FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Danish: Hvert 10 ml hætteglas med bortezomib skal forsigtigt rekonstitueres med 3,5 ml natriumchlorid 9 mg/ml (0,9 %) til injektionsvæske, opløsning ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: Response rate n: response-evaluable patients
Danish: Responsrate n: responseevaluérbare patienter Samlet komplet respons (CR+CRu)
English: • shortness of breath or cough
Danish: • Stakåndethed eller hoste
English: Prednisone is given orally at 100 mg/m on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Danish: Prednison administreres oralt i en dosis på 100 mg/m på dag 1, 2, 3, 4 og 5 i hver bortezomib behandlingscyklus.
English: When bortezomib is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Danish: Når bortezomib gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler kontrolleres for yderligere kontraindikationer.
English: Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Danish: demens)*, encefalopati*, posterior reversibelt encefalopati syndrom neurotoksicitet, epileptiske anfald*, postherpetisk neuralgi, taleforstyrrelser*, restless legs syndrom, migræne, skiatika, opmærksomhedsforstyrrelser, abnorme reflekser*, parosmi
English: Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Danish: Akut pankreatitis, peritonitis*, tungeødem*, ascites, øsofagitis, læbebetændelse, fækal inkontinens, analsfinkteratoni, fækalom*, gastrointestinal ulcus og perforation*, gingival hypertrofi, megacolon, rektalt udflåd, blisterdannelse i hals og svælg*, læbesmerter, parodontitis, analfissur, forandringer i peristaltikken, proktalgi, anormal fæces
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Danish: 1.1 Præparation af 3,5 mg hætteglas: Tilsæt forsigtigt 3,5 ml steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske til hætteglasset, der indeholder bortezomib pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Danish: Psykiske forstyrrelser Almindelig Humørlidelser og humørforstyrrelser*, angsttilstande*, søvnlidelser og -forstyrrelser*
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Danish: 1.1 Præparation af 3,5 mg hætteglas: Tilsæt forsigtigt 1,4 ml steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske til hætteglasset, der indeholder bortezomib pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Danish: Efter rekonstituering indeholder 1 ml opløsning til subkutan injektion 2,5 mg bortezomib.
English: Efficacy results are presented in table 16:
Danish: Effektresultaterne fremgår af tabel 16.
English: Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Danish: Almindelig Leukopeni*, lymfopeni* Ikke almindelig Pancytopeni*, febril neutropeni, koagulopati*,
English: Very common Thrombocytopenia*, Febrile neutropenia, Neutropenia*, Leukopenia*, Anaemia*, Lymphopenia*
Danish: Trombocytopeni*, febril neutropeni, neutropeni*, leukopeni*, anæmi*, lymfopeni* Ikke almindelig Pancytopeni*
English: Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Danish: Almindelig Dehydrering, hypokalæmi*, hyponatræmi*, abnorm blodglucose*, hypocalcæmi*, enzymforstyrrelser * Ikke almindelig Tumourlysesyndrom, manglende trivsel*, hypomagnesæmi*, hypofosfatæmi*, hyperkalæmi*, hypercalcæmi*, hypernatræmi*, abnorm urinsyre*, diabetes mellitus*, væskeretention
English: Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Danish: Almindelig Dyspnø*, hoste*, hikke Ikke almindelig Akut respiratory distress syndrome, lungeemboli, pneumonitis, pulmonal hypertension, lungeødem (inkl.
English: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Danish: Efter rekonstituering indeholder 1 ml opløsning til intravenøs injektion 1 mg bortezomib.
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m Since dialysis may reduce bortezomib concentrations, bortezomib should be administered after the dialysis procedure (see section 5.2).
Danish: Det er uvist, om bortezomibs farmakokinetik bliver påvirket hos patienter med svært nedsat nyrefunktion (CrCl < 20 ml/min/1,73 m2), som ikke er i dialyse.
