Dupixent 300 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dupixent 300 mg solution for injection in pre-filled syringe

dupilumab

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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. It may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Dupixent is and what it is used for

What Dupixent is

Dupixent contains the active substance dupilumab.

Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a key role in the development of signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), nodular prurigo (NP), eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU).

What it is used for

Dupixent is used to treat adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children aged 6 months to 11 years with severe atopic dermatitis. Dupixent may be used together with eczema medications applied to the skin or may be used alone.

Dupixent is also used, together with other asthma medications, for the maintenance treatment of severe asthma in adults, adolescents, and children aged 6 years and older whose asthma is not controlled with their current medication (e.g., corticosteroids).

Dupixent is also used, together with other medications, for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medication. Dupixent may also reduce the need for surgery and the need for systemic corticosteroids.

Dupixent is also used to treat adults with moderate-to-severe nodular prurigo (NP), also known as chronic nodular prurigo (CNP). Dupixent may be used together with NP medications applied to the skin or may be used alone.

Dupixent is also used to treat adults, adolescents, and children aged 1 year and older, with a minimum body weight of 15 kg, with eosinophilic esophagitis (EoE).

Dupixent is also used, together with other medications, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults with uncontrolled COPD.

Dupixent is also used to treat adults, adolescents, and children aged 2 years and older with moderate-to-severe chronic spontaneous urticaria (CSU) not controlled with antihistamines, who have not received immunoglobulin E (IgE) blockers for their CSU.

How Dupixent works

Using Dupixent for atopic dermatitis (atopic eczema) may improve your skin condition and reduce itching. Dupixent has also shown improvement in pain, anxiety, and depression symptoms associated with atopic dermatitis. In addition, Dupixent helps improve sleep disturbances and overall quality of life.

Dupixent helps prevent severe asthma attacks (exacerbations) and may improve your breathing ability. Dupixent may also help reduce the amount of another group of medications you need to control your asthma, called oral corticosteroids, while preventing severe asthma attacks and improving your breathing ability.

Dupixent helps prevent moderate or severe COPD flare-ups (exacerbations) and may improve your breathing ability. Dupixent may also help improve general COPD symptoms.

Using Dupixent for CSU may improve your skin condition by reducing itching and hives.

2. What you need to know before using Dupixent

Do not use Dupixent

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

If you think you may be allergic, or are unsure, consult your doctor, pharmacist, or nurse before using Dupixent.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Dupixent:

Dupixent is not a rescue medicine and should not be used to treat a sudden asthma or COPD attack.

Each time you receive a new pack of Dupixent, it is important to record the name of the medicine, the date of administration, and the batch number (found on the pack after "Batch") and keep this information in a safe place.

Allergic reactions

• Rarely, Dupixent may cause serious adverse effects, including allergic reactions (hypersensitivity), anaphylactic reaction, and angioedema. These reactions may occur from minutes after administration of Dupixent up to seven days later. While using Dupixent, you should monitor for signs of these conditions (i.e., breathing difficulties, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, lightheadedness (low blood pressure), fever, general feeling of being unwell, swollen lymph nodes, hives, itching, joint pain, skin rash). These signs are listed under "Serious adverse effects" in section 4.
• Stop using Dupixent and tell your doctor or seek immediate medical help if you notice any signs of an allergic reaction.

Eosinophilic conditions

• Rarely, patients taking medication for asthma may develop inflammation of blood vessels or lungs due to an increase in a certain type of white blood cells (eosinophilia).
• It is not known whether this is caused by Dupixent. This usually, but not always, occurs in people who are also taking a steroid medicine that has been stopped or whose dose is being reduced.
• If you experience a combination of symptoms including flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms and/or rash, inform your doctor immediately.

Parasitic infection (intestinal parasites)

• Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic infection, it should be treated before starting treatment with Dupixent.
• Consult your doctor if you have diarrhea, gas, stomach discomfort, greasy stools, or dehydration, which may be signs of a parasitic infection.
• If you live in or are traveling to an area where such infections are common, consult your doctor.

Asthma
If you have asthma and are taking asthma medication, do not change or stop taking your asthma medication without consulting your doctor. Talk to your doctor before stopping treatment with Dupixent or if your asthma is not controlled or worsens during treatment with this medicine.

Eye problems

Talk to your doctor if you develop eye problems or if existing eye problems worsen, including eye pain or changes in vision.

Children and adolescents

• The safety and benefits of Dupixent in children under 6 months of age with atopic dermatitis are not yet known.
• The safety and benefits of Dupixent in children under 6 years of age with asthma are not yet known.
• The safety and benefits of Dupixent in children under 18 years of age with CRSwNP are not yet known.
• The safety and benefits of Dupixent in children under 18 years of age with NP are not yet known.
• The safety and benefits of Dupixent in children under 1 year of age, or with body weight < 15 kg, with EoE are not yet known.
• The safety and benefits of Dupixent in children under 18 years of age with COPD are not yet known.
• The safety and benefits of Dupixent in children under 2 years of age with UC are not yet known.

Other medicines and Dupixent

Tell your doctor or pharmacist

• if you are currently using, have recently used, or might need to use any other medicines.
• if you have recently been vaccinated or need to be vaccinated.

Other asthma medicines

Do not stop or reduce your asthma medicines unless instructed by your doctor.

• These medicines (especially corticosteroids) should be stopped gradually.
• This should be done under the direct supervision of your doctor and depending on your response to Dupixent.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The effects of this medicine in pregnant women are unknown; therefore, it is preferable to avoid using Dupixent during pregnancy unless your doctor advises otherwise.
• If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. Your doctor and you must decide whether to breastfeed or use Dupixent. You should not do both at the same time.

Driving and using machines

It is unlikely that Dupixent will affect your ability to drive or use machines.

Dupixent contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg dose; essentially “sodium-free”.

Dupixent contains polysorbate

This medicine contains 4 mg of polysorbate 80 in each 300 mg dose (2 ml). Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

3. How to use Dupixent

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose of Dupixent you will receive

Your doctor will decide which dose of Dupixent is appropriate for you.

Recommended dose in adults with atopic dermatitis

For patients with atopic dermatitis, the recommended dose of Dupixent is:

• An initial dose of 600 mg (two injections of 300 mg)
• Followed by 300 mg every two weeks by subcutaneous injection.

Recommended dose in adolescents with atopic dermatitis

The recommended dose of Dupixent for adolescents (aged 12 to 17 years) with atopic dermatitis is based on body weight:

Patient body weight	Initial dose	Subsequent doses (every two weeks)
Less than 60 kg	400 mg (two injections of 200 mg)	200 mg
60 kg or more	600 mg (two injections of 300 mg)	300 mg

Recommended dose for children aged 6 to 11 years with atopic dermatitis

The recommended dose of Dupixent for children (aged 6 to 11 years) with atopic dermatitis is based on body weight:

Body weight of the patient	Initial dose	Subsequent doses
15 kg to less than 60 kg	300 mg (one 300 mg injection) on day 1, followed by 300 mg on day 15	300 mg every 4 weeks*, starting 4 weeks after the day 15 dose
60 kg or more	600 mg (two 300 mg injections)	300 mg every two weeks

• The dose may be increased to 200 mg every two weeks according to the physician's judgment.

Recommended dose in children 6 months to 5 years of age with atopic dermatitis

The recommended dose of Dupixent for children 6 months to 5 years of age with atopic dermatitis is based on body weight:

Patient body weight	Initial dose	Subsequent doses
5 kg to less than 15 kg	200 mg (one 200 mg injection)	200 mg every 4 weeks
15 kg to less than 30 kg	300 mg (one 300 mg injection)	300 mg every 4 weeks

Recommended dose in adult and adolescent patients with asthma (12 years of age and older)

For patients with severe asthma who are taking oral corticosteroids or for patients with severe asthma and comorbid moderate-to-severe atopic dermatitis or adults with comorbid severe chronic rhinosinusitis with nasal polyposis, the recommended dose of Dupixent is:

• An initial dose of 600 mg (two 300 mg injections)
• Followed by 300 mg administered every two weeks by subcutaneous injection.

For all other patients with severe asthma, the recommended dose of Dupixent is:

• An initial dose of 400 mg (two 200 mg injections)
• Followed by 200 mg administered every two weeks by subcutaneous injection.

Recommended dose in children with asthma

The recommended dose of Dupixent for children (6 to 11 years of age) with asthma is based on body weight:

Patient body weight	Initial and subsequent doses
15 kg to less than 30 kg	300 mg every 4 weeks
30 kg to less than 60 kg	200 mg every two weeks or 300 mg every 4 weeks
60 kg or more	200 mg every two weeks

For patients aged 6 to 11 years with asthma and coexisting severe atopic dermatitis, your doctor will decide which dose of Dupixent is appropriate for you.

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP)

In CRSwNP, the recommended initial dose of Dupixent is 300 mg, followed by 300 mg every two weeks by subcutaneous injection.

Recommended dose in adults with nodular prurigo (NP)

For patients with nodular prurigo, the recommended dose of Dupixent is:

• An initial dose of 600 mg (two injections of 300 mg)
• Followed by 300 mg administered every two weeks by subcutaneous injection.

Recommended dose in adults, adolescents, and children (from 1 year of age) with eosinophilic esophagitis (EoE)

Body weight	Dosage
≥15 kg to <30 kg	200 mg every two weeks
≥30 kg to <40 kg	300 mg every two weeks
≥40 kg	300 mg every week

Recommended dose in adults with chronic obstructive pulmonary disease (COPD)

In COPD, the recommended dose of Dupixent is 300 mg administered every two weeks by subcutaneous injection.

Recommended dose in adults with chronic spontaneous urticaria (CSU)

The recommended dose of Dupixent for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg administered every two weeks.

Recommended dose in children and adolescents aged 6 to 17 years with chronic spontaneous urticaria (CSU)

The recommended dose of Dupixent for children and adolescents (aged 6 to 17 years) with chronic spontaneous urticaria is based on body weight:*

Body weight	Initial dose	Subsequent doses
15 kg to less than 30 kg	300 mg (one 300 mg injection) on day 1, followed by 300 mg on day 15	300 mg every 4 weeks (Q4W), starting 4 weeks after the day 15 dose
30 kg to less than 60 kg	400 mg (two 200 mg injections)	200 mg every two weeks (Q2W)
60 kg or more	600 mg (two 300 mg injections)	300 mg every two weeks (Q2W)

*For patients weighing 5 kg to less than 15 kg, the recommended dose is 200 mg every 4 weeks (Q4W).

Recommended dose in children 2 to 5 years of age with chronic spontaneous urticaria (CSU)

The recommended dose of Dupixent for children (2 to 5 years of age) with chronic spontaneous urticaria is based on body weight:

Body weight	Initial and subsequent dose
5 kg to less than 15 kg	200 mg every four weeks (E4W)
15 kg to less than 30 kg	300 mg every four weeks (E4W)

Dupixent Injection

Dupixent is administered by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide whether you should inject Dupixent yourself.

Before self-injecting Dupixent, you must be properly trained by your doctor or nurse. Your Dupixent injection may also be administered by a caregiver after appropriate training by a healthcare professional. Each pre-filled syringe contains one dose of Dupixent (300 mg). Do not shake the pre-filled syringe. Carefully read the “Instructions for Use” included at the end of the leaflet before using Dupixent.

If you use more Dupixent than you should

If you use more Dupixent than you should, or if you have administered the dose too soon, consult your doctor, pharmacist, or nurse.

If you forget to use Dupixent

If you have forgotten to inject a dose of Dupixent, consult your doctor, pharmacist, or nurse.

Additionally,

If your dosing schedule is every week and you miss a dose of Dupixent:

• administer the Dupixent injection as soon as possible and start a new weekly dosing schedule from the time you remember your missed injection.

If your dosing schedule is every two weeks and you miss a dose of Dupixent:

• administer the Dupixent injection within 7 days of the missed dose, then continue with your original schedule.
• if the missed dose is not administered within 7 days, wait until the next scheduled dose to administer your Dupixent injection.

If your dosing schedule is every 4 weeks and you miss a dose of Dupixent:

• administer the Dupixent injection within 7 days of the missed dose, then continue with your original schedule.
• if the missed dose is not administered within 7 days, start a new dosing schedule every 4 weeks from the time you remember your missed injection.

If you stop treatment with Dupixent

Do not stop treatment with Dupixent without first discussing it with your doctor.

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

4. Possible adverse effects

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

Dupixent may cause serious adverse effects, including rare allergic reactions (hypersensitivity), such as anaphylactic reaction, serum sickness, serum sickness-like reaction; signs may include:

• breathing problems
• swelling of the face, lips, mouth, throat or tongue (angioedema)
• fainting, dizziness, feeling faint (low blood pressure)
• fever
• general feeling of discomfort
• swollen lymph nodes
• hives
• itching
• joint pain
• skin rash

If you develop an allergic reaction, stop using Dupixent and contact your doctor immediately.

Other adverse effects

Frequent (may affect up to 1 in 10 people):

• injection site reactions (e.g., localized redness, swelling, itching, pain, bruising)
• redness and itching of the eyes
• eye infection
• herpes (of the lips and skin)
• an increase in a certain type of white blood cells (eosinophils)
• joint pain (arthralgia)

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

• swelling of the face, lips, mouth, throat or tongue (angioedema)
• itching, redness and swelling of the eyelids
• inflammation of the surface of the eye, sometimes with blurred vision (keratitis)
• facial rash or redness
• dry eyes

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

• severe allergic reactions (hypersensitivity)
• ulcers in the outer transparent layer of the eye, sometimes with blurred vision (ulcerative keratitis)

Additional adverse effects in children aged 6 to 11 years with asthma

Frequent: pinworm infection (enterobiasis)

Reporting of adverse effects

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

5. Storage of Dupixent

Keep this medicine out of the sight and reach of children.

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.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep in the original packaging to protect from light.

If necessary, the pre-filled syringe may be removed from the refrigerator and stored in its packaging at room temperature up to 25 °C for a maximum of 14 days, protected from light. The date when it was removed from the refrigerator should be recorded in the space provided for this purpose on the outer carton. The carton must be discarded if it has been kept outside the refrigerator for more than 14 days or if the expiry date has passed.

Do not use this medicine if you notice that the solution is cloudy, discolored, or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dupixent

• The active substance is dupilumab.
• Each pre-filled syringe contains 300 mg of dupilumab in 2 ml of injectable solution.
• The other components are L-arginine monohydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sodium acetate trihydrate, glacial acetic acid (E 260), sucrose, and water for injections.

Nature and contents of the container

Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a pre-filled glass syringe with a needle cap.

Dupixent is available as 300 mg pre-filled syringes in packs containing 1 or 2 pre-filled syringes, or in a multiple pack containing 6 (3 packs of 2) pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

SANOFI WINTHROP INDUSTRIE

1051 Boulevard Industriel,

76580 LE TRAIT,

France

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40
	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium)
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111	Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996 Tel. from abroad: +49 69 305 70 13	Netherlands Sanofi B.V. Tel: + 31 20 245 4000
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece Sanofi-Aventis Monoprosopi EPE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00	Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00
France Sanofi Winthrop Industrie Tel: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Iceland Vistor ehf. Sími: +354 535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italy Sanofi S.r.l. Tel: 800 536389	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50

Date of last review of this leaflet:

Other sources of information

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

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Dupixent 300mg solution for injection in pre-filled syringe with needle guard

dupilumab

Instructions for use

The drawing below shows the parts of the Dupixent pre-filled syringe with needle guard.

Important information

This device is a single-use pre-filled syringe. It contains 300 mg of Dupixent for injection under the skin (subcutaneous injection).

Do not attempt to give the injection to yourself or another person unless you have been trained by your healthcare professional. In adolescents aged 12 years and older, Dupixent is recommended to be administered by or under the supervision of an adult. In children under 12 years of age, Dupixent should be administered by a caregiver.

• Read all instructions carefully before using the syringe.
• Check with your healthcare professional how often the medicine should be injected.
• Ask your healthcare professional to show you how to use the syringe correctly before using it for the first time.
• Change the injection site each time you give the injection.
• Do not use the syringe if it has been dropped on a hard surface or if it has been damaged.
• Do not use the syringe if the needle cap is missing or not properly attached.
• Do not touch the plunger rod until you are ready for the injection.
• Do not inject through clothing.
• Do not try to remove air bubbles from the syringe.
• To help prevent accidental needle injuries, each pre-filled syringe comes with a needle guard that automatically activates to cover the needle after the injection has been administered.
• Never pull back on the plunger rod.
• Do not reuse the syringe.

Storage of Dupixent

• Keep the syringe(s) out of the reach of children.
• Keep unused syringes in their original packaging and store them in the refrigerator at 2 °C to 8 °C.
• Do not keep Dupixent at room temperature (< 25 °C) for more than 14 days. If you need to remove the pack from the refrigerator permanently, write the date you removed it in the space provided on the outer carton, and use Dupixent within the following 14 days.
• Do not shake the syringe at any time.
• Do not heat the syringe.
• Do not freeze the syringe.
• Do not expose the syringe to direct sunlight.

Step 1: Remove

Remove the syringe from the pack by holding it in the middle of the syringe barrel.

Do not remove the needle cap until you are ready for the injection.

Do not use the syringe if it has been dropped on a hard surface or if it has been damaged.

Step 2: Prepare

Make sure you have the following:

• the Dupixent pre-filled syringe
• 1 alcohol wipe*
• 1 cotton ball or gauze*
• a sharps disposal container* (see Step 12)

*Items not included in the pack

Check the label:

• Verify the expiration date.
• Confirm you have the correct medicine and dose.

Do not use the syringe if the expiration date has passed.

Do not store Dupixent at room temperature for more than 14 days.

Step 3: Check

Look at the medicine through the viewing window of the syringe:

Ensure the liquid is clear and colourless to pale yellow.

Note: It is possible to see an air bubble, which is normal.

Do not use the syringe if the liquid is cloudy or discoloured, or if it contains flakes or particles.

Step 4: Wait 45 minutes

Place the syringe on a flat surface for at least 45 minutes and allow it to reach room temperature naturally.

Do not heat the syringe in a microwave, hot water, or direct sunlight.

Do not expose the syringe to direct sunlight.

Do not keep Dupixent at room temperature for more than 14 days.

Step 5: Choose

Select the injection site.

• You may inject the medicine into your thigh or abdomen (belly), avoiding the area within about 5 cm around your navel.
• If someone else is giving you the injection, they may also inject into the upper arm.
• Change the injection site each time you give the injection.

Do not administer the injection into sensitive, damaged, bruised, or scarred skin.

Step 6: Clean

Wash your hands.

Clean the injection site with an alcohol wipe.

Allow the skin to dry before proceeding with the injection.

Do not touch the injection site again or blow on it before the injection.

Step 7: Remove

Hold the syringe in the middle of the barrel with the needle pointing away from you and remove the needle cap.

Do not recap the needle.

Do not touch the needle.

Inject the medicine immediately after removing the needle cap.

Step 8: Pinch

Pinch a fold of skin at the injection site, as shown in the drawing.

Step 9: Insert

Insert the needle fully into the skin fold at an angle of approximately 45°.

Step 10: Push

Release the skin pinch.

Slowly and steadily push the plunger rod down until it stops and the syringe is empty.

Note: You may feel slight resistance, which is normal.

Step 11: Release and Remove

Lift your thumb to release the plunger rod until the needle is covered by the needle guard, then remove the syringe from the injection site.

If you see a small amount of blood, gently press on the injection site with a cotton ball or gauze.

Do not recap the needle.

Do not rub the skin after the injection.

Step 12: Dispose

Dispose of the syringe and needle cap in a sharps disposal container.

Do not recap the needle.

Always keep the container out of reach of children.