FrancophonIA/ELRC3.0 huggingface dataset:
English: vial and pre-filled syringe.
Icelandic: Hettuglas og sprauta undirbúin
English: • bleeding in muscle tissue
Icelandic: • blæðing í vöðvavef
English: No other factors were significantly associated with inhibitor development.
Icelandic: Engir aðrir þættir tengdust mótefnamyndun marktækt.
English: The analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.
Icelandic: Greining plasmasýna var gerð með einsþrepsstorkuprófi og litrófsgreiningu.
English: Hypertension, lymphoedema, hyperaemia
Icelandic: Höfuðverkur, sundl, sviðatilfinning
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Icelandic: Myndun hlutleysandi mótefna (hemla) getur átt sér stað hjá sjúklingum með dreyrasýki A sem fá meðhöndlun með þætti VIII, þ.m.t. NovoEight.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Icelandic: Klínískt gildi mótefnamyndunar verður háð títra mótefnisins, ef mótefnin eru í lágum títra er minni hætta á ófullnægjandi klínískri svörun en þegar mótefnin eru í háum títra.
English: Disposal
Icelandic: útbrot
English: Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Icelandic: Tafla 6 Lyfjahvarfaþættir fyrir staka skammta af NovoEight (50 a.e./kg) eftir BMI flokkumaEinsþreps storkupróf - Meðaltal (SD)
English: Degree of haemorrhage/Type of surgical procedure
Icelandic: Alvarleiki blæðingar/Tegund skurðaðgerðar
English: NovoEight 3000 IU EU/1/13/888/006
Icelandic: NovoEight 3000 a.e. EU/1/13/888/006
English: See section 4.
Icelandic: Tafla 7
English: Very commonb
Icelandic: Mjög algengar**b
English: Adolescents <18 years) PTP
Icelandic: Unglingar (12 - < 18 ára) PTP
English: administration of 50 IU/kg
Icelandic: BMI ≥35 kg/m2.
English: Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Icelandic: Tafla 4 Lyfjahvarfaþættir fyrir staka skammta af NovoEight (50 a.e./kg) eftir aldrieinsþrepsstorkupróf - Meðaltal (SD)
English: <12 years) PTP
Icelandic: Eldri börn (6 - < 12 ára) PTP
English: NovoEight 1500 IU EU/1/13/888/004
Icelandic: NovoEight 1500 a.e. EU/1/13/888/004
English: tap the syringe gently to let any air bubbles rise to the top.
Icelandic: Með hettuglasið á hvolfi skaltu slá létt í sprautuna til að loftbólur, ef einhverjar eru, safnist fyrir efst.
English: In case of shock, standard medical treatment for shock should be implemented.
Icelandic: Ef lost kemur fram skal veita viðeigandi meðferð við losti.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Icelandic: Snemmkomin liðblæðing, blæðing í vöðva eða munnholi
English: NovoEight 500 IU EU/1/13/888/002
Icelandic: NovoEight 500 a.e. EU/1/13/888/002
English: SN: NN:
Icelandic: SN:
English: NovoEight 1500 IU powder and solvent for solution for injection.
Icelandic: NovoEight 1500 a.e. stungulyfsstofn og leysir, lausn.
English: Catheter-related complications
Icelandic: Vandamál tengd lyfi
English: NovoEight 1000 IU powder and solvent for solution for injection.
Icelandic: NovoEight 1000 a.e. stungulyfsstofn og leysir, lausn.
English: NovoEight 250 IU powder and solvent for solution for injection
Icelandic: NovoEight 250 a.e. stungulyfsstofn og leysir, lausn.
English: After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 62,5 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: Solvent:
Icelandic: Stofn:
English: NovoEight 1000 IU EU/1/13/888/003
Icelandic: NovoEight 1000 a.e. EU/1/13/888/003
English: Turn the syringe with the vial upside down.
Icelandic: Snúðu sprautunni með áföstu hettuglasinu á hvolf.
English: Haemostasis was successful in all surgeries and no treatment failures were reported.
Icelandic: Í öllum tilvikunum var blæðingastöðvun árangursrík og ekki var greint frá meðferðarbresti.
English: One ml of NovoEight contains approximately 62.5 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 62,5 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: Prophylaxis
Icelandic: Stimpill
English: Do not use solutions that are cloudy or have deposits.
Icelandic: Ekki á að nota lausnina ef hún er skýjuð eða inniheldur botnfall.
English: The reconstituted NovoEight must be injected into your vein (intravenous injection).
Icelandic: Sprauta þarf blönduðu NovoEight í bláæð (inndæling í æð).
