FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with anuria and in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Danish: På grund af indholdet af hydrochlorthiazid er Rasilez HCT kontraindiceret til patienter med anuri og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR)
English: Thiazides, including hydrochlorothiazide, potentiate the action of skeletal muscle relaxants such as curare derivatives.
Danish: Thiazider, herunder hydrochlorthiazid, forstærker virkningen af perifert virkende muskelrelaksantia såsom curarederivater.
English: 98 film-coated tablets (2 packs of 49)
Danish: 98 filmovertrukne tabletter (2 pakninger med 49)
English: - if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Danish: Det kan medføre permanent synstab, hvis det ikke bliver behandlet; - hvis du har nyrearteriestenose (forsnævring af blodkarrene til en eller begge nyrer).
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Danish: Amantadin Thiazider, herunder hydrochlorthiazid, kan øge risikoen for bivirkninger forårsaget af amantadin.
English: There was no significant benefit of adding aliskiren to enalapril (primary endpoint: hazard ratio of 0.93 with 95% Confidence Interval:
Danish: Der var ingen signifikant fordel ved at tilføje aliskiren til enalapril (primært endepunkt: Hazard Ratio på 0,93 med 95 % konfidensinterval: 0,85-1,03; p = 0,1724, kombinationen versus enalapril).
English: You should take this medicine either with a light meal or without a meal, once a day, preferably at the same time each day.
Danish: Brug af Rasilez HCT sammen med mad og drikke Du skal tage dette lægemiddel enten sammen med et let måltid mad eller uden mad, én gang daglig, fortrinsvis på samme tidpunkt hver dag.
English: Rasilez HCT 150 mg/25 mg film-coated tablets EU/1/08/491/021-040
Danish: Rasilez HCT 150 mg/25 mg filmovertrukne tabletter EU/1/08/491/021-040
English: RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see section 4.8).
Danish: methyldopa, en angiotensin-II receptorblokker eller en angiotensin-konverteringsenzym (ACE)-hæmmer (se punkterne ”Tag ikke Rasilez
English: Contents of the pack and other information What Rasilez HCT contains - The active substances are aliskiren and hydrocholorothiazide.
Danish: Rasilez HCT indeholder: - Aktive stoffer: aliskiren og hydrochlorthiazid.
English: 98 film-coated tablets (2 packs of 49x1)
Danish: 98 filmovertrukne tabletter (2 pakninger med 49x1)
English: Hydrochlorothiazide may reduce the response to pressor amines such as noradrenaline.
Danish: Karkontraherende aminer (fx noradrenalin, adrenalin) Hydrochlorthiazid kan hæmme virkningen af karkontraherende aminer såsom noradrenalin.
English: The other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate (see section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 400, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon type A, lactosemonohydrat (se pkt.2), hvedestivelse (se pkt.2),, povidon K-30, magnesiumstearat, kolloid vandfri silica, talcum, hypromellose substitutionstype 2910 (3 mPa s), macrogol 400, titandioxid (E171), rød jernoxid (E172), sort jernoxid (E172).
English: Rasilez HCT 300 mg/25 mg film-coated tablets EU/1/08/491/061-080
Danish: Rasilez HCT 300 mg/25 mg filmovertrukne tabletter EU/1/08/491/061-080
English: • Itchy rash and other types of rash
Danish: • Kløende udslæt og andre former for udslæt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED PA/ALU/PVC-BLISTERKORT
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets EU/1/08/491/041-060
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter EU/1/08/491/041-060
English: Rasilez HCT 150 mg/25 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Danish: Rasilez HCT 150 mg/25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 150 mg aliskiren (som hemifumarat) og 25 mg hydrochlorthiazid.
English: Colloidal anhydrous silica Talc
Danish: Kolloid vandfri silica
English: Iodine contrasting agents
Danish: Kontraststoffer med iod
English: The other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate (see section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon type A, lactosemonohydrat (se pkt.2), hvedestivelse (se pkt.2), povidon K-30, magnesiumstearat, kolloid vandfri silica, talcum, hypromellose substitutionstype 2910 (3 mPa s), macrogol 4000, titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172).
