FrancophonIA/ELRC3.0 huggingface dataset:
English: Mixtard is indicated for treatment of diabetes mellitus.
Icelandic: Mixtard er ætlað til meðferðar á sykursýki.
English: Mixtard is human insulin with both a fast-acting and a long-acting effect.
Icelandic: Mixtard er mannainsúlín með bæði skjótverkandi og langverkandi áhrif.
English: What Mixtard is and what it is used for
Icelandic: Upplýsingar um Mixtard og við hverju það er notað
English: However, the Mixtard dose may need to be adjusted.
Icelandic: Þó getur þurft að breyta skömmtum Mixtard.
English: ► Mixtard Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Icelandic: ► Mixtard Penfill rörlykjur eru hannaðar til að nota með Novo Nordisk insúlín inndælingartækjum og NovoFine eða NovoTwist nálum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (VIAL - with blue box)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM MERKIMIÐI Á YTRI UMBÚÐUM FJÖLPAKKNINGAR (HETTUGLAS - með blue box)
English: Check the name and coloured label of your pen to make sure that it contains the correct type of insulin.
Icelandic: Athugaðu heiti og litaða merkimiðann á pennnaum til að fullvissa þig um að hann innihaldi rétta tegund af insúlíni.
English: Do not use the pen if the resuspended insulin does not look uniformly white and cloudy.
Icelandic: Ekki nota pennann er blandaða insúlínið er ekki einsleitt, hvítt og skýjað.
English: Mixtard 30 vial (100 international units/ml) EU/1/02/231/003
Icelandic: Mixtard 30 vial (100 alþjóðlegar einingar/ml) EU/1/02/231/003
English: After removing Mixtard Penfill from the refrigerator, it is recommended to allow the Mixtard Penfill to reach room temperature before resuspending the insulin as instructed for first time use.
Icelandic: Eftir að Mixtard Penfill hefur verið fjarlægt úr kæli er mælt með að láta Mixtard Penfill ná stofuhita áður en insúlínið er blandað samkvæmt leiðbeiningum um fyrstu notkun.
English: Other medicines and Mixtard
Icelandic: Notkun annarra lyfja samhliða Mixtard
English: Patients transferred to Mixtard from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Icelandic: Sjúklingar sem skipta yfir á Mixtard af annarri insúlíntegund þurfa hugsanlega að nota fleiri inndælingar eða aðra skammta en þá sem þeir þurftu af insúlínlyfinu sem þeir notuðu áður.
English: Mixtard Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Icelandic: Mixtard Penfill er hannaður til notkunar í Novo Nordisk inndælingartækjum og með NovoFine eða NovoTwist nálum.
English: What you need to know before you use Mixtard Do not use Mixtard
Icelandic: Áður en byrjað er að nota Mixtard Ekki má nota Mixtard
English: Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Icelandic: Mixtard 30 hettuglas (40 alþjóðlegar einingar/ml)/Mixtard 30 hettuglas (100 alþjóðlegar einingar/ml) Hettuglas (gler af gerð 1) lokað með skífu (brómóbútýl/pólýísópren gúmmí) og innsiglaðri hlífðarhettu úr plasti með 10 ml af dreifu.
English: Before opening: Store in a refrigerator (2°C - 8°C).
Icelandic: Geymið í kæli (2°C -8°C).
English: After removing Mixtard vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Mixtard vial, cartridge or pre-filled pen to reach room temperature before resuspending the insulin as instructed for first time use.
Icelandic: Eftir að Mixtard hettuglas, rörlykja eða áfylltur lyfjapenni hefur verið fjarlægt úr kæli er mælt með að láta Mixtard hettuglasið, rörlykjuna eða áfyllta lyfjapennann ná stofuhita áður en insúlínið er blandað samkvæmt leiðbeiningum fyrir fyrstu notkun.
English: Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
Icelandic: Dældu inn skammtinum með því að ýta þrýstihnappnum í botnstöðu þar til 0 er í beinni línu við vísinn.
