Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cegfila

Document Subject

Generated Narrative: MedicinalProductDefinition mpe3be0c3afac35b40ee152976f7a06c61

identifier: http://ema.europa.eu/identifier/EU/1/19/1409/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cegfila 6 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e3be0c3afac35b40ee152976f7a06c61

identifier: http://ema.europa.eu/identifier/EU/1/19/1409/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cegfila

Attesters

What is in this leaflet

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

Cegfila 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.

Cegfila is used in adult patients 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 Cegfila 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 Cegfila if

• you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Cegfila:

• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch

• if you experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory Distress Syndrome (ARDS)

• if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These could be symptoms of condition called Capillary Leak Syndrome which causes blood to leak from the small blood vessels into your body. See section 4. - if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly)

• if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)

• if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.

• if you have sickle cell anaemia. Your doctor may monitor your condition more closely.

• if you are a patient with breast cancer or lung cancer, Cegfila in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.

• if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.

• If you have symptoms of inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), this has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience these symptoms.

Your doctor will check your blood and urine regularly as Cegfila can harm the tiny filters inside your kidneys (glomerulonephritis).

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Cegfila. Stop using Cegfila and seek medical attention immediately if you notice any of the symptoms described in section 4. You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use Cegfila, unless instructed by your doctor.

Loss of response to pegfilgrastim

If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim s activity.

Other medicines and Cegfila

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Cegfila has not been tested in pregnant women. It is important to tell your doctor if you:

• are pregnant;
• think you may be pregnant; or
• are planning to have a baby.

If you become pregnant during Cegfila treatment, please inform your doctor.

Unless your doctor directs you otherwise, you must stop breast-feeding if you use Cegfila.

Driving and using machines

Cegfila has no or negligible effect on the ability to drive or use machines.

Cegfila contains sorbitol (E 420) and sodium acetate

This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg / mL.

This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially sodium-free .

Cegfila is for use in adults aged 18 and over.

Always use Cegfila 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 at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Do not shake Cegfila vigorously as this may affect its activity.

Injecting Cegfila yourself

Your doctor may decide that it would be more convenient for you to inject Cegfila 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 Cegfila, please read the section at the end of this leaflet.

If you use more Cegfila than you should

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

If you forget to inject Cegfila

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

Please tell your doctor immediately if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion. These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called Capillary Leak Syndrome which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

Very common side effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will tell you what you can take to ease the bone pain.
• nausea and headaches.

Common side effects (may affect up to 1 in 10 people):

• pain at the site of injection.
• general aches and pains in the joints and muscles.
• some changes may occur in your blood, but these will be detected by routine blood tests. Your white blood cell count may become high for a short period of time. Your platelet count may become low which might result in bruising.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
• serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• increased spleen size.
• spleen rupture. 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.
• breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.
• Sweet s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters inside your kidneys (glomerulonephritis).
• redness at the site of injection.
• 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 which transports blood from the heart to the body), see section 2. - Bleeding from the lung (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Cegfila if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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 carton and on the syringe label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).

You may take Cegfila out of the refrigerator and keep it at room temperature (not above C) for no longer than 4 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 4 days or disposed of.

Do not freeze. Cegfila may be used if it is accidentally frozen for two periods of less than 72 hours each.

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

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Cegfila contains

• 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 (E 420), polysorbate 20 and water for injections. See section 2. What Cegfila looks like and contents of the pack Cegfila is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).

Each pack contains 1 pre-filled glass syringe with an attached stainless steel needle and needle cap. The syringe is provided with an automatic needle guard.

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

Manufacturer
PharmaKorell GmbH
Georges-K hler-Str. 2, D-79539 L rrach
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Mundipharma BV
T l/Tel: +32 2 358 54 info@mundipharma.be Lietuva EGIS Pharmaceuticals PLC atstovyb
Tel.:+ 370 5 231 4info@egis.lt

 . . .  

Te .: + 359 2 962 13 mundipharma@mundipharma.bg Luxembourg/Luxemburg Mundipharma BV
T l/Tel: +32 2 358 54 info@mundipharma.be esk republika Mundipharma Gesellschaft m.b.H.,
organiza n slo ka
Tel: + 420 222 318 office@mundipharma.cz Magyarorsz g Egis Gy gyszergy r Zrt. Tel.: +36 1 803 5mailbox@egis.hu Danmark Mundipharma A/S Tlf:

• 45 45 17 48 nordics@mundipharma.dk

Malta Mundipharma Corporation (Ireland) Limited Tel: +353 1 206 3Deutschland STADAPHARM GmbH Tel: +49 6101 6Nederland Mundipharma Pharmaceuticals B.V. Tel: + 31 (0)33 450 82 info@mundipharma.nl Eesti KBM Pharma O
Tel: +372 733 8Norge Mundipharma AS Tlf:

• 47 67 51 89 nordics@mundipharma.dk

Mundipharma Corporation (Ireland) Limited : + 353 1 206 3 sterreich Mundipharma Gesellschaft m.b.H. Tel: +43 (0)1 523 25 05-0 info@mundipharma.at Espa a Mundipharma Pharmaceuticals, S.L. Tel: +34 91 3821infomed@mundipharma.es Polska Mundipharma Polska Sp. z o.o. Tel.: + (48 22) 866 87 biuro@mundipharma.pl France
Laboratoires Biogaran T l: +33 (0) 800 970 Portugal Mundipharma Farmac utica Lda Tel: +351 21 901 31 medinfo@mundipharma.pt Hrvatska Medis Adria d.o.o Tel: + 385 (0) 1 230 34 info@medisadria.hr Rom nia Egis Pharmaceuticals PLC Rom nia Tel: +40 21 412 00 office@egis.ro Ireland Mundipharma Pharmaceuticals Limited Tel: +353 1 206 3Slovenija Medis, d.o.o. Tel: +386 158969 info@medis.si sland Slovensk republika Icepharma hf. Mundipharma Ges.m.b.H.-o.z. S mi: + 354 540 8Tel: + 4212 6381 1icepharma@icepharma.is mundipharma@mundipharma.sk

Italia

Suomi/Finland Mundipharma Pharmaceuticals Srl Mundipharma Oy Tel: +39 02 3182Puh/Tel: + 358 (0)9 8520 2infomedica@mundipharma.it nordics@mundipharma.dk

Sverige Mundipharma Pharmaceuticals Ltd Mundipharma AB : +357 22 815Tel: + 46 (0)31 773 75 info@mundipharma.com.cy nordics@mundipharma.dk

Latvija EGIS Pharmaceuticals PLC parstavniecibas Tel: + 371 676 13 info@egis.lv United Kingdom (Northern Ireland) Mundipharma Pharmaceuticals Limited
Tel: +353 1 206 3This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: