FrancophonIA/ELRC3.0 huggingface dataset:
English: Imprida should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Imprida skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serum-kreatinin kan stige hos disse patienter.
English: Do not take Imprida if you are allergic to amlodipine or to any other calcium channel blockers.
Danish: Tag ikke Imprida - hvis du er allergisk over for amlodipin eller andre calciumantagonister.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Danish: Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af angiotensin IIantagonister (AIIA), men lignende risici kan eksistere for denne gruppe af lægemidler.
English: Some of these patients previously experienced angioedema with other medicinal products, including ACEinhibitors.
Danish: Nogle af disse patienter havde tidligere udviklet angioødem ved behandling med andre lægemidler, herunder ACE-hæmmere.
English: If any of the following happen, tell your doctor straight away:
Danish: Hvis noget af følgende sker for dig, skal du straks kontakte din læge:
English: Clinically significant hypotension due to Imprida overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering med Imprida kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Imprida was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Danish: Imprida er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med middel siddende diastolisk blodtryk ≥110 mmHg og <120 mmHg.
English: If you stop taking Imprida
Danish: Hvis du holder op med at tage Imprida
English: Following oral administration of Imprida, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Danish: Efter oral administration af Imprida opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6-8 timer.
English: The rate and extent of absorption of Imprida are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Danish: Hastigheden og graden af Imprida-absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: No dosage adjustment of Imprida is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion (GFR >30 ml/min/1,73 m2).
English: Patients taking Imprida and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Imprida, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Imprida as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Yderligere information om de individuelle komponenter Bivirkninger, som tidligere er indrapporteret for hver enkelt af de individuelle komponenter (amlodipin eller valsartan), kan også være potentielle bivirkninger med Imprida, selv i de tilfælde, hvor de ikke er set i kliniske studier eller i perioden efter markedsføring.
English: Imprida combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Danish: Imprida kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister og valsartan tilhører klassen kaldet angiotensin II-antagonister.
English: Posology The recommended dose of Imprida is one tablet per day.
Danish: Dosering Den anbefalede dosis af Imprida er én tablet daglig.
English: If hypotension occurs with Imprida, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer hypotension med Imprida, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: Stopping your treatment with Imprida may cause your disease to get worse.
Danish: Hvis du holder op med at tage Imprida, kan det resultere i, at din sygdom bliver værre.
English: Fertility There are no clinical studies on fertility with Imprida.
Danish: Fertilitet Der er ikke udført fertilitetsstudier med Imprida.
English: Do not take Imprida with grapefruit or grapefruit
Danish: Tag ikke Imprida sammen med grapefrugt eller grapefrugtjuice.
English: Amlodipine/Valsartan
Danish: Amlodipin/Valsartan
English: Marketing Authorisation Holder Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Storbritannien
English: The safety and efficacy of Imprida in children aged below 18 years have not been established.
Danish: Pædiatrisk population Impridas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Caution should be exercised in patients with liver disease (see section 4.2).
Danish: Der skal udvises forsigtighed over for patienter med leverlidelser (se pkt.4.2).
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Brug ikke Imprida efter den udløbsdato, der står på pakningen.
English: Imprida tablets contain two substances called amlodipine and valsartan.
Danish: Imprida tabletter indeholder to stoffer, som kaldes amlodipin og valsartan.
English: Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous Magnesium stearate
Danish: Cellulose, mikrokrystallinsk Crospovidon Type A Silica, kolloid vandfri Magnesiumstearat
English: Talk to your doctor before taking Imprida: if you have been sick (vomiting or diarrhoea).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Imprida: - hvis du har været syg (opkastning eller diarré).
English: Patients with high cardiovascular risks - heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one yearwere excluded.
Danish: Patienter med høje kardiovaskulære risicihjertesvigt, type I- og dårligt kontrolleret type II-diabetes og en historie med myokardieinfarkt eller slagtilfælde inden for det sidste år - blev ekskluderet.
English: Frequency Imprida Amlodipine Valsartan
Danish: Frekvens Imprida Amlodipin Valsartan
English: Imprida is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Danish: Imprida er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter, eller 20 kartoner med hver 14 tabletter.
English: If any of the above applies to you, do not take Imprida and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Imprida, men skal kontakte din læge.
