Actemra (tocilizumab) Product Information (PI) - Roche Australia

• Single use vial containing 80 mg of ACTEMRA in 4 mL (20 mg/mL). Packs of 1
and 4* vials.
• Single use vial containing 200 mg of ACTEMRA in 10 mL (20 mg/mL). Packs
of 1 and 4* vials.
• Single use vial containing 400 mg of ACTEMRA in 20 mL (20 mg/mL). Packs
of 1 and 4* vials.
Store vials at 2ºC – 8ºC. (Refrigerate. Do not freeze.) Keep the container in the outer
carton in order to protect from light.
ACTEMRA does not contain any antimicrobial agent; therefore care must be taken to
ensure the sterility of the prepared solution. Product is for single use in one patient only.
Discard any residue.
The prepared infusion solution of ACTEMRA is physically and chemically stable in
0.9% w/v sodium chloride solution at 30ºC for 24 hours. To reduce microbiological
hazard, the prepared infusion should be used immediately. If storage is necessary, hold at
2ºC – 8ºC for not more than 24 hours.
Do not use after the expiry date (EXP) shown on the pack.
Disposal of Medicines
The release of medicines into the environment should be minimised. Medicines should
not be disposed of via wastewater and disposal through household waste should be
avoided. Unused or expired medicine should be returned to a pharmacy for disposal.
POISON SCHEDULE
Prescription Only Medicine (S4)
SPONSOR
Roche Products Pty Limited
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
AUSTRALIA
Customer enquiries: 1800 233 950
Distributed in New Zealand by:
Actemra ® PI 131004 36 of 37
CDS 8.0