Примери за използване на Bypassing agents на Английски и техните преводи на Български
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Treated bleeds: bleeds treated with bypassing agents.
Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis.
Treated bleeds= bleeds treated with bypassing agents.
Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy.
All bleeds= bleeds treated andnot treated with bypassing agents.
This is because treatment with bypassing agents may need to change while receiving Hemlibra.
The study also enrolled patients who were already taking preventive treatment with medicines known as bypassing agents.
Due to the short half-life of bypassing agents, no carryover effect is assumed after it's discontinuation.
In case a bypassing agent is indicated in apatient receiving Hemlibra prophylaxis, see below for dosing guidance on the use of bypassing agents.
Only a few medicines, called bypassing agents, are suitable for patients with haemophilia A who have developed factor VIII inhibitors.
In the HAVEN 1 study a randomised, multicentre, open-label clinical study in 109 adolescent and adult males(aged≥ 12 years old) with haemophilia A with factor VIII inhibitors who had previouslyreceived either episodic or prophylactic treatment with bypassing agents(aPCC and rFVIIa).
Examples of bypassing agents include activated prothrombin complex concentrate(aPCC) and recombinant FVIIa(rFVIIa).
Forty-nine patients previously treated with prophylactic bypassing agents were enrolled in Arm C to receive Hemlibra prophylaxis.
If bypassing agents(e.g. aPCC and rFVIIa) are required in the perioperative period, please refer to the dosing guidance on the use of bypassing agents in section 4.4.
Before you start using Hemlibra,it is very important to talk to your doctor about using“bypassing agents”(medicines that help blood clot but which work in a different way from factor VIII).
Guidance on the use of bypassing agents concomitantly with emicizumab and on the dosing recommendations for patients requiring treatment with bypassing agents in the perioperative setting;
The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic(on-demand)and prophylactic bypassing agents(separate comparisons) in patients who had participated in the NIS prior to enrolment(Arms A and C, respectively)(see Table 7).
The dose and duration of treatment with bypassing agents will depend on the location and extent of bleeding, and the patient's clinical condition.
The company that markets Hemlibra will issue educational materials for healthcare professionals, patients, carers and laboratory professionals about abnormal clotting side effects,the risk of taking Hemlibra at the same time as bypassing agents and how laboratory tests should be carried out for these patients.
In those cases, doctors prescribe“bypassing agents”― yet another specialty drug that can help the blood clot, but needs even more intensive monitoring.
Treatment(including routine prophylaxis) with bypassing agents(e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy(see section 4.4).
Seven patients previously treated with episodic(“on-demand”) bypassing agents who had participated in the NIS prior to enrolment but were unable to enroll in HAVEN 1 prior to the closure of Arms A and B were enrolled in Arm D to receive Hemlibra prophylaxis.
The day before starting Hemlibra treatment, patients should stop treatment with bypassing agents(medicines used to prevent bleeding in patients with factor VIII inhibitors, such as activated prothrombin complex concentrate or recombinant factor VIIa).
Fifty-three patients previously treated with episodic(“on-demand”) bypassing agents were randomised in a 2:1 ratio to receive Hemlibra prophylaxis(Arm A) or no prophylaxis(Arm B), with stratification by prior 24-week bleed rate(< 9 or≥ 9).
Arm CNIS: previous bypassing agent prophylaxis.
Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator.
There is limited experience with bypassing agent or FVIII use during surgeries and procedures.
The study evaluated the pharmacokinetics, safety, andefficacy including the efficacy of weekly Hemlibra prophylaxis compared with previous episodic and prophylactic bypassing agent treatment in patients who had participated in the NIS prior to enrolment(intra-patient comparison).
In the HAVEN 1 intra-patient analysis, Hemlibra prophylaxis resulted in statistically significant(p= 0.0003) andclinically meaningful reduction(79%) in bleed rate for treated bleeds compared with previous bypassing agent prophylaxis collected in the NIS prior to enrolment(see Table 7).
For bypassing agent guidance refer to section 4.4.