FrancophonIA/ELRC3.0 huggingface dataset:
English: Although not specifically studied with the CoAprovel, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Estonian: Tagasilöögihüpertensiooni ei ole täheldatud ei eraldi manustatud irbesartaani ega hüdroklorotiasiidiga, kuigi vastavaid uuringuid CoAprovel'iga ei ole tehtud.
English: CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Estonian: CoAprovel 150 mg/12,5 mg tabletid irbesartaan/hüdroklorotiasiid
English: EU/1/98/086/016 - 14 tablets EU/1/98/086/017 - 28 tablets EU/1/98/086/030 - 30 tablets EU/1/98/086/018 - 56 tablets EU/1/98/086/019 - 56 x 1 tablets EU/1/98/086/022 - 84 tablets EU/1/98/086/033 - 90 tablets EU/1/98/086/020 - 98 tablets
Estonian: EU/1/98/086/016 - 14 tabletti EU/1/98/086/017 - 28 tabletti EU/1/98/086/030 - 30 tabletti EU/1/98/086/018 - 56 tabletti EU/1/98/086/019 - 56 x 1 tabletti EU/1/98/086/022 - 84 tabletti EU/1/98/086/033 - 90 tabletti EU/1/98/086/020 - 98 tabletti
English: CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Estonian: CoAprovel 300 mg/12,5 mg tabletid irbesartaan/hüdroklorotiasiid
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Estonian: Virsikuvärvi, kaksikkumer, ovaalne, sissepressitud südame kujutis ühel poolel ja sissegraveeritud number 2775 teisel poolel.
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased; Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Estonian: Tiasiidide poolt põhjustatud hüpokaleemia või hüpomagneseemia soodustavad digitaalisest indutseeritud südame rütmihäirete teket (vt lõik 4.4).
English: Do not take CoAprovel if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Estonian: Ärge kasutage CoAprovel'i kui olete irbesartaani või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline, kui te olete allergiline (ülitundlik) hüdroklorotiasiidi või mõne teise sulfoonamiidiga keemiliselt sarnase ravimi suhtes, kui rasedus on kestnud üle 3 kuu (ka raseduse algul on parem vältida CoAprovel'i kasutamistvt lõiku rasedus), kui teil on raske maksa- või neerukahjustus, kui teil on raskusi urineerimisega, kui teie arst leiab, et teil on veres püsivalt kõrge kaltsiumi või madal kaaliumi tase, kui teil on suhkurtõbi (diabeet) või neerutalitluse häire ja te saate ravi vererõhku langetava ravimiga, mis sisaldab aliskireeni.
English: (It is also better to avoid CoAprovel in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Estonian: Ärge kasutage CoAprovel'i kui olete irbesartaani või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline, kui te olete allergiline (ülitundlik) hüdroklorotiasiidi või mõne teise sulfoonamiidiga keemiliselt sarnase ravimi suhtes, kui rasedus on kestnud üle 3 kuu (ka raseduse algul on parem vältida CoAprovel'i kasutamistvt lõiku rasedus), kui teil on rasked maksa- või neerukahjustused, kui teil on raskusi urineerimisega, kui teie arst leiab, et teil on veres püsivalt kõrge kaltsiumi või madal kaaliumi tase kui teil on suhkurtõbi (diabeet) või neerutalitluse häire ja te saate ravi vererõhku langetava ravimiga, mis sisaldab aliskireeni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks tablett sisaldab 300 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Estonian: Virsikuvärvi, kaksikkumer, ovaalne, sissepressitud südame kujutis ühel poolel ja sissegraveeritud number 2875 teisel poolel.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Estonian: Virsikuvärvi, kaksikkumer, ovaalne, sissepressitud südame kujutis ühel poolel ja sissegraveeritud number 2876 teisel poolel.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Estonian: Virsikuvärvi, kaksikkumer, ovaalne, sissepressitud südame kujutis ühel poolel ja sissegraveeritud number 2776 teisel poolel.
English: CoAprovel 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Estonian: CoAprovel'i 300 mg/12,5 mg õhukese polümeerikattega tabletid on pakendatud 14, 28, 30, 56, 84, 90 või 98 tableti kaupa blisterpakendisse.
English: Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Estonian: Üks õhukese polümeerikattega tablett sisaldab 38,5 mg laktoosi (laktoosmonohüdraadina).
English: Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Estonian: Iga CoAprovel 300 mg/ 12,5 mg õhukese polümeerikattega tablett sisaldab 300 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi.
English: chest pain
Estonian: naha punetus
English: OTHER
Estonian: N
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg film-coated tablets.
Estonian: RAVIMPREPARAADI NIMETUS CoAprovel 300 mg/12,5 mg õhukese polümeerikattega tabletid.
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Estonian: Iga tablett sisaldab: 300 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi.
English: Skin and subcutaneous tissue disorders:
Estonian: Maksa ja sapiteede häired:
English: Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Estonian: Iga tablett sisaldab: 150 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi.
English: CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
Estonian: 300 mg irbesartaani või CoAprovel 150 mg/12,5 mg ei ole piisav;  CoAprovel 300 mg/25 mg võib manustada patsientidele, kelle vererõhu kontrollimiseks
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Estonian: Anioonsete ioonvahetusvaikude juuresolekul hüdroklorotiasiidi imendumine häirub.
English: In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Estonian: Irbesartaani farmakokineetika ei muutu märkimisväärselt neerukahjustusega või hemodialüüsitavatel patsientidel.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks õhukese polümeerikattega tablett sisaldab 300 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi.
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Estonian: CoAprovel 150 mg/12,5 mg õhukese polümeerikattega tabletid irbesartaan/hüdroklorotiasiid
English: CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Estonian: CoAprovel 300 mg/12,5 mg õhukese polümeerikattega tabletid irbesartaan/hüdroklorotiasiid
English: Fri
Estonian: Üldised
English: GENERAL CLASSIFICATION FOR SUPPLY
Estonian: Kaaliumisisaldust mõjutavad preparaadid
English: Hypromellose
Estonian: Laktoos
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Estonian: Teadmata anafülaktiline reaktsioon, k.a anafülaktiline šokk Tabel 3: Kõrvaltoimed, mis on teatatud vaid hüdroklorotiasiidi kasutamisel
English: cough
Estonian: köha
English: Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Pakendis on 98 õhukese polümeerikattega tabletti PVC/PVDC/Alumiinium blistris.
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Estonian: CoAprovel 150 mg/12,5 mg õhukese polümeerikattega tablett on virsikuvärvi, kaksikkumer, ovaalne, sissepressitud südamekujuga ühel poolel ja sissegraveeritud number 2875 teisel poolel.
English: CoAprovel 300 mg/12.5 mg.
Estonian: CoAprovel 300 mg/12,5 mg ei ole piisav.
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Pakendis on 84 õhukese polümeerikattega tabletti PVC/PVDC/Alumiinium blistris.
English: Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Pakendis on 56 õhukese polümeerikattega tabletti PVC/PVDC/Alumiinium blistris.
English: Treatment is given for 5 to 14 days.
Estonian: Ravi kestab 5-14 päeva.
English: As a result, the bacteria cannot multiply and die.
Estonian: Selle tulemusel ei saa bakterid paljuneda ja hävivad.
English: After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Estonian: Pärast veeniinfusiooniga alustamist võib arst otsustada üle minna suukaudsele tabletile üks kord iga 12 tunni järel.
English: Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Estonian: Lisateave Quofenixi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/quofenix.
English: Quofenix must not be used in children or adolescents under 18 years of age.
Estonian: Quofenixit ei tohi kasutada alla 18-aastastel lapsed ega noorukid.
English: What measures are being taken to ensure the safe and effective use of Quofenix?