English: NovoEight 2000 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 2000 a.e. stungulyfsstofn, lausn turoctocog alfa
English: It must be clear to slightly opalescent
Icelandic: Hún verður að vera tær til lítillega ópallýsandi (ekki alveg tær).
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Icelandic: 1 hettuglas með stungulyfsstofni, 4 ml af leysi í áfylltri sprautu, stimpilstöng og millistykki fyrir hettuglas
English: NovoEight 250 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 250 a.e. stungulyfsstofn, lausn turoctocog alfa
English: After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 375 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 2000 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 375 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: NovoEight 2000 IU powder and solvent for solution for injection.
Icelandic: NovoEight 2000 a.e. stungulyfsstofn og leysir, lausn.
English: Each powder vial contains nominally 3000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 3000 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
Icelandic: CL (ml/klst./kg) 3,91 (0,94) 3,20 (1,00) t½ (klst.)
English: NovoEight 1500 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 1500 a.e. stungulyfsstofn, lausn turoctocog alfa
English: NovoEight 1000 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 1000 a.e. stungulyfsstofn, lausn turoctocog alfa
English: NovoEight is a powder and solvent for solution for injection.
Icelandic: NovoEight er stungulyfsstofn og leysir, lausn.
English: One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 125 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: Remove the protective cap from the vial adapter.
Icelandic: Fjarlægðu hlífðarhettuna af millistykkinu.
English: Clinical efficacy
Icelandic: Fyrirbyggjandi meðferð
English: NovoEight 3000 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 3000 a.e. stungulyfsstofn, lausn turoctocog alfa
English: NovoEight 500 IU powder and solvent for solution for injection.
Icelandic: NovoEight 500 a.e. stungulyfsstofn og leysir, lausn.
English: After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 125 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 2000 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: The reconstituted solution will be clear to slightly opalescent.
Icelandic: Blandaða lausnin á að vera tær eða örlítið ópallýsandi.
English: NovoEight 3000 IU powder and solvent for solution for injection.
Icelandic: NovoEight 3000 a.e. stungulyfsstofn og leysir, lausn.
English: Each powder vial contains nominally 250 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 250 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: NovoEight 250 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 250 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 250 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: NovoEight 500 IU powder for solution for injection turoctocog alfa
Icelandic: NovoEight 500 a.e. stungulyfsstofn, lausn turoctocog alfa
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 750 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Icelandic: Lyfið inniheldur 30,5 mg af natríum í hverju blönduðu hettuglasi.
English: One ml of NovoEight contains approximately 500 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 500 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: System Organ Class Frequencya in PTPs
Icelandic: Tíðni*a hjá PTP Tíðni*a hjá PUP Aukaverkun
English: One ml of NovoEight contains approximately 750 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 750 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: After reconstitution NovoEight contains approximately 500 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Eftir blöndun inniheldur NovoEight um það bil 500 a.e./ml af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 1000 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: One ml of NovoEight contains approximately 250 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Icelandic: Einn ml af NovoEight inniheldur um það bil 250 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa eftir blöndun
English: NovoEight 1000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 1000 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: Each powder vial contains nominally 1500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 1500 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 3000 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 500 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Icelandic: Hvert hettuglas með stofni inniheldur 500 a.e. af manna storkuþætti VIII (rDNA), turoctocog alfa.
English: Taken out of refrigerator: _____________Stored at ≤30°C __ Stored at 30°C up to 40°C __
Icelandic: hærri hita en stofuhita (30°C til allt að 40°C) í eitt tímabil ekki lengur en í 3 mánuði Tekið úr kæli:_____________Geymt við ≤30°C __ Geymt við 30°C til allt að 40°C __ Geymið í upprunalegum umbúðum til varnar gegn ljósi
English: NovoEight 1500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Icelandic: NovoEight 1500 a.e. stungulyfsstofn og leysir, lausn turoctocog alfa (manna storkuþáttur VIII (rDNA))
English: t½ (h)
Icelandic: ****d
English: • pain in muscles
Icelandic: verkur í vöðvum
English: Contusion
Icelandic: Innihald
English: Vomiting
Icelandic: Blæðingar
English: Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Icelandic: Skrúfaðu áfylltu sprautuna fasta á millistykkið þar til þú finnur fyrir mótstöðu.
English: • joint disease
Icelandic: • hósti
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Icelandic: Tafla 5 Lyfjahvarfaþættir fyrir staka skammta af NovoEigh (50 a.e./kg) eftir aldrilitrófsgreining
English: Table 7 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaChromogenic assay - Mean (SD)
Icelandic: Lyfjahvarfaþættir fyrir staka skammta af NovoEight (50 a.e./kg) eftir BMI flokkumaLitrófsgreining
English: Repeat every 12 to 24 hours, at least 1 day, until the bleeding episode as indicated by pain is resolved or healing achieved
Icelandic: 1 sólarhring þar til verkir gefa til kynna að blæðing hefur minnkað eða bata er náð
English: Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Icelandic: Stífleiki í stoðkerfi, liðkvilli, verkur í útlimum, verkur í stoðkerfi
English: Heart rate increased
Icelandic: þyngsli fyrir brjósti
English: • bleeding into joint spaces
Icelandic: blæðing inn í liði
English: On-demand treatment
Icelandic: Meðferð eftir þörfum
English: b Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. c Injection site reactions include injection site erythema, injection site extravasation and injection site pruritus.
Icelandic: **b Tíðni er byggð á rannsóknum á öllum FVIII lyfjum þar sem sjúklingar með alvarlega dreyrasýki A tóku þátt.
English: Rash, rash erythematous
Icelandic: B. FYLGISEÐILL
English: Pyrexia, catheter site erythema
Icelandic: YTRI UMBÚÐUM Askja
English: • rash, hives, weals or generalised itching
Icelandic: • útbrot, ofsakláði, kláðablettir eða útbreiddur kláði
English: Study MO16419
Icelandic: Rannsókn MO16419
English: 88397 Biberach an der Riss Germany
Icelandic: 88397 Biberach an der Riss Þýskaland
English: * are summarized in Table 7.
Icelandic: *, eru dregnar saman í töflu 7.
English: Your doctor will discuss this with you.
Icelandic: Læknirinn mun ræða um það við sjúklinginn.
English: DO NOT SHAKE!
Icelandic: HRISTIÐ EKKI!
English: Trazimera can cause breathing difficulties, especially when it is first given.
Icelandic: Trazimera getur valdið öndunarörðugleikum, einkum þegar það er gefið í fyrsta skipti.
English: The effects may be moderate to severe and could cause death.
Icelandic: Áhrifin geta verið miðlungi alvarleg eða alvarleg og geta leitt til dauða.
English: • you have ever had any other treatment for cancer.
Icelandic: þú hefur áður fengið meðferð við krabbameini.
English: The powder is a white cake.
Icelandic: Duftið er frostþurrkuð, hvít kaka.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Icelandic: Ekki má blanda þessu lyfi saman við né þynna það með öðrum lyfjum en þeim sem nefnd eru í kafla 6.6.
English: Children and adolescents Trazimera is not recommended for anyone under the age of 18 years.
Icelandic: Notkun Trazimera er ekki ráðlögð hjá einstaklingum undir 18 ára aldri.
English: Not known: frequency cannot be estimated from the available data
Icelandic: Tíðni ekki þekkt: ekki er hægt að áætla tíðni út frá fyrirliggjandi gögnum
English: Talk to your doctor, pharmacist or nurse before you are given Trazimera if:
Icelandic: Talaðu við lækninn, lyfjafræðing eða hjúkrunarfræðing áður en þér er gefið Trazimera ef:
English: AUC0-21days (µg.day/mL)
Icelandic: AUC0-21dagar (µg.dag/ml)
English: What Trazimera is and what it is used for
Icelandic: Upplýsingar um Trazimera og við hverju það er notað
English: Either of which was administered with:
Icelandic: Með hvoru um sig var gefið:
English: For storage conditions of the reconstituted medicinal product, see sections 6.3 and 6.6.
Icelandic: Geymsluskilyrði fyrir blandað lyfið, sjá kafla 6.3 og 6.6.
English: 30-60 minutes repeated every 3 weeks for a total of six cycles
Icelandic: 30-60 mínútum, endurtekið á 3 vikna fresti, alls sex lotur
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Icelandic: Línuleg úthreinsun var 0,136 l/dag fyrir MBC, 0,112 l/dag fyrir EBC og 0,176 l/dag fyrir AGC.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Icelandic: Sum þessara einkenna geta verið alvarleg og það hefur komið fyrir að sjúklingar hafa látist (sjá kafla 2 undir ,,Varnaðarorð og varúðarreglur”).
English: Discard at the end of this 3-month period or by the expiry date on the vial, whichever occurs first.
Icelandic: Fargið í lok þessa 3 mánaða tímabils eða fyrir fyrningardagsetningu sem er á hettuglasinu, hvort sem fyrr verður.
English: In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), 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: Í þessum kafla eru notaðir eftirtaldir tíðniflokkar: mjög algengar ( 1/10), algengar ( 1/100 til < 1/10), sjaldgæfar ( 1/1.000 til < 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: Only patients with a large amount of HER2 will be treated with Trazimera.
Icelandic: Aðeins sjúklingar með mikið magn af HER2 eru meðhöndlaðir með Trazimera.
