Примери за използване на Intravenous formulation на Английски и техните преводи на Български
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Ketorolac is available in an intravenous formulation.
MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
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.
The absolute bioavailability is unknown due to the lack of an acceptable intravenous formulation for use in man.
The duration of treatment with the intravenous formulation should be no longer than 6 months(see section 5.3).
The median Tmax in the MabThera subcutaneous formulation was approximately 3 days as compared to the Tmax occuring at orclose to the end of the infusion for the intravenous formulation.
Duration of treatment The duration of treatment with the intravenous formulation should be no longer than 6 months see section.
This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
KANJINTI intravenous formulation is given as an intravenous infusion(“drip”) directly into your veins.
Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
For this indication, only the intravenous formulation is of relevance, in line with the outcome of the procedure under Article 45 of Regulation(EC) No.
Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation. .
KANJINTI intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Patients achieving at least PR were entered on MabThera intravenous formulation maintenance therapy once every 8 weeks for 24 months.
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.
Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
The efficacy of infliximab intravenous formulation was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
The rate ofsevere infections(NCI CTCAE grade≥3) was 5.0% versus 7.1%, in the Herceptin intravenous formulation arm and the Herceptin subcutaneous formulation arm respectively.
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.
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.
During the development programme, the safety profile of MabThera subcutaneous formulation was comparable to that of the intravenous formulation with the exception of local cutaneous reactions.
Adverse reactions reported during the two studies with the intravenous formulation(n=35) but not in studies using hard capsules, were infusion site reactions: pain, irritation, pruritus, warmth, swelling, and erythema, as well as haematoma.
Caution is recommended with Herceptin subcutaneous formulation as severe pulmonary events have been reported with the use of the intravenous formulation in the post-marketing setting(see section 4.8).
During infusion of the intravenous formulation of voriconazole in healthy subjects, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnoea, faintness, nausea, pruritus and rash have occurred.
Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with MabThera intravenous formulation(including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials involving MabThera intravenous formulation, and were predominantly seen during the first infusion, usually in the first one to two hours.
The recommended dose is: first cycle,MabThera intravenous formulation: 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle. In total: 8 cycles.