natgillin/translations-raw huggingface dataset:
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Exforge 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 Exforge HCT nije prikladan 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 Exforge 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 Exforge HCT-a, 10 mg/320 mg/25 mg, jer su dostupni podaci u ovoj populaciji bolesnika ograničeni.
Concomitant use of Exforge 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 Exforge 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).
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 Exforge 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 Exforge HCT-a na snižavanje krvnog tlaka.
At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Exforge 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 Exforge 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 any of the above applies to you, do not take Exforge HCT and talk to your doctor.
Ako se bilo što od navedenog odnosi na Vas, nemojte uzeti Exforge HCT i obavijestite svog liječnika.
The reductions in systolic/diastolic blood pressure with Exforge 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 Exforge 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.
The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg.
Najviša preporučena doza Exforge HCT-a je 10 mg/320 mg/25 mg.
Exforge HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Exforge HCT smije se primjenjivati tek nakon korigiranja snižene razine natrija i/ili volumena tekućine.
If you forget to take Exforge HCT
Ako ste zaboravili uzeti Exforge HCT
Exforge HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Exforge HCT je kontraindiciran u bolesnika s teškim oštećenjem bubrega, anurijom ili u bolesnika na dijalizi (vidjeti dio 4.3).
Due to the valsartan component, Exforge HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Zbog komponente valsartana, Exforge HCT je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Exforge 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 Exforge HCT stoga nije pogodan za ovu skupinu bolesnika (vidjeti dijelove 4.3, 4.4 i 5.2).
an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. aliskiren.
Due to the valsartan component, Exforge HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Zbog valsartanske komponente Exforge HCT je kontraindiciran u bolesnika s oštećenjem jetre (vidjeti djelove 4.2 i 4.3).
There are no clinical studies on fertility with Exforge HCT.
Ne postoje klinička ispitivanja djelovanja Exforge HCT-a na plodnost.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg.
Savjetuje se oprez u bolesnika sa zatajenjem srca i bolešću koronarnih arterija, posebno u najvišoj dozi Exforge HCT-a, 10 mg/320 mg/25 mg.
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 5 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete
How to take Exforge HCT
Kako uzimati Exforge HCT
Exforge 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 Exforge HCT-a i više ga ne smiju ponovo uzimati.
This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Exforge HCT is not recommended.
To je bolest kod koje nadbubrežne žlijezde stvaraju previše hormona aldosterona.
Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Exforge 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 Exforge 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).
Treatment with Exforge HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Liječenje Exforge HCT-om smije se započeti tek nakon korigiranja hipokalijemije i eventualne prateće hipomagnezijemije.
If you take more Exforge HCT than you should If you have accidentally taken too many Exforge HCT tablets, talk to a doctor immediately.You may require medical attention.
Ako ste slučajno uzeli previše tableta Exforge HCT-a, odmah se obratite liječniku.
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 5 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Exforge HCT.
Bolesnici kojima je propisan Exforge HCT ne smiju konzumirati grejp ili sok od grejpa.
There is no experience of overdose with Exforge HCT.
Nema iskustva s predoziranjem Exforge HCT-om.
Exforge HCT individual component
Pojedinačna komponenta Exforge HCT-a
Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete
What Exforge HCT looks like and contents of the pack Exforge 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 Exforge HCT izgleda i sadržaj pakiranja Exforge 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.
Frequency Exforge HCT
Učestalost Exforge HCT
How to store Exforge HCT
Kako čuvati Exforge HCT
if you experience dizziness and/or fainting during treatment with Exforge HCT, tell your doctor as soon as possible.
Nemojte više nikad uzimati Exforge HCT. ako tijekom liječenja Exforge HCT-om osjetite omaglicu i/ili nesvjesticu, o tome što prije obavijestite svoga liječnika.
Exforge HCT should be discontinued if hypercalcaemia develops during treatment.
Ako se tijekom liječenja Exforge HCT-om razvije hiperkalcijemija, liječenje treba prekinuti.
Blood potassium decreased Uncommon Blood potassium increased
Povišena dušična urea u krvi Manje često -Povišena mokraćna kiselina u krvi
EU/1/09/569/007 280 film-coated tablets
EU/1/09/569/007 280 filmom obloženih tableta
There is limited experience with the use of Exforge 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 Exforge HCT-a, posebno u najvišoj dozi.
EU/1/09/569/016 56 film-coated tablets
EU/1/09/569/016 56 filmom obloženih tableta
EU/1/09/569/042 98 film-coated tablets
EU/1/09/569/042 98 filmom obloženih tableta
EU/1/09/569/043 280 film-coated tablets
EU/1/09/569/043 280 filmom obloženih tableta
EU/1/09/569/004 56 film-coated tablets
EU/1/09/569/004 56 filmom obloženih tableta
EU/1/09/569/018 98 film-coated tablets
EU/1/09/569/018 98 filmom obloženih tableta
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets
Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete
EU/1/09/569/027 30 film-coated tablets
EU/1/09/569/027 30 filmom obloženih tableta
Exforge HCT 5 mg/160 mg/25 mg film-coated tablets
Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete
Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets
Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets
Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete
EU/1/09/569/041 90 film-coated tablets
EU/1/09/569/041 90 filmom obloženih tableta
EU/1/09/569/038 28 film-coated tablets
EU/1/09/569/038 28 filmom obloženih tableta
Exforge 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.
Exforge 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/1/09/569/031 280 film-coated tablets
EU/1/09/569/031 280 filmom obloženih tableta
Exforge 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.
Exforge 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.
EU/1/09/569/054 98 film-coated tablets
EU/1/09/569/054 98 filmom obloženih tableta
EU/1/09/569/006 98 film-coated tablets
EU/1/09/569/006 98 filmom obloženih tableta
EU/1/09/569/026 28 film-coated tablets
EU/1/09/569/026 28 filmom obloženih tableta
EU/1/09/569/055 280 film-coated tablets
EU/1/09/569/055 280 filmom obloženih tableta
EU/1/09/569/040 56 film-coated tablets
EU/1/09/569/040 56 filmom obloženih tableta
Exforge 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.
Exforge 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.
EU/1/09/569/019 280 film-coated tablets
EU/1/09/569/019 280 filmom obloženih tableta
EU/1/09/569/030 98 film-coated tablets
EU/1/09/569/030 98 filmom obloženih tableta
EU/1/09/569/052 56 film-coated tablets
EU/1/09/569/052 56 filmom obloženih tableta
EU/1/09/569/001 14 film-coated tablets
EU/1/09/569/001 14 filmom obloženih tableta
EU/1/09/569/005 90 film-coated tablets
EU/1/09/569/005 90 filmom obloženih tableta
EU/1/09/569/025 14 film-coated tablets
EU/1/09/569/025 14 filmom obloženih tableta
Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge 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 Exforge HCT-a, 10 mg/320 mg/25 mg.
EU/1/09/569/003 30 film-coated tablets
EU/1/09/569/003 30 filmom obloženih tableta
EU/1/09/569/053 90 film-coated tablets
EU/1/09/569/053 90 filmom obloženih tableta
EU/1/09/569/029 90 film-coated tablets
EU/1/09/569/029 90 filmom obloženih tableta
Exforge HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Exforge HCT 10 mg/320 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/569/017 90 film-coated tablets
EU/1/09/569/017 90 filmom obloženih tableta
EU/1/09/569/049 14 film-coated tablets
EU/1/09/569/049 14 filmom obloženih tableta
EU/1/09/569/037 14 film-coated tablets
EU/1/09/569/037 14 filmom obloženih tableta
EU/1/09/569/014 28 film-coated tablets
EU/1/09/569/014 28 filmom obloženih tableta
EU/1/09/569/015 30 film-coated tablets
EU/1/09/569/015 30 filmom obloženih tableta
EU/1/09/569/051 30 film-coated tablets
EU/1/09/569/051 30 filmom obloženih tableta
EU/1/09/569/002 28 film-coated tablets
EU/1/09/569/002 28 filmom obloženih tableta
Exforge 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.
Exforge 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/1/09/569/039 30 film-coated tablets
EU/1/09/569/039 30 filmom obloženih tableta
EU/1/09/569/044 56 x 1 film-coated tablet (unit dose) EU/1/09/569/045 98 x 1 film-coated tablet (unit dose) EU/1/09/569/046 280 x 1 film-coated tablet (unit dose)
EU/1/09/569/044 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/046 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/569/008 56 x 1 film-coated tablet (unit dose) EU/1/09/569/009 98 x 1 film-coated tablet (unit dose) EU/1/09/569/010 280 x 1 film-coated tablet (unit dose)
EU/1/09/569/008 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/010 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/569/056 56 x 1 film-coated tablet (unit dose) EU/1/09/569/057 98 x 1 film-coated tablet (unit dose) EU/1/09/569/058 280 x 1 film-coated tablet (unit dose)
EU/1/09/569/056 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/058 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/569/032 56 x 1 film-coated tablet (unit dose) EU/1/09/569/033 98 x 1 film-coated tablet (unit dose) EU/1/09/569/034 280 x 1 film-coated tablet (unit dose)
EU/1/09/569/032 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/034 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/569/013 14 film-coated tablets
EU/1/09/569/013 14 filmom obloženih tableta
EU/1/09/569/050 28 film-coated tablets
EU/1/09/569/050 28 filmom obloženih tableta
EU/1/09/569/028 56 film-coated tablets
EU/1/09/569/028 56 filmom obloženih tableta
Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/569/020 56 x 1 film-coated tablet (unit dose) EU/1/09/569/021 98 x 1 film-coated tablet (unit dose) EU/1/09/569/022 280 x 1 film-coated tablet (unit dose)
EU/1/09/569/020 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/569/022 280 x 1 filmom obloženih tableta (jedinična doza)
Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
Exforge HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Exforge HCT 5 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Exforge HCT 10 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Exforge HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/569/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/569/048 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
EU/1/09/569/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/569/012 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
EU/1/09/569/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/569/060 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
EU/1/09/569/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/569/036 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
EU/1/09/569/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
EU/1/09/569/024 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/569/023 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
No dose adjustment of Exforge 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 Exforge
Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Each bottle contains 60 tablets.
Jedna boca sadrži 60 tableta.
The tablets may be taken with or without food.
Tablete se mogu uzimati s hranom ili bez nje.
No formal interaction studies with other medicinal products have been conducted.
Nisu provedena službena ispitivanja interakcija s drugim lijekovima.
What Nityr looks like and contents of the pack
Kako Nityr izgleda i sadržaj pakiranja
For patients who require additional strengths (i.e. between multiples of 10 mg or lower than 10 mg) other medicinal products with lower strengths are available.
Za bolesnike kojima je potrebna dodatna jačina (tj. jačina između višekratnika 10 mg ili manja od 10 mg) dostupni su drugi lijekovi slabije jačine.
Other medicines and Nityr
Drugi lijekovi i Nityr
For paediatric patients who have difficulties swallowing tablets, other pharmaceutical forms are available.
Za pedijatrijske bolesnike koji imaju poteškoća s gutanjem tableta dostupni su drugi farmaceutski oblici.
What Nityr is and what it is used for
Što je Nityr i za što se koristi
However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Ipak, ako osjetite nuspojave koje utječu na vid, ne smijete upravljati vozilima ili raditi sa strojevima dok Vam vid ponovo ne postane normalan (vidjeti dio 4 „Moguće nuspojave“).
Tablets are not suitable for breaking to make up additional strengths.
Tablete nisu pogodne za lomljenje kako bi se dobila dodatna jačina.
In 23 healthy volunteers, after administration of a single dose of Nityr tablets (10 mg) the terminal half-life (median) of nitisinone in plasma was 59 hours (ranging from 41 to 74 hours).
U 23 zdrava dobrovoljca nakon primjene pojedinačne doze tableta Nityr (10 mg) terminalni poluvijek (medijan) nitizinona u plazmi bio je 59 sati (u rasponu od 41 do 74 sata).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 tablets
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 tableta
For storage conditions after first opening of the medicinal product, see section 6.3.
Za uvjete čuvanja nakon prvog otvaranja lijeka, vidjeti dio 6.3.
Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Nityr se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje nitizinonom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Datum prvog odobrenja: 26. srpnja 2018
Contact your doctor immediately for an eye examination.
Odmah se obratite svom liječniku radi pregleda očiju.