FrancophonIA/ELRC3.0 huggingface dataset:
English: For those products mentioned in the above paragraph that have maximum recommended doses that exceed those used in the corresponding residue studies, the worst case withdrawal period derived directly from residue data, i.e. 192 days, should be applied provided the total dose as per the SPC recommendations does not exceed the total dose administered in the study that yielded this withdrawal period (i.e. 24 mg gentamicin base per kg bw).
Estonian: Eelmises lõigus nimetatud ravimite korral, mille suurim soovitatav annus ületab vastavas jääkide uuringus kasutatud annust, peab kohaldama vahetult jääkide andmete põhjal saadud pikimat keeluaega (192 päeva), kui ravimi omaduste kokkuvõttes soovitatud koguannus ei ületa selle keeluaja saamiseks tehtud uuringus manustatud koguannust (24 mg gentamütsiini alusena kehamassi kg kohta).
English: GENTA-KEL 50 000 IU/ml injekční roztok
Estonian: gentamütsiin 50000 UI/ml vasikad, põrsad intramuskulaarne
English: G. For products listed in Annex I for which the recommended total dose is between 24 mg gentamicin base per kg bw and 50 mg gentamicin base per kg bw for cattle
Estonian: G. I lisas loetletud ravimid, mille soovitatav koguannus on veistel 24-50 mg gentamütsiini alusena kehamassi kg kohta
English: Therefore, no reliable withdrawal period can be established from these data.
Estonian: Seega ei ole nende andmete põhjal võimalik määrata usaldusväärset keeluaega.
English: Where cattle and/or pigs have already been approved as target species and provided that the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and 50 mg gentamicin base per kg bw in pigs, the wording below relating to the relevant species should be used:
Estonian: Kui veised ja/või sead on sihtliikidena juba heaks kiidetud ning kui ravimiteabes soovitatav suurim koguannus ei ületa veistel 12 mg ja sigadel 50 mg gentamütsiini alusena kehamassi kg kohta, tuleb nende liikide korral kasutada järgmist sõnastust.
English: In renewal assessment reports as assessed by the Belgian NCA, a study was identified supporting the withdrawal period for Genta-kel 5% in calves (MAH: Kela).
Estonian: Belgia pädeva asutuse hinnatud pikendamise hindamisaruannetes sisaldus uuring, mis toetas ravimi Genta-kel 5% (müügiloa hoidja: Kela) keeluaega vasikatel.
English: Genta-Kel 5% gentamicin 50 mg/ml
Estonian: Genta-Kel 5% gentamütsiin 50 mg/ml veised (vasikad) intramuskulaarne
English: GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos
Estonian: GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos veised, sead, koerad, kassid intramuskulaarne, subkutaanne (ainult koerad)
English: No reliable withdrawal period can be established from these data.
Estonian: Nende andmete põhjal ei saa määrata usaldusväärset keeluaega.
English: Radnička cesta 48 10000 Zagreb Croatia
Estonian: 10000 Zagreb
English: The analytical method used liquid-liquid chromatography with fluorometric detection but data demonstrating the validity of the method were not available; only 3 of the 4 recommended gentamicin marker residue components were monitored.
Estonian: Analüüsimiseks kasutati vedelik-vedelik-kromatograafiat koos fluoromeetrilise tuvastamisega, kuid meetodi valiidsust tõendavad andmed ei ole kättesaadavad.
English: Groups of 4 animals were treated at a dose of 2 mg/kg bw every 12 hours for 3 days, and slaughtered at days 76, 90, 104, and 126 after the last administration.
Estonian: 4 loomast koosnevaid rühmi raviti annusega 2 mg kehamassi kg kohta (mg/kg) iga 12 tunni järel 3 päeva jooksul ning loomad tapeti 76., 90., 104. ja 126. päeval pärast viimast manustamiskorda.
English: At day 49, the last sampling point, levels in kidney and liver were above the MRLs in all samples, with some values being more than 2x MRL in kidney and more than 3x MRL in liver.
Estonian: Viimasel proovivõtukorral (49. päeval) ületas jääkide sisaldus kõigis maksa- ja neeruproovides jääkide piirnormid, kusjuures mõni neeruväärtus oli üle 2 korra ja mõni maksaväärtus üle 3 korra jääkide piirnormist suurem.
English: Groups of 5 animals were treated at a dose of 4 mg/kg body weight (bw) once a day for 3 days, and slaughtered at days 30, 40, 50, 60, 70, 80 and 90 after the last administration.
Estonian: 5 loomast koosnevaid rühmi raviti annusega 4 mg kehamassi kg kohta (mg/kg) üks kord ööpäevas kolme päeva jooksul ning loomad tapeti 30., 40., 50., 60., 70., 80. ja 90. päeval pärast viimast manustamiskorda.
English: Groups of 4 animals were treated at a dose of 4 mg/kg bw every 12 hours for 3 days, and slaughtered at days 80, 100, 130, and 170 after the last administration.
Estonian: 4 loomast koosnevaid rühmi raviti annusega 4 mg kehamassi kg kohta (mg/kg) iga 12 tunni järel 3 päeva jooksul ning loomad tapeti 80., 100., 130. ja 170. päeval pärast viimast manustamiskorda.
English: A study is available concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Estonian: Kättesaadav on uuring ravimiga Aagent 50 mg/ml solution for injection (müügiloa hoidja: Fatro).
English: A. For Aagent 50 mg/ml listed in Annex I (Marketing Authorisation Holder: Fatro S.p.A.)
Estonian: A. I lisas nimetatud ravim Aagent 50 mg/ml (müügiloa hoidja: Fatro S.p.A.)
English: Indeed, given the especially long persistence of gentamicin in tissues, which is not the case for the other substances in combination products, in view of the withdrawal periods generally approved for products containing trimethoprim and sulphonamides, there is no reason to expect any long-term effect on residues due to interaction.
Estonian: Gentamütsiin püsib kudedes eriti kaua, kuid kombinatsioonravimite muud toimeained mitte, nagu järeldub trimetopriimi ja sulfoonamiide sisaldavate ravimite jaoks üldiselt heaks kiidetud keeluaegadest.
English: In all residue depletion studies submitted, gentamicin was used as an injectable aqueous solution and was administered by the intramuscular route.
Estonian: Kõigis esitatud ravimijääkide kadumise uuringutes kasutati gentamütsiini intramuskulaarselt süstitava vesilahusena.
English: Cattle (calves up to 250 kg), nonfood-producing horses
Estonian: veised (kuni 250 kg vasikad), hobused (v.a toiduloomad)
English: In pigs do not administer more than 50 mg gentamicin per injection site.
Estonian: Sigadel ei tohi ühte süstekohta manustada üle 50 mg gentamütsiini.
English: C. For Gentavall 5 mg/ml listed in Annex I (Marketing Authorisation Holder: Mevet S.A.U.)
Estonian: C. I lisas nimetatud ravim Gentavall 5 mg/ml (müügiloa hoidja: Mevet S.A.U.)
English: C-17, Km 17 08150 Parets del Valles (Barcelona)
Estonian: 08150 Parets del Valles (Barcelona)
English: 40 mg/ml 30 mg/ml 200 mg/ml
Estonian: 40 mg/ml 30 mg/ml 200 mg/ml veised, sead intramuskulaarne
English: GENTIPRA - 305 ESP gentamicin 50 mg/ml
Estonian: GENTIPRA - 305 ESP gentamütsiin 50 mg/ml veised (kuni 250 kg vasikad)
English: In all residue depletion studies provided, gentamicin was used as an injectable aqueous solution and was administered by the intramuscular route.
Estonian: Kõigis esitatud uuringutes jääkide kadumise kohta kasutati gentamütsiini intramuskulaarselt süstitava vesilahusena.
