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AstraZeneca

Accofil
filgrastim

PACKAGE LEAFLET: INFORMATION FOR THE USER


Accofil 30 MU/0.5 ml (0.6 mg/ml) solution for injection or 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.



Rare side effects (seen in more than 1 in 10,000 people taking Accofil):


If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.


Reporting of side effects


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If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.


  1. How to store Accofil


    Keep out of the sight and reach of children.


    Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.


    Store in a refrigerator (2°C - 8°C). Do not freeze.


    The syringe can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period, that ends within the labelled expiry date, of up to a maximum of 15 days. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.


    Keep the pre-filled syringe in the carton in order to protect from light.


    Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it.


    Do not put the cover back on used needles, as you may accidentally prick yourself. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  2. Contents of the pack and other information What Accofil contains


What Accofil looks like and contents of the pack


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


Accofil is available in packs containing 1, 3, 5, 7 and 10 pre-filled syringes, with or without prefixed needle safety guard and alcohol swabs.


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

Accord Healthcare Limited Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF United Kingdom


Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland


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Accord Healthcare B.V., Winthontlaan 200,

3526 KV Utrecht,

The Netherlands


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This leaflet was last revised in


.eu


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


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

Accidental exposure to freezing temperatures for up to 48 hours does not affect the stability of Accofil. If exposure has been greater than 48 hours or frozen more than once then Accofil should NOT be used.


In order to improve traceability of granulocyte-colony stimulating factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient file


Accofil 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, Accofil 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, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.


After dilution


Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 30 hours at 25 °C ± 2 °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 30 hours at 25 °C ± 2 °C, unless dilution has taken place in controlled and validated aseptic conditions.


Using the pre-filled syringe with a needle safety guard


The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.


Using the pre-filled syringe without a needle safety guard


Administer the dose as per standard protocol.


Do not use a pre-filled syringe if it has been dropped on a hard surface.


Disposal


Any unused product or waste material should be disposed of in accordance with local requirements.