FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/573/025 EU/1/09/573/026 EU/1/09/573/027 EU/1/09/573/028 EU/1/09/573/040 EU/1/09/573/041 EU/1/09/573/042
Icelandic: EU/1/09/573/001 EU/1/09/573/002 EU/1/09/573/029
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Icelandic: Eporatio 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 30 mánuðir
English: Eporatio 5,000 IU/0.5 ml
Icelandic: Eporatio 5.000 a.e./0,5 ml:
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/573/023
Icelandic: Eporatio 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/023
English: Eporatio 2,000 IU/0.5 ml
Icelandic: Eporatio 2.000 a.e./0,5 ml:
English: Eporatio 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Icelandic: Ein áfyllt sprauta inniheldur 2.000 alþjóðlegar einingar (a.e.) (16,7 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 4.000 alþjóðlegum einingum (a.e.) (33,3 míkrógrömm) á ml.
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 3 820 73 73
Icelandic: Teva Pharma Belgium N.V./S.A./AG
English: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 3.000 alþjóðlegar einingar (a.e.) (25 µg) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 6.000 a.e. (50 µg) af epóetín teta á ml.
English: Eporatio 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 international units (IU) (16.7 micrograms) per ml.
Icelandic: Ein áfyllt sprauta inniheldur 1.000 alþjóðlegar einingar (a.e.) (8,3 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 2.000 alþjóðlegum einingum (a.e.) (16,7 míkrógrömm) á ml.
English: Eporatio 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 international units (IU) (66.7 micrograms) per ml.
Icelandic: Ein áfyllt sprauta inniheldur 4.000 alþjóðlegar einingar (a.e.) (33,3 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 8.000 alþjóðlegum einingum (a.e.) (66,7 míkrógrömm) á ml.
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/573/011
Icelandic: Eporatio 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/011
English: Eporatio 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml..
Icelandic: Ein áfyllt sprauta inniheldur 5.000 alþjóðlegar einingar (a.e.) (41,7 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 10.000 alþjóðlegum einingum (a.e.) (83,3 míkrógrömm) á ml.
English: Eporatio 3,000 IU/0.5 ml
Icelandic: Eporatio 3.000 a.e./0,5 ml:
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/009
Icelandic: Eporatio 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/009
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 1.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 5,000 IU/0.5 ml injection Epoetin theta
Icelandic: Eporatio 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/007
Icelandic: Eporatio 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/007
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/003
Icelandic: Eporatio 2.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/003
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Eporatio 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Eporatio 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30,000 international units (IU) (250 µg) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 µg) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 30.000 alþjóðlegar einingar (a.e.) (250 µg) af epóetín teta í 1 ml af stungulyfi, lausn, sem jafngildir 30.000 a.e. (250 µg) af epóetín teta á ml.
English: Eporatio 2,000 IU/0.5 ml injection Epoetin theta
Icelandic: Eporatio 2.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 micrograms) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 1.000 alþjóðlegar einingar (a.e.) (8,3 µg) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 2.000 a.e. (16,7 µg) af epóetín teta á ml.
English: EU/1/09/573/004 6 pre-filled syringes with safety device EU/1/09/573/030 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/573/003 6 áfylltar sprautur EU/1/09/573/004 6 áfylltar sprautur með öryggisbúnaði EU/1/09/573/030 6 áfylltar sprautur með öryggisnál
English: Eporatio 4,000 IU/0.5 ml injection Epoetin theta
Icelandic: Eporatio 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 20.000 alþjóðlegar einingar (a.e.) (166,7 µg) af epóetín teta í 1 ml af stungulyfi, lausn, sem jafngildir 20.000 a.e. (166,7 µg) af epóetín teta á ml.
English: Eporatio 10,000 IU/1 ml: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml.
Icelandic: Ein áfyllt sprauta inniheldur 10.000 alþjóðlegar einingar (a.e.) (83,3 míkrógrömm) af epóetín teta í 1,0 ml af stungulyfi, lausn, sem jafngildir 10.000 alþjóðlegum einingum (a.e.) (83,3 míkrógrömm) á ml.
English: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 2.000 alþjóðlegar einingar (a.e.) (16,7 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 4.000 a.e. (33,3 míkrógrömm) af epóetín teta á ml.
English: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 micrograms) epoetin theta per ml.
Icelandic: Ein áfyllt sprauta inniheldur 4.000 alþjóðlegar einingar (a.e.) (33,3 µg) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 8.000 a.e. (66,7 µg) af epóetín teta á ml.
English: EU/1/09/573/002 6 pre-filled syringes with safety device EU/1/09/573/029 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/573/001 6 áfylltar sprautur EU/1/09/573/002 6 áfylltar sprautur með öryggisbúnaði EU/1/09/573/029 6 áfylltar sprautur með öryggisnál
English: Eporatio 3,000 IU/0.5 ml injection Epoetin theta
Icelandic: Eporatio 3.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/005
Icelandic: Eporatio 3.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/573/005
English: EU/1/09/573/008 6 pre-filled syringes with safety device EU/1/09/573/032 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/573/007 6 áfylltar sprautur EU/1/09/573/008 6 áfylltar sprautur með öryggisbúnaði EU/1/09/573/032 6 áfylltar sprautur með öryggisnál
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: EU/1/09/573/006 6 pre-filled syringes with safety device EU/1/09/573/031 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/573/005 6 áfylltar sprautur EU/1/09/573/006 6 áfylltar sprautur með öryggisbúnaði EU/1/09/573/031 6 áfylltar sprautur með öryggisnál
English: EU/1/09/573/010 6 pre-filled syringes with safety device EU/1/09/573/033 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/573/009 6 áfylltar sprautur EU/1/09/573/010 6 áfylltar sprautur með öryggisbúnaði EU/1/09/573/033 6 áfylltar sprautur með öryggisnál
English: Eporatio 1,000 IU/0.5 ml
Icelandic: Eporatio 1.000 a.e./0,5 ml
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 2.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 5.000 a.e./0,5 ml stungulyf Epóetín teta s.c. i.v.
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 2.000 a.e./0,5 ml stungulyf Epóetín teta s.c. i.v.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 3.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Icelandic: Eporatio 1.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml af lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 4.000 a.e./0,5 ml stungulyf Epóetín teta s.c. i.v.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 3.000 a.e./0,5 ml stungulyf Epóetín teta s.c. i.v.
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Icelandic: Eporatio 20.000 a.e./1 ml stungulyf Epóetín teta s.c. i.v.
English: Anaemia caused by chronic renal failure
Icelandic: Blóðleysi af völdum langvinnrar nýrnabilunar
English: 90 (3 x 30) tablets
Icelandic: Lyfjaglas (HDPE) 90 (3 x 30) töflur
English: 30 tablets
Icelandic: Lyfjaglas (HDPE) 30 töflur
English: - if you have blood in your urine that your doctor has not checked.
Icelandic: Ef þú ert með blóð í þvagi sem læknirinn hefur ekki rannsakað.
English: Your doctor will advise you to discontinue this medicine.
Icelandic: Læknirinn mun ráðleggja þér að hætta töku lyfsins.
English: Frequencies are defined as:
Icelandic: Tíðni er skilgreind þannig:
English: - if you have liver disease.
Icelandic: Ef þú ert með lifrarsjúkdóm.
English: - if you have or ever had bladder cancer.
Icelandic: Ef þú ert með eða hefur haft krabbamein í þvagblöðru.
English: - if you have heart failure or have had heart failure in the past.
Icelandic: Ef þú ert með hjartabilun eða hefur einhvern tíma haft hjartabilun.
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Icelandic: Ef ALT gildið er ennþá > 3 sinnum efri viðmiðunarmörk, skal meðferð hætt.
English: - if you have a problem with your liver or heart.
Icelandic: Ef þú hefur einkenni í/frá lifur eða hjarta.
English: Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Icelandic: Upphafsskammtur pioglitazóns er 15 mg eða 30 mg einu sinni á dag.
English: How to store Pioglitazone Krka Contents of the pack and other information
Icelandic: Hvernig geyma á Pioglitazone Krka Pakkningar og aðrar upplýsingar
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Krka.
Icelandic: Venjulega geturðu haldið áfram að taka önnur lyf meðan þú færð meðferð með Pioglitazone Krka.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnunni á eftir "EXP".
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Icelandic: Rannsóknir á milliverkunum hafa sýnt að pioglitazón hefur engin marktæk áhrif hvorki á lyfjahvörf né lyfhrif digoxíns, warfaríns, phenprocoumons og metformíns.
English: Before you start taking Pioglitazone Krka you will have a blood sample taken to check your liver function.
Icelandic: Áður en þú byrjar að taka Pioglitazone Krka verður tekin blóðprufa til að kanna lifrarstarfsemi hjá þér.
English: not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Icelandic: tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi upplýsingum) hækkun lifrarensíma ofnæmisviðbrögð
English: Pioglitazone has no or negligible influence on the ability to drive and use machines.
Icelandic: Pioglitazón hefur engin eða óveruleg áhrif á hæfni til aksturs eða notkunar véla.
English: If you take more Pioglitazone Krka than you should If you accidentally take too many Pioglitazone Krka tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Icelandic: Ef tekinn er stærri skammtur af Pioglitazone Krka en mælt er fyrir um Ef teknar eru of margar Pioglitazone Krka töflur, eða einhver annar eða barn tekur lyfið, hafðu þá strax samband við lækni eða lyfjafræðing.
English: The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.
Icelandic: Töflurnar fást í öskjum sem innihalda 14, 28, 30, 56, 60, 90 og 98 töflur í þynnum.
English: - This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Icelandic: Þessum fræðslupakka er ætlað að auka skilning á mikilvægum áhættuþáttum tengdum krabbameini í þvagblöðru og hjartabilun sem komið hafa fram og öllum ráðleggingum sem ætlaðar eru til að hámarka hlutfall ávinnings-áhættu hjá sjúklingi.
English: One tablet should be taken once daily.
Icelandic: Taka skal eina töflu á dag.
English: When Pioglitazone Krka is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Icelandic: Krka er tekið með öðru lyfi við sykursýki (svo sem insúlín, chlorpropamid, glibenclamid, gliclazid, tolbutamid) segir læknirinn þér hvort þú þurfir að minnka skammtinn.
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Icelandic: Lyfjahvörf eftir að stöðug þéttni hefur náðst eru svipuð meðal sjúklinga 65 ára og eldri og hjá ungum sjúklingum.
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Icelandic: Ef þú verður finnur fyrir einhverjum af þessum einkennum hafðu samband við lækni þegar í stað, sérstaklega ef þú ert eldri en 65 ára.
English: 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 98 tablets
Icelandic: 30 töflur 56 töflur 60 töflur 90 töflur 98 töflur
English: - The risk of heart failure and relevant risk minimisation advice.
Icelandic: Hættunni á hjartabilun og viðeigandi ráðleggingum varðandi lágmörkun áhættu.
English: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Icelandic: Meðferð með pioglitazóni skal ekki hafin hjá sjúklingum með hækkuð lifrarensím (ALT > 2,5 sinnum efri viðmiðunarmörk) eða ef önnur einkenni um lifrarsjúkdóm finnast.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Icelandic: Ekki er ljóst hvort beint samband er á milli pioglitazóns og sjónudepilsbjúgs, en þeir sem ávísa lyfinu ættu að vera á varðbergi gagnvart mögulegum sjónudepilsbjúgi ef sjúklingar lýsa truflun á sjónskerpu; íhuga þarf þá viðeigandi tilvísun til augnlæknis.
English: - Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Icelandic: Varúðarreglum við notkun hjá öldruðum í ljósi aldurstengdrar áhættu (einkum krabbameini í þvagblöðru, beinbrotum og hjartabilun).
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Icelandic: Áður en leiðbeiningum til lækna er dreift í hverju aðildarlandi, skal markaðsleyfishafi komast að samkomulagi við yfirvöld í hverju aðildarlandi, varðandi innihald og form fræðsluefnis og samskiptaáætlun.
English: - if you have cysts on your ovaries (polycystic ovary syndrome).
Icelandic: Ef þú ert með blöðrur á eggjastokkunum (fjölblöðruheilkenni í eggjastokkum).
English: Your doctor will check whether Pioglitazone Krka is working 3 to 6 months after you start taking it.
Icelandic: Krka er að virka 3 til 6 mánuðum eftir að þú byrjar að taka það.
English: If you take Pioglitazone Krka with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Icelandic: Krka samhliða öðrum lyfjum við sykursýki eru meiri líkur á að blóðsykurinn falli niður fyrir eðlileg mörk (blóðsykurslækkun).
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Icelandic: Enda þótt rannsóknin hafi brugðist hvað varðar aðal endapunkt hennar, sem var samsettur úr dauðsföllum af öllum orsökum, hjartadrepi án dauðsfalls, heilablóðfalli, bráðri kransæðastíflu, alger aflimun fótleggjar, kransæðavíkkun og víkkun æða í fótleggjum, þá benda niðurstöðurnar til þess að notkun pioglitazóns hafi engin langtímaáhrif á hjarta- og æðakerfið.
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Icelandic: Helmingunartími óbreytts pioglitazóns í plasma í mönnum er 5 til 6 klst. og helmingunartími allra virkra umbrotsefna þess er 16 til 23 klst.