English: Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Icelandic: Því á ekki að meðhöndla þessa sjúklinga með trastuzúmabi (sjá kafla 4.3).
English: Trazimera may affect your ability to drive a car or operate machines.
Icelandic: Trazimera gæti haft áhrif á hæfni til aksturs eða stjórnunar véla.
English: White lyophilised powder or cake.
Icelandic: Hvítt frostþurrkað duft eða kaka.
English: Like all medicines, Trazimera can cause side effects, although not everybody gets them.
Icelandic: Eins og við á um öll lyf getur þetta lyf valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Trazimera treatment.
Icelandic: Komi fram einhver einkenni hjartabilunar (ófullnægjandi dæling hjartans á blóði), er hugsanlegt að hjartastarfsemin verði rannsökuð oftar (á sex til átta vikna fresti), hugsanlegt er að þú fáir meðferð við hjartabilun eða að stöðva þurfi Trazimera meðferðina.
English: Other side effects can occur at any time during treatment with Trazimera, not just related to an infusion.
Icelandic: Aðrar aukaverkanir geta komið fram hvenær sem er meðan á meðferð með Trazimera stendur, ekki einungis í tengslum við innrennsli.
English: If you experience any of the above symptoms when your treatment with Trazimera has finished, you should see your doctor and tell them that you have previously been treated with Trazimera.
Icelandic: Ef þú finnur fyrir einhverjum ofantalinna einkenna þegar meðferð með Trazimera er lokið skalt þú fara til læknis og upplýsa hann um að þú hafir áður fengið meðferð með Trazimera.
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Icelandic: TTP = tími að versnun; „ne“ þýðir að ekki var hægt að meta eða ekki var komið að því Rannsókn H0649g:
English: Pfizer Manufacturing Belgium NV Rijksweg 12
Icelandic: Belgium NV Rijksweg 12
English: Treatment with Trazimera alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Icelandic: Meðferð með Trazimera einu sér eða ásamt taxanlyfi getur haft áhrif á hjartað, einkum ef þú hefur einhvern tímann notað antracýklínlyf (taxanlyf og antracýklínlyf eru tveir aðrir flokkar krabbameinslyfja).
English: If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Icelandic: Ef þunguð kona er á trastuzúmabn meðferð eða ef kona verður þunguð meðan hún er á trastuzúmab meðferð eða innan 7 mánaða eftir að hún fær síðasta skammt af trastuzúmabi er æskilegt að hún sé undir nánu eftirliti þverfaglegs teymis.
English: After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C.
Icelandic: Eftir blöndum með sæfðu vatni fyrir stungulyf er blandaða lausnin eðlis- og efnafræðilega stöðug í 48 klukkustundir við 2-8°C.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Icelandic: D7D og klínísk áhrif aukningar á þessu niðurbrotsefni var óþekkt.
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Icelandic: Þegar greiningin var gerð höfðu dáið samtals 349 sjúklingar sem hafði verið slembiraðað; 182 sjúklingar (62,8%) í samanburðarhópi og 167 sjúklingar (56,8%) í meðferðarhópi.
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Icelandic: Niðurstöður varðandi virkni úr BCIRG 006 rannsókninni eru teknar saman í töflum 9 og 10.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Icelandic: Trastuzúmab gæti þó aukið heildarútsetningu fyrir einu niðurbrotsefni doxórúbicíns, (7-deoxý13 díhýdró- doxórúbicínóns, D7D).
English: Trazimera may have a minor influence on the ability to drive or use machines (see section 4.8).
Icelandic: Trazimera gæti haft lítil áhrif á hæfni til aksturs og notkunar véla (sjá kafla 4.8).
English: A careful risk-benefit assessment should be made before deciding to treat with Trazimera.
Icelandic: Gera skal áhættumat áður en ákveðið er að meðhöndla með Trazimera.
English: Cmin,ss = Cmin at steady state Cmax,ss = Cmax at steady state time to 90% of steady-state
Icelandic: Cmin,ss = Cmin við jafnvægi Cmax,ss = Cmax við jafnvægi tími að 90% af jafnvægisgildi
English: If you stop using Trazimera
Icelandic: Ef hætt er að nota Trazimera
English: What Trazimera is and what it is used for What you need to know before you are given Trazimera How Trazimera is given
Icelandic: Upplýsingar um Trazimera og við hverju það er notað Áður en byrjað er að nota Trazimera Hvernig nota á Trazimera
English: A vial of Trazimera reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Icelandic: Hettuglas með Trazimera sem búið er að blanda með vatni fyrir stungulyf (fylgir ekki) er stöðugt í 48 klukkustundir við 2°C - 8°C eftir blöndun og má ekki frjósa.