FrancophonIA/ELRC3.0 huggingface dataset:
English: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf statistical method as per CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)
Danish: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf
English: Animal species Route of administration
Danish: Administrations vej
English: Residue depletion in pig meat and offal
Danish: Depletion af restkoncentrationer i kød og indmad fra grise
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.
Danish: Der er udført en GLP-undersøgelse hos kvæg og grise med gentamicin 40 mg/kg, injektionsvæske, opløsning (markedsføringstilladelsesindehaver: Vetprom) med et enzymkoblet immunoassay som analysemetode.
English: Gentafromm
Danish: oprundet
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.
Danish: Grupper på 5 dyr blev behandlet med en dosis på 4 mg/kg kropsvægt én gang dagligt i 3 dage og slagtet på dag 30, 40, 50, 60, 70, 80 og 90 efter sidste administration.
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.
Danish: Grupper på 5 dyr blev behandlet med en dosis på 4 mg/kg kropsvægt én gang dagligt i 3 dage og slagtet på dag 30, 40, 50 og 60 efter sidste administration.
English: Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats
Danish: kvæg (kalve op til 250 kg), grise (pattegrise), heste ikke bestemt til konsum, hunde, katte
English: Cattle, pigs
Danish: kvæg, grise
English: Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats
Danish: kvæg, grise, heste ikke bestemt til slagtning til konsum, hunde, katte
English: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
Danish: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf på dag 76, 90, 104 og 126 efter sidste administration.
English: Delete, where applicable, any references to subcutaneous use in cattle and pigs.
Danish: Enhver omtale af subkutan anvendelse til kvæg og grise slettes, når det er relevant.
English: Where cattle and/or pigs have already been approved as target species and provided that the maximum total dose of gentamicin, as recommended in the product information, does not exceed 24 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:
Danish: Hvor kvæg og/eller grise allerede er godkendt som måldyrearter, og forudsat at den maksimale totale dosis, der anbefales i produktinformationen, ikke er over 24 mg gentamicinbase/kg kropsvægt til kvæg eller 50 mg gentamicinbase/kg kropsvægt til grise, anvendes nedenstående ordlyd for den pågældende dyreart:
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.
Danish: Nyre, lever, fedt, muskel og injektionssted (uden kontrolprøve af omgivende væv) blev analyseret ved hjælp af en valideret LC-MS/MS-metode; resultaterne for fedt foreligger dog ikke.
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:
Danish: Hvor kvæg og/eller grise allerede er godkendt som måldyrearter, og forudsat at den maksimale totale dosis, der anbefales i produktinformationen, ikke er over 12 mg gentamicinbase/kg kropsvægt til kvæg eller 50 mg gentamicinbase/kg kropsvægt til grise, anvendes nedenstående ordlyd for den pågældende dyreart:
English: Cattle, pigs, horses
Danish: kvæg, grise, heste
English: Cattle (calves up to 250 kg), nonfood-producing horses
Danish: kvæg (kalve op til 250 kg), ikkefødevareproducer ende heste
English: SC, IM, slow IV
Danish: SC, IM, langsom IV
English: IM, IV: Meat and offal: 103 days.
Danish: IM, IV: Kød og indmad: 103 dage.
English: Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
Danish: GENTAVET solução injectavel kvæg (kalve), grise (smågrise), fugle (kyllinger, kalkuner), hunde, katte
English: PANGRAM 4 % gentamicin 40000 UI/ml
Danish: PANGRAM 4 % gentamicin 40000 UI/ml kalve, hunde, katte
English: IM, IV: Meat and offal: 139 days.
Danish: IM, IV: Kød og indmad: 139 dage.
English: 40 mg/ml 30 mg/ml 200 mg/ml
Danish: 40 mg/ml 30 mg/ml 200 mg/ml kvæg, grise
English: A GLP-compliant study in calves was submitted concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Danish: Der er forelagt en GLP-overensstemmende undersøgelse hos kalve for produktet Aagent 50 mg/ml, injektionsvæske, opløsning (markedsføringstilladelsesindehaver: Fatro).
English: Radnička cesta 48 10000 Zagreb Croatia
Danish: 10000 Zagreb
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:
Danish: Når den maksimale totaldosis, der anbefales i produktinformationen, er op til 80 mg gentamicinbase/kg kropsvægt til kvæg, benyttes nedenstående ordlyd:
English: C-17, Km 17 08150 Parets del Valles (Barcelona)
Danish: 08150 Parets del Valles (Barcelona)
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.
Danish: Grupper på kun 3 dyr blev behandlet med en dosis på 4 mg/kg kropsvægt hver 12. time i 4,5 dage (9 injektioner) og slagtet på dag 15 og 60 efter sidste administration.