English: If you forget to take Imprida
Danish: Hvis du har glemt at tage Imprida
English: Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Danish: Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
English: Other medicines and Imprida
Danish: Brug af anden medicin sammen med Imprida
English: What you need to know before you take Imprida
Danish: Det skal du vide, før du begynder at tage Imprida
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the
Danish: • Overfølsomhed over for de aktive stoffer, over for dihydropyridinderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Danish: Overfølsomhedsreaktioner med symptomer som udslæt, kløe, hævet ansigt, læber eller tunge, svært ved at få luft, for lavt blodtryk (følelsen af bevidstløshed, uklarhed).
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Imprida containing the same component doses.
Danish: Patienter, som får valsartan og amlodipin fra hver sin tablet/kapsel, kan for nemhedens skyld skifte til Imprida med den samme dosis af hver komponent.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Imprida in placebo-controlled studies.
Danish: Under placebokontrollerede studier blev der set udtalt hypotension hos 0,4% af patienterne med ukompliceret hypertension, som blev behandlet med Imprida.
English: The amlodipine component of Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Imprida hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: Particular caution should be exercised when administering Imprida to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Danish: Der bør udvises særlig forsigtighed, når Imprida gives til patienter med let til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
English: If any of these apply to you, tell your doctor before taking Imprida.
Danish: Hvis dette gælder for dig, så tal med din læge inden du tager Imprida.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Imprida or observed with a higher frequency than with Imprida:
Danish: Bivirkninger, som er rapporteret ved behandling med valsartan og amlodipin alene, og som enten ikke er set ved behandling med Imprida, eller som er set hyppigere end ved behandling med Imprida:
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF
English: • Concomitant use of Imprida with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: • Samtidig brug af Imprida og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Others
Danish: ANDET
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Imprida.
Danish: Du må ikke indtage grapefrugt og grapefrugtjuice, mens du tager Imprida.
English: Other possible side effects of Imprida:
Danish: Andre bivirkninger ved brug af Imprida
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere og ARBer eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: Imprida is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Danish: Imprida er indiceret til voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin eller valsartan monoterapi.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGLESER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: What Imprida contains - The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
Danish: Imprida indeholder: - Aktive stoffer: amlodipin (som amlodipinbesylat) og valsartan.
English: Hepatic impairment Imprida is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Nedsat leverfunktion Imprida er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: Very rare Very rare Very rare
Danish: Meget sjælden Meget sjælden
English: Imprida is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Danish: Imprida bruges til at behandle forhøjet blodtryk hos voksne, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
English: You should never take Imprida if you are taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
Danish: - hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyreproblemer i forbindelse med sukkersyge); aliskiren.
English: Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from
Danish: Amlodipin forhindrer calcium i at bevæge sig ind i blodårernes vægge.
English: Caution should be exercised when administering Imprida to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Danish: Der skal udvises forsigtighed, når Imprida gives til patienter med nedsat leverfunktion eller biliære obstruktive lidelser (se pkt.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Imprida.
Danish: Det skyldes, at grapefrugt og grapefrugtjuice kan føre til en øget mængde af det aktive stof, amlodipin, i blodet.
English: (It is also better to avoid Imprida in early pregnancy, see Pregnancy section).
Danish: - hvis du er mere end 3 måneder henne i graviditeten (brug af Imprida tidligt i graviditeten bør også undgås, se afsnittet om Graviditet).
English: - Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions.
Danish: - Alvorlige hudreaktioner som udbredt hududslæt, nældefeber, hudrødme over hele kroppen, intens kløe, blæredannelse, afskalning eller hævelse i huden, betændelseslignende tilstand i slimhinderne (Stevens-Johnsons syndrom) eller andre allergiske reaktioner.
English: Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Danish: Hypromellose Titandioxid (E171) Jernoxid, gul (E172) Macrogol 4000
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Imprida” and diuretics (a type of medicine also called “water tablets” which increases the amount of urine lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Danish: Det gælder især for den medicin, som er beskrevet herunder: - hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Imprida” og ”Advarsler og forsigtighedsregler”); - diuretika (en type medicin, som også kaldes ”vanddrivende tabletter”, og som forhøjer den mængde urin, du producerer); - medicin til behandling af visse typer depression (lithium); - kaliumbesparende diuretika, kaliumtilskud, salterstatninger, som indeholder kalium eller andre stoffer, der kan øge indholdet af kalium i blodet; - en bestemt type smertestillende medicin, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller selektive cyclooxygenase-2-hæmmere (COX-2-hæmmere).
