FrancophonIA/ELRC3.0 huggingface dataset:
English: • Epileptic seizures
Icelandic: 15. NOTKUNARLEIÐBEININGAR
English: Pulmonary arterial hypertension
Icelandic: Áhrif lyfjaflokks
English: Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Icelandic: 24% sjúklinga varanlegt mótefni gegn interferoni beta-1a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 4 OR 12 CARTRIDGES
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 4 OG 12 RÖRLYKJUM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/017
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/017
English: Pulmonary arterial hypertension has been seen at various time points during treatment,
Icelandic: Lungnaháþrýstingur hefur sést á ýmsum tímum meðan á meðferð stendur, þ.m.t. nokkrum árum eftir að meðferð með
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/011
English: Composition: Each Rebif 8.8 micrograms pre-filled pen contains 8.8 micrograms (2.4 Million IU) of interferon beta-1a in 0.2 mL solution.
Icelandic: Hver Rebif 8,8 míkrógramma áfylltur lyfjapenni inniheldur 8,8 míkrógrömm (2,4 milljón a.e.) af interferoni beta-1a í 0,2 ml lausn.
English: • Suicide attempt
Icelandic: Sjálfsvígstilraunir
English: Composition: Each pre-filled pen contains 44 micrograms (12 MIU) of interferon beta-1a in 0.5 mL solution.
Icelandic: Hver áfylltur lyfjapenni inniheldur 44 míkrógrömm (12 milljón a.e.) af interferoni beta-1a í 0,5 ml lausn.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 2 CARTRIDGES
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 2 RÖRLYKJUM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/014
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/014
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Icelandic: Greint var frá þessum tilvikum á ýmsum tímum þ.m.t. allt að nokkrum árum eftir að meðferð með interferón beta hófst.
English: Rebif 22 micrograms is a solution for injection in a pre-filled pen for self-administration.
Icelandic: Rebif 22míkrógrömm fæst sem stungulyf, lausn í áfylltum lyfjapenna, til inndælingar af sjúklingum.
English: What you need to know before you use Rebif
Icelandic: Áður en byrjað er að nota Rebif
English: Drug-induced lupus erythematosus* Renal and urinary disorders Rare:
Icelandic: VIRK(T) EFNI Innihald:
English: Store the cartridge in the original package in order to protect from light.
Icelandic: Geymið rörlykjuna í upprunalegum umbúðum til varnar gegn ljósi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/010
English: • a dry cotton ball or gauze
Icelandic: Þurran bómullarhnoðra eða grisju.
English: Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a Initiation pack
Icelandic: Rebif 8,8 míkrógrömm stungulyf, lausn í áfylltri sprautu Rebif 22 míkrógrömm stungulyf, lausn í áfylltri sprautu interferon beta-1a
English: Reporting of side effects
Icelandic: Frávik á niðurstöðum rannsókna
English: Rebif 8.8 micrograms solution for injection in pre-filled pen interferon beta-1a
Icelandic: Rebif 8,8 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna interferon beta-1a
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms solution for injection in pre-filled syringe
Icelandic: HEITI LYFS Rebif 22 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna
English: Pruritus, rash, erythematous rash, maculo-papular rash, alopecia*
Icelandic: Kláði, útbrot, roðalík útbrot, dröfnuörðu-útbrot, skalli*
English: Before the injection
Icelandic: Fyrir inndælingu
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Icelandic: Rebif 22 míkrógrömm/0,5 ml stungulyf, lausn í rörlykju interferon beta-1a
English: Rebif 44 micrograms solution for injection in pre-filled syringe interferon beta-1a
Icelandic: Rebif 44 μg stungulyf, lausn interferon beta-1a
English: • Diarrhoea, nausea, vomiting
Icelandic: Niðurgangur, ógleði, uppköst
English: NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a
Icelandic: Rebif 8,8 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna Rebif 22 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna interferon beta-1a
English: NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe
Icelandic: Rebif 8,8 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna Rebif 22 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna
English: Anaphylactic reactions*
Icelandic: Bráðaofnæmisviðbrögð*
English: Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Icelandic: Ekki hefur verið sýnt fram á verkun á sjúklinga með síversnandi form MS án kasta.