English: IM, IV: Meat and offal: 192 days.
Danish: IM, IV: Kød og indmad: 192 dage.
English: IM, IV: Meat and offal: 228 days.
Danish: IM, IV: Kød og indmad: 228 dage.
English: Intramuscular or intravenous use: Meat and offal: 139 days.
Danish: Intramuskulær eller intravenøs anvendelse: Kød og indmad: 139 dage.
English: Intramuscular or intravenous use: Meat and offal: 103 days.
Danish: Intramuskulær eller intravenøs anvendelse: Kød og indmad: 103 dage.
English: Kidney, liver, and the injection site were analysed.
Danish: Nyre, lever, og injektionssted blev undersøgt.
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.
Danish: Af disse data kan udledes en tilbageholdelsestid på 44 dage for smågrise ved en enkeltdosis på 5 mg pr. dyr, idet der er anvendes den alternative metode med 10 procents sikkerhedsmargin.
English: A study is available concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Danish: Der foreligger en undersøgelse for produktet Aagent 50 mg/ml, injektionsvæske, opløsning, (markedsføringstilladelsesindehaver: Fatro).
English: Delete, where applicable, any references to subcutaneous use in calves and piglets.
Danish: Enhver omtale af subkutan anvendelse til kalve og smågrise slettes, når det er relevant.
English: IM, IV: Meat and offal: 214 days.
Danish: IM, IV: Kød og indmad: 214 dage.
English: IM, SC, slow IV
Danish: IM, SC, langsom IV
English: Genta-Kel 5% gentamicin 50 mg/ml
Danish: Genta-Kel 5% gentamicin 50 mg/ml kvæg (kalve)
English: Calves and piglets in the first month of life, horses declared as not intended for slaughter for human consumption
Danish: Aagent 50 mg/ml injekčný roztok kalve og smågrise i den første levemåned, heste ikke bestemt til slagtning til konsum
English: Kidney, liver, fat, muscle, injection site (with no control surrounding sample) were analysed for residue depletion, using an LC-MS/MS method.
Danish: Nyre, lever, fedt, muskel og injektionssted (uden kontrol af omgivende væv) blev analyseret for depletion af restkoncentrationer med en valideret LC/MS-MS-metode.
English: Cattle, calves, pigs
Danish: kvæg, kalve, grise
English: Intramuscular or intravenous use: Meat and offal: 228 days.
Danish: Intramuskulær eller intravenøs anvendelse: Kød og indmad: 228 dage.
English: Intramuscular or intravenous use: Meat and offal: 192 days.
Danish: Intramuskulær eller intravenøs anvendelse: Kød og indmad: 192 dage.
English: Cattle, pigs, dogs, cats, pet birds
Danish: kvæg, grise, hunde, katte, selskabsfugle
English: Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19
Danish: Tyskland Bela-Pharm GmbH & Co.
English: Bela-Pharm GmbH & Co. KG Lohner Str. 19
Danish: Bela-Pharm GmbH & Co.
English: Intramuscular or intravenous use: Meat and offal: 214 days.
Danish: Intramuskulær eller intravenøs anvendelse: Kød og indmad: 214 dage.
English: Cattle (calves up to 250 kg), nonfood producing horses, dogs, cats
Danish: kvæg, (kalve op til 250 kg), ikke fødevareproducer ende heste, hunde, katte
English: Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Danish: Nyre, lever og injektionsstedet (kerne og omgivende væv) blev analyseret med en valideret HPLC/MS-MS-metode.
English: Calves, dogs
Danish: Gentacin kalve, hunde
English: Cattle, calves, pigs, piglets
Danish: kvæg, kalve, grise, smågrise
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:
Danish: Når den totaldosis, der anbefales i produktinformationen, ikke er over 12 mg gentamicinbase/kg kropsvægt til kvæg og grise, anvendes nedenstående ordlyd:
English: Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Danish: Nyre, lever, hud+fedt, muskel og injektionssted (kerne og omgivelser) blev analyseret med en valideret HPLC/MSMS-metode.
English: Residue depletion was only followed in kidney and liver; notably the injection site was not analysed.
Danish: Depletionen af restkoncentrationer blev kun fulgt i nyre og lever.
English: No surrounding control injection site was sampled.
Danish: Der blev ikke taget kontrolprøver fra omgivende væv ved injektionsstedet.
English: Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Danish: Der blev analyseret nyre, lever, hud+fedt og injektionssted ved hjælp af en valideret LC-MS/MS-metode.
