FrancophonIA/ELRC3.0 huggingface dataset:
English: The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or decrease your daily dose.
Icelandic: Skammtur REKOVELLE er sá sami allan meðferðartímann og sólarhringsskammtur er hvoki aukinn né minnkaður.
English: Tabulated list of adverse reactions
Icelandic: Tafla 3 Skammtaáætlun
English: REKOVELLE 12 micrograms/0.36 mL solution for injection REKOVELLE 36 micrograms/1.08 mL solution for injection REKOVELLE 72 micrograms/2.16 mL solution for injection
Icelandic: REKOVELLE 12 míkróg/0,36 ml stungulyf, lausn REKOVELLE 36 míkróg/1,08 ml stungulyf, lausn REKOVELLE 72 míkróg/2,16 ml stungulyf, lausn
English: In particular, patients should be evaluated for hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given.
Icelandic: Sérstaklega skal rannsaka konuna með tilliti til vanstarfsemi skjaldkirtils, of mikils prólaktíns í blóði og veita viðeigandi meðferð.
English: For instructions on the administration with the pre-filled pen, see the ”Instructions for Use”.
Icelandic: Fyrir leiðbeiningar um gjöf lyfsins með áfyllta lyfjapennanum, sjá notkunarleiðbeiningar.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 9 pen injection needles
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn í áfylltum lyfjapenna 1 fjölskammta áfylltur lyfjapenni með 9 inndælingarnálum í penna
English: The instructions for use of the pen must be followed.
Icelandic: Fylgja verður notkunarleiðbeiningum pennans.
English: Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Icelandic: Pakkning með 1 rörlykju og 6 inndælingarnálum (ryðfrítt stál) til notkunar með REKOVELLE inndælingarpenna.
English: • Inject the remaining dose of medicine (the number in column C) using your new pen to complete your prescribed dose.
Icelandic: Sprautaðu skammtinum sem eftir er af lyfinu (talan í dálki C) með nýja lyfjapennanum til að ljúka gjöf ávísaðs skammts.
English: Elderly There is no relevant use of REKOVELLE in the elderly population.
Icelandic: Aldraðir Notkun REKOVELLE á ekki við hjá öldruðum.
English: • Only use the single-use click-on needles supplied with the pen.
Icelandic: Notaðu aðeins einnota ásmellanlegu nálarnar sem fylgja lyfjapennanum.
English: Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Icelandic: Pakkning með 1 rörlykju og 3 inndælingarnálum (ryðfrítt stál) til notkunar með REKOVELLE inndælingarpenna.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn í áfylltum lyfjapenna 1 fjölskammta áfylltur lyfjapenni með 6 inndælingarnálum í penna
English: Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Icelandic: Hver áfylltur lyfjapenni með fjölskammta rörlykju inniheldur 36 míkróg af follitropin delta í 1,08 ml af lausn.
English: 1 multidose cartridge with 3 pen injection needles
Icelandic: 1 fjölskammta rörlykja með 3 inndælingarnáluum í penna
English: • made of a heavy-duty plastic,
Icelandic: • gert úr þykku plasti,
English: PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (injection).
Icelandic: Stungulyf, lausn í áfylltum lyfjapenna (stungulyf)
English: The solution should not be administered if it contains particles or is not clear.
Icelandic: Lausnina má ekki nota ef hún er ekki tær eða ef hún inniheldur agnir.
English: Needles:
Icelandic: Fylgiseðill:
English: REKOVELLE 12 micrograms/0.36 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Icelandic: REKOVELLE 12 míkróg/0,36 ml stungulyf, lausn 3 ml fjölskammta rörlykja (gler af tegund I) með stimpli (halóbútýlgúmmí) og álhettu með gúmmíi.
English: Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Icelandic: Hver áfylltur lyfjapenni með fjölskammta rörlykju inniheldur 72 míkróg af follitropin delta í 2,16 ml af lausn.
English: Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Icelandic: Pakkning með 1 áfylltum lyfjapenna og 9 inndælingarnálum (ryðfrítt stál).
English: Split-dose diary
Icelandic: Dagbók yfir skiptan skammt
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 3 pen injection needles
Icelandic: Stungulyf, lausn í áfylltum lyfjapenna 1 fjölskammta áfylltur lyfjapenni með 3 inndælingarnáluum í penna
English: There are no data from the inadvertent exposure to REKOVELLE in pregnant women.
Icelandic: Gögn um ótilætlaða útsetningu fyrir REKOVELLE á meðgöngu liggja ekki fyrir.
English: Vomiting
Icelandic: RÖRLYKJA
English: When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally.
Icelandic: Þegar gengist er undir tæknifrjóvgun eru meiri líkur á utanlegsfóstri en undir eðlilegum kringumstæðum.
English: Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Icelandic: Hver áfylltur lyfjapenni með fjölskammta rörlykju inniheldur 12 míkróg af follitropin delta í 0,36 ml af lausn.
English: • Dizziness
Icelandic: • niðurgang
English: REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
Icelandic: REKOVELLE er notað við ófrjósemi hjá konum og hjá konum sem gangast undir tæknifrjóvgun eins og glasafrjóvgun og smásjárfrjóvgun.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 72 micrograms follitropin delta in 2.16 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver fjölskammta rörlykja inniheldur 72 míkróg follitropin delta í 2,16 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: Do not use REKOVELLE if:
Icelandic: Ekki má nota REKOVELLE
English: Vaginal haemorrhage Breast pain Breast tenderness
Icelandic: Blæðing frá fæðingarvegi Verkur í brjóstum
English: 4.6 Fertility, pregnancy and lactation
Icelandic: 4.6 Meðganga og brjóstagjöf
English: Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Icelandic: Útsetning fyrir follitropin delta eykst í réttu hlutfalli við skammt innan lækningalegra gilda.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Icelandic: REKOVELLE 72 míkróg/2,16 ml stungulyf, lausn Follitropin delta
English: OHSS is an intrinsic risk of the ovarian stimulation.
Icelandic: Eðlislæg hætta er á eggjastokkaoförvunarheikenni við örvun eggjastokka.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 36 micrograms follitropin delta in 1.08 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver fjölskammta rörlykja inniheldur 36 míkróg follitropin delta í 1,08 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
Icelandic: Pakkning með 1 áfylltum lyfjapenna og 3 inndælingarnálum (ryðfrítt stál).
English: It is available in packs of 1 pre-filled pen and 9 pen injection needles.
Icelandic: Það er í pakkningu með 1 áfylltum lyfjapenna og 9 inndælingarnálum í penna.
English: It is available in packs of 1 cartridge and 9 pen injection needles.
Icelandic: Það er í pakkningu með 1 rörlykju og 9 inndælingarnálum í penna.
English: It is available in packs of 1 cartridge and 6 pen injection needles.
Icelandic: Það er í pakkningu með 1 rörlykju og 6 inndælingarnálum í penna.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Icelandic: REKOVELLE 36 míkróg/1,08 ml stungulyf, lausn Follitropin delta
English: You will need to give a split-dose injection or throw away (dispose of) your current pen and use a new pen for your injection.
Icelandic: Þú munt þurfa að fá inndælingu með skiptum skammti eða fleygja (farga)
English: Mood swings
Icelandic: Blæðing frá leggöngum
English: • Pelvic pain and discomfort, including of ovarian origin
Icelandic: Verkur í mjaðmagrind og óþægindi þar með talin óþægindi frá eggjastokkum
English: In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age, although twin pregnancy can in rare occasions develop from single embryo transfers.
Icelandic: Hjá konum sem fara í tæknifrjóvgun tengist hættan á fjölburaþungun fyrst og fremst fjölda fósturvísa sem settir eru upp, gæðum þeirra og aldri konunnar.
English: Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
Icelandic: Pakkning með 1 áfylltum lyfjapenna og 6 inndælingarnálum (ryðfrítt stál).
English: REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Icelandic: REKOVELLE 12 míkróg/0,36 ml stungulyf, lausn follitropin delta
English: Thromboembolic events
Icelandic: UAB PharmaSwiss
English: The dose of REKOVELLE is individualised for each patient to obtain an ovarian response with favourable safety/efficacy profile.
Icelandic: Skammtur REKOVELLE er einstaklingsbundinn til þess að ná svörun eggjastokka þar sem hlutfall öryggis og verkunar er hagstætt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 12 micrograms follitropin delta in 0.36 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver fjölskammta rörlykja inniheldur 12 míkróg follitropin delta í 0,36 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: It is available in packs of 1 pre-filled pen and 6 pen injection needles.
Icelandic: Það er í pakkningu með 1 áfylltum lyfjapenna og 6 inndælingarnálum í penna.
English: • Constipation
Icelandic: • uppköst
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 72 micrograms follitropin delta in 2.16 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver áfylltur fjölskammta lyfjapenni gefur 72 míkróg follitropin delta í 2,16 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: • gain weight
Icelandic: Áhrif skammta
English: Ovarian and other reproductive system tumours
Icelandic: Æxli í eggjastokkum og öðrum æxlunarfærum
English: Pelvic pain Adnexa uteri pain Pelvic discomfort
Icelandic: Eggjastokkaoförvunarheilkenni Mjaðmagrindarverkir Verkur í legpípum og eggjakerfi Óþægindi í mjaðmagrind
English: • you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus
Icelandic: þú ert með æxli í legi, eggjastokkum, brjóstum, heiladingli eða undirstúku
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 36 micrograms follitropin delta in 1.08 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver áfylltur fjölskammta lyfjapenni gefur 36 míkróg follitropin delta í 1,08 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: It is available in packs of 1 cartridge and 3 pen injection needles.
Icelandic: Það er í pakkningu með 1 rörlykju og 3 inndælingarnálum í penna.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta
Icelandic: REKOVELLE 36 míkróg/1,08 ml stungulyf, lausn í áfylltum lyfjapenna Follitropin delta
English: Blood clotting problems (thromboembolic events)
Icelandic: Blóðtappi (segamyndun)
English: It is available in packs of 1 pre-filled pen and 3 pen injection needles.
Icelandic: Það er í pakkningu með 1 áfylltum lyfjapenna og 3 inndælingarnálum í penna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 12 micrograms follitropin delta in 0.36 mL One mL of solution contains 33.3 micrograms of follitropin delta
Icelandic: Hver áfylltur fjölskammta lyfjapenni gefur 12 míkróg follitropin delta í 0,36 ml Einn ml af lausn inniheldur 33.3 míkróg af follitropin delta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/002
English: REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection).
Icelandic: REKOVELLE er tær og litlaus stungulyf, lausn í áfylltum lyfjapenna.
English: • Store the pen in a refrigerator at 2 °C to 8 °C.
Icelandic: Geymið lyfjapennann í kæli við 2°C til 8°C. Má ekki frjósa.
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation for ART than following natural conception.
Icelandic: Tíðni fósturláta sem verða af sjálfu sér eða sem eru framkölluð er aukin hjá konum sem eru í örvunarmeðferð í tengslum við tæknifrjóvgun en hjá konum almennt.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Icelandic: stækkun eggjastokka eða blöðrur í eggjastokkum sem ekki er vegna fjölblöðruheilkennis í eggjastokkum
English: Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be at risk of developing OHSS.
Icelandic: Hjá konum sem eru í meðferð til að örva þroska eggbúa er aukin hætta á stækkun eggjastokka eða eggjastokkaoförvunarheilkenni.
English: Pregnancy loss
Icelandic: Stök inndæling
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2016
Icelandic: 12. desember 2016
English: REKOVELLE is not indicated during pregnancy.
Icelandic: REKOVELLE á ekki að nota á meðgöngu.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta
Icelandic: REKOVELLE 72 míkróg/2,16 ml stungulyf, lausn í áfylltum lyfjapenna Follitropin delta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/006
English: • you have had an early menopause
Icelandic: ef tíðahvörf eru snemma
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Icelandic: Örsjaldan getur eggjastokkssnúningur eða segarek, t.d. lungnasegarek, blóðþurrðarslag eða hjartadrep fylgt alvarlegu OHSS.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/004
English: Ectopic pregnancy
Icelandic: ÁFYLLTUR LYFJAPENNI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/001
English: The prevalence of ectopic pregnancy after ART has been reported to be higher than in the general population.
Icelandic: Greint hefur verið frá hærri tíðni utanlegsfóstra við tæknifrjóvgun miðað við hjá konum almennt.
English: REKOVELLE contains sodium
Icelandic: REKOVELLE inniheldur natríum
English: Occurrence of ovarian torsion has been reported for ART cycles.
Icelandic: Greint hefur verið frá snúningi á eggjastokkum eftir tæknifrjóvgunarlotur.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta
Icelandic: REKOVELLE 12 míkróg/0,36 ml stungulyf, lausn í áfylltum lyfjapenna follitropin delta
English: Polycystic ovarian syndrome patients with anovulatory disorders Anovulatory patients with polycystic ovarian syndrome have not been studied.
Icelandic: Fjölblöðruheilkenni í eggjastokkum hjá konum með röskun á egglosi Konur með fjölblöðruheilkenni í eggjastokkum með röskun á egglosi hafa ekki verið rannsakaðar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/16/1150/003
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Icelandic: Gert er ráð fyrir nokkurri stækkun á eggjastokkum vegna örvunar eggjastokka.
English: OHSS
Icelandic: Lot
English: After first use: 28 days when stored at or below 25 °C.
Icelandic: 28 dagar þegar það er geymt við lægri hita en 25 °C. Geymið rörlykjuna í REKOVELLE inndælingarpennanum.
English: Keep the cartridge in the REKOVELLE injection pen.
Icelandic: Haltu lyfjapennanum þannig að nálin snúi upp.
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Icelandic: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Icelandic: VÍSINDALEGAR NIÐURSTÖÐUR OG ÁSTÆÐUR FYRIR BREYTINGUM Á SKILMÁLUM
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Icelandic: Á grundvelli vísindalegra niðurstaðna fyrir {heiti virks efnis/efna} telur CHMP að jafnvægið á milli ávinnings og áhættu af lyfinu, sem inniheldur {heiti virks efnis/efna}, sé óbreytt að því gefnu að áformaðar breytingar á lyfjaupplýsingunum séu gerðar.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Icelandic: PRAC um PSUR fyrir {heiti virks efnis/efna} eru vísindalegar niðurstöður CHMP svohljóðandi:
English: OF THE MARKETING AUTHORISATION(S)
Icelandic: MARKAÐSLEYFISINS
English: You should tell your doctor:
Icelandic: Láta skal lækninn vita:
English: There was no change to Tmax or half-life.
Icelandic: Engin breyting varð á Tmax eða helmingunartíma.
English: Caution should be exercised in such situations.
Icelandic: Gæta skal varúðar við slíkar aðstæður.
English: Best Overall Response Rate (CR/PR)
Icelandic: Besta heildarsvörunarhlutfall (CR/PR)
English: Tarceva has not been studied in patients under the age of 18 years.
Icelandic: Tarceva hefur ekki verið rannsakað hjá sjúklingum undir 18 ára aldri.
English: Talk to your doctor, he will need to regularly monitor you with some blood tests.
Icelandic: Ræddu við lækninn, hann þarf að viðhafa reglulegt eftirlit með blóðrannsóknum.
English: 90% of patients on Tarceva developed rash within the first 44 days.
Icelandic: 90% sjúklinga á Tarceva fengu útbrot á fyrstu 44 dögunum.
English: See also section 4 “Possible side effects”.
Icelandic: Sjá jafnframt 4. kafla, “Hugsanlegar aukaverkanir”.
English: Tarceva is indicated for adults.
Icelandic: Tarceva er ætlað fullorðnum.
English: 1 In clinical study PA.3.
Icelandic: 1 Í klínísku rannsókninni PA.3.
English: Plasma protein binding is approximately 95%.
Icelandic: Próteinbinding í plasma er um 95%.
English: Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Icelandic: Því er búist við að tíminn sem það tekur að ná plasmaþéttni í jafnvægi sé um 7-8 dagar.
English: It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Icelandic: Einnig er hægt að ávísa því ef fyrri krabbameinslyfjameðferð hefur ekki gagnast til að stöðva sjúkdóminn.
English: The study did not meet its primary endpoint.
Icelandic: Rannsóknin náði ekki meginmarkmiði sínu.
English: The treatment with this medicine is not recommended for children and adolescents.
Icelandic: Meðferð með þessu lyfi er ekki ráðlögð hjá börnum og unglingum.
English: It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Icelandic: Ekki er vitað hvort Tarceva hefur önnur áhrif ef lifrin eða nýrun starfa ekki eðlilega.
English: What Tarceva is and what it is used for
Icelandic: Upplýsingar um Tarceva og við hverju það er notað
English: A higher incidence has been observed in patients in Japan (see section 4.4).
Icelandic: Hærri tíðni hefur sést hjá sjúklingum í Japan (sjá kafla 4.4).
English: If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Icelandic: Ef blóðpróf sýna fram á alvarlegar breytingar á lifrarstarfsemi, gæti læknirinn þurft að stöðva meðferðina.
English: Most were Grade 1/2 in severity and manageable without intervention.
Icelandic: Flestar voru af stigi 1/2 hvað varðar alvarleika og viðráðanlegar án þess að gripið væri inn í.
English: The primary endpoint of the study included progression free survival (PFS) in all patients.
Icelandic: Meðal aðalendapunkta rannsóknarinnar var lifun án versnunar sjúkdóms (PFS, progression-free survival) hjá öllum sjúklingum.
English: The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Icelandic: Fyrstu 330 sjúklingarnir voru miðlægt metnir (svörunarhlutfall 6,2%); 401 sjúklingur var metinn af rannsakanda (svörunarhlutfall 11,2%).
English: See also section 3 ‘How to take Tarceva'
Icelandic: Sjá jafnframt 3. kafla, “Hvernig nota á Tarceva”.
English: Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Icelandic: 19. september 2005 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: -Interstitial lung disease (ILD)3
Icelandic: Millivefslungna sjúkdómur (ILD)3
English: PVC blister sealed with aluminium foil containing 30 tablets.
Icelandic: PVC þynnupakkning innsigluð með álþynnu sem inniheldur 30 töflur.
English: In patients who do not develop rash within the first 4 - 8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
Icelandic: Hjá sjúklingum sem ekki fá útbrot á fyrstu 4 - 8 vikum meðferðar, á að endurmeta frekari meðferð með Tarceva (sjá kafla 5.1).
English: Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Icelandic: Einungis á að halda meðferð áfram hjá þunguðum konum ef hugsanlegur ávinningur fyrir móður vegur þyngra en áhættan fyrir fóstrið.
English: A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Icelandic: Rannsókn á venjulegum, heilbrigðum sjálfboðaliðum leiddi í ljós áætlað heildaraðgengi sem nam 59%.
English: The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Icelandic: Miðgildi þess tíma sem svörun varir var 34,3 vikur, á bilinu 9,7 til 57,6+ vikur.
English: The effect on overall survival was explored across different patient subsets.
Icelandic: Áhrif á heildarlifun voru rannsökuð hjá mismunandi undirhópum sjúklinga.
English: In some cases dose reduction may be necessary.
Icelandic: Stundum getur þurft að minnka skammta.
English: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Icelandic: Sýnt hefur verið fram á að sígarettureykingar minnka útsetningu fyrir erlótiníbi um 50-60%.
English: Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing.
Icelandic: Heilbrigðir einstaklingar þoldu illa endurtekna 200 mg skammta tvisvar á dag eftir einungis nokkurra daga skömmtun.
English: -Stevens-Johnson syndrome/Toxic epidermal necrolysis7
Icelandic: -StevensJohnson heilkenni/drep í húðþekju (toxic epidermal necrolysis)7
English: Erlotinib and smokers
Icelandic: Erlótiníb og reykingar
English: Tarceva (months)
Icelandic: Tarceva (mánuðir)
English: If you forget to take Tarceva
Icelandic: Ef gleymist að taka Tarceva
English: First-Line Treatment of Patients with EGFR Mutations
Icelandic: Fyrsta meðferð hjá sjúklingum með stökkbreytingar í EGFR
English: When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4).
Icelandic: Ef aðlaga þarf skammt, ætti að minnka hann um 50 mg í einu (sjá kafla 4.4).
English: Females
Icelandic: Konur