FrancophonIA/ELRC3.0 huggingface dataset:
English: The amount to be administered and the frequency of administration should always be targeted to the clinical effectiveness required in the individual case.
Icelandic: Magn og tíðni lyfjagjafa skal alltaf miðast við þá klínísku virkni sem óskað er eftir í hverju einstöku tilviki.
English: System Organ Class
Icelandic: MedDRA líffæraflokkur
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with IbliasIf such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Icelandic: Myndun hlutleysandi mótefna (hemla) getur komið fram hjá sjúklingum með dreyrasýki A sem fá meðferð með storkuþætti VIII, þar á meðal með Iblias.
English: • chest tightness/general feeling of being unwell
Icelandic: þyngslum fyrir brjósti/almennri vanlíðunartilfinningu
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Icelandic: Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverjum skammti, þ.e.a.s. nær laust við natríum.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long-term treatment with Iblias, the MAH will submit the results of the ongoing study “13400 - Leopold Kids extension”
Icelandic: Iblias hjá sjúklingum sem ekki hafa áður fengið meðferð mun markaðsleyfishafi leggja fram niðurstöður rannsóknarinnar 13400 - Leopold Kids framhaldsrannsókn, sem enn stendur yfir
English: Since Iblias is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Icelandic: Þar sem Iblias er prótein sem bætir upp eigin skort á storkuþætti VIII er ekki gert ráð fyrir neinum aukaverkunum á frjósemi.
English: Detailed instructions for reconstitution and administration of Iblias using the Mix2Vial adapter:
Icelandic: Nákvæmar leiðbeiningar um blöndun og gjöf Iblias með notkun á hettuglasi með Mix2Vial millistykki fyrir hettuglas:
English: Study participants
Icelandic: Þátttakendur í rannsókn
English: 32 IU/kg 50 IU/kg)
Icelandic: 32 a.e./kg 50 a.e./kg)
English: 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Icelandic: 250 a.e. (októkóg alfa) (100 a.e./ml eftir blöndun).
English: • One mL Iblias 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Iblias 250 a.e. inniheldur u.þ.b. 100 a.e. (250 a.e. / 2,5 ml) af raðbrigða mannastorkuþætti VIII (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: 1 vial: 250 IU octocog alfa (100 IU/mL after reconstitution).
Icelandic: 1 hettuglas: 250 a.e. októkóg alfa (100 a.e./ml eftir blöndun).
English: Treatment with Iblias will be started by a doctor who is experienced in the care of patients with haemophilia A.Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Icelandic: Notið lyfið alltaf eins og fram kemur í fylgiseðlinum eða eins og læknirinn eða lyfjafræðingur hefur sagt til um.
English: How Iblias is prepared for administration
Icelandic: Undirbúningur Iblias fyrir lyfjagjöf
English: ANNEX II
Icelandic: Rannsók n 2
English: The cumulative incidence of all inhibitors was 26.8% (95% confidence interval [CI], 18.4 to 35.2) with pdFVIII and 44.5% (95% CI, 34.7 to 54.3) with rFVIII; the cumulative incidence of high-titre inhibitors was 18.6% (95% CI, 11.2 to 26.0) and 28.4% (95% CI, 19.6 to 37.2), respectively.
Icelandic: Árangurshlutfall* 92,4% 86,7% 86,3% 95,0% 97,7% 91,4%
English: The solvent will automatically flow into the product vial.
Icelandic: Leysirinn rennur sjálfkrafa inn í hettuglasið með lyfinu.
English: • One mL Iblias 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Iblias 3000 a.e. inniheldur u.þ.b. 600 a.e. (3.000 a.e. / 5 ml) af raðbrigða mannastorkuþætti VIII (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: 31 IU/kg 72 IU/kg)
Icelandic: 31 a.e./kg 72 a.e./kg)
English: FVIII inhibition uncommon (PTPs)*
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: • One mL Iblias 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Iblias 500 a.e. inniheldur u.þ.b. 200 a.e. (500 a.e. / 2,5 ml) af raðbrigða mannastorkuþætti VIII (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Icelandic: Sjá leiðbeiningar í kafla 6.6 og fylgiseðli um blöndun lyfsins fyrir gjöf.
English: Iblias contains sodium
Icelandic: Iblias inniheldur natríum
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Icelandic: Leiðbeiningar um skömmtun við blæðingar og skurðaðgerðir Alvarleiki blæðingar /
English: 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Icelandic: 3000 a.e. (októkóg alfa) (600 a.e./ml eftir blöndun).
English: For major surgery in particular, close monitoring of the replacement therapy by means of coagulation analysis must be carried out.
Icelandic: Sér í lagi við stórar skurðaðgerðir verður að viðhafa náið eftirlit með uppbótarmeðferð með því að nota blóðstorknunargreiningu.
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Icelandic: MARKAÐSLEYFISHAFI Bayer AG 51368 Leverkusen Þýskaland
English: • One mL Iblias 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Iblias 1000 a.e. inniheldur u.þ.b. 400 a.e. (1.000 a.e. / 2,5 ml) af raðbrigða mannastorkuþætti VIII (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: 28 IU/kg 39 IU/kg)
Icelandic: 28 a.e./kg 39 a.e./kg
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Icelandic: Fargið hettuglasinu með leysinum og áfasta bláa Mix2Vial millistykkinu.
English: Abdominal pain, abdominal discomfort, dyspepsia common
Icelandic: Kviðverkir, óþægindi í kvið, meltingartruflanir
English: 1 vial: 2000 IU octocog alfa (400 IU/mL after reconstitution).
Icelandic: 1 hettuglas: 2000 a.e. októkóg alfa (400 a.e./ml eftir blöndun).
English: What Iblias contains
Icelandic: Iblias inniheldur
English: 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Icelandic: 500 a.e. (októkóg alfa) (200 a.e./ml eftir blöndun).
English: 29 IU/kg 54 IU/kg)
Icelandic: 29 a.e./kg 54 a.e./kg
English: 36 IU/kg 58 IU/kg)
Icelandic: 36 a.e./kg 58 a.e./kg
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: The table 4 below provides PK parameters based on the population PK model.
Icelandic: Tafla 4 hér að neðan sýnir lyfjahvarfabreytur sem byggðar eru á líkaninu fyrir lyfjahvörf þýðis.
English: 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
Icelandic: 2000 a.e. (októkóg alfa) (400 a.e./ml eftir blöndun).
English: Nervous system disorders
Icelandic: Hjartsláttarónot, sínushraðtaktur
English: restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Icelandic: FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN Ávísun lyfsins er háð sérstökum takmörkunum (sjá viðauka I:
English: • One mL Iblias 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Iblias 2000 a.e. inniheldur u.þ.b. 400 a.e. (2.000 a.e. / 5 ml) af raðbrigða mannastorkuþætti VIII (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: België/Belgique/Belgien CSL Behring N.V.
Icelandic: België/Belgique/Belgien
English: Success rate*
Icelandic: tímabundinn roði)
English: 1 vial: 3000 IU octocog alfa (600 IU/mL after reconstitution).
Icelandic: 3000 a.e. októkóg alfa (600 a.e./ml eftir blöndun).
English: 31 IU/kg 49 IU/kg)
Icelandic: 31 a.e./kg 49 a.e./kg
English: Single dose administration only.
Icelandic: Aðeins einskammta gjöf.
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code: B02BD02
Icelandic: Blæðingalyf: storkuþáttur VIII, ATC-flokkur:
English: CSL Behring S.A. Tél: +33-(0)1-53585400
Icelandic: Tél: +33-(0)1-53585400
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Icelandic: Lyf sem notuð eru í æð skal skoða fyrir lyfjagjöf með tilliti til agna og mislitunar.
English: Inject air into the product vial.
Icelandic: Dælið lofti í hettuglasið með lyfinu.
English: 31 IU/kg 43 IU/kg)
Icelandic: 31 a.e./kg (21-43 a.e ./kg)
English: 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Icelandic: 1000 a.e. (októkóg alfa) (400 a.e./ml eftir blöndun).
English: Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection
Icelandic: Iblias 250 a.e. stungulyfsstofn og leysir, lausn Iblias 500 a.e. stungulyfsstofn og leysir, lausn Iblias 1000 a.e. stungulyfsstofn og leysir, lausn Iblias 2000 a.e. stungulyfsstofn og leysir, lausn Iblias 3000 a.e. stungulyfsstofn og leysir, lausn
English: Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
Icelandic: Opnið Mix2Vial pakkninguna með því að fletta burtu lokinu.
English: 1 vial: 500 IU octocog alfa (200 IU/mL after reconstitution).
Icelandic: 500 a.e. októkóg alfa (200 a.e./ml eftir blöndun).
English: Dose/injection for bleed treatment Median (min; max)
Icelandic: Skammtur/inndæl ing til meðferðar á blæðingu
English: Sodium content
Icelandic: VIRK EFNI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: 32 IU/kg 58 IU/kg)
Icelandic: 32 a.e./kg (21-58 a.e./kg)
English: Palpitation, sinus tachycardia common
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Icelandic: Iblias 250 a.e. stungulyfsstofn og leysir, lausn Iblias 500 a.e. stungulyfsstofn og leysir, lausn Iblias 1000 a.e. stungulyfsstofn og leysir, lausn Iblias 2000 a.e. stungulyfsstofn og leysir, lausn Iblias 3000 a.e. stungulyfsstofn og leysir, lausn Raðbrigða mannastorkuþáttur VIII (októkóg alfa)
English: 30 IU/kg 34 IU/kg)
Icelandic: 30 a.e./kg (21-34 a.e ./kg)
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Icelandic: Hvolfið hettuglasinu með leysinum með Mix2Vial settinu áföstu og ýtið oddi glæra millistykkisins beint niður í gegnum tappann á hettuglasinu með lyfinu.
English: Skin and subcutaneous tissue disorders Pruritus, rash***, dermatitis allergic common
Icelandic: Kláði, útbrot***, ofnæmishúðbólga
English: Iblias 250 IU powder for solution for injection Iblias 500 IU powder for solution for injection Iblias 1000 IU powder for solution for injection Iblias 2000 IU powder for solution for injection Iblias 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Icelandic: Iblias 250 a.e. stungulyfsstofn, lausn Iblias 500 a.e. stungulyfsstofn, lausn Iblias 1000 a.e. stungulyfsstofn, lausn Iblias 2000 a.e. stungulyfsstofn, lausn Iblias 3000 a.e. stungulyfsstofn, lausn raðbrigða manna storkuþáttur VIII (októkóg alfa)
English: 4.9 Overdose No symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Icelandic: Ekki hefur verið greint frá neinum einkennum ofskömmtunar raðbrigða mannastorkuþáttar VIII.
English: CSL Behring AB Tel: +46-(0)8-54496670
Icelandic: Tel: +46-(0)8-54496670
English: What you need to know before you use Iblias
Icelandic: Áður en byrjað er að nota Iblias
English: 1 vial: 1000 IU octocog alfa (400 IU/mL after reconstitution).
Icelandic: 1000 a.e. októkóg alfa (400 a.e./ml eftir blöndun).
English: Cardiac disorders
Icelandic: • hraður hjartsláttur
English: You are filtering by using the Mix2Vial adapter.
Icelandic: Þú síar lausnina með því að nota millistykkið fyrir hettuglasið.
English: Headache, dizziness common
Icelandic: kviðverkir eða óþægindi
English: Puncture the vein and secure the venipuncture set with a plaster.
Icelandic: 15. Stingið á bláæðina og festið bláæðarástungusettið með plástri.
English: Inhibitors are less likely to occur in previously-treated patients (PTPs).
Icelandic: Sjaldgæfar (sjúklingar sem hafa fengið meðferð áður)*
English: 37 IU/kg 42 IU/kg)
Icelandic: 37 a.e./kg (30-42 a.e
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/499/002 Valdoxan
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti
English: This treatment cycle will normally be repeated every three weeks.
Icelandic: Þessi meðferðarlota er venjulega endurtekin á þriggja vikna fresti.
English: This leaflet was last revised in MM/YYYY.
Icelandic: Þessi fylgiseðill var síðast uppfærður í MM/ÁÁÁÁ
English: If you experience this, do not drive or use machines.
Icelandic: Ef þú finnur fyrir þreytu eða slappleika skaltu ekki aka eða nota vélar.
English: Not all pack sizes may be marketed.
Icelandic: Ekki eru allar pakkningastærðir markaðssettar.
English: They may require hospitalisation and could even be life threatening.
Icelandic: Þær gætu krafist innlagnar á sjúkrahús og jafnvel verið lífshættulegar.
English: A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into your arm over about 30 minutes.
Icelandic: Læknir eða hjúkrunarfræðingur mun gefa þér þynnta Topotecan Teva lausn með innrennsli (dreypi), venjulega í handlegg á um 30 mínútum.
English: Topotecan must be further diluted before use (see section 6.6).
Icelandic: Tópótecan þarf að þynna frekar áður en það er notað (sjá kafla 6.6).
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Icelandic: Rauð blóðkorn voru gefin 52 % sjúklinga (21 % meðferða).
English: The experience in children is limited and treatment is therefore not recommended.
Icelandic: Reynsla hjá börnum er takmörkuð og því er ekki mælt með meðferð þeirra með lyfinu.
English: Not known (frequency cannot be estimated from the available data)
Icelandic: Aukaverkanir þar sem tíðni er ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: Teva Nederland B.V.
Icelandic: Teva Nederland B.V. Tel:
English: Very common Anorexia (which may be severe)
Icelandic: Lystarleysi (sem getur verið alvarlegt)
English: Österreich ratiopharm Arzneimittel Vertriebs GmbH
Icelandic: Österreich ratiopharm Arzneimittel Vertriebs GmbH Tel:
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Icelandic: Miðgildi lifunar í hópunum tveimur var annars vegar 25,0 vikur og hins vegar 24,7 vikur.
English: Tartaric acid (E334)
Icelandic: Vínsýra (E334)
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Icelandic: Dreifingarrúmmál minnkaði lítillega og helmingunartími lengdist þannig aðeins um 14 %.
English: Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Icelandic: Tópótecan hafði líka stórt dreifirúmmál eða um 132 l (SD 57) og tiltölulega stuttan helmingunartíma eða 2-3 klukkustundir.
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Icelandic: þessum rannsóknum var enginn sýnilegur munur á lyfjahvörfum tópótecans hjá börnum, unglingum og ungum fullorðnum sjúklingum með æxli eða hvítblæði, en upplýsingarnar eru of takmarkaðar til þess að hægt sé að draga afdráttarlausar ályktanir.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
Icelandic: 21. september 2009 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: NL-2031 GA Haarlem The Netherlands
Icelandic: NL-2031 GA Haarlem Hollandi
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á umbúðum og hettuglasi á eftir EXP.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Icelandic: Hjá sjúklingum sem fengu fleiri en 6 meðferðarlotur lauk 91 % rannsókninni eins og gert hafði verið ráð fyrir eða fékk meðferð þar til sjúkdómurinn ágerðist.
English: Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
Icelandic: Karlmenn sem vilja geta barn skulu leita ráða hjá lækninum varðandi barneignir eða meðferð.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Icelandic: Þú verður að láta lækninn vita án tafar ef þú finnur fyrir einhverjum af eftirfarandi alvarlegu aukaverkunum.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Icelandic: Auk þess fengu 5 % allra meðhöndlaðra sjúklinga (1 % meðferða) blóðsýkingu (sjá kafla 4.4).
English: България Тева Фармасютикълс България ЕООД
Icelandic: Тева Фармасютикълс България ЕООД Teл:
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Icelandic: Af öllum sjúklingunum sem fengu meðferð við klínískar rannsóknir (bæði þeim sem fengu alvarlega daufkyrningafæð og hinum sem fengu hana ekki), fengu 11 % (4 % meðferða) hita og 26 % (9 % meðferða) fengu sýkingu.