English: Kidney, liver, fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Danish: Nyre, lever, fedt, muskel og injektionssted (kerne og omgivende væv) blev analyseret med en valideret HPLC/MS-MS-metode.
English: GENTA-JECT 10% gentamicin 100 mg/ml
Danish: GENTA-JECT 10% gentamicin 100 mg/ml kvæg, grise
English: GENTAMICIN/PROVET gentamicin 50 mg/ml
Danish: GENTAMICIN/PROVET gentamicin 50 mg/ml kalve, hunde, katte
English: Cattle (calves up to 250 kg), nonfood-producing horses, dogs
Danish: kvæg (kalve op til 250 kg), ikkefødevareproducer ende heste, hunde
English: Cattle, horses, dogs, cats
Danish: kvæg, heste, hunde, katte
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.
Danish: I den restkoncentrationsundersøgelse for mælk, der beskrives i CVMP's EPMAR for gentamicin (EMA/CVMP/619817/2015)
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:
Danish: Når den maksimale totaldosis, der anbefales i produktinformationen, ikke er over 50 mg gentamicinbase/kg kropsvægt til grise, anvendes nedenstående ordlyd:
English: gentamicin 50000 UI/ml
Danish: gentamicin 50000 UI/ml kalve, smågrise IM
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:
Danish: Når den maksimale totaldosis, der anbefales i produktinformationen, ikke er over 5 mg gentamicinbase/kg kropsvægt til grise, anvendes nedenstående ordlyd:
English: No control injection site surrounding sample was analysed.
Danish: Der blev ikke taget kontrolprøver fra det omgivende væv ved injektionsstedet.
English: Str. Principala nr. 944 Filipestii de Padure Jud.
Danish: Str. Principala nr. 944
English: Cattle, pigs, horses, dogs, cats
Danish: kvæg, grise, heste, hunde, katte
English: Genta-ject 10% gentamicin 100 mg/ml
Danish: Genta-ject 10% gentamicin 100 mg/ml kalve indtil 13 uger gamle
English: Piglets, dogs, cats
Danish: smågrise, hunde, katte
English: Calves, dogs, cats
Danish: kvæg, hunde, katte
English: The study concerns non-ruminating animals weighing approximately 50-60 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.
Danish: Undersøgelsen blev udført hos drøvtyggende kvæg (350-380 kg) og grise på 35-40 kg. Der blev administreret en dosis på 4 mg/kg kropsvægt med 12 timers mellemrum den første dag, derefter med 24 timers mellemrum til og med dag 5.
English: Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Danish: Gentacin, injekcinis tirpalas kvæg, kalve, grise, smågrise, fravænnede grise, heste, føl, hunde, katte
English: Calves, piglets, dogs, cats
Danish: Gentabiotic kalve, smågrise, hunde, katte
English: Calves, pigs, dogs
Danish: kvæg, grise, hunde
English: GENTAMICIN 40 mg/ml solutio pro injectionibus
Danish: GENTAMICIN 40 mg/ml solutio pro injectionibus kalve, grise, hunde, katte
English: GENTA-KEL 50 000 IU/ml injekční roztok
Danish: GENTA-KEL 50 000 IU/ml injekční roztok kvæg, grise, hunde
English: Cattle, calves, pigs, piglets, horses, dogs, cats
Danish: Gentacin kvæg, grise, heste, hunde, katte
English: GENTAMICIN 5% Gentamicin Provet 50mg/ml
Danish: GENTAMICIN 5% Gentamicin Provet 50mg/ml kalve, smågrise, hunde, katte
English: Belgium VMD nv Hoge Mauw 900
Danish: VMD nv
English: This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Aprovel, som allerede er godkendt i Den Europæiske Union (EU).
English: Previously known as Irbesartan Winthrop.
Danish: Tidligere kendt som Irbesartan Winthrop.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Winthrop den 19. januar 2007.
English: It is available as tablets (75, 150 and 300 mg).
Danish: Det fås som tabletter (75, 150 og 300 mg).
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.
Danish: Den fuldstændige EPAR for Irbesartan Zentiva findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: There was a 23% relative risk reduction compared with amlodipine.
Danish: Der var en 23 % relativ risikoreduktion sammenlignet med amlodipin.
English: Irbesartan Zentiva was used for two years or more.
Danish: Irbesartan Zentiva blev anvendt i 2 år eller mere.
English: The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Danish: Lægemidlets navn blev ændret til Irbesartan Zentiva den 6. februar 2012.
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Danish: Dets virkning i kombination med hydrochlorothiazid blev også undersøgt hos 1 736 patienter.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Danish: Behandlingen startes ved 150 mg en gang dagligt og øges sædvanligvis til 300 mg en gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Irbesartan Zentiva.