English: Gastrointestinal disorders Very common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Danish: Kvalme og opkasning symptomer*, Diarré*, forstoppelse
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia (inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Danish: hiatus)*, nedsat sårheling*, inflammation, flebitis på injektionsstedet*, ømhed, ulcus, irritabilitet, ikke-kardielle brystsmerter, smerter på kateterstedet, fornemmelse af fremmedlegeme
English: In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients.
Danish: I det samme lægemiddelinteraktionsstudie blev effekten af den svagere CYP3A4-induktor dexamethason på bortezomibs farmakokinetik (som intravenøs injektion) vurderet.
English: Marketing Authorisation Holder Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
Danish: Efterfølgende kan bortezomib re-initieres ved en dosis, som er reduceret 1 dosisniveau (fra 1,3 mg/m til 1
English: In B-ALL patients with relapse within 18 months of diagnosis (n=27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Danish: efter diagnosticering (n=27), var CR-raten 67 % (95 % CI: 46, 84); den 4-mdr.
English: Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Danish: Hypermagnesæmi*, acidose, forstyrrelser i elektrolytbalancen *, væskeophobning, hypochloræmi*, hypovolæmi, hyperchloræmi*, hyperfosfatæmi*, stofskiftesygdom, B-vitaminmangel, B12-vitaminmangel, gigt, øget appetit, alkoholintolerance
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Danish: Aplasi, misdannelse i mave-tarm-kanalen, iktyose
English: B (1.3 mg/m
Danish: B (1,3 mg/m2) Dag 1, 4
English: due to nerve damage
Danish: Nervesystemet
English: BR-CAP group compared with 18 months in the R-CHOP group.
Danish: Den mediane varighed af komplet respons var 42,1 måneder i BR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
English: • volume of reconstituted bortezomib (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Danish: og s.c. anvendelse) til forskellige arealer af legemsoverfladen (krydshenvisning til regnestok).
English: • Feeling sick (nausea) or vomiting, loss of appetite
Danish: • Kvalme og/eller opkastning, nedsat appetit
English: Hypotension*, Orthostatic hypotension, Hypertension*
Danish: Almindelig Hypotension*, ortostatisk hypotension, hypertension* Ikke almindelig Cerebrovaskulært attak
English: 9/l or ANC
Danish: 9/l eller
English: Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis
Danish: leversygdom), hepatitis*, kolestase
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning er tilgængelig til intravenøs eller subkutan administration.
English: • Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be
Danish: • Trombocyttal skal være ≥ 100.000 celler/µl og absolut neutrofiltal (ANC) skal være ≥ 1.500 celler/µl
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis
Danish: tyndtarmsobstruktion, ileus)*, abdominalt ubehag, mundsår*, enteritis*, gastritis*, gingival blødning, gastroøsofageal reflukssygdom*, colitis (inkl.
English: Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Danish: dissemineret & oftalmisk), herpes-virusinfektion*, bakterieinfektion*, øvre/nedre luftvejsinfektion*, svampeinfektion*, herpes simplex* Ikke almindelig Hepatitis B, infektion*, bronkopneumoni Blod og lymfesystem Meget almindelig
English: Patients in the BDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in cycles 1 and 2, and on days 1 to 4 in cycles 3 and 4).
Danish: 4, 8 og 11) og oralt dexamethason (40 mg/dag, dag 1 til 4 og dag 9 til 12 i cyklus 1 og 2 og dag 1 til 4 i cyklus 3 og 4).
English: (95% CI) p-value c a Kaplan-Meier estimate b
Danish: (95% CI) p-værdi c a
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Danish: • Lammelse, krampeanfald, fald, bevægelsesforstyrrelser, unormale, forandrede eller nedsatte sanser (føle-, høre-, smags- eller lugtesans), opmærksomhedsforstyrrelser, skælven, spjætten
English: Discontinue bortezomib
Danish: Bortezomib subkutan gruppe
English: PHARMACEUTICAL FORM Powder for solution for injection.
Danish: Pulver til injektionsvæske, opløsning.
