natgillin/translations-raw huggingface dataset:
Pres kanylen helt ind i huden med en hurtig, kort bevægelse i en vinkel mellem 45° og 90° (se billede 3).
With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 3).
333 5.
7.
Billede 4
361 Diagram 4
334
362
Enviage er et lægemiddel, der indeholder det aktive stof aliskiren.
Enviage is a medicine containing the active substance aliskiren.
Det leveres som tabletter: runde, lyserøde på 150 mg, og aflange, røde på 300 mg.
300 mg).
"Essentiel" betyder, at årsagen ikke kendes.
Enviage is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Det bør tages med et let måltid, helst på samme klokkeslæt hver dag.
It should be taken with a light meal preferably at the same time each day.
Dosis kan øges til 300 mg én gang dagligt, hvis blodtrykket ikke er tilfredsstillende kontrolleret.
The dose may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Enviage anbefales ikke til børn på grund af manglende data om sikkerhed og effekt hos denne aldersgruppe.
Enviage is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Det blokerer virkningen af enzymet renin, der i kroppen medvirker ved dannelsen af stoffet angiotensin I.
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance, angiotensin I, in the body.
Angiotensin I omdannes til hormonet angiotensin II, der virker stærkt sammentrækkende på blodkarrene.
Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (it narrows blood vessels).
Derved nedsættes risikoen for skader som følge af for højt blodtryk.
This causes vasodilation (widening of the blood vessels), so that the blood pressure drops and the potential risk of damage caused by high blood pressure may be reduced.
Virkningerne af Enviage blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Enviage were first tested in experimental models before being studied in humans.
Revlimid blev anvendt i 14 hovedundersøgelser, hvori der deltog 10 000 patienter med essentiel hypertension.
Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Én undersøgelse omfattede patienter med svær hypertension.
Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
I fem af undersøgelserne blev virkningerne af Enviage, anvendt alene, sammenlignet med virkningerne af placebo (virkningsløs behandling).
In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
Enviage blev dels taget alene, dels i kombination med andre lægemidler, og blev sammenlignet med anden medicin mod for højt blodtryk.
Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
I kombinationsundersøgelserne blev Enviage anvendt sammen med ramipril, der er en angiotensinkonvertaseenzymhæmmer (ACE- hæmmer), en angiotensin - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged receptorblokker (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diuretic (hydrochlorothiazide).
Undersøgelserne varede mellem seks og 52 uger, og virkningen blev hovedsagelig bedømt ved ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart are contracting (systolic).
Når Enviage blev anvendt uden tillægsmedicin, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Gennemsnitsværdien ved undersøgelsens start var 99, 4 mmHg.
When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Til sammenligning fik patienterne på placebo et fald på 5, 8 mmHg fra en startværdi på 99, 3 mmHg.
This was compared with a fall of 5.8 mmHg from 99.3 mmHg in those taking placebo.
Hos patienter over 65 år og hos dem, der fik Enviage i større doser, blev blodtrykket sænket yderligere.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Enviage.
Enviage nedsatte også blodtrykket hos patienter med sukkersyge, overvægtige patienter og patienter over 65 år.
Enviage also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Lægemidlets virkning holdt sig i indtil 52 uger i to af undersøgelserne.
The medicine’ s effects were maintained for up to 52 weeks in two of the studies.
Undersøgelserne viste også, at når Enviage anvendes sammen med andre lægemidler (især hydrochlorthiazid), kan det mindske blodtrykket mere, end når disse lægemidler anvendes uden Enviage.
The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Enviage.
Den almindeligste bivirkning af Enviage (som ses hos mellem 1 og 10 patienter ud af 100) er diarré.
The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
Den fuldstændige liste over de indberettede bivirkninger for Enviage fremgår af indlægssedlen.
For the full list of all side effects reported with Enviage, see the Package Leaflet.
Det må desuden ikke anvendes i svangerskabets sidste to tremånedersperioder (dvs. fra omkring fjerde måned).
It must also not be used during the second or third trimesters of pregnancy (from around the fourth month of pregnancy).
Det anbefales ikke at anvende det i første tremånedersperiode eller hos kvinder, der planlægger at blive gravide.
Its use during the first trimester of pregnancy and in women planning to become pregnant is not recommended.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Enviage til Novartis Europharm Limited den 22. august 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
EU- nummer EU/ 1/ 07/ 406/ 001 EU/ 1/ 07/ 406/ 002 EU/ 1/ 07/ 406/ 003 EU/ 1/ 07/ 406/ 004 EU/ 1/ 07/ 406/ 005 EU/ 1/ 07/ 406/ 006 EU/ 1/ 07/ 406/ 007 EU/ 1/ 07/ 406/ 008 EU/ 1/ 07/ 406/ 009 EU/ 1/ 07/ 406/ 010 EU/ 1/ 07/ 406/ 011 EU/ 1/ 07/ 406/ 012 EU/ 1/ 07/ 406/ 013 EU/ 1/ 07/ 406/ 014 EU/ 1/ 07/ 406/ 015 EU/ 1/ 07/ 406/ 016 EU/ 1/ 07/ 406/ 017 EU/ 1/ 07/ 406/ 018 EU/ 1/ 07/ 406/ 019 EU/ 1/ 07/ 406/ 020
EU/ 1/ 07/ 406/ 001 EU/ 1/ 07/ 406/ 002 EU/ 1/ 07/ 406/ 003 EU/ 1/ 07/ 406/ 004 EU/ 1/ 07/ 406/ 005 EU/ 1/ 07/ 406/ 006 EU/ 1/ 07/ 406/ 007 EU/ 1/ 07/ 406/ 008 EU/ 1/ 07/ 406/ 009 EU/ 1/ 07/ 406/ 010 EU/ 1/ 07/ 406/ 011 EU/ 1/ 07/ 406/ 012 EU/ 1/ 07/ 406/ 013 EU/ 1/ 07/ 406/ 014 EU/ 1/ 07/ 406/ 015 EU/ 1/ 07/ 406/ 016 EU/ 1/ 07/ 406/ 017 EU/ 1/ 07/ 406/ 018 EU/ 1/ 07/ 406/ 019 EU/ 1/ 07/ 406/ 020
Særnavn Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage
Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage
Styrke 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg
150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 150 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg 300 mg
Lægemiddelform Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC)
Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC) Blister (PA/ Alu/ PVC)
Pakningsstørrelse 7 tabletter 14 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 (3x28) tabletter 90 tabletter 98 (2x49) tabletter 280 (20x14) tabletter 7 tabletter 14 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 (3x28) tabletter 90 (3x30) tabletter 98 (2x49) tabletter 280 (20x14) tabletter
7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 tablets 98 (2x49) tablets 280 (20x14) tablets 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 (3x30) tablets 98 (2x49) tablets 280 (20x14) tablets
Lys pink, udadbuet, rund tablet, præget med ” IL ” på den ene side og ” NVR ” på den anden side.
Light-pink, biconvex, round tablet, imprinted “ IL ” on one side and “ NVR” on the other side.
Den antihypertensive effekt er til stede i betydelig grad inden for to uger (85- 90%) efter initiering af behandling med 150 mg en gang dagligt.
The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Enviage kan anvendes alene eller kombineres med andre antihypertensiva (se pkt 4. 4 og 5. 1).
Enviage may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
4. 4 og 5. 2).
Renal impairment No adjustment of the initial dose is required for patients with mild to severe renal impairment (see sections 4.4 and 5.2).
5. 2).
Hepatic impairment No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
5. 2).
Paediatric patients (below 18 years) Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
4. 6).
2 Second and third trimesters of pregnancy (see section 4.6).
4. 5).
The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent P- gp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
Patienter, som anvender andre lægemidler der hæmmer renin- angiotensin systemet (RAS), og/ eller har nedsat nyrefunktion og/ eller diabetes mellitus har en øget risiko for hyperkalæmi under behandling med aliskiren.
Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/ or those with reduced kidney function and/ or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Aliskiren bør anvendes med forsigtighed til patienter med svær hjertesvigt (New York Heart Association [NYHA] klasse III- IV).
Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Patienter med natrium - og/ eller væskemangel Symptomatisk hypotension kan forekomme hos patienter med markant væske - og/ eller natriummangel (f. eks. patienter, som får høje doser af diuretika) efter initiering af behandling med Enviage.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Enviage.
Nedsat nyrefunktion Enviage er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/ l eller 1, 70 mg/ dl hos kvinder og ≥ 177 μmol/ l eller 2, 00 mg/ dl hos mænd og/ eller estimeret glomerulær filtrationsrate (GFR) < 30 ml/ min.), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
Renal impairment In clinical studies Enviage has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Nyrearteriestenose Der er ingen tilgængelige data for brug af Enviage til patienter med unilateral eller bilateral nyrearteriestenose eller stenose til en enkelt nyre.
Renal artery stenosis No data are available on the use of Enviage in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Moderate P- gp- hæmmere Samtidig administration af aliskiren 300 mg og ketoconazol 200 mg resulterede i en 76% stigning i aliskirens AUC, men P- gp- hæmmere som ketoconazol kan forventes at øge vævskoncentrationerne mere end plasmakoncentrationerne.
Moderate P-gp inhibitors Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
4. 5).
Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole (see section 4.5).
Stoffer, som er undersøgt i kliniske farmakokinetiske studier inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid- 5- mononitrat, ramipril og hydrochlortiazid.
Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril and hydrochlorothiazide.
Samtidig administration af aliskiren med enten valsartan (↓28%), metformin (↓28%), amlodipin (↑29%) eller cimetidin (↑19%) resulterede i en ændring af Cmax eller AUC for Enviage på mellem 20% og 30%.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Ved samtidig administration med atorvastatin steg AUC og Cmax for Enviage ved steady state med 50%.
When administered with atorvastatin, steady-state Enviage AUC and Cmax increased by 50%.
3 Foreløbige data tyder på at irbesartan kan nedsætte AUC og Cmax for Enviage.
3 Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
I forsøgsdyr er det blevet vist a P- gp har stor indflydelse på Enviages biotilgængelighed.
In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Inducere af P- gp (prikbladet perikum, rifampicin) kan derfor nedsætte biotilgængeligheden af Enviage.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Interaktioner med CYP450 Aliskiren hæmmer ikke CYP450- isoenzymer (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A).
CYP450 interactions Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A).
Aliskiren metaboliseres minimalt af cytokrom P450- enzymer.
Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
CYP3A4- hæmmere påvirker dog ofte også P- gp.
However, CYP3A4 inhibitors often also affect P-gp.
Øget aliskiren- eksponering ved samtidig administration af CYP3A4- hæmmere, som også hæmmer P- gp, kan derfor forventes (se også P- glycoprotein interaktioner herunder).
Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Interaktioner med P- glycoprotein I prækliniske forsøg er det vist, at MDR1/ Mdr1a/ 1b (P- gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og galdeudskillelse.
P-glycoprotein interactions MDR1/ Mdr1a/ 1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Induktorer af P- gp (perikum, rifampicin) kan muligvis derfor nedsætte Enviages biotilgængelighed.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Selvom det ikke er blevet undersøgt for aliskiren, er det kendt, at P- gp også kontrollerer vævsoptaget for et stort udvalg af substrater, og P- gp kan øge koncentrationsforholdet mellem væv og plasma.
Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Derfor kan kan P- gp- induktorer øge vævskoncentrationen mere end plasmakoncentrationen.
Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Muligheden for interaktioner med lægemidler ved P- gp’ s bindingssted vil sandsynligvis afhænge af denne transportørs hæmningsgrad.
The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
P- gp- substrater eller svage hæmmere Der er ikke observeret nogen relevante interaktioner med atenolol, digoxin, amlodipin eller cimetidin.
P-gp substrates or weak inhibitors No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Ved samtidig administration af aliskiren (300 mg) og atorvastatin (80 mg) blev AUC og Cmax for aliskiren øget med 50% ved steady state.
When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by 50%.
Moderate P- gp- hæmmere Administration af ketoconazol (200 mg) sammen med aliskiren (300 mg) resulterede i en 80% stigning af plasmaniveauerne for aliskiren (AUC og Cmax).
Moderate P-gp inhibitors Co-administration of ketoconazole (200 mg) with aliskiren (300 mg) resulted in an 80% increase in plasma levels of aliskiren (AUC and Cmax).
Alligevel forventes det, at P- gp- hæmmere øger vævskoncentrationerne mere end plasmakoncentrationerne.
Yet, P-gp inhibitors are expected to increase tissue concentrations more than plasma concentrations.
Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen ketoconazol eller andre moderate P- gp- hæmmere (itraconazol, clarithromycin, telithromycin, erythromycin, amiodaron).
Therefore, caution should be exercised when aliskiren is administered with ketoconazole or other moderate pgp inhibitors (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
Potente P- gp- hæmmere Et interaktionsforsøg med raske frivillige personer, hvor dosis blev administreret en gang, har vist, at ciclosporin (200 og 600 mg) øger Cmax af aliskiren 75 mg cirka 2, 5 gange og AUC cirka 5 gange.
P-gp potent inhibitors A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
4. 3).
Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Furosemid Når aliskiren blev administreret sammen med furosemid, faldt AUC og Cmax for furosemid med henholdsvis 28% og 49%.
Furosemide When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49% respectively.
Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumen - overload.
It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of volume overload.
Kalium og kaliumbesparende diuretika Baseret på erfaringer med andre stoffer, som påvirker renin- angiotensin- systemet kan samtidig brug af kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre stoffer, som kan
Potassium and potassium-sparing diuretics Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing
4 øge koncentrationen af kalium i serum (f. eks. heparin), føre til øget serumkalium.
4 potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
Grapefrugt juice På grund af manglende data om mulig interaktion mellem grapefrugt juice og aliskiren kan denne interaktion ikke udelukkes.
Grapefruit juice Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Warfarin Effekten af Enviage på warfarins farmakokinetik er ikke blevet evalueret.
Warfarin The effects of Enviage on warfarin pharmacokinetics have not been evaluated.
Fødeindtag Måltider med højt fedtindhold reducerer absorptionen af Enviage betragteligt.
Food intake Meals with a high fat content have been shown to reduce the absorption of Enviage substantially.
Graviditet Der foreligger ikke data om brugen af hos gravide kvinder.
Pregnancy There are no data on the use of aliskiren in pregnant women.
5. 3).
Enviage was not teratogenic in rats or rabbits (see section 5.3).