Eksempler på bruk av Intravenous formulation på Engelsk og deres oversettelse til Norsk
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Tabulated list of adverse reactions with the intravenous formulation.
MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at Cycle 8.
KANJINTI intravenous formulation is not for subcutaneous use and should be given as an.
For instructions on reconstitution of Herceptin intravenous formulation before administration, see section 6.6.
MabThera intravenous formulation was used at the standard dose of 375 mg/m2 body surface area.
In light of these data the duration of treatment with the intravenous formulation should be no longer than 6 months.
The intravenous formulation produced local irritation at the site of injection in both rabbits and rats.
For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
KANJINTI intravenous formulation is given as an intravenous infusion(“drip”) directly into your veins.
The absolute bioavailability of stiripentol is not known since an intravenous formulation is not available for testing.
An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Hypertension: 4.7% versus 9.8% for the intravenous formulation versus subcutaneous formulation respectively.
Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in NHL(see section 4.8).
MabThera intravenous formulation(n= 205): 8 cycles of MabThera intravenous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
The MabThera intravenous formulation has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation. .
The objective of the Part 1 was to select a MabThera subcutaneous formulation dose that resulted in comparable MabThera serum Ctrough levels compared with MabThera intravenous formulation.
Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion,using MabThera intravenous formulation.
The rate of severe infections(NCI CTCAE grade≥3) was 5.0% versus 7.1%, in the Herceptin intravenous formulation arm and the Herceptin subcutaneous formulation arm respectively.
Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion,using MabThera intravenous formulation(see section 4.4).
MabThera subcutaneous formulation(n= 205):first cycle MabThera intravenous formulation plus 7 cycles of MabThera subcutaneous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Post-operative wound infections(severe and/or serious): 1.7% versus 3.0% for the intravenous formulation versus subcutaneous formulation, .
The safety profile of Herceptin subcutaneous formulation(evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively)from the pivotal trial BO22227 in EBC was overall similar to the known safety profile of the intravenous formulation.
The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is: MabThera intravenous formulation 375 mg/m2 body surface area administered on day 0 of the first cycle of treatment followed by MabThera subcutaneous formulation injected at a fixed dose of 1600 mg per cycle, on day 1 of each subsequent cycle in total: 6 cycles.
If patients were not able to receive one full MabThera intravenous infusion dose prior to the switch,they should continue the subsequent cycles with MabThera intravenous formulation until a full intravenous dose is successfully administered.
Severe adverse events(defined according to National Cancer Institute Common Terminology Criteriafor Adverse Events(NCI CTCAE grade≥3) version 3.0) were equally distributed between both Herceptin formulations 52.3% versus 53.5% in the intravenous formulation versus subcutaneous formulation respectively.
A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation demonstrated that trastuzumab is secreted in the milk.