Voorbeelden van het gebruik van Pasireotide in het Engels en hun vertalingen in het Nederlands
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Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity see section 5.3.
The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete.
Available data in rats in which pasireotide was administered via the subcutaneous route have shown excretion of pasireotide in milk see section 5.3.
Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies performed with the subcutaneous formulation.
Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate,
Based on in vitro data pasireotide appears to be a substrate of efflux transporter P-gp P-glycoprotein.
Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection pasireotide.
Signifor 0.3 mg: One ampoule of 1 ml solution contains 0.3 mg pasireotide.
Signifor 20 mg is available in unit packs containing one vial of powder with 20 mg pasireotide and one pre-filled syringe with 2 ml solvent.
patients receiving pasireotide in clinical studies.
were also observed in patients receiving pasireotide in clinical studies.
Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate,
Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 20 mg to 60 mg every 4 weeks in patients with acromegaly.
Safety assessment was made based on 491 acromegaly patients who received pasireotide(419 patients received pasireotide intramuscular use and 72 received pasireotide subcutaneous use) in phase I, II and III studies.
48.6% of patients(36/74) in the pasireotide intramuscular use group
solvent for suspension for injection pasireotide.
LLN was 25.9% in the pasireotide intramuscular use group
and other somatostatin analogues, pasireotide exerts its pharmacological activity via binding to somatostatin receptors.
were comparable between pasireotide intramuscular use
the study(i.e. month 3) by a higher proportion of patients in the pasireotide intramuscular use arm than in the octreotide intramuscular use arm(30.1%