Rheumatoid Arthritis From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose, and discard. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and add to the infusion bag. To mix the solution, gently invert the bag to avoid foaming. pJIA and sJIA patients 30 kg ≥ From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and dilute in a 100 mL infusion bag containing sterile, non-pyrogenic 0.9% sodium chloride solution. To mix the solution, gently invert the bag to avoid foaming. pJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.5 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. sJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.6 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. OVERDOSAGE are limited data available on overdosage with ACTEMRA. One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose-limiting neutropenia was observed. Treatment of overdose should consist of general supportive measures. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia). PRESENTATION AND STORAGE ACTEMRA is available as: *(not marketed)
Rheumatoid Arthritis From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose, and discard. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and add to the infusion bag. To mix the solution, gently invert the bag to avoid foaming. pJIA and sJIA patients ≥ 30 kg From a 100 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to the volume of the ACTEMRA solution required for the patient’s dose. Withdraw the required amount of ACTEMRA (0.4 mL per kg of the patient’s body weight) under aseptic conditions and dilute in a 100 mL infusion bag containing sterile, non-pyrogenic 0.9% sodium chloride solution. To mix the solution, gently invert the bag to avoid foaming. pJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.5 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. sJIA patients < 30 kg From a 50 mL infusion bag, withdraw a volume of 0.9% sodium chloride solution equal to 0.6 mL/kg of the patient’s body weight and discard. This volume should be replaced in the saline bag with an equal volume of ACTEMRA under aseptic conditions. To mix the solution, gently invert the bag to avoid foaming. OVERDOSAGE are limited data available on overdosage with ACTEMRA. One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose-limiting neutropenia was observed. Treatment of overdose should consist of general supportive measures. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia). PRESENTATION AND STORAGE ACTEMRA is available as: *(not marketed)
auspar-tocilizumab-150112-pi.docx