English: Some of the concerned products may be used in older animals than those used in the studies, leading to higher total injection volumes, which may entail a slowest depletion rate due to the decreased surface/volume ratio of the injection site bolus.
Estonian: Mõnda asjaomast ravimit võidakse kasutada vanematel kui uuritud loomadel, mistõttu on süste kogumaht suurem.
English: Cattle, pigs, dogs cattle, pigs: IM dogs: IM or SC
Estonian: veised, sead, koerad veised, sead: intramuskulaarne koerad: intramuskulaarne või subkutaanne
English: Cattle, pigs, horses
Estonian: veised, sead, hobused intramuskulaarne
English: D. For Gentaveto-5 (50 mg/ml) listed in Annex I (Marketing Authorisation Holder: V.M.D.
Estonian: D. I lisas nimetatud ravim Gentaveto-5 50 mg/ml (müügiloa hoidja: V.M.D.
English: Animals were slaughtered at 4, 11, 20, and 89 days after the last administration, in groups of 4 to 5.
Estonian: Loomad tapeti 4-5 loomast koosnevate rühmadena 4., 11., 20. ja 89. päeval pärast viimast manustamiskorda.
English: Groups of 5 animals were treated at a dose of 4 mg/kg bw once a day for 3 days, and slaughtered at days 30, 40, 50 and 60 after the last administration.
Estonian: 5 loomast koosnevaid rühmi raviti annusega 4 mg kehamassi kg kohta (mg/kg) 1 kord ööpäevas 3 päeva jooksul ning loomad tapeti 30., 40., 50. ja 60. päeval pärast viimast manustamiskorda.
English: Residues in both kidney and liver fall below the MRL at day 28.
Estonian: 28. uuringupäevaks olid jäägid nii neerus kui ka maksas langenud alla jääkide piirnormi.
English: It is acknowledged that there are some uncertainties in the data with respect to the terminal half-life and dose linearity of the depletion kinetics, both being conditions, that have to be fulfilled for a correct use of the extrapolation.
Estonian: On teada, et jääkide kadumise kineetikas on terminaalse poolväärtusaja ja annuse lineaarsuse andmetes teatud määramatusi.
English: The study concerns animals weighing 23 to 27 kg. Groups of only 3 animals were treated at a dose of 4 mg/kg bw every 12 hours for 4.5 days (9 injections), and slaughtered at days 15 and 60 after the last administration.
Estonian: Ainult 3 loomast koosnevaid rühmi raviti annusega 4 mg kehamassi kg kohta (mg/kg) iga 12 tunni järel 4,5 päeva jooksul (9 süstet) ning loomad tapeti 15. ja 60. päeval pärast viimast manustamiskorda.
English: Bela-Pharm GmbH & Co. KG Lohner Str. 19
Estonian: Bela-Pharm GmbH & Co.
English: A GLP-compliant study in calves was submitted concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Estonian: Vasikate kohta esitati headele laboritavadele vastav uuring ravimi Aagent 50 mg/ml solution for injection kohta (müügiloa hoidja: Fatro).
English: Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19
Estonian: Saksamaa Bela-Pharm GmbH & Co.
English: Gentafromm
Estonian: Veised
English: Laboratorios Maymo, S.A.
Estonian: Hispaania Laboratorios Maymo, S.A. Via Augusta, 302
English: Withdrawal periods for cattle meat and offal
Estonian: Veiseliha ja söödavate kudede keeluajad
English: Intramuscular or intravenous use: Meat and offal: 192 days.
Estonian: Intramuskulaarne või intravenoosne manustamine: liha ja söödavad koed: 192 päeva.
English: Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
Estonian: GENTAVET solução injectavel veised (vasikad), sead (põrsad), linnud (noorkanad, kalkunid), koerad, kassid intramuskulaarne, aeglane intravenoosne
English: Otherwise, it can be regarded as meeting current standards, although muscle (other than injection site) and fat were not analysed; this can be accepted as these tissues are recognised as not limiting with regard to gentamicin residue depletion.
Estonian: Seda võib pidada vastuvõetavaks, sest neid kudesid ei peeta gentamütsiini jääkide kadumise hindamisel piiravateks.
English: Cattle, calves, pigs
Estonian: veised, vasikad, sead intramuskulaarne
English: Intramuscular or intravenous use: Meat and offal: 103 days.
Estonian: Intramuskulaarne või intravenoosne manustamine: liha ja söödavad koed: 103 päeva.
English: Intramuscular or intravenous use: Meat and offal: 228 days.
Estonian: Intramuskulaarne või intravenoosne manustamine: liha ja söödavad koed: 228 päeva.
English: Intramuscular or intravenous use: Meat and offal: 139 days.
Estonian: Intramuskulaarne või intravenoosne manustamine: liha ja söödavad koed: 139 päeva.
English: The study involved groups of 4 animals receiving a dose of 4 mg/kg bw once a day for 5 days, which were slaughtered at days 21, 35, 49 and 70 after the last administration.
Estonian: 4 täiskasvanud seast koosnevatele rühmadele manustati annust 4 mg kehamassi kg kohta (mg/kg) üks kord ööpäevas 5 päeva ja loomad tapeti 7., 21., 35. ja 49. päeval pärast viimast manustamiskorda.
English: Where the maximum total dose, as recommended in the product information, does not exceed 5 mg gentamicin base per animal in pigs, the wording below should be used:
Estonian: Kui ravimiteabes soovitatav suurim koguannus ei ületa sigadel ühe looma kohta 5 mg gentamütsiini alusena, tuleb kasutada järgmist sõnastust.
English: Kidney, liver, muscle, fat and the injection site were analysed.
Estonian: Analüüsiti neere, maksa, rasv- ja lihaskude ning süstekohta.
English: Any such impact is likely to remain limited in view of the available product compositions, given the very long period over which depletion takes place, and given that all products concerned by this referral are aqueous solutions.
Estonian: Arvestades olemasolevate ravimite koostist, väga pikka jääkide kadumise aega ja asjaolu, et kõik esildise alla kuuluvad ravimid on vesilahused, on mis tahes selline mõju tõenäoliselt piiratud.
English: Intramuscular or intravenous use: Meat and offal: 214 days.
Estonian: Intramuskulaarne või intravenoosne manustamine: liha ja söödavad koed: 214 päeva.
English: Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats
Estonian: veised (kuni 250 kg vasikad), sead (piimapõrsad), hobused (v.a toiduloomad), koerad, kassid intramuskulaarne, aeglane intravenoosne
English: Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Estonian: Neere, maksa ja süstekohta (täpset süstekohta ja ümbritsevat kude) analüüsiti valideeritud HPLC/MS-MS-meetodiga.
English: FORTICINE SOLUTION gentamicin 40000 UI/ml
Estonian: FORTICINE SOLUTION gentamütsiin 40000 UI/ml vasikad intramuskulaarne, intravenoosne
English: Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Estonian: Neere, maksa, nahka koos rasvkoega ja süstekohti analüüsiti valideeritud LC-MS/MS-meetodiga.
English: Where the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and pigs, the wording below should be used:
Estonian: Kui ravimiteabes soovitatav suurim koguannus ei ületa veistel ja sigadel 12 mg gentamütsiini alusena kehamassi kg kohta, tuleb kasutada järgmist sõnastust.
English: Gentacin, injekcinis tirpalas
Estonian: veised intramuskulaarne
English: Calves, pigs, dogs
Estonian: vasikad, sead, koerad intramuskulaarne
English: Where the maximum total dose, as recommended in the product information, does not exceed 50 mg gentamicin base per kg bw in pigs, the wording below should be used:
Estonian: Kui ravimiteabes soovitatav suurim koguannus ei ületa sigadel 50 mg gentamütsiini alusena kehamassi kg kohta, tuleb kasutada järgmist sõnastust.
English: Kidney, liver, fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Estonian: Neere, maksa, rasv- ja lihaskude ning süstekohta (täpset süstekohta ja ümbritsevat kudet) analüüsiti valideeritud HPLC/MS-MS-meetodiga.
English: Calves, dogs, cats
Estonian: põrsad, koerad, kassid intramuskulaarne
English: The study is not GLP-compliant.
Estonian: Uuring ei vasta headele laboritavadele.
English: Cattle, pigs
Estonian: veised, sead intramuskulaarne
English: Str. Principala nr. 944 Filipestii de Padure Jud.
Estonian: Str. Principala nr. 944
English: Calves
Estonian: Sead
English: Cattle, dogs, cats IM, SC, slow IV
Estonian: veised, koerad, kassid intramuskulaarne, subkutaanne, aeglane intravenoosne
English: PANGRAM 4 % gentamicin 40000 UI/ml
Estonian: PANGRAM 4 % gentamütsiin 40000 UI/ml vasikad, koerad, kassid intramuskulaarne, intravenoosne
English: Genta-ject 10% gentamicin 100 mg/ml
Estonian: Genta-ject 10% gentamütsiin 100 mg/ml kuni 13nädalased vasikad intramuskulaarne
English: Where the maximum total dose, as recommended in the product information, is up to 80 mg gentamicin base per kg bw in cattle, the wording below should be used:
Estonian: Kui ravimiteabes soovitatav suurim koguannus ei ületa veistel 80 mg gentamütsiini alusena kehamassi kg kohta, tuleb kasutada järgmist sõnastust.
English: Cattle, pigs, horses, dogs, cats
Estonian: veised, sead, hobused, koerad, kassid intramuskulaarne, subkutaanne
English: In the milk residue study described in the CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015) five lactating cows were treated with repeated intramuscular doses of 4 mg gentamicin/kg bw/day for 3 days.
Estonian: 5 lakteerivat lehma korduvate intramuskulaarsete süstetega annuses 4 mg gentamütsiini kehamassi kg kohta ööpäevas (mg/kg/d) 3 päeva jooksul.
English: Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Estonian: Neere, maksa, nahka koos rasvkoega, lihaskude ja süstekohta (täpset süstekohta ja ümbritsevat kude) analüüsiti valideeritud HPLC/MS-MS-meetodiga.
English: GENTA-JECT, injekcinis tirpalas
Estonian: Gentacin vasikad, koerad intramuskulaarne, intravenoosne
English: Residues in both kidney and liver fall below the MRL at day 80.
Estonian: 80. päevaks olid jäägid neerus ja maksas alla piirnormi.
English: Cattle, pigs, dogs IM, SC, slow IV
Estonian: veised, vasikad, sead, põrsad intramuskulaarne, aeglane intravenoosne
English: Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Estonian: Gentacin, injekcinis tirpalas veised, vasikad, sead, põrsad, võõrdepõrsad, hobused, varsad, koerad, kassid intramuskulaarne, intravenoosne, subkutaanne
English: Alapis SA
Estonian: Vasikad
English: Residue depletion in pig meat and offal
Estonian: Jääkide kadumine sealihas ja söödavates kudedes
English: Cattle, calves, pigs, horses, foals, dogs, cats
Estonian: veised, sead, hobused, koerad, kassid intramuskulaarne, intravenoosne, subkutaanne
English: Cattle (calves up to 250 kg), nonfood-producing horses, dogs, cats
Estonian: veised (kuni 250 kg vasikad), hobused (v.a toiduloomad), koerad, kassid intramuskulaarne, aeglane intravenoosne
English: GENTAMICIN 5% Gentamicin Provet 50mg/ml
Estonian: GENTAMICIN 5% Gentamicin Provet 50mg/ml vasikad, põrsad, koerad, kassid intramuskulaarne
English: Belgium VMD nv Hoge Mauw 900
Estonian: VMD nv
English: Cattle, calves, pigs, piglets, horses, dogs, cats
Estonian: 200 mg/ml veised, sead, hobused, koerad, kassid intramuskulaarne
English: It is available as tablets (75, 150 and 300 mg).