English: Oedema (inc peripheral), Chills, Pain*, Malaise*
Danish: perifert), kuldegysninger, smerter*, utilpashed*
English: • memory loss, trouble thinking, difficulty with walking or loss of vision.
Danish: • Hukommelsestab, nedsat tankevirksomhed, gangbesvær eller synstab.
English: Note: Bortezomib is a cytotoxic agent.
Danish: NB: Bortezomib er en cellegift.
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Danish: kardiogent chok), torsades de pointes, ustabil angina, hjerteklapsygdomme*, koronarinsufficiens, sinusarrest
English: In addition, when bortezomib is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Danish: Når bortezomib gives i kombination med andre cytostatika, skal passende dosisreduktion af disse præparater overvejes i tilfælde af toksicitet.
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Danish: Rabdomyolyse, kæbeledssyndrom, fistel, ledeffusion, kæbesmerter, knoglesygdom, infektioner og inflammationer i knogler, led og bindevæv*, synovialcyste
English: In B-ALL patients with relapse 18-36 months from diagnosis (n=33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Danish: fradiagnosticering (n=33) var CR-raten 79 % (95 % CI: 61, 91) og den 4-mdr.
English: Very common Hair disorder* Common
Danish: Almindelig Synsforstyrrelser*
English: • kidney problems
Danish: • Problemer med nyrerne
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Danish: Anafylaktisk chok, amyloidose, immunekompleksmedieret (type III) overfølsomhedsreaktion Det endokrine system Ikke almindelig Cushing's syndrom*, hyperthyroidisme*, uhensigtsmæssig produktion af antidiuretisk hormon
English: Median OS was 90.7 months for the BR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Danish: Med en median opfølgningsvarighed på 40 måneder var den mediane OS (56,3 måneder i R-CHOP-gruppen og ikke nået i BR-CAP-gruppen) højest i BR-CAP-gruppen (estimeret HR=0,80; p=0,173).
English: Then, bortezomib may be reinitiated with one dose level reduction (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
Danish: Bortezomib kan så genoptages med et reduceret dosisniveau (fra 1,3 mg/m til
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Danish: Se det relevante produktresumé for yderligere oplysninger om pegyleret liposomal doxorubicin
English: #, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc
Danish: perikardie-effusion)*, kardiomyopati*, ventrikeldysfunktion*, bradykardi
English: Immune system disorders Common
Danish: Immunsystemet
English: Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Danish: dissemineret & oftalmisk), pneumoni*, herpes simplex*, svampeinfektion* Ikke almindelig Infektion*, bakterieinfektion*, virusinfektion*, sepsis (inkl.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning er til intravenøs eller subkutan anvendelse.
English: - Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL - Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration - Haemoglobin ≥ 8 g/dL - Non-haematological toxicities should have resolved to grade 1 or baseline.
Danish: • Trombocyttal skal være ≥ 75.000 celler/µl hos patienter med infiltreret knoglemarv eller sekvestration i milten.
English: Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Danish: Almindelig Dyspnø*, epistaxis, øvre/nedre luftvejsinfektion*, hoste* Ikke almindelig Lungeemboli, pleural effusion, lungeødem (inkl.
English: What Bortezomib Fresenius Kabi looks like and contents of the pack Bortezomib powder for solution for injection is a white to off-white lyophilized powder or cake.
Danish: Udseende og pakningsstørrelser Bortezomid pulver til injektionsvæske, opløsning er et hvidt til offwhite frysetørret pulver eller masse.
English: Combination therapy with pegylated liposomal doxorubicin Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: Kombinationsbehandling med pegyleret liposomal doxorubicin Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: * Survival update based on a median duration of follow-up at 60.1 months mo: months
Danish: Alle randomiserede patienter med sekretorisk sygdom * Opdatering af overlevelsesdata baseret på en median opfølgning på 60,1 måneder mdr.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: Fritaget fra krav om brailleskrift.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning ER BEREGNET TIL SUBKUTAN ELLER INTRAVENØS ANVENDELSE.