English: The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Danish: Den normalt anbefalede dosis af Irbesartan Zentiva er 150 mg en gang dagligt.
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.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Irbesartan Zentiva.
English: The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Zentiva.
Danish: Virksomheden, som fremstiller Aprovel, har givet tilladelse til, at dets videnskabelige oplysninger må anvendes for Irbesartan Zentiva.
English: The main benefit was on the effect on blood creatinine levels.
Danish: Den største fordel var virkningen på blodets indhold af kreatinin.
English: For more information about treatment with Irbesartan Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Irbesartan Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: EPAR summary for the public irbesartan
Danish: EPAR - Sammendrag for offentligheden irbesartan
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.
Danish: Hvis blodtrykket ikke bliver reguleret tilstrækkeligt, kan dosis øges til 300 mg dagligt, eller anden medicin mod forhøjet blodtryk, såsom hydrochlorthiazid, kan anvendes som tillægsbehandling.
English: Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Danish: Irbesartan Zentiva er et lægemiddel, der indeholder det aktive stof irbesartan.
English: Irbesartan Zentiva was originally studied in 11 trials for its effects on blood pressure.
Danish: Irbesartan Zentiva er oprindelig blevet undersøgt i 11 undersøgelser for dets virkning på blodtrykket.
English: The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Irbesartan Zentiva opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Other information about Irbesartan Zentiva
Danish: Andre oplysninger om Irbesartan Zentiva
English: One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Danish: Den ene undersøgelse så på markører for nyreskader ved at måle, om nyrerne udskilte proteinet albumin i urinen.
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.
Danish: Irbesartan Zentiva blev sammenlignet med placebo (en uvirksom behandling) hos 712 patienter og med andre lægemidler mod forhøjet blodtryk (atenolol, enalapril eller amlodipin) hos 823 patienter.
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.
Danish: Det aktive stof i Irbesartan Zentiva, irbesartan, er en 'angiotensin II-receptorantagonist', hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
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.
Danish: Irbesartan Zentiva i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
English: Irbesartan Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Danish: Irbesartan Zentiva må ikke anvendes til personer, som er overfølsomme (allergiske) over for irbesartan eller andre af indholdsstofferne.
English: In this study, Irbesartan Zentiva was compared with placebo and with amlodipine.
Danish: I denne undersøgelse blev Irbesartan Zentiva sammenlignet med placebo og amlodipin.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Danish: Når Irbesartan Zentiva blev anvendt i kombination med hydrochlorothiazid, var virkningerne af de to lægemidler additive.
English: Irbesartan Zentiva is used in adults who have essential hypertension (high blood pressure).
Danish: Irbesartan Zentiva anvendes til voksne med essentiel hypertension (forhøjet blodtryk).
English: In patients with hypertension and type 2 diabetes, Irbesartan Zentiva is added to some other treatments for hypertension.
Danish: Hos hypertensive patienter med type 2-diabetes anvendes Irbesartan Zentiva som tillægsbehandling til visse andre behandlinger af hypertension.
English: The second study looked at whether Irbesartan Zentiva increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Danish: Den anden undersøgelse så på, hvorvidt Irbesartan Zentiva forlænger den tid, der går, inden patienternes indhold af blodkreatinin (en markør for nyresygdom) fordobles, inden de får behov for en nyretransplantation eller dialyse, eller inden de dør.
English: Irbesartan Zentiva is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Danish: Irbesartan Zentiva anvendes desuden til behandling af nyresygdom hos voksne med hypertension og type 2-diabetes.
English: The most common side effect with Irbesartan Zentiva (seen in more than 1 patient in 10) is dizziness, hyperkalaemia (high blood potassium levels).
Danish: Den hyppigste bivirkning ved Irbesartan Zentiva (som ses hos flere end 1 ud af 10 patienter) er hyperkalæmi (forhøjet kaliumindhold i blodet).
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.
Danish: Irbesartan Zentiva var desuden genstand for to store undersøgelser vedrørende behandling af nyresygdom hos i alt 2 326 patienter med type 2-diabetes.
English: What is the risk associated with Irbesartan Zentiva?
Danish: Hvilken risiko er der forbundet med Irbesartan Zentiva?
English: In the second kidney disease study, Irbesartan Zentiva reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Danish: I den anden undersøgelse vedrørende nyresygdom reducerede Irbesartan Zentiva i løbet af undersøgelsen den relative risiko for en fordobling af indholdet af blodkreatinin, behovet for en nyretransplantation eller dialyse, eller risikoen for dødsfald i med 20 % sammenlignet med placebo.