English: What Mixtard looks like and contents of the pack
Icelandic: Lýsing á útliti Mixtard og pakkningastærðir
English: Mixtard 30 vial (40 international units/ml) EU/1/02/231/001
Icelandic: Mixtard 30 hettuglas (40 alþjóðlegar einingar/ml) EU/1/02/231/001
English: Setting the dose • Always check that the push-button is fully depressed and the dose selector is set to 0.
Icelandic: Athugið alltaf að þrýstihnappurinn sé niðri og að skammtakvarðinn sé stilltur á núll.
English: ► Needles and Mixtard InnoLet must not be shared.
Icelandic: ► Nálum og Mixtard InnoLet má ekki deila með öðrum.
English: Mixtard is a dual-acting human insulin.
Icelandic: Mixtard er mannainsúlín sem verkar á tvennan hátt.
English: In case of hypoglycaemia or if hypoglycaemia is suspected, Mixtard must not be injected.
Icelandic: Við blóðsykursfall eða grun um blóðsykursfall, má ekki nota Mixtard.
English: On rare occasions, injection site reactions may require discontinuation of Mixtard.
Icelandic: Í einstaka tilvikum getur þurft að hætta notkun Mixtard vegna einkenna á stungustað.
English: - If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Icelandic: H7 eða T6 þá er framleiðandinn Novo Nordisk Production SAS, 45 Avenue d'Orleans F-28000 Chartres, Frakkland.
English: How to handle Mixtard 30 FlexPen
Icelandic: Hvernig á að meðhöndla Mixtard 30 FlexPen
English: Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml)
Icelandic: Mixtard 30 hettuglas (40 alþjóðlegar einingar/ml)/Mixtard 30 hettuglas (100 alþjóðlegar einingar/ml)
English: - If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Icelandic: - Ef annar og þriðji stafur eru S6, P5, K7, R7, VG, FG eða ZF þá er framleiðandinn Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danmörk
English: Mixtard 30 InnoLet is a pre-filled disposable pen containing a mixture of fast-acting and long-acting human insulin in the ratio 30/70.
Icelandic: Mixtard 30 InnoLet er áfylltur einnota lyfjapenni sem inniheldur blöndu af skjótverkandi og langverkandi mannainsúlíni í hlutföllunum 30/70.
English: EU/1/02/231/036 5 packs of 1 x 10 ml vial
Icelandic: EU/1/02/231/036 5 pakkningar með 1 x 10 ml hettuglasi
English: EU/1/02/231/037 5 packs of 1 x 10 ml vial
Icelandic: EU/1/02/231/037 5 pakkningar með 1 x 10 ml hettuglasi
English: Mixtard 30 vial, Penfill and FlexPen:
Icelandic: Mixtard 30 hettuglas, Penfill og FlexPen:
English: Mixtard 30 vial (40 international units/ml)
Icelandic: Mixtard 30 hettuglas (40 alþjóðlegar einingar/ml)
English: Getting started
Icelandic: Að beiðni
English: ► Needles and Mixtard Penfill must not be shared.
Icelandic: ► Nálum og Mixtard Penfill má ekki deila með öðrum.
English: Preparing your Mixtard 30 FlexPen
Icelandic: Undirbúningur Mixtard 30 FlexPen
English: Read carefully the Instructions on how to use Mixtard 30 InnoLet included in this package leaflet.
Icelandic: Leiðbeiningar um hvernig á að nota Mixtard 30 InnoLet sem eru í þessum fylgiseðli.
English: Mixtard can be used in elderly patients.
Icelandic: Nota má Mixtard handa öldruðum sjúklingum.
English: 1 vial contains 10 ml equivalent to 400 international units.
Icelandic: 1 hettuglas inniheldur 10 ml, sem jafngildir 400 alþjóðlegum einingum.
English: Mixtard is a mixture consisting of 50% soluble human insulin and 50% isophane human insulin.
Icelandic: Mixtard er blanda af 50% uppleystu insúlíni og 50% isófan mannainsúlín.
English: Read carefully the Instructions on how to use Mixtard 30 FlexPen included in this package leaflet.
Icelandic: Leiðbeiningar um hvernig á að nota Mixtard 30 FlexPen sem eru í þessum fylgiseðli.
English: Mixtard is a mixture consisting of 40% soluble human insulin and 60% isophane human insulin.
Icelandic: Mixtard er blanda af 40% uppleystu insúlíni og 60% isófan mannainsúlíni.
English: Needles and Mixtard Penfill must not be shared.
Icelandic: Ekki má deila nálum og Mixtard Penfill.
English: ► Mixtard FlexPen is only suitable for injecting under the skin.
Icelandic: ► Mixtard FlexPen hentar aðeins til inndælingar undir húð.
English: ► Mixtard InnoLet is only suitable for injecting under the skin.
Icelandic: ► Mixtard InnoLet hentar aðeins til inndælingar undir húð.
English: How to inject Mixtard
Icelandic: Hvernig sprauta á Mixtard
English: How to store Mixtard
Icelandic: Hvernig geyma á Mixtard
English: Mixtard vials are for use with insulin syringes with a corresponding unit scale.
Icelandic: Mixtard hettuglös á að nota með insúlínsprautum með tilskildum einingakvarða.
English: Mixtard InnoLet is only suitable for injecting under the skin.
Icelandic: Mixtard InnoLet hentar aðeins til inndælingar undir húð.
English: Mixtard FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Icelandic: Mixtard FlexPen er áfylltur lyfjapenni sem er hannaður til notkunar með NovoFine eða NovoTwist einnota nálum sem eru allt að 8 mm langar.
English: Mixtard FlexPen is only suitable for injecting under the skin.
Icelandic: Mixtard FlexPen hentar aðeins til inndælingar undir húð.
English: There is no restriction on treatment with Mixtard during breast-feeding.
Icelandic: Engar takmarkanir eru í sambandi við notkun Mixtard hjá konum með barn á brjósti.
English: ► Mixtard Penfill is only suitable for injecting under the skin using a reusable pen.
Icelandic: ► Mixtard Penfill hentar aðeins til inndælingar undir húð með margnota insúlínpenna.
English: Mixtard Penfill is only suitable for injecting under the skin using a reusable pen.
Icelandic: Mixtard Penfill hentar aðeins til inndælingar undir húð með margnota insúlínpenna.
English: Mixtard 30 FlexPen is a pre-filled disposable pen containing a mixture of fast-acting and long-acting human insulin in the ratio 30/70.
Icelandic: FlexPen er áfylltur einnota lyfjapenni sem inniheldur blöndu af skjótverkandi og langverkandi mannainsúlíni í hlutföllunum 30/70.
English: Mixtard is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin.
Icelandic: Mixtard er blanda af 30% uppleystu mannainsúlíni og 70% isófan mannainsúlíni.
English: Each vial contains 1,000 IU of human insulin in 10 ml suspension for injection.
Icelandic: Hvert hettuglas inniheldur 1000 a.e. af mannainsúlíni í 10 ml af stungulyfi, dreifu.
English: You must use the pen as described in the Instructions on how to use Mixtard 30 InnoLet.
Icelandic: Leiðbeiningum um hvernig á að nota Mixtard 30 InnoLet.
English: Mixtard InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit.
Icelandic: Mixtard InnoLet er áfylltur lyfjapenni sem er hannaður til notkunar með NovoFine eða NovoTwist einnota nálum sem eru allt að 8 mm langar.
English: Each prefilled pen contains 300 IU of human insulin in 3 ml suspension for injection.
Icelandic: Hver áfylltur lyfjapenni inniheldur 300 a.e. af mannainsúlíni í 3 ml af stungulyfi, dreifu.
English: How to take Mixtard
Icelandic: Hvernig nota á Mixtard
English: You must use the pen as described in the Instructions on how to use Mixtard 30 FlexPen.
Icelandic: Leiðbeiningum um hvernig á að nota Mixtard 30 FlexPen.
English: Mixtard 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 30 is essentially ‘sodiumfree'.
Icelandic: Mixtard 30 innniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti, þ.e.a.s. Mixtard 30 er nær natríumfrítt.
English: ► If the resuspended insulin does not appear uniformly white and cloudy.
Icelandic: Ef insúlínið er ekki einsleitt, hvítt og skýjað eftir blöndun.
English: Novo Allé DK-2880 Bagsværd Denmark
Icelandic: DK-2880 Bagsværd Danmörk.
English: Mixtard 40 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 40 is essentially ‘sodiumfree'.
Icelandic: Mixtard 40 innniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti, þ.e.a.s. Mixtard 40 er nær natríumfrítt.
English: Mixtard 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 50 is essentially ‘sodiumfree'.
Icelandic: Mixtard 50 innniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti, þ.e.a.s. Mixtard 50 er nær natríumfrítt.
English: EU/1/02/231/001 1 vial of 10 ml EU/1/02/231/002 5 vials of 10 ml
Icelandic: EU/1/02/231/001 1 hettuglas með 10 ml EU/1/02/231/002 5 hettuglös með 10 ml
English: EU/1/02/231/003 1 vial of 10 ml EU/1/02/231/004 5 vials of 10 ml
Icelandic: EU/1/02/231/003 1 hettuglas með 10 ml EU/1/02/231/004 5 hettuglös með 10 ml
English: Mixtard contains sodium
Icelandic: Mixtard inniheldur natríum
English: Mixtard is a dual-acting insulin.
Icelandic: Mixtard er insúlín með tvenns konar verkun.
English: EU/1/02/231/033 1 pen of 3 ml EU/1/02/231/034 5 pens of 3 ml EU/1/02/231/035 10 pens of 3 ml
Icelandic: EU/1/02/231/033 1 lyfjapenni með 3 ml EU/1/02/231/034 5 lyfjapennar með 3 ml EU/1/02/231/035 10 lyfjapennar með 3 ml
English: EU/1/02/231/011 1 cartridge of 3 ml EU/1/02/231/012 5 cartridges of 3 ml EU/1/02/231/013 10 cartridges of 3 ml
Icelandic: EU/1/02/231/011 1 rörlykja með 3 ml EU/1/02/231/012 5 rörlykjur með 3 ml EU/1/02/231/013 10 rörlykjur með 3 ml
English: EU/1/02/231/014 1 cartridge of 3 ml EU/1/02/231/015 5 cartridges of 3 ml EU/1/02/231/016 10 cartridges of 3 ml
Icelandic: EU/1/02/231/014 1 rörlykja með 3 ml EU/1/02/231/015 5 rörlykjur með 3 ml EU/1/02/231/016 10 rörlykjur með 3 ml
English: Mixtard 50 Penfill 100 international units/ml suspension for injection in cartridge.
Icelandic: Mixtard 50 Penfill 100 alþjóðlegar einingar/ml stungulyf, dreifa í rörlykju.
English: Mixtard 30 40 IU/ml Suspension for injection Insulin human SC
Icelandic: Mixtard 30 40 a.e./ml Stungulyf, dreifa Mannainsúlín s.c.
English: EU/1/02/231/017 1 cartridge of 3 ml EU/1/02/231/018 5 cartridges of 3 ml EU/1/02/231/019 10 cartridges of 3 ml
Icelandic: EU/1/02/231/017 1 rörlykja með 3 ml EU/1/02/231/018 5 rörlykjur með 3 ml EU/1/02/231/019 10 rörlykjur með 3 ml
English: Mixtard 30 40 international units/ml suspension for injection in vial.
Icelandic: Mixtard 30 40 alþjóðlegar einingar/ml stungulyf, dreifa í hettuglasi.
English: Mixtard 30 InnoLet 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Icelandic: Mixtard 30 InnoLet 100 a.e./ml Stungulyf, dreifa í áfylltum lyfjapenna Mannainsúlín
English: Mixtard 30 Penfill 100 international units/ml suspension for injection in cartridge.
Icelandic: Mixtard 30 Penfill 100 alþjóðlegar einingar/ml stungulyf, dreifa í rörlykju.
English: Mixtard 40 Penfill 100 international units/ml suspension for injection in cartridge.
Icelandic: Mixtard 40 Penfill 100 alþjóðlegar einingar/ml stungulyf, dreifa í rörlykju.
English: You will hear clicks as the dose selector returns to 0.
Icelandic: Þegar skammtamælirinn fer á 0 heyrast smellir.
English: Mixtard is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region.
Icelandic: Mixtard er gefið með inndælingu undir húð á læri, kviði, rasskinn eða á axlarvöðvasvæði.
English: EU/1/02/231/030 1 pen of 3 ml EU/1/02/231/031 5 pens of 3 ml EU/1/02/231/032 10 pens of 3 ml
Icelandic: EU/1/02/231/030 1 lyfjapenni með 3 ml EU/1/02/231/031 5 lyfjapennar með 3 ml EU/1/02/231/032 10 lyfjapennar með 3 ml
English: Package leaflet: Information for the user Mixtard 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 30 InnoLet 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í áfylltum lyfjapenna
English: Package leaflet: Information for the user Mixtard 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 30 40 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í hettuglasi
English: Mixtard 30 100 IU/ml Suspension for injection Insulin human SC
Icelandic: Mixtard 30 100 a.e./ml Stungulyf, dreifa Mannainsúlín s.c.
English: Contents of the pack and other information What Mixtard 50 contains
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á Mixtard Pakkningar og aðrar upplýsingar
English: Mixtard contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard is essentially ‘sodium-free'.
Icelandic: Mixtard inniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti, þ.e.a.s. Mixtard er nær natríumfrítt.
English: Package leaflet: Information for the user Mixtard 50 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 50 Penfill 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í rörlykju
English: Mixtard 30 100 international units/ml suspension for injection in vial.
Icelandic: Mixtard 30 100 alþjóðlegar einingar/ml stungulyf, dreifa í hettuglasi.
English: Package leaflet: Information for the user Mixtard 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 40 Penfill 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í rörlykju
English: Mixtard 30 InnoLet 100 international units/ml suspension for injection in pre-filled pen.
Icelandic: Mixtard 30 InnoLet 100 alþjóðlegar einingar/ml stungulyf, dreifa í áfylltum lyfjapenna.
English: Mixtard 50 Penfill 100 IU/ml Suspension for injection Insulin human
Icelandic: Mixtard 50 Penfill 100 a.e./ml Stungulyf, dreifa í rörlykju
English: Package leaflet: Information for the user Mixtard 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 30 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í hettuglasi
English: Package leaflet: Information for the user Mixtard 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Icelandic: Upplýsingar fyrir notanda lyfsins Mixtard 30 Penfill 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í rörlykju
English: Mixtard is administered by injection under the skin (subcutaneously).
Icelandic: Mixtard á að sprauta undir húð.
English: Mixtard 40 Penfill 100 IU/ml Suspension for injection Insulin human
Icelandic: Mixtard 40 Penfill 100 a.e./ml Stungulyf, dreifa í rörlykju
English: Resuspend according to instructions Only use the resuspension if uniformly white and cloudy
Icelandic: Notið dreifuna einungis ef hún er einsleit, hvít og skýjuð eftir blöndun
English: Mixtard 30 Penfill 100 IU/ml Suspension for injection Insulin human
Icelandic: Mixtard 30 Penfill 100 a.e./ml Stungulyf, dreifa í rörlykju
English: Mixtard 50 Penfill 100 IU/ml Suspension for injection in cartridge Insulin human
Icelandic: Mixtard 50 Penfill 100 a.e./ml Stungulyf, dreifa Mannainsúlín s.c.
English: Mixtard 40 Penfill 100 IU/ml Suspension for injection in cartridge Insulin human
Icelandic: Mixtard 40 Penfill 100 a.e./ml Stungulyf, dreifa Mannainsúlín s.c.
English: Mixtard 30 FlexPen 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Icelandic: FlexPen 100 a.e./ml (alþjóðlegar einingar/ml) stungulyf, dreifa í áfylltum lyfjapenna
English: 1 vial contains 10 ml equivalent to 1,000 international units.
Icelandic: Mixtard 30 hettuglas (100 alþjóðlegar einingar/ml) 1 hettuglas inniheldur 10 ml, sem jafngildir 1.000 alþjóðlegum einingum.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Icelandic: Gild samantekt á eiginleikum lyfs, áletranir og fylgiseðill eru þær lokaútgáfur sem fengist hafa úr ferli CMDh-hópsins.
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Icelandic: SAMANTEKT Á EIGINLEIKUM LYFS, ÁLETRANIR OG FYLGISEÐILL
English: (see section 4.4),
Icelandic: (sjá kafla 4.4),
English: Interferon alpha
Icelandic: Interferón alfa
English: It may harm them,
Icelandic: Munnbólga,
English: STOP taking Capecitabine Teva immediately and contact your doctor if any of these symptoms occur:
Icelandic: HÆTTU strax að taka inn Capecitabine Teva og hafðu samband við lækninn ef einhver af eftirfarandi einkennum koma fram:
English: red iron oxide (E172).
Icelandic: rautt járnoxíð (E172).
English: България Актавис ЕАД
Icelandic: България Актавис ЕАД Тел:
English: 820 Patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Icelandic: 820 sjúklingum var slembiraðað og fengu þeir annars vegar kaflaskipta meðferð (sequential treatment) (n=410) eða samsetta meðferð (n=410).
English: Each pack contains 60 tablets.
Icelandic: Hver pakkning inniheldur 60 töflur.
English: 305, 74770 Opava-Komarov Czech Republic
Icelandic: 29, c.p. 305, 74770 Opava-Komarov Tékkland
English: Dose adjustment for next cycle/dose (% of starting dose)
Icelandic: Breyting á skammti við næstu lotu/skammt (% af byrjunarskammti)
English: See also section “Do not take Capecitabine Teva”.
Icelandic: Sjá einnig kaflann “Ekki má taka Capecitabine Teva”.
English: Careful monitoring of patients ≥60 years of age is advisable.
Icelandic: Ráðlagt er að fylgjast vandlega með sjúklingum ≥60 ára.
English: Each pack contains 120 tablets.
Icelandic: Hver pakkning inniheldur 120 töflur.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnu á eftir EXP.
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.
Icelandic: Íhuga má að minnka upphafsskammta hjá þessum sjúklingum til að forðast alvarleg eituráhrif.
English: • Fever: if you have a temperature of 38°C or greater.
Icelandic: Ef hitinn er 38°C eða hærri.
English: Date of latest renewal: 09 January 2017
Icelandic: 9. janúar 2017
English: • jaundice (yellowing of skin and eyes)
Icelandic: • gula (gulnun húðar og augna)
English: Palmar-plantar erythrodysaesthesi a syndrome**
Icelandic: Handa-fóta heilkenni (palmarplantar erythrodysae s-thesia syndrome)**
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine down-regulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Icelandic: Þar sem engin áhrif voru á umbrot R-warfaríns, benda þessar niðurstöður til þess að capecítabín dragi úr myndun ísóensíms 2C9, en hafi engin áhrif á ísóensímin 1A2 og 3A4.
English: Capecitabine Teva tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Icelandic: Teva töflur eru venjulega teknar í 14 daga og síðan er 7 daga hlé (þá eru engar töflur teknar).
English: Capecitabine Teva may be used either alone or in combination with other medicines.
Icelandic: Teva er annaðhvort hægt að nota eitt sér eða ásamt öðrum lyfjum.
English: Severe and/or Life-threatening (grade 3-4) or considered medically relevant
Icelandic: Alvarlegar og/eða lífshættulegar (gráða 3-4) eða taldar skipta læknisfræðilegu máli
English: • unusual bleeding from the vagina
Icelandic: • óvenjulegar blæðingar frá leggöngum
English: Tell your doctor immediately if you experience any of these symptoms.
Icelandic: Láttu lækninn vita tafarlaust ef vart verður við einhver þessara einkenna.
English: These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine.
Icelandic: Þessar milliverkanir sáust allt frá nokkrum dögum upp í allt að nokkrum mánuðum eftir upphaf capecítabíns meðferðar og í fáeinum tilvikum allt að einum mánuði eftir að hætt var að taka capecítabín.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Icelandic: Sumar þessara aukaverkana eru algengari þegar capecítabín er notað með öðrum lyfjum sem meðferð við krabbameini.
English: magnesium stearate.
Icelandic: magnesíumsterat.