Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - grastofil

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e61b46541cd782d75f47b06ddfea02f

identifier: http://ema.europa.eu/identifier/EU/1/13/877/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Grastofil 30 MU/0.5 ml solution for injection/infusion 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-8e61b46541cd782d75f47b06ddfea02f

identifier: http://ema.europa.eu/identifier/EU/1/13/877/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - grastofil

Attesters

What is in this leaflet

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

Grastofil contains the active substance filgrastim. Grastofil 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. Grastofil 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. Filgrastim stimulates the bone marrow to produce new white cells quickly.

Grastofil can be used:

to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;

to increase the number of white blood cells after a bone marrow transplant to help prevent infections;

to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;

in patients with advanced HIV infection which will help reduce the risk of infections;

before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells.

Do not use Grastofil

if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Grastofil.

Please tell your doctor before starting treatment if you have:

osteoporosis (bone disease),

sickle cell anaemia, as filgrastim may cause sickle cell crisis.

Please tell your doctor immediately during treatment with Grastofil, 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 as these could be signs of a severe allergic reaction (hypersensitivity).

experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).

get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen).

notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).

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

Your doctor may want to monitor you closely, see section 4 of the package leaflet.

If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)). You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done. If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.

If you are a stem cell donor, you must be aged between 16 and 60 years.

Take special care with other medicines that stimulate white blood cells Grastofil is one of a group of medicines that stimulate the production of white blood cells. Your healthcare professional should always record the exact medicine you are using.

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

Pregnancy and breast-feeding Grastofil has not been tested in pregnant or breast-feeding women.

Grastofil is not recommended during pregnancy.

It is important to tell your doctor if you:

are pregnant; or breast-feeding;

think you may be pregnant, or

are planning to have a baby.

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

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

Driving and using machines Grastofil may have a minor influence on your ability to drive and use machines. This medicine may cause dizziness. It is advisable to wait and see how you feel after taking Grastofil and before driving or operating machinery.

Grastofil contains sorbitol Grastofil contains 50 mg sorbitol in each ml.
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.

You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

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

Grastofil pre-filled syringe contains dry natural rubber The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

How is Grastofil given and how much should I take?

Grastofil 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 Grastofil you should take.

Patients having a bone marrow transplant after chemotherapy: You will normally receive your first dose of Grastofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.

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 by your health care provider.

How long will I have to take Grastofil?

You will need to take Grastofil 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 Grastofil.

Use in children

Grastofil is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children receiving chemotherapy is the same as for adults.

Instructions for injecting Grastofil

This section contains information on how to give yourself an injection of Grastofil.

Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.

Grastofil is injected into the tissue just under the skin. This is known as a subcutaneuous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a new pre-filled syringe of Grastofil; and

alcohol wipes or similar.

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

1. Remove the syringe from the refrigerator. Leave the syringe at room temperature
   (15 C to 25 C) 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 Grastofil 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. Wash your hands thoroughly.
5. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

How do I prepare my Grastofil injection?

Before you inject Grastofil you must do the following:

1. To avoid bending the needle, gently pull the cover from the needle without twisting.
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 need to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
4. The Grastofil syringe has a scale on the syringe barrel. Hold the syringe with the needle pointing up. Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.
5. You can now use the pre-filed syringe,

Where should I give my injection?

The best places to inject are the top of the 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.

How do I give my injection?

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. Do not put the cover back on used needles, as you may accidentally prick yourself.
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 Grastofil that may be left in the syringe.

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

If you use more Grastofil than you should

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 forget to use Grastofil

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 medicine, ask your doctor, nurse or pharmacist.

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

Please tell your doctor immediately during treatment if:

you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).

you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).

you experience kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

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 a condition called Capillary Leak Syndrome which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

you have a combination of any of the following symptoms: * fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin. These could be symptoms of a condition called sepsis (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.

you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).

you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).

A common side effect of Grastofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.

In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen, this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.

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

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

low red blood cell count (anaemia)

headache

diarrhoea

vomiting

nausea

unusual hair loss or thinning (alopecia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)

fever (pyrexia)

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

inflammation of the lung (bronchitis)

upper respiratory tract infection

urinary tract infection

decreased appetite

trouble sleeping (insomnia)

dizziness

decreased feeling of sensitivity, especially in the skin (hypoaesthesia)

tingling or numbness of the hands or feet (paraesthesia)

low blood pressure (hypotension)

high blood pressure (hypertension)

cough

coughing up blood (haemoptysis)

pain in your mouth and throat (oropharyngeal pain)

nose bleeds (epistaxis)

constipation

oral pain

enlargement of the liver (hepatomegaly)

rash

redness of the skin (erythema)

muscle spasm

pain when passing urine (dysuria)

chest pain

pain

generalised weakness (asthenia)

generally feeling unwell (malaise)

swelling in the hands and feet (oedema peripheral)

increase of certain enzymes in the blood

changes in blood chemistry

transfusion reaction

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

increase in white blood cells (leukocytosis)

allergic reaction (hypersensitivity)

rejection of transplanted bone marrow (graft versus host disease)

high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

lungs do not function as they should, causing breathlessness (respiratory failure)

swelling and/or fluid in the lungs (pulmonary oedema)

inflammation of the lungs (interstitial lung disease)

abnormal x-rays of the lungs (lung infiltration)

bleeding from the lung (pulmonary haemorrhage)

lack of absorption of oxygen in the lung (hypoxia)

bumpy skin rash (rash macuo-papular)

disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)

injection site reaction

Rare side effects (may affect up to 1 in 1,000 people):

severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)

sudden life-threatening allergic reaction (anaphylactic reaction)

pain and swelling of the joints, similar to gout (pseudogout)

a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)

inflammation of the blood vessels in the skin (cutaneous vasculitis)

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)

worsening of rheumatoid arthritis

unusual change in the urine

bone density decreased

Inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2. Reporting of side effects

If you get any side effects, talk to your doctor 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 outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.

Store in a refrigerator (2 C - 8 C). Do not freeze.

Keep the pre-filled syringe in the carton in order to protect from light.

Grastofil can be removed from the refrigerator and left at room temperature (not above 25 ) for a single period of up to 15 days that ends within the labelled expiry date. Once Grastofil has been out at room temperature it should not be put back into the refrigerator. Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.

Do not use Grastofil if you notice it is cloudy, or there is discoloration 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 Grastofil contains

The active substance is filgrastim. Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [ g]) of filgrastim. Each pre-filled syringe contains 30 MU (300 g) filgrastim in 0.5 mL solution.

The other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate and water for injections. See section 2 What you need to know before you use Grastofil .

What Grastofil looks like and contents of the pack

Grastofil is a clear colourless solution for injection or infusion. It is supplied in a pre-filled syringe with an injection needle marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel. Each pre-filled syringe contains 0.5 mL of solution.

Grastofil is available in packs containing 1 and 5 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center
Moll de Barcelona s/n, Edifici Est 6 planta 08039 Barcelona Spain

Manufacturer Apotex Nederland B.V. Archimedesweg 2 2333 CN Leiden
Netherlands

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95-200 Pabianice, Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PL / PT / RO / SE / SI / SK / UK(NI) Accord Healthcare S.L.U. Tel: +34 93 301 00 EL Rafarm AEBE 12, . , 15451,
: +30/2106776This leaflet was last revised in MM/YYYY

Other sources of information

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