English: Other forms of multiple sclerosis
Icelandic: Síðkomið síversnandi form MS
English: G. Safety guard H. Needle
Icelandic: D. Merking E. Aðal hluti F. Hnappur G. Öryggishlíf H. Nál
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Icelandic: Rebif 44 míkrógrömm/0,5 ml stungulyf, lausn í rörlykju interferon beta-1a
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU) of interferon beta-1a.
Icelandic: Hver áfyllt sprauta (0,5 ml) inniheldur 44 míkrógrömm (12 milljón a.e.) af interferoni beta-1a.
English: If you feel depressed or develop thoughts of suicide, report it immediately to your doctor.
Icelandic: Greindu lækninum tafarlaust frá því ef þú verður þunglynd/ur eða hugsar um sjálfsvíg.
English: • Alcohol wipes or similar.
Icelandic: Þurrkur vættar spritti eða eitthvað sambærilegt.
English: INFORMATION IN BRAILLE rebif 8.8 rebif 22
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI rebif 8,8 rebif
English: Elimination
Icelandic: ● Fjarlægðu
English: Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a
Icelandic: Rebif 22 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna interferon beta-1a
English: Psychiatric disorders Common:
Icelandic: Stoðkerfi og stoðvefur Algengar:
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms solution for injection in pre-filled syringe interferon beta-1a
Icelandic: Rebif 44 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna interferon beta-1a
English: including several years after starting treatment with Rebif.
Icelandic: Lungnaháþrýstingur hefur sést á ýmsum tímum meðan á meðferð stendur, þ.m.t. nokkrum árum eftir að meðferð með Rebif hefst.
English: For multidose use.
Icelandic: RebiDose af stungustaðnum.
English: • When you do this please read carefully and follow the “RebiDose Instructions for Use” provided separately in the booklet.
Icelandic: Þegar það er gert, vinsamlegast lestu vandlega og fylgdu
English: Composition: Each pre-filled pen contains 22 micrograms (6 MIU) of interferon beta-1a in 0.5 mL solution.
Icelandic: Hver áfylltur lyfjapenni inniheldur 22 míkrógrömm (6 milljón a.e.) af interferoni beta-1a í 0,5 ml lausn.
English: You should tell your doctor:
Icelandic: Þú skalt láta lækninn vita:
English: 9 to < 16 16 to 23 > 23 to 34
Icelandic: 9 til < 16 16 til 23 > 23 til 34 Fylgt eftir með:
English: These measures will help protect environment.
Icelandic: Markmiðið er að vernda umhverfið.
English: Component of a multipack, cannot be sold separately.
Icelandic: Hluti fjölpakkningar, má ekki selja sér.
English: In adults:
Icelandic: Fullorðnir:
English: The following information is intended for medical or healthcare professionals only
Icelandic: Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsfólki:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/254/002
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Icelandic: Ef þér er umhugað um að eignast barn skaltu ræða það við lækninn fyrir meðferð.
English: However, caution is recommended (see sections 4.8 and 5.2).
Icelandic: Hins vegar er ráðlagt að gæta varúðar (sjá kafla 4.8 og 5.2).
English: • The diluted solution must be mixed thoroughly by inverting several times.
Icelandic: Nauðsynlegt er að blanda lausnina vandlega með því að snúa nokkrum sinnum.
English: The patients received the dosing mentioned in section 4.2.
Icelandic: Sjúklingarnir fengu þá skammta sem gefnir eru upp í kafla 4.2.
English: During the same period there was no death in autologous recipients.
Icelandic: Á sama tímabili urðu engin dauðsföll hjá þeim sem fengu samgena ígræðslu.
English: The safety and efficacy of FB in pediatric population has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun FB hjá börnum.
English: VOD observed were neither fatal nor severe and resolved in all cases.
Icelandic: Bláæðateppusjúkdómurinn var hvorki banvænn né alvarlegur og hjaðnaði í öllum tilvikum.
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Icelandic: Endurvirkjun á CMV Endurvirkjun á EBV Bakteríusýking
English: By example:
Icelandic: Dæmi:
English: Incomplete development of teeth.
Icelandic: Tennur þroskast ekki fullkomlega.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
Icelandic: NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA Pierre Fabre Médicament
English: The long-term outcomes confirmed that the efficacy was maintained without unexpected effects.
Icelandic: Langtímaniðurstöður staðfestu að áhrifin héldust án óvæntra aukaverkana.
English: Vials: 3 years
Icelandic: Hettuglös:3 ár.
English: In new-born infants, children and adolescents (0 to 17 years):
Icelandic: Nýburar, börn og unglingar (0-17 ára):
English: Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
Icelandic: Tilkynnt var um hraða og fullkomna ígræðslutíðni hjá 80-100% sjúklinga í meirihluta rannsóknanna.
English: In both studies, all patients received a 16/16 dose regimen of Busilvex.
Icelandic: Í báðum rannsóknunum fengu sjúklingarnir 16/16 skammta meðferð með Busilvexi.
English: All children engrafted.
Icelandic: Ígræðsla tókst hjá öllum börnunum.
English: Other infections were considered severe in 3% of patients.
Icelandic: Aðrar sýkingar voru taldar alvarlegar hjá 3% sjúklinga.
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Icelandic: 39% sjúklinga (40/103) fengu eitt eða fleiri tilvik sýkinga, þar af voru 83% (33/40) flokkuð sem væg eða í meðallagi alvarleg.
English: DMA is teratogenic in rats.
Icelandic: DMA er krabbameinsvaldandi hjá rottum.
English: Same dose (see section 5.2) for elderly patients as for adults (< 50 years old) should be used.
Icelandic: Nota á sömu skammta (sjá kafla 5.2) handa öldruðum og fyrir fullorðna (< 50 ára).
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Icelandic: DMA dregur úr frjósemi hjá og kven- og karlnagdýrum (sjá kafla 4.6 og 5.3).
English: This signal was open based on an isolated case from the literature and no additional cases have been reported.
Icelandic: Hættumerkið var opnað eftir einstakt tilvik úr heimildum og ekki hefur verið tilkynnt um önnur tilvik.
English: Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
Icelandic: 09. júlí 2003 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Icelandic: Busilvex er notað handa fullorðnum, nýburum, börnum og unglingum sem meðferð fyrir ígræðslu.
English: At the recommended dose, this is the desired effect.
Icelandic: Við ráðlagða skammta eru þetta þau áhrif sem óskað er eftir.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Icelandic: Helmingunartími útskilnaðar var á frá 2,8 til 3,9 klst.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Icelandic: Látið lækninn vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð, einnig þau sem fengin eru án lyfseðils.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Icelandic: Tíðniflokkar eru skilgreindir sem eftirfarandi: mjög algengar (≥ 1/10), algengar (≥ 1/100, < 1/10), sjaldgæfar (≥ 1/1.000, < 1/100) eða tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Multipack containing 8 (2 packs of 4) vials.
Icelandic: Fjölpakkning sem inniheldur 8 (2 pakkningar með 4) hettuglös.
English: The other ingredients are dimethylacetamide and macrogol 400.
Icelandic: - Önnur innihaldsefni eru dímetýlacetamíð og macrógól 400.
English: IBW women (kg) = 45 + 0.91x (height in cm-152).
Icelandic: Kjörþyngd konur (kg) = 45 + 0,91 x (hæð í cm-152).
English: However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Icelandic: Hins vegar var greint frá fleiri en 500 sjúklingum ≥ 55 ára, í birtu efni um FB-undirbúningsmeðferðir, sem gáfu svipaðar niðurstöður og hjá yngri sjúklingum hvað varðar verkun.
English: VOD was reported with a range between 3.9% and 15.4%.
Icelandic: Tilkynnt var um bláæðateppusjúkdóm (VOD) með tíðni á bilinu 3,9-15,4%.
English: The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Icelandic: Uppsöfnuð tíðni fyrir endurheimtan eðlilegan hlutleysiskyrningafjölda á degi 28 var 98,8% (95% öryggisbil, 85,7-99,9%).
English: The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Icelandic: Tíðnin fyrir tveggja ára heildarlifun var 61,9% (95% öryggisbil, 51,1-72,7%)].
English: No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Icelandic: Enginn sjúklingur þurfti að hætta meðferð vegna aukaverkana tengdum Busilvexi.
English: Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Icelandic: Hækkuð gildi bilirúbíns (n=3) og hækkuð gildi AST (n=1) sáust einnig.
English: The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Icelandic: Hæsta tíðni ógleði og uppkasta var 59,1% og hæsta tíðni munnbólgu var 11%.
English: Respiratory: decrease in blood oxygen.
Icelandic: Öndunarfæri: minnkað súrefni í blóði.
English: It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Icelandic: Hugsanlegt er að notkun Busilvex geti aukið hættu á öðrum illkynja sjúkdómum síðar.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/(m²) > 30 kg/m² until further data become available.
Icelandic: Ekki er mælt með lyfinu fyrir of feit börn og unglinga með líkamsþyngdarstuðul (body mass index, (BMI)) þyngd (kg)/(m2) > 30 kg/m2 uns meiri upplýsingar verða fáanlegar.
English: Therefore careful monitoring will be performed.
Icelandic: Þess vegna verður sjúklingurinn undir nákvæmu eftirliti.
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Icelandic: Heildarúthreinsun í plasma var á bilinu 2,25-2,74 ml/mínútu/kg.
English: The pharmacokinetics of Busilvex has been investigated.
Icelandic: Lyfjahvörf Busilvex hafa verið rannsökuð.
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum) Truflun á starfsemi kynkirtla.
English: What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Icelandic: Upplýsingar um Busilvex og við hverju það er notað Áður en byrjað er að nota Busilvex Hvernig nota á Busilvex
English: 15% of SAEs involved liver toxicity.
Icelandic: 15% af alvarlegum aukaverkunum tengdust eituráhrifum á lifur.
English: F-92654 Boulogne Billancourt cedex
Icelandic: F-92654 Boulogne Billancourt cedex Frakkland
English: In children < 9 kg, a therapeutic drug monitoring may be justified on a case by case basis, in particular in extremely young children and neonates (see section 5.2).
Icelandic: Hjá börnum < 9 kg, getur verið þörf á að hafa eftirlit með þéttni í blóði hjá einstökum sjúklingum, sérstaklega hjá mjög ungum börnum og nýburum (sjá kafla 5.2).
English: Busilvex is available in multipacks comprising 2 packs, each containing 4 vials.
Icelandic: Busilvex er fáanlegt í fjölpakkningu sem inniheldur 2 pakkningar og hvor pakkning inniheldur 4 hettuglös.
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Icelandic: Heildarskammturinn af búsúlfani fyrir hvern sjúkling var á bilinu 6,4 mg/kg til 9,6 mg/kg.
English: Paediatric population (0 to 17 years)
Icelandic: Börn (0-17 ára)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Icelandic: Ef það er ekki notað strax er geymslutíminn og geymsluskilyrði á ábyrgð notanda og ætti ekki að vera lengri en nefnt er hér að ofan þegar þynning hefur átt sér stað samkvæmt gildandi reglum um smitgát.
English: Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Icelandic: Sjúklingar eldri en 50 ára (n=23) hafa með góðum árangri verið meðhöndlaðir með Busilvexi án þess að skömmtum hafi verið breytt.
English: In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Icelandic: Skammturinn 450 mg/kg af DMA á dag sem gefinn var rottum í 9 daga leiddi til óvirkrar sæðismyndunar.
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Icelandic: Í meirihluta birts efnis var greint frá algjörum kímruna gjafa (complete donor chimerism) á degi +30 hjá 90-100% sjúklinga.
English: Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
Icelandic: Eingöngu var greint frá langvinnri hýsilssótt (c-GVHD), ef hún var banvæn; einn sjúklingur dó 13 mánuðum eftir ígræðslu.
English: Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Icelandic: Búsúlfan olli litningafrávikum in vitro (nagdýr og frumur úr mönnum) og in vivo (nagdýr og menn).
English: It must be considered that overdose of Busilvex will also increase exposure to DMA.
Icelandic: Hafa verður hugfast að ofskömmtun Busilvex eykur einnig útsetningu fyrir DMA.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á miðanum á hettuglasinu og á öskjunni á eftir EXP.
English: What Busilvex is and what it is used for
Icelandic: Upplýsingar um Busilvex og við hverju það er notað
English: There was no regimen-related death through the first 100-day post-transplant and up to one year post-transplant.
