natgillin/translations-raw huggingface dataset:
9/l, myelocyt + metamyelocyt &lt; 5% i blodet, ingen blaster eller promyelocytter i blodet, basophiler &lt; 20%, ingen ekstramedullær involvering] og i undersøgelse 0102 and 0109 [ANC 1,5 x 10
9/l, myelocyte+metamyelocyte &lt; 5% in blood, no blasts and promyelocytes in blood, basophils &lt; 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC  1.5 x 10
Et andet multicenter, åbent fase-III-studie (SSG XVIII/AIO) sammenlignede 12 måneders behandling med Glivec 400 mg/dag vs. 36 måneders behandling hos patienter efter kirurgisk resektion af GIST og en af følgende: tumordiameter &gt; 5 cm og antal mitoser &gt; 5/50 HPF (high power fields); eller tumordiameter &gt; 10 cm og uanset antal mitoser; eller tumor af enhver størrelse med antal mitoser &gt; 10/50 HPF; eller tumorer, der er bristet i bughulen.
A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day Glivec 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter &gt; 5 cm and mitotic count &gt; 5/50 high power fields (HPF); or tumour diameter &gt; 10 cm and any mitotic count or tumour of any size with mitotic count &gt; 10/50 HPF or tumours ruptured into the peritoneal cavity.
9/l, myelocytter+metamyelocytter &lt; 5% i blod, ingen blaster og promyelocytter i blod, basofile &lt; 20%, ingen ekstramedullær påvirkning Cytogenetiske responskriterier: fuldstændig (0% Ph+ metafaser), delvis (1-35%), mindre (3665%) eller minimal (66-95%).
9/l, myelocyte+metamyelocyte &lt; 5% in blood, no blasts and promyelocytes in blood, basophils &lt; 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster &lt; 15% i blod og knoglemarv, perifere blodbasofiltal &lt; 20%, trombocyttal &gt; 100 x 10
Chronic phase CML is defined when all of the following criteria are met: blasts &lt; 15% in blood and bone marrow, peripheral blood basophils &lt; 20%, platelets &gt; 100 x 10
Glivec forlængede signifikant RFS, idet 75% af patienterne var recidivfrie efter 38 måneder i Glivecgruppen i forhold til efter 20 måneder i placebo-gruppen (95% konfidensinterval, [30 - ikke estimerbare]; [14 - ikke estimerbare]); (hazard ratio = 0,398 [0,259-0,610], p &lt; 0,0001).
Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p &lt; 0.0001).
Ved doser &gt; 6 mg/kg, sås hos rotter i 13-ugers undersøgelsen hyperplasi af det transitoriske epithel i nyrepapillerne og i urinblæren, uden ændringer i serum- eller urinparametre.
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses  6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Accelereret fase defineres som tilstedeværelse af én eller flere af følgende: blaster 15%, men &lt; 30% i blod eller knoglemarv, blaster plus promyelocytter 30% i blod eller knoglemarv (hvilket giver &lt; 30% blaster), perifere blodbasofiltal 20%, trombocyttal &lt; 100 x 10
Accelerated phase is defined by the presence of any of the following: blasts  15% but &lt; 30% in blood or bone marrow, blasts plus promyelocytes  30% in blood or bone marrow (providing &lt; 30% blasts), peripheral blood basophils  20%, platelets &lt; 100 x 10
Den estimerede frekvens af patienter fri for progressions til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i Glivec-armen end i IFN-armen (92,5% vs. 85,1%, p &lt; 0,001).
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Glivec arm compared to the IFN arm (92.5% versus 85.1%, p &lt; 0.001).
Major respons ved 84 måneder (%) * p &lt; 0,001, Fischers exact test ** Procentvise molekylære respons er baseret på tilgængelige prøver.
Major response at 84 months (%) * p &lt; 0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after  4 weeks): WBC &lt; 10 x 10
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er &lt; 0,1 µM, Gy= Gray
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is &lt; 0.1 µM, q6h = every 6 hours, Gy= Gray
Glivec-behandling i 36 måneder forlængede signifikant RFS sammenlignet med 12 måneders Glivecbehandling (samlet hazard ratio (HR) = 0,46 [0,32-0,65], p &lt; 0,0001) (Tabel 8, Figur 1).
Thirty-six (36) months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p &lt; 0.0001) (Table 8, Figure 1).
