natgillin/translations-raw huggingface dataset:
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN L. Molteni &amp; C. dei F.lli Alitti
NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni &amp; C. dei F.lli Alitti
Buprenorphins virkning og sikkerhed hos ældre patienter &gt; 65 år er ikke klarlagt.
The efficacy and safety of buprenorphine in elderly patients &gt; 65 years has not been established.
Informer straks lÃ¦gen, hvis du mener at du har en infektion pÃ¥ implantatstedet, eller hvis implantatet begynder at komme ud.
Inform your doctor immediately if you think you have an infection at the implant site or if the implant starts to come out.
ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10,000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories 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), not known (cannot be estimated from the available data).
CI=konfidensinterval, ITT=intent-to-treat, N=antal personer, SE=standardfejl I analysen af CDF (co-primært endepunkt 1) blev der set en statistisk signifikant forskel mellem behandlingerne (p &lt; 0,0001), til Sixmos fordel.
CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error In the analysis of the CDF (co-primary endpoint 1), a statistically significant difference between treatments (p &lt; 0.0001) was seen, which was in favour of Sixmo.
Der rådes til forsigtighed, når patienter med svært nedsat nyrefunktion doseres (kreatininclearance &lt; 30 ml/min) (se pkt.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance &lt; 30 mL/min) (see sections 4.2 and 5.2).
Infektioner og parasitÃ¦re sygdomme almindelig virusinfektion, bronkitis**, infektion**, influenza**, faryngitis**, rhinitis** ikke almindelig cellulitis, hudinfektion, peritonsillÃ¦r byld, pustulÃ¸st udslÃ¦t, urinvejsinfektion, vulvovaginal mykotisk infektion, infektion pÃ¥ implantatstedet*, byld pÃ¥ implantatstedet* Blod og lymfesystem ikke almindelig lymfadenopati, neutropeni Metabolisme og ernÃ¦ring almindelig nedsat appetit ikke almindelig unormal vÃ¦gtÃ¸gning, dehydrering, Ã¸get appetit
Frequency Adverse reactions Infections and infestations common viral infection, bronchitis**, infection**, influenza**, pharyngitis**, rhinitis** uncommon cellulitis, skin infection, peritonsillar abscess, rash pustular, urinary tract infection, vulvovaginal mycotic infection, implant site infection*, implant site abscess*
Informationen i folderen bÃ¸r oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure i situationer med forhÃ¸jet ALAT.
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Tumour størrelse ≤2 cm &gt; 2 cm
Tumour size ≤2 cm &gt; 2 cm
InfusionsvÃ¦sken bÃ¸r bruges inden for 4 timer under 25 ÂºC.
The infusion should be used within 4 hours below 25 ºC.
Dette regime blev administreret hver 3. uge i 4 cyklusser i tilfælde hvor der som mindstemål blev observeret mindre respons ( &gt; 25% reduktion i den bidimensionalt målte tumorstørrelse) efter 2 cyklusser.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25 % reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Alderskategori 2 &lt; 35 år
Age category 2 &lt; 35 years
Alderskategori 1 &lt; 50 år
Age category 1 &lt; 50 years
De mest almindeligt rapporterede bivirkninger med docetaxel var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni ( &lt; 500 celler/mm 3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse &gt; 5 cm
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor aER/PR-negative or Grade 3 or tumor size &gt; 5 cm
Med en hazard ratio &lt; 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau &gt; 1.500 celler/mm3 og blodplader gendannes til et niveau &gt; 100.000
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level &gt; 1,500 cells/mm3 and platelets recover to a level &gt; 100,000 cells/mm3.
Der var mindre brug af smertestillende morfika (p &lt; 0,01), smertestillende ikke-morfika (p &lt; 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p &lt; 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medications (p=0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
445 patienter med KPS &gt; 70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluorouracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluorouracil (1000 mg/m2 pr. dag i 5 dage).
A total of 445 patients with KPS &gt; 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på &lt; 1.500 celler/mm3.
Docetaxel must not be used in patients with baseline neutrophil count of &lt; 1,500 cells/mm3.
meget almindelig (≥ 1/10); almindelig (≥ 1/100, &lt; 1/10); ikke almindelig (≥ 1/1000, &lt; 1/100); sjælden (≥ 1/10.000, &lt; 1/1000); meget sjælden ( &lt; 1/10.000).
