natgillin/translations-raw huggingface dataset:
I et dobbeltblindt, randomiseret, aktiv-kontrolleret forsøg med patienter, der ikke responderede tilstrækkeligt på valsartan 80 mg, sås signifikant større middelreduktioner i systolisk/diastolisk blodtryk med kombinationen valsartan/hydrochlorthiazid 80/12,5 mg (9,8/8,2 mmHg) sammenlignet med valsartan 80 mg (3,9/5,1 mmHg) og valsartan 160 mg (6,5/6,2 mmHg).
In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 80 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (9.8/8.2 mmHg) compared to valsartan 80 mg (3.9/5.1 mmHg) and valsartan 160 mg (6.5/6.2 mmHg).
Sverige
Spain
Desuden responderede en signifikant højere procentdel af patienterne (diastolisk blodtryk <90 mmHg eller reduktion ≥10 mmHg) med valsartan/hydrochlorthiazid 160/25 mg (68 %) og 160/12,5 mg (62 %) sammenlignet med valsartan 160 mg (49 %).
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/25 mg (68%) and 160/12.5 mg (62%) compared to valsartan 160 mg (49%).
Desuden responderede en signifikant højere procentdel af patienterne (diastolisk blodtryk <90 mmHg eller reduktion ≥10 mmHg) med valsartan/hydrochlorthiazid 80/12,5 mg (51 %) sammenlignet med valsartan 80 mg (36 %) og valsartan 160 mg (37 %).
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (51%) compared to valsartan 80 mg (36%) and valsartan 160 mg (37%).
Cordinate plus 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
Cordinate plus 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
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 320/12,5 mg (21,7/15,0 mmHg) og 320/25 mg (24,7/16,6 mmHg) sammenlignet med placebo (7,0/5,9 mmHg) og de respektive monoterapier, dvs. hydrochlorthiazid 12,5 mg (11,1/9,0 mmHg), hydrochlorthiazid 25 mg (14,5/10,8 mmHg) og valsartan 320 mg (13,7/11,3 mmHg).
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 320/12.5 mg (21.7/15.0 mmHg) and 320/25 mg (24.7/16.6 mmHg) compared to placebo (7.0/5.9 mmHg) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (11.1/9.0 mmHg), hydrochlorothiazide 25 mg (14.5/10.8 mmHg) and valsartan 320 mg (13.7/11.3 mmHg).
Co-Dalzad (160+25) mg 160 mg / 25 mg Filmovertrukne tabletter
Co-Dalzad (160+25) mg 160 mg / 25 mg film-coated tablets oral
Desuden responderede en signifikant højere procentdel af patienterne (diastolisk blodtryk <90 mmHg eller reduktion ≥10 mmHg) med valsartan/hydrochlorthiazid 80/12,5 mg (60 %) sammenlignet med hydrochlorthiazid 12,5 mg (25 %) og hydrochlorthiazid 25 mg (27 %).
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (60%) compared to hydrochlorothiazide 12.5 mg (25%) and hydrochlorothiazide 25 mg (27%).
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).
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).
Co- Novacard 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
Co- Novacard 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg film-coated tablets oral
Cordinate plus 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Cordinate plus 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Hos rotter repræsenterede disse doser henholdsvis 3,0 og 12 gange den maksimale anbefalede humane dosis af valsartan og hydrochlorthiazid udtrykt i mg/m2.
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.
Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg Filmovertrukne tabletter
Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral
Knogler, led, muskler og bindevæv Ikke almindelig
Musculoskeletal and connective tissue disorders Uncommon
Cordinate plus 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
Cordinate plus 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Cotareg 160mg/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Cotareg 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Dalzad (320+25) mg 320 mg / 25 mg Filmovertrukne tabletter
Co-Dalzad (320+25) mg 320 mg / 25 mg film-coated tablets oral
Hver filmovertrukken tablet indeholder 320 mg valsartan og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide.
• stikken/prikken eller følelsesløshed
• tingling or numbness
Co- Novacard 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Co- Novacard 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg Filmovertrukne tabletter
Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg film-coated tablets oral
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).
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
• nyresvigt
• dizziness
Co- Novacard 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co- Novacard 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Diovan Comp 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Diovan Comp 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Valsartan er i høj grad bundet til plasmaprotein og fjernes ikke ved dialyse, mens clearance af hydrochlorthiazid vil kunne øges ved dialyse.
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.
Hver tablet indeholder 320 mg valsartan og 25 mg hydrochlorthiazid.
Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Hver filmovertrukken tablet indeholder 160 mg valsartan og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.
Cotareg 160mg/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Cotareg 160mg/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Cotareg 80mg/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
Cotareg 80mg/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
Diovan Comp 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
• ledsmerter
• light-headedness
Slovenien Novartis Pharma GmbH Roonstrasse 25
Slovenia Novartis Pharma GmbH Roonstrasse 25
Hver tablet indeholder 160 mg valsartan og 25 mg hydrochlorthiazid.
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Hver filmovertrukken tablet indeholder 320 mg valsartan og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
Co-Diovane 80/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral
Hver tablet indeholder 320 mg valsartan og 12,5 mg hydrochlorthiazid.
Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
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 %).
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%).
Hver filmovertrukken tablet indeholder 160 mg valsartan og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Diovan Comp bør anvendes med forsigtighed til patienter med mild til moderat leverinsufficiens uden cholestasis (se pkt.
In patients with mild to moderate hepatic impairment without cholestasis, Diovan Comp should be used with caution (see sections 4.2 and 5.2).
Co-Diovan (160 + 25 mg) 160 mg / 25 mg Filmovertrukne tabletter
Co-Diovan (160 + 25 mg) 160 mg / 25 mg film-coated tablets oral
Co-Diovan (320 + 25 mg) 320 mg / 25 mg Filmovertrukne tabletter
Co-Diovan (320 + 25 mg) 320 mg / 25 mg film-coated tablets oral
Hver filmovertrukken tablet indeholder 80 mg valsartan og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.
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.
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.
CORIXIL 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Hver tablet indeholder 160 mg valsartan og 12,5 mg hydrochlorthiazid.
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Co-Diovan (160 + 12.5 mg) 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (160 + 12.5 mg) 160 mg / 12.5 mg film-coated tablets oral
Co-Diovan (80 + 12.5 mg) 80 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (80 + 12.5 mg) 80 mg / 12.5 mg film-coated tablets oral
Overfølsomhedsreaktioner
Hypersenstivity reactions
Co-Diovan (320 + 12.5 mg) 320 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (320 + 12.5 mg) 320 mg / 12.5 mg film-coated tablets oral
Co-Diovan forte 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovan (160+25) mg 160 mg / 25 mg Filmovertrukne tabletter
Co-Diovan (160+25) mg 160 mg / 25 mg film-coated tablets oral
Hver tablet indeholder 80 mg valsartan og 12,5 mg hydrochlorthiazid.
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Comp.
Cough
Co-Diovan (160+12.5) mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (160+12,5) mg 160 mg / 12,5 mg film-coated tablets oral
Co-Diovan (80+12.5) mg 80 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (80+12,5) mg 80 mg / 12,5 mg film-coated tablets oral
Tyskland Novartis Pharma GmbH Roonstrasse 25
Germany Novartis Pharma GmbH Roonstrasse 25
• Lægen har ordineret Diovan Comp til dig personligt.
• This medicine has been prescribed for you.
Co-Diovan (320+25) mg 320 mg / 25 mg Filmovertrukne tabletter
Co-Diovan (320+25) mg 320 mg / 25 mg film-coated tablets oral
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.
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”
Storbritannien Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park
Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Co-Diovan (320+12.5) mg 320 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan (320+12,5) mg 320 mg / 12,5 mg film-coated tablets oral
Co-Diovan forte 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Co-Diovane 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovane 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Co-Diovane 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Diovan Comp 80mg/12.5 mg80 mg / 12,5 mg Filmovertrukne tabletter
Diovan Comp 80mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
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.
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.
CO-DIOVAN 320 MG/12.5 MG FILM-COATED TABLETS
CO-DIOVAN 320 mg/12,5 mg FILMCOATED TABLETS
Rumænien Novartis Pharma GmbH Roonstrasse 25
Romania Novartis Pharma GmbH Roonstrasse 25
Co-Diovane 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
Co-Diovane 320/25 mg 320 mg / 25 mg film-coated tablets oral
Estland Novartis Finland Oy Metsänneidonkuja 10
Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo
Co-Diovan 160/12.5 mg 160 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Diovan Comp 160mg/25 160 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral
Diovan Comp 320 mg/25 mg320 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral
Diovan Comp 160 mg/25 mg160 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral
Diovan Comp 320mg/25 mg 320 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan 320/12.5 mg 320 mg / 12,5 mg Filmovertrukne tabletter
Co-Diovan 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Diovan Comp 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral
Diovan Comp 80/12.5 mg 80 mg / 12,5 mg Filmovertrukne tabletter
Diovan Comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 80 mg/12,5 mg80 mg / 12,5 mg Filmovertrukne tabletter
Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Diovan Comp 160mg/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Co-Diovan 160/25 mg 160 mg / 25 mg Filmovertrukne tabletter
Co-Diovan 160/25 mg 160 mg / 25 mg film-coated tablets oral
Diovan Comp 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral
Co-Diovan 320/25 mg 320 mg / 25 mg Filmovertrukne tabletter
Co-Diovan 320/25 mg 320 mg / 25 mg film-coated tablets oral
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).
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.
Mave-tarm-kanalen Meget sjælden
Gastrointestinal disorders Very rare
Svimmelhed
Lactation
6.6 Regler for destruktion Ingen særlige forholdsregler.
For a full list of excipients, see section 6.1.
Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
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).
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DIOVAN COMP
BEFORE YOU TAKE DIOVAN COMP
Irbesartan Zentiva må ikke gives til børn under 18 år.
Irbesartan Zentiva should not be given to children under 18 years of age.
Du kan tage Irbesartan Zentiva med eller uden mad.
You can take Irbesartan Zentiva with or without food.
Se også information under ”Tag ikke Irbesartan Zentiva”.
See also information under the heading “Do not take Irbesartan Zentiva”.
Sådanne tilstande skal korrigeres før administration af Irbesartan Zentiva.
Such conditions should be corrected before the administration of Irbesartan Zentiva.
Irbesartan Zentiva er indiceret til voksne til behandling af essentiel hypertension.
Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension.
Virkningen af Irbesartan Zentiva afhænger ikke af alder eller køn.
The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Dato for første markedsføringstilladelse: 19. januar 2007 Dato for seneste genregistrering: 19. januar 2012
Date of first authorisation: 19 January 2007 Date of latest renewal: 19 January 2012
Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan Zentiva.
No specific information is available on the treatment of overdose with Irbesartan Zentiva.
Brug af Irbesartan Zentiva sammen med mad og drikke Irbesartan Zentiva kan tages med og uden mad.
Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food.
Lactose: Patienter med arvelig galactoseintolerans, total laktasemangel eller glukose-galaktose malabsorption bør ikke tage dette lægemiddel.
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
IDNT var et kontrolleret dobbelt-blindt morbiditets- og mortalitetsstudie, som sammenlignede Irbesartan Zentiva, amlodipin og placebo.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo.
Irbesartan Zentiva s sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke fastlagt.
The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established.
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).
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).
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.
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.
Det er vigtigt, at du fortsætter med at tage Irbesartan Zentiva, indtil lægen siger du kan stoppe.
It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.
Der foreligger ingen erfaring vedrørende administration af Irbesartan Zentiva til nyligt nyretransplanterede patienter.
There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation.
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.
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.
Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Irbesartan Zentiva (se pkt.
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).
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.
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.
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.
If you get any of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.
Regression til normo albuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik Irbesartan Zentiva 300 mg (34%) end i placebogruppen (21%).
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%).
Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum-kreatinin, slutstadium af nyresygdom (ESRD) eller total mortalitet.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Din læge kan blive nødt til at ændre din dosis og/eller tage andre forholdsregler, hvis du tager aliskiren.
Your doctor may need to change your dose and/or to take other precautions.
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).
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).
Irbesartan Zentiva påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines.
Selvom dette ikke er dokumenteret for Irbesartan Zentiva, kan der forventes en lignende effekt med angiotensin-IIreceptorantagonister.
While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists.