natgillin/translations-raw huggingface dataset:
I subgrupper bestående af
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
8 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det. Der sås forøget hyppighed af ikke- fatalt MI hos kvinder og en reduceet hyppighed af ikke- fatalt MI hos mænd i irbesartan - guirppen versus det placebo- baserede regime.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
Alligevel var der ingen forskel blandt de tre grupper i den overordnede population, hvad angår det sekundære endepunkt af fatal og ikke- fatal kardiovaskulær hændelse e.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
Der sås øget hyppighed af ikke- fatalt MI og slagtilfælde kvinder i det irbesartan- baserede regime versus det amlodipin- baserede regime, mens frekvensen af hospitalindlæggelse på grund af hjertefejl blev reduceret i den samlede population.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
8 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
IRMA 2 var et placebo- kontrolleret dobbelt blindt morbiditets studie med 590 patienter med type 2 diabetes, mikroalbuminuri (30- 300 mg/ dag) og normal nyrefunktion (serum - kreatinin ≤ 1, 5 mg/ dl hos mænd og < 1, 1 mg/ dl hos kvinder).
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
Studiet undersøgte langtidsvirkningerne (2 år) af Aprovel 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 Aprovel 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).
Den foruddefinerede blodtryksværdi var ≤ 135/ 85 mmHg.
The predefined blood pressure goal was ≤ 135/ 85 mmHg.
Yderligere antihypertensive præparater (eksklusiv ACE- hæmemer, angiotensin II- receptorantagonister og dihydropyridin- calciumblokkere) blev tilføjet efter behov for at nå blodtryksmålet.
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Der var dog færre patienter i irbesartan der fik 300 mg (5, 2%) som nåede endepunktet, klinisk proteinuri, sammenlignet med placebo- gruppen (14, 9%) og irbesartan- gruppen der fik 150 mg (9, 7%), hvilket viste en relativ risikoreduktion på 70% versus placebo (p= 0, 0004) ved den højere dosis.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Forhaling af progression til klinisk proteinuri var tydelig allerede efter 3 måneder og den varede ved gennemhele 2- års perioden.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Regression til normo albuminuri (< 30 mg/ dag) forekom hyppigere i gruppen, der fik Aprovel 300 mg (34%) end i placebogruppen (21%).
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Aprovel 300 mg group (34%) than in the placebo group (21%).
60- 80%.
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
96% med ubetydelig binding til cellulære blodkom - ponenter.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Fordelingsvolumenet er 53- 93 liter.
The volume of distribution is 53-93 litres.
Efter peroral eller intravenøs administration af 14C irbesartan, kan 80- 85% af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
Following oral or intravenous administration 14 of C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
6%).
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Isoenzym CYP3A4 har kun ubetydelig effekt.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Irbesartan udviser lineær og dosisproportional farmakokinetik i dosisinterval på 10- 600 mg.
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg.
Årsagen til dette er ukendt.
A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Spidskoncentrationen i plasma opnås 1, 5- 2 timer efter oral administration.
Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Total body - og nyre- clearance er henholdsvis 157- 176 og 3- 3, 5 ml/ min.
The total body and renal clearance are 157-176 and 3-3.5 ml/ min, respectively.
Den terminale halveringstid for irbesartan er 11- 15 timer.
The terminal elimination half-life of irbesartan is 11-15 hours.
Steady- state plasma - koncentrationen nås i løbet af 3 dage efter påbegyndelse af behandling 1 gang dagligt.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Der eri en undersøgelse af kvindelige, hypertensive patienter observeret noget højere plasma - koncentrationer af irbesartan.
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Irbesartan AUC - og Cmax - værdier var også noget større hos ældre patienter (≥ 65 år) end hos yngre patienter (18- 40 år).
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
20% radioaktivitet i urinen og resten i afføringen.
After either oral or IV 14 administration of C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
9 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg daglig i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
9 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/ moderat cirrose.
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Der var ikke tegn på abnorm systemisk toksicitet eller målorgan- toksicitet ved klinisk relevante doser.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
I ikke- kliniske sikkerhedsstudier forårsagede høje doser af irbesartan (≥ 250 mg/ kg/ dag hos rotter og ≥ 100 mg/ kg/ dag hos marekatte) en reduktion af røde blodlegeme- parametre (erytrocytter, hæmoglobin, hæmatokrit).
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Dette betragtes som værende en sekundær effekt af stoffets hypotensive virkning, som medførte nedsat renal perfusion.
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Herudover inducerede irbesartan hyperplasi/ hypertrofi af de juxtaglomerulære celler (hos rotte ved ≥ 90 mg/ kg/ dag, hos marekatte ved ≥ 10 mg/ kg/ dag).
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Ved terapeutiske doser af irbesartan hos mennesker synes hyperplasi/ hypertrofi af de renale juxtaglomerulære celler ikke at have nogen relevans.
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Denne toksiske effektforsvandt efter fødslen.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Kolloid silica Prægelatineret majsstivelse Poloxamer 188.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
10 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Æsker med 14 tabletter:
Cartons of 14 tablets:
1 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere.
1 blister card of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 28 tabletter:
10 Cartons of 28 tablets:
2 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere.
2 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 56 tabletter:
Cartons of 56 tablets:
4 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere.
4 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 98 tabletter:
Cartons of 98 tablets:
7 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere.
7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 56 x 1 tabletter; 7 blisterkort med 8 x 1 tablet i hvert perforeret PVC/ PVDC/ aluminiumblister med éngangsdoser.
Cartons of 56 x 1 tablet; 7 blister cards of 8 x 1 tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Frankrig
SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
27. august 1997 Dato for seneste fornyelse:
27 August 1997 Date of latest renewal:
27. august 2007
27 August 2007
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
30, 75 mg lactosemonohydrat per tablet.
30.75 mg of lactose monohydrate per tablet.
4. 3 Kontraindikationer
12 4.3 Contraindications
13 Graviditet:
Pregnancy:
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
13 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
14 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Imidlertid kan en lille øget risiko ikke udelukkes.
14 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
15 Undersøgelser:
Investigations:
Almindelig:
15 Common:
16 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Metabolisme og ernæring:
16 Metabolism and nutrition disorders:
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
17 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
18 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det. Der sås forøget hyppighed af ikke- fatalt MI hos kvinder og en reduceet hyppighed af ikke- fatalt MI hos mænd i irbesartan - guirppen versus det placebo- baserede regime.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
18 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
19 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg daglig i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
19 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
20 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Æsker med 28 tabletter:
20 Cartons of 28 tablets:
61, 50 mg lactosemonohydrat per tablet.
61.50 mg of lactose monohydrate per tablet.
4. 8, 5. 1 og 5. 2).
22 4.3 Contraindications
Som det også er observeret for angiotensin- konverterende enzymhæmmere er irbesartan og de andre angiotensin antagonister mindre effektive til at nedsætte blodtrykket hos sorte patienter end hos hvide, muligvis fordi reninniveauet ofte er lavere hos den sorte hypertensive befolkning (se pkt.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
5. 1).
Pregnancy:
Behandling med Angiotensin II- Receptor- Antagonister (AIIRAer) bør ikke påbegyndes under graviditet.
23 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
24 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Imidlertid kan en lille øget risiko ikke udelukkes.
24 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100, < 1/ 10); ikke almindelig (≥ 1/ 1. 000, < 1/ 100); sjælden (≥ 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
De alvorligste bivirkninger skal anføres først.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
25 Undersøgelser:
25 Common:
26 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Metabolisme og ernæring:
26 Metabolism and nutrition disorders:
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
27 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
28 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det. Der sås forøget hyppighed af ikke- fatalt MI hos kvinder og en reduceet hyppighed af ikke- fatalt MI hos mænd i irbesartan - guirppen versus det placebo- baserede regime.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
28 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
29 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg daglig i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
29 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
30 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Æsker med 28 tabletter:
30 Cartons of 28 tablets:
25, 50 mg lactosemonohydrat per tablet.
25.50 mg of lactose monohydrate per film-coated tablet.
Ved en dosis på 150 mg, 1 gang dagligt, giver Aprovel generelt en bedre 24- timers blodtrykskontrol end 75 mg.
Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang daglig, kan dosis af Aprovel øges til 300 mg, eller andre antihypertensiva kan tilføjes.
In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other anti-hypertensive agents can be added.
Hos hypertensive type- 2 diabetikere bør behandling starte ved 150 mg irbesartan 1 gang dagligt, og titreres op til 300 mg 1 gang dagligt, som den foretrukne vedligeholdelsesdosering til behandling af nyresygdom.
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Det er ikke nødvendigt, at dosisjustere atienter med nedsat nyrefunktion.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Selvom initialdosis på 75 mg bør overvejes til patienter > 75 år, er g det sædvanligvis ikke nødvendigt at dosisjustere ældre patienter.
Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
32 Pædiatriske patienter:
32 4.3 Contraindications
Specielt efter første dosis kan derforekomme symptomatisk hypotension hos patientermed hypovolæmi og/ eller hyponatriæmi forårsaget af kraftig diuretisk behandling, nedsat saltindtag gennem kosten, diarré eller opkastning.
Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Der er øget risiko for alvorlig hypotension og nyreinsufficiens, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til deres eneste fungerende nyre, behandles med lægemidler der påvirker renin- angiotensin- aldosteronsystemet.
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
I en undersøgelse med patienter med fremskreden nyresygdom var effekten af irbesartan på nyrer og kardiovaskulære hændelser ikke den samme i alle subgrupper.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Som med andre lægemidler, der påvirker renin- angiotensin- aldosteronsystemet, kan der opstå hyperkaliæmi under behandling med Aprovel, specielt i tilfælde af nyrefunktionsnedsættelse, klinisk proteinuri på grund af diabetisk nyresygdom og/ eller hjertefejl.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive lægemidler, der virker gennem hæmning af renin- angiotensinsystemet.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Som det også er observeret for angiotensin- konverterende enzymhæmmere er irbesartan og de andre angiotensin antagonister mindre effektive til at nedsætte blodtrykket hos sorte patienter end hos hvide, muligvis fordi reninniveauet ofte er lavere hos den sorte, hypertensive befolkning (se pkt.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Behandling med Angiotensin II- Receptor- Antagonister (AIIRAer) bør ikke påbegyndes under graviditet.
33 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.