English: a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c
Danish: Der indgik 222 forsøgspersoner i studiet, og 221 af disse blev behandlet med bortezomib c
English: Pulmonary disorders
Danish: Lungesygdomme
English: Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Danish: synkope), svimmelhed*, dysgeusi*, letargi, hovedpine* Ikke almindelig Tremor, perifer sensomotorisk neuropati, dyskinesi*, cerebral koordination og balanceforstyrrelser*, hukommelsestab (ekskl.
English: Bortezomib therapy should be withheld
Danish: Behandling med bortezomib skal indstilles.
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Danish: TTP (hazard ratio 0,385; 95 % CI 0,212--0,698; p = 0,001) for bortezomib sammen med dexamethason over bortezomib som monoterapi.
English: Immune system disorders Uncommon Angioedema
Danish: leversygdom) Ikke almindelig Leversvigt
English: Uncommon Cerebrovascular accident
Danish: Ikke almindelig Hjertetamponade
English: • Inflammation of the pancreas, obstruction of the bile duct
Danish: • Betændelse i bugspytkirtlen, tilstoppet galdegang
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Danish: trombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme.
English: Lot
Danish: Frekvens
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Danish: øjenlåg), erhvervet dacryoadenitis, fotofobi, fotopsi, optisk neuropati varierende grader af synsnedsættelse (indtil blindhed)*
English: (check that the syringe is marked as subcutaneous administration).
Danish: Tjek dosis og koncentration i sprøjten før brug (kontroller, at sprøjten er mærket som subkutan administration).
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Danish: Clostridium difficile)*, iskæmisk kolitis gastrointestinal inflammation*, dysfagi, colon irritabile, uspecificeret sygdom i mave-tarm-kanalen, belagt tunge, motilitetsforstyrrelser af mave-tarmkanalens funktion*, sygdom i spytkirtlerne*
English: Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
Danish: Responspopulation omfatter patienter, som havde målbar sygdom ved baseline f
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Danish: septisk chok)*, bronkopneumoni, herpes virusinfektion*, herpetisk meningoencefalitis bakteriæmi (inkl.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Renal impairment*
Danish: Hårsygdom*
English: Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention
Danish: Almindelig Hypokalæmi*, abnormal blodglucose*, hyponatræmi*, diabetes mellitus*, væskeretention Ikke almindelig Tumorlysesyndrom Psykiske forstyrrelser Almindelig Søvnlidelser og søvnforstyrrelser* Nervesystemet
English: • Drooling
Danish: • Savlen
English: Hepatotoxicity (inc liver disorder) Uncommon Hepatic failure
Danish: Lever og galdeveje Almindelig Abnorme leverenzymer* Ikke almindelig Hepatotoksicitet (inkl.
English: * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Danish: * VN.U: Vironeutraliserende antistoftiter efter vaccination af marsvin.
English: EU/2/99/017/001 Bovalto Ibraxion gE deleted inactivated IBR virus, at least 0.75
Danish: EU/2/99/017/001 Bovalto gE-deleted
English: Emulsion for injection
Danish: Injektionsvæske,
English: Target Species Route of administration
Danish: Type I-glasflaske 5 doser
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14. marts 2011
English: Postmarketing Studies
Danish: Postmarketing studier
English: If this happens to you, do not drive or use machines.
Danish: Hvis dette sker, må du hverken køre eller betjene maskiner.
English: Repso may make you dizzy.
Danish: Repso kan gøre dig svimmel.
English: Children and adolescents Repso is not recommended for use in children and adolescents below 18 years of age.
Danish: Børn og unge Repso anbefales ikke til børn og unge under 18 år.
English: For more information on these, please read section 4 (Possible Side Effects).
Danish: For at få mere information om dette, skal du læse punkt 4 (Bivirkninger).
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at gøre motorkøretøj og betjene maskiner
English: Oral contraceptives
Danish: Oral kontraceptiva