zdravila Azomyr približno enaka kot pri jemanju tablet placeba, vendar so pri njih pogosteje poročali o pojavu utrujenosti, suhih
However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
86 ust in glavobola med jemanjem zdravila kot med jemanjem tablet placeba.
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.
Med trženjem zdravila Azomyr so zelo redko poročali o primerih hudih alergijskih reakcij (težave z dihanjem, piskajoče in sopihajoče dihanje, srbenje, koprivnica in otekanje) ter izpuščajev.
Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “ A” branded on one side.
Azomyr 5 mg orodisperzibilne tablete so svetlo rdeče okrogle pikčaste tablete z oznako ″ A ″ na eni strani.
Azomyr oral solution is an antiallergy medicine that does not make you drowsy.
Azomyr peroralna raztopina je zdravilo proti alergiji, ki ne povzroča zaspanosti.
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.
Ti simptomi vključujejo kihanje, srbenje nosu ali izcedek iz nosu, srbenje ustnega neba in oči, vnetje očesne veznice, rdeče ali solzne oči.
Azomyr oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Azomyr peroralna raztopina se uporablja tudi za lajšanje simptomov urtikarije, (težave s kožo zaradi alergije).
of Azomyr.
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.
Zdravilo Azomyr peroralna raztopina je indiciran za zdravljenje otrok, starih od 1 do 11 let, mladostnikov (starost 12 let ali več) ter odraslih, vključno s starostniki.
93 Taking Azomyr with food and drink Azomyr may be taken with or without a meal.
90 Uporaba zdravila Azomyr skupaj s hrano in pijačo Azomyr se lahko jemlje s hrano ali brez nje.
If you are pregnant or nursing a baby, taking Azomyr oral solution is not recommended.
Če ste noseči ali če dojite otroka vam ne priporočamo uporabe zdravila Azomyr.
Important information about some of the ingredients of Azomyr Azomyr oral solution contains sorbitol.
Pomembne informacije o nekaterih sestavinah zdravila Azomyr Azomyr peroralna raztopina vsebuje sorbitol.
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.
Kar zadeva trajanje zdravljenja, bo vaš zdravnik najprej ugotovil vrsto alergijskega rinitisa, ki jo imate, in na podlagi tega določil, kako dolgo naj bi jemali zdravilo Azomyr peroralna raztopina..
If you take more Azomyr than you should Take Azomyr oral solution only as it is prescribed for you.
Če ste vzeli večji odmerek zdravila Azomyr, kot bi smeli Zdravilo Azomyr peroralna raztopina jemljite le tako, kot vam je bilo predpisano.
However, if you take more Azomyr oral solution than you were told to, contact your doctor or pharmacist.
Pri naključnem prevelikem odmeranju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Azomyr peroralna raztopina, kot bi morali, posvetujte s svojim zdravnikom ali farmacevtom.
Like all medicines, Azomyr oral solution can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Azomyr peroralna raztopina neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet.
Pri večini otrok in odraslih so bili neželeni učinki pri jemanju zdravila Azomyr približno enaki kot pri jemanju peroralne suspenzije placeba ali tablet.
Marketing Authorisation Holder and Manufacturer
92 Imetnik dovoljenja za promet z zdravilom in izdelovalec
95 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Azopt is a white eye drop suspension.
Zdravilo Azopt so kapljice za oko v obliki bele suspenzije.
It contains the active substance brinzolamide (10 mg/ ml).
Vsebuje zdravilno učinkovino brinzolamid (10 mg/ ml).
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).
Zdravilo Azopt se uporablja za zniževanje intraokularnega tlaka (tlaka v očesu) pri bolnikih z očesno hipertenzijo (njihov tlak v očesu je višji od normalnega) ali z glavkomom odprtega zakotja (bolezen, pri kateri se tlak v očesu poviša, ker tekočina ne more iztekati iz očesa).
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.
Zdravilo Azopt se uporablja kot dodatno zdravilo pri zdravljenju z zaviralci beta receptorjev ali analogi prostaglandina (druga zdravila za zdravljenje omenjenih bolezni) ali kot samostojno zdravilo pri bolnikih, ki ne smejo jemati zaviralcev beta receptorjev ali pa se nanje ne odzivajo.
The dose of Azopt is one drop into the affected eye(s) twice a day.
