Pelmeg

Package leaflet: Information for the user

Pelmeg 6 mg solution for injection in pre-filled syringe

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Pelmeg is and what it is used for
2. What you need to know before you use Pelmeg
3. How to use Pelmeg
4. Possible side effects
5. How to store Pelmeg
6. Contents of the pack and other information

1. What Pelmeg is and what it is used for

Pelmeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using biotechnology in a bacterial cell called Escherichia coli. It belongs to a group of proteins known as cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.
Pelmeg is used in adult patients to reduce the duration of neutropenia (low number of white blood cells) and the occurrence of febrile neutropenia (low number of white blood cells with fever) that may be caused by cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important because they help the body fight infections.
These cells are highly sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells in the body. If the number of white blood cells drops to a low level, there may not be enough cells left to fight bacteria, increasing the risk of developing an infection.
Your doctor has prescribed Pelmeg to stimulate the bone marrow (the part of the bones that produces blood cells) to produce more white blood cells, helping the body to fight infections.

2. What you need to know before using Pelmeg

Do not use Pelmeg
 if you are allergic to pegfilgrastim, filgrastim, or to proteins derived from Escherichia coli, or to any of the other ingredients of this medicine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Pelmeg:
 if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness, skin rash, or itchy skin areas.
 if you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
 if you experience one or more of the following side effects:

• swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These could be symptoms of a condition called "Capillary Leak Syndrome," which causes leakage of blood from small vessels in the body. See section 4.
   if you have pain in the upper left side of the abdomen or shoulder tip pain. These could be signs of a spleen problem (splenomegaly).
   if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (lung interstitial disease), or an abnormality detected on X-ray (pulmonary infiltration).
   if you know you have abnormal blood cell counts (e.g., increased white blood cells or anemia) or low platelet levels, which reduce the body’s ability to clot (thrombocytopenia). Your doctor may wish to monitor you closely.
   if you have sickle cell anemia. Your doctor may wish to monitor you closely.
   if you have breast or lung cancer, Pelmeg in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
   if you suddenly develop signs of allergy such as skin rash, hives, or itching, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing: these could be signs of a serious allergic reaction.
   if you experience symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), which has been reported rarely in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated inflammatory markers. Inform your doctor if such symptoms occur.

Your doctor will regularly check your blood and urine, as Pelmeg may damage the tiny filters in your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Pelmeg. If you notice any of the symptoms described in section 4, stop using Pelmeg and seek immediate medical attention.
You should discuss with your doctor the risks of developing blood cancer. If you have or may have blood cancer, you must not use Pelmeg unless instructed otherwise by your doctor.

Loss of response to pegfilgrastim
If you experience a reduced response or failure to maintain response to pegfilgrastim treatment, your doctor will investigate possible causes, including whether you have developed antibodies that neutralize the activity of pegfilgrastim.

Other medicines and Pelmeg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Pelmeg has not been studied in pregnant women. It is important that you inform your doctor if:
 you are pregnant;
 you suspect you may be pregnant; or
 you are planning a pregnancy.
If you become pregnant during treatment with Pelmeg, inform your doctor.
Unless otherwise advised by your doctor, you must stop breastfeeding while using Pelmeg.

Driving and using machines
Pelmeg does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

Pelmeg contains sorbitol (E420) and sodium acetate
This medicine contains 30 mg of sorbitol per pre-filled syringe, equivalent to 50 mg/mL.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e., essentially "sodium-free".

3. How to use Pelmeg

Pelmeg is intended for adults aged 18 years and older.
Use Pelmeg exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist. The usual dose is one subcutaneous injection (an injection under the skin) of 6 mg using a pre-filled syringe, which must be administered at least 24 hours after the last dose of chemotherapy, at the end of each chemotherapy cycle.
Do not shake Pelmeg vigorously, as this may impair its activity.

How to self-administer the Pelmeg injection
Your doctor may decide that it is better for you to self-administer the Pelmeg injection. Your doctor or nurse will show you how to inject yourself with Pelmeg. Do not attempt to give yourself the injection unless you have been properly instructed on how to do so.
Read the section at the end of this leaflet for instructions on how to self-administer the Pelmeg injection.

Pelmeg alone.

If you use more Pelmeg than you should
If you use more Pelmeg than you should, you must contact your doctor, pharmacist or nurse.
If you forget to inject Pelmeg
If you have forgotten a dose of Pelmeg, you must contact your doctor to determine when to administer the next injection.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediately if you experience any one or a combination of the following side effects:
 swelling or fluid retention, which may be associated with urinating less frequently, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly.
These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called "capillary leak syndrome", which causes blood to leak out of small blood vessels into the body tissues and requires urgent medical treatment.

Very common side effects (may affect more than 1 in 10 people):
 bone pain. Your doctor will advise you on what to take to relieve bone pain.
 nausea and headache.

Common side effects (may affect up to 1 in 10 people):
 pain at the injection site.
 general discomfort, joint and muscle pain.
 some blood changes may occur, but these will be detected during routine blood tests. White blood cell levels may temporarily increase. Platelet levels may decrease, leading to bruising.

Uncommon side effects (may affect up to 1 in 100 people):
 allergic-type reactions, including flushing and hot flushes, skin rash (reddening of the skin), and itchy skin swellings.
 severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
 enlargement of the spleen.
 rupture of the spleen. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you feel pain in the upper left side of your abdomen or in your left shoulder, as this may indicate spleen problems.
 breathing problems. If you develop cough, fever, or difficulty breathing, contact your doctor.
 cases of Sweet’s syndrome (painful, raised purple lesions on the limbs, and sometimes on the face and neck, associated with fever), although other factors may have contributed.
 cutaneous vasculitis (inflammation of the small blood vessels in the skin).
 damage to the tiny filters within the kidneys (glomerulonephritis).
 redness at the injection site.
 coughing up blood (haemoptysis).
 blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare side effects (may affect up to 1 in 1,000 people):
 inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
 bleeding from the lung (pulmonary haemorrhage).
 Stevens-Johnson syndrome, which may present as reddish or roundish patches, often with central blisters, typically on the trunk, skin peeling, mouth, throat, nose, genital and eye ulcers, and may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Pelmeg and contact your doctor or seek immediate medical assistance. See also section 2.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pelmeg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
You may remove Pelmeg from the refrigerator and keep it at room temperature (not above 30 °C) for no more than
4 days. Once the syringe has been removed from the refrigerator and has reached room temperature
(not above 30 °C), it must be used within 4 days or must be discarded.
Do not freeze. Pelmeg may be used if it has been accidentally frozen for two separate periods, each less than 72 hours.
Keep the container in the outer packaging to protect the medicine from light.
Do not use this medicine if it appears cloudy or if particles are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pelmeg contains
 The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.
 The other components are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections. See section 2.

Description of the appearance of Pelmeg and contents of the pack
Pelmeg is a clear, colourless injectable solution in a pre-filled syringe (6 mg/0.6 mL).
Each pack contains 1 glass pre-filled syringe with a stainless steel needle and needle cap. The syringe is packaged with an automatic needle protection device.

Marketing Authorisation Holder
Mundipharma Corporation (Ireland) Limited,
United Drug House Magna Drive, Magna Business Park,
Citywest Road, Dublin 24,
Ireland

Manufacturer
PharmaKorell GmbH
Georges-Köhler-Str. 2,
79539 Lörrach
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Mundipharma BV EGIS Pharmaceuticals PLC atstovybė
Tél/Tel: +32 2 358 54 68 Tel.: +370 5 231 4658
[email protected] [email protected]

България Luxembourg/Luxemburg
ТП„Мундифарма Гезелшафт м.б.Х. “ Mundipharma BV
Teл.: +359 2 962 13 56 Tél/Tel: +32 2 358 54 68
[email protected] [email protected]

Česká republika Magyarország
Mundipharma Gesellschaft m.b.H., Egis Gyógyszergyár Zrt.
organizační složka Tel.: +36 1 803 5555
Tel: +420 296 188 338 [email protected]
[email protected]

Danmark Malta
Mundipharma A/S Mundipharma Corporation (Ireland) Limited
Tlf: +45 45 17 48 00 Tel: +353 1 206 3800
[email protected]

Deutschland Nederland
Mundipharma GmbH Mundipharma Pharmaceuticals B.V.
Tel: +49 (0) 69 506029-000 Tel: +31 (0)33 450 82 70
[email protected] [email protected]

Eesti Norge
Medis Pharma Lithuania Mundipharma AS
Tel: +37052512550 Tlf: +47 67 51 89 00
[email protected] [email protected]

Ελλάδα Österreich
Mundipharma Corporation (Ireland) Limited Mundipharma Gesellschaft m.b.H.
Τηλ: +353 1 206 3800 Tel: +43 (0)1 523 25 05-0
[email protected]

España Polska
Mundipharma Pharmaceuticals, S.L. Mundipharma Polska Sp. z o.o.
Tel: +34 91 3821870 Tel.: + (48 22) 866 87 12
[email protected] [email protected]

France Portugal
MUNDIPHARMA SAS Mundipharma Farmacêutica Lda
Tél: +33 1 40 65 29 29 Tel: +351 21 901 31 62
[email protected] [email protected]