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); not known (cannot be estimated from the available data)
CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse &gt; 5 cm
ER/PR-negative or Grade 3 or tumor size &gt; 5 cm
Med en hazard ratio &lt; 1 kan docetaxel + cisplatin+5-FU anvendes med fordel * Ujusteret logrank test ** Ujusteret logrank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Not Applicable
(95% CI) ***p-value Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
I kombinationsbehandling med cisplatin og 5-fluorouracil til behandling af patienter med gastrisk adenocarcinom ekskluderede pivotalstudiet patienter med ALT og/eller AST &gt; 1,5 gange ULN associeret med alkalisk fosfatase &gt; 2,5 gange ULN, og bilirubin &gt; 1 gange ULN.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: &lt;
Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: 0.1%)
G3/4 ASAT forhøjet ( &lt; G3/4 ALAT forhøjet
G3/4 AST increased G3/4 ALT increased
Øget tåresekretion (G3/4: &lt; 0,1 %);
Lacrimation increased (G3/4: 0.1%);
G3/4 Forhøjet alkalisk fosfatase i blodet ( &lt;
G3/4 Blood alkaline phosphatase increased
Docetaxel forlængede median-tiden til progression (24,6 uger vs. 15,6 uger; p &lt; 0,01) og medianoverlevelse (15,3 måneder vs 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs. 25 %, p = 0,10), samlet respons rate (32 % vs 25 %, p = 0,10).
Without affecting the primary endpoint, overall response rate (32% vs 25%, p=0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p &lt; 0.01) and median survival (15.3 months vs 12.7 months; p=0.03).
Hoste (G3/4: &lt; 1 %); Epistaxis (G3/4: &lt; 1 %)
Dyspnoea (G3/4: 1%); Cough (G3/4: &lt; 1%); Epistaxis (G3/4: &lt; 1%)
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m2 til 75 mg/m2 og/eller fra 75 mg/m2 til 60 mg/m2: hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter &lt; 500 celler/mm3 i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count &lt; 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/ m2 to 75 mg/m2 and/or from 75 to 60 mg/ m2.
I de følgende tilfælde bør docetaxel-dosis reduceres til 65 mg/ m i de følgende behandlingsrunder: 1) hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på &lt; 25000 celler/mm3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke hæmatologisk toksicitet.
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is &lt; 25.000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Med en hazard ratio &lt; 1 kan docetaxel * Ujusteret logrank test
A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil
Smerter i ekstremiteterne (G3/4: &lt; 1 %);
Pain in extremity (G3/4: &lt; 1%); Back pain (G3/4: 1%);
Epistaxis (G3/4: &lt; 1 %)
Onycholysis (G3/4: 1%)
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse &gt; 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder &lt; 35 år).
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
Nedsat dosis anbefales hos patienter med nedsat nyrefunktion (kreatininclearance &lt; 79 ml/min).
Reduced dosages are for patients with renal impairment (creatinine clearance &lt; 79 ml/min).
c Hos patienter med kreatininclearance &lt; 15 ml/min, bør den daglige dosis nedsættes i forhold til kreatininclearance (f.eks. bør patienter med kreatininclearance på 7,5 ml/min have halv så stor daglig dosis, som patienter med kreatininclearance på 15 ml/min får).
c For patients with creatinine clearance &lt; 15 ml/min, the daily dose should be reduced in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 ml/min should receive one-half the daily dose that patients with a creatinine clearance of 15 ml/min receive).
Gabapentins plasmakoncentration hos børn &gt; 5 år er den samme som hos voksne, når dosis er beregnet i mg/kg.
In general, plasma gabapentin concentrations in children &gt; 5 years of age are similar to those in adults when dosed on a mg/kg basis.
&lt; 6 år 6-12 år
&lt; 6 Years Old 6 to 12 Years Old 17/99 (17.2%)
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN {Navn og adresse} &lt; {tlf} &gt; &lt; {fax} &gt; &lt; {email} &gt; [Se bilag I - Udfyldes nationalt]
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} &lt; {tel} &gt; &lt; {fax} &gt; &lt; {e-mail} &gt; [See Annex I - To be completed nationally]
(meget almindelig (≥1/10), almindelig (≥1/100, &lt; 1/10), ikke almindelig (≥1/1000 og &lt; 1/100), sjælden (≥1/10.000 og &lt; 1/1000).
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common ( &gt; 1/10), common ( &gt; 1/100, &lt; 1/10), uncommon ( &gt; 1/1000, &lt; 1/100) and rare ( &gt; 1/10,000; &lt; 1/1,000).
--1 Influenza A/ eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242)  5,3 log10 FAID50*/ml Influenza A/eq [H3N8] rekombinant canarypox virus (vCP3011)  5,3 log10 FAID50 */ml Clostridium tetani toxoid: &gt; 30 IU**/ml * vCP indhold kontrolleret ved global FAID50(fluorescent assay" infektiøs dosis 50 %) og qPCR rate mellem vCP.
--1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml Clostridium tetani toxoid: ≥ 30 IU**/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following adverse reactions have been reported during clinical trials and are ranked using the following 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); not known (cannot be estimated from the available data).
Infusionen bÃ¸r vare cirka 15 minutter.
The infusion should last around 15 minutes.
Bivirkningerne er anført i Tabel 5 efter behandlingsregime, systemorganklasse og hyppighed: 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) og meget sjælden ( &lt; 1/10.000).
Adverse reactions are listed in Table 5 by regimen, system organ class and 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)
** Patienten med virologisk gennembrud opfyldte den oprindelige protokoldefinition på bekræftet HCVRNA &lt; LLOQ, detekterbart ved uge 8.
** The patient with virologic breakthrough met the original protocol definition of confirmed HCV RNA &lt; LLOQ, detectable at treatment Week 8.
Dosis af ribavirin er vægtbaseret ved kombination med Daklinza (1.000 eller 1.200 mg hos patienter på henholdsvis &lt; 75 kg eller ≥75 kg).
The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients &lt; 75 kg or ≥75 kg, respectively).
** Andre ikke-responderende omfattede 4 patienter med HCV-RNA &lt; LLOQ ikke detekteret (target not detected) ved afslutning af behandling, men som var tabt ved opfølgningsuge 12 efter behandling og de efterfølgende tidspunkter, og 1 patient, som ikke havde nogen HCV-RNA-resultater under behandlingen
** Other non-responders included 4 patients with HCV RNA &lt; LLOQ target not detected (TND) at end of treatment, but who were lost to follow-up at post-treatment Week 12 and subsequent time points, and 1 patient who had no on-treatment HCV RNA results due to early discontinuation.
* Patienter, som havde manglende data ved opfølgningsuge 12, blev betragtet som responderende patienter, hvis deres næste tilgængelige HCV-RNA værdi var &lt; LLOQ.
* Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was &lt; LLOQ.
Daklinzas sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
The safety and efficacy of Daklinza in children and adolescents aged &lt; 18 years have not yet been established.
* Hovedsageligt interferon-baseret behandling +/-NS3/4 PI. ** Cirrose blev konstateret ved leverbiopsi, FibroScan &gt; 14,6 kPa eller FibroTest score ≥0,75 og aspartataminotransferase (ASAT): blodplade-indeks (APRI) &gt; 2.
* Mainly interferon-based therapy +/-NS3/4 PI. ** Cirrhosis was determined by liver biopsy, FibroScan &gt; 14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) &gt; 2.
Patienter, som oprindeligt blev placeret i behandlingsgruppen, der fik placebo og patienter i daclatasvir-gruppen, som ikke nåede HCV-RNA &lt; LLOQ ved uge 4 og ikke-detekterbart HCV-RNA ved uge 10 fortsattte med pegIFN/RBV og gennemførte 48 ugers behandling.
Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA &lt; LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV
** Cirrose blev konstateret ved hjælp af leverbiopsi (METAVIR F4) hos 14 patienter, FibroScan &gt; 14,6 kPa hos 11 patienter eller FibroTest score ≥0,75 og aspartataminotransferase (ASAT): indeks for trombocytratio (APRI) &gt; 2 hos 7 patienter.
* Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan &gt; 14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) &gt; 2 for 7 patients.
Distribution Penciclovir og dets 6-deoxy precursor har en ringe ( &lt; 20 %) plasmaproteinbinding.
Distribution Penciclovir and its 6-deoxy precursor are poorly ( &lt; 20%) bound to plasma proteins.
Bivirkningerne (Tabel 2) er opstillet efter frekvens ved anvendelse af følgende definition: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions (Table 2) are ranked under headings of frequency, using the following convention: 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).
Κύπρος Γ.Α.Σταμάτης &amp; Σια Λτδ.
Kύπρος Γ.Α.Σταμάτης &amp; Σια Λτδ.
Patienter med en baseline-score &lt; 2 blev ikke inkluderet i analysen.
Patients with baseline score &lt; 2 were not included in analysis.
Der er ikke gennemført studier med henblik på at undersøge farmakokinetikken af ocrelizumab hos børn og unge i aldersgruppen &lt; 18 år.
No studies have been conducted to investigate the pharmacokinetics of ocrelizumab in children and adolescents &lt; 18 years of age.
Infektionerne omfattede og var ikke begrÃ¦nset til atypisk pneumoni og pneumocystis jirovecii pneumoni, varicella-pneumoni, tuberkulose og histoplasmose.
Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis.
En patient med grad 3 (mellem 500 og 1000 celler/mm3) og en patient med grad 4 &lt; 500 celler/mm3) neutropeni behøvede specifik behandling med granulocyt-kolonistimulerende faktor og forblev på ocrelizumab efter episoden.
One patient with grade 3 (between 500 and 1000 cells/mm3) and one patient with grade 4 ( &lt; 500 cells/mm3) neutropenia required specific treatment with granulocyte-colony stimulating factor, and remained on ocrelizumab after the episode.
Patienter med kongestivt hjertesvigt i anamnesen (New York Heart Association III &amp; IV) er ikke undersøgt.
Patients with a history of congestive heart failure (New York Heart Association III &amp; IV) were not studied.
Infusionen mÃ¥ ikke genoptages fÃ¸r alle symptomer er forsvundet.
The infusion should be restarted only after all symptoms have resolved.
Infektionerne var fortrinsvis af mild til moderat karakter, og patienterne responderede pÃ¥ standardbehandling.
Infections were predominantly mild to moderate in severity and patients recovered with treatment by standard therapies.
Infektion i Ã¸vre luftveje, nasofaryngitis, influenza
Upper respiratory tract infection, nasopharyngitis, influenza
Infusionsrelaterede reaktioner kan opstÃ¥ under infusionen og i op til 24 timer efter infusionen.
Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
Hyppighed defineres som: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1000), meget sjælden ( &lt; 1/10.000).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000
Der var ingen rapporter for grad 4 lymfopeni ( &lt; 200 celler/mm3).
None of the patients was reported with Grade 4 lymphopenia ( &lt; 200 cells/mm3).
Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,4 %) og faldt ved efterfølgende doser til &lt; 10 % ved dosis 4.
The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to &lt; 10% at Dose 4.
De fleste tilfælde af fald i neutrofilocytter var forbigående (kun set én gang per patient behandlet med Ocrevus) og af sværhedsgrad 1 ( &lt; 1500 celler/mm3) og 2 (mellem 1000 og 1500 celler/mm3).
The majority of the neutrophil decreases were transient (only observed once for a given patient treated with Ocrevus) and were Grade 1 ( &lt; 1500 cells/mm3) and 2 (between 1000 and 1500 cells/mm3) in severity.
Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,5%) og faldt over tid til &lt; 10% ved dosis 4.
The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to &lt; 10% at Dose 4.
Infusionen kan gives langsommere, midlertidigt afbrydes eller afbrydes helt, hvis du fÃ¥r en infusionsrelateret reaktion, afhÃ¦ngigt af hvor alvorlig den er (se pkt.
The infusion may be slowed, temporarily stopped or permanently stopped if you have an infusion-related reaction, depending on how serious it is (see sections 2 and 4 for information about infusion-related reactions).
1 Defineret som stigning på ≥1,0 point fra baseline EDSS-score for patienter med en baseline-score på 5,5 eller derunder eller ≥0,5 hvis baseline-scoren er &gt; 5,5; Kaplan-Meier-estimater ved uge 120.
1 Defined as an increase of ≥ 1.0 point from the baseline EDSS score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is &gt; 5.5, Kaplan-Meier estimates at Week 120.
Størstedelen af disse indberettede fald i Ocrevus-behandlede patienter var sværhedsgrad 1 ( &lt; laveste referencegrænse - 800 celler/mm3) og 2 (mellem 500 og 800 celler/mm3).
The majority of these decreases reported in Ocrevus treated patients were Grade 1 ( &lt; LLN800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.