Estonian: Seda turustatakse tablettidena (75, 150 ja 300 mg).
English: Previously known as Irbesartan Winthrop.
Estonian: Varasem nimetus Irbesartan Winthrop.
English: The full EPAR for Irbesartan Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Irbesartan Zentiva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
Estonian: See ravim on samane Aproveliga, millel juba on Euroopa Liidus müügiluba.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Estonian: Euroopa Komisjon andis ravimi Irbesartan Winthrop müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. jaanuaril 2007.
English: The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Estonian: Ravimi nimetus muudeti 6. veebruaril 2012 Irbesartan Zentivaks.
English: The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Zentiva.
Estonian: Aproveli tootja on andnud nõusoleku, et tema teaduslikke andmeid tohib kasutada Irbesartan Zentiva toetuseks.
English: EPAR summary for the public irbesartan
Estonian: Kokkuvõte üldsusele irbesartaan
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Estonian: Ravi alustatakse annusega 150 mg üks kord ööpäevas ning tavaliselt suurendatakse seda annuseni 300 mg üks kord ööpäevas.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Estonian: Koos hüdroklorotiasiidiga kasutamisel olid kahe ravimi toimed aditiivsed.
English: The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Estonian: Irbesartan Zentiva tavaline soovitatav annus on 150 mg üks kord ööpäevas.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Estonian: Algannust 75 mg tohib kasutada hemodialüüsi (teatud verepuhastustehnika) saavatel patsientidel või üle 75-aastastel patsientidel.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Estonian: Kui see ei anna vererõhu alandamisel piisavat tulemust, tohib annust suurendada kuni 300 mg-ni ööpäevas või kasutada lisaks muid kõrgvererõhuravimeid, nt hüdroklorotiasiidi.
English: The main benefit was on the effect on blood creatinine levels.
Estonian: Põhiline kasulik toime avaldus vere kreatiniinisisaldusele.
English: There was a 23% relative risk reduction compared with amlodipine.
Estonian: Võrreldes amlodipiiniga vähenes suhteline risk 23%.
English: Other information about Irbesartan Zentiva
Estonian: Muu teave Irbesartan Zentiva kohta
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Estonian: Blokeerides retseptorid, millega angiotensiin II tavaliselt seondub, peatab irbesartaan hormooni toime ja soodustab veresoonte laienemist.
English: The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Irbesartan Zentiva kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: For more information about treatment with Irbesartan Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Irbesartan Zentivaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
Estonian: See on ravimi Irbesartan Zentiva Euroopa avaliku hindamisaruande kokkuvõte.
English: Irbesartan Zentiva was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Estonian: 712 patsiendil võrreldi Irbesartan Zentiva toimet platseebo (näiva ravimi) toimega ja 823 patsiendil teiste kõrgvererõhuravimite (atenolooli, enalapriili, amlodipiini) toimega.
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 Zentiva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Estonian: Irbesartan Zentiva on ravim, mis sisaldab toimeainena irbesartaani.
English: Irbesartan 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.
Estonian: Koos aliskireeni sisaldavate ravimitega (essentsiaalse hüpertensiooni ravimid) ei tohi Irbesartan Zentivat kasutada diabeediga või mõõduka või raske neerupuudulikkusega patsiendid.
English: For the treatment of kidney disease, Irbesartan Zentiva was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Estonian: Irbesartan Zentiva toimet neeruhaiguste ravis uuriti kahes ulatuslikus uuringus, milles osales 2326 II tüüpi diabeediga patsienti.
English: Irbesartan Zentiva was used for two years or more.
Estonian: Irbesartan Zentivat manustati vähemalt kahe aasta jooksul.