Source: Health Products Regulatory Authority (ZA) Revision Year: 2015 Publisher: Amgen South Africa (Pty) Ltd. Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, South Africa
To reduce the duration of neutropenia and the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Adults (≥18 years): One 6 mg dose (a single pre-filled syringe) of NEULASTIM is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Children and Adolescents: There are insufficient data to recommend the use of NEULASTIM in children and adolescents under 18 years of age.
NEULASTIM therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
NEULASTIM pre-filled syringe is for single use only.
NEULASTIM is a sterile but unpreserved solution.
Before administration, NEULASTIM solution should be inspected for visible particles. Only a solution that is clear and colourless should be injected.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Allow the pre-filled syringe to reach room temperature before injecting. Any unused product or waste material should be disposed of in accordance with local requirements.
Single doses of 300 µg/kg have been administered to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse effects. The adverse events were similar to those in subjects receiving lower doses of NEULASTIM.
Store at 2-8°C (in a refrigerator). Do not freeze. Keep the container in the outer carton, in order to protect from light.
Keep out of reach and sight of children.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of NEULASTIM.
NEULASTIM may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. NEULASTIM left at room temperature for more than 72 hours should be discarded. Do not use after the expiry date (EXP) shown on the pack.
1 ml clear colourless Type I glass pre-filled syringe (containing 0,6 ml) with a stainless steel needle, for single use only. Cartons with 1 or 5 syringes.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
