Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tevagrastim

Document Subject

Generated Narrative: MedicinalProductDefinition mp37659c041a93299fdf753eeff4621a42

identifier: http://ema.europa.eu/identifier/EU/1/08/445/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tevagrastim 30 MIU/0.5 mL solution for injection/infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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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-37659c041a93299fdf753eeff4621a42

identifier: http://ema.europa.eu/identifier/EU/1/08/445/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tevagrastim

Attesters

7. Information for injecting yourself
8. The following information is intended for healthcare professionals only

What is in this leaflet

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

What Tevagrastim is Tevagrastim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belong 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. Tevagrastim works by encouraging the bone marrow to produce more white blood cells.

What Tevagrastim is used for A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Tevagrastim stimulates the bone marrow to produce new white cells quickly.

Tevagrastim 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.
• 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.
• 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.

Do not use Tevagrastim

• 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 Tevagrastim.

Please tell your doctor before starting treatment, if you have

• sickle cell anaemia, as this medicine may cause sickle cell crisis
• osteoporosis (bone disease).

Talk to your doctor immediately during treatment with Tevagrastim, 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 Tevagrastim, 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 products that stimulate white blood cells

Tevagrastim is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.

Other medicines and Tevagrastim Tell your doctor or pharmacist if you are using have recently used or might use any other medicines.

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

Tevagrastim is not recommended during pregnancy.

It is important to tell your doctor if you:

• are pregnant or breast-feeding
• think you may be pregnant
• are planning to have a baby If you become pregnant during Tevagrastim treatment, please inform your doctor.

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

Driving and using machines Tevagrastim 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 using this medicine and before driving or operating machinery.

Tevagrastim contains sorbitol This medicine contains 50 mg sorbitol in each mL. For intravenous use 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.

Tevagrastim contains sodium This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially sodium-free .

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

How is Tevagrastim given and much should I take?

Tevagrastim 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 Tevagrastim you should take.

Patients having a bone marrow transplant after chemotherapy: You will normally receive your first dose of Tevagrastim 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 Tevagrastim? You will need to take Tevagrastim 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 Tevagrastim.

Use in children Tevagrastim 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.

If you use more Tevagrastim than you should Do not increase the dose your doctor has given you. If you use more Tevagrastim than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Tevagrastim 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, pharmacist or nurse.

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

Important side effects

It is important to contact your doctor immediately

• 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).
• if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if 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.
• 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 condition called capillary leak syndrome , which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

• if 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.

• if 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).
• if 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 Tevagrastim use is pain in your muscles or bones (musculoskeletal pain), which could be relieved 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.

You may experience the following side effects:

Very common (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 (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 (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 maculo-papular)
• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
• injection site reaction

Rare (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, 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 outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).

Within its shelf-life and for ambulatory use, the product may be removed from the refrigerator (2 C 8 C) and stored at a temperature up to 25 C for one single period of up to 4 days. If not used within 4 days, the product may be returned to the refrigerator (2 C 8 C) up to the expiry date. Dispose of syringes if stored above 8 C for more than 4 days.

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. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Tevagrastim contains

• The active substance is filgrastim. Each mL of solution for injection/infusion contains 60 million international units [MIU] (600 microgram) of filgrastim. Tevagrastim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution. Tevagrastim 48 MIU/0.8 mL: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL solution.
• The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.

What Tevagrastim looks like and contents of the pack Tevagrastim is a solution for injection/infusion in a pre-filled syringe. Tevagrastim is a clear and colourless solution. Each pre-filled syringe contains either 0.5 mL or 0.8 mL of solution.

Tevagrastim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes with injection needle and with or without a needle safety guard. Not all pack sizes may be marketed.

Marketing Authorisation Holder TEVA GmbH Graf-Arco-Stra e 3 89079 Ulm Germany

Manufacturer Teva Pharma B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Merckle GmbH Graf-Arco-Stra e 3 89079 Ulm Germany

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
TEVA HELLAS . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS . .

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in .

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