Примери за използване на Sarilumab на Английски и техните преводи на Български
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The active substance is sarilumab.
The metabolic pathway of sarilumab has not been characterised.
KEVZARA 150 mg injection sarilumab.
Sarilumab is eliminated by parallel linear and non-linear pathways.
Kevzara contains the active substance sarilumab.
Sarilumab was detected in the serum of neonates up to 1 month.
Kevzara contains the active substance sarilumab.
The excretion of sarilumab in Cynomolgus monkey's milk has not been studied.
Body weight influenced the pharmacokinetics of sarilumab.
The excretion of sarilumab in milk has not been studied in animals(see section 5.3).
Kevzara 200 mg solution for injection in a pre-filled pen sarilumab.
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution(131.6 mg/ml).
Mild to moderate renal impairment did not affect the pharmacokinetics of sarilumab.
Interaction of sarilumab with substrates of other CYPs(CYP2C9, CYP 2C19, CYP2D6) has not been studied.
Kevzara should not be used during pregnancy unless the clinical condition of the woman requires treatment with sarilumab.
Following single-dose subcutaneous(SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Sarilumab exposure was not affected when coadministered with MTX based on the population pharmacokinetic analyses and across study comparisons.
By preventing interleukin-6 from attaching to its receptors, sarilumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids(see section 4.4).
In 17 patients with RA, one week following a single 200-mg subcutaneous administration of sarilumab, exposure of simvastatin and simvastatin acid decreased by 45% and 36%, respectively(see section 4.5).
Sarilumab is a human monoclonal antibody selective for the interleukin-6(IL-6) receptor, produced in Chinese Hamster Ovary cells by recombinant DNA technology.
After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Population pharmacokinetic analyses in adult patients with RA(ranging in age from18 to 88 years with 14% over 65 years) showed that age, gender andrace did not meaningfully influence the pharmacokinetics of sarilumab.
As a monoclonal antibody sarilumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Because IgG1 are excreted in human milk,a decision should be made whether to discontinue breastfeeding or to discontinue sarilumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
The active substance in Kevzara, sarilumab, is a monoclonal antibody, a type of protein which has been designed to attach to and block the receptor(target) for a molecule called interleukin-6.
The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
Sarilumab is a human monoclonal antibody(IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors(IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130(gp130) and the Signal Transducer and Activator of Transcription-3(STAT-3).
Blockade of IL-6 signalling by IL-6Rα antagonists such as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered medicinal products concentrations.
Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations.