FrancophonIA/ELRC3.0 huggingface dataset:
English: Diovan Comp and associated names (see Annex I) 80 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/25 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/25 mg film-coated tablets [See Annex I - To be completed nationally] Valsartan/hydrochlorothiazide
Swedish: Diovan Comp och associerade namn (se bilaga I) 80 mg/12,5 mg filmdragerade tabletter Diovan Comp och associerade namn (se bilaga I) 160 mg/12,5 mg filmdragerade tabletter Diovan Comp och associerade namn (se bilaga I) 160 mg/25 mg filmdragerade tabletter Diovan Comp och associerade namn (se bilaga I) 320 mg/12,5 mg filmdragerade tabletter Diovan Comp och associerade namn (se bilaga I) 320 mg/25 mg filmdragerade tabletter [Se bilaga I - Kompletteras nationellt] Valsartan/hydroklortiazid
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 320 mg, significantly greater mean systolic/diastolic BP reductions were observed with both the combination of valsartan/hydrochlorothiazide 320/25 mg (15.4/10.4 mmHg) and valsartan/hydrochlorothiazide 320/12.5 mg (13.6/9.7 mmHg) compared to valsartan 320 mg (6.1/5.8 mmHg).
Swedish: I en dubbelblind, randomiserad, aktivkontrollerad, klinisk studie på patienter som inte kontrollerats tillfredsställande med valsartan 320 mg observerades signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) både med kombinationen valsartan/hydroklortiazid 320/25 mg (15,4/10,4 mmHg) och valsartan/hydroklortiazid 320/12,5 mg (13,6/9,7 mmHg) jämfört med valsartan 320 mg (6,1/5,8 mmHg).
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 160 mg, significantly greater mean systolic/diastolic BP reductions were observed with both the combination of valsartan/hydrochlorothiazide 160/25 mg (14.6/11.9 mmHg) and valsartan/hydrochlorothiazide 160/12.5 mg (12.4/10.4 mmHg) compared to valsartan 160 mg (8.7/8.8 mmHg).
Swedish: I en dubbelblind, randomiserad, aktivkontrollerad, klinisk studie på patienter som inte kontrollerats tillfredsställande med valsartan 160 mg observerades signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) både med kombinationen valsartan/hydroklortiazid 160/25 mg (14,6/11,9 mmHg) och valsartan/hydroklortiazid 160/12,5 mg (12,4/10,4 mmHg) jämfört med valsartan 160 mg (8,7/8,8 mmHg).
English: At the recommended dose of Diovan Comp no dose adjustment is required for patients with a creatinine clearance of 30-70 ml/min.
Swedish: Ingen dosjustering krävs för patienter med kreatininclearance 30-70 ml/min vid rekommenderad dos av Diovan Comp.
English: Cordinate plus 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Swedish: Cordinate plus 80/12.5 mg 80 mg / 12,5 mg filmdragerad tablett
English: 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%).
Swedish: Dessutom svarade en signifikant större andel patienter på behandlingen, (diastoliskt BP <90 mmHg eller sänkning med ≥10 mmHg), med valsartan/hydroklortiazid 80/12,5 mg (51 %) jämfört med valsartan 80 mg (36 %) och valsartan 160 mg (37 %).
English: 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).
Swedish: I en dubbelblind, randomiserad, aktivkontrollerad, klinisk studie på patienter som inte kontrollerats tillfredsställande med valsartan 80 mg observerades signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) med kombinationen valsartan/hydroklortiazid 80/12,5 mg (9,8/8,2 mmHg) jämfört med valsartan 80 mg (3,9/5,1 mmHg) och valsartan 160 mg (6,5/6,2 mmHg).
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.
Swedish: Valsartan binds i hög grad till plasmaproteiner och kan inte elimineras med dialys, medan hydroklortiazid kan elimineras med hjälp av dialys.
English: Co- Novacard 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Swedish: Co- Novacard 80/12.5 mg 80 mg / 12,5 mg filmdragerad tablett
English: Ear and labyrinth disorders Uncommon
Swedish: Öron och balansorgan Mindre vanliga
English: 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%).
Swedish: Dessutom svarade en signifikant större andel patienter på behandlingen, (diastoliskt BT <90 mmHg eller sänkning med ≥10 mmHg), med valsartan/hydroklortiazid 80/12,5 mg (60 %) jämfört med hydroklortiazid 12,5 mg (25 %) och hydroklortiazid 25 mg (27 %).
English: Co-Dalzad (160+25) mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Dalzad (160+25) mg 160 mg / 25 mg filmdragerad tablett
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.
Swedish: Dessa doser hos råtta motsvarar 3,0 respektive 12 gånger den högsta rekommenderade dosen till människa av valsartan och hydroklortiazid baserat på mg/m2.
English: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg filmdragerad tablett
English: Cordinate plus 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Cordinate plus 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: • spinning sensation
Swedish: • känsla av att snurra
English: Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide.
Swedish: En filmdragerad tablett innehåller 320 mg valsartan och 25 mg hydroklortiazid.
English: 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%).
Swedish: Dessutom svarade en signifikant större andel patienter på behandlingen, (diastoliskt BT <90 mmHg eller sänkning med ≥10 mmHg), med valsartan/hydroklortiazid 160/25 mg (68 %) och 160/12,5 mg (62 %) jämfört med valsartan 160 mg
English: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg filmdragerad tablett
English: Amantadine
Swedish: Utsöndring
English: Calcium excretion is decreased by thiazide diuretics.
Swedish: Kalciumutsöndringen reduceras av tiaziddiuretika, vilket kan resultera i hyperkalcemi.
English: Cotareg 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Cotareg 160mg/25 mg 160 mg / 25 mg filmdragerad tablett
English: Cordinate plus 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Swedish: Cordinate plus 320/12.5 mg 320 mg / 12,5 mg filmdragerad tablett
English: Co- Novacard 160/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co- Novacard 160/25 mg 160 mg / 25 mg filmdragerad tablett
English: Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.
Swedish: En filmdragerad tablett innehåller 160 mg valsartan och 25 mg hydroklortiazid.
English: Co-Dalzad (320+25) mg 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Dalzad (320+25) mg 320 mg / 25 mg filmdragerad tablett
English: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg filmdragerad tablett
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 160/12.5 mg (17.8/13.5 mmHg) and 160/25 mg (22.5/15.3 mmHg) compared to placebo (1.9/4.1 mmHg) and the respective monotherapies, i.e., hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg), hydrochlorothiazide 25 mg (12.7/9.3 mmHg) and valsartan 160 mg (12.1/9.4 mmHg).
Swedish: Signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) observerades med kombinationen valsartan/hydroklortiazid 160/12,5 mg (17,8/13,5 mmHg) och 160/25 mg (22,5/15,3 mmHg) jämfört med placebo (1,9/4,1 mmHg) och respektive monoterapi, dvs. hydroklortiazid 12,5 mg (7,3/7,2 mmHg), hydroklortiazid 25 mg (12,7/9,3 mmHg) och valsartan 160 mg (12,1/9,4 mmHg).
English: Co- Novacard 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Co- Novacard 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Diovan Comp 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Diovan Comp 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: • if you suffer from a narrowing of the kidney artery.
Swedish: • om du har förträngning i njurartärerna.
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
Swedish: I en dubbelblind, randomiserad, aktivkontrollerad, klinisk studie på patienter som inte kontrollerats tillfredsställande med hydroklortiazid 12,5 mg observerades signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) med kombinationen valsartan/hydroklortiazid 80/12,5 mg (14,9/11,3 mmHg) jämfört med hydroklortiazid 12,5 mg (5,2/2,9 mmHg) och hydroklortiazid 25 mg (6,8/5,7 mmHg).
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 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).
Swedish: Signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) observerades med kombinationen valsartan/hydroklortiazid 320/12,5 mg (21,7/15,0 mmHg) och 320/25 mg (24,7/16,6 mmHg) jämfört med placebo (7,0/5,9 mmHg) och respektive monoterapi, dvs. hydroklortiazid 12,5 mg (11,1/9,0 mmHg), hydroklortiazid 25 mg (14,5/10,8 mmHg) och valsartan 320 mg (13,7/11,3 mmHg).
English: Cotareg 160mg/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Cotareg 160mg/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Angioedema, rash, pruritus
Swedish: Angioneurotiskt ödem, utslag, klåda
English: Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
Swedish: En filmdragerad tablett innehåller 320 mg valsartan och 12,5 mg hydroklortiazid.
English: LIST OF EXCIPIENTS [To be completed nationally]
Swedish: FÖRTECKNING ÖVER HJÄLPÄMNEN [Kompletteras nationellt]
English: Diovan Comp 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Swedish: Diovan Comp 320/12.5 mg 320 mg / 12,5 mg filmdragerad tablett
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.
Swedish: Dessa doser hos råtta motsvarar 0,9 respektive 3,5 gånger den högsta rekommenderade dosen till människa av valsartan och hydroklortiazid baserat på mg/m2.
English: Cotareg 80mg/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Swedish: Cotareg 80mg/12.5 mg 80 mg / 12,5 mg filmdragerad tablett
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%).
Swedish: Dessutom svarade en signifikant större andel patienter på behandlingen, (BT <140/90 mmHg eller systoliskt blodtryck (SBT) sänkning med ≥20 mmHg eller diastoliskt blodtryck (DBT) sänkning med ≥10 mmHg), med valsartan/hydroklortiazid 160/12,5 mg (50 %) jämfört med hydroklortiazid 25 mg (25 %).
English: Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Swedish: En tablett innehåller 320 mg valsartan och 25 mg hydroklortiazid.
English: Slovenia Novartis Pharma GmbH Roonstrasse 25
Swedish: Slovenien Novartis Pharma GmbH Roonstrasse 25
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Swedish: INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING (NAMN OCH ADRESS) [Se bilaga I. - Kompletteras nationellt]
English: Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovane 80/12,5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Swedish: En tablett innehåller 160 mg valsartan och 25 mg hydroklortiazid.
English: Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.
Swedish: En filmdragerad tablett innehåller 80 mg valsartan och 12,5 mg hydroklortiazid.
English: Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Swedish: En filmdragerad tablett innehåller 160 mg valsartan och 12,5 mg hydroklortiazid.
English: These doses in marmoset, respectively, represent 0.3 and 1.2-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Swedish: Dessa doser hos vit silkesapa motsvarar 0,3 respektive 1,2 gånger den högsta rekommenderade dosen till människa av valsartan och hydroklortiazid baserat på mg/m2.
English: Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Swedish: En tablett innehåller 320 mg valsartan och 12,5 mg hydroklortiazid.
English: Romania Novartis Pharma GmbH Roonstrasse 25
Swedish: Rumänien Novartis Pharma GmbH Roonstrasse 25
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.
Swedish: Dessa doser hos vit silkesapa motsvarar 0,9 respektive 3,5 gånger den högsta rekommenderade dosen till människa av valsartan och hydroklortiazid baserat på mg/m2.
English: Luxembourg Novartis Pharma GmbH Roonstrasse 25
Swedish: Luxemburg Novartis Pharma GmbH Roonstrasse 25
English: Co-Diovan (320 + 25 mg) 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan (320 + 25 mg) 320 mg / 25 mg filmdragerad tablett
English: Co-Diovan (160 + 25 mg) 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan (160 + 25 mg) 160 mg / 25 mg filmdragerad tablett
English: CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: CORIXIL 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Lactation
Swedish: Svindel
English: Co-Diovan (160+25) mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan (160+25) mg 160 mg / 25 mg filmdragerad tablett
English: Co-Diovan (160 + 12.5 mg) 160 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan (160 + 12.5 mg) 160 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan (80 + 12.5 mg) 80 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan (80 + 12.5 mg) 80 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan (320 + 12.5 mg) 320 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan (320 + 12.5 mg) 320 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan (160+12,5) mg 160 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Diovan (160+12,5) mg 160 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan forte 160/25 mg 160 mg / 25 mg filmdragerad tablett
English: Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Swedish: En tablett innehåller 160 mg valsartan och 12,5 mg hydroklortiazid.
English: Co-Diovan (80+12,5) mg 80 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Diovan (80+12,5) mg 80 mg / 12,5 mg filmdragerad tablett
English: Germany Novartis Pharma GmbH Roonstrasse 25
Swedish: Tyskland Novartis Pharma GmbH Roonstrasse 25
English: Co-Diovan (320+25) mg 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan (320+25) mg 320 mg / 25 mg filmdragerad tablett
English: Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Swedish: En tablett innehåller 80 mg valsartan och 12,5 mg hydroklortiazid.
English: Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovane 160/25 mg 160 mg / 25 mg filmdragerad tablett
English: Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Swedish: Storbritannien Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park
English: Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovane 320/12.5 mg 320 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan (320+12,5) mg 320 mg / 12,5 mg film-coated tablets oral
Swedish: Co-Diovan (320+12,5) mg 320 mg / 12,5 mg filmdragerad tablett
English: Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovane 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan forte 320/25 mg 320 mg / 25 mg filmdragerad tablett
English: 80/12.5 mg film-coated tablets oral
Swedish: 80/12,5 mg filmdragerad tablett
English: Co-Diovan 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan 80/12.5 mg 80 mg / 12,5 mg filmdragerad tablett
English: CO-DIOVAN 320 mg/12,5 mg FILMCOATED TABLETS
Swedish: CO-DIOVAN 320 MG/12,5 MG FILM-COATED TABLETS
English: Co-Diovane 320/25 mg 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovane 320/25 mg 320 mg / 25 mg filmdragerad tablett
English: Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo
Swedish: Estland Novartis Finland Oy Metsänneidonkuja 10
English: Diovan Comp 80mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Swedish: Diovan Comp 80mg/12.5 mg80 mg / 12,5 mg filmdragerad tablett
English: Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 160mg/25 160 mg / 25 mg filmdragerad tablett
English: Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 320mg/25 mg 320 mg / 25 mg filmdragerad tablett
English: Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 320 mg/25 mg320 mg / 25 mg filmdragerad tablett
English: Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan 160/12.5 mg 160 mg / 12,5 mg filmdragerad tablett
English: Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Swedish: Diovan Comp 80 mg/12.5 mg80 mg / 12,5 mg filmdragerad tablett
English: Diovan Comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Swedish: Diovan Comp 80/12.5 mg 80 mg / 12,5 mg filmdragerad tablett
English: Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 160 mg/25 mg160 mg / 25 mg filmdragerad tablett
English: Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 160/25 mg 160 mg / 25 mg filmdragerad tablett
English: Co-Diovan 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Swedish: Co-Diovan 320/12.5 mg 320 mg / 12,5 mg filmdragerad tablett
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).
Swedish: Signifikant större genomsnittliga sänkningar i systoliskt/diastoliskt blodtryck (BT) observerades med kombinationen valsartan/hydroklortiazid 80/12,5 mg (16,5/11,8 mmHg) jämfört med placebo (1,9/4,1 mmHg) och både hydroklortiazid 12,5 mg (7,3/7,2 mmHg) och valsartan 80 mg (8,8/8,6 mmHg).
English: Ciclosporin
Swedish: Hypotoni
English: Digitalis glycosides
Swedish: BIPACKSEDEL
English: Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 160mg/25 mg 160 mg / 25 mg filmdragerad tablett
English: Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral
Swedish: Diovan Comp 320/25 mg 320 mg / 25 mg filmdragerad tablett
English: Co-Diovan 160/25 mg 160 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan 160/25 mg 160 mg / 25 mg filmdragerad tablett
English: Co-Diovan 320/25 mg 320 mg / 25 mg film-coated tablets oral
Swedish: Co-Diovan 320/25 mg 320 mg / 25 mg filmdragerad tablett
English: • itchy rash and other types of rash
Swedish: • kliande utslag och andra typer av utslag
English: • the level of haemoglobin decreased and the percentage of red cells decreased in the blood
Swedish: • minskat hemoglobinvärde och minskad andel röda blodkroppar i blodet (båda kan i allvarliga fall ge blodbrist (anemi))
English: • diarrhoea
Swedish: • dimsyn
English: Date of latest renewal: 19 January 2012
Swedish: Datum för den senaste förnyelsen: 19 januari 2012
English: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Swedish: Denna produkt bör inte användas av barn och ungdomar eftersom läkemedelets säkerhet och effekt inte har utvärderats fullständigt.
English: It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.
Swedish: Det är viktigt att du fortsätter att ta Irbesartan Zentiva tills din läkare ger dig andra instruktioner.
English: See also information under the heading “Do not take Irbesartan Zentiva”.
Swedish: Se även informationen under rubriken ”Ta inte Irbesartan Zentiva”.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Swedish: DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE Datum för det första godkännandet: 19 januari 2007
English: The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Swedish: Effekten av Irbesartan Zentiva påverkas ej av ålder eller kön.
English: What Irbesartan Zentiva is and what it is used for
Swedish: Vad Irbesartan Zentiva är och vad det används för
English: Therefore, the use of Irbesartan Zentiva is not recommended.
Swedish: Därför rekommenderas inte användning av Irbesartan Zentiva.
English: Zentiva Italia S.r.l.
Swedish: Italia Zentiva Italia S.r.l.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Swedish: Svälj tabletterna med tillräcklig mängd dryck (t ex ett glas vatten).
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Swedish: Dubbel blockad av renin-angiotensin-aldosteronsystemet (RAAS):
English: You can take Irbesartan Zentiva with or without food.
Swedish: Du kan ta Irbesartan Zentiva med eller utan föda.
English: Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food.
Swedish: Irbesartan Zentiva med mat och dryck Irbesartan Zentiva kan tas med eller utan föda.
English: Irbesartan Zentiva is unlikely to affect your ability to drive or use machines.
Swedish: Irbesartan Zentiva har sannolikt ingen inverkan på din förmåga att köra bil eller använda maskiner.