GRASUSTEK 6 mg Injectable Solution

Зміст інструкції

1. Grasustek 6 mg injectable solution in a pre-filled syringe
   1. What is Grasustek and what it is used for
   2. What you need to know before using Grasustek
   3. How to use Grasustek
   4. Possible side effects
   5. How to store Grasustek
   6. Content of the pack and other information

Grasustek 6 mg injectable solution in a pre-filled syringe

pegfilgrastim
.

Read this leaflet carefully before you use this medicine, as 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 you, as it may be harmful.
• - If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
• 1. What Grasustek is and what it is used for
• 2. What you need to know before you use Grasustek
• 3. How to use Grasustek
• 4. Possible side effects
• 5. How to store Grasustek
• 6. Contents of the pack and other information

1. What is Grasustek and what it is used for

Grasustek is indicated in adults aged 18 years or older.
Grasustek contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using a
biotechnological technique in bacteria called Escherichia coli. It belongs to a group of proteins
called cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced
by our body.
Grasustek is used 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 growing cells). White blood cells are
important because they help the body fight infections. These cells are very 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 left to fight bacteria and you may be at
greater risk of contracting an infection.
Your doctor has prescribed Grasustek to stimulate the bone marrow (the part of the bone that produces
blood cells) to produce more white blood cells that help the body fight infections.

2. What you need to know before using Grasustek

Do not use Grasustek

• - if you are allergic to pegfilgrastim, filgrastim, proteins derived from E. colior to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor, pharmacist or nurse before using Grasustek:
• - if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin areas
• - if you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS)
• - if you have one or a combination of the following side effects: ­ swelling or edema, which may be associated with decreased urination, difficulty breathing, abdominal bloating and a feeling of fullness and a general feeling of fatigue. These may be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from small blood vessels in the body (see section 4).
• - if you have pain in the upper left side of your abdomen or pain at the tip of your shoulder. This could be a sign of a problem with the spleen (splenomegaly).
• - if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease) or an abnormality found on an X-ray (pulmonary infiltrate).
• - if you know you have abnormal blood cell counts (e.g. increased white blood cells or anemia) or a decrease in platelet levels, which reduces the body's ability to clot (thrombocytopenia). Your doctor may want to monitor you closely
• - if you have sickle cell anemia. Your doctor may want to monitor you closely.
• if you have breast or lung cancer, Grasustek 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 have 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 severe allergic reaction.
• - if you have symptoms of inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), which have been rarely reported in cancer patients and healthy people. Symptoms may include fever, abdominal pain, malaise, back pain and increased markers of inflammation. Tell your doctor if you experience these symptoms. Your doctor will check your blood and urine regularly as Grasustek can damage the tiny filters inside your kidneys (glomerulonephritis). Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Grasustek. If you notice any of the symptoms described in section 4, stop using Grasustek and seek immediate medical attention. You should talk to your doctor about the risks of developing blood cancer. If you develop or may have blood cancer, you should not use Grasustek unless directed by your doctor. Loss of response to pegfilgrastimIf you have a decrease in response or failure to maintain response to treatment with pegfilgrastim, your doctor will investigate the reasons, including the possibility that you have developed antibodies that neutralize the activity of pegfilgrastim.

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

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Grasustek has not
been tested on pregnant women. It is important that you tell your doctor if:

• - you are pregnant or breastfeeding
• - you suspect you are pregnant or
• - you are planning to become pregnant.

If you become pregnant during treatment with Grasustek, tell your doctor.
Unless your doctor tells you otherwise, you should stop breastfeeding if you use Grasustek.

Driving and operating machinery
Grasustek does not alter or negligibly alters the ability to drive vehicles or operate
machinery.

Grasustek contains sorbitol (E420) and sodium
This medicine contains 30 mg of sorbitol in each 6 mg dose, which corresponds to 50 mg/mL.
This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose, i.e. it is practically
sodium-free.

3. How to use Grasustek

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. The usual dose is a subcutaneous injection (injection under the skin) of 6 mg
with a prefilled syringe that must be administered at least 24 hours after the last dose of
chemotherapy at the end of each chemotherapy cycle.

How to self-inject Grasustek
Your doctor may consider that it is better for you to self-inject Grasustek. Your doctor or
nurse will show you how to self-inject. Do not attempt to self-inject if
you have not been shown how to do it.
self-inject Grasustek.
Do not shake Grasustek vigorously as this may compromise its activity.

