Eksempler på bruk av Subcutaneous formulation på Engelsk og deres oversettelse til Norsk
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The interval between consecutive Herceptin subcutaneous formulation administrations should not be less than three weeks.
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. .
Post-operative wound infections(severe and/or serious): 1.7% versus 3.0% for the intravenous formulation versus subcutaneous formulation.
Results were consistent with the known safety profile for Herceptin intravenous and Herceptin subcutaneous formulations.
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. .
Amongst the most serious and/or common adverse reactions reported in Herceptin usage(intravenous and subcutaneous formulations) to date are cardiac dysfunction,
with a greater proportion of patients with severe events(NCI CTCAE grade≥3)< 1% versus 2.0% the intravenous and subcutaneous formulations respectively.
Administration-related reactions(ARRs) are known to occur with Herceptin subcutaneous formulation.
handling of Herceptin subcutaneous formulation refer to section 6.6.
All of the severe ARRs with the Herceptin subcutaneous formulation occurred during concurrent administration with chemotherapy.
The dose of 1600 mg of MabThera subcutaneous formulation was selected for the Part 2 of the study.
The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 18 years have not been established.
Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours
During the treatment course with Herceptin subcutaneous formulation other medicinal products for subcutaneous administration should preferably be injected at different sites.
During the treatment course with MabThera subcutaneous formulation, other medicinal products for subcutaneous administration should preferably be given at different sites.
Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies performed with the subcutaneous formulation.
The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild
Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
During the treatment course with Herceptin subcutaneous formulation in administration system, other medicinal products for subcutaneous administration should preferably be injected at different sites.