FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules
Icelandic: 30 forðahylki, hörð 30×1 forðahylki, hart 50 forðahylki, hörð 50×1 forðahylki, hart 100 forðahylki, hörð 100×1 forðahylki, hart
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Icelandic: -2 hemlinum daklízumab, lægri upphafsskammtar af takrólímus með æskilegri lágþéttni 10 til 15 ng/ml og síðast geislun ósamgena líffæris, eru taldar hafa átt þátt í að bæta árangur við þessa ábendingu með tímanum.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.
Icelandic: Greint hefur verið frá BK veirutengdum nýrnasjúkdómi sem og JC veirutengdri ágengri fjölhreiðra innlyksuheilabólgu hjá sjúklingum sem hafa fengið meðferð með ónæmisbælandi lyfjum þar á meðal Advagraf.
English: Each capsule contains 0.5 mg tacrolimus (as monohydrate).
Icelandic: Hvert hylki inniheldur 0,5 mg takrólímus (sem einhýdrat).
English: Advagraf 3 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).
Icelandic: Advagraf 3 mg forðahylki, hörð Hvert hart forðahylki inniheldur 3 mg takrólímus (sem einhýdrat).
English: The 12-month patient survival rates were 96.9% for Advagraf and 97.5% for Prograf; in the Advagraf arm 10 patients died (3 female, 7 male) and in the Prograf arm 8 patients died (3 female, 5 male).
Icelandic: Í Advagraf armi rannsóknarinnar dóu 10 sjúklingar (3 kvenkyns, 7 karlkyns) og í Prograf arminum dóu 8 sjúklingar (3 kvenkyns, 5 karlkyns).
English: Advagraf 1 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate).
Icelandic: Advagraf 1 mg forðahylki, hörð Hvert hart forðahylki inniheldur 1 mg takrólímus (sem einhýdrat).
English: Pain in joints, limbs, back and feet, muscle spasms
Icelandic: Liðverkir, bakverkur, vöðvakrampi, verkir í útlimum
English: Advagraf 3 mg prolonged-release hard capsules EU/1/07/387/011
Icelandic: Advagraf 3 mg forðahylki, hörð EU/1/07/387/011
English: Advagraf 5 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder.
Icelandic: Advagraf 5 mg forðahylki eru hörð matarlímshylki með „5 mg“ áprentað í rauðum lit á rauðgráa hylkislokið og „ 687“ á appelsínugula hylkisbotninn, en hylkin innihalda hvítt duft.
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ml.
Icelandic: Meðferð með takrólímus var hafin með samfelldu innrennsli í bláæð í skammti sem var 0,05 mg/kg/sólarhring og takrólímus til inntöku gefið í skömmtum 0,1 til 0,3 mg/kg/sólarhring með áframhaldandi skammtaaðlögun að æskilegri lágþéttni, 12 til 15 ng/ml.
English: Advagraf 1 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.
Icelandic: Advagraf 1 mg forðahylki eru hörð matarlímshylki með „1 mg“ áprentað í rauðum lit á hvíta hylkislokið og „ 677“ á appelsínugula hylkisbotninn, en hylkin innihalda hvítt duft.
English: hirsutism
Icelandic: Skellakk
English: Advagraf 3 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder.
Icelandic: Advagraf 3 mg forðahylki eru hörð matarlímshylki með „3 mg“ áprentað í rauðum lit á appelsínugula hylkislokið og „ 637“ á appelsínugula hylkisbotninn, en hylkin innihalda hvítt duft.
English: This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients.
Icelandic: Einungis læknir, með reynslu af meðferð líffæraþega, má ávísa þér lyfinu.
English: As tacrolimus is a substance with low clearance, following adjustments to the Advagraf dose regimen it may take several days before the targeted steady state is achieved.
Icelandic: Þar sem takrólímus er efni með hæga úthreinsun geta liðið nokkrir dagar áður en því jafnvægi, sem stefnt er að í meðferð með Advagraf, er náð.
English: - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - antiemetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem and verapamil) - anti-arrhythmic drugs (amiodarone) used to control arrhythmia (uneven beating of the heart) - medicines known as “statins” used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - nefazodone, used to treat depression
Icelandic: sýkingu - nilotiníb og imatiníb (notað við ákveðnum tegundum krabbameins) - mycofenólsýru notuð til að bæla ónæmiskerfið til að koma í veg fyrir höfnun ígræðslu - lyf við magasári og bakflæði (t.d. ómeprazól, lansóprazól eða címetidín) - uppsölulyf, notað við ógleði og uppköstum (t.d. metóclópramíð) - cisapríð eða sýrubindandi magnesíum-ál-hýdroxíð, notað við brjóstsviða - getnaðarvarnartöflur og aðra hormónameðferð með etinýlestradíóli, hormónameðferð með danazóli - lyf sem notuð eru við háum blóðþrýstingi eða hjartasjúkdómum (t.d. nífedipín, nícardipín,
English: However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).
Icelandic: Hins vegar er nákvæmt eftirlit með nýrnastarfsemi ráðlagt (þ.m.t. reglulegar mælingar á þéttni kreatíníns í sermi, útreikningur á kreatínínúthreinsun og eftirlit með þvagútskilnaði) vegna þess að takrólímus getur haft eiturverkun á nýru.
English: Hypromellose Ethylcellulose Lactose monohydrate Magnesium stearate.
Icelandic: Hýpromellósa Etýlsellulósa Laktósaeinhýdrat Magnesíumsterat.
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical data are not yet available for the prolonged-release formulation Advagraf.
Icelandic: Klínískar upplýsingar eru enn ekki fyrirliggjandi um forðalyfjaformið Advagraf, varðandi meðferð við höfnun, eftir ósamgena ígræðslu hjá fullorðnum sjúklingum, sem eru ónæmir fyrir annarri ónæmisbælandi lyfjameðferð.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 0.5 mg prolonged-release hard capsules
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNUPAKKNING Advagraf 0,5 mg forðahylki, hörð
English: Advagraf 5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate).
Icelandic: Advagraf 5 mg forðahylki, hörð Hvert hart forðahylki inniheldur 5 mg takrólímus (sem einhýdrat).
English: The 12-month patient survival rates were 98.6% for Advagraf, 95.7% for Prograf and 97.6% for ciclosporin; in the Advagraf arm 3 patients died (all male), in the Prograf arm 10 patients died (3 female, 7 male) and in the ciclosporin arm 6 patients died (3 female, 3 male).
Icelandic: Í Advagraf armi rannsóknarinnar dóu 3 sjúklingar (allir karlkyns), í Prograf arminum dóu 10 sjúklingar (3 kvenkyns., 7 karlkyns.) og í cíclósporín arminum dóu 6 sjúklingar (3 kvenkyns, 3 karlkyns.).
English: amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased very rare:
Icelandic: Hækkun á amýlasa í blóði, óeðlileg hjartalínurit, niðurstöður mælinga á hjartslætti og púls óeðlilegar, þyngdartap, aukning á laktat dehýdrogenasa í blóði
English: myasthenia
Icelandic: Mycofenólsýra.
English: Not known (frequency cannot be estimated from the available data): - Abnormality of the optic nerve (optic neuropathy)
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum):
English: Advagraf 5 mg prolonged-release hard capsules EU/1/07/387/007
Icelandic: Advagraf 5 mg forðahylki, hörð EU/1/07/387/007
English: For prophylaxis of transplant rejection in adult heart allograft recipients clinical data are not yet available for Advagraf.
Icelandic: Klínískar upplýsingar eru ekki enn fyrirliggjandi um Advagraf, varðandi fyrirbyggjandi meðferð við höfnun eftir ígræðslu hjá fullorðnum hjartaþegum sem fara í ósamgena ígræðslu.
English: Gelatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.
Icelandic: Matarlímshylki með „0,5 mg“ áprentað í rauðum lit á ljósgula hylkislokið og „ 647“ á appelsínugula hylkisbotninn, sem inniheldur hvítt duft.
English: Gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.
Icelandic: Matarlímshylki með „1 mg“ áprentað í rauðum lit á hvíta hylkislokið og „ 677“ á appelsínugula hylkisbotninn, sem inniheldur hvítt duft.
English: Gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and ” 687” on the orange capsule body, containing white powder.
Icelandic: Matarlímshylki með „5 mg“ áprentað í rauðum lit á rauðgráa hylkislokið og „ 687“ á appelsínugula hylkisbotninn, sem inniheldur hvítt duft.
English: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
Icelandic: Inflúensulík veikindi, taugaóstyrkur, óeðlileg líðan, bilun í mörgum líffærum, þyngsli fyrir bjósti, hitaóþol
English: Advagraf 1 mg prolonged-release hard capsules
Icelandic: Advagraf 1 mg forðahylki, hörð takrólímus
English: Each capsule contains 1 mg tacrolimus (as monohydrate).
Icelandic: Hvert hylki inniheldur 1 mg takrólímus (sem einhýdrat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 1 mg prolonged-release hard capsules
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNUPAKKNING Advagraf 1 mg forðahylki, hörð
English: Advagraf capsules contain lactose.
Icelandic: Advagraf hylki innihalda laktósa.
English: Each capsule contains 3 mg tacrolimus (as monohydrate).
Icelandic: Hvert hylki inniheldur 3 mg takrólímus (sem einhýdrat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 1 mg prolonged-release hard capsules (30, 50, 60, 100 Aluminium Wrapper)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUUMBÚÐUM ÁLUMBÚÐIR Advagraf 1 mg forðahylki, hörð (30, 50, 60, 100 álumbúðir)
English: Each capsule contains 5 mg tacrolimus (as monohydrate).
Icelandic: Hvert hylki inniheldur 5 mg takrólímus (sem einhýdrat).
English: Advagraf 3 mg prolonged-release hard capsules
Icelandic: Advagraf 3 mg forðahylki, hörð takrólímus
English: Advagraf 0.5 mg prolonged-release hard capsules
Icelandic: Advagraf 0,5 mg forðahylki, hörð takrólímus
English: Very rare side effects (may affect up to 1 in 10,000 people): Muscular weakness
Icelandic: Mjög sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 1.000 notendum):
English: Gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder.
Icelandic: Matarlímshylki með „3 mg“ áprentað í rauðum lit á appelsínugula hylkislokið og „ 637“ á appelsínugula hylkisbotninn, sem inniheldur hvítt duft.
English: Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting, abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver
Icelandic: Einkenni frá meltingarvegi, uppköst, verkir í meltingarvegi og kvið, bólgusjúkdómar í meltingarvegi, blæðingar í meltingarvegi, sármyndun eða rof í meltingarvegi, skinuholsvökvi, munnbólga og sáramyndun, hægðatregða, einkenni um meltingartruflanir, vindgangur, uppþemba og þan, linar hægðir
English: optic neuropathy Ear and labyrinth disorders common:
Icelandic: Eyru og völunarhús Algengar:
English: parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations uncommon:
Icelandic: Sjúkdómar í lungnavef (parenchymal lung disorders), mæði, vökvi í brjóstholi (pleural effusion), hósti, kokbólga, nefstífla og bólga
English: Contents of the pack and other information What Advagraf contains
Icelandic: Hvernig geyma á Advagraf Pakkningar og aðrar upplýsingar
English: Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1, 60×1 and 100×1 prolonged-release hard capsule in unit-dose perforated blisters.
Icelandic: 30, 50, 60 og 100 hörð forðahylki í þynnum eða 30×1, 50×1, 60×1 og 100×1 hart forðahylki í rifgötuðum stakskammtaþynnum.
English: Advagraf 5 mg prolonged-release hard capsules
Icelandic: Advagraf 5 mg forðahylki, hörð takrólímus
English: Advagraf 0.5 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Icelandic: Advagraf 0,5 mg er fáanlegt í þynnupakkningum eða rifgötuðum stakskammtaþynnum með 10 hylkjum á hverju þynnuspjaldi sem til hlífðar er pakkað í álumbúðir ásamt þurrkefni.
