FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Exforge HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Icelandic: Einungis skal hefja meðferð með Exforge HCT eftir að blóðkalíumlækkun og sérhver samfarandi blóðmagnesíumlækkun hefur verið leiðrétt.
English: Exforge HCT should be discontinued if hypercalcaemia develops during treatment.
Icelandic: Stöðva skal meðferð með Exforge HCT ef blóðkalsíumhækkun kemur fram meðan á meðferð stendur.
English: No dose adjustment of Exforge HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Icelandic: Exforge HCT handa sjúklingum með vægt til í meðallagi skerta nýrnastarfsemi (GFR ≥30 ml/mín./1,73 m²).
English: Do not take Exforge HCT if you are more than 3 months pregnant.
Icelandic: Ekki má nota Exforge HCT eftir þriðja mánuð meðgöngu.
English: 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.
Icelandic: Exforge HCT var 7,6/5,0 mmHg meiri en hjá þeim sem fengu valsartan/hýdróklórtíazíð, 6,2/3,3 mmHg meiri en hjá þeim sem fengu amlodipin/valsartan og 8,2/5,3 mmHg meiri en hjá þeim sem fengu amlodipin/hýdróklórtíazíð.
English: Do not take Exforge HCT with grapefruit or grapefruit juice.
Icelandic: Exforge HCT inn með greipaldini eða greipaldinsafa.
English: Clinically significant hypotension due to Exforge HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Icelandic: Klínískt marktækur lágþrýstingur vegna ofskömmtunar með Exforge HCT krefst inngrips til stuðnings við hjarta og blóðrás, þ.m.t. ört eftirlit með hjartastarfsemi og öndun, útlimum haldið í hárri stellingu og eftirlit með blóðrúmmáli og þvagmyndun.
English: How to store Exforge HCT
Icelandic: Hvernig geyma á Exforge HCT
English: There are no clinical studies on fertility with Exforge HCT.
Icelandic: Engar klínískar frjósemisrannsóknir hafa verið gerðar með Exforge HCT.
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Icelandic: Exforge HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur
English: 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.
Icelandic: Á 8. viku var meðal lækkun á slagbils-/þanbilsþrýstingi 39,7/24,7 mmHg hjá þeim sem fengu Exforge HCT, 32,0/19,7 mmHg hjá þeim sem fengu valsartan/hýdróklórtíazíð, 33,5/21,5 mmHg hjá þeim sem fengu amlodipin/valsartan og 31,5/19,5 mmHg hjá þeim sem fengu amlodipin/hýdróklórtíazíð.
English: The use of Exforge HCT during breastfeeding is not recommended.
Icelandic: Ekki er mælt með að nota Exforge HCT meðan barn er haft á brjósti.
English: 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.
Icelandic: Lýsing á útliti Exforge HCT og pakkningastærðir Exforge HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur eru hvítar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VCL“ á hinni hliðinni.
English: If you stop taking Exforge HCT
Icelandic: Ef hætt er að nota Exforge HCT
English: If hypokalaemia develops during hydrochlorothiazide therapy, Exforge HCT should be discontinued until stable correction of the potassium balance.
Icelandic: Ef blóðkalíumlækkun kemur fram meðan á meðferð með hýdróklórtíazíði stendur, skal stöðva meðferð með Exforge HCT þar til kalíumþéttni hefur verið leiðrétt og hún helst stöðug.
English: If any of the above applies to you, do not take Exforge HCT and talk to your doctor.
Icelandic: Ef eitthvað af framangreindu á við skal ekki nota Exforge HCT og hafa samband við lækninn.
English: Exforge HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Icelandic: Sjúklingar með blóðkalsíumhækkun mega ekki nota Exforge HCT og einungis skal nota það eftir að blóðkalsíumhækkun sem er til staðar hefur verið leiðrétt.
English: Due to the valsartan component, Exforge HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Icelandic: Skert lifrarstarfsemi er frábending við notkun Exforge HCT vegna þess að það inniheldur valsartan (sjá kafla 4.2 og 4.3).
English: If Exforge HCT is used during breast-feeding, doses should be kept as low as possible.
Icelandic: Ef konur sem hafa barn á brjósti nota Exforge HCT skal nota eins litla skammta og hægt er.
English: How to take Exforge HCT
Icelandic: Hvernig nota á Exforge HCT
English: Exforge HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Icelandic: Exforge HCT skal aðeins nota eftir að natríumskortur og/eða minnkað blóðrúmmál hefur verið leiðrétt.
English: Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in symptomatic hyperuricaemia.
Icelandic: Vegna hýdróklórtíazíðhlutans, má ekki nota Exforge HCT þegar þvagsýruhækkun í blóði með einkennum er til staðar.
English: Exforge HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Icelandic: Amlodipin tilheyrir flokki kalsíumgangaloka, valsartan tilheyrir flokki angíótensín II viðtakablokka og hýdróklórtíazíð tilheyrir þvagræsilyfjum af flokki tíazíða.
English: What Exforge HCT contains
Icelandic: Exforge HCT inniheldur
English: EU/1/09/569/007 280 film-coated tablets
Icelandic: EU/1/09/569/007 280 filmuhúðaðar töflur
English: 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.
Icelandic: Exforge HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur eru gulbrúnar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VFL“ á hinni hliðinni.
English: EU/1/09/569/042 98 film-coated tablets
Icelandic: EU/1/09/569/042 98 filmuhúðaðar töflur
English: EU/1/09/569/018 98 film-coated tablets
Icelandic: EU/1/09/569/018 98 filmuhúðaðar töflur
English: EU/1/09/569/027 30 film-coated tablets
Icelandic: EU/1/09/569/027 30 filmuhúðaðar töflur
English: EU/1/09/569/043 280 film-coated tablets
Icelandic: EU/1/09/569/043 280 filmuhúðaðar töflur
English: 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.
Icelandic: Exforge HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur eru gular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VEL“ á hinni hliðinni.
English: EU/1/09/569/004 56 film-coated tablets
Icelandic: EU/1/09/569/004 56 filmuhúðaðar töflur
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets
Icelandic: Exforge HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur
English: EU/1/09/569/031 280 film-coated tablets
Icelandic: EU/1/09/569/031 280 filmuhúðaðar töflur
English: 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.
Icelandic: Exforge HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur Virku innihaldsefnin í Exforge HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: EU/1/09/569/006 98 film-coated tablets
Icelandic: EU/1/09/569/006 98 filmuhúðaðar töflur
English: EU/1/09/569/055 280 film-coated tablets
Icelandic: EU/1/09/569/055 280 filmuhúðaðar töflur
English: EU/1/09/569/041 90 film-coated tablets
Icelandic: EU/1/09/569/041 90 filmuhúðaðar töflur
English: EU/1/09/569/030 98 film-coated tablets
Icelandic: EU/1/09/569/030 98 filmuhúðaðar töflur
English: EU/1/09/569/005 90 film-coated tablets
Icelandic: EU/1/09/569/005 90 filmuhúðaðar töflur
English: EU/1/09/569/001 14 film-coated tablets
Icelandic: EU/1/09/569/001 14 filmuhúðaðar töflur
English: EU/1/09/569/019 280 film-coated tablets
Icelandic: EU/1/09/569/019 280 filmuhúðaðar töflur
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets
Icelandic: Exforge HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur
English: 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.
Icelandic: Exforge HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur eru fölgular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VDL“ á hinni hliðinni.
English: EU/1/09/569/016 56 film-coated tablets
Icelandic: EU/1/09/569/016 56 filmuhúðaðar töflur
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Exforge HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: EU/1/09/569/054 98 film-coated tablets
Icelandic: EU/1/09/569/054 98 filmuhúðaðar töflur
English: EU/1/09/569/053 90 film-coated tablets
Icelandic: EU/1/09/569/053 90 filmuhúðaðar töflur
English: EU/1/09/569/025 14 film-coated tablets
Icelandic: EU/1/09/569/025 14 filmuhúðaðar töflur
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Exforge HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: EU/1/09/569/029 90 film-coated tablets
Icelandic: EU/1/09/569/029 90 filmuhúðaðar töflur
English: EU/1/09/569/038 28 film-coated tablets
Icelandic: EU/1/09/569/038 28 filmuhúðaðar töflur
English: EU/1/09/569/049 14 film-coated tablets
Icelandic: EU/1/09/569/049 14 filmuhúðaðar töflur
English: EU/1/09/569/040 56 film-coated tablets
Icelandic: EU/1/09/569/040 56 filmuhúðaðar töflur
English: EU/1/09/569/052 56 film-coated tablets
Icelandic: EU/1/09/569/052 56 filmuhúðaðar töflur
English: Exforge HCT individual component
Icelandic: Exforge HCT hvert um sig
English: EU/1/09/569/026 28 film-coated tablets
Icelandic: EU/1/09/569/026 28 filmuhúðaðar töflur
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Exforge HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: EU/1/09/569/003 30 film-coated tablets
Icelandic: EU/1/09/569/003 30 filmuhúðaðar töflur
English: EU/1/09/569/037 14 film-coated tablets
Icelandic: EU/1/09/569/037 14 filmuhúðaðar töflur
English: EU/1/09/569/017 90 film-coated tablets
Icelandic: EU/1/09/569/017 90 filmuhúðaðar töflur
English: EU/1/09/569/051 30 film-coated tablets
Icelandic: EU/1/09/569/051 30 filmuhúðaðar töflur
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Exforge HCT.
Icelandic: Notkun Exforge HCT með mat, drykk eða áfengi Þeir sem hafa fengið ávísað Exforge HCT eiga ekki að neyta greipaldins eða greipaldinsafa.
English: 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.
Icelandic: Exforge HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur eru gulbrúnar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VHL“ á hinni hliðinni.
English: EU/1/09/569/014 28 film-coated tablets
Icelandic: EU/1/09/569/014 28 filmuhúðaðar töflur
English: EU/1/09/569/039 30 film-coated tablets
Icelandic: EU/1/09/569/039 30 filmuhúðaðar töflur
English: EU/1/09/569/002 28 film-coated tablets
Icelandic: EU/1/09/569/002 28 filmuhúðaðar töflur
English: EU/1/09/569/013 14 film-coated tablets
Icelandic: EU/1/09/569/013 14 filmuhúðaðar töflur
English: EU/1/09/569/028 56 film-coated tablets
Icelandic: EU/1/09/569/028 56 filmuhúðaðar töflur
English: EU/1/09/569/015 30 film-coated tablets
Icelandic: EU/1/09/569/015 30 filmuhúðaðar töflur
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Icelandic: Önnur innihaldsefni eru örkristölluð sellulósa; crospovidon (gerð A); vatnsfrí kísilkvoða; magnesíumsterat; hýprómellósa (substitution type 2910 (3 mPa.s)); macrogol 4000; talkúm; gult járnoxíð (E172).
English: 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)
Icelandic: EU/1/09/569/056 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/057 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/058 280 x 1 filmuhúðuð tafla (stakskammtar)
English: 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.
Icelandic: Exforge HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur Virku innihaldsefnin í Exforge HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: 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)
Icelandic: EU/1/09/569/044 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/045 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/046 280 x 1 filmuhúðuð tafla (stakskammtar)
English: 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)
Icelandic: EU/1/09/569/032 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/033 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/034 280 x 1 filmuhúðuð tafla (stakskammtar)
English: 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)
Icelandic: EU/1/09/569/008 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/009 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/010 280 x 1 filmuhúðuð tafla (stakskammtar)
English: EU/1/09/569/050 28 film-coated tablets
Icelandic: EU/1/09/569/050 28 filmuhúðaðar töflur
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Exforge HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: 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.
Icelandic: Exforge HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur Virku innihaldsefnin í Exforge HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: 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.
Icelandic: Það er sjúkdómur sem felur í sér að nýrnahetturnar framleiða of mikið af hormóninu aldósteróni.
English: 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.
Icelandic: Exforge HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur Virku innihaldsefnin í Exforge HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Exforge HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: 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.
Icelandic: Exforge HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur Virku innihaldsefnin í Exforge HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: 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)
Icelandic: EU/1/09/569/020 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/021 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/569/022 280 x 1 filmuhúðuð tafla (stakskammtar)
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Icelandic: Önnur innihaldsefni eru örkristölluð sellulósa; crospovidon (gerð A); vatnsfrí kísilkvoða; magnesíumsterat; hýprómellósa (substitution type 2910 (3 mPa.s)); macrogol 4000; talkúm; títantvíoxíð (E171); gult járnoxíð (E172).
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Exforge HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Exforge HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: 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)
Icelandic: EU/1/09/569/036 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/569/035 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: 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)
Icelandic: EU/1/09/569/048 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/569/047 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: 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)
Icelandic: EU/1/09/569/012 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/569/011 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: 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)
Icelandic: EU/1/09/569/060 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/569/059 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: 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)
Icelandic: EU/1/09/569/024 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/569/023 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: Neutropenia
Icelandic: þunglyndi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
Icelandic: EU/1/18/1290/001
English: Each bottle contains 60 tablets.
Icelandic: Hvert glas inniheldur 60 töflur.
English: The tablets may be taken with or without food.