English: Detailed information on this medicine is available on the website of the European Medicines Agency
Icelandic: Ítarlegar upplýsingar um þetta lyf eru birtar á heimasíðu
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Icelandic: - Alvarlegt ofnæmi fyrir virka efninu eða einhverju hjálparefnanna sem talin eru upp í kafla 6.1.
English: Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Icelandic: Ekki skal nota Topotecan Teva ef agnir eru sjáanlegar eða lausnin er gruggug.
English: The concentrate must be diluted before administration.
Icelandic: Þykknið verður að þynna áður en það er gefið.
English: uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Icelandic: < 1/100), mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000), koma örsjaldan fyrir (< 1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Icelandic: 51 % var skilið út sem heildar tópótecan og 3 % voru skilin út sem N-desmetýltópótecan í þvagi.
English: Topotecan Teva should not be used in pregnant women, unless clearly necessary.
Icelandic: Þungaðar konur eiga ekki að nota Topotecan Teva nema það sé bráðnauðsynlegt.
English: Tell a doctor if any of these becomes troublesome.
Icelandic: Láttu lækninn vita ef einhverjar þessara aukaverkana valda óþægindum.
English: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Icelandic: Miðlungs eða alvarlegt (Hb ≤ 8,0 g/dl) hjá 37 % sjúklinga (14 % meðferða).
English: Response rate (%)
Icelandic: Tíðni svörunar ( %)
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Icelandic: Á meðal æxlistegunda voru Ewing sarkmein (Ewing's sarcoma/primitive neuroectodermal tumour), taugakímfrumuæxli (neuroblastoma), beinkímfrumuæxli (osteoblastoma), og rákvöðvasarkmein (rhabdomyosarcoma).
English: What Topotecan Teva is and what it is used for What you need to know before you use Toptecan Teva How to use Topotecan Teva Possible side effects
Icelandic: Upplýsingar um Topotecan Teva og við hverju það er notað Áður en byrjað er að nota Topotecan Teva Hvernig nota á Topotecan Teva Hugsanlegar aukaverkanir
English: CI = confidence interval.
Icelandic: CI = Öryggismörk.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Icelandic: Æxlishemjandi lyf, önnur æxlishemjandi lyf, ATC-flokkur: L01XX17.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Icelandic: Svörun í öllu ferlinu fyrir krabbamein í eggjastokkum (n=392, allar höfðu áður verið meðhöndlaðar með cisplatíni eða cisplatíni og paclitaxel) var 16 %.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Icelandic: Ítarlegar upplýsingar um lyfið eru birtar á heimasíðu Lyfjastofnunar Evrópu http://www.ema.europa.eu/.
English: Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Icelandic: Helmingunartími tópótecans lengdist um 30 % en engin greinileg breyting varð á dreifingarrúmmáli.
English: Topotecan Teva can make you feel tired or weak.
Icelandic: Topotecan Teva getur valdið þreytu eða slappleika.
English: Median time to progression (weeks)
Icelandic: Tími fram að versnun, miðgildi (vikur)
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Icelandic: Forklínískar rannsóknir benda til lítillar próteinbindingar tópótecans í plasma (35 %) og dreifing á milli blóðfrumna og plasma var nokkuð einsleit.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7% (range 4-9%) of the total topotecan related material accounted for in the urine and faeces.
Icelandic: Í heildina var N-desmetýl umbrotsefnið að meðaltali innan við 7 % (á bilinu 4-9 %) af öllu tópótecan-tengdu efni sem greindist í þvagi og hægðum.
English: Combination therapy (cervical carcinoma)
Icelandic: Samsett meðferð (krabbamein í leghálsi)
English: Staff should be trained to dilute the medicinal product.
Icelandic: Starfsfólk skal þjálfað í að þynna lyfið.
English: In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
Icelandic: Í klínískum rannsóknum var hætt að gefa tópótecan ef skammturinn hafði verið minnkaður niður í 1,0 mg/m2/dag og nauðsynlegt var að minnka hann enn frekar til að draga úr aukaverkunum.
English: You must not breast-feed while on treatment with Topotecan Teva.
Icelandic: Ekki vera með barn á brjósti ef þú ert í meðferð með Topotecan Teva.