English: EU/1/07/387/011 30 capsules EU/1/07/387/012 50 capsules EU/1/07/387/013 100 capsules EU/1/07/387/021 30×1 capsules EU/1/07/387/022 50×1 capsules EU/1/07/387/023 100×1 capsules
Icelandic: EU/1/07/387/011 30 hylki EU/1/07/387/012 50 hylki EU/1/07/387/013 100 hylki EU/1/07/387/021 30×1 hylki EU/1/07/387/022 50×1 hylki EU/1/07/387/023 100×1 hylki
English: EU/1/07/387/003 30 capsules EU/1/07/387/004 50 capsules EU/1/07/387/005 60 capsules EU/1/07/387/006 100 capsules EU/1/07/387/017 30×1 capsules EU/1/07/387/018 50×1 capsules EU/1/07/387/019 60×1 capsules EU/1/07/387/020 100×1 capsules
Icelandic: EU/1/07/387/003 30 hylki EU/1/07/387/004 50 hylki EU/1/07/387/005 60 hylki EU/1/07/387/006 100 hylki EU/1/07/387/017 30×1 hylki EU/1/07/387/018 50×1 hylki EU/1/07/387/019 60×1 hylki EU/1/07/387/020 100×1 hylki
English: Packs of 30, 50, 60 and 100 prolonged-release capsules are available in blisters and packs of 30×1, 50×1, 60×1 and 100×1 prolonged-release capsules are available in perforated unit-dose blisters.
Icelandic: Fáanlegar eru pakkningar með 30, 50, 60 og 100 hörðum forðahylkjum í þynnupakkningum og pakkningar með 30×1, 50×1 60×1 og 100×1 hörðu forðahylki eru fáanlegar í rifgötuðum stakskammtaþynnum.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 3 mg prolonged-release hard capsules
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNUPAKKNING Advagraf 3 mg forðahylki, hörð
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER Advagraf 5 mg prolonged-release hard capsules
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNUPAKKNING Advagraf 5 mg forðahylki, hörð
English: Advagraf 1 mg prolonged-release hard capsules EU/1/07/387/003
Icelandic: Advagraf 1 mg forðahylki, hörð EU/1/07/387/003
English: Advagraf is a once-a-day oral formulation of tacrolimus.
Icelandic: Advagraf er takrólímus lyfjaform til inntöku einu sinni á sólarhring.
English: Advagraf 1 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Icelandic: Advagraf 1 mg er fáanlegt í þynnupakkningum eða rifgötuðum stakskammtaþynnum með 10 hylkjum á hverju þynnuspjaldi sem til hlífðar er pakkað í álumbúðir ásamt þurrkefni.
English: febrile neutropenia
Icelandic: Brisígræðsla
English: Difficulties in breathing, respiratory tract disorders, asthma Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach
Icelandic: - Blóðtappi í bláæð útlims, lost - Öndunarerfiðleikar, öndunarfærakvillar, astmi - Stífla í þörmum, hækkun á þéttni ensímsins amýlasa í blóði, bakflæði magainnihalds upp í háls,
English: Advagraf 0.5 mg prolonged-release hard capsules EU/1/07/387/001
Icelandic: Advagraf 0,5 mg forðahylki, hörð EU/1/07/387/001
English: Advagraf 5 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Icelandic: Advagraf 5 mg er fáanlegt í þynnupakkningum eða rifgötuðum stakskammtaþynnum með 10 hylkjum á hverju þynnuspjaldi sem til hlífðar er pakkað í álumbúðir ásamt þurrkefni.
English: EU/1/07/387/007 30 capsules EU/1/07/387/008 50 capsules EU/1/07/387/010 100 capsules EU/1/07/387/024 30×1 capsules EU/1/07/387/025 50×1 capsules EU/1/07/387/026 100×1 capsules
Icelandic: EU/1/07/387/007 30 hylki EU/1/07/387/008 50 hylki EU/1/07/387/010 100 hylki EU/1/07/387/024 30×1 hylki EU/1/07/387/025 50×1 hylki EU/1/07/387/026 100×1 hylki
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 0.5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUUMBÚÐUM ÁLUMBÚÐIR Advagraf 0,5 mg forðahylki, hörð (30, 50, 100 álumbúðir)
English: Packs of 30, 50 and 100 prolonged-release capsules are available in blisters and packs of 30×1, 50×1 and 100×1 prolonged-release capsules are available in perforated unit-dose blisters.
Icelandic: Fáanlegar eru pakkningar með 30, 50 og 100 hörðum forðahylkjum í þynnupakkningum og pakkningar með 30×1, 50×1 og 100×1 hörðu forðahylki eru fáanlegar í rifgötuðum stakskammtaþynnum.
English: Abnormal heart scan
Icelandic: - Óeðlileg hjartaómskoðun
English: Advagraf 3 mg is supplied in blisters or perforated unit-dose blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Icelandic: Advagraf 3 mg er fáanlegt í þynnupakkningum eða rifgötuðum stakskammtaþynnum með 10 hylkjum á hverju þynnuspjaldi sem til hlífðar er pakkað í álumbúðir ásamt þurrkefni.
English: EU/1/07/387/001 30 capsules EU/1/07/387/002 50 capsules EU/1/07/387/009 100 capsules EU/1/07/387/014 30×1 capsules EU/1/07/387/015 50×1 capsules EU/1/07/387/016 100×1 capsules
Icelandic: EU/1/07/387/001 30 hylki EU/1/07/387/002 50 hylki EU/1/07/387/009 100 hylki EU/1/07/387/014 30×1 hylki EU/1/07/387/015 50×1 hylki EU/1/07/387/016 100×1 hylki
English: Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal - Blood clot in a vein of a limb, shock
Icelandic: - Óreglulegur hjartsláttur, hjartsláttur stöðvast, minnkuð afköst hjartans, kvilli í hjartavöðva,
English: Painful menstruation and abnormal menstrual bleeding Multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss
Icelandic: - Fjöllíffærabilun, flensulík veikindi, aukið næmi fyrir hita og kulda, þyngsli fyrir brjósti,
English: pure red cell aplasia, agranulocytosis, haemolytic anaemia Immune system disorders
Icelandic: rauðkornskímfrumnafæð (PRCA), kyrningahrap, rauðalosblóðleysi
English: Both the rate and extent of absorption of Advagraf were reduced when administered with food.
Icelandic: Advagraf minnkaði þegar það var gefið með máltíð.
English: Trembling, headache
Icelandic: Höfuðverkur, skjálfti
English: Excipients
Icelandic: Símetikón
English: In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for Advagraf on Day 1 was 30% and 50% lower respectively, when compared with that for the immediate release capsules (Prograf) at equivalent doses.
Icelandic: 1. degi 30% lægra en vegna samsvarandi skammta af hylkjum með hraða losun (Prograf), en 50% lægra hjá sjúklingum eftir lifrarígræðslu.
English: Common side effects (may affect up to 1 in 10 people): - Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts (seen in blood tests) - Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders Ringing sound in your ears
Icelandic: Efnaskiptablóðsýring, önnur frávik í saltbúskap, blóðnatríumlækkun, ofvökvun (fluid overload), aukning á þvagsýru í blóði, blóðmagnesíumlækkun, blóðkalíumlækkun, blóðkalsíumlækkun, minnkuð matarlyst, kólesterólhækkun í blóði, blóðfituhækkun, hækkun þríglýseríða í blóði, blóðfosfatlækkun
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUUMBÚÐUM ÁLUMBÚÐIR Advagraf 5 mg forðahylki, hörð (30, 50, 100 álumbúðir)
English: psychotic disorder Nervous system disorders very common:
Icelandic: Geðræn vandamál Mjög algengar:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Advagraf 0.5 mg prolonged-release hard capsules
Icelandic: YTRI UMBÚÐUM ASKJA Advagraf 0,5 mg forðahylki, hörð
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS ALUMINIUM WRAPPER Advagraf 3 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUUMBÚÐUM ÁLUMBÚÐIR Advagraf 3 mg forðahylki, hörð (30, 50, 100 álumbúðir)
English: Increased blood pressure
Icelandic: - Háþrýstingur
English: The treatment difference (Advagraf - Prograf) was 3.3% (95% confidence interval [5.7%, 12.3%]).The 12-month patient survival rates were 89.2% for Advagraf and 90.8% for Prograf; in the Advagraf arm 25 patients died (14 female, 11 male) and in the Prograf arm 24 patients died (5 female, 19 male).
Icelandic: Í Advagraf armi rannsóknarinnar dóu 25 sjúklingar (14 kvenkyns, 11 karlkyns) og í Prograf arminum dóu 24 sjúklingar (5 kvenkyns, 19 karlkyns).
English: PC:
Icelandic: Tlf:
English: nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Icelandic: - ef þú ert með slæman kviðverk með eða án annarra einkenna, eins og hrolli, hita, ógleði eða uppköstum - ef breyting er á rafvirkni í hjartanu sem kallast „QT-lenging“.
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Icelandic: Fyrirbyggjandi gegn líffærahöfnun við ósamgena ígræðslu hjá fullorðnum nýrna- og lifrarþegum.