Hrvatska România
Medis Adria d.o.o. Egis Rompharma SRL
Tel: +385 (0) 1 230 34 46 Tel: +40 21 412 00 17
[email protected] [email protected]

Ireland Slovenija
Mundipharma Pharmaceuticals Limited Medis, d.o.o.
Tel: +353 1 206 3800 Tel: +386 158969 00
[email protected]

Ísland Slovenská republika
Icepharma hf. Mundipharma Ges.m.b.H.-o.z.
Sími: +354 540 8000 Tel: +4212 6381 1611
[email protected] [email protected]

Italia Suomi/Finland
Mundipharma Pharmaceuticals Srl Mundipharma Oy
Tel: +39 02 3182881 Puh/Tel: +358 (0)9 8520 2065
[email protected] [email protected]

Κύπρος Sverige
Mundipharma Pharmaceuticals Ltd Mundipharma AB
Τηλ: +357 22 815656 Tel: +46 (0)31 773 75 30
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
EGIS Pharmaceuticals PLC parstavniecibas Mundipharma Pharmaceuticals Limited
Tel: +371 676 13 859 Tel: +353 1 206 3800
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for use:

Guide to parts
Before use After use

After use
Before use
Used plunger
Plunger
Syringe label
Barrel
Finger grip
used
Syringe label
Syringe barrel Used needle
Safety shield
of the syringe
Safety spring
Safety spring
of the needle of the used needle
Needle cap
Needle cap
inserted
removed
Important
Before using a Pelmeg pre-filled syringe with automatic needle safety device,
please read these important instructions:

• It is important that you do not attempt to administer the injection unless you have received adequate instructions from your doctor or healthcare professional.
• Pelmeg is administered as an injection into the tissue just beneath the skin (subcutaneous injection). Do not remove the needle cap from the pre-filled syringe until you are ready for
  the injection.
  Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new
  pre-filled syringe and contact your doctor or healthcare professional.
  Do not attempt to activate the pre-filled syringe before the injection.
  Do not attempt to remove the transparent safety shield from the pre-filled syringe.
  Do not attempt to remove the detachable label from the barrel of the pre-filled syringe before
  administering the injection.
  Contact your doctor or healthcare professional if you have any questions.

B Open the pouch by tearing the cover. Hold the safety shield of the pre-filled syringe
to remove the pre-filled syringe from the pouch.

Hold here
For safety reasons:
Do not hold the plunger.

Do not hold the needle cap.
C Check the medicine and the pre-filled syringe.

Medicine
Do not use the pre-filled syringe if:

• The medicine is cloudy or there are particles inside. It should be a clear, colourless liquid.
• Any parts appear cracked or broken.
• The needle cap is missing or not securely attached.
• The expiry date printed on the label has passed the last day of the month indicated. In all cases, contact your doctor or healthcare professional.

Step 2: Preparation
A Wash your hands thoroughly. Prepare and clean the injection site.

Upper arm
You may use:

• The upper thigh.
• The abdomen, except for an area of 5 centimetres around the navel.
• The outer upper arm (only if someone else is giving you the injection). Clean the injection site with an alcohol swab. Allow the skin to dry.

Abdomen
Upper thigh
Do not touch the injection site before injecting.

Do not inject into areas where the skin is tender, bruised, red, or hardened. Avoid injecting into
areas with scars or stretch marks.

B	Remove the needle cap carefully, pulling it outward and away from your body.
C	Lift the injection site to create a stable surface.
It is important to keep the skin lifted during the injection.
Step 3: Injection
A	Keep the skin lifted. INSERT the needle into the skin.

Do not touch the clean area of the skin.

B	PUSH the plunger with a slow and steady pressure until you feel or hear a "click". Push all the way to the click.
It is important to push all the way to the "click" to inject the full dose.
C	RELEASE your thumb. Then REMOVE the syringe from the skin.
After releasing the plunger, the safety shield of the pre-filled syringe will automatically cover the injection needle securely. Do not recap the needle on used pre-filled syringes.

For healthcare professionals only
The trade name and batch number of the administered product must be clearly
recorded in the patient's medical file.
Remove and retain the prefilled syringe label.

Rotate the plunger to move the label to a position where it can be removed.

Step 4: Completion
A	Dispose of the used pre-filled syringe and other materials in a sharps disposal container.

Medicines must be disposed of in accordance with local regulations. Ask your pharmacist
how to dispose of medicines you no longer use. These measures will help protect the environment.
Keep the syringe and the sharps disposal container out of sight and reach of children.
Do not reuse the prefilled syringe.

Do not recycle prefilled syringes or dispose of them in household waste.