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

If you forget to inject Grasustek
If you have forgotten a dose of Grasustek, contact your doctor to determine when to administer the
next injection
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediately if you experience any one or a combination of the following side effects:

• - swelling or edema, which may be associated with decreased urination, difficulty breathing, abdominal bloating 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 from small blood vessels inside the body and requires urgent medical attention. Very common side effects(may affect more than 1 in 10 people)
• - bone pain. Your doctor will tell you 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 pain and joint and muscle pain.
• - some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may rise for a short period of time. Platelet levels may decrease causing bruising. Uncommon side effects(may affect up to 1 in 100 people)
• - allergic-type reactions, including redness and flushing, skin rash (skin redness) and skin swelling with itching.
• - severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• - increased spleen volume.
• - 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 left shoulder as this may indicate problems with the spleen.
• - breathing problems. If you have cough, fever and difficulty breathing, contact your doctor.
• - cases of Sweet syndrome (purple, raised and painful lesions on the limbs and sometimes on the face and neck, associated with fever) have occurred, but other factors may have contributed to them.
• - cutaneous vasculitis (inflammation of the skin blood vessels).
• - damage to the tiny filters inside the kidneys (glomerulonephritis).
• - redness at the injection site.
• - coughing up blood (hemoptysis).
• blood diseases (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]). Rare side effects(may affect up to 1 in 1,000 people)
• - inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2.
• - bleeding from the lungs (pulmonary hemorrhage) Stevens-Johnson syndrome, which can manifest as reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes and which may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Grasustek and contact your doctor or seek immediate medical attention. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as detailed in Annex V. By reporting side
effects, you can help provide more information on the safety of this medicine.

5. How to store Grasustek

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack 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 can take Grasustek out of the refrigerator and keep it at room temperature (not exceeding 30  C) for no more than
3 days. Once the syringe has been removed from the refrigerator and has reached room temperature
(not exceeding 30  C) it must be used within 3 days or discarded.
Do not freeze. Grasustek can be used if it has been accidentally frozen once for
less than 24 hours.
Keep the container in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that it is cloudy or if you see particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Grasustek contains

• - The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of injectable solution.
• - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections (see section 2). Description of the appearance of Grasustek and content of the packGrasustek is a clear, colorless injectable solution in a pre-filled syringe (6 mg/0.6 mL). Each pack contains 1 pre-filled glass syringe, with a stainless steel needle and needle cap. The syringes are provided with automatic needle protection. Marketing Authorisation HolderJuta Pharma GmbH, Gutenbergstr. 13, 24941 Flensburg, Germany ManufacturerJuta Pharma GmbH, Gutenbergstr. 13, 24941 Flensburg, Germany

For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

Ελλάδα
RAFARM A.E.B.E
Κορίνθου 12, Ν. Ψυχικό, Ελλάδα
τηλ 210 6776550-1

България
Alvogen Pharma Bulgaria EOOD
бул. България 86А, ет. 1, София 1680,
България
+359 2 441 7136

Hrvatska
Alvogen d.o.o.
Av. V. Holjevca 40 , 10000 Zagreb, Hrvatska
Tel:+385 1 6641 830

Ísland
Alvogen ehf.
Sæmundargötu 15-19, 101 Reykjavík, Ísland
Tel: +354 522 2900

Magyarország
Aramis Pharma Kft
1095 Mester u. 28 Budapest Hungary
Tel:+36-1-299-1051

Polska
Alvogen Pharma Sp. Z o.o.
Ul Kniaźnina 4a lok 7
01-607 Warsaw, Poland.
Tel: + 48 22 460 92 00

România
Alvogen Romania SRL
44B, Theodor Pallady Blvd.
3rd district, 032266
Bucharest, Romania
Tel: +40 21 318 0377

Österreich
Vertrieb
G.L.Pharma GmbH
Schlossplatz 1, 8502 Lannach,
Österreich
Tel: +43 3136 82577

Česká republika
EGIS Praha, spol. s r.o.,
Praha1-Staré Město,Ovocný trh 1096/8, PSČ
11000
Tel: +420 227 129 111

Slovenská republika
EGIS Slovakia spol. s r.o.,
Prievozská 4D, 821 09 Bratislava
Tel: +421 2 32409422

Eesti
Apteegikaubanduse Hulgimüük OÜ (Auxilia
Pharma)
Karamelli 6, 11317 Tallinn
Tel: +372 605 0005

Deutschland
medac GmbH
Theaterstr. 6
22880 Wedel, Deutschland
Tel: +49 4103 / 8006-777

Italia
medac Pharma S.r.l.
Via Viggiano 90, 00178 Roma
Italia
Tel: +39 06 51 59 121

Sverige, Danmark, Norge
medac GmbH
Malmöhusvägen 1
211 18 Malmö
Schweden
Tel: +46 0340 64 54 70

Suomi/Finland
medac GmbH
Hirsalantie 11
02420 Jorvas
Finland
Tel: +358 10 420 4000

Lietuva
SIA „Unikmed Baltija“
Gertrūdos g. 33/35-2,
LV-1011, Ryga, Latvija
Tel .: +371 64 412-474

Latvija
SIA Unikmed Baltija
Ģertrūdes iela 33/35-2,
LV-1011, Rīga, Latvija
Tālr .: +371 64 412-474

Slovenija
Distribucija
G.L.Pharma GmbH
Schlossplatz 1, 8502 Lannach,
Avstrija
Tel: +43 3136 82577

België / Belgique / Belgien, España, Ireland,
Κύπρος, Luxembourg / Luxemburg, Malta,
Nederland, Portugal, United Kingdom
(Northern Ireland)
Juta Pharma GmbH
Tel: +49(0)461995799-0

France
Zentiva France
35 Rue du Val de Marne
75013 Paris
Tél: +33 (0) 800 089 219

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.
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Instructions for use:
Guide to the parts
Syringe before administration

Caution:avoid contact with the plunger and the needle while preparing the syringe. The

safety device is normally activated by pressing the plunger on the syringe.

Syringe after administration
(the protection is released and covers the needle)

o Important
c Before using a pre-filled syringe of Grasustek with automatic needle protection, read this important information: a - It is important that you do not try to administer the injection yourself unless you have received adequate instructions from your doctor or healthcare professional. m - Grasustek is administered as an injection into the tissue just below the skin (subcutaneous injection). Do not remove the grey cap from the needle of the pre-filled syringe until you are ready for r the injection. Do not use the pre-filled syringe if it has fallen onto a hard surface. Use a new a pre-filled syringe and contact your doctor or healthcare professional. Do not try to activate the pre-filled syringe before the injection. F Do not try to remove the transparent safety protection from the pre-filled syringe. Do not try to remove the detachable label from the pre-filled syringe before l giving yourself the injection. e Contact your doctor or healthcare professional if you have any questions.
	Step 1: Preparation
A.	d Remove the syringe pre-filled pack from the packaging and prepare the necessary materials for the injection: alcohol swabs, a cotton ball or gauze, a plaster and a sharps disposal container (not included).
a For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 n minutes before the injection. Wash your hands thoroughly with soap and water. Place the new pre-filled syringe on a clean, well-lit work surface along with the a necessary materials for the injection. i Do not try to heat the syringe using a heat source such as hot water or a microwave. l Do not expose the pre-filled syringe to direct sunlight. a Do not shake the pre-filled syringe vigorously. Keep the pre-filled syringe out of the sight and reach of children.
B.	Warning/caution: check that there are no loose fragments or fluid inside I the pack. If in doubt DO NOT open this pack and take another one instead. Open the blister by completely removing the cover as shown.
g e n z i a
A C.	Warning/Caution: DO NOT lift the product by gripping the plunger or the needle cover. Remove the pre-filled syringe from the blister as shown.

a r m a c o
D.			F Check the medicine through the viewing window of the pre-filled syringe.
l e d a n a Do not use the pre-filled syringe if: - The medicine is cloudy or there are particles inside. It should be a clear and colorless liquid. - Some parts appear cracked or broken. d - The grey needle cap is missing or is 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.
a Step 2: Preparation
A.		Wash your hands thoroughly. Prepare and clean the injection site.
n a i l a t I a i z n e g You can use: - The upper thigh e - 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. Do not touch the injection site before the injection. Do not inject into areas where the skin is sensitive, bruised, red, or hardened. Avoid injecting into areas with scars or stretch marks.
B.	Warning/caution: DO NOT rotate the needle cover or touch the needle or plunger.

	Remove the needle cap as shown, and hold the protection to avoid injury or bending the needle.
r m a c o

C.	Lift the injection site to create a firm surface.
F l e d a n a It is important to keep the skin lifted during the injection.
i Step 3: Injection
A.			l INSERT the needle into the skin. a Push the plunger while holding the ends. Push the plunger all the way in to inject all the solution.
t I a i z n e g Do not touch the injection site before the injection.
B.		To activate the protection, you must administer the entire dose.

m a c o
C.	After completing the injection, you can follow one of the following alternatives: Remove the needle from the injection site and release the plunger until the entire needle is covered by the protection. Release the plunger until the entire needle is covered by the protection and remove the needle from the injection site.
l e d a n a i l a t I a Warning/Caution: if the protection is not activated or is only partially activated, discard the syringe without replacing the needle cover.

For healthcare professionals only The trade name of the medicinal product must be clearly recorded in the patient's file.
c a m r a F Turn the plunger to move the label to a position where it can be removed.
Step 4: End
A.	l e Immediately dispose of the used medicine in a sharps disposal container or as directed by your healthcare professional.
d a n a i l a t I a Medicines must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. i Keep the syringe and sharps disposal container out of the sight and reach of children. z Do not reuse the pre-filled syringe. Do not recycle pre-filled syringes or dispose of them in household waste.
B.	Examine the injection site.
n e If you notice blood, press a cotton ball or gauze onto the injection site. Do not rub the injection site. If necessary, apply a plaster.