Icelandic: Engin dauðsföll tengdust meðferðinni fyrstu 100 dagana eftir ígræðslu og í allt að ár eftir ígræðslu.
English: The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Icelandic: Ígræðsla heppnaðist vel í öllum sjúklingum í II. fasa tilraunum og benda til þess að rétt hafi verið staðið að vali á AUC.
English: 93% of allogeneic patients showed complete chimerism.
Icelandic: Hjá 93% sjúklinga sem fengu ósamgena ígræðslu var um algjöran kímruna (chimerism) að ræða.
English: Concentrate 4 vials of 10ml.
Icelandic: Þykkni Fjögur 10 ml hettuglös.
English: The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Icelandic: Kaplan-Meier-mat á lifun án sjúkdóms eftir 2 ár var 49,9% (95% öryggisbil, 32,6-72,7).
English: No evidence of an induction effect of phenytoin has been seen on Busilvex data.
Icelandic: Engar vísbendingar eru um hvötunaráhrif fenýtóíns í gögnum um Busilvex.
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Icelandic: Niðurstöðum vegna tíðni bráðrar hýsilssóttar (a-GVHD) var safnað saman í OMC-BUS-4 rannsókn (ósamgena) (n=61).
English: The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Icelandic: Aðalbreyturnar hvað varðar verkun í þessum rannsóknum voru mergeyðing, ígræðsla, versnun og lifun.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 60 mg/10 ml
English: Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Icelandic: Lokadreifingarrúmmál Vz var á bilinu 0,62 og 0,85 l/kg.
English: Therefore Busilvex should be used with caution in this type of patients.
Icelandic: Þess vegna ætti að fara varlega í að ávísa Busilvex handa þannig sjúklingum.
English: For a microbiological point of view, the diluted solution should be used immediately.
Icelandic: Út frá örverufræðilegu sjónarmiði á að nota þynntu lausnina strax.
English: There are no or limited amount of data from the use of busulfan or DMA in pregnant women.
Icelandic: Engar eða takmarkaðar upplýsingar liggja fyrir um notkun á búsúlfani og DMA hjá konum á meðgöngu.
English: The treatment-related mortality/non-relapse mortality (TRM/NRM) reported until day+100 posttransplant has also been examined through a review of published data from clinical trials.
Icelandic: Dauðsföll tengd ígræðslu/dauðsföll án bakslags (TRM/NRM), sem tilkynnt var um fram að degi +100 eftir ígræðslu, hafa einnig verið skoðuð með endurmati á birtum gögnum úr klínískum rannsóknum.
English: Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Icelandic: Upplýsingar um aukaverkanir eru fengnar úr tveimur klínískum rannsóknum (n=103) með Busilvexi.
English: 5 How to store Busilvex Contents of the pack and other information
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á Busilvex Pakkningar og aðrar upplýsingar
English: However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Icelandic: Engu að síður á að fylgjast reglulega með hjartastarfsemi hjá sjúklingum sem fá Busilvex (sjá kafla 4.8).
English: Muscle and bone: back, muscle and joint pain.
Icelandic: Vöðvar og bein: verkir í baki, vöðvum og liðum.
English: Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Icelandic: Busilvex er tær og litlaus lausn í 10 ml litlausum hettuglösum úr gleri (tegund I).
English: However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Icelandic: Samt sem áður eru aðeins takmarkaðar upplýsingar varðandi örugga notkun Busilvex hjá sjúklingum eldri en 60 ára fyrir hendi.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Icelandic: Greint var frá þriðja stigs hækkun á transamínösum hjá 24% sjúklinga.
English: 4.7 Effects on ability to drive and use machines
Icelandic: 4.7. Áhrif á hæfni til aksturs og notkunar vela
English: Busilvex must always be added to the diluent, not the diluent to Busilvex.
Icelandic: Busilvex verður ávallt að blanda út í þynningarlausnina en ekki þynningarlausninni út í Busilvex.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Icelandic: Sjúklingar sem áður hafa gengist undir geislameðferð, sem jafngildir þremur lotum eða meira í krabbameinslyfjameðferð eða sjúklingar sem hafa áður gengist undir stofnfrumnaígræðslu geta verið í aukinni hættu (sjá kafla 4.8).