Icelandic: Taka má töflurnar með eða án matar.
English: Each tablet contains less than 120 mg of lactose (as monohydrate).
Icelandic: Hver tafla inniheldur minna en 120 mg af laktósa (sem einhýdrat).
English: Contact your doctor immediately for an eye examination.
Icelandic: Hafðu tafarlaust samband við lækninn til að komast í augnskoðun.
English: 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.
Icelandic: Upplýsingar sem liggja fyrir úr meðferðarrannsókn benda til þess að hjá yfir 90% sjúklinga hafi súkkínýlasetón í þvagi færst í eðlilegt horf á fyrstu viku meðferðar.
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Icelandic: Á grundvelli rannsókna in vitro er ekki búist við að nitisínón hamli umbrotum sem verða fyrir milligöngu CYP1A2, 2C9, 2C19, 2D6, 2E1 eða 3A4.
English: What Nityr is and what it is used for 2.
Icelandic: Upplýsingar um Nityr og við hverju það er notað 2.
English: Store in the original bottle to protect from light.
Icelandic: Geymið í upprunalegu glasi til varnar gegn ljósi.
English: Elms Industrial Estate
Icelandic: Elms Industrial Estate Bedford
English: Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Icelandic: Ekki hafa barn á brjósti meðan verið er að taka þetta lyf, sjá kaflann „Ekki má nota Nityr“.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
Icelandic: Þetta lyf er notað til að meðhöndla sjaldgæfan sjúkdóm sem kallast arfgengur týrósíndreyri af gerð 1 hjá fullorðnum, unglingum og börnum.
English: 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.
Icelandic: Ef sjúklingar þurfa aðra styrkleika (þ.e. margfeldi af 10 mg eða minna en 10 g) er hægt að fá önnur lyf af minni styrkleika.
English: The study demonstrated that Nityr can be administered with or without food without affecting its bioavailability.
Icelandic: Rannsóknin sýndi að hægt er að gefa Nityr með eða án matar án þess að það hafi áhrif á aðgengi þess.
English: Start age ≤ 24 months Start age > 24 months
Icelandic: Aldur við upphaf >24 mánuðir
English: MedDRA system organ class
Icelandic: MedDRA líffæraflokkun
English: Tablets are not suitable for breaking to make up additional strengths.
Icelandic: Ekki er hægt að brjóta töflurnar til að nota sem aðra styrkleika.
English: 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).
Icelandic: <1/100), mjög sjaldgæfar (≥1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000) og tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: The tablets are white to beige, round, flat which may display light yellow to brown speckles marked with “L” on one side and “10” on the other side.
Icelandic: Töflurnar eru hvítar eða drapplitaðar, kringlóttar flatar, hugsanlega með gulum eða brúnum dílum, merktar „L“ á annarri hliðinni og „10“ á hinni hliðinni.
English: Name and address of the manufacturer(s) responsible for batch release Central Pharma (Contract Packing) Limited Caxton Road
Icelandic: Central Pharma (Contract Packing) Limited Caxton Road
English: The tablets are packaged in plastic square bottles with a tamper-evident child-resistant closure.
Icelandic: Töflunum er pakkað í ferhyrnd glös úr plasti með innsigluðu barnaöryggisloki.
English: 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).
Icelandic: Hjá 23 heilbrigðum sjálfboðaliðum var lokahelmingunartími (miðgildi) nitisínóns í plasma 59 klst. (á bilinu 41 til 74 klst.) eftir að gefinn hafði verið stakur skammtur af Nityr töflum (10 mg).
English: During the shelf life, the patient may store the bottle after first opening for a period of 2 months, after which the medicinal product must be discarded.
Icelandic: Innan geymsluþolstímans má sjúklingurinn geyma glasið í 2 mánuði eftir að pakkning lyfsins hefur verið rofin, en eftir það verður að farga því.
English: If you forget to take Nityr
Icelandic: Ef gleymist að taka Nityr
English: Nityr with food Nityr can be taken with or without food throughout your course of treatment.
Icelandic: Nityr má taka með eða án matar meðan á meðferðinni stendur.
English: What Nityr is and what it is used for
Icelandic: Upplýsingar um Nityr og við hverju það er notað
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Icelandic: Lífslíkur eftir 2, 4 og 6 ára meðferð með nitisíóni eru teknar saman í töflunni hér að neðan.
English: A food effect study has been conducted with Nityr.
Icelandic: Rannsókn var framkvæmd á áhrifum matar við notkun Nityr.