Примери за използване на Brodalumab на Английски и техните преводи на Български
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The active substance is brodalumab.
Brodalumab belongs to a group of medicines called interleukin(IL) inhibitors.
Ml solution contains 140 mg brodalumab.
It is not known whether brodalumab passes into breast milk.
Kyntheum 210 mg injection brodalumab.
The pharmacokinetics of brodalumab was similar between Japanese and non-Japanese patients with psoriasis.
Kyntheum is a medicine that contains the active substance brodalumab.
Carcinogenicity studies with brodalumab have not been conducted.
Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab.
Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary(CHO) cells.
No data are available on the effect of brodalumab on human fertility.
Brodalumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Population pharmacokinetic analysis indicated that gender did not have an effect on brodalumab pharmacokinetics.
Renal elimination of intact brodalumab, an IgG monoclonal antibody, is expected to be low and of minor consequence.
Based on population pharmacokinetic modelling, the estimated mean steady-state volume of distribution of brodalumab was approximately 7.24 L.
Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body.
Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Brodalumab is expected to be mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance.
By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease.
Brodalumab clearance decreases with increasing dose and exposure increases in a greater than doseproportional manner.
Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance(CL/F) is 2.95 L/day.
Brodalumab concentrations below LLOQ(Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
Serum concentrations in monkey infants andin foetal rabbits indicated considerable passage of brodalumab from the mother to the foetus at the end of pregnancy.
The subcutaneous bioavailability of brodalumab estimated by population pharmacokinetic modelling was 54.7%(relative standard error[RSE]= 4.25%).
In a local tolerance test in rabbits,moderate to severe edema was observed after subcutaneous injection of a formulation containing brodalumab at the clinical concentration of 140 mg/ml.
Following subcutaneous administrations of 210 mg, brodalumab exhibits non-linear pharmacokinetics typical for a monoclonal antibody that undergoes target-mediated drug disposition.
In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.
As an IgG2 human monoclonal antibody brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Based on population pharmacokinetic modelling the estimated half-life of brodalumab was 10.9 days at steady-state after every other week subcutaneous dose of 210 mg.
As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.