Delvist Hæmatologiske responskriterier (hvert respons skal bekræftes ≥4 uger): CHR: Undersøgelse 0110 [leukocytter &lt; 10 x 10
Partial 1 Haematological response criteria (all responses to be confirmed after  4 weeks): CHR: Study 0110 [WBC &lt; 10 x 10 9/l, platelets &lt; 450 x 10
9/l, trombocytter &lt; 450 x 10
9/l, platelet &lt; 450 x 10
9/l) og trombocytopeni (trombocyttal &lt; 50 x 10
9/l) and thrombocytopenia (platelet count
G-CSF (5 μg/kg, s.c.): dag 5-14, eller indtil ANC &gt; 1500 post nadir Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 15 DEX (6 mg/m2/dag, p.o.): dag 1-7 og 15-21
G-CSF (5 μg/kg, SC): days 5-14 or until ANC &gt; 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 DEX (6 mg/m2/day, PO): days 1-7 and 15-21
RTC: &lt; 15% blaster I BM og PB, &lt; 30% blaster + promyelocytter in BM og PB, &lt; 20% basofilocytter i
only) RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
9/l) hos henholdsvis 3,6% og 1% af patienterne med nydiagnosticeret CML i kronisk fase.
9/l) were observed in 3.6% and &lt; 1% of patients, respectively.
): dag 22-26 G-CSF (5 μg/kg, s.c.): dag 27-36, eller indtil ANC &gt; 1500 post nadir ARA-C (3 g/m 2, q12h, i.v.
CPM (300 mg/m 2/day, IV): days 22-26 MESNA (150 mg/m 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC &gt; 1500 post nadir ARA-C (3 g/m 2, q12h, IV): days 43, 44 L-ASP (6000 IUnits/m 2, IM): day 44
ingen blaster i blodet, BM-blaster &lt; 5% og ingen ekstramedullær sygdom].
9/l, no blood blasts, BM blasts &lt; 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 10
G-CSF (5 μg/kg, s.c.): dag 5-14, eller indtil ANC &gt; 1500 post nadir Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 15 DEX (6 mg/m2/dag,p.o.
G-CSF (5 μg/kg, SC): days 6-15 or until ANC &gt; 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
): dag 2 og 3 G-CSF (5 μg/kg, s.c.): dag 4-13, eller indtil ANC &gt; 1500 post nadir
Triple IT therapy (age-adjusted): day 1 ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC &gt; 1500 post nadir
I tilfælde af recidiverende ANC &lt; 1,0 x 10
ANC &lt; 1.0 x 10
ANC &lt; 0,5 x 10 9/l og/eller trombocytter &lt; 10 x 10
ANC &lt; 0.5 x 10
(trombocyttal &lt; 10 x 10
&lt; 10 x 10
NEL: Samme kriterier som for CHR, men ANC 1 x 109/l og trombocytter 20 x 109/l (kun 0102 og
9/l, no blood blasts, BM blasts &lt; 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 109/l and platelets  20 x 109/l (0102 and 0109 only) RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
De efterfølgende overskrifter rangerer bivirkningerne efter frekvens: meget almindelig (≥ 1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000).
The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000).
Tid indtil progressiv sygdom var længere i kombinationsarmen med Capecitabin + docetaxel (p &lt; 0,0001).
Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p &lt; 0.0001).
Det høje distributionsvolumen (Vd) &gt; 4 l/kg legemsvægt indikerer god vævspenetration.
The high volume of distribution (Vd) &gt; 4 l/kg body weight indicates good tissue penetration.
Det høje distributionsvolumen (Vd) &gt; 2 l/kg legemsvægt indikerer god vævspenetration.
The high volume of distribution (Vd) &gt; 2 l/kg bodyweight indicates good tissue penetration.
CVMP begrundede ekstrapolering af produktets virkning på Linognatus vituli til de to andre foreslåede lusearter (Bovicola bovis og Solenopotes capillatus) på grundlag af resultaterne af en dosisfastsættelsesundersøgelse med monoproduktet, der indeholder moxidectin som aktivt stof, hvori det blev påvist, at de tre foreslåede påståede lusearter var kontrolleret ( &gt; 95 % med undtagelse af voksne individer af Solenopotes capillatus før dag 21) ved halv dosis for monoproduktet (0,25 mg/kg kropsvægt i stedet for 0,5 mg/kg kropsvægt ), hvilket understøttes af farmakokinetiske resultater, der ikke giver noget stærkt signal om samspillet mellem de to aktive stoffer i Cydectin TriclaMox.
The CVMP based the extrapolation of the efficacy of the product on Linognatus vituli to the two other lice species proposed (Bovicola bovis and Solenopotes capillatus) on the results of a dose determination study with the monoproduct containing moxidectin as active substance where the three proposed claimed lice species were shown to be controlled ( &gt; 95 % except for Solenopotes capillatus adult before day 21) at half dose for the monoproduct (0.25 mg/kg bw instead of 0.5 mg/kg bw), supported by the pharmacokinetics finding giving no strong signal of interaction between the two active substances in Cydectin TriclaMox.
126, Kyprou &amp; 25th Martiou str., 164 52 Argyroupolis-Athen Grækenland
126, Kyprou &amp; 25th Martiou str., 164 52 Argyroupolis-Athens Greece
De mest almindligt indberettede bivirkninger ( &gt; 1/10) fra kliniske undersøgelser var kvalme, mundtørhed, hovedpine og perspiration (incl.
The most commonly ( &gt; 1/10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).
John Wyeth &amp; Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Storbritanien
John Wyeth &amp; Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
Infusionen kan medfÃ¸re allergiske reaktioner, og patienten bÃ¸r derfor overvÃ¥ges under og efter infusionen for symptomer sÃ¥som feber og kulderystelser.
The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion for signs such as fever and chills.
Alder &lt; 65 år ≥ 65 år
Age &lt; 65 years ≥ 65 years
Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); and not known (cannot be estimated from available data).
Nyrefunktion Baseline CrCl &lt; 60 ml/min Baseline CrCl ≥ 60 ml/min
Renal function Baseline CrCl &lt; 60 mL/min Baseline CrCl ≥ 60 mL/min
28-dages cyklusser 1 &amp; 2
28-Day Cycles 1 &amp; 2
Forekomsten af lette til moderate infusionsreaktioner var &gt; 50% hos patienter, der ikke var præmedicinerede.
The rate of mild to moderate infusion reactions was &gt; 50% in patients who were not premedicated.
Empliciti er forbundet med infusionsreaktioner (se afsnit 2 “Advarsler og forsigtighedsregler”).
Infusion reactions Empliciti has been associated with infusion reactions (see section 2 âWarnings and precautionsâ).
Infusionsreaktioner var meget hyppigere hos patienter, der ikke var prÃ¦medicinerede.
The rate of infusion reactions was much higher in patients who were not premedicated.
PFS ITT-vurdering ifølge investigator blev evalueret i adskillige undergrupper inklusive alder ( &lt; 65 versus ≥ 65), race, ISS-stadie, tidligere behandlinger, transplantation, risikokategori, ECOG-status, kreatinin-clearance og cytogenetiske abnormiteter.
PFS ITT assessment per investigator was evaluated in several subgroups including age ( &lt; 65 versus ≥ 65), race, ISS stage, prior therapies, transplant, risk category, ECOG status, creatinine clearance, and cytogenic abnormalities.
De hyppigste bivirkninger (hos &gt; 10% af patienterne) ved elotuzumab-behandling var infusionsrelaterede reaktioner, diarre, herpes zoster, nasofaryngitis, hoste, pneumoni, infektion i de øvre luftveje, lymfopeni og vægttab.
The most common adverse reactions (occurring in &gt; 10% of patients) with elotuzumab treatment were infusion related reactions, diarrhoea, herpes zoster, nasopharyngitis, cough, pneumonia, upper respiratory tract infection, lymphopenia and weight decreased.
Fremskridt i PFS var konsistent på tværs af forsøgspersonerne uanset alder ( &lt; 65 versus ≥ 65), risikostatus, med eller uden tilstedeværelse af del17p eller t(4;14) (høj cytogenetisk risiko), ISS-stadium, antal tidligere behandlinger, tidligere immunmodulerende eksponering, tidligere bortezomib-eksponering, recidiverende eller refraktær status og nyrefunktion.
Improvements observed in PFS were consistent across subsets regardless of age ( &lt; 65 versus ≥ 65), risk status, presence or absence of cytogenetic categories del17p or t(4;14), ISS stage, number of prior therapies, prior immunomodulatory exposure, prior bortezomib exposure, relapsed or refractory status or renal function as shown in Table 9.
