natgillin/translations-raw huggingface dataset:
The amlodipine component of Copalia HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Componenta amlodipină din Copalia HCT inhibă pătrunderea transmembranară a ionilor de calciu la nivelul musculaturii netede cardiace sau vasculare.
If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance.
Dacă apare hipokaliemia în timpul tratamentului cu hidroclorotiazidă, trebuie întreruptă administrarea Copalia HCT până la stabilizarea echilibrului kaliemic.
Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Copalia HCT este contraindicat la pacienţii cu insuficienţă renală severă, anurie sau care efectuează şedinţe de dializă (vezi pct. 4.3).
Treatment with Copalia HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Tratamentul cu Copalia HCT trebuie început numai după corectarea hipokaliemiei şi a oricărei hipomagneziemii coexistente.
In the controlled trial of Copalia HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Într-un studiu controlat cu administrare de Copalia HCT, la mulţi dintre pacienţi, efectele contrare ale valsartanului 320 mg şi hidroclorotiazidei 25 mg asupra concentraţiei serice de potasiu s-au echilibrat.
Concomitant use of Copalia HCT 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).
- Administrarea concomitentă a Copalia HCT cu medicamente care conţin aliskiren la pacienţii cu diabet zaharat sau insuficienţă renală (RFG <60 ml/min şi 1,73 m2) (vezi pct. 4.5 şi 5.1).
thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Modul de acţiune al tiazidelor este prin inhibarea mecanismului simport de transport al grupelor ionice, Na+/Cl-, probabil prin competiţia pentru situsul Cl-, astfel afectând mecanismele electrolitice de reabsorbţie: în mod direct cresc eliminarea de sodiu şi clor într-o proporţie aproximativ egală, şi indirect, prin această acţiune diuretică scad volumul plasmatic, cu creşterea consecutivă a activităţii reninei plasmatice, secreţia de aldosteron şi pierderea urinară de potasiu, precum şi o scădere a concentraţiilor plasmatice ale potasiului.
When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to Copalia HCT, the lowest available dose of the amlodipine component should be used.
Când pacienţii hipertensivi (vezi pct. 4.1) cu insuficienţă hepatică trec la tratamentul cu amlodipină sau Copalia HCT, trebuie utilizată cea mai mică doză disponibilă a componentei amlodipină.
There is limited experience with the use of Copalia HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Insuficienţă cardiacă şi afecţiuni ale arterelor coronare Experienţa privind utilizarea Copalia HCT este limitată, mai ales la administrarea dozei maxime, la pacienţi cu insuficienţă cardiacă şi afecţiuni ale arterelor coronare.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Copalia HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
La pacienţii cu insuficienţă hepatică uşoară până la moderată fără colestază, doza maximă recomandată este de 80 mg valsartan, aşadar, Copalia HCT nu este adecvat pentru acest grup de pacienţi (vezi pct. 4.2, 4.3 şi 5.2).
Due to the valsartan component, Copalia HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Din cauza componentei valsartan, Copalia HCT este contraindicat la pacienţi cu insuficienţă hepatică (vezi pct. 4.2 şi 4.3).
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Copalia HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
La pacienţii cu insuficienţă hepatică uşoară până la moderată fără colestază, doza maximă recomandată este de 80 mg valsartan, aşadar Copalia HCT nu este adecvat pentru această grupă de pacienţi (vezi pct. 4.3, 4.4. şi 5.2.).
J. Uriach y Cia., S.A. Tel: +34 93 864 96 92
S.A. Tel: +34 93 864 96 92
Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Datorită componentei valsartan, Copalia HCT este contraindicat la pacienţii cu insuficienţă hepatică severă (vezi pct. 4.3).
No formal interaction studies with other medicinal products have been performed with Copalia HCT.
Nu s-au efectuat studii oficiale pentru Copalia HCT privind interacţiuni cu alte medicamente.
If you stop taking Copalia HCT
Dacă încetaţi să utilizaţi Copalia HCT
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Se recomandă precauţie, inclusiv monitorizarea mai frecventă a tensiunii arteriale, la pacienţii vârstnici, mai ales la administrarea dozei maxime de Copalia HCT, 10 mg/320 mg/25 mg deoarece datele disponibile pentru această categorie de pacienţi sunt limitate.
When switching eligible elderly hypertensive patients (see section 4.1) to Copalia HCT, the lowest available dose of the amlodipine component should be used.
Când pacienţii vârstnici hipertensivi (vezi pct. 4.1) cu insuficienţă hepatică trec la tratamentul cu amlodipină sau Copalia HCT, trebuie utilizată cea mai mică doză disponibilă a componentei amlodipină.
The reductions in systolic/diastolic blood pressure with Copalia HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Reducerea tensiunii arteriale diastolice şi sistolice la administrarea de Copalia HCT a fost cu 7,6/5,0 mmHg mai mare faţă de valsartan/hidroclorotiazidă, cu 6,2/3,3 mmHg mai mare faţă de amlodipină/valsartan şi cu 8,2/5,3 mmHg mai mare faţă de amlodipină/hidroclorotiazidă.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Se recomandă prudenţă la pacienţii cu insuficienţă cardiacă şi afecţiuni ale arterelor coronare, mai ales la administrarea dozei maxime de Copalia HCT, 10 mg/320 mg/25 mg, deoarece datele disponibile la aceste grupe de pacienţi sunt limitate.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg.
Se recomandă precauţie la pacienţii cu insuficienţă cardiacă şi afecţiuni ale arterelor coronare, mai ales la administrarea dozei maxime de Copalia HCT, 10 mg/320 mg/25 mg.
Copalia HCT individual component
Componentă individuală a Copalia HCT
At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Copalia HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
În săptămâna 8, reducerea medie a tensiunii arteriale sistolice/diastolice a fost de 39,7/24,7 mmHg la administrarea de Copalia HCT, 32,0/19,7 mmHg la administrarea de valsartan/hidroclorotiazidă, 33,5/21,5 mmHg la administrarea de amlodipină/valsartan şi 31,5/19,5 mmHg la administrarea de amlodipină/hidroclorotiazidă.
If you forget to take Copalia HCT
Dacă uitaţi să utilizaţi Copalia HCT
Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Copalia HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
S-a observat o hipotensiune arterială pronunţată în cazul a 1,7% dintre pacienţii trataţi cu doza maximă de Copalia HCT (10 mg/320 mg/25 mg) faţă de 1,8% dintre pacienţii trataţi cu valsartan/hidroclorotiazidă (320 mg/25 mg), 0,4% dintre pacienţii trataţi cu amlodipină/valsartan (10 mg/320 mg) şi 0,2% dintre cei trataţi cu of hidroclorotiazidă/amlodipină (25 mg/10 mg) în cadrul unui studiu controlat la pacienţi cu hipertensiune arterială moderată şi severă.
This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Copalia HCT is not recommended.
Aceasta este o boală în care glandele dumneavoastra suprarenale produc prea mult hormon aldosteron.
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Copalia HCT 5 mg/160 mg/12,5 mg comprimate filmate Copalia HCT 10 mg/160 mg/12,5 mg comprimate filmate Copalia HCT 5 mg/160 mg/25 mg comprimate filmate Copalia HCT 10 mg/160 mg/25 mg comprimate filmate Copalia HCT 10 mg/320 mg/25 mg comprimate filmate
What Copalia HCT contains
Ce conţine Copalia HCT
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Copalia HCT 5 mg/160 mg/12,5 mg comprimate filmate Copalia HCT 10 mg/160 mg/12,5 mg comprimate filmate Copalia HCT 5 mg/160 mg/25 mg comprimate filmate Copalia HCT 10 mg/160 mg/25 mg comprimate filmate Copalia HCT 10 mg/320 mg/25 mg comprimate filmate amlodipină/valsartan/hidroclorotiazidă
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 Copalia HCT.
Copalia HCT împreună cu alimente, băuturi şi alcool Grepfrut-ul şi sucul de grepfrut nu trebuie consumate de persoanele cărora li s-a prescris Copalia HCT deoarece grepfrut-ul şi sucul de grepfrut pot determina o creştere a nivelurilor substanţei active, amlodipină, din sânge, ceea ce poate cauza o creştere imprevizibilă a efectului Copalia HCT de reducere a tensiunii arteriale.
How to take Copalia HCT
Cum să utilizaţi Copalia HCT
• pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia, abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body)
• piele palidă, oboseală, respiraţie întretăiată, urină închisă la culoare (anemie hemolitică,
What Copalia HCT looks like and contents of the pack Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Cum arată Copalia HCT şi conţinutul ambalajului Copalia HCT 5 mg/160 mg/12,5 mg comprimate sunt albe, ovale, inscripţionate „NVR” pe o faţă şi „VCL” pe cealaltă.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Copalia HCT 10 mg/320 mg/25 mg comprimate filmate
If you think you may be allergic, do not take Copalia HCT and talk to your doctor.
Dacă dumneavoastră credeţi că este posibil să fiţi alergic, discutaţi cu medicul dumneavoastră.
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Copalia HCT 5 mg/160 mg/25 mg comprimate sunt galbene, ovale, inscripţionate „NVR” pe o faţă şi „VEL” pe cealaltă.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Copalia HCT 10 mg/160 mg/12,5 mg comprimate sunt galbene pal, ovale, inscripţionate „NVR” pe o faţă şi „VDL” pe cealaltă.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Copalia HCT 10 mg/320 mg/25 mg comprimate sunt galben-maronii, ovale, inscripţionate „NVR” pe o faţă şi „VFL” pe cealaltă.
EU/1/09/575/006 98 film-coated tablets
EU/1/09/575/006 98 comprimate filmate
EU/1/09/575/007 280 film-coated tablets
EU/1/09/575/007 280 comprimate filmate
EU/1/09/575/004 56 film-coated tablets
EU/1/09/575/004 56 comprimate filmate
EU/1/09/575/043 280 film-coated tablets
EU/1/09/575/043 280 comprimate filmate
EU/1/09/575/042 98 film-coated tablets
EU/1/09/575/042 98 comprimate filmate
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Copalia HCT 10 mg/320 mg/25 mg comprimate filmate Substanţele active din Copalia HCT sunt amlodipina (sub formă de besilat de amlodipină), valsartanul şi hidroclorotiazida.
EU/1/09/575/001 14 film-coated tablets
EU/1/09/575/001 14 comprimate filmate
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/320 mg/25 mg comprimate filmate amlodipină/valsartan/hidroclorotiaziadă
EU/1/09/575/031 280 film-coated tablets
EU/1/09/575/031 280 comprimate filmate
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 10 mg/160 mg/12,5 mg comprimate filmate
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 5 mg/160 mg/12,5 mg comprimate filmate
EU/1/09/575/019 280 film-coated tablets
EU/1/09/575/019 280 comprimate filmate
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Copalia HCT 5 mg/160 mg/25 mg comprimate filmate
EU/1/09/575/052 56 film-coated tablets
EU/1/09/575/052 56 comprimate filmate
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Copalia HCT 10 mg/160 mg/25 mg comprimate filmate
EU/1/09/575/005 90 film-coated tablets
EU/1/09/575/005 90 comprimate filmate
EU/1/09/575/018 98 film-coated tablets
EU/1/09/575/018 98 comprimate filmate
EU/1/09/575/003 30 film-coated tablets
EU/1/09/575/003 30 comprimate filmate
EU/1/09/575/030 98 film-coated tablets
EU/1/09/575/030 98 comprimate filmate
EU/1/09/575/055 280 film-coated tablets
EU/1/09/575/055 280 comprimate filmate
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Fiecare comprimat filmat conţine amlodipină 10 mg (sub formă de besilat de amlodipină), valsartan 320 mg şi hidroclorotiazidă 25 mg.
EU/1/09/575/049 14 film-coated tablets
EU/1/09/575/049 14 comprimate filmate
EU/1/09/575/054 98 film-coated tablets
EU/1/09/575/054 98 comprimate filmate
EU/1/09/575/016 56 film-coated tablets
EU/1/09/575/016 56 comprimate filmate
EU/1/09/575/002 28 film-coated tablets
EU/1/09/575/002 28 comprimate filmate
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• erupţie trecătoare la nivelul feţei, dureri la nivelul articulaţiilor, tulburare musculară, febră
EU/1/09/575/038 28 film-coated tablets
EU/1/09/575/038 28 comprimate filmate
EU/1/09/575/041 90 film-coated tablets
EU/1/09/575/041 90 comprimate filmate
EU/1/09/575/053 90 film-coated tablets
EU/1/09/575/053 90 comprimate filmate
EU/1/09/575/040 56 film-coated tablets
EU/1/09/575/040 56 comprimate filmate
EU/1/09/575/025 14 film-coated tablets
EU/1/09/575/025 14 comprimate filmate
EU/1/09/575/037 14 film-coated tablets
EU/1/09/575/037 14 comprimate filmate
EU/1/09/575/051 30 film-coated tablets
EU/1/09/575/051 30 comprimate filmate
EU/1/09/575/027 30 film-coated tablets
EU/1/09/575/027 30 comprimate filmate
EU/1/09/575/039 30 film-coated tablets
EU/1/09/575/039 30 comprimate filmate
EU/1/09/575/029 90 film-coated tablets
EU/1/09/575/029 90 comprimate filmate
EU/1/09/575/026 28 film-coated tablets
EU/1/09/575/026 28 comprimate filmate
EU/1/09/575/017 90 film-coated tablets
EU/1/09/575/017 90 comprimate filmate
EU/1/09/575/014 28 film-coated tablets
EU/1/09/575/014 28 comprimate filmate
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Copalia HCT 10 mg/160 mg/25 mg comprimate sunt galben-maronii, ovale, inscripţionate „NVR” pe o faţă şi „VHL” pe cealaltă.
EU/1/09/575/028 56 film-coated tablets
EU/1/09/575/028 56 comprimate filmate
EU/1/09/575/013 14 film-coated tablets
EU/1/09/575/013 14 comprimate filmate
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Copalia HCT 5 mg/160 mg/25 mg comprimate filmate Substanţele active din Copalia HCT sunt amlodipina (sub formă de besilat de amlodipină), valsartanul şi hidroclorotiazida.
EU/1/09/575/044 56 x 1 film-coated tablet (unit dose) EU/1/09/575/045 98 x 1 film-coated tablet (unit dose) EU/1/09/575/046 280 x 1 film-coated tablet (unit dose)
EU/1/09/575/044 56 x 1 comprimat filmat (unitate dozată) EU/1/09/575/045 98 x 1 comprimat filmat (unitate dozată) EU/1/09/575/046 280 x 1 comprimat filmat (unitate dozată)
EU/1/09/575/015 30 film-coated tablets
EU/1/09/575/015 30 comprimate filmate
EU/1/09/575/032 56 x 1 film-coated tablet (unit dose) EU/1/09/575/033 98 x 1 film-coated tablet (unit dose) EU/1/09/575/034 280 x 1 film-coated tablet (unit dose)
EU/1/09/575/032 56 x 1 comprimat filmat (unitate dozată) EU/1/09/575/033 98 x 1 comprimat filmat (unitate dozată) EU/1/09/575/034 280 x 1 comprimat filmat (unitate dozată)
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 5 mg/160 mg/25 mg comprimate filmate amlodipină/valsartan/hidroclorotiaziadă
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/12,5 mg comprimate filmate Substanţele active din Copalia HCT sunt amlodipina (sub formă de besilat de amlodipină), valsartanul şi hidroclorotiazida.
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Copalia HCT 5 mg/160 mg/12,5 mg comprimate filmate Substanţele active din Copalia HCT sunt amlodipina (sub formă de besilat de amlodipină), valsartanul şi hidroclorotiazida.
EU/1/09/575/008 56 x 1 film-coated tablet (unit dose) EU/1/09/575/009 98 x 1 film-coated tablet (unit dose) EU/1/09/575/010 280 x 1 film-coated tablet (unit dose)
EU/1/09/575/008 56 x 1 comprimat filmat (unitate dozată) EU/1/09/575/009 98 x 1 comprimat filmat (unitate dozată) EU/1/09/575/010 280 x 1 comprimat filmat (unitate dozată)
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/25 mg comprimate filmate Substanţele active din Copalia HCT sunt amlodipina (sub formă de besilat de amlodipină), valsartanul şi hidroclorotiazida.
EU/1/09/575/056 56 x 1 film-coated tablet (unit dose) EU/1/09/575/057 98 x 1 film-coated tablet (unit dose) EU/1/09/575/058 280 x 1 film-coated tablet (unit dose)
EU/1/09/575/056 56 x 1 comprimat filmat (unitate dozată) EU/1/09/575/057 98 x 1 comprimat filmat (unitate dozată) EU/1/09/575/058 280 x 1 comprimat filmat (unitate dozată)
EU/1/09/575/050 28 film-coated tablets
EU/1/09/575/050 28 comprimate filmate
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/160 mg/25 mg comprimate filmate amlodipină/valsartan/hidroclorotiaziadă
Other medicines and Copalia HCT
Copalia HCT împreună cu alte medicamente
EU/1/09/575/020 56 x 1 film-coated tablet (unit dose) EU/1/09/575/021 98 x 1 film-coated tablet (unit dose) EU/1/09/575/022 280 x 1 film-coated tablet (unit dose)
EU/1/09/575/020 56 x 1 comprimat filmat (unitate dozată) EU/1/09/575/021 98 x 1 comprimat filmat (unitate dozată) EU/1/09/575/022 280 x 1 comprimat filmat (unitate dozată)
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 5 mg/160 mg/12,5 mg comprimate filmate amlodipină/valsartan/hidroclorotiaziadă
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Fiecare comprimat filmat conţine amlodipină 10 mg (sub formă de besilat de amlodipină), valsartan 160 mg şi hidroclorotiazidă 25 mg.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/160 mg/12,5 mg comprimate filmate amlodipină/valsartan/hidroclorotiaziadă
EU/1/09/575/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/575/036 280 comprimate filmate (ambalaj colectiv, 20 cutii a 14 comprimate) EU/1/09/575/035 280 comprimate filmate (ambalaj colectiv, 4 cutii a 70 comprimate) (unitate dozată)
EU/1/09/575/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/575/048 280 comprimate filmate (ambalaj colectiv, 20 cutii a 14 comprimate) EU/1/09/575/047 280 comprimate filmate (ambalaj colectiv, 4 cutii a 70 comprimate) (unitate dozată)
EU/1/09/575/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/575/060 280 comprimate filmate (ambalaj colectiv, 20 cutii a 14 comprimate) EU/1/09/575/059 280 comprimate filmate (ambalaj colectiv, 4 cutii a 70 comprimate) (unitate dozată)
EU/1/09/575/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/575/012 280 comprimate filmate (ambalaj colectiv, 20 cutii a 14 comprimate) EU/1/09/575/011 280 comprimate filmate (ambalaj colectiv, 4 cutii a 70 comprimate) (unitate dozată)
EU/1/09/575/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/575/024 280 comprimate filmate (ambalaj colectiv, 20 cutii a 14 comprimate) EU/1/09/575/023 280 comprimate filmate (ambalaj colectiv, 4 cutii a 70 comprimate) (unitate dozată)
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Fiecare comprimat filmat conţine amlodipină 10 mg (sub formă de besilat de amlodipină), valsartan 160 mg şi hidroclorotiazidă 12,5 mg.
It is available as capsules (150 mg).
Este disponibil sub formă de capsule (150 mg).
The recommended dose is one capsule once a day.
Doza recomandată este de o capsulă o dată pe zi.
The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
Comisia Europeană a acordat o autorizație de punere pe piață pentru Erivedge, valabilă pe întreg teritoriul Uniunii Europene, la 12 iulie 2013.
Erivedge was not compared with another treatment.
Erivedge nu a fost comparat cu alt tratament.
The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
EPAR-ul complet pentru Erivedge este disponibil pe site-ul agenției: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Erivedge
Alte informații despre Erivedge
This is a summary of the European public assessment report (EPAR) for Erivedge.
Prezentul document este un rezumat al Raportului public european de evaluare (EPAR) pentru Erivedge.