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AstraZeneca

Grastofil
filgrastim

PACKAGE LEAFLET: INFORMATION FOR THE USER


Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe

filgrastim


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Grastofil looks like and contents of the pack


Grastofil is a clear colourless solution for injection or infusion. It is supplied in a pre-filled syringe with an injection needle marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel. Each pre-filled syringe contains 0.5 mL of solution.


Grastofil is available in packs containing 1 and 5 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center Moll de Barcelona

s/n, Edifici Est 6ª planta

08039 Barcelona Spain


Manufacturer

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden Netherlands


Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PL / PT / RO / SE / SI / SK / UK(NI)

Accord Healthcare S.L.U. Tel: +34 93 301 00 64


EL

Rafarm AEBE

Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Τηλ: +30/2106776550


This leaflet was last revised in MM/YYYY




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The following information is intended for medical or healthcare professionals only:


In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.


If required, Grastofil may be diluted in 5% glucose. 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 200 mg/mL (20%) human albumin solution added.

When diluted in 5% glucose, Grastofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.