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Potactasol
Eintrag öffnenPotactasol · 4.1 Therapeutic indications · 1
Eintrag öffnenPotactasol · 4.3 Contraindications · 1
Eintrag öffnenPotactasol · 4.3 · - Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-f
Eintrag öffnenPotactasol · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenPotactasol · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenPotactasol · 4.5 · No in vivo human pharmacokinetic interaction studies have been performed.
Eintrag öffnenPotactasol · 4.5 · Topotecan does not inhibit human P450 enzymes (see section 5.2). In a population study using the intravenous r
Eintrag öffnenPotactasol · 4.5 · When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may
Eintrag öffnenPotactasol · 4.5 · When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered
Eintrag öffnenPotactasol · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenPotactasol · 4.8 Undesirable effects · 1
Eintrag öffnenPotactasol · 4.8 · 6 uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (canno
Eintrag öffnenPotactasol · 4.8 · 7 Haematological Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, wit
Eintrag öffnenPotactasol · 4.8 · Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these eve
Eintrag öffnenPotactasol · 4.8 · Adverse reactions are listed below, by system organ class and absolute frequency (all reported events). Freque
Eintrag öffnenPotactasol · 4.8 · Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses). Red cell transfusions were
Eintrag öffnenPotactasol · 4.8 · Blood and lymphatic system disorders Very common: febrile neutropenia neutropenia (see Gastrointestinal disord
Eintrag öffnenPotactasol · 4.8 · Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan. Severe (Grade
Eintrag öffnenPotactasol · 4.8 · Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported
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