English: INFORMATION IN BRAILLE Rasilez HCT 300 mg/25 mg
Danish: INFORMATION I BRAILLESKRIFT Rasilez HCT 300 mg/25 mg
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat) og 12,5 mg hydrochlorthiazid.
English: INFORMATION IN BRAILLE Rasilez HCT 150 mg/12.5 mg
Danish: INFORMATION I BRAILLESKRIFT Rasilez HCT 150 mg/12,5 mg
English: INFORMATION IN BRAILLE Rasilez HCT 300 mg/12.5 mg
Danish: INFORMATION I BRAILLESKRIFT Rasilez HCT 300 mg/12,5 mg
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
Danish: • Alvorlige hudreaktioner (toksisk epidermal nekrolyse og/eller bivirkninger fra slimhinden i munden - rød hud, blæredannelse omkring læber, øjne eller mund, hudafskalning, feber)
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (forekommer hos op til 1 ud af 100 patienter):
English: • Palpitations
Danish: • Forstoppelse
English: INFORMATION IN BRAILLE Rasilez HCT 150 mg/25 mg
Danish: INFORMATION I BRAILLESKRIFT Rasilez HCT 150 mg/25 mg
English: • Low level of sodium in the blood
Danish: • Lavt indhold af natrium i blodet
English: Liver disordera,*, hepatitisa, liver failurea,** Skin and subcutaneous tissue disorders Common
Danish: Leverforstyrrelsera,*, hepatitisa, leversvigta,**
English: How to take Rasilez HCT
Danish: Sådan skal du tage Rasilez HCT
English: Rasilez HCT 300 mg/25 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Danish: Rasilez HCT 300 mg/25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat) og 25 mg hydrochlorthiazid.
English: 98 film-coated tablets (2 packs 49 x 1)
Danish: 98 filmovertrukne tabletter (2 pakninger med 49 x 1)
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter):
English: Rasilez HCT 300 mg/25 mg film-coated tablets
Danish: Rasilez HCT 300 mg/25 mg filmovertrukne tabletter
English: Do not stop taking this medicine, even if you are feeling well unless your doctor tells you to do so. People who have high blood pressure often do not notice any signs of the problem.
Danish: Du må ikke stoppe med denne medicin, selv om du har det godt, medmindre du har aftalt det med din læge.
English: What Rasilez HCT is and what it is used for What you need to know before you take Rasilez HCT How to take Rasilez HCT
Danish: Det skal du vide, før du begynder at tage Rasilez HCT Sådan skal du tage Rasilez HCT Bivirkninger
English: Digoxin and verapamil bioavailability may be slightly decreased by aliskiren.
Danish: - Aliskiren kan nedsætte biotilgængeligheden af digoxin og verapamil i let grad.
English: Rasilez HCT 150 mg/25 mg film-coated tablets
Danish: Rasilez HCT 150 mg/25 mg filmovertrukne tabletter
English: Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 50 mg lactose (som monohydrat) og 49 mg hvedestivelse.
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL MULTIPAKNING (INKLUSIV BLUE BOX) MED PA/ALU/PVCBLISTERPAKNINGER
English: Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat starch.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 25 mg lactose (som monohydrat) og 24,5 mg hvedestivelse.
English: Rasilez HCT 300 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 300 mg/12.5 mg or Rasilez HCT 150 mg/25 mg.
Danish: Rasilez HCT 300 mg/25 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt behandlet med aliskiren 300 mg eller hydrochlorthiazid 25 mg anvendt alene eller med Rasilez HCT 150 mg/12,5 mg eller Rasilez HCT 150 mg/25 mg.
English: Rasilez HCT 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone.
Danish: Rasilez HCT 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt behandlet med aliskiren 150 mg eller hydrochlorthiazid 12,5 mg anvendt alene.
English: - Each tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Danish: - Hver tablet indeholder 150 mg aliskiren (som hemifumarat) og 12,5 mg hydrochlorthiazid.
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter
English: (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Rasilez HCT - hvis du er allergisk over for aliskiren eller hydrochlorthiazid, sulfonamidafledt medicin (medicin, der anvendes til at behandle bryst- eller urinvejsinfektioner) eller et af de øvrige indholdsstoffer i Rasilez HCT (angivet i afsnit 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PVC/PCTFE BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX) MED PVC/PCTFE-BLISTERKORT
English: • Severe upper stomach pain (pancreatitis)
Danish: • Svære smerter øverst i maven (betændelse i bugspytkirtlen)
English: fever (toxic epidermal necrolysis)
Danish: • Kløende udslæt (nældefeber)
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter er violet-hvide, ovale, filmovertrukne tabletter, præget med ”CVI” på den ene side og ”NVR” på den anden.
English: Cardiac arrhythmiash
Danish: Lactosemonohydrat
English: - if you are taking either of the following classes of medicines used to treat high blood pressure: - an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or - an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Danish: eller - en angiotensin-II receptorblokker, som fx valsartan, telmisartan, irbesartan;
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Rasilez HCT Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Rasilez HCT 150 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 150 mg/12.5 mg.
Danish: Rasilez HCT 150 mg/25 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt behandlet med aliskiren 150 mg eller hydrochlorthiazid 25 mg anvendt alene eller med Rasilez HCT 150 mg/12,5 mg.
English: Ion exchange resins
Danish: Ionbytterresiner
English: • Constipation
Danish: • Kortåndethed
English: Rasilez HCT 300 mg/25 mg film-coated tablets Tablet core:
Danish: Rasilez HCT 300 mg/25 mg filmovertrukne tabletter Tabletkerne:
English: Rasilez HCT 300 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Rasilez HCT 150 mg/12.5 mg.
Danish: Rasilez HCT 300 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt behandlet med aliskiren 300 mg eller hydrochlorthiazid 12,5 mg anvendt alene eller med Rasilez HCT 150 mg/12,5 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PVC/PCTFE BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL MULTIPAKNING (INKLUSIV BLUE BOX) MED PVC/PCTFEBLISTERKORT
English: - medicines for the treatment of diabetes (oral agents such as metformin or insulins).
Danish: Antidiabetika (fx insulin og orale midler)
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other.
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter Hvid, udadbuet, oval, filmovertrukken tablet, præget med ”LCI” på den ene side og ”NVR” på den anden.
English: Rasilez HCT 150 mg/25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with “CLL” on one side and “NVR” on the other.
Danish: Rasilez HCT 150 mg/25 mg filmovertrukne tabletter er svagt gule, ovale, filmovertrukne tabletter, præget med ”CLL” på den ene side og ”NVR” på den anden.
English: Rasilez HCT 150 mg/25 mg film-coated tablets Tablet core:
Danish: Rasilez HCT 150 mg/25 mg filmovertrukne tabletter Tabletkerne:
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets Tablet core:
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter Tabletkerne:
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.
Danish: Rasilez HCT fås i pakninger med 7, 14, 28, 30, 50, 56, 90 eller 98 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX) MED PA/ALU/PVC-BLISTERKORT
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Tablet core:
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter Tabletkerne:
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/25 mg film-coated tablets aliskiren/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Rasilez HCT 150 mg/25 mg filmovertrukne tabletter aliskiren/hydrochlorthiazid
English: If co-administration with an agent affecting the level of serum potassium is considered necessary, caution is advisable (see sections 4.4 and 5.1).
Danish: Der bør udvises forsigtighed, hvis samtidig administration af et stof, som påvirker serumkalium, skønnes nødvendig (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/25 mg film-coated tablets aliskiren/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Rasilez HCT 300 mg/25 mg filmovertrukne tabletter aliskiren/hydrochlorthiazid
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Danish: - Hver tablet indeholder 300 mg aliskiren (som hemifumarat) og 12,5 mg hydrochlorthiazid.
