FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Irbesartan Hydrochlorothiazide Zentiva.
English: The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Zentiva.
Slovenian: Družba, ki izdeluje zdravilo CoAprovel, je dovolila, da se znanstveni podatki tega zdravila uporabijo tudi za zdravilo Irbesartan Hydrochlorothiazide Zentiva.
English: The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
Slovenian: Ime zdravila je bilo 6. februarja 2012 spremenjeno v Irbesartan Hydrochlorothiazide Zentiva.
English: The full list of these medicines is given in the package leaflet.
Slovenian: Za celoten seznam teh zdravil glejte navodilo za uporabo.
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Hydrochlorothiazide Zentiva, glejte navodilo za uporabo.
English: The dose of Irbesartan Hydrochlorothiazide Zentiva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Slovenian: Odmerek zdravila Irbesartan Hydrochlorothiazide Zentiva, ki ga naj bolnik jemlje, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
English: Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Slovenian: Zdravila Irbesartan Hydrochlorothiazide Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Irbesartan Hydrochlorothiazide Zentiva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Irbesartan Hydrochlorothiazide Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: EPAR summary for the public irbesartan / hydrochlorothiazide
Slovenian: Povzetek EPAR za javnost irbesartan/hidroklorotiazid
English: Irbesartan Hydrochlorothiazide Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
English: Irbesartan Hydrochlorothiazide Zentiva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva se uporablja pri odraslih bolnikih z esencialno hipertenzijo (visokim krvnim tlakom), ki ni ustrezno uravnana z uporabo zgolj irbesartana ali zgolj hidroklorotiazida.
English: Care must be taken when using Irbesartan Hydrochlorothiazide Zentiva with other medicines that have an effect on blood potassium levels.
Slovenian: Posebna previdnost je potrebna, če se zdravilo Irbesartan Hydrochlorothiazide Zentiva jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
English: Other information about Irbesartan Hydrochlorothiazide Zentiva
Slovenian: Druge informacije o zdravilu Irbesartan Hydrochlorothiazide Zentiva
English: Previously known as Irbesartan Hydrochlorothiazide Winthrop.
Slovenian: Prej znano kot zdravilo Irbesartan Hydrochlorothiazide Winthrop.
English: Irbesartan Hydrochlorothiazide Zentiva must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Slovenian: Zdravila Irbesartan Hydrochlorothiazide Zentiva prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
English: Irbesartan Hydrochlorothiazide Zentiva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: 25 mg hydrochlorothiazide once a day are not recommended.
Slovenian: Odmerki, večji od 300 mg irbesartana in 25 mg hidroklorotiazida enkrat dnevno, niso priporočeni.
English: What benefit has Irbesartan Hydrochlorothiazide Zentiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Irbesartan Hydrochlorothiazide Zentiva izkazalo med študijami?
English: Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
English: Irbesartan Hydrochlorothiazide Zentiva contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: What is the risk associated with Irbesartan Hydrochlorothiazide Zentiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Irbesartan Hydrochlorothiazide Zentiva?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva.
Slovenian: V podporo uporabi zdravila Irbesartan Hydrochlorothiazide Zentiva so bile uporabljene študije z zdraviloma Karvea in Aprovel, uporabljenima skupaj s hidroklorotiazidom v ločenih tabletah.
English: Why has Irbesartan Hydrochlorothiazide Zentiva been approved?
Slovenian: Zakaj je bilo zdravilo Irbesartan Hydrochlorothiazide Zentiva odobreno?
English: Irbesartan Hydrochlorothiazide Zentiva may be added to some other treatments for hypertension.
Slovenian: Hydrochlorothiazide Zentiva se lahko uvede sočasno z nekaterimi drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: What is Irbesartan Hydrochlorothiazide Zentiva?
Slovenian: Kaj je zdravilo Irbesartan Hydrochlorothiazide Zentiva?
English: How is Irbesartan Hydrochlorothiazide Zentiva used?
