Examples of using Benlysta in English and their translations into Polish
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Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered see section 4.2.
Patients treated with Benlysta should be made aware of the potential risk of severe
It is unknown whether Benlysta is excreted in human milk
The company will provide further information on the safety of Benlysta from a study and from a register of patients being followed up long-term.
The risk of using Benlysta in patients with active
Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Limited data suggest that Benlysta does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of Benlysta. .
The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Therefore, the use of Benlysta in elderly patients is not recommended unless the benefits are expected to outweigh the risks.
Patients received Benlysta 10 mg/kg intravenously over a 1-hour period on Days 0,
Then add the required volume of the reconstituted Benlysta solution into the infusion bag or bottle.
Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta.
The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient.
Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available.
Elderly(> 65 years of age): Benlysta has been studied in a limited number of elderly patients.
20% of patients receiving Benlysta and placebo, respectively.
Infections leading to discontinuation of treatment occurred in 0.6% of patients receiving Benlysta and 1% of patients receiving placebo.
The pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies.
Benlysta treatment should only be started and supervised by a