Yesintek 90 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Yesintek 90 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering Yesintek to a child, please read this information carefully.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Yesintek is and what it is used for

What Yesintek is

Yesintek contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain proteins in the body.

Yesintek belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What Yesintek is used for

Yesintek is used to treat the following inflammatory diseases:

• Plaque psoriasis – in adults and children aged 6 years and older
• Psoriatic arthritis – in adults
• Moderate to severe Crohn’s disease – in adults

Plaque psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Yesintek reduces inflammation and other signs of the disease.

Yesintek is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or for whom these treatments are ineffective.

Yesintek is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies, or for whom these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which usually occurs alongside psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well to these medications, you may be treated with Yesintek to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce joint damage.

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you may be given Yesintek to reduce the signs and symptoms of your disease.

2. What you need to know before using Yesintek

Do not use Yesintek

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using Yesintek.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Yesintek. Your doctor will check your condition before each treatment. Make sure to inform your doctor about any illness you may have before each treatment. Also, inform your doctor if you have recently been in close contact with someone who might have tuberculosis. Your doctor will examine you and perform a test to detect tuberculosis before you start using Yesintek. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious side effects

Yesintek may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using Yesintek. See the complete list of these side effects in section 4 under “Serious side effects”.

Before using Yesintek, tell your doctor:

• If you have ever had an allergic reaction to Yesintek – consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Yesintek weaken part of the immune system, which may increase the risk of developing cancer.
• If you have previously received treatment for psoriasis with other biological medicines (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
• If you currently have or have recently had an infection.
• If you have any new skin lesions or changes in existing lesions within the psoriasis-affected area or on intact skin.
• If you are taking any other treatments for psoriasis and/or psoriatic arthritis, such as other immunosuppressants or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Yesintek has not been studied. However, combining them could increase the likelihood of developing illnesses related to a weaker immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Yesintek may affect these treatments.
• If you are 65 years of age or older – you may be more likely to develop infections.

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before using Yesintek.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on sun-exposed skin areas, or if it is accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of psoriasis patients treated with Yesintek. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention if you experience chest pain, weakness or numbness on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

The use of Yesintek is not recommended in children under 6 years of age with psoriasis or in children under 18 years of age with psoriatic arthritis or Crohn’s disease, as it has not been studied in these age groups.

Use of Yesintek with other medicines and vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or might use any other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while you are using Yesintek.
• If you received Yesintek during pregnancy, inform your infant’s doctor about your Yesintek treatment before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant within the first twelve months after birth if you received Yesintek during pregnancy, unless your infant’s doctor advises otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to Yesintek in the womb. However, experience with Yesintek in pregnant women is limited. Therefore, it is preferable to avoid using Yesintek during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraception while using Yesintek and for at least 15 weeks after the last dose of Yesintek.
• Yesintek can cross the placenta to the fetus. If you received Yesintek during pregnancy, your infant may have an increased risk of developing an infection. It is important to inform your infant’s doctors and other healthcare professionals that you received Yesintek during pregnancy before the infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant within the first twelve months after birth if you received Yesintek during pregnancy, unless your infant’s doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether to breastfeed or use Yesintek. Do not do both at the same time.

Driving and using machines

Yesintek has no or negligible influence on the ability to drive and use machines.

Yesintek contains polysorbate 80 (E 433)

This medicine contains 0.04 mg of polysorbate 80 (E 433) in each 90 mg/1 ml pre-filled syringe, equivalent to 0.04 mg/ml (0.0004 mg/kg per day). Polysorbates may cause allergic reactions. Inform your doctor if you or your children have allergies.

3. How to use Yesintek

Yesintek should be used under the guidance and supervision of a physician experienced in the treatment of the conditions for which Yesintek is indicated.

Always follow exactly the administration instructions for this medicine provided by your doctor. If in doubt, consult your doctor. Ask your doctor when your injections should be given and about follow-up appointments.

How much Yesintek to use

Your doctor will decide the amount of Yesintek you need and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Yesintek. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks. The following doses are usually the same as the starting dose.

Crohn’s disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Yesintek as an intravenous infusion (via a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Yesintek 8 weeks later, and then every 12 weeks thereafter, via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, 90 mg of Yesintek will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of Yesintek to inject to achieve the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.
• A 45 mg vial is available for children who need to receive less than the full 45 mg dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Yesintek per kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Yesintek.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Yesintek.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

How Yesintek is administered

• Yesintek is administered by subcutaneous injection (under the skin). At the beginning of your treatment, medical or nursing staff may administer the injection for you.
• However, you and your doctor may decide that you will self-inject Yesintek. In this case, you will be trained on how to self-administer the injection.
• For instructions on how to inject Yesintek, see “Administration instructions” at the end of this leaflet.

Consult your doctor if you have any questions about self-injecting.

If you use more Yesintek than you should

If you have used or been given too much Yesintek, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.

If you forget to use Yesintek

If you miss a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop using Yesintek

Stopping the use of Yesintek is not dangerous. However, if you discontinue treatment, your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Some patients may experience serious adverse effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in the population using Yesintek (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing

• low blood pressure, which may cause dizziness or mild headaches

• swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (may affect up to 1 in 100 people).

In rare cases, lung-related allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience symptoms such as cough, difficulty breathing, or fever.

If you have a severe allergic reaction, your doctor may decide that you should no longer use Yesintek.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Nasal or throat infections and the common cold are common (may affect up to 1 in 10 people).
• Chest infections are uncommon (may affect up to 1 in 100 people).
• Inflammation of the tissues beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

Yesintek may affect your ability to fight infections. Some of these infections may become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. They include infections that primarily occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.

You should monitor for signs of infection while using Yesintek. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having difficulty breathing; persistent cough
• skin that feels warm, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or vision loss
• headache, neck stiffness, photophobia, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Yesintek until the infection resolves. Also contact your doctor if you have any open cuts or ulcers that could become infected.

Skin peeling – increased redness and widespread skin peeling may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you must inform your doctor immediately.

Other adverse effects

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

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching ("pruritus")
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Widespread redness and peeling of the skin, which may cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Blisters on the skin, which may be red and cause itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on sun-exposed skin areas, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yesintek

• Keep this medicine out of sight and reach of children.
• Store in a refrigerator (2 °C – 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• If necessary, individual pre-filled syringes of Yesintek may also be stored at room temperature up to 30°C for a maximum single period of up to 30 days in their original carton to protect them from light. Write the date when the pre-filled syringe is first removed from the refrigerator and the date when it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to a maximum of 30°C), it must not be returned to the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Yesintek. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging following “EXP”. The expiry date refers to the last day of the month indicated.
• After the recorded expiry date indicated on the packaging once the product has been stored at room temperature; i.e., more than 30 days at a maximum of 30°C.
• If the liquid changes colour, becomes cloudy, or contains floating foreign particles (see section 6 “Description of the product and contents of the container”).
• If you know or suspect it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been shaken vigorously.

Yesintek is for single use only. Any unused portion remaining in the syringe must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Package contents and other information

Composition of Yesintek

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.
• This medicine contains 0.04 mg of polysorbate 80 (E 433) in each 90 mg/1 ml pre-filled syringe, equivalent to 0.04 mg/ml (0.0004 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your children have allergies.

Appearance of the product and contents of the pack

Yesintek is a concentrate for solution for infusion, clear, ranging from pale yellow to colourless. It is supplied in a pack containing 1 ml single-dose glass pre-filled syringe. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorization Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate,

Dublin 13, DUBLIN

Ireland, D13 R20R

Manufacturer

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

More information about this medicine can be obtained by contacting the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Biocon Biologics Belgium BV Tel/Tel: 0080008250910	Lithuania Biosimilar Collaborations Ireland Limited Tel: 0080008250910
	Luxembourg/Luxembourg Biocon Biologics France S.A.S Tel/Tel: 0080008250910 (Belgium/Belgium)
Czech Republic Biocon Biologics Germany GmbH Tel: 0080008250910	Hungary Biosimilar Collaborations Ireland Limited Tel.: 0080008250910
Denmark Biocon Biologics Finland OY Tlf: 0080008250910	Malta Biosimilar Collaborations Ireland Limited Tel.: 0080008250910
Germany Biocon Biologics Germany GmbH Tel: 0080008250910	Netherlands Biocon Biologics France S.A.S Tel: 0080008250910
Estonia Biosimilar Collaborations Ireland Limited Tel: 0080008250910	Norway Biocon Biologics Finland OY Tlf: +47 800 62 671
Greece Biocon Biologics Greece MONOPROSOPI I.K.E Tel.: 0080008250910	Austria Biocon Biologics Germany GmbH Tel: 0080008250910
Spain Biocon Biologics Spain S.L. Tel: 0080008250910	Poland Biosimilar Collaborations Ireland Limited Tel: 0080008250910
France Biocon Biologics France S.A.S Tel: 0080008250910	Portugal Biocon Biologics Spain S.L. Tel: 0080008250910
Croatia Biocon Biologics Germany GmbH Tel: 0080008250910	Romania Biosimilar Collaborations Ireland Limited Tel: 0080008250910
Ireland Biosimilar Collaborations Ireland Limited Tel: 1800 777 794	Slovenia Biosimilar Collaborations Ireland Limited Tel: 0080008250910
Iceland Biocon Biologics Finland OY Sími: +345 800 4316	Slovakia Biocon Biologics Germany GmbH Tel: 0080008250910
Italy Biocon Biologics Spain S.L. Tel: 0080008250910	Finland/Suomi Biocon Biologics Finland OY Puh/Tel: 99980008250910
Cyprus Biosimilar Collaborations Ireland Limited Tel: 0080008250910	Sweden Biocon Biologics Finland OY Tel: 0080008250910
Latvia Biosimilar Collaborations Ireland Limited Tel: 0080008250910

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for administration of the Yesintek injection

Figure 1 shows what the pre-filled syringe looks like.

Administration instructions

At the beginning of treatment, a healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-inject Yesintek. In this case, you will be trained on how to administer Yesintek injections.

Speak with your doctor if you have any questions about administering the injections.

• Do not mix Yesintek with other injectable liquids.
• Do not shake the pre-filled syringes of Yesintek. The medicine may deteriorate if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

1. Check the number of pre-filled syringes and prepare materials:

Preparation for using the pre-filled syringe

• Remove the pre-filled syringe(s) from the refrigerator. Leave the pre-filled syringe outside the carton for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not remove the needle cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by the barrel with the needle cap pointing upwards.
• Do not hold the syringe by the plunger rod, plunger, needle shield wings, or needle cap.
• Do not pull out the plunger at any time.
• Do not remove the safety shield from the pre-filled syringe.
• Do not remove the needle cap from the pre-filled syringe until instructed to do so.
• Check the pre-filled syringe(s) to ensure:
  • The number of pre-filled syringes and concentration are correct.
  • If your dose is 45 mg, you will have one 45 mg pre-filled syringe of Yesintek. If your dose is 90 mg, you will have two 45 mg pre-filled syringes of Yesintek and will need to administer two injections. Choose two different injection sites (e.g., one in the right thigh and one in the left thigh), and inject one immediately after the other.
  • It is the correct medicine.
  • The expiration date has not passed.
  • The pre-filled syringe is not damaged.
  • The solution in the pre-filled syringe is clear, pale yellow to colorless.
  • The solution does not have an abnormal color, is not cloudy, and does not contain foreign particles.
  • The solution in the pre-filled syringe has not been frozen.
• Place all necessary items on a clean, flat, well-lit surface. Include antiseptic wipes, cotton wool or gauze, and a sharps container.

Storage

Yesintek pre-filled syringes must be stored at a temperature of 2 °C to 8 °C (36 °F to 46 °F) in the original packaging to protect from light until ready for use.

• Do not freeze. Do not shake.
• If necessary, individual pre-filled syringes may be stored at room temperature up to 30 °C (86 °F) for a maximum of 30 days in the original packaging to protect from light.
• Once the syringe has been kept at room temperature, it must not be returned to the refrigerator.
• Discard the syringe if not used within 30 days when stored at room temperature.

Prepare necessary items

Place all necessary items on a clean, flat, well-lit surface. This includes:

• antiseptic wipes
• cotton ball or gauze
• sharps container
• Your prescribed dose of Yesintek injection (See Figure 2)

Figure 2

1. Choose and prepare the injection site:

Choose the injection site (see Figure 3).

• Yesintek is administered by subcutaneous injection (under the skin).
• Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm from the navel.
• Whenever possible, avoid areas of skin showing signs of psoriasis.
• If someone else is administering the injection, the upper arm may also be used as an injection site.

*The blue areas represent recommended injection sites.

Prepare the injection site

• Wash your hands thoroughly with soap and lukewarm water. Do not touch your face or hair after washing your hands.
• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.
• Remove the pre-filled syringe from the cardboard packaging.
• Open the tray by removing the cover. Hold the needle safety shield (as shown in Figure 4) to remove the pre-filled syringe from the tray.

Figure 4

• Hold the pre-filled syringe without removing the needle safety shield, with the needle pointing upwards.

1. Remove the needle cap (see Figure 5):

• The needle cap must not be removed until you are ready to inject.
• Hold the pre-filled syringe and grasp the barrel with one hand.
• Remove and discard the needle cap. Do not touch the plunger while doing this.

Figure 5

• You may see an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle. Both are normal and do not need to be removed.
• Do not touch the needle or allow it to touch any surface.
• Do not use the pre-filled syringe if it has been dropped without the needle cap. If this happens, inform your doctor or pharmacist.
• Inject the dose immediately after removing the needle cap.

1. Administer the dose:

• Hold the pre-filled syringe with one hand between the index and middle fingers, place your thumb on the plunger head, and with the other hand gently pinch a fold of disinfected skin using your thumb and index finger. Do not squeeze tightly.
• Do not pull out the plunger at any time.
• With a single quick motion, insert the needle through the skin as far as it will go (see Figure 6).

Figure 6

Inject the entire medicine by pushing the plunger until the plunger head is completely within the wings of the needle safety shield (see Figure 7).

Figure 7

After pushing the plunger as far as it will go, maintain pressure on the plunger head, withdraw the needle, and release the skin (see Figure 8).

Figure 8

Slowly remove your thumb from the plunger head so that the empty syringe advances until the needle is completely covered by the needle safety shield, as shown in Figure 9:

Figure 9

1. After the injection:

• Press the injection site with an antiseptic wipe for several seconds after the injection.
• A small amount of blood or liquid may appear at the injection site. This is normal.
• You may press cotton wool or gauze against the injection site and hold for 10 seconds.
• Do not rub the skin at the injection site. You may cover the injection site with a bandage if needed.

1. Disposal:

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 10). For your safety and the safety of others, never reuse the syringe. Dispose of your sharps container according to local regulations.
• Antiseptic wipes and other materials may be discarded in regular trash.

Figure 10

Manufactured by:

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

Marketed by:

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate,

Dublin 13, DUBLIN

Ireland, D13 R20R

Reviewed: MM/YYYY