FrancophonIA/ELRC3.0 huggingface dataset:
English: GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos
Slovenian: GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos govedo, prašiči, psi, mačke i.m., s.c. (samo psi)
English: 4.9 Amounts to be administered and administration route
Slovenian: Odmerjanje in pot uporabe
English: Residues in both kidney and liver fall below the MRL at day 28.
Slovenian: Raven ostankov v ledvicah in jetrih je bila 28. dan pod najvišjo mejno vrednostjo ostanka.
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.
Slovenian: Skupine po 5 živali so zdravili z odmerkom 4 mg/kg telesne mase enkrat na dan v obdobju 3 dni, nato pa so jih zaklali 30., 40., 50., 60., 70., 80. oziroma 90. dan po zadnjem odmerku.
English: C. For Gentavall 5 mg/ml listed in Annex I (Marketing Authorisation Holder: Mevet S.A.U.)
Slovenian: C. Za zdravilo Gentavall 5 mg/ml, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Mevet S.A.U.)
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:
Slovenian: Kjer so govedo in/ali prašiči že odobreni kot ciljna vrsta in pod pogojem, da največji skupni odmerek, kot je priporočen v informacijah o zdravilu, ne presega 12 mg gentamicinijeve baze na kg telesne mase pri govedu in 50 mg gentamicinijeve baze na kg telesne mase pri prašičih, je treba uporabiti spodnje besedilo, ki se nanaša na ustrezno vrsto:
English: A further GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Slovenian: Naslednja študija, ki je bila opravljena v skladu z dobro laboratorijsko prakso in je vključevala govedo in prašiče, z zdravilom Gentamicin 40 mg/ml raztopina za injiciranje (imetnik dovoljenja za prometf: Vetprom) je kot analizno metodo uporabljala encimski imunski test.
English: A GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Slovenian: Študija, ki je bila opravljena v skladu z dobro laboratorijsko prakso in je vključevala govedo in prašiče, z zdravilom Gentamicin 40 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Vetprom) je kot analizno metodo uporabljala encimski imunski test.
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.
Slovenian: Skupine po 5 živali so zdravili z odmerkom 4 mg/kg telesne mase enkrat na dan v obdobju 3 dni, nato pa so jih zaklali 30., 40., 50. oziroma 60. dan po zadnjem odmerku.
English: Genta-kel 5% gentamicin 50 mg/ml
Slovenian: Genta-Kel 5% gentamicin 50 mg/ml govedo (teleta) i.m.
English: Bela-Pharm GmbH & Co. KG Lohner Str. 19
Slovenian: Bela-Pharm GmbH & Co.
English: Another study in calves was submitted in relation to the product Vetrigen (MAH: Ceva Sante Animale), but is not GLP-compliant.
Slovenian: V povezavi z zdravilom Vetrigen (imetnik dovoljenja za promet: Ceva Sante Animale) je bila predložena še ena študija na teletih, vendar ni bila opravljena v skladu z dobro laboratorijsko prakso.
English: IM, SC, slow IV
Slovenian: i.m., s.c., počasi i.v.
English: A. For Aagent 50 mg/ml listed in Annex I (Marketing Authorisation Holder: Fatro S.p.A.)
Slovenian: A. Za zdravilo Aagent 50 mg/ml, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Fatro S.p.A.)
English: No surrounding control injection site was sampled.
Slovenian: Iz okolice mesta injiciranja niso odvzeli kontrolnega vzorca.
English: Calves and piglets in the first month of life, horses declared as not intended for slaughter for human consumption
Slovenian: Aagent 50 mg/ml injekčný roztok teleta in prašički v prvem mesecu življenja, konji, ki niso namenjeni za zakol in prehrano ljudi i.m., s.c., počasi i.v.
English: Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats
Slovenian: govedo (teleta do 250 kg), prašiči (sesni prašiči), konji, ki niso namenjeni za prehrano ljudi, psi, mačke i.m., počasi i.v.
English: Kidney, liver, muscle, fat and the injection site were analysed.
Slovenian: Analizirali so ledvice, jetra, mišice, maščobo in mesto injiciranja.
English: Kidney, liver, fat, muscle, and injection site were analysed.
Slovenian: Analizirali so ledvice, jetra, maščobo, mišice in mesto injiciranja.
English: Intramuscular or intravenous use: Meat and offal: 139 days.
Slovenian: Intramuskularna ali intravenska uporaba: Meso in organi: 139 dni.
English: Cattle, pigs, dogs cattle, pigs: IM dogs: IM or SC
Slovenian: govedo, prašiči, psi govedo, prašiči: i.m.
English: Intramuscular or intravenous use: Meat and offal: 103 days.
