Nivestim Caution For Usage

Incompatibilities: Nivestim should not be diluted with sodium chloride solutions.
Diluted filgrastim may be adsorbed to glass and plastic materials unless it is diluted in 5% glucose solution (see Special precautions for disposal as follows).
This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal as follows.
Special precautions for disposal: If required, Nivestim may be diluted in 5% glucose solution.
Dilution to a final concentration less than 0.2 MU (2 μg) per ml is not recommended at any time.
The solution should be visually inspected prior to use. Only clear solutions without particles should be used.
For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 μg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 μg) should be given with 0.2 ml of 20% human albumin solution Ph. Eur. added.
Nivestim contains no preservative. In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.
When diluted in 5% glucose solution, filgrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Any unused product or waste material should be disposed of in accordance with local requirements.
Interchangeability and automatic substitution: Nivestim has been developed as a similar biological medicinal product to Neupogen and has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, interchangeability with the reference product, Neupogen, may be considered if this is in agreement with the treating physician. However, automatic substitution (i.e. the practice by which a different product to that specified on the prescription is dispensed to the patient without the prior informed consent of the treating physician) and active substance-based prescription cannot apply to biologicals, including biosimilars. Such a differentiating approach towards biologicals ensures that treating physicians can make informed decisions about treatments in the interest of patients' safety.