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Dovprela (previously Pretomanid FGK) · 4.8 · ECG QT interval prolongation QT prolongation is a known adverse reaction of bedaquiline. Bedaquiline in combin
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · In the TB-PRACTECAL trial in which moxifloxacin was administered along with BPaL regimen, ADRs of increased tr
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · In the TB-PRACTECAL trial, 52 patients reported ADRs of myelosuppression in the BPaLM arm, out of which 27 (18
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · In the ZeNix trial overall, 4 (2.2%) patients reported a treatment emergent event of optic neuropathy. All 4 p
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · In the ZeNix trial, there was a greater incidence of events of myelosuppression, 28.9% versus 13.3%, for the 1
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · In the combined study data, 2 patients reported serious events of anaemia with linezolid 1200 mg, and none wer
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Increased transaminases In the Nix-TB trial in which 109 patients were treated with pretomanid in combination
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Most of these adverse reactions were grade 1 and occurred after 8 weeks.
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Myelosuppression Myelosuppression is a known adverse reaction of linezolid. In the Nix-TB trial, 37% (very com
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Optic neuropathy Optic neuropathy is a known adverse reaction of linezolid. Two patients (2%, common) in the N
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Refer to the Summary of Product Characteristics of bedaquiline, linezolid and moxifloxacin for more informatio
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · System Organ Very Common Common Uncommon Class ≥1/10 ≥1/100 to <1/10 ≥1/1,000 to <1/100 Infections and Vulvova
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Table 1: Adverse Drug Reactions from Clinical Studies
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · Tabulated list of pretomanid adverse reactions
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · The most frequent adverse drug reactions (ADRs) during treatment with pretomanid in combination with bedaquili
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · The table below displays ADRs, by system organ class and frequency, which are considered at least possibly rel
Eintrag öffnenDovprela (previously Pretomanid FGK) · 4.8 · When pretomanid in BPaL regimen was administered along with moxifloxacin in the TB- PRACTECAL trial in BPaLM a
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