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AstraZeneca

Filgrastim ratiopharm
filgrastim

PACKAGE LEAFLET: INFORMATION FOR THE USER


Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion


Filgrastim


Read all of this leaflet carefully before you start using this medicine.


THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY


Filgrastim ratiopharm does not contain any preservative. In view of the possible risk of microbial contamination, Filgrastim ratiopharm syringes are for single use only.


Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.


Filgrastim ratiopharm should not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except those mentioned below. Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.


If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion. Dilution to a final concentration less than 0.2 MIU (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 MIU (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 MIU (300 μg) should be given with

0.2 ml of 200 mg/ml (20%) human albumin solution added. When diluted in glucose 50 mg/ml (5%) solution for infusion, Filgrastim ratiopharm is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.


Medicinal product no longer authorised

After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.