natgillin/translations-raw huggingface dataset:
Ikke almindelig Akut respiratorisk distress syndrom, lungeemboli, pneumonitis, pulmonal hypertension, lungeødem (inkl.
Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
105 (81%) og 78 (61%) patienter i henholdsvis BTDx- og TDx-gruppen fik en enkelt autolog stamcelletransplantation.
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Patienterne i BR-CAP-gruppen fik bortezomib (1,3 mg/m på dag 1, 4, 8, 11, pause dag 12-21), rituximab 375 mg/m 2 i.v.
Patients in the BR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab
Brug ikke Bortezomib Hospira - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i Bortezomib
Do not use Bortezomib Hospira - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Dyspnø*, hoste*, hikke
Dyspnoea*, Cough*, Hiccups
Muskelspasmer*, muskuloskeletale smerter*, ekstremitetssmerter
Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Afbryd behandling med Bortezomib Hospira, indtil toksicitetssymptomerne er svundet til grad 1 eller niveauet ved baseline.
Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
• Information om, at kravene til rekonstitution af Bortezomib Hospira 1 mg, 2,5 mg, 3 mg og 3,5
• different reconstitution requirements for Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg IV or
#, bronkospasme, kronisk obstruktiv lungesygdom*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning
#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Hvis der opstår lokale reaktioner på injektionsstedet efter en subkutan injektion af Bortezomib Hospira, bør det enten gives i en lavere koncentration (Bortezomib Hospira rekonstitueres til 1 mg/ml i stedet for 2,5 mg/ml), eller der bør skiftes til intravenøs injektion.
If local injection site reactions occur following Bortezomib Hospira subcutaneous injection, either a less concentrated Bortezomib Hospira solution (Bortezomib Hospira to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Patienter, som er egnede til stamcelletransplantation Der blev gennemført 2 randomiserede, åbne fase III-multicenter-forsøg (IFM-2005-01, MMY-3010) til påvisning af bortezomibs sikkerhed og effekt i dobbelte og tredobbelte kombinationer med andre cytostatika som induktionsterapi forud for stamcelletransplantation hos patienter med tidligere ubehandlet myelomatose.
Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Hos B-ALL-patienter med recidiv inden for 18-36 måneder efter diagnosticering (n=33) var CR-raten 79% (95% CI: 61-91), og den hændelsesfrie overlevelsesrate efter 4 måneder var 73% (95% CI: 54, 85).
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).
Hvis bortezomib gives sammen med pegyleret liposomal doxorubicin, får du bortezomib intravenøst eller subkutant i en 21-dages behandlingscyklus, og pegyleret liposomal doxorubicin gives i en dosis på 30 mg/m2 på dag 4 i den 21-dages behandlingscyklus med bortezomib som en intravenøs infusion efter injektionen af bortezomib.
When bortezomib is given together with pegylated liposomal doxorubicin, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the bortezomib 21-day treatment cycle as an intravenous infusion after the bortezomib injection.
Der gives 9 behandlingscyklusser med denne kombination.
Nine treatment cycles of this combination therapy are administered.
• Stivhed i led eller muskler, følelse af tunghed, smerter i lysken
• Joint or muscle stiffness, sense of heaviness, pain in your groin
De bivirkninger, du kan få, hvis du får bortezomib sammen med andre lægemidler til behandling af mantle-celle-lymfom, er angivet nedenfor:
If you are given bortezomib together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
(24,7; 31,1) 19,2 mdr.
27.0 mo (24.7, 31.1) 19.2 mo (17.0, 21.0)
CR-raten hos patienter med første recidiv af T-celle-ALL (n=22) var 68% (95% CI: 45-86), og den hændelsesfrie overlevelsesrate efter 4 måneder var 67% (95% CI: 42, 83).
The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Alvorlige, ikke almindelige bivirkninger, der er indberettet under behandling med bortezomib, omfatter hjerteinsufficiens, tumorlysesyndrom, pulmonal hypertension, posteriort reversibelt encefalopatisyndrom samt akutte, diffuse, infiltrative lungesygdomme.
Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
B = bortezomib; BTDx = bortezomib, thalidomid, dexamethason; TDx = thalidomid, dexamethason; PR = partielt respons;
B=bortezomib; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
Reaktivering og infektion af hepatitis B-virus (HBV) Hvis rituximab anvendes i kombination med Bortezomib Hospira, skal patienter med risiko for HBVinfektion altid screenes for HBV, inden behandlingen startes.
When rituximab is used in combination with Bortezomib Hospira, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Der er hos patienter behandlet med bortezomib indberettet meget sjældne tilfælde af John Cunningham-virus (JC-virus), der førte til PML og dødsfald.
Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Bortezomib Hospira pulver til injektionsvæske, opløsning, er en hvid til offwhite masse eller et hvidt til offwhite pulver.
What Bortezomib Hospira looks like and contents of the pack Bortezomib Hospira powder for solution for injection is a white to off-white cake or powder.
Bortezomib-pulveret skal opløses, før det gives.
Bortezomib powder has to be dissolved before administration.
Hos B-ALL-patienter med recidiv inden for 18 måneder efter diagnosticering (n=27) var CR-raten 67% (95% CI: 46-84), og den hændelsesfrie overlevelsesrate efter 4 måneder var 44% (95% CI: 26, 62).
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).
FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Sjælden Respirationssvigt, akut respiratorisk distress syndrom, apnø, pneumothorax, atelektase, pulmonal hypertension, hæmoptysis, hyperventilation, ortopnø, pneumonitis, respirationsalkalose, takypnø, lungefibrose, bronkiesygdom*, hypokapni*, interstitiel lungesygdom, lungeinfiltration, sammensnøring af halsen, tørhed i halsen, øget sekret i de øvre luftveje, halsirritation, hostesyndrom i øvre luftveje
Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upperairway cough syndrome
Afbryd behandlingen med Bortezomib Hospira, indtil toksicitetssymptomerne er forsvundet.
Withhold Bortezomib Hospira treatment until symptoms of toxicity have resolved.
• Vejledning i dosering med eksempler: Beregning af patientens legemsoverfladeareal og det nødvendige volumen rekonstitueret Bortezomib Hospira (både til i.v.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Hospira (both IV and SC use) required for different body surface areas.
RR (efter induktion) *CR+nCR
RR (Post-induction) *CR+nCR
Fritaget for krav om brailleskrift.
Justification for not including Braille accepted.
1,0 mg/m 2; 1,0 mg/m reduceret til 0,7 mg/m 2).
1 mg/m 2, or from 1 mg/m 2 to 0.7 mg/m 2).
Bortezomib bruges til behandling af mantle-celle-lymfom (en type kræft, som påvirker lymfeknuderne) i kombination med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison, til patienter på 18 år og derover, hvis sygdom ikke tidligere er blevet behandlet, og som ikke er egnede til at gennemgå en transplantation af blodstamceller.
Bortezomib is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Bortezomib Hospira indeholder:
What Bortezomib Hospira contains
I det samme lægemiddelinteraktionsforsøg med undersøgelse af virkningen af dexamethason, en svagere CYP3A4-induktor, på bortezomibs farmakokinetik (som intravenøs injektion) er der ingen signifikant virkning på bortezomibs farmakokinetik, baseret på data fra 7 patienter.
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.
• Forandringer i afføringsmønsteret eller unormalt afføringsmønster
• Changes in or abnormal bowel function
Bortezomib Hospira som monoterapi eller i kombination med pegyleret liposomal doxorubicin eller dexamethason er indiceret til behandling af voksne patienter med progressiv myelomatose, som tidligere har fået mindst én behandling, og som allerede har gennemgået eller er uegnede til hæmatopoietisk stamcelletransplantation.
Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
• Seponér Bortezomib Hospira, hvis toksiciteten ikke svinder efter afbrydelse af behandlingen som defineret ovenfor.
• If, after Bortezomib Hospira has been held, the toxicity does not resolve, as defined above, then Bortezomib Hospira must be discontinued.
p-værdi d
p-value c
dissemineret og oftalmisk), pneumoni*, herpes simplex*, svampeinfektion*
Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
• Infektioner, herunder lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Henviser til responsrate efter den anden transplantation hos patienter, der blev transplanteret 2 gange
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ]
I cyklus 5-9 indgives Bortezomib Hospira én gang om ugen på dag 1, 8, 22 og 29.
In Cycles 5-9, Bortezomib Hospira is administered once weekly on days 1, 8, 22 and 29.
Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter)
Very common side effects (may affect more than 1 in 10 people)
-- Dag
Day
Der er dog påvist kemisk og fysisk stabilitet for det rekonstituerede produkt i 8 timer ved 5°C og 25°C, når det opbevares i det originale hætteglas og/eller i en sprøjte.
However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
• Halsbrand, oppustethed, ræben, luft i tarmene, mavesmerter, blødning fra tarme eller mave
• Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Dosering til patienter med tidligere ubehandlet mantle-celle-lymfom (MCL) Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP) Bortezomib Hospira administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal 2 gange om ugen i 2 uger på dag 1, 4, 8 og 11 efterfulgt af en 10-dages pause på dag 12-21.
Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BR-CAP) Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8 and 11, followed by a 10-day rest period on days 12-21.
I cyklus 1-4 indgives Bortezomib Hospira 2 gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
In Cycles 1-4, Bortezomib Hospira is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Der er dog påvist kemisk og fysisk stabilitet i 8 timer ved 5°C og 25°C, når produktet opbevares i det originale hætteglas og/eller en sprøjte.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
• Knoglebrud
• Fracture
Thalidomid administreres oralt i en dosis på 50 mg dagligt på dag 1-14 og forhøjes, hvis denne dosis tolereres, til 100 mg på dag 15-28.
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Bortezomib Hospira fås til intravenøs eller subkutan administration.
Bortezomib Hospira is available for intravenous or subcutaneous administration.
subaraknoidal-blødning)*, hjerneødem, transitorisk cerebral iskæmi (TCI), koma, ubalance i det autonome nervesystem, autonom neuropati, kraniel parese*, paralyse*, parese*, præsynkope, hjernestammesyndrom, cerebrovaskulær sygdom, nerverodsskade, psykomotorisk hyperaktivitet, kompression af rygmarven, uspecificeret kognitiv forstyrrelse, motorisk dysfunktion, uspecificeret sygdom i nervesystemet, radikulitis, savlen, hypotoni
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Meget almindelig Kvalme og opkastning*, diarré*, stomatitis*, obstipation Almindelig
Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
• Muskelkramper, muskelspasmer, muskelsvaghed, smerter i arme og ben
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af melphalan-prednison på bortezomibs farmakokinetik (som intravenøs injektion) viser en gennemsnitlig stigning i bortezomibs AUC på 17%, baseret på data fra 21 patienter.
A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients.
Der er indberettet tilfælde af ileus (med frekvensen ”ikke almindelig”se pkt.
Cases of ileus have been uncommonly reported (see section 4.8).
Tid indtil progression Hændelser n (%) Median a
Time to progression Events n (%) Median a (95% CI)
blindhed)*
Vision abnormal*
• Information om, at kravene til rekonstitution er forskellige ved intravenøs (i.v.)
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
Det er yderst vigtigt, at der anvendes aseptisk teknik under håndteringen af Bortezomib Hospira, da det ikke indeholder konserveringsmiddel.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB HOSPIRA SINCE NO PRESERVATIVE IS PRESENT.
#, neurotoksicitet, krampeanfald*, postherpetisk neuralgi, taleforstyrrelser*, restless legs-syndrom, migræne, iskias, opmærksomhedsforstyrrelser, unormale reflekser*, parosmi Sjælden Hjerneblødning*, intrakraniel blødning (inkl.