Dosisjustering af Empliciti er ikke nødvendig hos patienter med let (CrCl = 60-89 ml/min), moderat (CrCl = 30-59 ml/min), svært (CrCl &lt; 30 ml/min) nedsat nyrefunktion eller terminal nyresygdom, der kræver dialyse (se pkt.
No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl &lt; 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2).
Effekten af nedsat nyrefunktion på elotuzumabs farmakokinetik blev undersøgt hos patienter med normal nyrefunktion (CrCl &gt; 90 ml/min; N = 8), svært nedsat nyrefunktion uden dialyse (CrCl &lt; 30 ml/min; N = 9) og terminal nyresygdom med dialyse (CrCl &lt; 30 ml/min; N = 9).
The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl &gt; 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl &lt; 30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl &lt; 30 mL/min; N = 9).
På dage, hvor Empliciti ikke administreres, men hvor der er planlagt en dosis dexamethason (dag 8, 15 og 22 i cyklus 3 og alle efterfølgende cyklusser), gives 40 mg oralt til patienter ≤ 75 år og 20 mg oralt til patienter &gt; 75 år.
On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients &gt; 75 years old.
Dexamethason (mg) intravenøst Dexamethason (mg) oralt  75 år Dexamethason (mg) oralt &gt; 75 år Cyklusdag 1 8 15 22 1 8 15 22
Dexamethasone (mg) intravenously Dexamethasone (mg) orally  75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally &gt; 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22
På de uger med Emplicitiinfusion, blev dexamethasone administeret før Empliciti som en delt dosis: forsøgspersoner  75 år en oral dosis på 28 mg og en intravenøs dosis på 8 mg, og for forsøgspersoner &gt; 75 år en oral dosis på 8 mg og en intravenøs dosis på 8 mg. På uger uden en Empliciti-infusion og hos kontrolgruppen, blev dexamethason administreret til forsøgspersoner 75 år som en oral dosis på 40 mg og hos forsøgspersoner &gt; 75 år som en oral dosis på 20 mg dexamethason.
On weeks with Empliciti infusion, dexamethasone was administered before Empliciti as a divided dose: subjects  75 years an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects &gt; 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an Empliciti infusion and in the control group, dexamethasone was administered in subjects  75 years as an oral dose of 40 mg and in subjects &gt; 75 years as an oral dose of 20 mg dexamethasone.
Effekten af nedsat leverfunktion på Empliciticlearance blev undersøgt i populationsfarmakokinetiske analyser hos patienter med let nedsat leverfunktion (total-bilirubin [TB] ≤ den øvre normale grænse [ULN] og ASAT &gt; ULN eller TB &lt; 1 til 1,5 x ULN og enhver ASAT; N = 33).
The effect of hepatic impairment on the clearance of Empliciti was evaluated by population PK analyses in patients with mild hepatic impairment (total bilirubin [TB] ≤ the upper limit of normal [ULN] and AST &gt; ULN or TB &lt; 1 to 1.5 × ULN and any AST; N = 33).
På dage, hvor Empliciti administreres, til patienter ≤ 75 år gives dexamethason 28 mg oralt mellem 3 og 24 timer før Empliciti plus 8 mg intravenøst mellem 45 og 90 minutter før Empliciti og til patienter &gt; 75 år gives dexamethason 8 mg oralt mellem 3 og 24 timer før Empliciti plus 8 mg intravenøst mellem 45 og 90 minutter før Empliciti.
On days that Empliciti is administered, patients ≤ 75 years old give dexamethasone 28 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti and for patients &gt; 75 years old give dexamethasone 8 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti.
Dosisjustering af Empliciti er ikke nødvendig hos patienter med let nedsat leverfunktion (total-bilirubin [TB] ≤ øvre normalgrænse [ULN] og ASAT &gt; ULN eller TB &lt; 1-1,5 x ULN og enhver ASAT).
