natgillin/translations-raw huggingface dataset:
If any of the above applies to you, do not take Copalia HCT and talk to your doctor.
Ako se bilo što od navedenog odnosi na Vas, nemojte uzeti Copalia HCT i obavijestite svog liječnika.
The maximum recommended dose of Copalia HCT is 10 mg/320 mg/25 mg.
Najviša preporučena doza Copalia HCT-a je 10 mg/320 mg/25 mg.
Do not use any Copalia HCT pack that is damaged or shows signs of tampering.
Copalia HCT se ne smije upotrijebiti ukoliko primjetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
If you stop taking Copalia HCT
Ako prestanete uzimati Copalia HCT
There is no experience of overdose with Copalia HCT.
Nema iskustva s predoziranjem Copalia HCT-om.
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).
U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg, stoga Copalia HCT nije prikladna u toj skupini bolesnika (vidjeti dijelove 4.2, 4.3 i 5.2).
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.
Savjetuje se oprez u bolesnika sa zatajivanjem srca i bolešću koronarnih arterija, osobito pri najvišoj dozi Copalia HCT-a, 10 mg/320 mg/25 mg, jer su dostupni podaci u ovoj populaciji bolesnika ograničeni.
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).
Istodobna primjena Copalia HCT s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Copalia HCT je kontraindicirana u bolesnika s teškim oštećenjem bubrega, anurijom ili u bolesnika na dijalizi (vidjeti dio 4.3).
Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Zbog komponente valsartana, Copalia HCT je kontraindicirana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
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.
Grejp i sok od grejpa u nekih bolesnika može dovesti do povećanja razina djelatne tvari amlodipina u krvi, što može uzrokovati neočekivano pojačani učinak Copalia HCT-a na snižavanje krvnog tlaka.
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.
U 8. tjednu, srednja vrijednost sniženja sistoličkog/dijastoličkog krvnog tlaka bila je 39,7/24,7 mmHg s Copalia HCT-om, 32,0/19,7 mmHg s valsartanom/hidroklorotiazidom, 33,5/21,5 mmHg s amlodipinom/valsartanom te 31,5/19,5 mmHg s amlodipinom/hidroklorotiazidom.
If you forget to take Copalia HCT
Ako ste zaboravili uzeti Copalia HCT
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.
Sniženje sistoličkog/dijastoličkog krvnog tlaka postignuto Copalia HCT-om bilo je 7,6/5,0 mmHg veće nego s valsartanom/hidroklorotiazidom, za 6,2/3,3 mmHg veće od onog s amlodipinom/valsartanom te za 8,2/5,3 mmHg veće od onog s amlodipinom/hidroklorotiazidom.
Copalia HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Copalia HCT smije se primjenjivati tek nakon korigiranja snižene razine natrija i/ili volumena tekućine.
Treatment with Copalia HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Liječenje Copalia HCT-om smije se započeti tek nakon korigiranja hipokalijemije i eventualne prateće hipomagnezijemije.
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).
U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg te Copalia HCT stoga nije pogodna za ovu skupinu bolesnika (vidjeti dijelove 4.3, 4.4 i 5.2).
Due to the valsartan component, Copalia HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Zbog valsartanske komponente Copalia HCT je kontraindicirana u bolesnika s oštećenjem jetre (vidjeti djelove 4.2 i 4.3).
There are no clinical studies on fertility with Copalia HCT.
Ne postoje klinička ispitivanja djelovanja Copalia HCT-a na plodnost.
Amlodipine/Valsartan/Hydrochlorothiazide
Amlodipin/valsartan/hidroklorotiazid
Amlodipine/valsartan/hydrochlorothiazide
Amlodipin/Valsartan/Hidroklorotiazid
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.
Savjetuje se oprez u bolesnika sa zatajenjem srca i bolešću koronarnih arterija, posebno u najvišoj dozi Copalia HCT-a, 10 mg/320 mg/25 mg.
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 filmom obložene tablete Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete Copalia HCT 10 mg/320 mg/25 mg filmom obložene tablete
Copalia HCT individual component
Pojedinačna komponenta Copalia HCT-a
Copalia HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Bolesnici u kojih se razvije angioedem trebaju odmah prekinuti primjenu Copalia HCT-a i više je ne smiju ponovo uzimati.
How to take Copalia HCT
Kako uzimati Copalia HCT
If you take more Copalia HCT than you should If you have accidentally taken too many Copalia HCT tablets, talk to a doctor immediately.You may require medical attention.
Ako ste slučajno uzeli previše tableta Copalia HCT-a, odmah se obratite liječniku.
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.
To je bolest kod koje nadbubrežne žlijezde stvaraju previše hormona aldosterona.
Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Macrogol 4000
Hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) makrogol 4000 talk
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.
U kontroliranom ispitivanju provedenom u bolesnika s umjerenom do teškom nekompliciranom hipertenzijom, izrazita hipotenzija, uključujući ortostatsku hipotenziju, viđena je u 1,7% bolesnika liječenih najvišom dozom Copalia HCT-a (10 mg/320 mg/25 mg) u usporedbi s 1,8% bolesnika liječenih valsartanom/hidroklorotiazidom (320 mg/25 mg), 0,4% bolesnika liječenih amlodipinom/valsartanom (10 mg/320 mg) i 0,2% bolesnika liječenih hidroklorotiazidom/amlodipinom (25 mg/10 mg).
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 filmom obložene tablete Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete Copalia HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Frequency Copalia HCT
Učestalost Copalia HCT
How to store Copalia HCT
Kako čuvati Copalia HCT
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia HCT.
Bolesnici kojima je propisan Copalia HCT ne smiju konzumirati grejp ili sok od grejpa.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Copalia HCT 10 mg/320 mg/25 mg filmom obložene tablete
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.
Kako Copalia HCT izgleda i sadržaj pakiranja Copalia HCT 5 mg/160 mg/12,5 mg filmom obložene tablete su bijele, ovalne tablete s oznakom „NVR“ na jednoj strani i „VCL“ na drugoj strani.
There is limited experience with the use of Copalia HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
U bolesnika sa zatajenjem srca i bolešću koronarnih arterija postoji ograničeno iskustvo s primjenom Copalia HCT-a, posebno u najvišoj dozi.
Copalia HCT should be discontinued if hypercalcaemia develops during treatment.
Ako se tijekom liječenja Copalia HCT-om razvije hiperkalcijemija, liječenje treba prekinuti.
if you experience dizziness and/or fainting during treatment with Copalia HCT, tell your doctor as soon as possible.
Nemojte više nikad uzimati Copalia HCT. ako tijekom liječenja Copalia HCT-om osjetite omaglicu i/ili nesvjesticu, o tome što prije obavijestite svoga liječnika.
EU/1/09/575/043 280 film-coated tablets
EU/1/09/575/043 280 filmom obloženih tableta
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 5 mg/160 mg/12,5 mg filmom obložene tablete
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete
EU/1/09/575/004 56 film-coated tablets
EU/1/09/575/004 56 filmom obloženih tableta
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete
EU/1/09/575/042 98 film-coated tablets
EU/1/09/575/042 98 filmom obloženih tableta
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 filmom obložene tablete su blijedo žute, ovalne tablete s oznakom „NVR“ na jednoj strani i „VDL“ na drugoj strani.
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 filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VFL“ na drugoj strani.
EU/1/09/575/031 280 film-coated tablets
EU/1/09/575/031 280 filmom obloženih tableta
EU/1/09/575/007 280 film-coated tablets
EU/1/09/575/007 280 filmom obloženih tableta
EU/1/09/575/041 90 film-coated tablets
EU/1/09/575/041 90 filmom obloženih tableta
EU/1/09/575/006 98 film-coated tablets
EU/1/09/575/006 98 filmom obloženih tableta
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 filmom obložene tablete su žute, ovalne tablete s oznakom „NVR“ na jednoj strani i „VEL“ na drugoj strani.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/016 56 film-coated tablets
EU/1/09/575/016 56 filmom obloženih tableta
EU/1/09/575/054 98 film-coated tablets
EU/1/09/575/054 98 filmom obloženih tableta
EU/1/09/575/018 98 film-coated tablets
EU/1/09/575/018 98 filmom obloženih tableta
EU/1/09/575/040 56 film-coated tablets
EU/1/09/575/040 56 filmom obloženih tableta
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 filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/575/026 28 film-coated tablets
EU/1/09/575/026 28 filmom obloženih tableta
EU/1/09/575/019 280 film-coated tablets
EU/1/09/575/019 280 filmom obloženih tableta
EU/1/09/575/049 14 film-coated tablets
EU/1/09/575/049 14 filmom obloženih tableta
EU/1/09/575/055 280 film-coated tablets
EU/1/09/575/055 280 filmom obloženih tableta
EU/1/09/575/030 98 film-coated tablets
EU/1/09/575/030 98 filmom obloženih tableta
EU/1/09/575/027 30 film-coated tablets
EU/1/09/575/027 30 filmom obloženih tableta
EU/1/09/575/001 14 film-coated tablets
EU/1/09/575/001 14 filmom obloženih tableta
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.
Zbog ograničenog broja dostupnih podataka u ovoj populaciji bolesnika, u starijih bolesnika se preporučuje oprez, uključujući češće praćenje krvnog tlaka, posebno pri najvišoj dozi Copalia HCT-a, 10 mg/320 mg/25 mg.
EU/1/09/575/052 56 film-coated tablets
EU/1/09/575/052 56 filmom obloženih tableta
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan, and 25 mg hydrochlorothiazide.
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 320 mg valsartana i 25 mg hidroklorotiazida.
EU/1/09/575/029 90 film-coated tablets
EU/1/09/575/029 90 filmom obloženih tableta
EU/1/09/575/005 90 film-coated tablets
EU/1/09/575/005 90 filmom obloženih tableta
EU/1/09/575/038 28 film-coated tablets
EU/1/09/575/038 28 filmom obloženih tableta
EU/1/09/575/025 14 film-coated tablets
EU/1/09/575/025 14 filmom obloženih tableta
EU/1/09/575/003 30 film-coated tablets
EU/1/09/575/003 30 filmom obloženih tableta
EU/1/09/575/053 90 film-coated tablets
EU/1/09/575/053 90 filmom obloženih tableta
EU/1/09/575/037 14 film-coated tablets
EU/1/09/575/037 14 filmom obloženih tableta
EU/1/09/575/014 28 film-coated tablets
EU/1/09/575/014 28 filmom obloženih tableta
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 filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VHL“ na drugoj strani.
EU/1/09/575/017 90 film-coated tablets
EU/1/09/575/017 90 filmom obloženih tableta
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Hipromeloza zamjenski tip 2910 (3 mPas) makrogol 4000 talk titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
EU/1/09/575/039 30 film-coated tablets
EU/1/09/575/039 30 filmom obloženih tableta
EU/1/09/575/015 30 film-coated tablets
EU/1/09/575/015 30 filmom obloženih tableta
EU/1/09/575/051 30 film-coated tablets
EU/1/09/575/051 30 filmom obloženih tableta
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 filmom obloženih tableta (jedinična doza) EU/1/09/575/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/046 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/575/002 28 film-coated tablets
EU/1/09/575/002 28 filmom obloženih tableta
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/013 14 film-coated tablets
EU/1/09/575/013 14 filmom obloženih tableta
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 filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
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 filmom obloženih tableta (jedinična doza) EU/1/09/575/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/034 280 x 1 filmom obloženih tableta (jedinična doza)
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 filmom obloženih tableta (jedinična doza) EU/1/09/575/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/010 280 x 1 filmom obloženih tableta (jedinična doza)
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/028 56 film-coated tablets
EU/1/09/575/028 56 filmom obloženih tableta
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 filmom obloženih tableta (jedinična doza) EU/1/09/575/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/058 280 x 1 filmom obloženih tableta (jedinična doza)
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 filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
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 filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
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 filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/575/050 28 film-coated tablets
EU/1/09/575/050 28 filmom obloženih tableta
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 filmom obloženih tableta (jedinična doza) EU/1/09/575/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/022 280 x 1 filmom obloženih tableta (jedinična doza)
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
No dose adjustment of Copalia HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m 2) dozu Copalia
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
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 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
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 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/023 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Hipromeloza zamjenski tip 2910 (3 mPas) makrogol 4000 talk željezov oksid, žuti (E172)
It is available as capsules (150 mg).
Dostupan je u obliku kapsula (150 mg).
The recommended dose is one capsule once a day.
Preporučena je doza jedna kapsula na dan.
The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Erivedge nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
Približno 33 % (11 od 33) bolesnika s metastatskom bolesti i 48 % (30 od 63) bolesnika s lokalno uznapredovalom bolesti reagiralo je na terapiju.
Erivedge was not compared with another treatment.
Erivedge nije uspoređivan ni s jednom drugom terapijom.
What is Erivedge and what is it used for?
Što je Erivedge i za što se koristi?
What measures are being taken to ensure the safe and effective use of Erivedge?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Erivedge?
The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate).
Glavna mjera djelotvornosti bio je odgovor na terapiju na temelju smanjenja veličine tumora od barem 30 % ili nestanka svih znakova karcinoma (objektivna stopa odgovora).
Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Lijeku Erivedge je prvotno izdano „uvjetno odobrenje” jer su se očekivali dodatni dokazi o lijeku.
The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study.
Bolesnici su dobivali Erivedge sve dok im se bolest nije pogoršala ili dok nisu mogli podnositi terapiju ili dok se nisu povukli iz ispitivanja.