Slovenian: Intramuskularna ali intravenska uporaba: Meso in organi: 103 dni.
English: Delete, where applicable, any references to subcutaneous use in calves and piglets.
Slovenian: Kjer je ustrezno, pri teletih in prašičkih izbrišite vse sklice na subkutano uporabo.
English: Overall, a withdrawal period cannot be derived from this study.
Slovenian: V celoti iz te študije ni mogoče izpeljati karence.
English: Via Augusta, 302
Slovenian: Laboratorios Maymo, S.A. Via Augusta, 302
English: The withdrawal period derived from those data, based on the alternative method with a 10% safety span, and relating to a single dose of 5 mg/animal, is 44 days for piglets.
Slovenian: Kot je pričakovano glede na dani odmerek, je izločanje očitno hitro v vseh tkivih, ravni pa so bile pod najvišjo mejno vrednostjo ostanka že v prvi časovni točki, tj. 40. dan. Karenca za prašičke, izpeljana iz teh podatkov na podlagi alternativne metode z 10-odstotno varnostno mejo in pri enkratnem odmerku 5 mg/žival, je 44 dni.
English: Intramuscular or intravenous use: Meat and offal: 192 days.
Slovenian: Intramuskularna ali intravenska uporaba: Meso in organi: 192 dni.
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:
Slovenian: Kadar je največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri govedu do največ 80 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
English: Kidney, liver, fat, muscle and injection site (with no surrounding sample) were analysed using a validated LC-MS/MS method; however the results for fat are not available.
Slovenian: MS/MS so analizirali ledvice, jetra, maščobo, mišice in mesto injiciranja (brez vzorca iz okolice), vendarrezultati za maščobo niso na voljo.
English: Cattle, pigs, horses
Slovenian: govedo, prašiči, konji i.m.
English: Cattle, pigs
Slovenian: Karenca za prašiče
English: Intramuscular or intravenous use: Meat and offal: 228 days.
Slovenian: Intramuskularna ali intravenska uporaba: Meso in organi: 228 dni.
English: IM, SC (only dogs)
Slovenian: (konji), s.c. (psi, mačke)
English: IM, slow IV
Slovenian: i.m., počasi i.v.
English: Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Slovenian: Izločanje ostankov so analizirali z validirano metodo LC-MS/MS v ledvicah, jetrih, koži z maščobo in mestu injiciranja.
English: Due to a LLOQ which is unclear and possibly higher than the respective MRLs no conclusion can be drawn as to residues in muscle and liver.
Slovenian: Sklepa o ostankih v mišicah in jetrih ni mogoče oblikovati zaradi spodnje meje določljivosti, ki ni jasna in je morda višja od ustreznih najvišjih mejnih vrednosti ostanka.
English: Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
Slovenian: GENTAVET solução injectavel govedo (teleta), prašiči (prašički), ptice (piščanci, purani), psi, mačke i.m., počasi i.v.
English: Intramuscular or intravenous use: Meat and offal: 214 days.
Slovenian: Intramuskularna ali intravenska uporaba: Meso in organi: 214 dni.
English: Kidney, liver, fat, muscle and the injection site, with no control surrounding sample, were analysed using a microbiological method, for which no adequate validation data are available.
Slovenian: Z mikrobiološko metodo, za katero niso na voljo ustrezni podatki o validaciji, so analizirali ledvice, jetra, maščobo, mišice in mesto injiciranja brez kontrolnega vzorca iz okolice.
English: PANGRAM 4 % gentamicin 40000 UI/ml
Slovenian: PANGRAM 4 % gentamicin 40000 UI/ml teleta, psi, mačke i.m., i.v.
English: Cattle, dogs, cats IM, SC, slow IV
Slovenian: govedo, psi, mačke i.m., s.c., počasi i.v.
English: 40 mg/ml 30 mg/ml 200 mg/ml
Slovenian: 40 mg/ml 30 mg/ml 200 mg/ml govedo, prašiči i.m.
English: Kidney, liver, and the injection site were analysed.
Slovenian: Analizirali so ledvice, jetra in mesto injiciranja.
English: IM, IV: Meat and offal: 139 days.
Slovenian: : Meso in organi: 139 dni.
English: IM, IV: Meat and offal: 192 days.
Slovenian: : Meso in organi: 192 dni.
English: IM, IV: Meat and offal: 103 days.
Slovenian: : Meso in organi: 103 dni.
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:
Slovenian: Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri govedu in prašičih ne presega 12 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
English: IM, IV: Meat and offal: 214 days.
Slovenian: : Meso in organi: 214 dni.
English: Cattle, dogs, cats IM, IV, SC
Slovenian: Gentafromm govedo, psi, mačke i.m., i.v., s.c.
English: Cattle, calves, pigs
Slovenian: govedo, teleta, prašiči i.m.
English: gentamicin 50000 UI/ml
Slovenian: gentamicin 50000 UI/ml teleta, prašički i.m.
English: IM, IV: Meat and offal: 228 days.
Slovenian: : Meso in organi: 228 dni.
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:
Slovenian: Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri posameznem prašiču ne presega 5 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
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:
Slovenian: Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri prašičih ne presega 50 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
English: Lithuania Dopharma Research B.V. Zalmweg 24m
Slovenian: Nizozemska Dopharma Research B.V.
English: Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats
Slovenian: Gentacin govedo, prašiči, konji, ki niso namenjeni za zakol in prehrano ljudi, psi, mačke i.m., i.v., s.c.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Slovenian: Podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo ob upoštevanju naslednjega:
English: Str. Principala nr. 944 Filipestii de Padure Jud.
Slovenian: Str. Principala nr. 944
English: CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2016/03/WC500203742.pdf
Slovenian: V študiji ostankov v mleku, opisani v evropskem javnem poročilu o najvišji mejni vrednosti ostanka (EPMAR) za gentamicin odbora CVMP (EMA/CVMP/619817/2015)
English: Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Slovenian: Gentacin, injekcinis tirpalas govedo, teleta, prašiči, prašički, odstavljenci, konji, žrebeta, psi, mačke i.m., i.v., s.c.
English: Cattle (calves up to 250 kg), nonfood producing horses, dogs, cats
Slovenian: govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil, psi, mačke i.m., počasi i.v.
English: Groups of 4 adult pigs receiving a dose of 4 mg/kg bw once a day for 5 days, were slaughtered at days 7, 21, 35, and 49 after the last administration, and kidney, liver, fat, muscle, and injection site were analysed.
Slovenian: Skupine po 4 odrasle živali so prejemale odmerek 4 mg/kg telesne mase enkrat na dan v obdobju 5 dni in so jih zaklali 7., 21., 35. oziroma 49. dan po zadnjem odmerku.
English: Genta-ject 10% gentamicin 100 mg/ml
Slovenian: Genta-ject 10% gentamicin 100 mg/ml teleta do 13. tedna starosti i.m.
English: Piglets, dogs, cats
Slovenian: prašički, psi, mačke i.m.
English: Cattle, pigs, dogs IM, SC, slow IV
Slovenian: govedo, prašiči, konji, psi, mačke s.c., i.m., počasi i.v.
English: Piglets:
Slovenian: Teleta:
English: Cattle, pigs, horses, dogs, cats
Slovenian: govedo, prašiči, konji, psi, mačke i.m., s.c.
English: Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Slovenian: Z validirano metodo HPLC/MS-MS so analizirali ledvice, jetra, kožo z maščobo, mišice in mesto injiciranja (sredino in okolico).
English: IM, IV
Slovenian: i.m., i.v.
English: Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Slovenian: Z validirano metodo HPLC/MS-MS so analizirali ledvice, jetra in mesto injiciranja (sredino in okolico).
English: Genta
Slovenian: Karenca
English: Cattle (calves up to 250 kg), nonfood-producing horses
Slovenian: govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil i.m., počasi i.v.
English: Cattle, pigs, dogs, cats, pet birds
Slovenian: govedo, prašiči, psi, mačke, hišne ptice i.m., i.v., s.c.
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.
Slovenian: V drugih pogledih je izpolnjevala trenutne standarde, čeprav niso analizirali mišic (razen na mestu injiciranja) in maščobe.
English: The study is not GLP-compliant.
Slovenian: Ta študija ni bila opravljena v skladu z dobro laboratorijsko prakso.
English: Kidney, liver, fat, muscle, injection site (with no control surrounding sample) were analysed for residue depletion, using an LC-MS/MS method.
Slovenian: Izločanje ostankov so analizirali z metodo LC-MS/MS v ledvicah, jetrih, maščobi, mišicah in na mestu injiciranja (brez kontrolnega vzorca iz okolice).
English: Cattle, non-food producing horses, pigs, dogs, cats
Slovenian: govedo, prašiči, konji, ki niso namenjeni za zakol in prehrano ljudi, psi, mačke i.m., i.v., s.c.
English: IM, SC
Slovenian: ali s.c.
English: Cattle, calves, pigs, piglets, horses, dogs, cats
Slovenian: GENTA-JECT, injekcinis tirpalas govedo, teleta, prašiči, prašički, konji, psi, mačke i.m., i.v., s.c.
English: Cattle (calves up to 250 kg), nonfood-producing horses, dogs
Slovenian: govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil, psi i.m., počasi i.v.
English: Alapis SA
Slovenian: Jakost
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.
Slovenian: 4, so krave v obdobju laktacije zdravili z večkratnimi intramuskularnimi odmerki 4 mg gentamicina/kg telesne mase na dan v obdobju 3 dni.
English: Belgium VMD nv Hoge Mauw 900
Slovenian: VMD nv
English: Calves, pigs, dogs
Slovenian: teleta, prašiči, psi i.m.
English: IM, IV, endo peritoneal
Slovenian: Gentacin teleta, psi i.m., i.v.
English: This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Aprovel, ki je že odobreno v Evropski uniji (EU).
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: „Esencialna“ pomeni, da za hipertenzijo ni jasnega vzroka.
English: It is available as tablets (75, 150 and 300 mg).
Slovenian: Na voljo je v obliki tablet (75, 150 in 300 mg).
English: Previously known as Irbesartan Winthrop.
Slovenian: Prej znano pod imenom Irbesartan Winthrop.
English: The main benefit was on the effect on blood creatinine levels.
Slovenian: Glavna korist je bil učinek na raven kreatinina v krvi.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Zentiva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Winthrop, veljavno po vsej Evropski uniji, odobrila dne 19. januarja 2007.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Slovenian: Zdravljenje se začne z odmerkom 150 mg enkrat dnevno, ki ga običajno povečamo na 300 mg enkrat dnevno.
English: The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Slovenian: Ime zdravila je bilo 6. februarja 2012 spremenjeno v Irbesartan Zentiva.
English: The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Slovenian: Običajni priporočeni odmerek zdravila Irbesartan Zentiva znaša 150 mg enkrat dnevno.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Irbesartan Zentiva.
English: The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Zentiva.
Slovenian: Družba, ki izdeluje zdravilo Aprovel, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Irbesartan Zentiva.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Slovenian: Posledica tega je znižanje krvnega tlaka, zaradi česar se zmanjšajo tveganja, povezana z visokim krvnim tlakom, kot je denimo tveganje kapi.
English: For more information about treatment with Irbesartan Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Irbesartan Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: There was a 23% relative risk reduction compared with amlodipine.
Slovenian: V primerjavi z amlodipinom je bilo ugotovljeno 23-odstotno zmanjšanje relativnega tveganja.
English: EPAR summary for the public irbesartan
Slovenian: Povzetek EPAR za javnost irbesartan
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Slovenian: Pri njegovi sočasni uporabi s hidroklorotiazidom se učinka obeh zdravil seštevata.
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.
Slovenian: Če krvni tlak ni zadostno nadzorovan, se odmerek lahko poveča na 300 mg dnevno ali dodajo druga zdravila za
English: The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Irbesartan Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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.
Slovenian: Zdravilo Irbesartan Zentiva so glede zdravljenja ledvičnega obolenja preučevali v okviru dveh velikih študij, ki sta vključevali skupno 2 326 bolnikov s sladkorno boleznijo tipa 2.
English: The active substance in Irbesartan Zentiva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Irbesartan Zentiva, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: Other information about Irbesartan Zentiva
Slovenian: Druge informacije o zdravilu Irbesartan Zentiva
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Slovenian: Pri 1 736 bolnikih so proučevali tudi njegovo uporabo v kombinaciji s hidroklorotiazidom.
English: In this study, Irbesartan Zentiva was compared with placebo and with amlodipine.
Slovenian: V tej študiji so zdravilo Irbesartan Zentiva primerjali s placebom in amlodipinom.
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Irbesartan Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Irbesartan Zentiva was used for two years or more.
Slovenian: Bolniki so zdravilo Irbesartan Zentiva jemali dve leti ali več.
English: Irbesartan Zentiva is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Irbesartan Zentiva se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
English: What benefit has Irbesartan Zentiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Irbesartan Zentiva izkazalo med študijami?
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.
Slovenian: Zdravilo Irbesartan 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 Zentiva was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Slovenian: Zdravilo Irbesartan Zentiva so pri 712 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine), pri 823 bolnikih pa z drugimi zdravili za zdravljenje visokega krvnega tlaka (atenololom, enalaprilom ali amlodipinom).
English: Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Slovenian: Irbesartan Zentiva je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
English: Irbesartan Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Slovenian: Zdravila Irbesartan Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan ali katero koli drugo sestavino zdravila.
English: In patients with hypertension and type 2 diabetes, Irbesartan Zentiva is added to some other treatments for hypertension.
Slovenian: Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Irbesartan Zentiva dodaja nekaterim drugim zdravilom za zdravljenje visokega krvnega tlaka.