This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Neupogen Singleject 30 MU (0.6 mg/ml)
Neupogen Singleject 48 MU (0.96 mg/ml)
solution for injection in a pre-filled syringe
filgrastim
1. What Neupogen is and what it is used for 2. Before you use Neupogen 3. How to use Neupogen 4. Possible side effects 5. How to store Neupogen 6. Further information 7. Instructions for injecting Neupogen
Neupogen is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Neupogen works by encouraging the bone marrow to produce more white blood cells.
A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Neupogen stimulates the bone marrow to produce new white cells quickly.
Neupogen can be used:
Please tell your doctor before starting treatment:
If you are a patient with severe congenital neutropenia and you develop leukaemia (cancer of the blood) or are likely to develop leukaemia, you should not use Neupogen.
If you are a stem cell donor, you must be aged between 16 and 60 years.
Take special care with other products that stimulate white blood cells.
Neupogen is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as they may affect the way Neupogen works.
Neupogen has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine. Neupogen could affect your ability to become pregnant or stay pregnant.
You must not use this medicine if you are breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Neupogen should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Neupogen and before driving or operating machinery.
Neupogen contains less than 1 mmol (23 mg) sodium per 0.6 mg/ml or 0.96 mg/ml dose, i.e. essentially sodium free.
Neupogen contains sorbitol (E420), if you have been told by your doctor that you have a reaction to some sugars, contact your doctor before taking this medicinal product.
Always use Neupogen exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Neupogen is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion). The usual dose varies depending on your illness and weight. Your doctor will tell you how much Neupogen you should take.
You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home. However, you should not attempt this unless you have been properly trained first.
You will need to take Neupogen until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Neupogen.
Neupogen is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children is the same as for adults.
Do not increase the dose your doctor has given you. If you think you have injected more than you should, contact your doctor as soon as possible.
If you have missed an injection, or injected too little, contact your doctor as soon as possible. Do not take a double dose to make up for any missed doses.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
Please tell your doctor immediately during treatment:
Like all medicines, Neupogen can cause side effects, although not everybody gets them.
Very common side effects (seen in more than 1 in 10 people who take Neupogen):
in cancer patients
in normal stem cell donors
in severe chronic neutropenia patients
in HIV patients
Common side effects (seen in more than 1 in 100 people taking Neupogen):
Uncommon side effects (seen in more than 1 in 1000 people taking Neupogen):
Rare side effects (seen in more than 1 in 10,000 people taking Neupogen):
Very rare side effects (seen in less than 1 in 10,000 people taking Neupogen):
Frequency unknown
Some changes may occur in your blood, but these will be detected by routine blood tests.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C).
Accidental freezing will not harm Neupogen.
Do not use Neupogen after the expiry date which is stated on the syringe label and carton after EXP.
The expiry date refers to the last day of that month.
Do not use Neupogen if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.
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.
Neupogen is a clear colourless solution for injection (injection) /concentrate for solution for infusion (sterile concentrate) in a pre-filled syringe.
Neupogen is available in packs of one or five pre-filled syringes. Not all pack sizes may be marketed.
This medicine is marketed in the European Economic Area under the name Neupogen, except in Cyprus, Greece and Italy where it is called Granulokine.
This leaflet was last approved in March 2011.
Detailed information on this medicine can be found on the following web sites:
This section contains information on how to give an injection of Neupogen.
Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.
Neupogen is injected into the tissue just under the skin. This is known as a subcutaneous injection.
To give yourself a subcutaneous injection you will need:
1. Remove the syringe from the refrigerator. Leave the syringe at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes. This will make the injection more comfortable. Do not warm Neupogen in any other way (for example, do not warm it in a microwave or in hot water). 2. Do not shake the pre-filled syringe. 3. Do not remove the needle cover until you are ready to inject. 4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown. 5. Check the appearance of Neupogen. It must be a clear and colourless liquid. If there is discolouration, cloudiness or particles in it, you must not use it. 6. Wash your hands thoroughly. 7. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Before you inject Neupogen you must do the following:
1. To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2. 2. Do not touch the needle or push the plunger.
3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless. 4. You can now use the pre-filled syringe.
The best places to inject are the top of your thighs and the abdomen. If someone else is injecting you, they can also use the back of your arms.
You may change the injection site if you notice the area is red or sore.
1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger. 2. Put the needle fully into the skin as shown by your nurse or doctor. 3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place. 4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty. 5. Remove the needle and let go of your skin. 6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster. 7. Only use each syringe for one injection. Do not use any Neupogen that may be left in the syringe.
Remember: if you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Local representative of the marketing authorisation holder:
Ireland
Neupogen is available on the Royal National Institute of the Blind (RNIB) Medicines Information Line who can provide this leaflet in a number of physical formats including large/clear print, Braille and audio CD.
You can also listen to this leaflet when you call the Medicines Information Line.
The RNIB Medicines Information Line is free to use and available 24 hours a day, 7 days a week. Please call them on 0800 198 5000.
Link to this document from your website:http://www.medicines.ie/medicine/7894/XPIL/Neupogen+Singleject+Syringes/