natgillin/translations-raw huggingface dataset:
Anvendelse af losartan til børn og unge På baggrund af de data, der blev indsendt under artikel 30- indbringelsesproceduren, og resultatet af EU- arbejdsgruppens vurdering af disse pædiatriske data var CHMP af den opfattelse, at det europæiske pædiatriske arbejdsprojekt vedrørende losartan skulle inkorporeres i afsnit 4. 2, 4. 4, 4. 8, 5. 1 og 5. 2 i produktresuméet og de relevante afsnit af indlægssedlen.
19 Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
Følgende ordlyd er tilføjet produktresuméets afsnit 4. 2 Dosering og indgivelsesmåde:
The following wording has been added to SPC section 4.2 Posology and Method of Administration:
Pædiatrisk hypertension Der er begrænsede data om virkningen af og sikkerheden ved losartan hos børn og unge i alderen 6- 16 år i forbindelse med behandling af hypertension (se afsnit 5. 1:
Paediatric hypertension There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1:
Farmakodynamiske egenskaber).
Pharmacodynamic properties).
Der foreligger begrænsede farmakokinetiske data for hypertensive børn, der er over én måned gamle (se afsnit 5. 2:
Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2:
Farmakokinetiske egenskaber).
Pharmacokinetic properties).
Den anbefalede dosis til patienter, der kan synke en tablet, er 25 mg én gang dagligt hos patienter > 20 til < 50 kg.
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg.
Undtagelsesvist kan dosis øges til maksimalt 50 mg én gang dagligt.
In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
Dosen bør justeres i forhold til blodtryksrespons.
Dosage should be adjusted according to blood pressure response.
Til patienter > 50 kg er den sædvanlige dosis 50 mg én gang dagligt.
In patients > 50 kg, the usual dose is 50 mg once daily.
Undtagelsesvist kan dosis justeres til maksimalt 100 mg én gang dagligt.
In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
Doser på over 1, 4 mg/ kg (eller på over 100 mg) dag - ligt er ikke undersøgt hos pædiatriske patienter.
Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in paediatric patients.
Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/ min/ 1, 73 m2, da der ikke foreligger data herfor (se også afsnit 4. 4).
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Losartan anbefales heller ikke til børn med leverinsufficiens (se også afsnit 4. 4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Følgende ordlyd er tilføjet produktresuméets afsnit 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen:
The following wording has been added to SPC Section 4.4 Special warnings and precautions for use:
Symptomatisk hypotension, især efter den første dosis og efter dosisøgning, kan forekomme hos patienter med væske - og/ eller natriummangel som følge af behandling med højdosis- diuretika, begrænsning på salt i kosten, diarré eller opkastning.
Hypotension and Electrolyte/ Fluid Imbalance Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/ or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Disse tilstande bør korrigeres før behandlings - start med Cozaar, eller der bør anvendes reduceret startdosis (se afsnit 4. 2).
These conditions should be corrected prior to administration of< COZAAR >, or a lower starting dose should be used (see section 4.2).
Leverinsufficiens Baseret på farmakokinetiske data, som viser signifikant forhøjede plasmakoncentrationer af losartan hos cirrhotiske patienter, bør det overvejes at anvende en lavere dosis til patienter med nedsat leverfunktion i anamnesen.
Liver Function Impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
Losartan må derfor ikke gives til patienter med svært nedsat leverfunktion (se afsnit 4. 2, 4. 3 og 5. 2).
Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3and 5.2).
Losartan anbefales heller ikke til børn med leverinsufficiens (se afsnit 4. 2).
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
14 Som følge af hæmningen af renin- angiotensinsystemet er der rapporteret om forandringer i nyrefunktionen, herunder nyreinsufficiens (især hos patienter, hvis nyrefunktion er afhængig af renin - angiotensin- aldosteronsystemet, som f. eks. patienter med svær hjerteinsufficiens eller præeksisterende renal dysfunktion).
Renal Function Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Disse forandringer i nyrefunktionen kan være reversible ved seponering af behandlingen.
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon 20 discontinuation of therapy.
Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/ min/ 1, 73 m2, da der ikke foreligger data herfor (se afsnit 4. 2).
Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Dette gælder især, når losartan gives samtidig med, at patienten har andre tilstande (feber, dehydrering), der let kan svække nyrefunktionen.
This applies particularly when losartan is given in the presence of other conditions (fever, dehydratation) likely to impair renal function.
Samtidig brug af losartan og ACE- hæmmere har vist sig at svække nyrefunktionen.
Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.
Samtidig brug frarådes derfor.
Therefore, concomitant use is not recommended.
Følgende ordlyd er tilføjet produktresuméet, afsnit 4. 8 Bivirkninger:
The following wording has been added to SPC Section 4.8 Undesirable effects:
Bivirkningsprofilen for pædiatriske patienter synes at være den samme som bivirkningsprofilen for voksne patienter.
The adverse experience profile for paediatric patients appears to be similar to that seen in adult patients.
Følgende ordlyd er tilføjet produktresuméet, afsnit 5. 1 Farmakodynamiske egenskaber:
The following wording has been added to SPC Section 5.1. Pharmacodynamic Properties:
Pædiatrisk hypertension Cozaars antihypertensive virkning blev fastslået i en klinisk undersøgelse, der omfattede 177 hypertensive pædiatriske patienter i alderen 6- 16 år med en kropsvægt på > 20 kg og en glomerulær filtrationsrate på > 30 ml/ min/ 1, 73 m2.
Paediatric Hypertension The antihypertensive effect of Cozaar was established in a clinical study involving 177 hypertensive paediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Patienter, som vejede > 20 kg til < 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 uger medførte administrationen af losartan én gang dagligt en sænkning af 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.
Samlet set var der dosisrespons.
Overall, there was a dose-response.
Dosis- respons- forholdet blev meget tydeligt i lavdosisgruppen sammenlignet med mellemdosisgruppen (periode I: - 6, 2 mmHg kontra - 11, 65 mmHg), men blev svækket, når mellemdosisgruppen blev sammenlignet med højdosisgruppen (periode I: - 11, 65 mmHg kontra - 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 laveste doser, der blev undersøgt, 2, 5 mg og 5 mg, som svarer til en gennemsnitlig daglig dosis på 0, 07 mg/ kg, syntes ikke at give en konsistent antihypertensiv virkning.
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.
Resultaterne blev bekræftet i løbet af undersøgelsens periode II, hvor patienterne blev randomiseret til at fortsætte med losartan eller placebo efter tre ugers behandling.
These results were confirmed during period II of the study where patients were randomized to continue losartan or placebo, after three weeks of treatment.
Forskellene i blodtryksstigningen sammenlignet med placebo var størst i middeldosisgruppen (6, 70 mmHg for middeldosis kontra 5, 38 mmHg for højdosis).
5.38 mmHg high dose).
Stigningen i det laveste diastoliske blodtryk var det samme hos de patienter, der fik placebo, som hos dem, der fortsatte med at få losartan i den laveste dosis i hver gruppe, hvilket igen peger på, at den laveste dosis i hver gruppe ikke havde nogen signifikant antihypertensiv virkning.
The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.
Følgende ordlyd er tilføjet produktresuméet, afsnit 5. 2 Farmakokinetiske egenskaber:
The following wording has been added to SPC Section 5.2 Pharmacokinetic properties:
0, 54 til 0, 77 mg/ kg losartan (gennemsnitlige doser) én gang dagligt.
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).
Resultaterne viste, at den aktive metabolit dannes af losartan i alle aldersgrupper.
The results showed that the active metabolite is formed from losartan in all age groups.
Ifølge resultaterne var de farmakokinetiske losartanparametre stort set ens efter oral administration hos spædbørn, småbørn, børnehavebørn, børn i skolealderen og unge.
The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
De farmakokinetiske parametre for metabolitten afveg i stor udstrækning aldersgrupperne imellem.
The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Forskellene blev statistisk signifikante, når børnehavebørnene blev sammenlignet med de unge.
When comparing preschool children with adolescents these differences became statistically significant.
Eksponeringen hos spædbørn/ småbørn var relativt høj.
Exposure in infants/ toddlers was comparatively high.
Følgende ordlyd er tilføjet indlægssedlen, afsnit 2 Vigtig information som De skal læse, før De tager COZAAR:
21 The following wording has been added to the Package Leaflet Section 2 Before you take Cozaar:
< COZAAR > er blevet undersøgt til børn.
< COZAAR > has been studied in children.
Tal med lægen for at få yderligere oplysninger.
For more information, talk to your doctor.
- Indbringelsen skulle afdække harmoniseringen af produktresuméer, etikettering og indlægsseddel.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- De produktresuméer, den etikettering og indlægsseddel, som indehaveren af
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
Behandling af nyresygdom hos patienter med hypertension og type 2- diabetes mellitus med proteinuri > 0, 5 g/ dag som led i en antihypertensiv behandling
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/ day as part of an antihypertensive treatment
Risikoreduktion af slagtilfælde hos hypertensive patienter med venstresidig ventrikelhypertrofi dokumenteret ved EKG (se afsnit 5. 1 Life- undersøgelsen, Race)
Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (See section 5.1 Life Study, Race)
Behandling af kronisk hjerteinsufficiens (hos patienter på ≥ 60 år), når behandling med ACE- hæmmere ikke anses for at være egnet på grund af inkompatibilitet, især hoste, eller kontraindikation.
Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Patienter med hjerteinsufficiens, som er blevet stabiliseret med en ACE- hæmmer, bør ikke skiftes over til losartan.
Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Patienterne bør have en venstre ventrikels uddrivningsfraktion, der er ≤ 40%, og bør stabiliseres under behandlingen for den kroniske hjerteinsufficiens.
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure
og 4. 6 i produktresuméet samt i de relevante afsnit af indlægssedlen.
4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
- Anvendelse af losartan til pædiatriske patienter bør inkluderes i afsnit 4. 2, 4. 4, 4. 8, 5. 1 og 5. 2 i
- The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of
produktresuméet samt i de relevante afsnit i indlægssedlen.
the SPC, and the relevant sections of the Package Leaflet.
Produktresuméer, etikettering og indlægsseddel fremgår af bilag III.
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar and associated names (see Annex I).
17 BILAG III
22 ANNEX III
18 PRODUKTRESUME
23 SUMMARY OF PRODUCT CHARACTERISTICS
19 1.
24 1.
Cozaar og tilhørende navne (Se bilag I) 100 mg filmovertrukne tabletter.
Cozaar and associated names (see Annex I) 12.5 mg film-coated tablets Cozaar and associated names (see Annex I) 25 mg film-coated tablets Cozaar and associated names (see Annex I) 50 mg film-coated tablets Cozaar and associated names (see Annex I) 100 mg film-coated tablets
Hver Cozaar 12, 5 mg tablet indeholder 12, 5 mg losartan (som kaliumsalt).
Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Hver Cozaar 12, 5 mg tablet indeholder 25, 5 mg lactosemonohydrat.
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Hver Cozaar 25 mg tablet indeholder 12, 75 mg lactosemonohydrat.
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Hver Cozaar 50 mg tablet indeholder 25, 5 mg lactosemonohydrat.
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Hver Cozaar 100 mg tablet indeholder 51, 0 mg lactosemonohydrat.
Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Cozaar 12, 5 mg tablet Blå, ovale, filmovertrukne tabletter mærket 11 på den ene side og glatte på den anden side.
Cozaar 12,5 mg tablet Blue, oval film-coated tablets marked 11 on one side and plain on the other.
Cozaar 25 mg tablet Hvide, ovale filmovertrukne tabletter uden delekærv mærket 951 på den ene side og glatte på den anden side.
Cozaar 25 mg tablet White, oval unscored film-coated tablets marked 951 on one side and plain on the other..
Tabletten kan deles i to lige store dele.
Cozaar 50 mg tablet White, oval film-coated tablets marked 952 on one side and scored on the other .< The tablet can be divided into equal halves .>
Cozaar 100 mg tablet Hvide, dråbeformede filmovertrukne tabletter mærket 960 på den ene side og glatte på den anden side.
Cozaar 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
• Behandling af essentiel hypertension. • Behandling af nyresygdom hos patienter med hypertension og type 2- diabetes mellitus med proteinuri ≥0, 5 g/ dag som del af en antihypertensiv behandling.
• Treatment of essential hypertension. • Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/ day as part of an antihypertensive treatment.
20 • Behandling af kronisk hjerteinsufficiens (hos patienter ≥60 år), når behandling med ACE - hæmmere ikke anses for at være velegnet på grund af uforligelighed, især hoste, eller kontraindikation.
25 • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Patienter med hjerteinsufficiens, som er stabile i behandling med en ACE - hæmmer, behøver ikke skiftes til losartan.
Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
LIFE undersøgelsen, Race).
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure. • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Hypertension Normal start - og vedligeholdelsesdosis er 50 mg én gang dagligt til de fleste patienter.
Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients.
Maksimal antihypertensiv virkning opnås 3- 6 uger efter initiering af behandling.
The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
Cozaar kan administreres sammen med andre antihypertensiva, især sammen med diuretika (f. eks. hydrochlorthiazid).
Cozaar may be administered with other antihypertensive agents, especially with diuretics (e. g. hydrochlorothiazide).
Pædiatrisk hypertension Der er begrænset dokumentation for losartans sikkerhed og virkning hos børn og unge i alderen 6- 16 år mht. behandling for hypertension (se pkt.
Pediatric hypertension There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1:
5. 1).
Pharmacodynamic properties).
Der er begrænset farmakokinetisk dokumentation for hypertensive børn > 1 måned (se pkt.
Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2:
5. 2).
Pharmacokinetic properties).
Til patienter, der kan sluge en tablet, er den anbefalede dosis 25 mg én gang dagligt til patienter > 20 til < 50 kg.
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg.
I særlige tilfælde kan dosis øges til maksimalt 50 mg én gang dagligt.
In exceptional cases the dose can be increased to a maximum of 50 mg once daily.
Til patienter > 50 kg er startdosis 50 mg én gang dagligt.
In patients > 50 kg, the usual dose is 50 mg once daily.
Doser over 1, 4 mg/ kg (eller mere end 100 mg) dagligt er ikke blevet undersøgt hos pædiatriske patienter.
Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Losartan bør ikke gives til børn under 6 år, da der ikke findes dokumentation for disse patientgrupper.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
4. 4).
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
4. 4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Hypertensive type 2- diabetikere med proteinuri ≥0, 5 g/ dag Normal startdosis er 50 mg én gang dagligt.
Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/ day The usual starting dose is 50 mg once daily.
Cozaar kan administreres sammen med andre antihypertensiva (f. eks. diuretika, calciumkanalblokkere, alfa - eller betablokkere samt centralt virkende lægemidler) såvel som med insulin og andre almindeligt anvendte hypoglykæmiske lægemidler (f. eks. sulfonylurinstoffer, glitazoner og glucosidasehæmmere).
Cozaar may be administered with other antihypertensive agents (e. g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e. g. sulfonylureas, glitazones and glucosidase inhibitors).
Hjerteinsufficiens Den normale startdosis for Cozaar til patienter med hjerteinsufficiens er 12, 5 mg én gang dagligt.
Heart Failure The usual initial dose of Cozaar in patients with heart failure is 12.5 mg once daily.
Generelt bør dosis titreres med ugentlige intervaller (f. eks.
The dose should generally be titrated at weekly intervals (i. e.
12, 5 mg dagligt, 25 mg dagligt, 50 mg dagligt) til normal vedligeholdelsesdosis på 50 mg én gang dagligt, som det kan tolereres af patienten.
12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Reduktion af risikoen for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG Normal startdosis er 50 mg Cozaar én gang dagligt.
26 Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG The usual starting dose is 50 mg of Cozaar once daily.
En lav dosis hydrochlorthiazid bør tilføjes og/ eller dosis af Cozaar bør øges til 100 mg én gang dagligt på basis af blodtryksrespons.
A low dose of hydrochlorothiazide should be added and/ or the dose of Cozaar should be increased to 100 mg once daily based on blood pressure response.
4. 4).
For patients with intravascular volume-depletion (e. g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).
Patienter med leverinsufficiens Lavere dosis bør overvejes til patienter med leverinsufficiens i anamnesen.
A lower dose should be considered for patients with a history of hepatic impairment.
4. 3 og 4. 4).
Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Ældre Selvom det bør overvejes, hvorvidt behandling med 25 mg skal initieres hos patienter over 75 år, er dosisjustering ikke nødvendig hos ældre.
Use in Elderly Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Svær leverinsufficiens.
2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6) Severe hepatic impairment
Overfølsomhed Angioødem.
Hypersensitivity Angiooedema.
4. 8).
Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).