English: Rasilez HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “CVV” on one side and “NVR” on the other.
Danish: Rasilez HCT 300 mg/25 mg filmovertrukne tabletter er lysegule, ovale, filmovertrukne tabletter, præget med ”CVV” på den ene side og ”NVR” på den anden.
English: The other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate and wheat starch (see section 2 under ‘Rasilez HCT contains lactose and wheat starch'), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171).
Danish: 2 under ‘Rasilez HCT indeholder lactose og hvedestivelse'), povidon K30, magnesiumstearat, kolloid vandfri silica, talcum, hypromellose substitutionstype 2910 (3 mPa s), macrogol 4000, titandioxid (E171).
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Danish: • Udslæt, kløe, nældefeber, besvær med vejrtrækningen eller med at synke, svimmelhed
English: What Rasilez HCT is
Danish: Rasilez HCTs virkning
English: Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary (see sections 4.5 and 4.8).
Danish: Hvis samtidig brug skønnes nødvendig, tilrådes regelmæssig kontrol af nyrefunktionen inklusive serumelektrolytter i overensstemmelse med standardpraksis (se pkt.
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Danish: Der kræves ingen justering af initialdosis for patienter med let til moderat nedsat leverfunktion (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 300 mg aliskiren (som hemifumarat) og 12,5 mg hydrochlorthiazid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 150 mg aliskiren (som hemifumarat) og 12,5 mg hydrochlorthiazid.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Danish: - Hver indeholder 300 mg aliskiren (som hemifumarat) og 25 mg hydrochlorthiazid.
English: • Low level of potassium in the blood
Danish: • Lavt indhold af kalium i blodet
English: Aplastic anaemiah
Danish: Aplastisk anæmih
English: Heart failure
Danish: • Hjertebanken
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 150 mg aliskiren (som hemifumarat) og 25 mg hydrochlorthiazid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 300 mg aliskiren (som hemifumarat) og 25 mg hydrochlorthiazid.
English: • Weakness
Danish: • Svaghedsfølelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/079
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/079
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/039
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/039
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/070
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/070
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/059
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/059
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/12.5 mg film-coated tablets aliskiren/hydrochlorothiazide
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter aliskiren/hydrochlorthiazid
English: Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Danish: Det anbefales at foretage individuel dosistitrering med de enkelte komponenter, inden der skiftes til den faste kombination.
English: Contains lactose and wheat starch.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose og hvedestivelse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/061
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/061
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/030
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/028
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/028
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Danish: Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter aliskiren/hydrochlorthiazid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/050
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/050
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/040
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/040
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/069
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/069
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/068
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/068
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/060
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/060
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/048
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/048
English: B.
Danish: NN:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/049
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/049
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/080
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/080
English: Possible side effects
Danish: ”Sjældne” bivirkninger herunder)
English: blistering of the lips, eyes or mouth, skin peeling, fever)
Danish: • Svær hudsygdom med udslæt, hudrødme, blæredannelser på læber, øjne eller mund, afskalning af hud, feber (toksisk epidermal nekrolyse)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/041
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/041
English: Hepatic impairment
Danish: Hovedpineh, paræstesih
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/019
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/491/019
English: What Rasilez HCT looks like and contents of the pack Rasilez HCT 150 mg/12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with “LCI” on one side and “NVR” on the other.
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter er hvide, ovale, filmovertrukne tabletter, præget med ”LCI” på den ene side og ”NVR” på den anden.
English: If co-medication with an agent affecting the level of serum potassium is considered necessary, routine monitoring of potassium levels would be advisable.
Danish: Der tilrådes rutinemæssig monitorering, hvis samtidig administration af et stof, som påvirker serumkalium, skønnes nødvendig.