No dose adjustment for Empliciti is required for patients with mild hepatic impairment (total bilirubin [TB] ≤ to the upper limit of normal [ULN] and AST &gt; ULN or TB &lt; 1 to 1.5 × ULN and any AST).
a p-værdi baseret på log-rank test stratificeret efter B2 mikroglobuliner ( &lt; 3,5 mg/l versus ≥ 3,5 mg/l), antal tidligere behandlinger (1 versus 2 eller 3) og tidligere immunmodulerende behandling (ingen versus tidligere udelukkende thalidomid versus anden behandling).
a p-value based on the log-rank test stratified by B2 microglobulins ( &lt; 3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
d p-værdi baseret på Cochran-Mantel-Haenszel chi i-anden-test- stratificeret efter B2-mikroglobuliner ( &lt; 3,5 mg/l versus ≥ 3,5 mg/l), antal tidligere behandlinger (1 versus 2 eller 3) og tidligere immunmodulerende behandling (ingen versus tidligere udelukkende thalidomid versus anden behandling).
d p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by B2 microglobulins ( &lt; 3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
Empliciti er ikke undersøgt hos patienter med moderat (TB &gt; 1,5-3 x ULN og enhver ASAT) eller svært (TB &gt; 3 x ULN og enhver ASAT) nedsat leverfunktion (se pkt.
Empliciti has not been studied in patients with moderate (TB &gt; 1.5 to 3 × ULN and any AST) or severe (TB &gt; 3 × ULN and any AST) hepatic impairment (see section 5.2).
Elotuzumab er ikke blevet undersøgt hos patienter med moderat (TB &gt; 1,5 til 3 x ULN og enhver ASAT) og svært (TB &gt; 3 x ULN og enhver ASAT) nedsat leverfunktion (se pkt.
Elotuzumab has not been studied in patients with moderate (TB &gt; 1.5 to 3 × ULN and any AST) or severe hepatic impairment (TB &gt; 3 × ULN and any AST) (see section 4.2).
(≥1/100 til &lt; 1/10)
Common (≥ 1/100 to &lt; 1/10)
Pegfilgrastims sikkerhed og virkning hos de novoAML-patienter &lt; 55 år med cytogenetik t(15;17) er ikke klarlagt.
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged &lt; 55 years with cytogenetics t(15;17) have not been established.
Der er indberettet leukocytose (WBC &gt; 100 x 109/l) (almindelig) (se pkt.
Common cases of leukocytosis (White Blood Count [WBC] &gt; 100 x 109/L) have been reported (see section 4.4).
Incidensen af febril neutropeni var lavere hos patienter, som var randomiseret til at få pegfilgrastim, end hos patienter i placebogruppen (1% imod 17%, p &lt; 0,001).
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1%
Der er indberettet kapillærlækage-syndrom hos cancerpatienter, der fik kemoterapi efter indgift af granulocytkolonistimulerende faktor, med frekvensen ”ikke almindelige” (≥ 1/1.000 til &lt; 1/100).
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to &lt; 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Meget almindelig (≥1/10) Almindelig (≥1/100 til &lt; 1/10) Ikke almindelig (1/1.000 til &lt; 1/100) Sjælden (1/10.000 til &lt; 1/1.000) Meget sjælden ( &lt; 1/10.000)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10) Uncommon (≥1/1,000 to &lt; 1/100) Rare (≥1/10,000 to &lt; 1/1,000) Very rare ( &lt; 1/10,000)
Feber ≥ 38 °C (≥ 40 °C) Enhver anden utilsigtet hændelse Børn (3- &lt; 9 år)
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Children (3- &lt; 9 years)
Influenzavirus-overfladeantigener (hÃ¦magglutinin og neuraminidase)* fra stammen:
QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Indehaver af markedsføringstilladelsen og fremstiller Novartis Vaccines and Diagnostics S.r.l.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines &amp; Diagnostics S.r.l.
Børn (3- &lt; 9 år)
Toddlers (6- &lt; 36 months) Children (3- &lt; 9 years) Adolescents (9- &lt; 18 years) N=91
Influenzavirus-overfladeantigener (hÃ¦magglutinin og neuraminidase)* fra stammen: A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 7,5 mikrogram** pr. 0,5 ml dosis * dyrket i Ã¦g ** udtrykt som mikrogram hÃ¦magglutinin.
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Daclizumab beta kunne detekteres i mælken hos 11 ud af 14 diegivende aber med niveauer, der var &lt; 0,122% af moderens serumniveau, uden observation af bivirkninger hos afkommet.
Daclizumab beta was detected in the milk of 11/14 lactating monkeys at levels that were &lt; 0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.