Odmerek zdravila Azopt je ena kapljica v prizadeto oko (ali očesi) dvakrat dnevno.
Some patients may have a better response with one drop three times a day.
Nekateri bolniki se bolje odzivajo na dajanje ene kapljice trikrat dnevno.
The suspension needs to be shaken before use.
Suspenzijo pred uporabo pretresite.
Azopt is not recommended for patients with liver disease, because of a lack of information on safety and effectiveness in this group.
Zdravilo Azopt ni priporočeno za bolnike z obolenji jeter, ker ni dovolj podatkov o varnosti in učinkovitosti zdravila v tej skupini bolnikov.
Azopt should not be used in patients with severe kidney disease.
Zdravila Azopt ne smejo uporabljati bolniki s hudo ledvično okvaro.
There is limited information on the use of Azopt in children.
Podatki o uporabi zdravila Azopt pri otrocih so omejeni.
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.
Povišan intraokularni tlak povzroča poškodbe mrežnice (membrane na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidnega žica, ki pošilja signale iz očesa v možgane.
This can result in serious vision loss and even blindness.
To lahko pripelje do resne okvare vida in celo slepote.
By lowering the pressure, Azopt reduces the risk of damage.
Zdravilo Azopt z zniževanjem tlaka zmanjša tveganje za pojav poškodb.
The active substance in Azopt, brinzolamide, is a carbonic anhydrase inhibitor.
Zdravilna učinkovina zdravila Azopt, brinzolamid, je zaviralec karboanhidraze.
It works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Deluje tako, da zavira encim, imenovan karboanhidraza, ki v telesu tvori bikarbonatne ione.
Bicarbonate is required for the production of the aqueous humour (the watery fluid in the eye).
Bikarbonat je potreben za tvorjenje očesne vodice (vodi podobne tekočine v očesu).
By blocking the production of bicarbonate in the eye, Azopt slows down the production of aqueous humour, reducing the pressure within the eye.
Z zaviranjem tvorjenja bikarbonata zdravilo Azopt upočasni nastajanje očesne vodice in tako zniža tlak v očesu.
Reproduction is authorised provided the source is acknowledged. timolol (a beta-blocker).
Kako je bilo zdravilo Azopt raziskano?
Two of these studies lasted three months, and the third, comparing Azopt with timolol, lasted 18 months.
Dve od teh študij sta trajali tri mesece, tretja, v kateri so zdravilo Azopt primerjali s timololom, pa je trajala 18 mesecev.
Two studies compared the effects of adding Azopt, dorzolamide or placebo (a dummy treatment) to timolol over three months.
V dveh študijah so v trajanju treh mesecev primerjali učinke dodajanja zdravila Azopt, dorzolamida ali placeba (zdravila brez zdravilne učinkovine) k timololu.
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.
V nadaljnjih dveh študijah so učinkovitost zdravila Azopt, uporabljenega dvakrat dnevno, primerjali z učinki timolola, pri čemer so obe zdravili v trajanju 12 tednov dodajali travoprostu (analogu prostaglandina) pri skupno 390 bolnikih.
In all studies, the main measure of effectiveness was the change in eye pressure measured in ‘ millimetres of mercury’ (mmHg).
V vseh študijah je bilo glavno merilo učinkovitosti sprememba očesnega tlaka, merjena v „ milimetrih živega srebra “ (mmHg).
When used alone, Azopt was less effective than timolol.
Zdravilo Azopt, uporabljeno samostojno, je bilo manj učinkovito kot 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.
Zdravilo Azopt je očesni tlak znižalo za 2, 7 do 5, 7 mmHg v primerjavi z znižanjem za 5, 2 do 6, 0 mmHg pri bolnikih, ki so prejemali timolol.
In a patient with glaucoma, the eye pressure is generally higher than 21 mmHg.
Pri bolnikih z glavkomom je očesni tlak navadno višji od 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.
Zdravilo Azopt je bilo tako učinkovito kot dorzolamid, če so ga uporabljali samostojno ali kot dodatek k timololu, tlak pa se je znižal za 3, 4 do 5, 7 mmHg.
Dorzolamide led to decreases of between 4.3 and 4.9 mmHg.
Dorzolamid je očesni tlak znižal za 4, 3 do 4, 9 mmHg.
Azopt was also more effective than placebo when used as an add-on to timolol.
Zdravilo Azopt je bilo kot dodatek k timololu učinkovitejše od placeba.
When used as an add-on to travoprost, Azopt had a similar effectiveness to timolol in reducing eye pressure.
Zdravilo Azopt, uporabljeno kot dodatek k travoprostu, je bilo pri zniževanju očesnega tlaka podobno učinkovito kot timolol.
In both studies, adding either Azopt or timolol caused a further decrease in eye pressure of around 3.5 mmHg after 12 weeks.
V obeh študijah je dodajanje bodisi zdravila Azopt ali timolola povzročilo nadaljnje znižanje očesnega tlaka za okoli 3, 5 mmHg po 12 tednih.
Overall, Azopt showed similar effectiveness when used twice or three times per day.
V celoti gledano, je zdravilo Azopt pri uporabi dvakrat ali trikrat na dan izkazalo podobno učinkovitost.
However, the results suggested that some patients may show a greater reduction in eye pressure when using the drops three times per day.
Vendar pa je na podlagi rezultatov mogoče sklepati, da je pri nekaterih bolnikih znižanje tlaka večje, kadar uporabljajo kapljice trikrat na dan.
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.
Najpogostejši neželeni učinki zdravila Azopt (opaženi pri 1 do 10 bolnikih izmed 100) so disgevzija (grenak ali nenavaden okus v ustih), glavobol, blefaritis (vnetje očesnih vek), zamegljen vid, draženje očesa, očesne bolečine, suho oko, izcedek iz očesa, očesni pruritus (srbenje), občutek tujka v očeh, očesna hiperemija (pordelo oko) in suha usta.
For the full list of all side effects reported with Azopt, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Azopt, glejte navodilo za uporabo.
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).
Zdravila Azopt ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) brinzolamid, katero koli drugo sestavino zdravila ali sulfonamide (kamor spadajo npr. nekateri antibiotiki).
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).
Zdravila prav tako ne smejo uporabljati bolniki s hudo ledvično okvaro ali hiperkloremično acidozo (prevelika kislost krvi, ki ga povzroča prevelika količina klorida).
Azopt contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo Azopt vsebuje benzalkonijev klorid, katerega znana lastnost je, da razbarva mehke kontaktne leče.
Therefore, care should be taken by people who wear soft contact lenses.
Zato morajo biti ljudje, ki uporabljajo mehke kontaktne leče, pri uporabi zdravila previdni.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Azopt pri zniževanju povišanega intraokularnega tlaka pri očesni hipertenziji in glavkomu odprtega zakotja večje od z njim povezanih tveganj.
The Committee recommended that Azopt be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Azopt odobri dovoljenje za promet.
Other information about Azopt:
Druge informacije o zdravilu Azopt:
The European Commission granted a marketing authorisation valid throughout the European Union for Azopt to Alcon Laboratories (UK) Limited on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom Azopt, veljavno po vsej Evropski uniji, odobrila družbi Alcon Laboratories (UK) Limited dne 9. marca 2000.
The marketing authorisation was renewed on 9 March 2005.
Dovoljenje za promet je bilo obnovljeno dne 9. marca 2005.
The full EPAR for Azopt can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azopt je na voljo tukaj.
Pharmaceutical form
Velikost pakiranja
Route of administration
EU/ 1/ 00/ 129/ 001
Packaging
Azopt
Content
10 mg/ ml
Package size
1 steklenička
EU/ 1/ 00/ 129/ 01 EU/ 1/ 00/ 129/ 02 EU/ 1/ 00/ 129/ 03
EU/ 1/ 00/ 129/ 002
Azopt Azopt Azopt
Azopt
Eye drops, suspension Eye drops, suspension Eye drops, suspension
kapljice za oko, suspenzija
Ocular use Ocular use Ocular use
kapljice za oko, suspenzija
Bottle (LDPE) Bottle (LDPE) Bottle (LDPE)
steklenička (LDPE)
5 ml 10 ml 5 ml
5 ml
1 bottle 1 bottle 3 bottles
3 stekleničke
AZOPT 10 mg/ ml eye drops, suspension
AZOPT 10 mg/ ml kapljice za oko, suspenzija
1 ml of suspension contains 10 mg brinzolamide.
1 ml suspenzije vsebuje 10 mg brinzolamida.
Excipients: benzalkonium chloride 0.15 mg, (see section 4.4).
Pomožne snovi: benzalkonijev klorid 0, 15 mg (glejte poglavje 4. 4).
For a full list of excipients, (see section 6.1).
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Azopt is a white to off-white suspension.
AZOPT je bela do belkasta suspenzija.
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).
AZOPT je indiciran za znižanje zvišanega očesnega tlaka pri: • očesni hipertenziji • glavkomu odprtega zakotja, bodisi za monoterapijo pri bolnikih, ki se ne odzivajo na zaviralce beta receptorjev ali so pri njih zaviralci beta receptorjev kontraindicirani, ali pa kot dodatno zdravljenje poleg zaviralcev beta receptorjev ali prostaglandinskih analogov (glejte poglavje 5. 1).
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
Če bolnik sočasno uporablja več topikalnih očesnih zdravil, naj jih uporabi z razmikom najmanj 5 minut.
Shake well before use.
Pred uporabo plastenko dobro pretresite.
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.
Kontaminacijo vrha kapalnega dela plastenke in suspenzije preprečimo tako, da pazimo, da se z vrhom kapalnega dela plastenke ne dotaknemo vek, kože v bližini ali drugih površin.
Keep the bottle tightly closed when not in use.
Ko ni v uporabi, mora biti plastenka tesno zaprta.
Use in elderly No dosage alteration in elderly patients is necessary.
Uporaba pri starejših ljudeh Pri starejših bolnikih ni potrebna prilagoditev odmerka.
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 Uporaba pri otrocih Učinkovitost in varnost zdravila AZOPT pri bolnikih, mlajših od 18 let, še nista bili ugotovljeni, zato njegove uporabe pri teh bolnikih ne priporočamo.
However, there is limited experience in children.
Vendar pa so pri otrocih omejene izkušnje z uporabo zdravila AZOPT.
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).
Varnost in učinkovitost zdravila AZOPT so proučevali le pri majhnem številu pediatričnih bolnikov, mlajših od 6 let (glejte tudi 4. 4, 4. 8 in 5. 1).
Use in hepatic and renal impairment AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in such patients.
Uporaba pri jetrni in ledvični okvari Zdravila AZOPT še niso preskušali pri bolnikih z jetrno okvaro in ga pri njih zato ne priporočamo.
AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/ min) or in patients with hyperchloraemic acidosis.
Zdravila AZOPT še niso preskušali pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/ min) ali pri tistih s hiperkloremično acidozo.
Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZOPT is therefore contra-indicated in such patients (see also 4.3).
Ker se brinzolamid in njegov glavni presnovek izločata predvsem skozi ledvice, je zdravilo AZOPT pri teh bolnikih kontraindicirano (glejte tudi 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).
• Preobčutljivost za brinzolamid ali za katerokoli pomožno snov, • znana preobčutljivost za sulfonamide (glejte tudi poglavje 4. 4), • huda ledvična okvara, • hiperkloremična acidoza (glejte tudi poglavje 4. 2).
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Pri uporabi peroralnih zaviralcev karboanhidraze so poročali o motnjah kislinsko- baznega ravnotežja.
The same types of undesirable effects that are attributable to sulphonamides may occur with topical administration.
Pri topikalni uporabi zdravila se lahko pojavijo enake vrste neželenih učinkov kot pri drugih sulfonamidih.
The concomitant administration of AZOPT and oral carbonic anhydrase inhibitors has not been studied and is not recommended.
Sočasne uporabe zdravila AZOPT in peroralnih zaviralcev karboanhidraze še niso raziskovali in je ne priporočamo.
Additionally the IOP-reducing effect of Azopt as adjunctive therapy to the prostaglandin analogue travoprost has been studied.
Poleg tega so proučevali tudi učinek zdravila Azopt na znižanje očesnega tlaka kot dodatno zdravljenje ob uporabi prostaglandinskega analoga travoprosta.
No long term data are available on the use of AZOPT as adjunctive therapy to travoprost. (see section 5.1)
Ni dolgoročnih podatkov o uporabi zdravila AZOPT za dodatno zdravljenje ob travoprostu (glejte poglavje 5. 1).
AZOPT has not been studied in patients with narrow-angle glaucoma.
Zdravila AZOPT še niso preskušali pri bolnikih z glavkomom ozkega zakotja.