#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
• I cyklus 1 til 4 gives bortezomib to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
• In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
#, blefaritis øjeninflammation*, diplopi, tørre øjne*, øjenirritation*, øjensmerter, øget tåreflåd, øjenflåd
#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
*RR (efter induktion) CR+nCR
*RR (Post-induction) CR+nCR
Derefter kan Bortezomib Hospira reinitieres med en reduktion på 1 dosisniveau (fra 1,3 mg/m2 til 1 mg/m2 eller fra 1 mg/m2 til 0,7
Then, Bortezomib Hospira may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
dissemineret og oftalmisk), herpes-virusinfektion*, bakterieinfektion*, øvre/nedre luftvejsinfektion*, svampeinfektion*, herpes simplex*
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
De bivirkninger, du kan opleve, hvis du får bortezomib til behandling af myelomatose, er angivet nedenfor:
If you are given Bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
Behandlingen med Bortezomib Hospira skal initieres under tilsyn af en læge med erfaring inden for behandling af cancerpatienter.
Bortezomib Hospira treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Hospira may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
I et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af rifampicin, en potent CYP3A4induktor, på bortezomibs farmakokinetik (som intravenøs injektion) ses en gennemsnitlig reduktion af bortezomibs AUC på 45%, baseret på data fra 6 patienter.
A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
140 patienter med ALL eller LL blev inkluderet og evalueret for så vidt angår sikkerhed.
There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Den rekonstituerede opløsning skal før administration undersøges visuelt for partikler og misfarvning.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Bortezomib Hospira kombineret med rituximab, cyclophosphamid, doxorubicin og prednison er indiceret til behandling af voksne patienter med tidligere ubehandlet mantle-celle-lymfom, som ikke er egnede til hæmatopoietisk stamcelletransplantation.
Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Meget almindelig Pyreksi*, træthed, asteni Almindelig
Very Common Pyrexia*, Fatigue, Asthenia Common
Hvis bortezomib gives sammen med dexamethason, får du bortezomib intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med bortezomib.
When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the bortezomib, 21-day treatment cycle.
og s.c. anvendelse
SC use
Genbehandling af patienter med recidiverende myelomatose I et forsøg, hvor bortezomib-behandling blev gentaget hos 130 patienter med recidiverende myelomatose, som tidligere havde opnået mindst partielt respons med et regimen, der omfattede bortezomib, var de hyppigste bivirkninger af alle grader, der opstod hos mindst 25% af patienterne, thrombocytopeni (55%), neuropati (40%), anæmi (37%), diarré (35%) og obstipation (28%).
Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%),
• Problemer med blodets størkningsevne
• Problems with blood clotting
RR (efter transplantation) CR+nCR
RR (Post-transplant) CR+nCR
tinnitus)* Ikke almindelig Vertigo*, nedsat hørelse (inkl.
Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Se det relevante produktresumé for yderligere oplysninger om melphalan om prednison.
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Tegnene på en sådan reaktion kan være vejrtrækningsbesvær, smerter i brystet eller trykken for brystet og/eller svimmelhed/følelse af at skulle besvime, voldsom kløe i huden eller hævede knuder på huden, hævelser i ansigt, læber, tunge og/eller svælg, som kan give synkebesvær, kollaps
• Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing,
I et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af omeprazol, en potent CYP2C19hæmmer, på bortezomibs farmakokinetik (som intravenøs injektion) er der ingen signifikant virkning på bortezomibs farmakokinetik, baseret på data fra 17 patienter.
In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Dexamethason administreres oralt i en dosis på 20 mg på dag 1, 2, 4, 5, 8, 9, 11 og 12 i behandlingscyklussen med Bortezomib Hospira.
Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of the Bortezomib Hospira treatment cycle.
Hvis bortezomib gives sammen med dexamethason, får du bortezomib intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 21-dages behandlingscyklus med bortezomib.
When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 21-day treatment cycle.