Примери за използване на Caplacizumab на Английски и техните преводи на Български
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Each vial contains 10 mg caplacizumab.
The effects of caplacizumab on fertility in humans are unknown.
Powder vial The active substance is caplacizumab.
Go to step 10 to inject caplacizumab under the skin of the belly.
Cablivi contains the active substance caplacizumab.
The t1/2 of caplacizumab is, therefore, concentrationand target level-dependent.
STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
The median treatment duration with caplacizumab in the double blind period was 35 days.
Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.
Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses(see section 5.3).
In studied populations; gender, age, blood group andrace did not affect the pharmacokinetics of caplacizumab.
The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor.
No formal study of the effect of hepatic orrenal impairment on the pharmacokinetics of caplacizumab has been conducted.
After absorption, caplacizumab binds to the target and distributes to well perfused organs.
A follow-up toxicokinetic study in pregnant guinea pigs assessed exposure of caplacizumab in the dams and foetuses.
Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count response(p< 0.01).
If a recurrence occurred while on study drug treatment,patients were switched to open-label caplacizumab.
In the clinical development program, caplacizumab has been administered daily for up to 65 days.
As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
In case of overdose,based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding.
The pharmacokinetics of caplacizumab have been investigated in healthy subjects after single intravenous infusions and after single and repeated subcutaneous injections.
Patients received a single intravenous bolus injection of 10 mg caplacizumab or placebo prior to the first plasma exchange on study.
Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
No studies have been performed to evaluate the mutagenic potential of caplacizumab, as such tests are not relevant for biologicals.
The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis on pooled pharmacokinetic data.
The proportion of patients with a recurrence of aTTP(exacerbation or relapse) in the overall study period(including the 28 day follow-up after discontinuation of study drug treatment)was 67% lower in the caplacizumab group(9/72; relapse: 6/72) compared to the placebo group(28/73; relapse 0/73)(p< 0.001).
After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed(estimated F> 0.901) in the systemic circulation.
Full inhibition of von Willebrand factor-mediated platelet aggregation by caplacizumab is indicated by RIPA and RICO levels dropping below 10% and 20%, respectively.
Target-bound caplacizumab is assumed to be catabolised within the liver, whereas unbound caplacizumab is assumed to be renally cleared.
Dedicated animal studies assessing the effects of caplacizumab on male and female fertility have not been performed.