natgillin/translations-raw huggingface dataset:
Exforge 5 mg/ 80 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 80 mg alene.
Exforge 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.
Patienter, som får valsartan og amlodipin fra hver sin tablet/ kapsel, kan for nemhedens skyld skifte til Exforge med den samme dosis af hver komponent.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Exforge containing the same component doses.
4. 4).
Hepatic impairment Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
2 Børn og unge Exforge bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
2 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Patienter med natrium - og/ eller væskemangel Under placebokontrollerede undersøgelser blev der set udtalt hypotension hos 0, 4% af patienterne med ukompliceret hypertension, som blev behandlet med Exforge.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
Hvis der forekommer hypotension med Exforge, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af normalt saltvand.
If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Nyrearteriestenose Der er ingen tilgængelige data om brug af Exforge til patienter med bilateral nyrearteriestenose eller stenose i en enkelt nyre.
Renal artery stenosis No data are available on the use of Exforge in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Nyretransplantation På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Exforge til patienter, som kort tid forinden har modtaget nyretransplantation.
Kidney transplantation To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Der bør udvises særlig forsigtighed, når Exforge gives til patienter med mildt til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
Particular caution should be exercised when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
3 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Almindelige interaktioner med kombinationen Der er ikke udført interaktionsundersøgelser med Exforge og andre lægemidler.
Interactions common to the combination No drug interaction studies were performed with Exforge and other medicinal products.
Der er ingen erfaring med brug af Exforge til gravide kvinder.
There is no experience on the use of Exforge in pregnant women.
Sikkerheden ved brug af Exforge er blevet evalueret i fem kontrollerede kliniske undersøgelser med 5. 175 patienter, hvoraf 2. 613 modtog valsartan i kombination med amlodipin.
The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Ødem, fingertryksødem, ansigtsødem, perifert ødem, træthed, opblussen, asteni, hedeture
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush 6
0 40
40
0 2, 5
5.5
3, 0 5, 5 8, 0 2, 3
2.4
2, 4 5, 4
2.3 4.8
1, 6 2, 4
5.4 2.3
0, 9 3, 9
2.4 2.1
Amlodipin (mg)
3.9 2.4
5 10
10
3, 1 4, 8 10, 3 NA
10.3
2, 3 NA
NA NA
2, 1 9, 0
9.0
2, 4 9, 5
9.5
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 Exforge, selv i de tilfælde, hvor de ikke er set i kliniske undersøgelser eller i perioden efter markedsføring.
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Symptomer Der er ingen erfaring med overdosering af Exforge.
Symptoms There is no experience of overdose with Exforge.
Klinisk signifikant hypotension pga. overdosering med Exforge kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte - og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
Clinically significant hypotension due to Exforge 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.
Exforge 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.
Exforge 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.
Amlodipin Amlodipin- delen af Exforge hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
Amlodipine The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Ved kronisk dosering
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
8 ledsages det nedsatte blodtryk ikke af en signifikant påvirkning af pulsen eller af plasmakatecholaminer.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
Amlodipin/ valsartan Mere end 1. 400 hypertensive patienter har fået Exforge en gang daglig i to placebokontrollerede undersøgelser.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Exforge once daily in two placebo-controlled trials.
9 hjertesvigt, type I - og dårligt kontrolleret type II- diabetes og en historie med myokardieinfarkt eller slagtilfælde inden for det sidste år – blev ekskluderet.
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
Exforge er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med diastolisk blodtryk ≥110 mmHg og < 120 mmHg.
Exforge was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Til sammenligning nedsatte et behandlingsregime bestående af lisinopril/ hydrochlorthiazid 10/ 12, 5 mg titreret op til 20/ 12, 5 mg blodtrykket i siddende stilling med 32/ 28 mmHg.
In this study (baseline blood pressure 171/ 113 mmHg), an Exforge 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.
I to langtids- og opfølgningsstudier blev effekten af Exforge opretholdt i over et år.
In two long-term follow-up studies the effect of Exforge was maintained for over one year.
Alder, køn og race havde ingen indflydelse på Exforges virkning.
Age, gender and race did not influence the response to Exforge.
10 Distribution:
Distribution:
Amlodipin/ valsartan Efter oral administration af Exforge opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6- 8 timer.
Amlodipine/ Valsartan Following oral administration of Exforge, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Hastigheden og graden af Exforge- absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Derfor kræves forsigtighed, når dosis øges.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young, therefore caution is required when increasing the dosage.
11 eksponering af valsartan (målt ved AUC- værdier) to gange højere end den, der er set hos raske frivillige (passet sammen efter alder, køn og vægt).
On average, in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
Exforge 5 mg/ 160 mg filmovertrukne tabletter
Exforge 5 mg/ 160 mg film-coated tablets
Exforge 5 mg/ 160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
Exforge 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.
15 Børn og unge Exforge bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
14 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
16 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Dyreforsøg indikerer, at kombinationen af valsartan/ amlodipin har reproduktionstoksicitet på linie med det, der er beskrevet for valsartan og andre angiotensin II- antagonister (se pkt.
Animal studies indicate that the valsartan/ amlodipine has reproductive toxicity in line with what has been described for valsartan and
21 ledsages det nedsatte blodtryk ikke af en signifikant påvirkning af pulsen eller af plasmakatecholaminer.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
22 hjertesvigt, type I - og dårligt kontrolleret type II- diabetes og en historie med myokardieinfarkt eller slagtilfælde inden for det sidste år – blev ekskluderet.
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
23 Distribution:
Distribution:
24 eksponering af valsartan (målt ved AUC- værdier) to gange højere end den, der er set hos raske frivillige (passet sammen efter alder, køn og vægt).
On average, in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
25 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Exforge 10 mg/ 160 mg filmovertrukne tabletter
Exforge 10 mg/ 160 mg film-coated tablets
Exforge 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 Exforge 5 mg/ 160 mg.
Exforge 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 Exforge 5 mg/ 160 mg.
28 Børn og unge Exforge bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
26 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
29 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Ødem, fingertryksødem, ansigtsødem, perifert ødem, træthed, opblussen, asteni, hedeture
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, 30
Forstyrrelser i immunsystemet
asthenia, hot flush Immune system disorders
I sjældne tilfælde har patienter, især dem med svær obstruktiv koronarsygdom, udviklet en øget hyppighed, varighed eller sværhedsgrad af angina eller akut myokardieinfarkt ved behandlingsstart med calciumantagonister eller ved dosisstigning.
Arrhythmia, myocardial infarction, Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
34 ledsages det nedsatte blodtryk ikke af en signifikant påvirkning af pulsen eller af plasmakatecholaminer.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
35 hjertesvigt, type I - og dårligt kontrolleret type II- diabetes og en historie med myokardieinfarkt eller slagtilfælde inden for det sidste år – blev ekskluderet.
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
36 Distribution:
Distribution:
38 6. 3 Opbevaringstid
6.3 Shelf life
Exforge 5 mg/ 80 mg filmovertrukne tabletter amlodipin/ valsartan
Exforge 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
Exforge 5 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Exforge 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Exforge 10 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Exforge 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
- Lægen har ordineret Exforge til dig personligt.
- This medicine has been prescribed for you.
Exforges virkning og hvad du skal bruge det til 2.
What Exforge is and what it is used for 2.
Det skal du vide, før du begynder at tage Exforge 3.
Before you take Exforge 3.
Sådan skal du tage Exforge 4.
How to take Exforge 4.
Sådan opbevarer du Exforge 6.
How to store Exforge 6.
EXFORGES VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT EXFORGE IS AND WHAT IT IS USED FOR
Exforge bruges til at behandle forhøjet blodtryk hos patienter, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
Exforge is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE EXFORGE
BEFORE YOU TAKE EXFORGE
- hvis du har alvorlige leverlidelser, som f. eks. biliær cirrhose eller cholestasi.
Do not take Exforge − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Exforge.
Hvis noget af ovenstående gælder for dig, skal du ikke tage Exforge og du skal underrette din læge.
If you think you may be allergic, talk to your doctor before taking Exforge. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- hvis du har været syg (opkastning eller diarré).
If any of the above applies to you, do not take Exforge and talk to your doctor.
- hvis du tager anden medicin eller andre stoffer, som øger mængden af kalium i dit blod (f. eks.
64 Take special care with Exforge − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
- hvis du har problemer med lever eller nyrer.
If any of these apply to you, tell your doctor before taking Exforge.
- hvis du har haft hjertesvigt.
You must tell your doctor if you think that you are (or might become) pregnant.
Exforge kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten (se afsnittet om ” Graviditet og amning ”).
Exforge is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
Brug af Exforge til børn og unge frarådes.
The use of Exforge in children and adolescents is not recommended.
Du skal også fortælle din læge, hvis du har fået en nyretransplantation eller hvis du har fået at vide, at du har forsnævret blodtilførelse til nyrerne.
Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
Det kan være nødvendigt for din læge at ændre din dosis eller at foretage andre forsigtighedsregler.
Your doctor may need to change the dose or take other precautions.
Det gælder især for den medicin, som er beskrevet herunder:
In some cases you may have to stop taking one of the medicines.
- krampehæmmende stoffer (f. eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin,
This applies especially to the medicines listed below: − 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; − anticonvulsant agents (e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St.
- nitroglycerin og andre nitrater eller andre stoffer, som hedder ” vasodilatorer ”;
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
Brug af Exforge sammen med mad og drikke Du kan tage Exforge med eller uden mad.
Taking Exforge with food and drink You can take Exforge with or without food.
Exforge og ældre patienter Der kræves forsigtighed, når dosis øges.
Exforge and older people Caution is required when increasing the dosage.
Graviditet og amning Du skal fortælle det til din læge, hvis du tror, du er gravid (eller planlægger at blive gravid).
Pregnancy and breast-feeding You must tell your doctor if you think you are (or might become) pregnant.
Exforge frarådes i den tidlige periode af graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten.
Usually, your doctor will advise you to take another medicine instead of Exforge, as Exforge is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalt skal en anden passende behandling mod forhøjet blodtryk erstatte Exforge inden graviditetens begyndelse.
An appropriate antihypertensive medication must usually replace Exforge before starting a pregnancy.
Exforge må ikke bruges under andet og tredje trimester af graviditeten.
The product should not be used during the second and third trimesters of pregnancy.
Din læge vil normalt råde dig til at stoppe med at tage Exforge, så snart du ved, at du er gravid.
Your doctor will normally advise you to stop taking Exforge as soon as you know you are pregnant.
68 Hvis du bliver gravid, mens du er i behandling med Exforge, skal du konsultere din læge med det samme.
If you become pregnant during therapy with Exforge, please inform and see your doctor without delay.
Giv din læge besked, hvis du ammer.
65 Tell your doctor if you are breast-feeding.
Behandling med Exforge frarådes mens du ammer.
Treatment with Exforge is not recommended during breast- feeding.
Trafik - og arbejdssikkerhed Denne medicin kan få dig til at føle svimmelhed.
Driving and using machines This medicine may make you feel dizzy.
SÅDAN SKAL DU TAGE EXFORGE
HOW TO TAKE EXFORGE
Tag altid Exforge nøjagtig efter lægens anvisning.
Always take this medicine exactly as your doctor has told you.
Den sædvanlige dosis af Exforge er én tablet daglig.
This will help you get the best results and lower the risk of side effects.
- Det tilrådes at tage din medicin på samme tidspunkt hver dag, helst om morgenen.
The usual dose of Exforge is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Exforge with or without food.
Hvis du har taget for meget Exforge Hvis du har taget for mange Exforge- tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
If you take more Exforge than you should If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.
Hvis du har glemt at tage Exforge Hvis du glemmer at tage din medicin, skal du tage den så snart du kommer i tanke om det.
If you forget to take Exforge If you forget to take this medicine, take it as soon as you remember.
Exforge kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Exforge can cause side effects, although not everybody gets them.
Svimmelhed; kvalme og mavesmerter; mundtørhed; sløvhed; prikken og følelsesløshed i hænder eller fødder; svimmelhed;
Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
SÅDAN OPBEVARER DU EXFORGE
HOW TO STORE EXFORGE
Brug ikke Exforge efter den udløbsdato, der står på æsken og blisterkortet.
Do not use Exforge after the expiry date stated on the carton and blister.
70 6.
6.
Hvad Exforge indeholder
FURTHER INFORMATION
Hver tablet
What Exforge contains − The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan.
Exforges udseende og pakningstørrelse Exforge 5 mg/ 80 mg tabletter er runde og mørkegule, præget med ” NVR ” på den ene side og ” NV ” på den anden side.
What Exforge looks like and contents of the pack Exforge 5 mg/ 80 mg tablets are round and dark yellow with “ NVR” on one side and “ NV” on the other side.
Exforge 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.
Exforge 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.
Hvis du vil have yderligere oplysninger om Exforge, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
71 Ελλάδα Novartis (Hellas) A. E. B. E.
Ελλάδα Novartis (Hellas) A. E. B. E.