natgillin/translations-raw huggingface dataset:
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.
V kontroliranem preskušanju pri bolnikih z zmerno do hudo nezapleteno hipertenzijo so čezmerno hipotenzijo, vključno z ortostatsko hipotenzijo, opažali pri 1,7 % bolnikov, ki so prejemali najvišji odmerek zdravila Exforge HCT (10 mg/320 mg/25 mg), v primerjavi z 1,8 % bolnikov, ki so prejemali valsartan/hidroklorotiazid (320 mg/25 mg), z 0,4 % bolnikov, ki so prejemali amlodipin/valsartan (10 mg/320 mg), in z 0,2 % bolnikov, ki so prejemali hidroklorotiazid/amlodipin (25 mg/10 mg).
Stopping your treatment with Exforge HCT may cause your disease to get worse.
Če ste prenehali jemati zdravilo Exforge HCT Če prenehate jemati zdravilo Exforge HCT, se lahko vaša bolezen poslabša.
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.
Pri starejših bolnikih je priporočena previdnost, kar vključuje bolj pogosto merjenje krvnega tlaka, zlasti pri uporabi najvišjega odmerka zdravila Exforge HCT 10 mg/320 mg/25 mg, saj je za to skupino bolnikov na voljo le malo podatkov.
Exforge HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Zdravilo Exforge HCT se sme uporabiti šele po ureditvi morebitnega že prisotnega primanjkljaja natrija in/ali hipovolemije.
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.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Exforge HCT 10 mg/320 mg/25 mg, saj je pri teh skupinah bolnikov na voljo le malo podatkov.
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.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Exforge HCT 10 mg/320 mg/25 mg.
There is no experience of overdose with Exforge HCT.
Izkušenj s prevelikim odmerjanjem zdravila Exforge HCT ni.
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 filmsko obložene tablete Exforge HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Exforge HCT 5 mg/160 mg/25 mg filmsko obložene tablete Exforge HCT 10 mg/160 mg/25 mg filmsko obložene tablete Exforge HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
Protect your skin from sun exposure and UV rays while taking Exforge HCT.
Med jemanjem zdravila Exforge HCT zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
How to take Exforge HCT
Kako jemati zdravilo Exforge HCT
Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Exforge HCT 10 mg/320 mg/25 mg filmsko obložene tablete
You should never take Exforge HCT again.
Ti bolniki ne smejo več prejemati zdravila Exforge HCT.
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Exforge HCT.
Zdravilo Exforge HCT skupaj s hrano, pijačo in alkoholom Ljudje, ki jim je zdravnik predpisal zdravilo Exforge HCT, ne smejo uživati grenivk in grenivkinega soka.
There is limited experience with the use of Exforge HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je le malo izkušenj z uporabo zdravila Exforge HCT, zlasti z uporabo najvišjega odmerka.
Exforge HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Bolnikom, pri katerih pride do angioedema, je treba zdravilo Exforge HCT takoj ukiniti.
if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies if you have been sick (vomiting or diarrhoea).
Če imate to bolezen, uporaba zdravila Exforge HCT za vas ni priporočena; če imate bolezen, ki se imenuje sistemski eritematozni lupus (ki ga kratko imenujemo tudi “lupus” ali s kratico “SLE”); če imate sladkorno bolezen (visoko raven sladkorja v krvi); če imate visoke ravni holesterola ali trigliceridov v krvi; če imate po izpostavljanju soncu kožne reakcije, npr izpuščaj; če ste že imeli alergijsko reakcijo na druga zdravila za uravnavanje visokega krvnega tlaka ali na diuretike (skupino zdravil, ki jim pravimo tudi “tablete za odvajanje vode”), zlasti če imate astmo ali alergije;
EU/1/09/569/007 280 film-coated tablets
EU/1/09/569/007 280 filmsko obloženih tablet
What Exforge HCT contains
Kaj vsebuje zdravilo Exforge HCT
EU/1/09/569/004 56 film-coated tablets
EU/1/09/569/004 56 filmsko obloženih tablet
EU/1/09/569/043 280 film-coated tablets
EU/1/09/569/043 280 filmsko obloženih tablet
EU/1/09/569/016 56 film-coated tablets
EU/1/09/569/016 56 filmsko obloženih tablet
EU/1/09/569/042 98 film-coated tablets
EU/1/09/569/042 98 filmsko obloženih tablet
EU/1/09/569/018 98 film-coated tablets
EU/1/09/569/018 98 filmsko obloženih tablet
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets
Exforge HCT 10 mg/160 mg/25 mg filmsko obložene tablete
Exforge HCT 5 mg/160 mg/25 mg film-coated tablets
Exforge HCT 5 mg/160 mg/25 mg filmsko obložene tablete
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets
Exforge HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete
Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets
Exforge HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete
EU/1/09/569/027 30 film-coated tablets
EU/1/09/569/027 30 filmsko obloženih tablet
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 filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VFL” na drugi.
EU/1/09/569/031 280 film-coated tablets
EU/1/09/569/031 280 filmsko obloženih tablet
Exforge HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Pri bolnikih s hudo okvaro ledvic, z anurijo in pri bolnikih na dializi je uporaba zdravila Exforge HCT kontraindicirana (glejte poglavje 4.3).
Exforge HCT individual component
Sočasna uporaba ni priporočena posamezna sestavina zdravila Exforge HCT
EU/1/09/569/041 90 film-coated tablets
EU/1/09/569/041 90 filmsko obloženih tablet
No dose adjustment of Exforge HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Pri bolnikih z blago do zmerno okvaro ledvic (GFR ≥30 ml/min/1,73 m 2) odmerka zdravila Exforge
EU/1/09/569/006 98 film-coated tablets
EU/1/09/569/006 98 filmsko obloženih tablet
EU/1/09/569/038 28 film-coated tablets
EU/1/09/569/038 28 filmsko obloženih tablet
EU/1/09/569/001 14 film-coated tablets
EU/1/09/569/001 14 filmsko obloženih tablet
EU/1/09/569/055 280 film-coated tablets
EU/1/09/569/055 280 filmsko obloženih tablet
EU/1/09/569/030 98 film-coated tablets
EU/1/09/569/030 98 filmsko obloženih tablet
EU/1/09/569/005 90 film-coated tablets
EU/1/09/569/005 90 filmsko obloženih tablet
EU/1/09/569/054 98 film-coated tablets
EU/1/09/569/054 98 filmsko obloženih tablet
EU/1/09/569/040 56 film-coated tablets
EU/1/09/569/040 56 filmsko obloženih tablet
EU/1/09/569/019 280 film-coated tablets
EU/1/09/569/019 280 filmsko obloženih tablet
EU/1/09/569/052 56 film-coated tablets
EU/1/09/569/052 56 filmsko obloženih tablet
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 filmsko obložene tablete so rumene ovalne tablete z oznako “NVR” na eni strani in “VEL” na drugi.
EU/1/09/569/003 30 film-coated tablets
EU/1/09/569/003 30 filmsko obloženih tablet
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 filmsko obložene tablete Učinkovine v zdravilu Exforge HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
EU/1/09/569/025 14 film-coated tablets
EU/1/09/569/025 14 filmsko obloženih tablet
Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/569/026 28 film-coated tablets
EU/1/09/569/026 28 filmsko obloženih tablet
EU/1/09/569/053 90 film-coated tablets
EU/1/09/569/053 90 filmsko obloženih tablet
EU/1/09/569/029 90 film-coated tablets
EU/1/09/569/029 90 filmsko obloženih tablet
EU/1/09/569/049 14 film-coated tablets
EU/1/09/569/049 14 filmsko obloženih tablet
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 filmsko obložene tablete so bledo rumene ovalne tablete z oznako “NVR” na eni strani in “VDL” na drugi.
EU/1/09/569/017 90 film-coated tablets
EU/1/09/569/017 90 filmsko obloženih tablet
EU/1/09/569/051 30 film-coated tablets
EU/1/09/569/051 30 filmsko obloženih tablet
EU/1/09/569/037 14 film-coated tablets
EU/1/09/569/037 14 filmsko obloženih tablet
EU/1/09/569/014 28 film-coated tablets
EU/1/09/569/014 28 filmsko obloženih tablet
EU/1/09/569/002 28 film-coated tablets
EU/1/09/569/002 28 filmsko obloženih tablet
Talk to your doctor or pharmacist before taking Exforge HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Pred začetkom jemanja zdravila Exforge HCT se posvetujte z zdravnikom ali farmacevtom če imate v krvi nizke ravni kalija ali magnezija (s simptomi, kot so šibkost mišic, mišični krči in nepravilen srčni ritem, ali brez teh simptomov); če imate v krvi nizke ravni natrija (s simptomi, kot so utrujenost, zmedenost, trzanje mišic in napadi krčev, ali brez teh simptomov); če imate v krvi visoko raven kalcija (s simptomi, kot so slabost, bruhanje, zapeka, bolečine v trebuhu, pogosto uriniranje, žeja, šibkost in trzanje mišic, ali brez teh simptomov); če imate težave z ledvicami, če so vam presadili ledvico ali so vam povedali, da imate zoženje ledvičnih arterij; če imate težave z jetri; če imate ali ste imeli kdaj prej srčno popuščanje ali koronarno bolezen, zlasti če vam je zdravnik predpisal najvišji odmerek zdravila Exforge HCT (10 mg/320 mg/25 mg); če ste preživeli srčni infarkt.
EU/1/09/569/015 30 film-coated tablets
EU/1/09/569/015 30 filmsko obloženih tablet
EU/1/09/569/013 14 film-coated tablets
EU/1/09/569/013 14 filmsko obloženih tablet
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 filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VHL” na drugi.
EU/1/09/569/039 30 film-coated tablets
EU/1/09/569/039 30 filmsko obloženih tablet
Exforge HCT should be discontinued if hypercalcaemia develops during treatment.
Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Exforge HCT prekiniti.
EU/1/09/569/050 28 film-coated tablets
EU/1/09/569/050 28 filmsko obloženih tablet
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 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/033 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/034 280 x 1 filmsko obložena tableta (za enkratni odmerek)
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 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/045 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/046 280 x 1 filmsko obložena tableta (za enkratni odmerek)
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 filmsko obložene tablete Učinkovine v zdravilu Exforge HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
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 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/057 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/058 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 5 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/569/028 56 film-coated tablets
EU/1/09/569/028 56 filmsko obloženih tablet
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 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/009 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/010 280 x 1 filmsko obložena tableta (za enkratni odmerek)
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 filmsko obložene tablete Učinkovine v zdravilu Exforge HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 10 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
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 filmsko obložene tablete Učinkovine v zdravilu Exforge HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in 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 filmsko obložene tablete Učinkovine v zdravilu Exforge HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in 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 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/021 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/569/022 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Exforge HCT 5 mg/160 mg/12,5 mg filmsko 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 filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
if you experience dizziness and/or fainting during treatment with Exforge HCT, tell your doctor as soon as possible.
V tem primeru zdravila Exforge HCT nikoli več ne smete več jemati; če med zdravljenjem z zdravilom Exforge HCT pride do omotičnosti in/ali izgube zavesti, čimprej obvestite zdravnika; če se vam poslabša vid ali vas začne boleti oko.
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 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/035 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
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 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/047 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
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 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/011 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
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 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/059 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
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 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/569/023 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
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.
Exforge HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR” na eni strani in “VCL” na drugi.
• anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);
• mišičnih relaksantov (zdravil za sproščanje mišic, ki jih uporabljajo med operacijami); nitroglicerina in drugih nitratov ter učinkovin, ki jih imenujemo “vazodilatatorji”; drugih zdravil za zdravljenje visokega krvnega tlaka, vključno z metildopo; rifampicina (ki ga uporabljamo za zdravljenje npr. tuberkuloze); eritromicin, klaritromicin (antibiotiki); šentjanževke; dantrolen (zdravilo v infuziji pri hudih odstopanjih telesne temperature); vitamina D in kalcijevih soli.
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).
Pogostnost neželenih učinkov je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki, <1/10.000, neznana (ni mogoče oceniti iz razpoložljivih podatkov.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1290/001
The tablets may be taken with or without food.
Tablete se lahko jemljejo s hrano ali brez nje.
Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Obisk monitorja naj bi bil izveden vsakih 6 mesecev, krajši razmiki med posameznimi obiski so priporočljivi v primeru neželenih dogodkov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Datum prve odobritve: 26. julij 2018
This medicine does not require any special temperature storage conditions.
To zdravilo ne zahteva posebnih temperaturnih pogojev shranjevanja.
Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalised during the first week of treatment.
Razpoložljivi podatki klinične študije so pokazali, da se je sukcinilaceton v urinu pri več kot 90 % bolnikov normaliziral v prvem tednu zdravljenja.
Start age ≤ 24 months Start age > 24 months
Začetna starost ≤ 24 mesecev Začetna starost > 24 mesecev
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 bolnike, ki potrebujejo drugačne jakosti (npr. med večkratniki 10 mg ali nižje od 10 mg), so na voljo druga zdravila z nižjimi jakostmi.
Probability of no HCC (95% confidence interval) at Start 2 years 4 years 6 years 2 years
Verjetnost za nepojav HCK (95 % interval zaupanja) po na začetku po 2 letih po 4 letih po 6 letih
For paediatric patients who have difficulties swallowing tablets, other pharmaceutical forms are available.
Za pediatrične bolnike, ki imajo težave s požiranjem tablet, so na voljo druge farmacevtske oblike.
Each carton contains 1 bottle.
Ena kartonska škatla vsebuje 1 plastenko.
Each tablet contains less than 120 mg of lactose (as monohydrate).
Ena tableta vsebuje manj kot 120 mg laktoze (v obliki monohidrata).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intolerance za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
2-, 4- in 6-letna verjetnost, da se HCK med zdravljenjem z nitizinonom ne bo pojavil pri bolnikih, starih 24 mesecev ali manj na začetku zdravljenja, in pri bolnikih, starih več kot 24 mesecev na začetku zdravljenja, je prikazana v naslednji preglednici:
Nityr should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Zdravila Nityr ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje z nitizinonom.
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).
Pri 23 zdravih prostovoljcih je bil končni razpolovni čas (mediana) nitizinona v plazmi po zaužitju tablet Nityr (10 mg) 59 ur (od 41 do 74 ur).
Each bottle contains 60 tablets.
Ena plastenka vsebuje 60 tablet.
What Nityr is and what it is used for
Kaj je zdravilo Nityr in za kaj ga uporabljamo
Excipient with known effect
Pomožna snov z znanim učinkom.
This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
To zdravilo se uporablja za zdravljenje redke bolezni, imenovane dedna tirozinemija tipa 1 pri odraslih, mladostnikih in otrocih.
Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Verjetnosti preživetja po 2, 4 in 6 letih zdravljenja z nitizinonom so povzete v spodnji preglednici.
Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Matere, ki jemljejo zdravilo Nityr, ne smejo dojiti, ker tveganja za dojenčka ni mogoče izključiti (glejte poglavji 4.3 in 5.3).
Patients who have problems swallowing Nityr tablets whole, are recommended to take alternative nitisinone formulations.
Bolnikom, ki imajo težave s požiranjem celih tablet zdravila Nityr, se priporoča jemanje drugačnih formulacij nitizinona.