Neulasta 6 mg solution for injection

Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

Do not use Neulasta

• if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neulasta.

Take special care with Neulasta

Please tell your doctor:

• if you experience a cough, fever and difficulty breathing;
• if you have sickle cell anaemia;
• if you get left upper abdominal pain or pain at the tip of your shoulder;
• if you have an allergy to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Neulasta 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 become pregnant.

You must stop breast feeding if you use Neulasta.

Drivingandusingmachines

The effect of Neulasta on the ability to drive or use machines is not known.

Important information about some of the ingredients of Neulasta

Neulasta contains sorbitol (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neulasta. Neulasta is essentially sodium-free.

Neulasta is for use in adults aged 18 and over.

Always take Neulasta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Do not shake Neulasta vigorously as this may affect its activity

Injecting Neulasta yourself

Your doctor may decide that it would be more convenient for you to inject Neulasta yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.

If you use more Neulasta than you should

If you use more Neulasta than you should contact your doctor, nurse or pharmacist.

If you forget to inject Neulasta

If you have forgotten a dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.

Like all medicines, Neulasta can cause side effects, although not everybody gets them.

A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain. Your doctor will tell you what you can take to ease the bone pain.

Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back. An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.

Allergic-type reactions to Neulasta, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1,000 patients) been reported.

Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients) of spleen rupture have been reported after the use of Neulasta. Some cases of splenic rupture were fatal.

It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.

Rare (likely to occur in fewer than 1 in 1,000 patients) cases of breathing problems have been reported after taking G-CSFs. If you have a cough, fever and difficulty breathing please tell your doctor.

Some changes may occur in your blood, but these will be detected by routine blood tests. Your platelet count may become low which might result in bruising. Your white blood cell count may become high for a short period of time.

Sweet?s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.

Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neulasta.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Neulasta after the expiry date which is stated on the box and on the syringe label (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C ? 8°C).

You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.

Do not freeze. Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.

Keep the container in the outer carton in order to protect from light.

Do not use Neulasta if you notice it is cloudy or there are particles in it.

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.

What Neulasta contains

Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.

The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.

The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.

What Neulasta looks like and contents of the pack

Neulasta is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 pre-filled syringe. The syringes are provided either with or without an automatic needle guard or blister wrapping. It is a clear, colourless liquid.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Further information

If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711

359 0 2 805 7020 Magyarország Amgen Kft. Tel 36 1 35 44 700

eská republika Amgen s.r.o Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 0 76 5732500

Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 0 76 5732500

Deutschland AMGEN GmbH Tel 49 089 1490960 Norge Amgen AB Tel 47 23308000

Eesti Amgen Switzerland AG Eesti filiaal Tel 372 5125 501 Österreich Amgen GmbH Tel 43 0 1 50 217

Genesis Pharma S.A. 30 210 8771500 Polska Amgen Sp. z o.o. Tel 48 22 581 3000

España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550

France Amgen S.A.S Tél 33 01 40 88 27 00 România Amgen România SRL Tel 4021 527 3000

Ireland Amgen Limited United Kingdom Tel 44 01223 420305 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Amgen Switzerland AG Slovakia Tel 421 33 321 13 22

Italia Amgen Dompé S.p.A. Tel 39 02 6241121 Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767

K Genesis Pharma Cyprus Ltd 357 22 76 99 46 Sverige Amgen AB Tel 46 08 6951100

Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305

Lietuva

Amgen Switzerland AG Vilniaus filialas
Tel: +370 6983 6600

This leaflet was last approved in.

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INSTRUCTIONS FOR INJECTING WITH THE NEULASTA PRE-FILLED SYRINGE

This section contains information on how you, or the person injecting you, use the Neulasta pre-filled syringe. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

Before you begin

Read all instructions thoroughly before using the pre-filled syringe.

To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with a needle guard that is automatically activated to cover the needle after complete delivery of the pre-filled syringe content.

DO NOT attempt to unlock the pre-filled syringe prior to injection.

DO NOT use the pre-filled syringe if the needle cover has been removed, or the needle guard has been activated (covering the needle).

DO NOT try to remove the detachable label on the pre-filled syringe barrel before administering the injection.

How do I use the Neulasta pre-filled syringe?

Your doctor has prescribed a Neulasta pre-filled syringe for injection into the tissue just under the skin. Your doctor, nurse, or pharmacist will tell you how much Neulasta you need and how frequently it should be injected.

Equipment:

To give yourself an injection you will need:

• a new Neulasta pre-filled syringe; and
• alcohol wipes or similar.

What should I do before I give myself a subcutaneous injection of Neulasta?

1. Remove the pre-filled syringe from the refrigerator. Do not pick up the pre-filled syringe by the plunger or needle cover. This could damage the device.

2. Leave the pre-filled syringe at room temperature for approximately 30 minutes. This will make the injection more comfortable. Do not warm Neulasta in any other way (for example, in a microwave or in hot water). Do not leave the syringe exposed to direct sunlight.

3. Do not shake the pre-filled syringe.

4. Do not remove the cover from the pre-filled syringe until you are ready to inject.

5. 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.

6. Check the appearance of Neulasta. It must be a clear and colourless liquid. If it is cloudy or there are particles in it, you must not use it.

7. Wash your hands thoroughly.

8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

Where should I give my injection The best places to inject yourself are the top of your thighs and the abdomen. If someone else is injecting for you, they can also use the back of your arms. Change the injection site if you notice the area is red or sore. How do I give my injection

1. Disinfect your skin by using an alcohol wipe.

2. To avoid bending the needle, gently pull the cover from the needle straight off without twisting as shown. 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. Pinch (without squeezing) the skin between your thumb and forefinger. Put the needle fully into the skin as shown by your nurse or doctor.

5. 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 after disinfecting the skin. 6. Push the plunger with a slow constant pressure, always keeping your skin pinched. Push the plunger all the way down as far as it will go to inject all the liquid.

The needle guard will not activate unless you empty the pre-filled syringe.

7. While the plunger is still pressed all the way down, remove the needle from the skin, then release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard. If the needle guard is not activated, an incomplete injection may have occurred. Call your health care provider if you think you have not received the full dose.

DO NOT put the needle cover back on the needle.

8. 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.

9. Only use each pre-filled syringe for one injection. Do not use any Neulasta that is left in the syringe.

Remember: If you have any problems, please ask your doctor or nurse for help and advice.

Disposing of used syringes

• You do not need to put the needle cover back on used syringes.
• Keep used syringes out of the reach and sight of children.
• The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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

How to remove the detachable label

The Neulasta pre-filled syringe comes with a detachable label that can be removed and placed on a patient?s chart.

NOTE: Only perform this step U afterU you have given the injection and the safety guard is covering the needle.

1. Hold the syringe as shown and rotate the plunger U towards youU until you can see the tab of the label within the opening of the window as shown below.

2. Slightly rotate the plunger U away from youU until the tab sticks up through the window as shown below.

3. Pull the tab up through the window, and then tear across the perforation, as shown below.

Tear at perforation.