FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ,ČE STA RAZLIČNA
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intradermal use
Slovenian: NAČIN IN POT(I) UPORABE
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: 5831AN Boxmeer Nizozemska
English: For intradermal use.
Slovenian: Intradermalna uporaba.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: SPECIAL WARNING(S) Special precautions for use in animals Not applicable.
Slovenian: POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih:
English: PCV2 ORF2 subunit antigen ≥1436 AU
Slovenian: En odmerek (0,2 ml) vsebuje: PCV2 ORF2 podenota antigen ≥1436 AU
English: 4.2 Indications for use, specifying the target species For the active immunisation of fattening pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo pitancev z namenom zmanjšati viremijo, virusno breme v pljučih in limfoidnih tkivih; ter širjenje virusa, ki ga povzroči okužba s PCV2; poleg tega z namenom zmanjšanja izgube prirasta in smrtnosti, povezane v zvezi z okužbo s PCV2.
English: Onset of immunity: 2 weeks after vaccination.
Slovenian: Začetek imunosti: 2 tedna po cepljenju.
English: Porcine circovirus type 2 ORF2 subunit antigen
Slovenian: Prašičji cirkovirus, tip 2, antigenska podenota ORF2
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis PCV ID emulzija za injiciranje za prašiče
English: Glass vial (type I) of 10 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina Steklena viala (tip I) z 10 ml, zaprta z nitrilnim gumijastim zamaškom in zavarjena z aluminijasto zaporko.
English: 8.3 mg Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Slovenian: 1Enote antigena, določene z in vitro testom učinkovitosti (test antigenske mase)
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Slovenian: INDIKACIJE Za aktivno imunizacijo prašičev z namenom zmanjšati viremijo, virusno breme v pljučih in limfoidnih tkivih ter širjenje virusa, ki ga povzroči okužba s PCV2, poleg tega z namenom zmanjšanja izgube prirasta in smrtnosti, povezane v zvezi z okužbo s PCV2.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali
English: PACKAGE LEAFLET: Porcilis PCV ID emulsion for injection for pigs
Slovenian: NAVODILO ZA UPORABO Porcilis PCV ID emulzija za injiciranje za prašiče
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.5831 AN Boxmeer
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Intervet International B.V.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID
Slovenian: Porcilis PCV ID
English: WITHDRAWAL PERIOD(S) Zero days.
Slovenian: KARENCA(E) Nič dni.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca biološke učinkovine proizvajalca zdravila, odgovornega za sproščanje serij
English: ROUTE(S) OF ADMINISTRATION Intradermal use
Slovenian: intradermalna uporaba
English: Simethicone
Slovenian: 4.11 Karenca
English: WITHDRAWAL PERIOD(S)
Slovenian: NAVEDBA UČINKOVIN(E)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIALS OF 10 AND 20 ML
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: London, 18 October 2006 Doc.
Slovenian: London, 18. oktober 2006 Dok.
English: International non-proprietary name (INN): repaglinide
Slovenian: Mednarodno nelastniško ime (INN): repaglinid
English: It is used together with diet and exercise.
Slovenian: Uporablja se skupaj z dieto in telesno dejavnostjo.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če pa ste vključeni v klinično preskušanje in potrebujete več podatkov o svojem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The company presented information on 2 clinical studies, involving 498 patients with type 2 diabetes.
Slovenian: Podjetje je predstavilo podatke iz dveh 2 kliničnih raziskav, v kateri je bilo vključenih 498 bolnikov z diabetesom tipa 2.
English: It is available as tablets containing 0.5 mg, 1 mg and 2 mg of the active substance repaglinide.
Slovenian: Na voljo je v tabletah, ki vsebujejo 0,5 mg, 1 mg ali 2 mg zdravilne učinkovine repaglinid.
English: Following the CHMP's opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Slovenian: Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Slovenian: HbA1c kaže, kako dobro je raven glukoze v krvi nadzorovana.