Slovenian: Kako se zdravilo Irbesartan Hydrochlorothiazide Zentiva uporablja?
English: How has Irbesartan Hydrochlorothiazide Zentiva been studied?
Slovenian: Kako je bilo zdravilo Irbesartan Hydrochlorothiazide Zentiva raziskano?
English: What is Irbesartan Hydrochlorothiazide Zentiva used for?
Slovenian: Za kaj se zdravilo Irbesartan Hydrochlorothiazide Zentiva uporablja?
English: How does Irbesartan Hydrochlorothiazide Zentiva work?
Slovenian: Kako zdravilo Irbesartan Hydrochlorothiazide Zentiva deluje?
English: 7 - 21 days
Slovenian: 7 - 21 dni
English: The following wording was adopted:
Slovenian: Sprejeto je bilo naslednje besedilo:
English: A precautionary measure would be to more frequently monitor the INR.
Slovenian: Previdnostni ukrep bi bil bolj pogosto spremljanje INR.
English: The usual dose for adults is one bottle bag once daily.
Slovenian: Običajen odmerek za odrasle je ena steklenica vreča enkrat na dan.
English: It is important that you complete the course of treatment, even if you begin to feel better after a few days.
Slovenian: Pomembno je, da se zdravljenje v celoti zaključi, tudi če se po nekaj dneh počutite bolje.
English: The text proposed for 4.4 was shortened in order to make it clearer.
Slovenian: Besedilo, predlagano za 4.4, so skrajšali zaradi jasnosti.
English: The major concern was the need for further qualification of the conditions of use.
Slovenian: Glavni zadržek je bila potreba po nadaljnjih določitvah pogojev uporabe.
English: If you are female or elderly, you may be more sensitive to ECG changes.
Slovenian: Če ste ženskega spola ali starejša oseba, ste lahko bolj občutljivi na EKG spremembe.
English: 95, Marathonos Avenue 190-09 Pikermi Greece
Slovenian: 95, Marathonos Avenue 190-09 Pikermi Grčija
English: Studies in rats (p.o. and i.v.)
Slovenian: Študije na podganah (p.o. in i.v.)
English: The recommended dose and duration of treatment should not be exceeded (see section 2.
Slovenian: Priporočenega odmerka in trajanja zdravljenja se ne sme preseči (glejte poglavje 2.
English: (Invented) Name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: Any prospective surveillance study would need to be very carefully designed such that data collected from year to year could be compared with some degree of confidence and the Applicant proposal would not fulfil this requirement.
Slovenian: Kakršna koli prospektivna študija nadzora bi morala biti skrbno načrtovana, tako da bi lahko podatke, zbrane leto za letom, primerjali z neko stopnjo zaupanja, predlagateljev predlog pa te zahteve ne bi izpolnil.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria:
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija:
English: The infectious and inflammatory conditions, age and general status of the patient appear to be risk factors.
Slovenian: Zdi se, da so okužbe in vnetna stanja, starost in splošno stanje bolnika dejavniki tveganja.
English: The CHMP maintained its previous position.
Slovenian: CHMP je ohranil svoje predhodno mnenje.
English: If any such data was necessary, the Applicant should work with already established projects, adequately designed to collect reliable data prospectively.
Slovenian: Če bi bili tovrstni podatki potrebni, bi se moral predlagatelj zateči k že uveljavljenim projektom, ki so primerno oblikovani za prospektivno zbiranje zanesljivih podatkov.
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Slovenian: Po odločbi komisij pristojnih organov oblasti v zadevnih državah članicah in v sodelovanju z referenčno državo, bodo podatki o zdravilu ustrezno posodobljeni.
English: The Applicant attended an oral explanation at the May 2009 CHMP, during which the Applicant argumentation and data previously submitted in the context of the written responses was re-iterated.
Slovenian: Predlagatelj se je maja 2009 udeležil ustnih pojasnil pred CHMP, kjer so znova preučili predlagateljevo argumentacijo in predhodno predložene podatke v obliki pisnih odgovorov.
English: If necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Slovenian: Če je potrebno, je treba peroralni odmerek antikoagulanta ustrezno prilagoditi.
English: The CHMP maintained its previous position, as no new data was provided.
Slovenian: CHMP je ohranil svoje predhodno mnenje, saj novi podatki niso bili predloženi.
English: The CHMP and requested the Applicant to further discuss this issue.
Slovenian: CHMP je prosil predlagatelja za nadaljnjo razpravo o tem vprašanju.
English: The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI.
Slovenian: Priporočeno skupno trajanje intravenskega in peroralnega zdravljenja je 7 do 14 dni za CAP in 7 do 21 dni za cSSSI.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice glede primerne uporabe protibakterijskih učinkovin.
English: The duration of treatment depends upon the type of infection, and how well you respond to treatment but the recommended durations of use are:
Slovenian: Trajanje zdravljenja je odvisno od vrste okužbe in vašega odziva na zdravljenje; sicer se priporoča naslednje trajanje zdravljenja:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF OCTEGRA AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA OCTEGRA IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Microbiological Susceptibility
Slovenian: Mikrobiološka občutljivost
English: The CHMP considered that the literature reviews were neither valid nor helpful.
Slovenian: CHMP je menil, da pregledi gradiva niso bili niti veljavni niti koristni.
English: Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission.
Slovenian: Hkrati je treba zagotoviti ustrezen nadzor, da bi s tem zmanjšali prenos okužbe.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: Streptococcus agalactiae (Group B)
Slovenian: Streptococcus agalactiae (skupina B)
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Slovenian: Na podlagi do sedaj opravljenih farmakokinetičnih študij pri bolnikih z okvaro jeter (Child-Pugh A, B), ni mogoče dokazati, ali obstajajo kakršnekoli razlike v primerjavi z zdravimi prostovoljci.
English: - Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Slovenian: Kinolonski antibiotiki lahko povzročijo večjo občutljivost vaše kože na sončno ali UV svetlobo.
English: - If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.
Slovenian: če imate hudo jetrno bolezen ali zvečane vrednosti jetrnih encimov (transaminaz), ki za več kot petkrat presegajo zgornje normalne meje.
English: The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg.
Slovenian: Ustrezno največja koncentracija v alveolarnih makrofagih je 56,7 mg/kg.
English: The proposed restricted indication does not preclude the use of moxifloxacin for the initial treatment of CAP if in accordance with the local/regional/national guidance.
Slovenian: Predlagana omejena indikacija ne izključuje uporabe moksifloksacina pri začetnem zdravljenju izvenbolnišnično pridobljene pljučnice, če je v skladu z lokalnimi/regionalnimi/nacionalnimi smernicami.
English: With regard to pathogens associated with atypical pneumonia, the data must be interpreted with extreme caution.
Slovenian: V zvezi s patogeni, povezanimi z netipično pljučnico, morajo biti podatki razloženi zelo previdno.
English: The steady-state volume of distribution (Vss) is approximately 2 l/kg.
Slovenian: Razporeditveni volumen v dinamičnem ravnovesju (Vss) je približno 2 l/kg.
English: 6.3 Shelf life Polyolefine bag: 3 years Glass bottle:
Slovenian: 6.3 Rok uporabnosti poliolefinska vreča: 3 leta steklenica: 5 let
English: 7 - 14 days Most patients with pneumonia were switched to oral treatment with Octegra tablets within 4 days.
Slovenian: 7 - 14 dni Večina bolnikov s pljučnico je prešla na peroralno zdravljenje s tabletami Octegra v 4 dneh.
English: Neither the CAPNETZ data nor the meta-analysis support the conclusion that moxifloxacin is better than alternatives.
Slovenian: Niti podatki mreže CAPNETZ niti meta-analiza ne podpirajo zaključka, da je moksifloksacin boljši od alternativ.