Estonian: Mis meetmed võetakse, et tagada Quofenixi ohutu ja efektiivne kasutamine?
English: The main measure of effectiveness in both studies was whether the infection was cured.
Estonian: Efektiivsuse põhinäitaja oli mõlemas uuringus see, kas patsient paranes infektsioonist.
English: The European Medicines Agency decided that Quofenix's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Quofenixi kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Quofenix (delafloxacin) EMA/572803/2019
Estonian: Quofenix (delafloksatsiin) EMA/572803/2019
English: As for all medicines, data on the use of Quofenix are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Quofenixi kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Quofenix are carefully evaluated and any necessary action taken to protect patients.
Estonian: Quofenixi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Quofenix (delafloxacin)
Estonian: Quofenix (delafloksatsiin)
English: Other information about Quofenix
Estonian: Muu teave Quofenixi kohta
English: For more information about using Quofenix, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Quofenixi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Quofenix have been included in the summary of product characteristics and the package leaflet.
Estonian: Quofenixi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Since Quofenix's safety profile was similar to that of other fluoroquinolones, it was considered that, as for other fluoroquinolones, it should be authorised for use only when other antibiotics are not suitable.
Estonian: Kuna Quofenixi ohutusprofiil oli sarnane teiste fluorokinoloonide omaga, leiti, et nagu ka teiste fluorokinoloonide puhul, tuleb ravimi müügiloas määrata näidustuseks ainult olukord, kui muud antibiootikumid ei sobi.
English: Why is Quofenix authorised in the EU?
Estonian: Miks Quofenix ELis heaks kiideti?
English: Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Estonian: Ravimit Quofenix turustatakse infusioonilahuse pulbri (300 mg) ja tablettidena (450 mg).
English: What is Quofenix and what is it used for?
Estonian: Mis on Quofenix ja milleks seda kasutatakse?
English: Quofenix has a different chemical structure to other fluoroquinolones, which means that it can enter bacterial cells more easily.
Estonian: Quofenixi keemiline struktuur erineb teiste fluorokinoloonide omast, mistõttu siseneb see bakterirakkudesse lihtsamalt.
English: It must not be used in women who are pregnant or breast feeding, or women who are able to have children who are not using contraception.
Estonian: Ravimit ei tohi kasutada rasedad, imetavad ega rasestumisvastaseid vahendeid mittekasutavad rasestumisvõimelised naised.
English: Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Estonian: Quofenixit ei tohi kasutada patsiendid, kes on kinolooni või fluorokinolooni sisaldavate antibiootikumide suhtes ülitundlikud (allergilised), ega patsiendid, kellel on esinenud fluorokinolooni sisaldava antibiootikumraviga seoses kõõlusehäired.
English: Quofenix is given by infusion (drip) into a vein over one hour every 12 hours.
Estonian: Quofenixit manustatakse üks tund kestva veeniinfusioonina iga 12 tunni järel.
English: Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Estonian: Fluorokinoloonide toimemehhanism seisneb selles, et need takistavad nahainfektsioonides osalevatel bakteritel oma DNA (geneetiline materjal) kopeerimist.
English: Quofenix is as effective as alternative antibiotics given into a vein in treating acute bacterial skin and skin structure infections and offers the possibility of switching to treatment by mouth, which may be more convenient for the patient and could reduce hospitalisation costs.
Estonian: Quofenix on naha ja nahastruktuuri ägedate bakterinfektsioonide ravis sama efektiivne kui veeni manustatavad muud antibiootikumid ning võimaldab üle minna suukaudsele ravile, mis võib olla patsiendile mugavam ja vähendada haiglaravi kulusid.
English: The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Estonian: Quofenixi toimeaine delafloksatsiin kuulub fluorokinoloonideks nimetatavate antibiootikumide rühma.
English: For the full list of side effects and restrictions with Quofenix, see the package leaflet.
Estonian: Quofenixi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: In the first study involving 660 patients, Quofenix given into a vein was compared with vancomycin plus aztreonam (two other antibiotics) both given into a vein.
Estonian: Esimeses uuringus (660 patsienti) võrreldi veeni manustatavat Quofenixit vankomütsiini ja astreonaami kombinatsiooniga (kaks muud antibiootikumi), mida manustati samuti veeni.
English: What are the risks associated with Quofenix?
Estonian: Mis riskid Quofenixiga kaasnevad?
English: The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Estonian: Quofenixi kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on kerge kuni mõõdukas kõhulahtisus ja iiveldus.
English: Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Estonian: Quofenix on antibiootikum, mida kasutatakse täiskasvanutel naha ja nahaaluste kudede ägedate bakterinfektsioonide raviks, kui muud ravimid ei sobi.
English: How is Quofenix used?
Estonian: Kuidas Quofenixit kasutatakse?
English: How does Quofenix work?
Estonian: Kuidas Quofenix toimib?
English: Persistent and disabling side effects have occurred with fluoroquinolone antibiotics in some patients.
Estonian: Mõnel patsiendil on esinenud fluorokinolooni sisaldavate antibiootikumide manustamisel püsivad ja invaliidistavad kõrvalnähud.
English: Quofenix can only be obtained with a prescription and prescribers should take into account official guidance on the use of antibiotics.
Estonian: Ravimi määrajad peavad arvestama antibiootikumide kasutamise ametlikke suuniseid.
English: After treatment for up to 14 days, 58% of patients who received Quofenix were cured of their infection compared with 60% of patients who received vancomycin and aztreonam.
Estonian: Kuni 14päevase ravi järel paranes infektsioonist 58% Quofenixit saanud patsientidest ning 60% vankomütsiini ja astreonaami kombinatsiooni saanud patsientidest.
English: In the second study involving 850 patients, Quofenix given into a vein for 3 days and afterwards given as tablets by mouth was compared with vancomycin plus aztreonam given into a vein.
Estonian: Teises uuringus(850 patsienti) võrreldi Quofenixit, mida manustati 3 päeva jooksul veeni ja seejärel suu kaudu tablettidena, intravenoosse vankomütsiini ja astreonaami kombinatsiooniga.
English: An overview of Quofenix and why it is authorised in the EU
Estonian: Ülevaade ravimist Quofenix ja ELis müügiloa väljastamise põhjendus
English: What benefits of Quofenix have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Quofenixi kasulikkus?
English: It contains the active substance delafloxacin.
Estonian: Quofenix sisaldab toimeainena delafloksatsiini.
English: patients treated with Quofenix were cured of their infection, compared with 51% of patients treated with vancomycin and aztreonam.
Estonian: Kuni 14päevase ravi järel paranes infektsioonist 52% Quofenixit saanud patsientidest ning 51% vankomütsiini ja astreonaami saanud patsientidest.
English: Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Estonian: Kahes naha ja nahastruktuuride ägedate bakterinfektsioonidega täiskasvanute põhiuuringus tõendati, et Quofenix on sama efektiivne kui muud antibiootikumid.
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Estonian: Direktiivi 2001/83/EÜ artikli 29 kohase menetluse tulemused
English: The European Commission issued a decision on 19 November 2012.
Estonian: Euroopa Komisjon tegi otsuse 19. novembril 2012.
English: However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.
Estonian: Siiski ei suutnud liikmesriigid jõuda kokkuleppele ja Portugali ravimiamet pöördus 31. mail 2012 vahekohtumenetluseks inimravimite komitee poole.
English: As a result, blood glucose is reduced and this helps to control type 2 diabetes.
Estonian: Selle tulemusena väheneb veresuhkrusisaldus ja see aitab II tüübi diabeeti kontrolli alla saada.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Cyprus, France, Germany, Italy, Sweden and the United Kingdom).
Estonian: See on menetlus, mille käigus üks liikmesriik (viiteliikmesriik, käesoleval juhul Portugal) hindab ravimit seoses müügiloa andmisega, mis kehtib selles riigis ja teistes liikmesriikides (asjaomased liikmesriigid, käesoleval juhul Küpros, Prantsusmaa, Saksamaa, Itaalia, Rootsi ja Ühendkuningriik).
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Estonian: Kaks ravimit on bioekvivalentsed, kui nad saavutavad veres sama toimeainesisalduse.
English: The active substance, glimepiride, stimulates the pancreas to produce more insulin.
Estonian: Toimeaine glimepiriid stimuleerib kõhunääret tootma rohkem insuliini.
English: What is Glimepirida Parke-Davis?
Estonian: Mis on Glimepirida Parke-Davis?
English: Glimepirida Parke-Davis is a medicine used to treat type 2 diabetes (a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively).
Estonian: Glimepirida Parke-Davis on ravim, mida kasutatakse II tüübi diabeedi (haigus, mille puhul kõhunääre ei tooda vere glükoosisisalduse kontrolli all hoidmiseks piisavalt insuliini või kui organism ei suuda insuliini efektiivselt kasutada) raviks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Glimepirida Parke-Davis outweigh its risks, and that the marketing authorisation can be granted in Portugal and in the following Member States of the EU: Cyprus, France, Germany, Italy, Sweden and the United Kingdom.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et Glimepirida Parke-Davise kasulikkus ületab sellega kaasnevad riskid ja müügiloa võib anda Portugalis ning järgmistes ELi liikmesriikides: Küpros, Prantsusmaa, Saksamaa, Itaalia, Rootsi ja Ühendkuningriik.
English: Why was Glimepirida Parke-Davis reviewed?
Estonian: Miks Glimepirida Parke-Davise taotlus uuesti läbi vaadati?
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EMA/480596/2012 rev1
Estonian: Teave Glimepirida Parke-Davise kohta (glimepiriid, tabletid, 2, 3 ja 4 mg) EMA/480596/2012 rev1
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the bioequivalence study conducted with the 1 mg tablet is adequate to show that the higher strengths of Glimepirida Parke-Davis and Amaryl are also bioequivalent.
Estonian: Praegu olemasolevate andmete hindamise ja komitees toimunud teadusliku arutelu alusel jõudis inimravimite komitee järeldusele, et 1 mg tabletiga läbi viidud bioekvivalentsuse uuring on piisav näitamaks, et Glimepirida Parke-Davise ja Amaryli suuremad tugevused on samuti bioekvivalentsed.
English: Glimepirida Parke-Davis is a ‘generic medicine', which means that it is similar to a ‘reference medicine', already authorised in the EU, called Amaryl.
Estonian: Glimepirida Parke-Davis on geneeriline ravim, mis tähendab, et see on sarnane võrdlusravimiga Amaryl, millel juba on Euroopa Liidus müügiluba.
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg).
Estonian: Euroopa Ravimiamet lõpetas 19. juulil 2012 vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Glimepirida Parke-Davis (glimepiriid, 2, 3 ja 4 mg tabletid) heakskiitmises.
English: bioequivalence study submitted by the company was carried out using 1 mg of Glimepirida ParkeDavis, and the results were applied to the higher strengths.
Estonian: Ettevõtte esitatud bioekvivalentsuse uuring viidi läbi Glimepirida Parke-Davise 1 mg annusega ja tulemused kohaldati suurematele annustele.
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg)
Estonian: Teave Glimepirida Parke-Davise kohta (glimepiriid, tabletid, 2, 3 ja 4 mg)
English: Parke-Davis submitted an application for Glimepirida Parke-Davis (1, 2, 3 and 4 mg tablets) to the Portuguese medicines regulatory agency for a decentralised procedure.
Estonian: Parke-Davis esitas Portugali ravimiametile taotluse Glimepirida Parke-Davise (1, 2, 3 ja 4 mg tabletid) detsentraliseeritud menetluseks.