English: There are no consequences for NovoNorm/Prandin's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.©EMEA 2006
Slovenian: Omenjeno nima posledic za uporabo zdravila NovoNorm/Prandin za indikacije, za katere je bilo zdravilo že odobreno, in pri katerih ostajajo koristi in tveganja nespremenjeni.©EMEA 2006
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NOVONORM/PRANDIN
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom NOVONORM/PRANDIN
English: The studies measured the level of a substance in the blood (glycosylated haemoglobin, HbA1c) after 24 weeks of treatment.
Slovenian: V teh raziskavah so merili raven snovi v krvi (glikoziliranega hemoglobina HbA1c) po 24 tednih zdravljenja.
English: NovoNorm/Prandin is an antidiabetic medicine.
Slovenian: NovoNorm/Prandin je antidiabetično zdravilo.
English: Consequently, they could not be regarded as having failed treatment with thiazolidinediones.
Slovenian: Zaradi tega jih ni mogoče obravnavati, kot da zdravljenje z tiazolidinedioni pri njih ni bilo uspešno.
English: Both studies included patients whose blood sugar levels were not controlled satisfactorily with a sulphonylurea or metformin (other antidiabetic medicines).
Slovenian: V obeh raziskavah so sodelovali bolniki, katerih krvni sladkor ni bil zadovoljivo nadzorovan z sulfonilsečnino ali metforminom (drugima antidiabetičnima zdraviloma).
English: What were the concerns of the CHMP at the time of the withdrawal?
Slovenian: Kakšni so bili zadržki CHMP v času umika?
English: On 12 October 2006, Novo Nordisk A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for NovoNorm/Prandin, to add the use of NovoNorm/Prandin in combination with a thiazolidinedione for the treatment of type 2 diabetes.
Slovenian: Dne 12. oktobra 2006 je podjetje Novo Nordisk A/S uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za spremembo dovoljenja za promet z zdravilom NovoNorm/Prandin, in sicer je hotelo dodati uporabo zdravila NovoNorm/Prandin v kombinaciji z tiazolidinedionom za zdravljenje diabetesa tipa 2.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Podjetje je umaknilo vlogo na 175. dan. Potem, ko je CHMP je ocenil odgovore podjetja na seznam vprašanj, je še vedno ostalo nekaj pomembnih vprašanj nerešenih.
English: The major concern of the CHMP was that the studies presented by the company did not support the requested change in the marketing authorisation, as the patients treated in the studies had not been treated with the highest permitted dose of either rosiglitazone or pioglitazone before entering the studies.
Slovenian: Glavni zadržek CHMP je bil, da zahtevane spremembe v dovoljenju za promet z zdravilom niso dovolj podprte z raziskavami, ki jih je predstavilo podjetje, saj v raziskavah sodelujoči bolniki niso prejemali najvišjega dovoljenega odmerka ali rosiglitazona ali pioglitazona, preden so bili vključeni v raziskave.
English: The CHMP may take 90 days or more to adopt an opinion after it has received an application for a change to a marketing authorisation.
Slovenian: CHMP po prejemu vloge za spremembo dovoljenja za promet potrebuje 90 dni ali več, da poda svoje mnenje.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with NovoNorm/Prandin?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila NovoNorm/Prandin?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood.
Slovenian: Diabetes tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje koncentracije glukoze v krvi.
English: Based on the review of the data submitted for this variation and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that NovoNorm/Prandin in combination with a thiazolidinedione could not have been approved for the treatment of type 2 diabetes.
Slovenian: Na podlagi pregleda podatkov za to spremembo in odgovorov podjetja na seznam vprašanj, ki jih je postavil CHMP ob času umika, je imel CHMP zadržke in je bil začasnega mnenja, da za zdravilo NovoNorm/Prandin v kombinaciji z tiazolidinedionom ni mogoče odobriti dovoljenja za zdravljenje diabetesa tipa 2.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of NovoNorm/Prandin in combination with a thiazolidinedione had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je zato v času umika menil, da koristi zdravila NovoNorm/Prandin v kombinaciji z tiazolidinedionom niso bile dokazane v zadostni meri in da kakršna koli korist ne odtehta ugotovljenih tveganj.
English: It can be used on its own to lower blood glucose (sugar) in patients whose hyperglycaemia (high blood glucose) cannot be controlled by diet, weight reduction and exercise.
Slovenian: Lahko se uporablja samostojno za zniževanje glukoze v krvi (sladkorja) pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni mogoče nadzorovati z dieto, z zmanjšanjem telesne mase in telesno dejavnostjo.
English: The studies compared the effects of NovoNorm/Prandin combined with either rosiglitazone or pioglitazone, compared to the medicines taken alone.
Slovenian: V raziskavah so primerjali učinke zdravila NovoNorm/Prandin, kadar je kombiniran z rosiglitazonom ali pioglitazonom, z učinki, kadar se jemlje samostojno.
English: Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus or maturity onset diabetes.
Slovenian: Diabetes tipa 2 imenujemo tudi od insulina neodvisni diabetes mellitus, ali starostni diabetes.
English: The withdrawal has no consequences for patients currently included in clinical trials with NovoNorm/Prandin.
Slovenian: Umik nima za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila NovoNorm/Prandin, nobenih posledic.
English: NovoNorm/Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Slovenian: NovoNorm/Prandin pomaga trebušni slinavki, da v času obrokov tvori več insulina, in se uporablja za nadzor diabetesa tipa 2.
English: NovoNorm/Prandin is authorised for use in patients who have non insulin-dependent diabetes (type 2 diabetes).
Slovenian: Zdravilo NovoNorm/Prandin je odobreno za uporabo pri bolnikih, ki imajo od insulina neodvisni diabetes (diabetes tipa 2).
English: In addition, the CHMP was concerned that the studies did not compare NovoNorm/Prandin with a thiazolidinedione to a combination of a thiazolidinedione with sulphonylurea, which is an approved treatment for patients who have failed to respond to a thiazolidinedione taken alone.
Slovenian: CHMP je imel poleg tega pomisleke tudi zato, ker zdravila NovoNorm/Prandin v kombinaciji s tiazolidinedioni v raziskavah niso primerjali s kombinacijo tiazolidinediona in sulfonilsečnine, kar je odobreno zdravljenje za bolnike, ki se niso odzvali na sam tiazolidinedion.
English: NovoNorm/Prandin was to be used for the treatment of type 2 diabetes in combination with a thiazolidinedione (another type of anti-diabetes medicine) such as rosiglitazone or pioglitazone, in patients whose blood sugar levels could not be controlled by a thiazolidinedione taken alone.
Slovenian: Zdravilo NovoNorm/Prandin naj bi se v kombinaciji s tiazolidinedioni (drugo vrsto antidiabetičnega zdravila), kot sta rosiglitazon ali pioglitazon, uporabljalo za zdravljenje diabetesa tipa 2 pri bolnikih, pri katerih raven sladkorja v krvi ne more biti nadzorovana s samim tiazolidinedionom.
English: NovoNorm/Prandin may also be used with metformin (another anti-diabetes medicine) in patients with type 2 diabetes who are not satisfactorily controlled on metformin alone.
Slovenian: NovoNorm/Prandin se lahko uporablja tudi skupaj z metforminom (drugim antidiabetičnim zdravilom) pri bolnikih z diabetesom tipa 2, pri katerih nadzor s samim metforminom ni zadosten.
English: What is happening with NovoNorm/Prandin used in its current indications?
Slovenian: Kaj to pomeni za uporabo zdravila NovoNorm/Pradin za trenutno odobrene indikacije?
English: How does NovoNorm/Prandin work?
Slovenian: Kako zdravilo NovoNorm/Prandin deluje?
English: What is NovoNorm/Prandin?
Slovenian: Kaj je zdravilo NovoNorm/Prandin?
English: What was NovoNorm/Prandin expected to be used for?
Slovenian: Za kaj naj bi se zdravilo NovoNorm/Prandin uporabljalo?
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 29 January 2010
Slovenian: Datum prve odobritve: 9. marec 2000 Datum zadnjega podaljšanja: 29. januar 2010
English: Currently available data are described in sections 4.8 and 5.1.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8 in 5.1.
English: Treatment should be symptomatic and supportive.
Slovenian: Zdravljenje naj bo simptomatsko in podporno.
English: If the pressure in the eye is too high, it can damage your sight.
Slovenian: Če tlak postane previsok, lahko poškoduje vaš vid.
English: • If you take drops in both eyes, repeat the steps for your other eye.
Slovenian: • Če uporabljate kapljice v obeh očesih, ponovite te korake tudi na drugem očesu.
English: 1 drop in the affected eye or eyes twice a day - morning and night.
Slovenian: 1 kapljica v prizadeto oko ali oči dvakrat na dan, zjutraj in zvečer.
English: 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.
Slovenian: Če ste prenehali uporabljati zdravilo AZOPT, ne da bi se pogovorili s svojim zdravnikom, vaš očesni tlak ne bo nadzorovan in to lahko vodi do izgube vida.
English: Use a single drop as soon as you remember, and then go back to your regular routine.
Slovenian: Vkapajte eno kapljico, takoj ko se spomnite, potem pa nadaljujte z rednim režimom odmerjanja.
English: Binding to plasma proteins is not extensive (about 60%).
Slovenian: Vezava na plazemske proteine ni velika (le približno 60 %).
English: Contact with soft contact lenses is to be avoided.
Slovenian: Stiku z mehkimi kontaktnimi lečami se je potrebno izogibati.
English: For a pack containing a single bottle, write only one date.
Slovenian: Pri pakiranjih z enim samim kapalnim vsebnikom zapišite le en datum.
English: MedDRA Preferred Term (v.15.1)
Slovenian: Izraz po klasifikaciji MedDRA (v.15.1)
English: This medicine contains 3.35 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Slovenian: To zdravilo vsebuje 3,35 µg benzalkonijevega klorida na kapljico (= 1 odmerek), kar je enako 0,01 % ali 0,1 mg/ml.
English: Do not use AZOPT - if you have severe kidney problems.
Slovenian: Ne uporabljajte zdravila AZOPT - če imate resne težave z ledvicami.
English: Some patients may have a better response with one drop three times a day.
Slovenian: Pri nekaterih bolnikih je lahko odziv na zdravljenje boljši pri odmerku ena kapljica trikrat na dan.
English: AZOPT is not to be used by infants, children or adolescents under 18 years of age unless advised by your doctor.
Slovenian: Zdravila AZOPT ne smejo uporabljati dojenčki, otroci ali mladostniki, mlajši od 18 let, razen če tako svetuje vaš zdravnik.
English: - if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na brinzolamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The dose should not exceed one drop in the affected eye(s) three times daily.
Slovenian: Odmerek ne sme prekoračiti ene kapljice v prizadeto oko (oči) trikrat na dan.
English: • Known hypersensitivity to sulphonamides (see also section 4.4).
Slovenian: • znana preobčutljivost na sulfonamide (glejte tudi poglavje 4.4),
English: • After using AZOPT, press a finger to the corner of your eye, by the nose (picture 3) for at least
Slovenian: • Po uporabi zdravila AZOPT pritisnite s prstom na očesni kot ob nosu (slika 3) za vsaj 1 minuto.
English: AZOPT may cause the same allergy.
Slovenian: lahko povzroči enako vrsto alergije.
English: • Hyperchloraemic acidosis.
Slovenian: • hiperkloremična acidoza.
English: What you need to know before you use AZOPT
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo AZOPT
English: Carbonic anhydrase activity was approximately 40-70% of predose levels.
Slovenian: Aktivnost karboanhidraze je bila približno od 40 do 70 % ravni, izmerjene pred dajanjem odmerka.
English: The following adverse reactions have been reported with brinzolamide 10mg/ml eye drops, suspension 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), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Slovenian: Pri uporabi kapljic za oko, suspenzije z brinzolamidom 10 mg/ml so poročali o naslednjih neželenih učinkih, ki so razvrščeni v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) ali pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
English: If a dose is missed, treatment should be continued with the next dose as planned.
Slovenian: Če bolnik izpusti odmerek, naj nadaljuje zdravljenje z naslednjim odmerkom po načrtu.
English: You must throw away a bottle four weeks after you first opened it, to prevent infections.
Slovenian: Kapalni vsebnik zavrzite štiri tedne po tem, ko ste ga prvič odprli, s čimer boste preprečili okužbe.
English: This helps to stop AZOPT getting into the rest of the body.
Slovenian: Tako boste preprečili, da bi zdravilo AZOPT prišlo tudi v druge dele telesa.
English: No dose adjustment in elderly patients is necessary.
Slovenian: Pri starejših bolnikih ni potrebna prilagoditev odmerka.
English: The events were mild and did not affect the overall discontinuation rates in the studies (see also section 4.8).
Slovenian: Ti učinki pa so bili blagi in niso vplivali na skupno stopnjo prekinitve zdravljenja v študijah (glejte tudi poglavje 4.8).
English: Dysgeusia (bitter or unusual taste in the mouth following instillation) was the most frequently reported systemic adverse reaction associated with the use of AZOPT during clinical studies.
Slovenian: Disgevzija (grenak ali nenavaden okus v ustih po vkapanju zdravila) je bila najpogostejši sistemski neželeni učinek, povezan z uporabo zdravila AZOPT v kliničnih študijah.
English: Other medicines and AZOPT
Slovenian: Druga zdravila in zdravilo AZOPT
English: You may find that your vision is blurred for a time just after using AZOPT.
Slovenian: Vaš vid bo lahko zamegljen še nekaj časa po uporabi zdravila AZOPT.
English: Brinzolamide has not been studied in pre-term infants (less than 36 weeks gestational age) or those less than 1 week of age.
Slovenian: Brinzolamida niso proučevali pri nedonošenčkih z manj kot 36 tedni gestacijske dobe ali pri tistih, ki so mlajši od 1 tedna.
English: Animal studies with brinzolamide demonstrated no effect on fertility.
Slovenian: Študije na živalih z brinzolamidom niso pokazale učinkov na plodnost.
English: If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Slovenian: Če se pojavijo znaki resnih reakcij ali preobčutljivosti za zdravilo, prenehajte z njegovo uporabo.
English: Use this much unless your doctor told you to do something different.
Slovenian: Uporabite toliko, razen če vam zdravnik svetuje drugače.
English: What AZOPT is and what it is used for
Slovenian: Kaj je zdravilo AZOPT in za kaj ga uporabljamo
English: 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.
Slovenian: Posledica tega je znižanje očesnega tlaka (IOP-“intraocular pressure”, ki je poglavitni dejavnik tveganja v patogenezi poškodbe vidnega živca in izgube vidnega polja pri glavkomu.
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines (see also section 4.8).
Slovenian: Začasno zamegljen vid ali druge motnje vida lahko vplivajo na sposobnost vožnje ali upravljanja strojev (glejte tudi poglavje 4.8).
English: - if you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
Slovenian: - če imate preveliko kislost krvi (motnja, ki jo imenujemo hiperkloremična acidoza).
English: The adverse reactions were obtained from clinical trials and post-marketing spontaneous reports.
Slovenian: Neželeni učinki so bili pridobljeni v kliničnih preskušanjih in s spontanimi poročili po prihodu zdravila na trg.
English: 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.
Slovenian: Pri preiskovancih z največjo stopnjo ledvične okvare je bila inhibicija celotne aktivnosti CA večja, četudi je bila nižja od 90 % v stanju dinamičnega ravnovesja.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZOPT therapy taking in to account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom AZOPT, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Only use AZOPT for your eyes.
Slovenian: Zdravilo AZOPT smete uporabljati le za oči.
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Slovenian: Če ima po vkapanju bolnik zamegljen vid, mora počakati, da se mu vid zbistri, preden sme voziti in upravljati stroje.
English: AZOPT is indicated to decrease elevated intraocular pressure in:
Slovenian: AZOPT je indiciran za znižanje zvišanega očesnega tlaka pri:
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu