FrancophonIA/ELRC3.0 huggingface dataset:
English: In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (16.5/11.8 mmHg) compared to placebo (1.9/4.1 mmHg) and both hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg) and valsartan 80 mg (8.8/8.6 mmHg).
Danish: I et dobbeltblindt, randomiseret, placebo-kontrolleret faktorforsøg til sammenligning af forskellige dosiskombinationer af valsartan/hydrochlorthiazid i forhold til deres respektive komponenter sås signifikant større middelreduktioner i systolisk/diastolisk blodtryk med kombinationen valsartan/hydrochlorthiazid 80/12,5 mg (16,5/11,8 mmHg) sammenlignet med placebo (1,9/4,1 mmHg) og både hydrochlorthiazid 12,5 mg (7,3/7,2 mmHg) og valsartan 80 mg (8,8/8,6 mmHg).
English: Co- Novacard 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Danish: Co- Novacard 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg film-coated tablets oral
Danish: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Cordinate plus 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Cordinate plus 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: These doses in rat, respectively, represent 3.0 and 12 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Danish: Hos rotter repræsenterede disse doser henholdsvis 3,0 og 12 gange den maksimale anbefalede humane dosis af valsartan og hydrochlorthiazid udtrykt i mg/m2.
English: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral
Danish: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Musculoskeletal and connective tissue disorders Uncommon
Danish: Knogler, led, muskler og bindevæv Ikke almindelig
English: Cordinate plus 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Danish: Cordinate plus 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: Cotareg 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Cotareg 160mg/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Dalzad (320+25) mg 320 mg / 25 mg film-coated tablets oral
Danish: Co-Dalzad (320+25) mg 320 mg / 25 mg Filmovertrukne tabletter
English: Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukken tablet indeholder 320 mg valsartan og 25 mg hydrochlorthiazid.
English: • tingling or numbness
Danish: • stikken/prikken eller følelsesløshed
English: Co- Novacard 160/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Co- Novacard 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg film-coated tablets oral
Danish: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on hydrochlorothiazide 12.5 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (14.9/11.3 mmHg) compared to hydrochlorothiazide 12.5 mg (5.2/2.9 mmHg) and hydrochlorothiazide 25 mg
Danish: I et dobbeltblindt, randomiseret, aktiv-kontrolleret forsøg med patienter, der ikke responderede tilstrækkeligt på hydrochlorthiazid 12,5 mg, sås signifikant større middelreduktioner i systolisk/diastolisk blodtryk med kombinationen valsartan/hydrochlorthiazid 80/12,5 mg (14,9/11,3 mmHg) sammenlignet med hydrochlorthiazid 12,5 mg (5,2/2,9 mmHg) og hydrochlorthiazid 25 mg (6,8/5,7 mmHg).
English: • dizziness
Danish: • nyresvigt
English: Co- Novacard 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Co- Novacard 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Diovan Comp 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: In patients with severe renal impairment (creatinine clearance <30 ml/min) and patients undergoing dialysis no data are available for Diovan Comp. Valsartan is highly bound to plasma protein and is not to be removed by dialysis, whereas clearance of hydrochlorothiazide will be achieved by dialysis.
Danish: Valsartan er i høj grad bundet til plasmaprotein og fjernes ikke ved dialyse, mens clearance af hydrochlorthiazid vil kunne øges ved dialyse.
English: Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Hver tablet indeholder 320 mg valsartan og 25 mg hydrochlorthiazid.
English: Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukken tablet indeholder 160 mg valsartan og 25 mg hydrochlorthiazid.
English: Cotareg 160mg/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Cotareg 160mg/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Cotareg 80mg/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Danish: Cotareg 80mg/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Danish: Diovan Comp 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: • light-headedness
Danish: • ledsmerter
English: Slovenia Novartis Pharma GmbH Roonstrasse 25
Danish: Slovenien Novartis Pharma GmbH Roonstrasse 25
English: Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Hver tablet indeholder 160 mg valsartan og 25 mg hydrochlorthiazid.
English: Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukken tablet indeholder 320 mg valsartan og 12,5 mg hydrochlorthiazid.
English: Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovane 80/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Danish: Hver tablet indeholder 320 mg valsartan og 12,5 mg hydrochlorthiazid.
English: In addition, a significantly greater percentage of patients responded (BP <140/90 mmHg or SBP reduction ≥20 mmHg or DBP reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/12.5 mg (50%) compared to hydrochlorothiazide 25 mg (25%).
Danish: Desuden responderede en signifikant højere procentdel af patienterne (blodtryk <140/90 mmHg eller reduktion i systolisk blodtryk ≥20 mmHg eller reduktion i diastolisk blodtryk ≥10 mmHg ) med valsartan/hydrochlorthiazid 160/12,5 mg (50 %) sammenlignet med hydrochlorthiazid 25 mg (25 %).
English: Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukken tablet indeholder 160 mg valsartan og 12,5 mg hydrochlorthiazid.
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan Comp should be used with caution (see sections 4.2 and 5.2).
Danish: Diovan Comp bør anvendes med forsigtighed til patienter med mild til moderat leverinsufficiens uden cholestasis (se pkt.
English: Co-Diovan (160 + 25 mg) 160 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan (160 + 25 mg) 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan (320 + 25 mg) 320 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan (320 + 25 mg) 320 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan forte 160 mg/12,5 mgFilmtabletten
Danish: Co-Diovan forte 160 mg/12,5 mg - Filmtabletten
English: Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukken tablet indeholder 80 mg valsartan og 12,5 mg hydrochlorthiazid.
English: These doses in rat, respectively, represent 0.9 and 3.5-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Danish: Hos rotter repræsenterede disse doser henholdsvis 0,9 og 3,5 gange den maksimale anbefalede humane dosis af valsartan og hydrochlorthiazid udtrykt i mg/m2.
English: CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: CORIXIL 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Danish: Hver tablet indeholder 160 mg valsartan og 12,5 mg hydrochlorthiazid.
English: Co-Diovan (160 + 12.5 mg) 160 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan (160 + 12.5 mg) 160 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovan (80 + 12.5 mg) 80 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan (80 + 12.5 mg) 80 mg / 12,5 mg Filmovertrukne tabletter
English: Hypersenstivity reactions
Danish: Overfølsomhedsreaktioner
English: Co-Diovan (320 + 12.5 mg) 320 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan (320 + 12.5 mg) 320 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan forte 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan (160+25) mg 160 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan (160+25) mg 160 mg / 25 mg Filmovertrukne tabletter
English: Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Danish: Hver tablet indeholder 80 mg valsartan og 12,5 mg hydrochlorthiazid.
English: Cough
Danish: Comp.
English: Co-Diovan (160+12,5) mg 160 mg / 12,5 mg film-coated tablets oral
Danish: Co-Diovan (160+12.5) mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovan (80+12,5) mg 80 mg / 12,5 mg film-coated tablets oral
Danish: Co-Diovan (80+12.5) mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Germany Novartis Pharma GmbH Roonstrasse 25
Danish: Tyskland Novartis Pharma GmbH Roonstrasse 25
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Diovan Comp til dig personligt.
English: Co-Diovan (320+25) mg 320 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan (320+25) mg 320 mg / 25 mg Filmovertrukne tabletter
English: The clinical response to Diovan Comp should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Diovan Comp 320 mg/25 mg”
Danish: Den kliniske reaktion på Diovan Comp bør evalueres efter påbegyndelse af terapien, og hvis blodtrykket stadig ikke kan kontrolleres, kan dosis øges ved at øge mængden af en af komponenterne til en maksimumdosis Diovan Comp 320 mg/25 mg." Det tredje spørgsmål, der blev diskuteret, drejede sig om, at den gensidige anerkendelsesprocedure for produktresuméer begrænser anvendelsen af både valsartan/HCTZ 160/25 og 320/25 mg hos patienter, hvis gennemsnitlige diastoliske blodtryk i siddende stilling er > 100 mmHg.
English: Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Danish: Storbritannien Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park
English: Co-Diovan (320+12,5) mg 320 mg / 12,5 mg film-coated tablets oral
Danish: Co-Diovan (320+12.5) mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan forte 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Co-Diovane 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovane 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovane 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 80mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Danish: Diovan Comp 80mg/12.5 mg80 mg / 12,5 mg Filmovertrukne tabletter
English: These doses in marmoset, respectively, represent 0.9 and 3.5 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Danish: Hos silkeaber repræsenterede disse doser henholdsvis 0,9 og 3,5 gange den maksimale anbefalede humane dosis af valsartan og hydrochlorthiazid udtrykt i mg/m2.
English: CO-DIOVAN 320 mg/12,5 mg FILMCOATED TABLETS
Danish: CO-DIOVAN 320 MG/12.5 MG FILM-COATED TABLETS
English: Romania Novartis Pharma GmbH Roonstrasse 25
Danish: Rumænien Novartis Pharma GmbH Roonstrasse 25
English: Co-Diovane 320/25 mg 320 mg / 25 mg film-coated tablets oral
Danish: Co-Diovane 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
English: Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo
Danish: Estland Novartis Finland Oy Metsänneidonkuja 10
English: Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 160mg/25 160 mg / 25 mg Filmovertrukne tabletter
English: Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 320 mg/25 mg320 mg / 25 mg Filmovertrukne tabletter
English: Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 160 mg/25 mg160 mg / 25 mg Filmovertrukne tabletter
English: Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 320mg/25 mg 320 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Danish: Co-Diovan 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Diovan Comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Danish: Diovan Comp 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Danish: Diovan Comp 80 mg/12,5 mg80 mg / 12,5 mg Filmovertrukne tabletter
English: Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 160mg/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan 160/25 mg 160 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
English: Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral
Danish: Diovan Comp 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
English: Co-Diovan 320/25 mg 320 mg / 25 mg film-coated tablets oral
Danish: Co-Diovan 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
English: These doses in rat, respectively, represent 18 and 73 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Danish: Hos rotter repræsenterede disse doser henholdsvis 18 og 73 gange den maksimale anbefalede humane dosis af valsartan og hydrochlorthiazid udtrykt i mg/m2 (beregningerne forudsætter en oral dosis på 320 mg/dag valsartan kombineret med 25 mg/dag hydrochlorthiazid og en patient på 60 kg).
English: Gastrointestinal disorders Very rare
Danish: Mave-tarm-kanalen Meget sjælden
English: Lactation
Danish: Svimmelhed
English: For a full list of excipients, see section 6.1.
Danish: 6.6 Regler for destruktion Ingen særlige forholdsregler.
English: the CHMP has recommended the amendment of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Diovan comp and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: BEFORE YOU TAKE DIOVAN COMP
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DIOVAN COMP
English: Irbesartan Zentiva should not be given to children under 18 years of age.
Danish: Irbesartan Zentiva må ikke gives til børn under 18 år.
English: You can take Irbesartan Zentiva with or without food.
Danish: Du kan tage Irbesartan Zentiva med eller uden mad.
English: See also information under the heading “Do not take Irbesartan Zentiva”.
Danish: Se også information under ”Tag ikke Irbesartan Zentiva”.
English: Such conditions should be corrected before the administration of Irbesartan Zentiva.
Danish: Sådanne tilstande skal korrigeres før administration af Irbesartan Zentiva.
English: Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension.
Danish: Irbesartan Zentiva er indiceret til voksne til behandling af essentiel hypertension.
English: The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Danish: Virkningen af Irbesartan Zentiva afhænger ikke af alder eller køn.
English: Date of first authorisation: 19 January 2007 Date of latest renewal: 19 January 2012
Danish: Dato for første markedsføringstilladelse: 19. januar 2007 Dato for seneste genregistrering: 19. januar 2012
English: No specific information is available on the treatment of overdose with Irbesartan Zentiva.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan Zentiva.
English: Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food.
Danish: Brug af Irbesartan Zentiva sammen med mad og drikke Irbesartan Zentiva kan tages med og uden mad.
English: Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Lactose: Patienter med arvelig galactoseintolerans, total laktasemangel eller glukose-galaktose malabsorption bør ikke tage dette lægemiddel.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo.
Danish: IDNT var et kontrolleret dobbelt-blindt morbiditets- og mortalitetsstudie, som sammenlignede Irbesartan Zentiva, amlodipin og placebo.
English: The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established.
Danish: Irbesartan Zentiva s sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke fastlagt.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000).
English: Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Irbesartan Zentiva, inden du bliver gravid, eller så snart du ved, at du er gravid, og anbefale, at du tager anden medicin i stedet for Irbesartan Zentiva.
English: It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Irbesartan Zentiva, indtil lægen siger du kan stoppe.
English: There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation.
Danish: Der foreligger ingen erfaring vedrørende administration af Irbesartan Zentiva til nyligt nyretransplanterede patienter.
English: Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Irbesartan Zentiva anbefales ikke til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Zentiva (see section 4.5).
Danish: Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Irbesartan Zentiva (se pkt.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Zentiva, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Danish: Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg Irbesartan Zentiva, fra 2,5 mg til 10 mg amlodipin eller placebo i henhold til tolerance.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.
Danish: Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage Irbesartan Zentiva og straks søge lægehjælp.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%).
Danish: Regression til normo albuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik Irbesartan Zentiva 300 mg (34%) end i placebogruppen (21%).
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Danish: Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum-kreatinin, slutstadium af nyresygdom (ESRD) eller total mortalitet.
English: Your doctor may need to change your dose and/or to take other precautions.
Danish: Din læge kan blive nødt til at ændre din dosis og/eller tage andre forholdsregler, hvis du tager aliskiren.
English: The study examined the long-term effects (2 years) of Irbesartan Zentiva on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Danish: Studiet undersøgte langtidsvirkningerne (2 år) af Irbesartan Zentiva med henblik på progression til klinisk proteinuri (urinalbumin udskillelsesrate (UAER) > 300 mg/dag, og en stigning i UAER på mindst 30% i forhold til baseline).
English: Irbesartan Zentiva is unlikely to affect your ability to drive or use machines.
Danish: Irbesartan Zentiva påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Danish: Selvom dette ikke er dokumenteret for Irbesartan Zentiva, kan der forventes en lignende effekt med angiotensin-IIreceptorantagonister.
English: The blood pressure lowering effect of Irbesartan Zentiva is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Danish: Irbesartan Zentivas blodtrykssænkende effekt er tydelig i løbet af 1-2 uger, og den maksimale effekt viser sig 4-6 uger efter behandlingsstart.
English: Clinical efficacy:
Danish: Klinisk effekt:
English: Some undesirable effects have been reported since marketing of Irbesartan Zentiva.
Danish: Der er indberettet bivirkninger efter markedsføring af Irbesartan Zentiva.
English: Therefore, the use of Irbesartan Zentiva is not recommended.
Danish: Derfor frarådes brug af Irbesartan Zentiva.
English: Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Danish: Ved en dosis på 150 mg 1 gang dagligt giver Irbesartan Zentiva generelt en bedre 24timers blodtrykskontrol end 75 mg.
English: If you forget to take Irbesartan Zentiva
Danish: Hvis du har glemt at tage Irbesartan Zentiva
English: o aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Danish: Din læge vil måske regelmæssigt kontrollere din nyrefunktion, dit blodtryk og mængden af elektrolytter (f.eks. kalium) i dit blod.
English: Lithium: the combination of lithium and Irbesartan Zentiva is not recommended (see section 4.5).
Danish: Lithium: Kombination af lithium og Irbesartan Zentiva frarådes (se pkt.