English: However, such data may indicate a true excess risk of hepatotoxicity for the IV formulation.
Slovenian: Kljub temu pa taki podatki lahko nakazujejo resničen presežek tveganja za hepatotoksičnost pri intravenozni formulaciji.
English: In addition, the comparisons made are not considered robust enough and the pooling of the data is inappropriate due to the very varied comparative regimens and patient populations treated.
Slovenian: Poleg tega primerjave niso dovolj zanesljive, zbiranje podatkov pa je zaradi zelo različnih primerjalnih načinov zdravljenja in populacij zdravljenih bolnikov neprimerno.
English: It is therefore recommended not to store the infusion solution in a refrigerator.
Slovenian: Zato priporočamo, da raztopine za infundiranje ne hranite v hladilniku.
English: Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio) disorder.
Slovenian: V takih okoliščinah je težko ovrednotiti, ali motnje INR (internacionalno normalizirano razmerje) povzroča okužba ali zdravljenje.
English: Method of administration For intravenous use; constant infusion over 60 minutes (see also section 4.4).
Slovenian: Način uporabe Za intravensko uporabo; neprekinjeno infundiranje naj traja 60 minut (glejte tudi poglavje 4.4).
English: Content (concentration)
Slovenian: Pot uporabe zdravila Vsebina (koncentracija)
English: Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Slovenian: Varnost in učinkovitost uporabe moksifloksacina pri otrocih in mladostnikih ni dokazana (glejte poglavje 4.3).
English: Do not use Octegra after the expiry date which is stated on the label on the bottle bag and carton.
Slovenian: Zdravilo Octegra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na steklenici vreči in škatli.
English: Outcomes by pathogen did not reveal any potentially alarming differences between treatments.
Slovenian: Izidi glede na patogen niso pokazali nikakršnih potencialno skrb vzbujajočih razlik med posameznimi oblikami zdravljenja.
English: The Applicant proposed the insertion of a section on QTc interval in section 4.4, as well as the following box-warning at the beginning of section 4.4:
Slovenian: Predlagatelj je predlagal umestitev poglavja o intervalu QTc v poglavje 4.4 in naslednjega opozorilnega okvirja na začetek poglavja 4.4:
English: In clinical studies most patients switched to oral therapy within 4 days (CAP) or 6 days (cSSSI).
Slovenian: V kliničnih študijah je večina bolnikov prešla na peroralno zdravljenje v 4 dneh (CAP) ali 6 dneh (cSSSI).
English: Therefore, the duration of infusion should not be less than the recommended 60 minutes and the intravenous dose of 400 mg once a day should not be exceeded.
Slovenian: Zato naj trajanje infuzije ne bo krajše od priporočenih 60 minut, intravenozni odmerek 400 mg enkrat dnevno pa ne sme biti presežen.
English: - If you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
Slovenian: če jemljete druga zdravila, ki povzročajo določene spremembe v EKG-ju (glejte poglavje Uporaba drugih zdravil)
English: The first submission of moxifloxacin IV for CAP in 2002 included data from 550 moxifloxacin-treated subjects from two controlled clinical trials, which were later supplemented with an additional 942 subjects from five additional CAP studies.
Slovenian: Prva predložitev intravenoznega moksifloksacina za izvenbolnišnično pridobljeno pljučnico leta 2002 je vključevala podatke 550 oseb, zdravljenih z moksifloksacinom, iz dveh nadzorovanih kliničnih študij, ki so jih pozneje dopolnili z dodatnimi 942 osebami iz petih dodatnih študij izvenbolnišnično pridobljene pljučnice.
English: No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu moksifloksacina na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: The CHMP adopted a List of Questions, to be addressed by the Applicant.
Slovenian: CHMP je sprejel seznam vprašanj, na katera naj odgovori predlagatelj.
English: If the treatment with this medicine is stopped too soon your infection may not be completely cured.
Slovenian: Če se zdravljenje s tem zdravilom preneha prekmalu, okužba morda ne bo v celoti pozdravljena.
English: Your doctor should ensure that the infusion is given at a constant flow over 60 minutes.
Slovenian: Vaš zdravnik mora zagotoviti, da bo infundiranje trajalo neprekinjeno 60 minut.
English: 400 mg moxifloxacin, infused once daily.
Slovenian: 400 mg moksifloksacina, infundirano enkrat na dan.
English: The safety of moxifloxacin in human pregnancy has not been evaluated.
Slovenian: Varnosti moksifloksacina med nosečnostjo niso preučevali.
English: All AEs that might potentially reflect arrhythmias need to be taken into account and therefore the concerns regarding hepatotoxicity were reiterated.
Slovenian: Upoštevati je treba vse neželene učinke, ki bi se lahko odražali kot aritmije, zato so se ponavljali zadržki glede hepatotoksičnosti.
English: Possible side effects) contact your doctor immediately before you continue the treatment.
Slovenian: Možni neželeni učinki), se pred nadaljevanjem zdravljenja takoj posvetujte z zdravnikom.
English: Packs of 1 and 5 bottles.
Slovenian: Pakiranje po 1 in 5 steklenic.
English: Packs of 5 and 12 bags.
Slovenian: Pakiranje po 5 in 12 vreč.
English: This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes.
Slovenian: Ta učinek lahko poveča tveganje za ventrikularne aritmije, vključno s torsade de pointes.
English: The prevalence of resistance among pneumococci is very variable across the EU and this is reflected in different treatment guidelines, including the need to use high doses of beta-lactam agents, combination therapy or to use fluoroquinolones in some regions.
Slovenian: Razširjenost odpornosti med pnevmokoki v EU zelo variira, kar se odraža v različnih smernicah zdravljenja, ki vključujejo potrebo po uporabi visokih odmerkov beta-laktamskih učinkovin, kombiniranega zdravljenja ali uporabi fluorokinolonov v nekaterih regijah.
English: The Applicant also discussed the feasibility of European surveillance, proposing to undertake an annual surveillance plan to collect moxifloxacin MIC data in European countries.
Slovenian: Predlagatelj je prav tako razpravljal o možnosti evropskega nadzora in predlagal izvedbo letnega načrta nadzora za zbiranje podatkov o najnižji inhibicijski koncentraciji moksifloksacina v evropskih državah.
English: Infections Common:
Slovenian: Okužbe Pogosti:
English: The data revealed no new decrease in moxifloxacin susceptibility and the Applicant concluded that the susceptibilities for relevant species were correctly reflected in section 5.1 of the SPC with no significant trends or changes.
Slovenian: Podatki niso razkrili novega padca občutljivosti na moksifloksacin, predlagatelj pa je zaključil, da so bile občutljivosti pomembnih vrst pravilno izražene v poglavju 5.1 povzetka glavnih značilnosti zdravila, brez znatnih tendenc ali sprememb.
English: Colourless glass bottles (type 2) with a chlorobutyl rubber stopper as closure.
Slovenian: Brezbarvne steklenice (steklo tipa 2) s klorobutilnim gumijastim zamaškom, ki služi kot zapiralo.
English: WHAT OCTEGRA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO OCTEGRA IN ZA KAJ GA UPORABLJAMO
English: Your doctor will decide on the duration of your treatment with Octegra.
Slovenian: Vaš zdravnik se bo odločil koliko časa bo trajalo zdravljenje z zdravilom Octegra.
English: Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14
Slovenian: Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine, fluorokinoloni, oznaka ATC: J01MA14
English: However, the observed pharmacokinetic changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin).
Slovenian: Vendar pa opažene farmakokinetične spremembe (ki veljajo za glibenklamid) niso povzročile sprememb farmakodinamičnih parametrov (vrednosti glukoze v krvi, inzulin).
English: Ringing/noise in the ears Cardiovascular System Common:
Slovenian: zvonjenje v ušesih Srčno-žilni sistem Pogosti: