natgillin/translations-raw huggingface dataset:
Patienter med proteinuri og serumkreatinin på 1, 3- 3, 0 mg/ dl blev, i tillæg til konventionel antihypertensiv behandling med undtagelse af ACE- hæmmere og angiotensin II- antagonister, randomiseret til losartan 50 mg én gang dagligt, og blev titreret til, hvis nødvendigt, til blodtryksrespons, eller placebo.
Patients with proteinuria and a serum creatinine of 1.3 – 3.0 mg/ dl were randomised to receive Losartan 50 mg once a day, titrated if necessary, to achieve blood pressure response, or to placebo, on a background of conventional antihypertensive therapy excluding ACE-inhibitors and angiotension II antagonists.
Investigatorerne blev instrueret i at titrere forsøgsmedicinen til 100 mg én gang dagligt, hvis dette var relevant; 72% af patienterne fik 100 mg dagligt det meste af tiden.
Investigators were instructed to titrate the study medication to 100 mg daily as appropriate; 72% of patients were taking the 100 mg daily dose for the majority of the time.
Andre antihypertensive lægemidler (diuretika, calciumantagonister, alfa - og betablokkere samt centralt virkende antihypertensiva) var tilladt som tillægsbehandling efter behov i begge grupper.
Other antihypertensive agents (diuretics, calcium antagonists, alpha- and beta-receptor blockers and also centrally acting antihypertensives) were permitted as supplementary treatment depending on the requirement in both groups.
Patienterne blev fulgt i op til 4, 6 år (i gennemsnit 3, 4 år).
Patients were followed up for up to 4.6 years (3.4 years on average).
Undersøgelsens primære effektmål var det kombinerede effektmål med fordobling af serumkreatinin, endstage nyresvigt (behov for dialyse eller transplantation) eller død.
The primary endpoint of the study was a composite endpoint of doubling of the serum creatinine end- stage renal failure (need for dialysis or transplantation) or death.
29 Resultaterne viste, at behandling med losartan (327 hændelser) sammenlignet med placebo (359 hændelser) gav 16, 1% risikoreduktion (p=0, 022) for, at patienter nåede det primære, samlede effektmål.
The results showed that the treatment with Losartan (327 events) as compared with placebo (359 events) resulted in a 16.1% risk reduction (p = 0.022) in the number of patients reaching the primary composite endpoint.
For følgende individuelle og kombinerede komponenter af de primære effektmål viste resultaterne ligeledes signifikant risikoreduktion i gruppen, der blev behandlet med losartan:
For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with Losartan:
25, 3% risikoreduktion i fordobling af serumkreatinin (p=0, 006); 28, 6% risikoreduktion i kronisk nyresvigt (p=0, 002); 19, 9% risikoreduktion i kronisk nyresvigt eller død (p=0, 009); 21, 0% risikoreduktion i fordobling af serumkreatinin eller kronisk nyresvigt (p=0, 01).
25.3% risk reduction for doubling of the serum creatinine (p = 0.006); 28.6% risk reduction for end-stage renal failure (p = 0.002); 19.9% risk reduction for end-stage renal failure or death (p = 0.009); 21.0% risk reduction for doubling of serum creatinine or end-stage renal failure (p = 0.01).
ELITE I og II- undersøgelserne I ELITE- undersøgelsen, som var af 48 ugers varighed, sås hos patienter (n=722) med hjerteinsufficiens (NYHA klasse II- IV) ingen forskel mellem de patienter, der blev behandlet med losartan og de patienter, der fik captopril med hensyn til det primære effektmål for en langtidsændring i nyrefunktionen.
ELITE I and ELITE II Study In the ELITE Study carried out over 48 weeks in 722 patients with heart failure (NYHA Class II-IV), no difference was observed between the patients treated with Losartan and those treated with captopril was observed with regard to the primary endpoint of a long-term change in renal function.
Observationen i ELITE I- undersøgelsen, at losartan reducerede risikoen for dødsfald sammenlignet med captopril, blev ikke bekræftet i den efterfølgende ELITE II- undersøgelse, som beskrives nedenfor.
The observation of the ELITE I Study, that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study, which is described in the following.
I ELITE II- undersøgelsen blev losartan 50 mg én gang dagligt (startdosis 12, 5 mg titreret til 25 mg og derefter 50 mg én gang dagligt) sammenlignet med captopril 50 mg tre gange dagligt (startdosis 12, 5 mg titreret til 25 mg og derefter 50 mg tre gange dagligt).
In the ELITE II Study Losartan 50 mg once daily (starting dose 12.5 mg, increased to 25 mg, then 50 mg once daily) was compared with captopril 50 mg three times daily (starting dose 12.5 m, increased to 25 mg and then to 50 mg three times daily).
I denne undersøgelse blev 3152 patienter med hjerteinsufficiens (NYHA klasse II- IV) fulgt i næsten to år (median 1, 5 år) for at undersøge, om losartan reducerede den totale mortalitet bedre end captopril.
1.5 years) in order to determine whether Losartan is superior to captopril in reducing all cause mortality.
Der sås en stigning i mortalitet i ELITE II i den lille undergruppe (22% af alle HF- patienter), der tog beta- blokkere ved baseline.
An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline.
Pædiatrisk hypertension Cozaars antihypertensive virkning blev fastslået i en klinisk undersøgelse med 177 hypertensive pædiatriske patienter i alderen 6- 16 år med en kropsvægt > 20 kg og glomerulær filtrationshastighed > 30 ml/ min/ 1, 73m2.
35 The antihypertensive effect of Cozaar was established in a clinical study involving 177 hypertensive pediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filration rate > 30 ml/ min/ 1.73 m2.
Patienter, som vejede > 20 - < 50 kg fik enten 2, 5, 25 eller 50 mg losartan dagligt, og patienter som vejede > 50 kg fik enten 5, 50 eller 100 mg losartan dagligt.
Patients who weighted > 20kg to< 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily.
Efter tre ugers administration af losartan én gang dagligt reduceredes det laveste blodtryk på en dosisafhængig måde.
At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dose-dependent manner.
Dosisresponsforholdet var meget tydeligt i den gruppe, der fik lav dosis sammenlignet med den gruppe, der fik middeldosis (periode I: - 6, 2 mmHg versus - 11, 65 mmHg), men det var mindre tydeligt, når man sammenlignede gruppen, der fik middeldosis med gruppen, der fik høj dosis (periode I: - 11, 65 mmHg versus - 12, 21 mmHg).
The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg).
De lavest undersøgte doser, 2, 5 mg og 5 mg, svarende til en gennemsnitlig daglig dosis på 0, 07 mg/ kg, gav ingen konsistent antihypertensiv effekt.
The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/ kg, did not appear to offer consistent antihypertensive efficacy.
Forskellen i blodtryksstigning sammenlignet med placebo var størst i den gruppe, der fik middeldosis (6, 70 mmHg middeldosis versus 5, 38 mmHg høj dosis).
5.38 mmHg high dose).
30 Losartans langtidsvirkning på vækst, pubertet og generel udvikling er ikke undersøgt.
Long-term effects of losartan on growth, puberty and general development have not been studied.
Efter peroral administration absorberes losartan godt og undergår first- pass metabolisme, hvorved der dannes en aktiv carboxylsyremetabolit og andre inaktive metabolitter.
Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Både losartan og dets aktive metabolit bindes ≥99% til plasmaproteiner, primært albumin.
Both losartan and its active metabolite are ≥ 99% bound to plasma proteins, primarily albumin.
14% af en intravenøs eller peroralt administreret dosis af losartan omdannes til dets aktive metabolit.
About 14% of an intravenously- or orally-administered dose of losartan is converted to its active metabolite.
Efter peroral og intravenøs administration af 14C- mærket losartankalium, er cirkulerende plasmaradioaktivitet primært knyttet til losartan og dets aktive metabolit.
Following oral and intravenous administration of 14C-labeled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite.
600 ml/ min og 50 ml / min.
Plasma clearance of losartan and its active metabolite is about 600 mL/ min and 50 mL/ min, respectively.
2 timer og 6- 9 timer.
36 Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively.
35% / 43% af radioaktiviteten genfundet i urin og 58% / 50% i fæces.
Following an oral dose/ intravenous administration of 14C-labeled losartan in man, about 35% / 43% of radioactivity is recovered in the urine and 58%/ 50% in the faeces.
4. 2 og 4. 4).
In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).
31 Losartans plasmakoncentration er uændret hos patienter med kreatinin- clearance > 10 ml/ minut.
Plasma concentrations of Losartan are not altered in patients with a creatinine clearance above 10 ml/ minute.
2 gange højere hos patienter i hæmodialyse.
Compared to patients with normal renal function, the AUC for Losartan is about 2-times higher in haemodialysis dialysis patients.
0, 54- 0, 77 mg/ kg losartan (gennemsnitlige doser).
Pharmacokinetics in paediatric patients The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients > 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).
Eksponering hos spædbørn/ små børn var forholdsvis høj.
Exposure in infants/ toddlers was comparatively high.
I gentagne dosistoksicitetsundersøgelser inducerede administration af losartan et fald i de røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), en stigning i urinstof- N i serum og lejlighedsvise stigninger i serumkreatinin, fald i hjertevægt (uden histologisk korrelat) og gastrointestinale forandringer (læsion af slimhindemembranen, mavesår, erosioner, blødninger).
In repeated dose toxicity studies, the administration of losartan induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Som andre lægemidler, der direkte påvirker renin- angiotensinsystemet, inducerer losartan bivirkninger i det sene stadie af fosterudviklingen, som medfører fosterdød og misdannelser.
Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations.
6. 1 Hjælpestoffer
37 6.1 List of excipients
Mikrokrystallinsk cellulose (E460) Lactosemonohydrat Prægelatineret majsstivelse Magnesiumstearat (E572) Hydroxypropylcellulose (E463) Hypromellose (E464)
Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Cozaar 12. 5 mg, 25 mg, 50 mg og 100 mg indeholder kalium i følgende mængder:
Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts:
Henholdsvis 1, 06 mg (0, 027 mEq), 2, 12 mg (0, 054 mEq), 4, 24 mg (0, 108 mEq) og 8, 48 mg (0, 216 mEq).
1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
Cozaar 12, 5 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171), indigocarmin (E132).
Cozaar 12.5 mg tablets also may contain carnauba wax E 903, titanium dioxideE171, indigo carmine E132 aluminum lake.
Cozaar 25 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Cozaar 50 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Cozaar 100 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
32 6. 2 Uforligeligheder
6.2 Incompatibilities
Cozaar 12, 5 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 21, 28, 50, 98, 210 eller 500 tabletter.
Cozaar 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
HDPE- flasker à 100 tabletter.
HDPE bottles of 100 tablets.
En pakning med 35 tabletter (21 stk. à 12, 5 mg og 14 stk. à 50 mg) eller 28 tabletter (21 stk. à 12, 5 mg og 7 stk. à 50 mg) kan fås i en PVC/ PE/ PVDC titreringspakning.
A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/ PE/ PVDC titration blister package.
Cozaar 25 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 7 eller 28 tabletter.
Cozaar 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Cozaar 50 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter.
Cozaar 50 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
HDPE- flasker à 100 tabletter eller 300 tabletter.
HDPE bottles of 100 or 300 tablets.
PVC/ aluminiumsfolie/ nylonblister med aluminiumsfolie i pakninger à 10, 14 og 28 tabletter.
PVC/ aluminum foil/ nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
Cozaar 100 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
Cozaar 100 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
6. 6 Regler for destruktion
38 6.6 Special precautions for disposal
< DD, MM, ÅÅÅÅ >
< {DD/MM/YYYY} > < {DD month YYYY} >
33 < MM/ ÅÅÅÅ >
{MM/ YYYY}
34 ETIKETTERING
39 LABELLING
35 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 12, 5 mg blister
Outer carton for Cozaar 12.5 mg blister
Cozaar 12, 5 mg filmovertrukne tabletter
Cozaar 12.5 mg film-coated tablets
Hver tablet indeholder 12, 5 mg losartankalium.
Each tablet contains 12.5 mg losartan potassium.
7, 14, 21, 28, 50, 98, 210 eller 500 filmovertrukne tabletter.
7, 14, 21, 28, 50, 98, 210 or 500 film-coated tablets.
Opbevares i den originale yderpakning.
Keep the blister in the outer carton.
36 [Udfyldes nationalt]
[To be completed nationally]
37 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister til Cozaar 12, 5 mg filmovertrukne tabletter
Blister for Cozaar 12.5 mg film-coated tablets
[Se bilag I – Udfyldes nationalt]
[See Annex I - To be completed nationally] [For referral procedures]
38 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 12, 5 mg HDPE- flaske
Outer carton for Cozaar 12.5 mg HDPE bottle
40 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Flaskeetiket til Cozaar 12, 5 mg HDPE- flaske
Bottle label for Cozaar 12.5 mg HDPE bottle
41 12.
12.
FREMSTILLERENS BATCHNUMMER
[To be completed nationally]
Receptpligtigt lægemiddel.
[To be completed nationally]
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
[To be completed nationally] [For referral procedures]
42 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 25 mg blister
Outer carton for Cozaar 25 mg
Cozaar 25 mg filmovertrukne tabletter
Cozaar 25 mg film-coated tablets
Hver tablet indeholder 25 mg losartankalium.
Each tablet contains 25 mg losartan potassium.
7 filmovertrukne tabletter 28 filmovertrukne tabletter
7 film-coated tablets 28 film-coated tablets
43 [Udfyldes nationalt]
[To be completed nationally]
44 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister til Cozaar 25 mg filmovertrukne tabletter
Blister for Cozaar 25 mg film-coated tablets
45 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 50 mg blister
Outer carton for Cozaar 50 mg blister
Cozaar 50 mg filmovertrukne tabletter
Cozaar 50 mg film-coated tablets
Hver tablet indeholder 50 mg losartankalium.
Each tablet contains 50 mg losartan potassium.
7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter.
7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
46 [Udfyldes nationalt]
[To be completed nationally]
47 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister til Cozaar 50 mg filmovertrukne tabletter
Blister for Cozaar 50 mg film-coated tablets
48 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 50 mg HDPE- flaske
Outer carton for Cozaar 50 mg HDPE bottle
100 eller 300 tabletter.
100 or 300 tablets.
49 12.
12.
50 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Flaskeetiket til Cozaar 50 mg HDPE- flaske
Bottle label for Cozaar 50 mg HDPE bottle
51 12.
12.
52 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 100 mg blister
Outer carton for Cozaar 100 mg blister
Cozaar 100 mg filmovertrukne tabletter
Cozaar 100 mg film-coated tablets
Hver tablet indeholder 100 mg losartankalium.
Each tablet contains 100 mg losartan potassium.
7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
53 [Udfyldes nationalt]
[To be completed nationally]
54 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
59 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister til Cozaar 100 mg filmovertrukne tabletter
Blister for Cozaar 100 mg film-coated tablets
55 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 100 mg HDPE- flaske
Outer carton for Cozaar 100 mg HDPE Bottle
100 tabletter.
100 tablets.
Opbevares i den originale yderpakning.
Store in the original bottle.
10.
61 10.
57 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Flaskeetiket til Cozaar 100 mg HDPE- flaske
Bottle label for Cozaar 100 mg HDPE Bottle
58 [Udfyldes nationalt]
[To be completed nationally]
59 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre karton for Cozaar 12, 5 mg og 50 mg (startpakke)
Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Cozaar 12, 5 mg filmovertrukne tabletter Cozaar 50 mg filmovertrukne tabletter
Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Hver Cozaar 12, 5 mg filmovertrukken tablet indeholder 12, 5 mg losartankalium Hver Cozaar 50 mg filmovertrukken tablet indeholder 50 mg losartankalium.
Each Cozaar 50 mg film-coated mg tablet contains 50 mg losartan potassium.
28 dages startpakke Hver pakke indeholder i alt 35 tabletter:
28 day initiation pack Each pack contains a total of 35 tablets:
21 filmovertrukne tabletter à 12, 5 mg og 14 filmovertrukne tabletter à 50 mg losartankalium.
21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
21 filmovertrukne tabletter à 12, 5 mg og 7 filmovertrukne tabletter à 50 mg losartankalium.
21 film-coated tablets of 12.5 mg and 7 film-coated tablets of 50 mg losartan potassium.
Opbevares i den originale yderpakning.
65 Keep the blister in the outer carton.
61 MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Trefold Blister til Cozaar 12, 5 mg filmovertrukne tabletter Blister til Cozaar 50 mg filmovertrukne tabletter
66 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Trifold Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
UGE 1 (dag 1- 7) 1 tablet = 12, 5 mg dagligt Anvend dette blisterkort først
WEEK 1 (day 1-7) 1 tablet = 12,5 mg daily Use this card first
UGE 2 (dag 8- 14) 2 tabletter = 25 mg dagligt
WEEK 2 (Day 8-14) 2 tablets = 25 mg once daily
UGE 3 (dag 15- 21) 1 tablet = 50 mg dagligt
WEEK 3 (day 15-21) 1 tablet = 50 mg daily
UGE 4 (dag 22- 28) 1 tablet = 50 mg dagligt
WEEK 4 (day 22-28) 1 tablet = 50 mg daily
63 INDLÆGSSEDDEL:
67 PACKAGE LEAFLET:
Læs denne indlægssseddel grundigt, inden De begynder at tage medicinen. • Gem indlægssedlen.
Read all of this leaflet carefully before taking this medicine.
De kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, De vil vide. • Lægen har ordineret Cozaar til Dem personligt.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
Cozaars virkning og hvad De skal bruge det til 2.
What Cozaar is and what it is used for 2.
Det skal De vide, før De begynder at tage Cozaar 3.
Before you take Cozaar 3.
Sådan skal De tage Cozaar 4.
How to take Cozaar 4.
Sådan opbevarer De Cozaar 6.
How to store Cozaar 6.
Cozaar tilhører en medicingruppe, der er kendt som angiotensin II- receptorantagonister.
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Cozaar forsinker nedgang i nyrefunktionen hos patienter med forhøjet blodtryk og type II- diabetes.
Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes
Cozaar anvendes til • at behandle patienter med forhøjet blodtryk (hypertension); • at beskytte nyrerne hos type 2- diabetikere med forhøjet blodtryk, hvor laboratorieprøver viser nedsat nyrefunktion og proteinuri ≥0, 5 g pr. dag (en tilstand hvor urinen indeholder en unor - mal mængde protein); • at behandle patienter med kronisk nedsat hjertefunktion, når lægen finder behandling med særlige lægemidler, der kaldes angiotensinkonverterende enzymhæmmere uegnet (ACE - hæmmere, medicin til at sænke blodtrykket).
Cozaar is used • to treat patients with high blood pressure (hypertension) • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein). • to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor.
Hvis Deres nedsatte hjertefunktion er blevet stabiliseret med ACE- hæmmere, behøver De ikke at skifte til Cozaar; • patienter med både højt blodtryk og en fortykkelse af hjertevæggen, hvor Cozaar kan nedsætte risikoen for slagtilfælde ("LIFE" - indikationen).
If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan. • in patients with high blood pressure and a thickening of the left ventricle, COZAAR has been shown to decrease the risk of stroke (“ LIFE indication”).
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE COZAAR
BEFORE YOU TAKE Cozaar