English: In this study (baseline blood pressure 171/113 mmHg), an Imprida regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Danish: I dette studie (baseline blodtryk 171/113 mmHg) nedsatte Imprida 5 mg/160 mg titreret op til 10 mg/160 mg blodtrykket i siddende stilling med 36/29 mmHg.
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Danish: Resultatet af et in vitro studie med humant levervæv indikerede, at valsartan er substrat for den hepatiske optagelsestransportør OATP1B1 og af den hepatiske effluxtransportør MRP2.
English: Imprida can be used with or without food.
Danish: Imprida kan tages uden hensyn til fødeindtagelse.
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Danish: ImpridaDet er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Imprida 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Imprida 5 mg/160 mg.
Danish: Imprida 10 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg eller valsartan 160 mg alene eller med Imprida 5 mg/160 mg.
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Danish: CYP3A4-inducerende stoffer (antikrampemidler [f.eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon], rifampicin, perikon)
English: Imprida 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Danish: Imprida 5 mg/80 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 80 mg alene.
English: medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Danish: talithromycin); - verapamil, diltiazem (hjertemedicin); - simvastatin (medicin som bruges til at behandle højt kolesterol); - dantrolen (infusion ved alvorligt forhøjet kropstemperatur); - medicin som bruges til at beskytte mod organafstødning efter transplantation (ciclosporin).
English: Not known Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Danish: Fald i hæmoglobin, fald i hæmatokrit, neutropeni, trombocytopeni, øget serumkalium, forhøjede leverfunktionstal, inklusive øget serum-bilirubin, nyresvigt og nedsat nyrefunktion, forhøjet serum-kreatinin, angioødem, myalgi, vaskulitis,
English: Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) Macrogol 4000
Danish: Hypromellose Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172) Macrogol 4000
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Imprida, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Danish: 4.1) med nedsat leverfunktion skiftes til amlodipin eller Imprida, skal den laveste tilgængelige dosis af henholdvis amlodipin-monoterapi eller amlodipinkombination anvendes.
English: Uncommon Uncommon Not known Uncommon Very rare
Danish: Ikke almindelig Ikke kendt Almindelig Almindelig Meget sjælden
English: Imprida 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Danish: Imprida 5 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
English: - The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon type A; kolloid vandfri silica; magnesiumstearat; hypromellose; macrogol 4000; talcum; titandioxid (E171); gul jernoxid (E172).
English: Blood potassium increased
Danish: Forhøjet kreatinin i blodet
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER
English: No information is available regarding the use of Imprida during breast-feeding, therefore Imprida is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: I stedet foretrækkes alternative behandlinger med bedre dokumenterede sikkerhedsprofiler ved amning, især ved amning af et nyfødt spædbarn eller et for tidligt født spædbarn.
English: The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon type A; kolloid vandfri silica; magnesiumstearat; hypromellose; macrogol 4000; talcum; titandioxid (E171); gul jernoxid (E172); rød jernoxid (E172).
English: ACE inhibitors and ARBs should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).
Danish: ACE-hæmmere og ARBer bør derfor ikke anvendes samtidigt hos patienter med diabetisk nefropati.
English: Imprida 5 mg/80 mg film-coated tablets
Danish: Imprida 5 mg/80 mg filmovertrukne tabletter
English: Imprida 10 mg/160 mg film-coated tablets
Danish: Imprida 10 mg/160 mg filmovertrukne tabletter
English: What Imprida looks like and contents of the pack Imprida 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Danish: Imprida 5 mg/80 mg tabletter er runde og mørkegule, præget med ”NVR” på den ene side og ”NV” på den anden side.
English: Imprida 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Imprida 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: What Imprida looks like and contents of the pack Imprida 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Danish: Imprida 10 mg/160 mg tabletter er ovale og lysegule, præget med ”NVR” på den ene side og ”UIC” på den anden side.